Standards Interpretation Frequently Asked Questions (FAQs)
Manual: Advanced DSC - Acute Stroke Ready Hospital
A staff member competent to perform each test, as defined by each organization, should complete the dysphagia screen.
The National Institutes of Health Stroke Survey (NIHSS) is an appropriate assessment tool used to determine the neurological status of a stroke patient. ֱ does require that a full NIHSS assessment be performed on all patient who receive tissue plasminogen activator(t-pa) but does not prescribe use of other neurological assessment scales or tools. Organizations need to determine which assessment tools will be utilized based on selected Clinical Practice Guidelines. The organization should also define the parameters for assessing and by whom the assessments will be conducted.
An Emergency Department physician can order tissue plasminogen activator. It is required that Emergency Department physicians be knowledgeable of the indications for and contraindications of IV thrombolytic therapy.
No. The Primary Stroke Center is not required to have a neurosurgeon. However, there must be a referral mechanism in place to provide for neurosurgical care within two hours.
Professional recommendations support the use of dysphagia screenings in all stroke patients. It would be up to the organization to determine which type of dysphagia screening would be best used in the stroke patient population and how that would be implemented in a standardized manner throughout the organization.
Patient satisfaction tools and post discharge phone surveys may be methods used to evaluate patient perception of care. Program-specific perception of care, for example, may be obtained through a stroke patient-specific satisfaction survey that is not related to a survey of the general nursing unit where the patient received care. Organizations may also collect program specific information through informal processes such as during administrative rounding and stroke support group interactions.
ֱ does not require organizations to use Get With The Guidelines to meet the requirement for participation in a stroke registry.
Yes, an organization can develop additional, non-standardized performance measures if it chooses to do so; however, it must collect data for all standardized stroke measures mandated by ֱ. Non-standardized measures and data elements selected by an organization cannot be used to replace data collection and reporting for the standardized stroke measures.
is a product of the American Heart Association / American Stroke Association designed as a data collection tool and database that helps ensure continuous quality improvement of acute stroke treatment and stroke prevention. The Joint Commission Stroke PMT® corresponds with the numerator and denominator statements for stroke performance measures as prescribed by ֱ. Joint Commission's data element definitions and definitions used by GWTG have also been aligned in the Joint Commission Stroke PMT®.
Yes. Four months of data for each of the stroke measures is required at the time of initial certification review and the organization must be able to demonstrate the ability to collect and analyze its data.
No. The performance measure is specific to IV thrombolytic.
Quarterly data reporting is required on all standardized measures. Monthly aggregate numerator and denominator values on each of the required Stroke (STK) measures and the Comprehensive Stroke (CSTK) measure must be reported to ֱ on a quarterly basis and are due four months after the close of the calendar quarter.
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital's Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
Patients who present to the Emergency Department with new onset of stroke symptoms would need to be evaluated to determine the time of symptoms onset or last known well. The organization would define in their Clinical Practice Guidelines using evidence based practices, would identify a window for consideration for treatment with tissue plasminogen activator(t-PA). Patients who present within the treatment window, would activate the Acute Stroke Activation Response and would be required to perform the diagnostic brain image (head CT) completed (and results reported to or reviewed by a member of the stroke team) within 45 minutes of it being ordered, when clinically indicated (in acute hemorrhagic or ischemic stroke resuscitation candidates)."
Acute resuscitation or treatment may include evaluation for use of MERCI retrieval device for ischemic stroke, reversible of coagulopathy, surgical intervention, or blood pressure management as evidenced-based approved modalities for hemorrhagic stroke. If in the judgment of the treating physician(s) it is determined that an expedited CT is not required, the rationale for this decision should be documented in the medical record, and the team should proceed accordingly. However, in the event of unknown time of symptom onset, the recommendation would be to treat the patient as a candidate for IV thrombolytic therapy until such time of symptom onset is known.
The time last known well is the time the patient was last known to be without the signs and symptoms of the current stroke or at his or her prior baseline. When the onset of symptoms is clearly witnessed, then the time last known well is identical to the time of symptom onset. Under other circumstances, these terms are not synonymous.
This is acceptable. However, the organization should be prepared to explain the clinical decision-making process in place involving two medical directors, including roles and responsibilities specific to the individuals.
Manual: Advanced DSC - Comprehensive Stroke
A staff member competent to perform each test, as defined by each organization, should complete the dysphagia screen.
CEUs to meet the education requirements for Certified Stroke Centers can include any education regarding the physiology or care of the stroke patient. Examples include NIHSS certification, education regarding neurologic assessment, care of the ischemic or hemorrhagic stroke patient.
If your organization performs mechanical thrombectomies, then education regarding the procedure or care of the patient pre or post-procedure is acceptable. The same is true if your organization cares for subarachnoid hemorrhage patients. If you have a question regarding a specific education module, please contact your Account Executive who can assist you.
- Core stroke team members,as defined by the organization, are required tohave 8 hours of stroke education annually.
- ED nurses, as identified by the organization, are required to have 2 hours of education on cerebro-vascular disease annually.
- Non-nursing ED staff, for example, Physician Assistants, EKG/Respiratory Care Technicians, Imaging/Laboratory staff, etc., as identified by the organization, arerequired tohave 2 hours of education on cerebrovascular disease annually.
- Nurses (other than ED) caring for comprehensive stroke patients as identified by the organization, are required to have 8 hrs. of stroke education annually. Examples may include, but not limited to: nurses providing stroke care in the stroke unit, ICU that contains the dedicated neuro-intensive care beds forcomplex stroke patients, endovascular catheterization laboratory, patient care units, a rehabilitation unit, etc.
The National Institutes of Health Stroke Survey (NIHSS) is an appropriate assessment tool used to determine the neurological status of a stroke patient. ֱ does require that a full NIHSS assessment be performed on all patient who receive tissue plasminogen activator(t-pa) but does not prescribe use of other neurological assessment scales or tools. Organizations need to determine which assessment tools will be utilized based on selected Clinical Practice Guidelines. The organization should also define the parameters for assessing and by whom the assessments will be conducted.
An Emergency Department physician can order tissue plasminogen activator. It is required that Emergency Department physicians be knowledgeable of the indications for and contraindications of IV thrombolytic therapy.
Professional recommendations support the use of dysphagia screenings in all stroke patients. It would be up to the organization to determine which type of dysphagia screening would be best used in the stroke patient population and how that would be implemented in a standardized manner throughout the organization.
Patient satisfaction tools and post discharge phone surveys may be methods used to evaluate patient perception of care. Program-specific perception of care, for example, may be obtained through a stroke patient-specific satisfaction survey that is not related to a survey of the general nursing unit where the patient received care. Organizations may also collect program specific information through informal processes such as during administrative rounding and stroke support group interactions.
ֱ does not require organizations to use Get With The Guidelines to meet the requirement for participation in a stroke registry.
Yes, an organization can develop additional, non-standardized performance measures if it chooses to do so; however, it must collect data for all standardized stroke measures mandated by ֱ. Non-standardized measures and data elements selected by an organization cannot be used to replace data collection and reporting for the standardized stroke measures.
is a product of the American Heart Association / American Stroke Association designed as a data collection tool and database that helps ensure continuous quality improvement of acute stroke treatment and stroke prevention. The Joint Commission Stroke PMT® corresponds with the numerator and denominator statements for stroke performance measures as prescribed by ֱ. Joint Commission's data element definitions and definitions used by GWTG have also been aligned in the Joint Commission Stroke PMT®.
Yes. Four months of data for each of the stroke measures is required at the time of initial certification review and the organization must be able to demonstrate the ability to collect and analyze its data.
No. The performance measure is specific to IV thrombolytic.
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital’s Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
To view FAQs or submit questions specific to performance measures, click here:
Quarterly data reporting is required on all standardized measures. Monthly aggregate numerator and denominator values on each of the required Stroke (STK) measures and the Comprehensive Stroke (CSTK) measure must be reported to ֱ on a quarterly basis and are due four months after the close of the calendar quarter.
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital's Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
Patients who present to the Emergency Department with new onset of stroke symptoms would need to be evaluated to determine the time of symptoms onset or last known well. The organization would define in their Clinical Practice Guidelines using evidence based practices, would identify a window for consideration for treatment with tissue plasminogen activator(t-PA). Patients who present within the treatment window, would activate the Acute Stroke Activation Response and would be required to perform the diagnostic brain image (head CT) completed (and results reported to or reviewed by a member of the stroke team) within 45 minutes of it being ordered, when clinically indicated (in acute hemorrhagic or ischemic stroke resuscitation candidates)."
Acute resuscitation or treatment may include evaluation for use of MERCI retrieval device for ischemic stroke, reversible of coagulopathy, surgical intervention, or blood pressure management as evidenced-based approved modalities for hemorrhagic stroke. If in the judgment of the treating physician(s) it is determined that an expedited CT is not required, the rationale for this decision should be documented in the medical record, and the team should proceed accordingly. However, in the event of unknown time of symptom onset, the recommendation would be to treat the patient as a candidate for IV thrombolytic therapy until such time of symptom onset is known.
The time last known well is the time the patient was last known to be without the signs and symptoms of the current stroke or at his or her prior baseline. When the onset of symptoms is clearly witnessed, then the time last known well is identical to the time of symptom onset. Under other circumstances, these terms are not synonymous.
This is acceptable. However, the organization should be prepared to explain the clinical decision-making process in place involving two medical directors, including roles and responsibilities specific to the individuals.
No, a separate neuro-intensive care unit is not required. However, there must be dedicated neuro-intensive care beds with appropriately trained staff available 24 hours a day, 7 days a week for the care of complex stroke patients.
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Senior residents with adequate previous training and experience in cerebrovascular and neurocritical care as determined by the residency program – we recommend review and approval by the director of the residency program and the director of the comprehensive stroke center APNs or PAs with training and experience in cerebrovascular and neurocritical care. Training in cerebrovascular and neurocritical care can be demonstrated through completion of a comprehensive educational program focusing on neurological emergencies. One example of this is Emergency Neurological Life Support (ENLS) certification or equivalent training for providers covering neuro-intensive care beds.
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Senior residents with adequate previous training and experience in cerebrovascular and neurocritical care as determined by the residency program – we recommend review and approval by the director of the residency program and the director of the comprehensive stroke center APNs or PAs with training and experience in cerebrovascular and neurocritical care. Training in cerebrovascular and neurocritical care can be demonstrated through completion of a comprehensive educational program focusing on neurological emergencies. One example of this is Emergency Neurological Life Support (ENLS) certification or equivalent training for providers covering neuro-intensive care beds.
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Senior residents with adequate previous training and experience in cerebrovascular and neurocritical care as determined by the residency program – we recommend review and approval by the director of the residency program and the director of the comprehensive stroke center APNs or PAs with training and experience in cerebrovascular and neurocritical care. Training in cerebrovascular and neurocritical care can be demonstrated through completion of a comprehensive educational program focusing on neurological emergencies. One example of this is Emergency Neurological Life Support (ENLS) certification or equivalent training for providers covering neuro-intensive care beds.
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Senior residents with adequate previous training and experience in cerebrovascular and neurocritical care as determined by the residency program – we recommend review and approval by the director of the residency program and the director of the comprehensive stroke center APNs or PAs with training and experience in cerebrovascular and neurocritical care. Training in cerebrovascular and neurocritical care can be demonstrated through completion of a comprehensive educational program focusing on neurological emergencies. One example of this is Emergency Neurological Life Support (ENLS) certification or equivalent training for providers covering neuro-intensive care beds.
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Senior residents with adequate previous training and experience in cerebrovascular and neurocritical care as determined by the residency program – we recommend review and approval by the director of the residency program and the director of the comprehensive stroke center APNs or PAs with training and experience in cerebrovascular and neurocritical care. Training in cerebrovascular and neurocritical care can be demonstrated through completion of a comprehensive educational program focusing on neurological emergencies. One example of this is Emergency Neurological Life Support (ENLS) certification or equivalent training for providers covering neuro-intensive care beds.
The following providers can meet this requirement:
- Physicians with training and experience in cerebrovascular and neurocritical care who have been granted neurocritical care privileges.
- Fellows with training and experience in neurocritical and cerebrovascular care.
Yes. Comprehensive Stroke Centers must be currently participating in patient-centered research that is approved by the Institutional Review Board. However, we recognize that there are fluctuations in activities over the course of a study, and there may be times at the start or the end of a study when no patients are currently enrolled in a protocol or there is a short gap between the end of a study and the start of a new one. The organization should be prepared to speak to any gaps in the process and discuss next steps during the onsite review or during the intra-cycle monitoring call.
Manual: Advanced DSC - Inpatient Diabetes
DSDF.6 EP.1.a The element of performance requires a follow up appointment, but if the diabetes is stable during the inpatient stay and no changes to medication are made during the hospitalization, then the currently scheduled appointment would meet the requirement. The follow up appointment date and time with the physician name noted should be in the discharge instructions to the patient and documented in the record.
In this specific requirement, the diabetes program/the hospital determines who will do the assessment and what glucose targets will trigger the assessment. The intent of this standard is to identify if the food intake or lack of is creating blood glucose levels outside of the established glucose targets. The glucose target targets can be hypoglycemic levels or hyperglycemic levels.
Yes, pre-printed protocols/order sets can be used; however, they need to be individualized per patient if the clinical condition dictates or changes, such as patient receiving steroids who is then tapered off or an elderly patient becomes combative with blood glucose at 79 mg/dl rather than a blood glucose level at 69 mg/dL.
The educational content and activities need to be related to policies, procedures, and management of the diabetic patient. It can be accomplished through Grand Rounds, literature review, and seminars. It does not specifically need to be CE or CEU activity.
The hospital determines how much diabetes specific education the staff members are required to have and how often the diabetes specific education is completed. Element of Performance 7 requires ongoing education to be provided, but the amount is determined by each organization.
No.This would not be required for Gestational Diabetes patients.
Blood Glucose level less than 70 mg/dL.
All episodes of hypoglycemia have to be evaluated for root cause and causes need to be aggregated and analyzed for system issues. The "Topics" library availablefrom our websiteoffers an example of a framework for conducting a root cause analysis.However, this specific framework is not mandated as there are other root cause analysis tools available that may better meet the needs of the organization. The following link will take you to our website whereour tool may be downloaded: Framework for Conducting a Root Cause Analysis and Action Plan
There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
Yes. The Program-Specific Eligibility reads "Acute care hospitals that provide care and services to patients who have a medical history of diabetes – that is, diabetes diagnosed and acknowledged by the treating physician – are eligible for certification under this program …". Diabetes Mellitus diagnosis includes: type 1, type 2 and GDM. Women with preexisting diabetes who are pregnant, have diabetes regardless if they are pregnant.There is one standard where it is identified that it is not applicable to women with gestational diabetes. This standard is DSDF.2 EP.5.a.
All patients admitted to the hospital with a principle diagnosis of Diabetes Mellitus or a past medical history of Diabetes Mellitus or diagnosed with Diabetes Mellitus during the hospital admission are included in the program.
Yes. The pediatric unit within the hospital would be included in the certification review. However, independent freestanding pediatric specialty hospitals are not eligible for Advanced Inpatient Diabetes certification.
The interdisciplinary team consists of a licensed practitioner, registered nurse, pharmacist, dietitian/nutritionist, and a diabetes educator. The diabetes educator does not have to be certified and can be fulfilled by any member of the interdisciplinary team deemed qualified to serve in this role.
Manual: Advanced DSC - Primary Stroke Center
A staff member competent to perform each test, as defined by each organization, should complete the dysphagia screen.
The National Institutes of Health Stroke Survey (NIHSS) is an appropriate assessment tool used to determine the neurological status of a stroke patient. ֱ does require that a full NIHSS assessment be performed on all patient who receive tissue plasminogen activator(t-pa) but does not prescribe use of other neurological assessment scales or tools. Organizations need to determine which assessment tools will be utilized based on selected Clinical Practice Guidelines. The organization should also define the parameters for assessing and by whom the assessments will be conducted.
An Emergency Department physician can order tissue plasminogen activator. It is required that Emergency Department physicians be knowledgeable of the indications for and contraindications of IV thrombolytic therapy.
Professional recommendations support the use of dysphagia screenings in all stroke patients. It would be up to the organization to determine which type of dysphagia screening would be best used in the stroke patient population and how that would be implemented in a standardized manner throughout the organization.
Patient satisfaction tools and post discharge phone surveys may be methods used to evaluate patient perception of care. Program-specific perception of care, for example, may be obtained through a stroke patient-specific satisfaction survey that is not related to a survey of the general nursing unit where the patient received care. Organizations may also collect program specific information through informal processes such as during administrative rounding and stroke support group interactions.
ֱ does not require organizations to use Get With The Guidelines to meet the requirement for participation in a stroke registry.
Yes, an organization can develop additional, non-standardized performance measures if it chooses to do so; however, it must collect data for all standardized stroke measures mandated by ֱ. Non-standardized measures and data elements selected by an organization cannot be used to replace data collection and reporting for the standardized stroke measures.
is a product of the American Heart Association / American Stroke Association designed as a data collection tool and database that helps ensure continuous quality improvement of acute stroke treatment and stroke prevention. The Joint Commission Stroke PMT® corresponds with the numerator and denominator statements for stroke performance measures as prescribed by ֱ. Joint Commission's data element definitions and definitions used by GWTG have also been aligned in the Joint Commission Stroke PMT®.
Yes. Four months of data for each of the stroke measures is required at the time of initial certification review and the organization must be able to demonstrate the ability to collect and analyze its data.
No. The performance measure is specific to IV thrombolytic.
Quarterly data reporting is required on all standardized measures. Monthly aggregate numerator and denominator values on each of the required Stroke (STK) measures and the Comprehensive Stroke (CSTK) measure must be reported to ֱ on a quarterly basis and are due four months after the close of the calendar quarter.
The monthly aggregate values for each of measure must be manually entered into the measure data tables in the Certification Measure Information Process (CMIP) application accessed through the hospital's Joint Commission Connect extranet site. In the alternative, the hospital and its certified program can elect to have its measure data submitted to ֱ electronically through a Joint Commission-listed vendor that supports data collection and reporting for purposes of certification. After contracting with the vendor the hospital must notify ֱ. ֱ will process and analyze the data that are received through a vendor and populate the measure data tables in CMIP with the appropriate aggregate values.
While monthly data are due four months after the close of a calendar quarter, certified programs manually entering the monthly aggregate values for each measure in CMIP may do so at any time. If submitting data through a vendor, it will take approximately two additional weeks for the data to appear in CMIP.
For additional information, click here: Performance Measurement
Patients who present to the Emergency Department with new onset of stroke symptoms would need to be evaluated to determine the time of symptoms onset or last known well. The organization would define in their Clinical Practice Guidelines using evidence based practices, would identify a window for consideration for treatment with tissue plasminogen activator(t-PA). Patients who present within the treatment window, would activate the Acute Stroke Activation Response and would be required to perform the diagnostic brain image (head CT) completed (and results reported to or reviewed by a member of the stroke team) within 45 minutes of it being ordered, when clinically indicated (in acute hemorrhagic or ischemic stroke resuscitation candidates)."
Acute resuscitation or treatment may include evaluation for use of MERCI retrieval device for ischemic stroke, reversible of coagulopathy, surgical intervention, or blood pressure management as evidenced-based approved modalities for hemorrhagic stroke. If in the judgment of the treating physician(s) it is determined that an expedited CT is not required, the rationale for this decision should be documented in the medical record, and the team should proceed accordingly. However, in the event of unknown time of symptom onset, the recommendation would be to treat the patient as a candidate for IV thrombolytic therapy until such time of symptom onset is known.
The time last known well is the time the patient was last known to be without the signs and symptoms of the current stroke or at his or her prior baseline. When the onset of symptoms is clearly witnessed, then the time last known well is identical to the time of symptom onset. Under other circumstances, these terms are not synonymous.
This is acceptable. However, the organization should be prepared to explain the clinical decision-making process in place involving two medical directors, including roles and responsibilities specific to the individuals.
Manual: Ambulatory
ֱ standard for an organization's recovery and continuity of operations is performance based (EM.02.01.01). The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness, the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
The requirements for a Continuity of Operations Plan (COOP) is defined in EM.02.01.01 EP12. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plan, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Volunteer Licensed Practitioners that have been granted disaster privileges may continue to provide care, treatment and services under the disaster privileging option (see EM.02.02.13) for the period of time the organization continues to operate under its Emergency Operations Plan (EOP). Organizations should periodically assess the number and specialty of those volunteer practitioners initially granted disaster privileges to ensure the ongoing needs of the patient population are being met and that the medical staff can maintain oversight over practitioner performance.
If an important patient care need continues at the time the organization discontinues operation of the EOP, the medical staff could either grant temporary privileges or consider granting full privileges.
NOTE: All Credentialing and Privileging must be consistent with applicable law, regulation and medical staff requirements.
Additional Resources:
FAQ: Emergency Management - Requirements for Granting Privileges During a Disaster
FAQ:Credentialing and Privileging - Temporary Privileges
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include but not be limited to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
Someone from the medical staff or physician member and someone from the hospital executive leadership (as opposed to middle management) team should participate in planning activities prior to the development of the Emergency Operations Plan. Medical staff and hospital leadership will be directly involved in the management of an implementation of the emergency operations plan, so their input is essential to establish the expected capabilities and duties of these entities.
It is also important for medical staff and executive leadership to understand the duties and capabilities for the staff that will support the emergency operations plan, and the capabilities of community support entities. Many disaster scenarios involve patient care regarding management of current patients and managing influx of patients. Hospital leaders must understand the command structure and how it functions.
The applicable requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Ambulatory Health Care manual at EM.02.02.13. NOTE: The disaster privileging option ONLY applies when the organization has implemented their emergency management plan.
Licensed Practitioners (LP) currently credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that 'telehealth' be delineated as a separate privilege.
For volunteer Licensed Practitioners that are NOT currently credentialed and privileged by the organization, disaster privileges may be granted to volunteer LPs by following the requirements outlined in the Emergency Management chapter of the accreditation manual.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Additional Resources
FAQ: Emergency Management - Requirements for Granting Privileges During a Disaster
FAQ: Emergency Management – Privileging Requirements When Providing Services via Telehealth Links During a Disaster
The requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Ambulatory Health Care Accreditation Manual at EM.02.02.13.Disaster privileges can only be granted to volunteer licensed practitioners when the organization's Emergency Operations Plan has been activated. A disaster is an emergency that, due to its complexity, scope, or duration, threatens the organization's capabilities and requires outside assistance to sustain patient care, safety, or security functions. Providing outpatient elective surgery or treating non-life-threatening illness wouldNOTapply.
Before granting emergency privileges, the organization must:
- A current picture identification card from a health care organization that clearly identifies professional designation
- A current license to practice
- Primary source verification of licensure. NOTE: Primary source verification of licensure occurs as soon as the disaster is under control or within72 hours from the time the volunteer licensedpractitioner presents him- or herself to the organization, whichever comes first.(see also EM.02.02.13 EP 8 & 9 for additional information).
- Identification indicating that the individual is a member of a Disaster Medical Assistance Team (DMAT), the Medical Reserve Corps (MRC), the
- Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), or other recognized state or federal response organization or group
- Identification indicating that the individual has been granted authority by a government entity to provide patient care, treatment, or services in disaster circumstances
- Confirmation by a licensedpractitioner currently privileged by the organization or by a staff member with personal knowledge of the volunteer practitioner's ability to act as a licensedpractitioner during a disaster
The medical staff must have a process in place to oversee the performance of each volunteer LP. Based on its oversight of each volunteer licensed practitioner, the organization determines, within 72 hours of the practitioner's arrival, if granted disaster privileges should continue.
Note: The requirements for assigning disaster responsibilities to volunteer practitioners who are NOT licensed practitioners, but who are required by law and regulation to have a license, certification, or registration, are found in Ambulatory Health Care Accreditation manual at EM.02.02.15. Examples of such practitioners may include, but are not limited to: Nurses, Physician Assistants, Nurse Practitioners, Respiratory Therapists, etc.
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or in their absence thelatest edition ofFGI Guidelines for the Design and Construction of Outpatient Facilities.
The FGI Guidelines documents state "the number and placement of both hand-washing stations and hand sanitation dispensers shall be determined by the ICRA." (Section 2.1-7.2.2.8) The ICRA or infection control risk assessment, which should be done at the programming stage of the project and should help guide the decisions on where to locate them. The individual facility chapters, though, have additional specific requirements for hand washing stations in certain locations. For example, each exam or treatment room is required to have one.
Additional Resources:
To access a read only copy of the FGI Guidelines for Design and Construction of Outpatient Facilities the hyperlink is provided here for your convenience:
Reference EC.02.06.05 EP1
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2010 edition of NFPA 10 Standard for Portable Fire Extinguishers which is a mandatory reference in chapter 2 of the 2012 edition of NFPA 99, Healthcare Facilities Code.
The organization is expected to determine and select an appropriate fire extinguisher based upon a site-specific risk assessment that would include but not limited to:
- potential fire size
- types of fuels present
- sources of ignition
- flammable skin prep products
- potential for chemical reactions with the extinguishing agent
- presence of electrical equipment
According to the NFPA, a water-mist or carbon dioxide extinguisher may be used in the OR. Water mist-extinguishers are rated Class 2A:C. ECRI Institute has published information that water-mist fire extinguishers may not be appropriate in the operating room due to infection control concerns if used on a patients open surgical site cavity. Alternatively, a close-by basin of sterile water with a sponge to quench a surgical site fire might be most appropriate.
Carbon dioxide extinguishers are rated Class B and Class C, and can also be used for Class A fires.
Electrical fires or Class C, once the equipment is unplugged and de-energized, the fuel source is considered to be either a class A or B, allowing a carbon dioxide extinguisher to be utilized.
Additional Resources
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
- Each facility should develop policies about the specific frequency and methods for wall box surface disinfection
- Wall box surfaces should be disinfected at least daily
- Cleaning and disinfection of the wall box should be performed after the patient has left the station
- Disinfectant should be applied to all surfaces of the wall box and any attached hoses
- Ensure high touch surfaces (e.g., connections for acid, bicarbonate, and reverse osmosis water) are disinfected
- Wipes or other supplies used to disinfect the wall box should be discarded after use and not used to disinfect other surfaces in the dialysis station
- More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
Yes. Freestanding emergency departments accredited under the Ambulatory Care Accreditation Program must comply with the emergency department recommendations.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
If your organization is using ֱ accreditation process for deemed status purposes, then all medical equipment is required to be included in the written inventory.
The written inventory identifies high-risk devices. High-risk medical equipment includes all life support equipment and any other device for which there is a risk of serious injury or death to a patient or staff member should it fail. The term high-risk equipment is equivalent in scope and nature to the CMS term critical equipment.
Maintenance activities and frequencies follow manufacturers' instructions and recommendations for maintaining, inspecting, and testing all medical equipment in the inventory. These maintenance activities and frequencies, including an alternative equipment maintenance (AEM) strategy, are documented in writing.
The alternative equipment maintenance (AEM) strategy program must not reduce safety and is based on accepted standards of practice such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of maintenance and run-to-fail strategies.
AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers' recommendations:
- Equipment subject to federal or state law or Medicare Conditions of Participation
- Imaging and radiologic equipment (diagnostic or therapeutic)
- Medical LASER devices
- New medical equipment with insufficient maintenance history to support the use of an AEM strategy
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
The labeling shall include:
- the name or chemical symbol for the specific medical gas or vacuum system
- room or areas served
- caution to not close or open the valve except in an emergency
Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its hidden location may be identified by a label, icon, etc., or on a utility system map in accordance with EC.02.05.01 EP 17.
Reference EC.02.05.09 EP11
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
ֱ references NFPA 99-2012 Chapter 9, that requires the use of ASHRAE 170-2008, Ventilation Table 7-1. This document provides allowances to exceed minimum temperature ranges. To use this exception, it must be done by following the established organizational policy. In accordance with the allowances, the policy or formal process must be limited to cases based on either surgeon, patient, or procedure. It is not acceptable to consistently maintain temperatures outside of the required ranges.
Reference EC.02.05.01 EP 15
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
ֱ standards are not prescriptive regarding testing frequencies for piped medical gas and vacuum systems. The facility may determine its testing frequency by policy and the surveyor will evaluate testing based on that policy.
In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and reliable condition.
The organization is required by EC.02.05.01 to develop a maintenance strategy based upon either manufacturer's recommendations or an alternative equipment maintenance (AEM) strategy. Piped medical gas and vacuum systems are considered high-risk utility systems.
Issues such as system complexity, system age/condition, patient acuity, etc. are to be used to assess maintenance strategies. NFPA 99-2012 Appendix B can be used as a guide for establishing a maintenance strategy, but appendix material is not required unless adopted by a controlling authority. The survey process will evaluate the maintenance strategy assessment process for effectiveness and validate that it has been properly implemented.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
- applicable staff
- type of training
- level of training
- required credentials
The security management plan may be a stand-alone document or may be combined with other Environment of Care plans (one overarching plan or combined with another, such as the safety management plan, for instance). Components of the plan are outlined in EC.02.01.01 EPs, which include but not limited to:
- how will security risks be assessed and mitigated
- staff roles in security management
- how the facility is secured
- how the organization contact external security forces if needed
- how the organization will control access to areas identified as security sensitive
- how physical or verbal threats, acts of violence, inappropriate behavior will be managed
- If the organization has an MRI, there is to be an assessment for safety and security risk that addresses patient comfort and safety, equipment safety and security, and staff safety
Any requirements from the local authority having jurisdiction (AHJ) are expected to be followed.
Reference:
EC.01.01.01 EP 5
EC.02.01.01.
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
Specific to expiration dating and discarding unused food, organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable law/regulation that may be defined by your local authority having jurisdiction (i.e., local or state health department, etc.).
Specific to expiration dating and discarding unused food, organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable law/regulation that may be defined by your local authority having jurisdiction (i.e., local or state health department, etc.).
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Surveillance is another form of security, the risk assessment can consider proximity to continuously staffed areas such as nurse stations, to monitor persons attempting to enter the room.
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Surveillance is another form of security, the risk assessment can consider proximity to continuously staffed areas such as nurse stations, to monitor persons attempting to enter the room.
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Surveillance is another form of security, the risk assessment can consider proximity to continuously staffed areas such as nurse stations, to monitor persons attempting to enter the room.
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore, some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
For ambulatory surgical centers and outpatient surgical departments that use ֱ deemed status option, that were constructed, or had a change in occupancy type, or have undergone an electrical system upgrade since 1983, a Type 1 or Type 3 essential electrical system is required as defined in the 2012 edition of NFPA 99.
This essential electrical system must be divided into three branches, including the:
- life safety branch
- critical branch
- equipment branch
Type 1 essential electrical system is required for:
- Critical care areas are those special care units in which patients are intended to be subjected to invasive procedures using electrical patient care medical equipment. Type 1 systems should be installed where there would be a risk of death or serious injury to the patient in the event of power failure.
- To supply emergency power in facilities that do not provide electrical life support or use general anesthesia. Type 3 systems are permitted where equipment failure is less critical to human life and safety.
Additional Resources:
EC.02.05.03
NFPA 99-2012: 6.3.2.2.10, 6.4.1, 6.4.2.2, 6.6.3
CMS S&C 07-21
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
ֱ standard EC.02.05.01 EP 15 references NFPA 99-2012, which includes ANSI/ASHRAE/ASHE Standard 170-2008, or state design requirements if more stringent for temperature, pressure, and humidity requirements. This applies to hospital and outpatient facilities that were built, altered, or renovated after July 5, 2016. This document states that soiled workroom shall be negative with a temperature between 72-78 degrees Fahrenheit and no humidity requirement. The Clean workroom shall be positive, with temperature between 72-78 and a maximum relative humidity of 60%. For existing facilities (prior to July 5, 2016), you may comply with either these requirements, or the requirements that were in effect at the time of construction. In existing one-room layouts, the air flow within the room shall be from clean to dirty (with negative air flow overall).
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list toStandard 170-2008 Ventilation of Health Care Facilities.
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
The definition of a peer (see HR 02.01.03 EP 6) is someone from the same discipline. For example, physicians for physicians, dentists for dentists, podiatrists for podiatrists, etc. It does not have to be someone in the same specialty (orthopedist, etc.).
To be able to provide a recommendation, the peer must be familiar with the individual's actual performance. For a nurse practitioner, physician assistant, psychologist or social worker, ideally, this would be an individual from the same discipline. Therefore, the organization should attempt to obtain such recommendations. This could be an individual from within the same organization or someone from outside the organization. The organization determines the number of required peer recommendations.
In situations where there is no nurse practitioner, physician assistant, psychologist, or social worker to provide a peer recommendation, it is acceptable for a physician with like qualifications that is familiar with the practitioner's performance, to provide the recommendation. For example, an internist could provide a recommendation for a physician assistant, an anesthesiologist for a nurse anesthetist, a psychiatrist for a psychologist, and a psychologist, with similar responsibilities, could provide a recommendation for a social worker.
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and privileged. Compliance with the organization's process for monitoring a practitioner's professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LP who was asked to evaluate a patient and provide consultation, by way of an order from another LP. The consultant's findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
ֱ requires that organizations verify the identity of the applicant by viewing one of the following:
- A current picture organizational ID card
- A valid picture ID issued by a state or federal agency (for example, a driver's license or passport)
- Identity Assurance Level 2 (IAL2) credentials may be used as defined by the US Government's National Institute of Standards and Technology (NIST). The requirements to meet this standard are outlined in NIST Special Publication 800-63.
- To pick up the application
- For an interview by the department chair
- When arriving to first provide services
- When having their photo ID badge picture taken
- Use of a telecommunications link that includes both audio and video capabilities
If the verification is performed at a remote location, then the confirmation of the verification should be forwarded to the credentialing office for inclusion in the credentials file.It isNOT required or recommended that a copy of the photo ID be taken or placed in the credentials files due to potential for identity theft.
If the applicant provides only a copy of the photo ID, or a notarized document indicating the identity was verified by another entity, it would not satisfy the requirement for verification.
For telehealth service providers only
Applicant identity verification may be completed offsite at the distant (provider) location, as the practitioner never comes onsite where the patient is located. The organization determines the process for verifying practitioner identity.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Additional Resources
FAQ: Emergency Management - Requirements for Granting Privileges During a Disaster
FAQ: Emergency Management – Privileging Requirements When Providing Services via Telehealth Links During a Disaster
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
ֱ's,expectation is thatthe organization is aware of anyoneentering the organizationand their purpose in order to maintain patient safety. Leadership is responsible to ensure that the processes are in place and implemented to ensure patient privacy and safety.
For non-licensed, non-employees that have a direct impact on patient care. E.g. HCIRs or Vendorsin procedure rooms/operating rooms providing guidance to the surgeon or staff, trainingof staff on equipment use, surgical assistants brought in by surgeons additional requirements include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information, as well as obtaining informed consent in accordance with organization policy and law/regulation.
- Awareness of applicable infection control and patient safe processes/procedures.
- For non-employees brought into the organization by licensedpractitioners,organizations must also addressqualifications, competency and performance evaluation.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB.
There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB.
There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB.
There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates
Reappointment/re-privileging is due no later than three^ years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter. For example, if the reappointment period is July 1, 2021 through June 30, 2024, the reappointment date would be July 1, 2024.
Governing Body Approval Dates
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in June, the board would approve all July reappointments/reprivileging effective periods and in July the board would be approving all August reappointments/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
^ Additional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame. The change will also be reflected in a future release date of the accreditation manuals.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master’s Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master’s Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master’s Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as ‘paper’ or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master's Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as 'paper' or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)." The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence thatprimary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the Ambulatory accreditation manual at HR 02.01.03 EP 3,(for training) EP 4 (for license) Also HR 02.01.05 EP 2 for Temporary privileges.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Joint Commission standards require that when developing infection prevention and control activities, the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert consensus. The is published by the CDC's Healthcare Infection Control Practice Advisory Committee (HICPAC).
Recommendation V.B.3.b.i. from the HICPAC guideline states, "Wear a gown whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient. Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment."
Joint Commission surveyors will expect healthcare workers to wear a gown if their "clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient". The difficulty lies in "anticipating" when this may occur. For example, it is very probable that a nurses' aide preparing to perform a bed bath will have contact as described above, and therefore a gown would be expected. However, one of a large group of residents performing rounds with an attending physician would have a lower likelihood of clothing contamination.
Each organization may decide what guidance to provide to its healthcare workers within the parameters provided by HICPAC. However, ֱ would encourage organizations to consider the high morbidity and mortality of healthcare-associated infections in our nation when deciding what constitutes "anticipated contact" in each facility. Additionally, organizations may want to discourage non-essential personnel from entering the rooms of patients on isolation precautions.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensedpractitioners, screenings must be made available in some cases, but each organization may decide whether these screenings are mandatory if not required by state law/local regulatory requirements. The health status of an applicant for medical staff privileges is also addressed in the HR chapter (AHC, OBS) or MS chapter (HAP and CAH).
- Treatment or referral must be initiated if the organization becomes aware of any individual, including non- employed physicians and other licensedpractitioners, who "have, or are suspected of having, an infectious disease that puts others at risk".(Action is needed only if the organization becomes aware of such an exposure).
- Treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, who "have been occupationally exposed to an infectious disease". (Action is needed only if the organization becomes aware of such an exposure).
- The use of evidence-based national guidelines, such as the CDC, or, in the absence of such guidelines, expert consensus to develop an organizational plan for developing guidelines to prevent disease transmission in healthcare settings.
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
Any examples are for illustrative purposes only.
Immediate-Use Steam Sterilization (IUSS), formerly termed "flash" sterilization, is described as "the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field". IUSS items are not intended to be stored for future use.
Considerations for IUSS
- Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the IFUs regarding cycle type, temperature setting, exposure time, and drying times.
- IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
- Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
- IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
Evidence-based guidelines should be adopted to minimize the use of IUSS.Scenarios when IUSS may be appropriate include:
- When a specific instrument is needed for an emergency procedure.
- When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
- When an item has dropped on the floor and is needed to continue a surgical procedure.
- When 'loaner' trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery occurssufficiently in advance of scheduled case(s)to allow complete reprocessing of trays by the organization.Such a requirement is an example of a performance expectation to include in a contract (seeLD.04.03.09).
- Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
- Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
- Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
- Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
- Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
- When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care.
- Ensure that sterilization practices, in all locations, have been fully incorporated into the organization's Quality Assessment Performance Improvement (QAPI) activities.
- Evaluate the IUSS process in all locations that it is being performed.Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization.
Resources
- The Association for Professionals in Infection Control and Epidemiology (APIC)
- The Association of periOperative Registered Nurses (AORN)
- The Association for the Advancement of Medical Instrumentation (AAMI).
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
NOTE: This FAQ does not apply to any clothing that has been designated by the organization as personal protective equipment (PPE) as defined by Occupational Safety and Health Department (OSHA): specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.)
ֱ standards do not require employers to launder surgical scrubs or other attire. However, ֱ's Leadership Standard LD.04.01.01 requires health care organizations to adhere to applicable federal (e.g. OSHA), state and local regulations (e.g., licensing requirements), and if deemed, Centers for Medicare and Medicaid Conditions of Participation and/or Conditions of Coverage. The hierarchical approach to infection control standards as described in ֱ Perspectives, April 2019, should be used to guide development of infection control related policies and procedures for laundering surgical scrubs or attire that is not designated as personal protective equipment and is worn in the healthcare setting.
Applicable elements to consider include the following:
- The OSHA Bloodborne Pathogen Standard requires that all clothing, including scrubs and personally owned attire such as uniforms or street clothing, which have been visibly soiled with blood or other potentially infectious materials, be laundered by the employer at no cost to the employee.
- For surgical scrubs, uniforms, or other attire not considered personal protective equipment and which are not visibly contaminated, organizations should determine if there any requirements that the facility provide clean attire to staff to perform their job duties. For example, some states, require that hospitals and ambulatory care facilities provide hospital laundered scrubs for healthcare workers working in the restricted or semi-restricted areas. State requirements may be more stringent and prescriptive than those from OSHA.
- To our knowledge, Center for Medicare and Medicaid Services (CMS) does not have any requirements for laundering surgical attire or uniforms. But as recommended by the Joint Commission and CMS, organizations should consult evidence-based guidelines for best practices and consider their adoption. Examples of guidelines include the Guideline for Surgical Attire (effective July 1, 2019) from the Association for periOperative Nursing (AORN), the AST Guidelines for Best Practices for Laundering Scrub Attire (revised April 14, 2017) from The Association of Surgical Technologists and the Statement on operating room attire (approved July 2016) from the American College of Surgeons.
Additional Resources:
See also the Perspectives®, April 2019, Volume 39, Issue 4 Page 15:Clarifying Infection Control Policy Requirements
No, requirements for managing linen are notdefined within ֱ standards. Organizations are expected to develop their linen cleaning, storage and management requirements in accordance with evidence-based sources, such as the CDC, the National Association of Institutional Linen Management and/or the local or state authority having jurisdiction.
For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be used to store linens on patient-care areas (hallways) must have covers on them during transportation and storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."
If an organization is unsure whether their linen management processes are compliant with such guidelines, conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
The focus of the IC standards is prevention of transmission of infectious disease. If no patient or specimen contact occurs, no transmission is possible. While a risk assessment would not be required, if performed it would reveal no risk at all. As such, no surveillance or reporting would be required, even for staff.
If the organization receives back contaminated equipment, then all IC standards apply.
Please note, however, that interpretive reading services do play a critical role in disease detection and communication. These services bear the responsibility for notification of infectious disease-related results, especially those for which the differential diagnosis might necessitate isolation or public health action. Examples would be a radiology study showing a right upper lobe cavity lesion (suspicious for pulmonary tuberculosis), or mediastinal widening (suspicious for inhalation anthrax). Pathology studies would include those that identify pathogens considered reportable to a public health authority.
Therefore, interpretive reading providers must have clearly defined processes for communication of such results. An agreement should be in place with each organization for which services are provided. It should specify which results are to be communicated urgently, whom should be notified, and in what time frame. It is expected that many organizations will choose to have their infection control practitioner notified in addition to the provider who orders the test.
Employee health programs may or may not be required. If your organization determines that one is not needed, please check with your state's health department or healthcare licensing act, which may have further regulations.
In conclusion, Teleradiology services will only be evaluated for compliance as delineated above. They are encouraged, but not required, to incorporate practices for hand hygiene (please see NPSG.07.01.01).
ֱ does not determine which items are prohibited from a behavioral health setting. Items that are prohibited from use in an organization, due to the risk of harm to self or others, should be determined by the organization.
Source control involves having people wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions and thus reduce the dispersion of droplets from an infected individual.
TheCDC recommendsimplementing source control (use of masks) in a healthcare facility to prevent dispersal of respiratory droplets from known, asymptomatic and pre-symptomatic people with COVID when are high.Compliance with this recommendation should be based upon the organization's assessment, policies/procedures, individual care plans, and applicable state rules or regulations.
When evaluating the updated CDC recommendations for a patient with behavioral health needs, it is important to complete an assessment of the impact that wearing a face covering or mask would have on the safety of a patient(s), staff and visitors. The expectation is for organizations to complete a clinical risk assessment of the individual for possible self-harm or harm to others if they will wear a mask. The organization must have a process to determine if the patient is capable of wearing a face covering, or mask, based on clinical assessment.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
No, there is no requirement that all surgical procedures be included in an organization's surveillance for surgical site infections (SSI). We expect organizations to follow a hierarchical approach when establishing infection surveillance. We would first expect organizations to follow applicable federal and state law and regulation, then if deemed or required by state regulation, to follow CMS requirements. Some states have specified surgical procedures for which surveillance must be performed. If mandated by your state, then the Joint Commission would expect your organization to be compliant to that requirement.
In the absence of federal/state mandates for specific surgical site infection surveillance requirements, organizations may choose to target SSI surveillance based on the results of a risk assessment. If an organization's risk assessment shows that risk is greatest for certain procedures or settings, the surveillance program may be targeted to focus resources on those high-risk procedures. Organizations may wish to consider conducting periodic risk assessments to ensure that the scope of the targeted procedures included in surveillance activities remains current. Conducting a risk assessment is a helpful way of identifying risks associated with various procedures performed. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
The risk assessment should focus on all components of the surgical continuum, including – but not limited to - staff knowledge and competency, adoption of – and compliance with - evidence-based guidelines for reprocessing of instruments, policies and procedures, surgical attire, practitioner engagement, and patient education. Compliance with any state-specific reporting requirements should also be evaluated. From a quality and safety perspective, ensure that surgical procedures performed in all locations have been integrated into the organization-wide quality assessment and performance improvement (QAPI) program.
Additional Resources
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
- A decision that individuals who work in the organization may use any abbreviation, acronym, or symbol that is not on the list of unacceptable abbreviations. However, if multiple abbreviations, symbols, or acronyms exist for the same term, the organization identifies what will be used to eliminate ambiguity.
U,u
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
Note 1: A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
Note 2: The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
ֱ standards require organizations to comply with applicable law and regulation to ensure the privacy and integrity of protected health information (PHI) are maintained. When an organization's staff is not present to monitor medical records storage areas, alternative approaches must be employed to protect privacy and confidentiality of this information. Keeping such information secure when staff is not present generally requires a process that includes a locking mechanism. The use of alternative approaches, such as a signed confidentiality statement in lieu of a locking mechanism, should be thoroughly evaluated by the organization's legal and risk management leadership to determine if such approaches comply with regulatory requirements (CMS, state law/regulation, etc.).
In conclusion, all areas should have a process in place for maintaining the security and integrity of PHI. The adopted processes should be subject to security audits that can identify system vulnerabilities and policy violations. Signed, confidentiality statements alone may not necessarily result in the proper security and integrity of PHI. Additionally, per IM.02.01.03, the hospital must follow their policy regarding security of health information. Such a policy may include who has access to medical records when staff is not present to monitor the records. The policy should also address all areas where medical records are stored.
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(^).
Rules or regulation -States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states "Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas." and "Surgical masks are worn fully covering mouth and nose
Manufacturer instructions for use -Instructions for use of medical equipment or devices may include instructions for particular attire during use.
Evidence-based guidelines and consensus statements -If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
Facility policy -Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization's chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
- In the state of Illinois Hospital and Ambulatory Surgery Center regulations it states in the restricted area, "Cloth head coverings shall be laundered by the hospital. Additional garments shall be completely contained or covered within the scrub attire." According to organizational policy, the facility follows AORN guidelines 1.7.1 "Establish and implement a process for managing personal clothing that may be worn under scrub attire" and 5.3.1 "An interdisciplinary team, including members of the surgical team and infection preventionists, may determine the type of head covers that will be worn at the health care organization." The policy states that staff may wear long sleeve shirts under hospital scrub attire as long as they are not scrubbed into a case and cloth head coverings that they launder at home. This organization could be found out of compliance with Joint Commission standards because organizations must follow state licensing requirements.
- A non-deemed ambulatory surgery center creates a multidisciplinary team to create a dress code policy. They review state regulations, manufacturer instructions for us, and evidence-based guidelines. The team reaches consensus and establish a policy that staff may wear long sleeves shirts under scrub attire and cloth caps may be worn so long as staff are not scrubbed into a case and reference AORN guidelines. The organization would be found in compliance with Joint Commission standards.
Hierarchical approach
- Regulation
- Conditions of Participation
- Manufacturer's Instructions For Use
- Evidence-based Guidelines
- Consensus documents
- Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
patient assessment and reassessment criteria.
* Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Resources:
R3 Report: Pain assessment and management standards for Hospitals
R3 Report: Pain assessment and management standards for Critical Access Hospitals
R3 Report: Pain assessment and management standards for Ambulatory Care
R3 Report: Pain assessment and management standards for Office-based Surgery
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals
ċċċċċ
Each organization determines what educational resources and programs to have readily available to staff and licensed independent practitioners, giving consideration to staff needs, services provided, and patient population served.Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management*, patient assessment and reassessment criteria.
* Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Resources:
R3 Report: Pain assessment and management standards for Ambulatory Care
R3 Report: Pain assessment and management standards for Office-based Surgery
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals
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Each organization determines what educational resources and programs to have readily available to staff and licensed independent practitioners, giving consideration to staff needs, services provided, and patient population served.Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management*, patient assessment and reassessment criteria.
* Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Resources:
R3 Report: Pain assessment and management standards for Ambulatory Care
R3 Report: Pain assessment and management standards for Office-based Surgery
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals
ċċċċċ
Each organization determines what educational resources and programs to have readily available to staff and licensed independent practitioners, giving consideration to staff needs, services provided, and patient population served.Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management*, patient assessment and reassessment criteria.
* Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Resources:
R3 Report: Pain assessment and management standards for Ambulatory Care
R3 Report: Pain assessment and management standards for Office-based Surgery
Sentinel Event Alert Issue 49: Safe use of opioids in hospitals
Providing staff and licensed practitioners with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Leadership responsibilities for developing and monitoring performance improvement activities specific to safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Note: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Providing information to staff and licensed practitioners on available services for consultation and referral of patients with complex pain management needs
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record
NOTE 1: This element of performance is only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
NOTE 2: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Screening vs. assessing pain
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and (re)assessment criteria and procedures are readily available and used appropriately. The approach to assessing pain may differ depending on a patient's age, condition, and ability to understand. For example, different tools are used for pediatric patients compared to adult patients. For an episode of acute pain from an identified cause, brief assessment of pain intensity and characteristics may be sufficient.
Chronic pain generally requires more extensive patient assessment, including various domains of physical and functional impairment. Reassessment is conducted as necessary based on the patient's plan of care or changes in his or her condition.
Educating the patient and family on discharge related to pain management
Pain Assessment and Management Resources
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
Physical Presence
Advance Practice Nurses
Supervision or Collaborative Agreement Requirements
- Joint Commission Resources publishes Environment of Care News (the official TJC environment of care, emergency management and life safety news source), ֱ Perspectives (the official newsletter of TJC), and E-Alerts.
- Accredited organizationsmay access the TJC Leading Practices Library on the intranet.
- Other publications for purchase are available through .
- Frequently Asked Questions for various standards can be found on the .
- For additional detail concerning specific standards, see ֱ Physical Environment Portal (JCPEP), which is a partnership with .
- A helpful source for clarification of terms found in the standards chapters is the Glossary section of the organization's applicable accreditation manual.
- Joint Commission Resources publishes Environment of Care News (the official TJC environment of care, emergency management and life safety news source), ֱ Perspectives (the official newsletter of TJC), and E-Alerts.
- Accredited organizationsmay access the TJC Leading Practices Library on the intranet.
- Other publications for purchase are available through .
- Frequently Asked Questions for various standards can be found on the .
- For additional detail concerning specific standards, see ֱ Physical Environment Portal (JCPEP), which is a partnership with .
- A helpful source for clarification of terms found in the standards chapters is the Glossary section of the organization's applicable accreditation manual.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
The requirements for the installation of smoke and fire dampers may be found in NFPA 90A Installation of Air Conditioning and Ventilating Systems, 2012 edition, Section 5.3 and 5.4.
Generally, fire dampers are required where air ducts penetrate walls that are rated for 2-hours or more. They are needed in all air transfer openings (non-ducted) in rated walls, regardless of the rating. And they are required at some, but not all penetrations of rated floor assemblies and shaft enclosures.
Smoke dampers are required at penetrations of smoke barriers, unless the HVAC system is fully ducted and there is a sprinkler system installed throughout the facility, in which case they are not required. Smoke dampers are also required in air transfer openings (non-ducted) in smoke partitions.
Where a penetration requires both a fire damper and a smoke damper, combination units that are both smoke responsive and heat responsive may be used.
Reference LS.02.01.10 EP13, LS.02.01.30 EP22 & EP23
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
ֱ uses the 2012 edition of NFPA 101 Life Safety Code. For consistency, no equipment is allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance with section 7.1.3.2.3. This would include evacuation chairs/sleds.
Security cameras, card readers, Wi-Fi routers and repeaters can be in the exit enclosure, so long as it doesn't interfere with the use of the exit and is used for surveillance of the exit enclosure. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Any penetrations into the rated exit enclosure must be sealed with a fire stop material that is appropriate to the rating of the enclosure. Properly protected system penetrations into existing (prior to July 5, 2016) exit enclosures are acceptable as long as they were part of the original construction and no alterations have since been made; once an alteration has been made, the current code should be followed.
Reference LS.02.01.20 EP 13, LS.03.01.20 EP 11
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ's Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
The Life Safety (LS) chapter of the Accreditation Manual has not been applicable for non-deemed status Joint Commission accredited office-based surgery practices since January 1, 2015. The criteria limits office-based surgery practices to a business occupancy, which is an occupancy having three or fewer patients at the same time who are undergoing treatment or anesthesia that renders them incapable of taking action for self-preservation under emergency conditions without the assistance of others.
The LS chapter applies to office-based surgery organizations classified as an ambulatory health care occupancy, which is an occupancy having at least four patients at the same time who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia. Note: CMS considers the Life Safety code applicable to ambulatory health care occupancies with at least one person who is either rendered incapable of self-preservation or undergoing general anesthesia; therefore, TJC will survey the LS standards if there is only one person meeting this criteria.
Reference LS.01.01.01
The Life Safety (LS) chapter of the Accreditation Manual has not been applicable for non-deemed status Joint Commission accredited office-based surgery practices since January 1, 2015. The criteria limits office-based surgery practices to a business occupancy, which is an occupancy having three or fewer patients at the same time who are undergoing treatment or anesthesia that renders them incapable of taking action for self-preservation under emergency conditions without the assistance of others.
The LS chapter applies to office-based surgery organizations classified as an ambulatory health care occupancy, which is an occupancy having at least four patients at the same time who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia. Note: CMS considers the Life Safety code applicable to ambulatory health care occupancies with at least one person who is either rendered incapable of self-preservation or undergoing general anesthesia; therefore, TJC will survey the LS standards if there is only one person meeting this criteria.
Reference LS.01.01.01
The Life Safety (LS) chapter of the Accreditation Manual has not been applicable for non-deemed status Joint Commission accredited office-based surgery practices since January 1, 2015. The criteria limits office-based surgery practices to a business occupancy, which is an occupancy having three or fewer patients at the same time who are undergoing treatment or anesthesia that renders them incapable of taking action for self-preservation under emergency conditions without the assistance of others.
The LS chapter applies to office-based surgery organizations classified as an ambulatory health care occupancy, which is an occupancy having at least four patients at the same time who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia. Note: CMS considers the Life Safety code applicable to ambulatory health care occupancies with at least one person who is either rendered incapable of self-preservation or undergoing general anesthesia; therefore, TJC will survey the LS standards if there is only one person meeting this criteria.
Reference LS.01.01.01
The Life Safety (LS) chapter of the Accreditation Manual has not been applicable for non-deemed status Joint Commission accredited office-based surgery practices since January 1, 2015. The criteria limits office-based surgery practices to a business occupancy, which is an occupancy having three or fewer patients at the same time who are undergoing treatment or anesthesia that renders them incapable of taking action for self-preservation under emergency conditions without the assistance of others.
The LS chapter applies to office-based surgery organizations classified as an ambulatory health care occupancy, which is an occupancy having at least four patients at the same time who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia. Note: CMS considers the Life Safety code applicable to ambulatory health care occupancies with at least one person who is either rendered incapable of self-preservation or undergoing general anesthesia; therefore, TJC will survey the LS standards if there is only one person meeting this criteria.
Reference LS.01.01.01
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
Joint Commission-accredited ambulatory health care organizations that routinely prescribe antimicrobial medications are required to address antimicrobial stewardship. These include organizations providing medical or dental services, episodic care, occupational/worksite health, urgent/immediate care, or convenient care. The requirements are not applicable to ambulatory surgery centers (ASCs) or the office-based surgery (OBS) program.
Joint Commission-accredited ambulatory health care organizations that routinely prescribe antimicrobial medications are required to address antimicrobial stewardship. These include organizations providing medical or dental services, episodic care, occupational/worksite health, urgent/immediate care, or convenient care. The requirements are not applicable to ambulatory surgery centers (ASCs) or the office-based surgery (OBS) program.
Joint Commission-accredited ambulatory health care organizations that routinely prescribe antimicrobial medications are required to address antimicrobial stewardship. These include organizations providing medical or dental services, episodic care, occupational/worksite health, urgent/immediate care, or convenient care. The requirements are not applicable to ambulatory surgery centers (ASCs) or the office-based surgery (OBS) program.
The inappropriate use of antimicrobial medications contributes to antibiotic resistance and adverse drug events, and improving antimicrobial prescribing practices is a patient safety priority. As a result, ֱ implemented an antimicrobial stewardship standard (MM.09.01.03) for the Ambulatory Health Care (AHC) accreditation program on January 1, 2020.
Joint Commission-accredited ambulatory health care organizations that routinely prescribe antimicrobial medications are required to address antimicrobial stewardship. These include organizations providing medical or dental services, episodic care, occupational/worksite health, urgent/immediate care, or convenient care. The requirements are not applicable to ambulatory surgery centers (ASCs) or the office-based surgery (OBS) program.
The recently published a resource titled "" which is consistent with our current accreditation requirements. Organizations are encouraged to review this document which provides guidance in shortage management and conservation.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
Allergens may be prepared outside of an ISO 5 environment as long as they are prepared with the following conditions:
- The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances
- All allergen extracts shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms.
- Perform thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water.
- Garb with hair covers, facial hair covers, gowns, and face masks.
- Perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity.
- Don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) be- fore beginning compounding manipulations.
- Disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen ex- tracts as CSPs.
- Ampule necks and vial stoppers must be disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.
- The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers).
- The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications.
- Single-dose allergen extracts may not be stored for subsequent additional use.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
ֱ has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids is outside the scope of the USP 797 chapter. ֱ will survey to organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies, procedures, staff education/competencies, etc., should also take into account:
- Product and device manufacturer's instructions for use
- Evidence-based guidelines for safe administration practices
- Applicable law and regulation
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required. After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Practitioners (LP) and staff who participate in medication management (MM.02.01.01). Examples of 'staff' may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources
Individual State Pharmacy Boards
Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all identified risk points. As a general rule, concentrated electrolytesare not be kept in patient care areas where access is not urgently needed.
The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served in each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadership would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets, dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device or storage location should also be evaluated as such storage areas may serve a mixed patient population.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards must be developed to prevent inadvertent administration of these medications without proper dilution.Examples of strategies to prevent errors may include:
- Segregation from all other medications stored in the device or area.
- Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amount necessary to meet patient care needs over a limited time period (for example, one day).
- A system for regularly checking and restocking to par level by pharmacy staff. .
- Prominent warning labels applied to the drug container.
- Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
If your state has implemented programs/processes that oversee the procurement, storage, and dispensing of opioid reversal agents, surveyors will evaluate compliance based on the requirements outlined per your state.
If your state has not implemented a program that has been adopted by your organization, you should consider the following:
Security
As with all medications, the security and integrity of such medications must be assured. Therefore, the medications must be stored in a manner to prevent tampering, theft or diversion at all times (see MM.03.01.01).While ֱ standards do not define what process must be followed to ensure medication security, organizations should consider conducting a risk assessment as a helpful way of identifying risks associated with various options being considered by the organization. The assessment must include all applicable accreditation, law and regulatory requirements.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
Storage
Medications must be stored in a manner consistent with the manufacturer's instructions for use to ensure stability. Therefore, a risk assessment should include environmental factors, such as temperature, light exposure, etc., that may impact medication integrity. NOTE -The guidance for storage listed in a package insert must be followed and cannot be superseded by an organization's risk assessment.
Orders
Protocols should include pre-established and approved patient assessment criteria in order to provide timely care and services to patients. The organization needs to define, in writing, who is authorized to administer medication in accordance with law and regulation (MM.06.01.01).The implementation of a protocol must be documented as an order in the patient's medical record and dated, timed and signed by the practitioner responsible for the care of the patient. However, the timing of such documentation should not be a barrier to providing timely and necessary care, or other patient safety advances.
Documentation
Once the organization chooses to treat an individual, they become a patient of the organization. Therefore, a medical record would be required that reflects all care, treatment and services provided in accordance with the requirements found in the Record of Care (RC) chapter of the accreditation manual, law and regulation.
Education and Training
Each organization determines education, training or competency requirements for those individuals involved in responding to patient emergencies.
Evaluating Medication Management Systems
Organizations are required to evaluate the effectiveness of their medication management systems (see MM.08.01.01). Therefore, organizations are encouraged to include emergency response processes, that include the safe medication practices, into their performance analysis activities. Such activities should include the collection and analysis of data that allows leadership to identify and implement performance improvement opportunities.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient’s bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient’s bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient’s bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient's bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Yes, the health care equity leader(s) may be assigned at the corporate or system level as long as the leader is able to coordinate and implement health care equity activities at each location and address the site-specific health care disparities identified. However, larger organizations may still want to identify individuals to lead activities at the site level, but the overall responsibilities for system-wide health care equity initiatives can be assigned at the corporate or system level.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Information:
- ֱ Tools and Resources: Universal Protocol
- Pre-procedure Verification FAQ
- Organizations accredited by ֱ also have access to the Leading Practice Library (LPL) via their secure Extranet site. The LPL contains examples ofpolicies, procedures, checklists, etc., that organizations may find helpful when developing their own requirements.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Information:
- ֱ Tools and Resources: Universal Protocol
- Pre-procedure Verification FAQ
- Organizations accredited by ֱ also have access to the Leading Practice Library (LPL) via their secure Extranet site. The LPL contains examples ofpolicies, procedures, checklists, etc., that organizations may find helpful when developing their own requirements.
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that “are” or “maybe” required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Information:
- ֱ Tools and Resources: Universal Protocol
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that “are” or “maybe” required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Information:
- ֱ Tools and Resources: Universal Protocol
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that “are” or “maybe” required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Information:
- ֱ Tools and Resources: Universal Protocol
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts^ in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
^The organization determines where emergency carts are located within the organization.
No, except in emergencies^, an H & P that has been dictated, but not entered into the medical record would not be compliant. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination (see PC.03.01.03 ). The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
- review the history and physical examination document
- determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
- obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
- review the history and physical examination document
- determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
- obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
The organization can have arequirement, such as in the medical staff rules, regulations or bylaws,that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization,permitted by state law,organization policy and familiar with the organization'srequirements for the history and physicalmust do the following:
review the history and physical examination document
determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
The organization can have arequirement, such as in the medical staff rules, regulations or bylaws,that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization,permitted by state law,organization policy and familiar with the organization'srequirements for the history and physicalmust do the following:
review the history and physical examination document
determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
The organization can have arequirement, such as in the medical staff rules, regulations or bylaws,that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization,permitted by state law,organization policy and familiar with the organization'srequirements for the history and physicalmust do the following:
review the history and physical examination document
determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
The organization can have arequirement, such as in the medical staff rules, regulations or bylaws,that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization,permitted by state law,organization policy and familiar with the organization'srequirements for the history and physicalmust do the following:
review the history and physical examination document
determine if the information is compliant with the organization's history and physical policy/bylaws/rules and regulations
obtain missing information through further assessment and update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
No. Moderate anddeep sedationare not without risks. As such, ֱ includes these in its glossary definition of anesthesia and sedation. As a result, therequirementsfound atPC.03.01.07apply to these levels of sedation, regardless of less stringent interpretation by organizational policy or interpretive guidelines.
Providing staff and licensed practitioners with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
NOTE: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Leadership responsibilities for developing and monitoring performance improvement activities specific to safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Note: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Providing information to staff and licensed practitioners on available services for consultation and referral of patients with complex pain management needs
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record
NOTE 1: This element of performance is only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
NOTE 2: This requirement is not applicable to all settings in the ambulatory care program. Refer to an applicability grid in the E-dition or standards manual for details.
Screening vs. assessing pain
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and (re)assessment criteria and procedures are readily available and used appropriately. The approach to assessing pain may differ depending on a patient's age, condition, and ability to understand. For example, different tools are used for pediatric patients compared to adult patients. For an episode of acute pain from an identified cause, brief assessment of pain intensity and characteristics may be sufficient.
Chronic pain generally requires more extensive patient assessment, including various domains of physical and functional impairment. Reassessment is conducted as necessary based on the patient's plan of care or changes in his or her condition.
Educating the patient and family on discharge related to pain management
Pain Assessment and Management Resources
The practice of providing discharge instructions or after-visit summaries via the electronic medical record (i.e. patient portal) in lieu of a paper copy provided at discharge would not be prohibited by Joint Commission accreditation requirements.
Prior to providing instructions and information electronically, organizations need to consider the individual patient's ability to access electronic devices (e.g. computers, smartphone, tablet, etc.) technical ability, and overall comfort in using such devices to access electronic information. When another individual will be responsible for ensuring ongoing care of the patient, the same considerations apply.
Organizations that have the capability to provide discharge instructions and after-visit summaries electronically, are encouraged to handle on a case-by-case basis and allow the patient to determine how to receive discharge information. If your organization has a written policy or procedure on your requirements for providing discharge information, consider including this process in that document.
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions^
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no changes in the patient's status since the initial assessment. This re-evaluation occurs immediately prior to (meaning without delay) the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by a qualified individual and consistent with state law and regulation.
- In deemed(^^)organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LP, or the patient may bedischarged upon a LP's order based on criteria established by the medical staff.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
The "qualified individual/ transfusionist" is determined by the organization considering any professional guidelines, state laws and regulations that define qualifications necessary to transfuse blood and blood products. The organization must also ensure the qualified individual/ transfusionist is competent in transfusing blood and blood products and the identification verification process defined by the organization.
The second individual involved in a two-person verification process is determined by the organization. This individual must be competent in conducting the identification verification process for blood and blood products defined and implemented by the organization.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LP could authenticate for another LP.Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP)/Conditions for Coverage(CfC), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LP responsible for the care of that patient, when the ordering LP is not available. This does not apply totranscribed progress notes as they can only be authenticated by the LP who dictated the progress note.
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The answer is NO except in emergencies*. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination. (PC 3.01.03 ) The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
* In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
The answer is NO except in emergencies*. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination. (PC 3.01.03 ) The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
* In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
The answer is NO except in emergencies*. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination. (PC 3.01.03 ) The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
* In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
No, except in emergencies^, an H & P that has been dictated, but not entered into the medical record would not be compliant. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination (see PC.03.01.03 ). The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
The requirement to collect race and ethnicity has historically applied to hospitals (Standard RC.02.01.01, EP 25). As of January 1, 2023, it will also apply to organizations in the ambulatory health care (RC.02.01.01, EP 31), behavioral health and human services (RC.02.01.01, EP 26) and critical access hospital (RC.02.01.01, EP 25) programs.
The intent of the requirement is to collect race and ethnicity information to identify potential health care disparities, and organizations have the flexibility to determine which categories of race and ethnicity are appropriate for the population they serve. ֱ does not specify which categories an organization should use to collect race and ethnicity data.
While ֱ requirement is not prescriptive of which categories of race and ethnicity should be collected, many state reporting entities and payers do specify these requirements. Organizations are encouraged to use, at a minimum, the race and ethnicity categories from the Office of Management and Budget (OMB) and US Census Bureau, and to consider collecting ethnicity categories based on the population to obtain additional granularity. Resources such as the Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement and the Health Research and Educational Trust Disparities Toolkit provide additional guidance on collecting race and ethnicity information.
Resources
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
No. If there was no blood loss^ and/or no specimens removed, there is no requirement for the proceduralist to document those two items, unless the organization specifically requires this level of documentation. The word "any" was specifically chosen to reflect the need to only document those items when applicable to the procedure performed.
^As applicable to the procedure, it is acceptable to document 'quantitative blood loss' in lieu of 'estimated blood loss' which is common in OB/GYN procedures.
The report must be written or dictated immediately after an operative or other high risk procedure^ and entered into the medical record.This information could be entered as the operative report or as a hand-written progress note. If the operative or procedural report is not placed in the medical record immediately following the procedure, then a progress note must be immediately entered after the procedure to provide pertinent information to the next provider of care. The goal is to ensure there is sufficient information about the procedure in the record immediately after surgery or other high risk procedure to manage the patient throughout the post procedure period.
'Immediately after surgery or procedure' is defined as "upon completion of procedure, before the patient is transferred to the next level of care". This is to ensure that pertinent information is available to the next caregiver. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit or area of care, the report can be written or dictated in the new unit or area of care. For the purposes of this requirement, ֱ considers the Pre-Op, O.R. and PACU as the same level of care as the clinical team is essentially intact across these areas.
If the progress note option is used (see RC.02.01.03 EP 7), it must contain, at a minimum, comparable operative/procedural report information. The minimum required elements include; the name of the primary surgeon and assistants procedures performed and description of each procedure findings any estimated blood loss, any specimens removed, and the post operative diagnosis.
^ See definition in the glossary of the accreditation manual.
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
- Reporting Adverse Patient Reactions to the Donor Source Facility:
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the introduction to the Transplant Safety chapter found in the accreditation manual.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The source facility must be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.Each organization must check with their state for the status of Tissue License Requirements.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer’s instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
• Apply for accreditation in the laboratory program.
ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
• Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer’s instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
• Apply for accreditation in the laboratory program.
ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
• Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer’s instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
• Apply for accreditation in the laboratory program.
ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
• Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer’s instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
• Apply for accreditation in the laboratory program.
ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
• Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Assisted Living Community
ֱ standard for an organization's recovery and continuity of operations is performance based (EM.02.01.01). The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness, the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
The requirements for a Continuity of Operations Plan (COOP) is defined in EM.02.01.01 EP12. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plan, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include but not be limited to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
An organization needs to establish a process to manage its emergency inventory, however there is no requirement for centralization of the inventory. The inventory must be itemized. The emergency inventory includes, but is not limited to, personal protective equipment, water, fuel, and medical, surgical and medication related resources and assets. The organization should conduct an annual inventory review to determine if all items assessed are available for use during an emergency. The inventory and annual review must be documented.
ֱ recognizes that it can be problematic with "just in time" purchasing and recognizes it is important to use stock with a shelf-life. Tracking assets and inventory for a year is recommended in order to accurately ascertain what the capabilities and needs are for the organization. Many organizations consider emergency requirements when establishing par levels. Some healthcare systems create a process by which to store and transport emergency inventory between system locations.
Memorandums of Understanding (MOUs) or other agreements may be formed with other entities to help the organization maintain its inventory during an emergency. However, MOUs are most useful during isolated emergencies, and are often not effective during large emergency events impacting a large region. Therefore, it is very important to test and/or document this along with the other five critical areas during an exercise or actual event to look for areas of risk. If an event or exercise is initiated, one of the initial responses should be for those entities holding emergency inventories to report available inventories to the incident commander.
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
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ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ is not prescriptive to monitor or log temperature for refrigerators provided for personal patient use. However, a process is required to be in place to ensure that the refrigerator functions properly to safely store its contents.
ֱs standards require that organizations store food and nutrition products, including those brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and security as per PC.02.02.03.
When nutritional products, such as breast milk or baby formula are stored in these refrigerators, refer to evidence-based guidelines from the formula manufacturer's instructions for use (IFU), the Centers for Disease Control and Prevention (CDC), etc. to ensure safe storage.
Organizations should also have processes that address cleaning between patients and identifies maintenance responsibilities.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Additional Resources:
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO's leadership, does not substitute for the surveyor's request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed practitioners (see alsoLD.01.03.01 and LD.03.04.01).
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
No, requirements for managing linen are notdefined within ֱ standards. Organizations are expected to develop their linen cleaning, storage and management requirements in accordance with evidence-based sources, such as the CDC, the National Association of Institutional Linen Management and/or the local or state authority having jurisdiction.
For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be used to store linens on patient-care areas (hallways) must have covers on them during transportation and storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."
If an organization is unsure whether their linen management processes are compliant with such guidelines, conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Yes, accredited organization's are expected to demonstrate compliance with all accreditation or certification requirements for their respective program. In general, the contractual agreements that are reviewed during survey are those that relatemost directlyto resident safety, care,andtreatment (see also LD.04.03.09 and HR.01.02.07).Contracts that relate to other support issues(lawn care, snow removal, and plant technology maintenance)arelower priorities during survey.
Contractual agreementsmust give theaccredited organization's therightto enrollthe direct care and supportcontract employees intothe orientation, competency assessment, on-going education, performance evaluation, health screening, and emergency and fire prevention programs that are established by the organization.To these ends, the contracted service/agency/vendor deploys properly trained and credentialed staff andmaterials. The compliance of all staff, including contracted staffmust bedocumentedbut this documentation may reside with the employer.
Theaccredited organization policies and procedures must be followed by all staff, even if the contract company does nothave comparable requirements. For example,if the organization or the local government or public health entity requires tuberculosis testing and the contract company does not, the contract staff must comply with tuberculosis screening.The screening can be done by the contractor or by the accredited organizationand must be documented.
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO's leadership, does not substitute for the surveyor's request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed practitioners (see alsoLD.01.03.01 and LD.03.04.01).
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the organization's residents. This standard does not apply to contracted services that are not directly related to resident care. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their organization to oversee the quality and safety of services provided through contractual agreement. Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and residents.
- Review of resident satisfaction studies.
- Review of results of risk management activities.
Note: This FAQ applies only to staff and contractors of accredited or certified organizations and not to licensed practitioners.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Intent
Physical Presence
There is no expectation that the physician be physically present in the ALC or provide direct resident care. The Assisted Living Community determines how the roles and responsibilities of the designated physician are performed. For example, the physician may participate in developing policies or in-service training with others on the interdisciplinary team or only contribute expertise for the content. They may collaborate with a pharmacist at a consulting pharmacy to review reports of psychotropic medication use. Once the organization determines how the responsibilities will be carried out, they will need to provide evidence of or demonstrate their processes during survey activities.
Additional Resources
Memory Care Certification
Assisted Living Community Accreditation
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
National Patient Safety Goal.09.02.01-EP1 requires the organization to evaluate the patient's risk for falls and take action to reduce the risk of falling as well as the risk of injury, should a fall occur. The evaluation could include a patient's fall history; review of medications and alcohol consumption; gait and balance screening; assessment of walking aids, assistive technologies, and protective devices; and environmental assessments.
It is helpful to identify medications that are frequently associated with increased risk of falling. Some suggested classifications are: hypnotics, sedatives, analgesics, psychotropics, antihypertensives, laxatives and diuretics. Please consider not only the class of drug, but the number of drugs (polypharmacy) and the potential for additive effects when they accumulate in the body that also increases risk.
The organization's fall reduction program is expected to include all patient/resident care settings and populations. We don't prescribe what the program must include but there must be something to address the risk of harm from falls for all of the organization's settings and populations. That includes the possibility that a specific unit or population had been assessed and determined to have a minimal risk of patient/resident harm from falls and that nothing further needs to be done for that setting or population. However, if a particular setting or population was simply ignored in the organization's program, then it would not meet the requirement.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
A multi-component approach is recommended. The plan of care for a resident at risk for developing a pressure ulcer should include the following:
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Manual: Behavioral Health
The applicability grid located in the "Standards Applicability Process(SAP)" chapter of the Behavioral Health and Human Services accreditation manual allow an agency to quickly find the services they offer, as identified in its electronic Application for Survey (E-App), and the related standards that apply.
The new child welfare requirements are also tagged with the lead in "For child welfare." However, some child welfare standards are specific to service, so the agency must confirm it applies to specific services by using applicability grids, or their service profile in E-app.
The new and revised requirements for Child Welfare are designed to improve the quality and safety of care provided to individuals served and their families in settings/domains such as adoption, family preservation, foster care, kinship care, respite care, reunification and child protective services.
ֱ evaluated expert literature to determine what areas of a child welfare program held the most potential to impact key quality and safety issues. The literature review revealed that intake, assessment, reunification, trauma-informed care, and case closing were all areas that could improve quality and safety. The new requirements incorporate the latest research, leading practices, and federal regulations with the primary goal of improving quality and safety in these settings.
ֱ standard requirements for adoption agencies
These can be identified by clicking on the adoption service in your service profile on E-dition and in applicability grid in the SAP chapter for adoption services. The same process of determining the applicable standards can be applied to other child welfare services such as family preservation, reunification, child protective services etc.
Pain and nutrition screening requirements
When the state department of child and family services provides foster care, adoption, reunification, and other services, and the agency is not responsible for the care plan and/or assessment, the standard applicability is determined by the services selected on E-App.
- Agencies that provide clinical mental health services (for example, therapeutic intervention or behavioral management provided by or under supervision of a master's prepared staff or LicensedPractitioner)need to perform the required screenings.
- Agencies that provide only non-clinical case management and care coordination services (for example, afterschool programs, parenting groups, or similar), will not need to perform these services.
The agency is not responsible for developing and re-evaluating the treatment plan if they are contracted to provide the services based on the case plan/treatment plan provided by the state/county. The expectation is to make the relevant documentation used to inform care treatment and services available at the time of survey. The documents from the state/county are not subject to standard requirements.
Survey requirements
The agency is expected to comply with the standard requirements applicable to the services they are contracted to provide. If they state does not allow the agency to develop any of the key case files, the agency must make a copy of the relevant documents such as the contract, assessment and/or case plan provided by the state available at the time of survey.
The standard applicability is determined by the services selected on E-App. Contact your account executive for guidance of completing the E-App. Once the services provided are identified on the E-App, applicable requirements (standards) can be viewed under the service profile on E-dition.
Additional Resources
Child Welfare Requirement, Rationale and Reference (R3) Report
Content of history and physical
The organization has the flexibility of determining the content required of the medical history and physical examination to be completed based on the setting(s), service(s) and population(s) served. The organization is required to have a practitioner qualified by the scope of the practitioner's license participate in developing the data to be collected for the physical health screening process to determine a need for a medical history and physical examination (CTS.02.01.05). There are identified requirements in the standards manual for specific service(s), setting(s) and population(s) served.Population groups that have specific medical history and physical requirements and/or assessment are identified in the respective standards. These include:
- CTS.02.02.01 for organizations certified as Behavioral Health Homes
- CTS.02.02.07 and CTS.02.02.09 for Opioid Treatment Programs
- CTS.02.03.03 for Children and Youth
- CTS.02.03.05 for Individuals with Intellectual/Development Disabilities
- CTS.02.03.09 and CTS.02.03.11 for Eating Disorders Treatment; and
- CTS.02.03.07 and CTS.02.03.13 for Addictions Treatment.
If state law and regulation and professional practice acts allows delegation of a history and physical examination then, the organization must have a process to ensure:
- Only authorized staff conduct history and physicals.
- Only authorized staff perform the components of a history and physical examination that have been delegated by a Physician or LP.
- The medical history and physical examination is performed under the supervision of, or through appropriate delegation by, a specific qualified physician who countersigns in accordance with law, regulation and organizational policy, and retains accountability for the patient's medical history and physical examination.
Time frame for completion
The organization has the flexibility of determining the time frame for completing the medical history and physical examination (H & P) based on the setting(s), service(s) and population(s) served.
H & P must be signed and completed within the time frame specified by the needs of the individual served, organization policy, and law and regulation (RC.01.01.01 EP 7 and RC.01.02.01 EP 3).
For Non-Medical Psychiatric Evaluation or Comprehensive Assessment, the organization defines the time frame for completion based on their setting, services and population served and state law and regulation as required by CTS.02.01.03 EP 2.
There are identified requirements in the standards manual for specific service(s), setting(s) and population(s) served.Setting(s) and Service(s) that have specific time frames for completing H & P requirements are identified in the respective standards. These include:
- CTS.02.01.07 EP 1. for In-Patient Crisis Stabilization Unit/Acute 24-hour settings that require H and P within 24 hours of admission
- CTS.02.01.07 EP 3. for Opioid Treatment Programs that require H and P within 14 days of admission
- CTS.02.01.06 EP 3. for Residential Treatment Facilities that require H &P within 30 days of admission, and
- CTS.02.01.05 for Out-Patient/non-24-hour settings that require completion of a physical health screening to identify a need for H & P and if the time frame from the last physical examination exceeds 1 year to complete one internally or provide a referral
Guidelines for selecting a standardized tool to monitor progress towards treatment goals
Based on its setting, scope, and services, the organization selects measures that are meaningful to the organization and that address the needs of the individuals served. ֱ standard CTS.03.01.09 requires that outcomes of care, treatment, or services be monitored over the course of service using a standardized instrument – a practice generally known as measurement-based care.
Most measurement-based care instruments monitor progress from the individual’s perspective, however, depending upon the population served outcomes may be assessed from alternate perspectives (e.g., parent/guardian, clinician). The tool or instrument may be focused on a population or diagnostic category (such as depression or anxiety), or the tool or instrument may have a more global focus such as general distress, functional status, quality of life (especially in regard to intellectual/developmental disabilities and other physical and/or sensory disabilities), well-being, or permanency (especially in regard to foster care). Multiple tools or instruments can be selected that are relevant to different populations served, settings and services to ensure that a tool is utilized to measure progress on every individual served.
Criteria for a tool to be considered a standardized instrument
The choice of an instrument(s) belongs to the accredited organization; however, any instrument used must meet the criteria listed below for routine outcome measures:
- Well-established psychometric properties (i.e., reliability and validity)
- Documented sensitivity to change (i.e., the ability to detect true/meaningful changes over time)
- Use as a repeated measure (i.e., can reliably detect change from administration to administration)
- Has established norms (i.e., the instrument can distinguish between populations that need or do not need services)
In order to use a standardized measure to monitor progress, and to use the data to potentially make changes to the treatment process, the organization is expected to
- administer a standardized instrument at multiple intervals throughout the care process
- use feedback derived through these standardized instruments to inform goals and objectives, monitor individual progress, and inform decisions related to individual plans for care, treatment, or services
- aggregate data from the tools for organizational performance improvement efforts and evaluate outcomes of care, treatment, or services provided to the population(s) served
Resources:
Guidelines for selecting a standardized tool to monitor progress towards treatment goals
Based on its setting, scope, and services, the organization selects measures that are meaningful to the organization and that address the needs of the individuals served. ֱ standard CTS.03.01.09 requires that outcomes of care, treatment, or services be monitored over the course of service using a standardized instrument – a practice generally known as measurement-based care.
Most measurement-based care instruments monitor progress from the individual’s perspective, however, depending upon the population served outcomes may be assessed from alternate perspectives (e.g., parent/guardian, clinician). The tool or instrument may be focused on a population or diagnostic category (such as depression or anxiety), or the tool or instrument may have a more global focus such as general distress, functional status, quality of life (especially in regard to intellectual/developmental disabilities and other physical and/or sensory disabilities), well-being, or permanency (especially in regard to foster care). Multiple tools or instruments can be selected that are relevant to different populations served, settings and services to ensure that a tool is utilized to measure progress on every individual served.
Criteria for a tool to be considered a standardized instrument
The choice of an instrument(s) belongs to the accredited organization; however, any instrument used must meet the criteria listed below for routine outcome measures:
- Well-established psychometric properties (i.e., reliability and validity)
- Documented sensitivity to change (i.e., the ability to detect true/meaningful changes over time)
- Use as a repeated measure (i.e., can reliably detect change from administration to administration)
- Has established norms (i.e., the instrument can distinguish between populations that need or do not need services)
In order to use a standardized measure to monitor progress, and to use the data to potentially make changes to the treatment process, the organization is expected to
- administer a standardized instrument at multiple intervals throughout the care process
- use feedback derived through these standardized instruments to inform goals and objectives, monitor individual progress, and inform decisions related to individual plans for care, treatment, or services
- aggregate data from the tools for organizational performance improvement efforts and evaluate outcomes of care, treatment, or services provided to the population(s) served
Resources:
Guidelines for selecting a standardized tool to monitor progress towards treatment goals
Based on its setting, scope, and services, the organization selects measures that are meaningful to the organization and that address the needs of the individuals served. ֱ standard CTS.03.01.09 requires that outcomes of care, treatment, or services be monitored over the course of service using a standardized instrument – a practice generally known as measurement-based care.
Most measurement-based care instruments monitor progress from the individual’s perspective, however, depending upon the population served outcomes may be assessed from alternate perspectives (e.g., parent/guardian, clinician). The tool or instrument may be focused on a population or diagnostic category (such as depression or anxiety), or the tool or instrument may have a more global focus such as general distress, functional status, quality of life (especially in regard to intellectual/developmental disabilities and other physical and/or sensory disabilities), well-being, or permanency (especially in regard to foster care). Multiple tools or instruments can be selected that are relevant to different populations served, settings and services to ensure that a tool is utilized to measure progress on every individual served.
Criteria for a tool to be considered a standardized instrument
The choice of an instrument(s) belongs to the accredited organization; however, any instrument used must meet the criteria listed below for routine outcome measures:
- Well-established psychometric properties (i.e., reliability and validity)
- Documented sensitivity to change (i.e., the ability to detect true/meaningful changes over time)
- Use as a repeated measure (i.e., can reliably detect change from administration to administration)
- Has established norms (i.e., the instrument can distinguish between populations that need or do not need services)
In order to use a standardized measure to monitor progress, and to use the data to potentially make changes to the treatment process, the organization is expected to
- administer a standardized instrument at multiple intervals throughout the care process
- use feedback derived through these standardized instruments to inform goals and objectives, monitor individual progress, and inform decisions related to individual plans for care, treatment, or services
- aggregate data from the tools for organizational performance improvement efforts and evaluate outcomes of care, treatment, or services provided to the population(s) served
Resources:
Guidelines for selecting a standardized tool to monitor progress towards treatment goals
Most measurement-based care instruments monitor progress from the individual's perspective, however, depending upon the population served outcomes may be assessed from alternate perspectives (e.g., parent/guardian, clinician). The tool or instrument may be focused on a population or diagnostic category (such as depression or anxiety), or the tool or instrument may have a more global focus such as general distress, functional status, quality of life (especially in regard to intellectual/developmental disabilities and other physical and/or sensory disabilities), well-being, or permanency (especially in regard to foster care). Multiple tools or instruments can be selected that are relevant to different populations served, settings and services to ensure that a tool is utilized to measure progress on every individual served.
Criteria for a tool to be considered a standardized instrument
The choice of an instrument(s) belongs to the accredited organization; however, any instrument used must meet the criteria listed below for routine outcome measures:
- Well-established psychometric properties (i.e., reliability and validity)
- Documented sensitivity to change (i.e., the ability to detect true/meaningful changes over time)
- Use as a repeated measure (i.e., can reliably detect change from administration to administration)
- Has established norms (i.e., the instrument can distinguish between populations that need or do not need services)
In order to use a standardized measure to monitor progress, and to use the data to potentially make changes to the treatment process, the organization is expected to
- administer a standardized instrument at multiple intervals throughout the care process
- use feedback derived through these standardized instruments to inform goals and objectives, monitor individual progress, and inform decisions related to individual plans for care, treatment, or services
- aggregate data from the tools for organizational performance improvement efforts and evaluate outcomes of care, treatment, or services provided to the population(s) served
Resources
Screening vs. Assessment for physical pain - CTS.02.01.09
Performing physical pain screening and/or assessment
Education and training for screening, assessment and management of pain
^Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioid.
NOTE: This requirement is not applicable to all settings in the Behavioral Health and Human Services Program. Refer to the standards applicability process chapter (SAP) in E-dition or your standards manual for details.
For organizations that prescribe medication: Practitioner access to the Prescription Drug Monitoring Program (PDMP) databases (MM.01.01.01)
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record
NOTE: This requirement is not applicable to all settings in the Behavioral Health and Human Services Program. Refer to the standards applicability process chapter (SAP) in E-dition or your standards manual for details.
Pain Assessment and Management Resources
The practice of providing discharge instructions or after-visit summaries via the electronic medical record (i.e. patient portal) in lieu of a paper copy provided at discharge would not be prohibited by Joint Commission accreditation requirements.
Prior to providing instructions and information electronically, organizations need to consider the individual patient's ability to access electronic devices (e.g. computers, smartphone, tablet, etc.) technical ability, and overall comfort in using such devices to access electronic information. When another individual will be responsible for ensuring ongoing care of the patient, the same considerations apply.
Organizations that have the capability to provide discharge instructions and after-visit summaries electronically, are encouraged to handle on a case-by-case basis and allow the patient to determine how to receive discharge information. If your organization has a written policy or procedure on your requirements for providing discharge information, consider including this process in that document.
ֱ does not specifically require temperature logs for refrigerators and freezers used for food storage. Standard CTS.04.03.33 requires that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. These variables must be monitored to assure proper storage. A digital minimum/maximum thermometer with a built in alarm could be used to monitor the temperature of the refrigerator and freezer if the temperature range for minimum and maximum temperatures are properly established.
With this device if the temperature goes outside the set range an alarm will sound. As a result daily monitoring by staff would not need to occur. However, staff would need to periodically check to be assured that the thermometer battery is still charged and the thermometer remains accurate. Staff would also need to demonstrate competence to set the appropriate temperature range and activate the alarm. If the alarm has sounded appropriate steps would need to be taken to determine how long the refrigerator or freezer has been out of the designated range. This may require the disposal of the food products.
No. A telemedicine link does not fulfill the in-person requirement for the evaluation by a Licensed Practitioner (LP) of the individual in restraint or seclusion. The evaluation must be in-person (face-to-face) and completed by the LIP primarily responsible for the ongoing care, treatment, or services of the individual served, or his or her LP designee, or other LP.
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. [Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.]
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. [Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.]
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. [Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.]
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. [Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.]
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. [Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.]
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
Joint Commission standards require that a physician or other licensed practitioner responsible for the patient's care order restraint^ or seclusion^. When restraint or seclusion is used for the management of violent or self-destructive behavior an in-person (face-to-face) evaluation of the patient within one hour of the initiation of the restraint or seclusion is also required.
Four requirements must be met for a resident (a physician in a graduate medical education program) to order restraint or seclusion or conduct the required face-to-face evaluation of a patient in restraint or seclusion for the management of violent or self-destructive behavior:
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
^Please see the glossary of the accreditation manual for definition of terms.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
No, how the plan of care is documented in the medical record is up to each organization. A treatment plan is not referring to a particular document rather the process to plan and implement coordinated, client-centered care. Some organizations have chosen to create a plan of care template/document. However, each element of the individual's treatment plan, as reflected in ֱ requirements, may be incorporated in various aspects of the medical record such as progress notes.Compliance will be assessed per organization policies/procedures.
For the required elements as part of the plan of care, such as problems, goals, objectives and interventions, refer to The Comprehensive Accreditation Manual for Behavioral Healthcare and Human services (CAMBHC) CTS.03.01.01 and CTS.03.01.03
ֱ standard for an organization's recovery and continuity of operations is performance based (EM.02.01.01). The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness, the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
The requirements for a Continuity of Operations Plan (COOP) is defined in EM.02.01.01 EP12. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plan, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include but not be limited to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
Someone from the medical staff or physician member and someone from the hospital executive leadership (as opposed to middle management) team should participate in planning activities prior to the development of the Emergency Operations Plan. Medical staff and hospital leadership will be directly involved in the management of an implementation of the emergency operations plan, so their input is essential to establish the expected capabilities and duties of these entities.
It is also important for medical staff and executive leadership to understand the duties and capabilities for the staff that will support the emergency operations plan, and the capabilities of community support entities. Many disaster scenarios involve patient care regarding management of current patients and managing influx of patients. Hospital leaders must understand the command structure and how it functions.
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or the 2018 FGI Guidelines for Design and Construction of Hospitals.
Reference: EC.02.06.05 EP 1
Additional Resources
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or in their absence thelatest edition ofFGI Guidelines for the Design and Construction of Outpatient Facilities.
The FGI Guidelines documents state "the number and placement of both hand-washing stations and hand sanitation dispensers shall be determined by the ICRA." (Section 2.1-7.2.2.8) The ICRA or infection control risk assessment, which should be done at the programming stage of the project and should help guide the decisions on where to locate them. The individual facility chapters, though, have additional specific requirements for hand washing stations in certain locations. For example, each exam or treatment room is required to have one.
Additional Resources:
To access a read only copy of the FGI Guidelines for Design and Construction of Outpatient Facilities the hyperlink is provided here for your convenience:
Reference EC.02.06.05 EP1
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
The labeling shall include:
- the name or chemical symbol for the specific medical gas or vacuum system
- room or areas served
- caution to not close or open the valve except in an emergency
Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its hidden location may be identified by a label, icon, etc., or on a utility system map in accordance with EC.02.05.01 EP 17.
Reference EC.02.05.09 EP11
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
ֱ standards are not prescriptive regarding testing frequencies for piped medical gas and vacuum systems. The facility may determine its testing frequency by policy and the surveyor will evaluate testing based on that policy.
In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and reliable condition.
The organization is required by EC.02.05.01 to develop a maintenance strategy based upon either manufacturer's recommendations or an alternative equipment maintenance (AEM) strategy. Piped medical gas and vacuum systems are considered high-risk utility systems.
Issues such as system complexity, system age/condition, patient acuity, etc. are to be used to assess maintenance strategies. NFPA 99-2012 Appendix B can be used as a guide for establishing a maintenance strategy, but appendix material is not required unless adopted by a controlling authority. The survey process will evaluate the maintenance strategy assessment process for effectiveness and validate that it has been properly implemented.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
- applicable staff
- type of training
- level of training
- required credentials
The security management plan may be a stand-alone document or may be combined with other Environment of Care plans (one overarching plan or combined with another, such as the safety management plan, for instance). Components of the plan are outlined in EC.02.01.01 EPs, which include but not limited to:
- how will security risks be assessed and mitigated
- staff roles in security management
- how the facility is secured
- how the organization contact external security forces if needed
- how the organization will control access to areas identified as security sensitive
- how physical or verbal threats, acts of violence, inappropriate behavior will be managed
- If the organization has an MRI, there is to be an assessment for safety and security risk that addresses patient comfort and safety, equipment safety and security, and staff safety
Any requirements from the local authority having jurisdiction (AHJ) are expected to be followed.
Reference:
EC.01.01.01 EP 5
EC.02.01.01.
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
For ambulatory surgical centers and outpatient surgical departments that use ֱ deemed status option, that were constructed, or had a change in occupancy type, or have undergone an electrical system upgrade since 1983, a Type 1 or Type 3 essential electrical system is required as defined in the 2012 edition of NFPA 99.
This essential electrical system must be divided into three branches, including the:
- life safety branch
- critical branch
- equipment branch
Type 1 essential electrical system is required for:
- Critical care areas are those special care units in which patients are intended to be subjected to invasive procedures using electrical patient care medical equipment. Type 1 systems should be installed where there would be a risk of death or serious injury to the patient in the event of power failure.
- To supply emergency power in facilities that do not provide electrical life support or use general anesthesia. Type 3 systems are permitted where equipment failure is less critical to human life and safety.
Additional Resources:
EC.02.05.03
NFPA 99-2012: 6.3.2.2.10, 6.4.1, 6.4.2.2, 6.6.3
CMS S&C 07-21
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource Management (HRM) chapter apply to contract staff providing care, treatment or services. A well-written contract should specify that the contract organization will provide only staff who meet the minimum qualifications and competencies to perform specific duties and responsibilities. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HRM standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and privileged. Compliance with the organization's process for monitoring a practitioner's professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LP who was asked to evaluate a patient and provide consultation, by way of an order from another LP. The consultant's findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
ֱ requires that organizations verify the identity of the applicant by viewing one of the following:
- A current picture organizational ID card
- A valid picture ID issued by a state or federal agency (for example, a driver's license or passport)
- Identity Assurance Level 2 (IAL2) credentials may be used as defined by the US Government's National Institute of Standards and Technology (NIST). The requirements to meet this standard are outlined in NIST Special Publication 800-63.
- To pick up the application
- For an interview by the department chair
- When arriving to first provide services
- When having their photo ID badge picture taken
- Use of a telecommunications link that includes both audio and video capabilities
If the verification is performed at a remote location, then the confirmation of the verification should be forwarded to the credentialing office for inclusion in the credentials file.It isNOT required or recommended that a copy of the photo ID be taken or placed in the credentials files due to potential for identity theft.
If the applicant provides only a copy of the photo ID, or a notarized document indicating the identity was verified by another entity, it would not satisfy the requirement for verification.
For telehealth service providers only
Applicant identity verification may be completed offsite at the distant (provider) location, as the practitioner never comes onsite where the patient is located. The organization determines the process for verifying practitioner identity.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
Screening vs. Assessment for physical pain - CTS.02.01.09
Performing physical pain screening and/or assessment
Education and training for screening, assessment and management of pain
^Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioid.
NOTE: This requirement is not applicable to all settings in the Behavioral Health and Human Services Program. Refer to the standards applicability process chapter (SAP) in E-dition or your standards manual for details.
For organizations that prescribe medication: Practitioner access to the Prescription Drug Monitoring Program (PDMP) databases (MM.01.01.01)
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record
NOTE: This requirement is not applicable to all settings in the Behavioral Health and Human Services Program. Refer to the standards applicability process chapter (SAP) in E-dition or your standards manual for details.
Pain Assessment and Management Resources
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
No, primary source verification of education is not required at this element of performance.Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description.For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master's Degree in Nursing (MSN), the organization must verify the individual has this credential.Organizations determine how verification and documentation of education and experience will be managed.Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as 'paper' or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO).The glossary of the accreditation manual contains a definition of a CVO.
There is no standard requirement to verify hospital/other healthcare organization affiliations, clinical responsibilities, or work history for any applicant. Standard HRM.01.02.01 EP 6 does require the following information to make decision about hiring and assigning staff duties and responsibilities:
- Verified licensure, certification, or registration required by law or regulation and organization policy
- Verified education and experience Results of criminal background check(s), in accordance with law and regulation and organization policy
- Outcomes of applicable health screenings and staff member's health statement, in accordance with law and regulation and organization policy
- Any challenges to licensure or registration
- Voluntary or involuntary limitation of license or registration
- Voluntary or involuntary limitation, reduction, or loss of clinical responsibilities
- Professional liability actions that resulted in a final judgment against the staff member
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
Suicide Prevention Portal
FAQ Ligatures and/or Suicide Risk Reduction – Video Monitoring of Patients at High Risk for Suicide
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
ֱ does not determine which items are prohibited from a behavioral health setting. Items that are prohibited from use in an organization, due to the risk of harm to self or others, should be determined by the organization.
Source control involves having people wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions and thus reduce the dispersion of droplets from an infected individual.
TheCDC recommendsimplementing source control (use of masks) in a healthcare facility to prevent dispersal of respiratory droplets from known, asymptomatic and pre-symptomatic people with COVID when are high.Compliance with this recommendation should be based upon the organization's assessment, policies/procedures, individual care plans, and applicable state rules or regulations.
When evaluating the updated CDC recommendations for a patient with behavioral health needs, it is important to complete an assessment of the impact that wearing a face covering or mask would have on the safety of a patient(s), staff and visitors. The expectation is for organizations to complete a clinical risk assessment of the individual for possible self-harm or harm to others if they will wear a mask. The organization must have a process to determine if the patient is capable of wearing a face covering, or mask, based on clinical assessment.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
Any examples are for illustrative purposes only.
Centers for Medicare & Medicaid Services (CMS) revised its position on the use of texting in a February 8, 2024, memorandum stating that texting patient information and orders is permissible in hospitals and critical access hospitals if accomplished through a Health Insurance Portability and Accountability Act (HIPAA)-compliant Secure Texting Platform (STP) and in compliance with the Conditions of Participation at 42 CFR 482.24 and 41 CFR 485.638.
Therefore, CMS states that when certain conditions are met, organizations may choose to text patient care information and orders. While there is no specific requirement that the secure text must be electronically transmitted into the electronic health record, these messages are still subject to HIPAA regulations.
According to the CMS memorandum, organizations that choose to use texting for patient information and orders are required to do the following:
- Utilize and maintain systems/platforms that are secure and encrypted and must ensure the integrity of author identification as well as minimize the risks to patient privacy and confidentiality, as per the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations.
- Confirm that texted orders are promptly placed in the medical record dated, timed, and authenticated.
- Make sure that the information transmitted into the EHR is accurately written, promptly completed, properly filed and retained, and accessible.
Additionally, providers should implement procedures/processes that routinely assess the security and integrity of the texting systems/platforms that are being utilized to avoid negative outcomes that could compromise the care of patients.
Please refer to the CMS memo for further details:
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
Sleeping room automatic door closing devices are only required in residential board and care occupancies that are unsprinklered. Additionally, in existing large unsprinklered residential board and care occupancies, sleeping rooms shall be equipped with self-closing or automatic closing devices unless the following life safety features are also in place:
- The building is two stories or less in height
- Each sleeping room has an additional means of egress to the outside that does not pass through a corridor (examples include doors or egress-sized windows that open directly outside)
- The building's occupants are capable of moving to safety in a timely manner and are not slowed due to age, impairment, or other reason
Reference:
LS.04.01.30 EP 8: Small facility, 4 to 16 residents
LS.04.02.30 EP 12: Large facility, more than 17 residents
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
The requirements for the installation of smoke and fire dampers may be found in NFPA 90A Installation of Air Conditioning and Ventilating Systems, 2012 edition, Section 5.3 and 5.4.
Generally, fire dampers are required where air ducts penetrate walls that are rated for 2-hours or more. They are needed in all air transfer openings (non-ducted) in rated walls, regardless of the rating. And they are required at some, but not all penetrations of rated floor assemblies and shaft enclosures.
Smoke dampers are required at penetrations of smoke barriers, unless the HVAC system is fully ducted and there is a sprinkler system installed throughout the facility, in which case they are not required. Smoke dampers are also required in air transfer openings (non-ducted) in smoke partitions.
Where a penetration requires both a fire damper and a smoke damper, combination units that are both smoke responsive and heat responsive may be used.
Reference LS.02.01.10 EP13, LS.02.01.30 EP22 & EP23
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as “no exit”.
Reference LS.02.01.20 EP 41
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as “no exit”.
Reference LS.02.01.20 EP 41
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as “no exit”.
Reference LS.02.01.20 EP 41
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as "no exit".
Reference LS.02.01.20 EP 41
ֱ uses the 2012 edition of NFPA 101 Life Safety Code. For consistency, no equipment is allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance with section 7.1.3.2.3. This would include evacuation chairs/sleds.
Security cameras, card readers, Wi-Fi routers and repeaters can be in the exit enclosure, so long as it doesn't interfere with the use of the exit and is used for surveillance of the exit enclosure. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Any penetrations into the rated exit enclosure must be sealed with a fire stop material that is appropriate to the rating of the enclosure. Properly protected system penetrations into existing (prior to July 5, 2016) exit enclosures are acceptable as long as they were part of the original construction and no alterations have since been made; once an alteration has been made, the current code should be followed.
Reference LS.02.01.20 EP 13, LS.03.01.20 EP 11
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Doors in means of egress are required to be opened without the "use of a tool or key from the egress side". Occupant movement cannot be restricted during an emergency; however, locking certain doors may be necessary for the safety of the patient in certain situations.
When a healthcare facility determines that doors must be locked to protect patients the locking configuration must comply with one of the following:
- Delayed-egress locking system as defined by NFPA 101-2012: 7.2.1.6.1
- Access-controlled egress door assemblies as defined in NFPA 101-2012: 7.2.1.6.2
- Elevator lobby exit access door locking compliant with NFPA 101-2012: 7.2.1.6.3
Pediatric units, maternity units, and emergency departments are examples of areas where patients might have special needs that justify door locking. Patients that require additional protective measures to ensure safety and security are allowed to have door locking arrangements provided that all of 5 criteria of NFPA 101-2012: 18/19.2.2.2.5.2 are met, in summary these are:
- Staff can readily unlock all doors at all times
- A total (complete) smoke detection system is provided throughout the locked space, compliant with NFPA 101-2012: 9.6.2.9, or locked doors can be remotely unlocked at an approved, constantly attended location within the locked space.
- The building is protected throughout by an approved, supervised sprinkler system in accordance with NFPA 101-2012: 18/19.2.2.2.5.2
- Locks are electrical and fail safe to release upon loss of power
- The locks release by independent activation of each:
- Activation of the smoke detection system NFPA 101-2012: 18/19.2.2.2.5.2(2)
- Waterflow in the automatic sprinkler system NFPA 101-2012: 18/19.2.2.2.5.2(3)
Additional Resources
LS.02.01.20
NFPA 101-2012: 18/19.2.2.2.4; 19.2.2.2.5
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ's Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LP controlled orders for the items listed at MM.05.01.01 EP 4.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
1. That the medication order is written in a manner that supports deferring to patient preference when:
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.
2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.06.01.01 EP 3).
3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
5. The use of a protocol is not required. However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7. The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
7. The medical record must accurately reflect that the lesser potent medication was administered based on patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference.
8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the following is an example for consideration:
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization’s medication management policy (MM.04.01.01).
The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, or a lower dose of the same agent. If the policy allows a lower dose of the same medication, the reduced dose would have to be a part of an existing range order.
1. That the medication order is written in a manner that supports deferring to patient preference when:
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.
2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.06.01.01 EP 3).
3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
5. The use of a protocol is not required. However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7. The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
7. The medical record must accurately reflect that the lesser potent medication was administered based on patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference.
8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the following is an example for consideration:
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization’s medication management policy (MM.04.01.01).
The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, or a lower dose of the same agent. If the policy allows a lower dose of the same medication, the reduced dose would have to be a part of an existing range order.
The practice described may be acceptable as long as an organization has determined ALL of the following:
1. That the medication order is written in a manner that supports deferring to patient preference when:
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.
2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.06.01.01 EP 3).
3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
5. The use of a protocol is not required. However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7. The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
7. The medical record must accurately reflect that the lesser potent medication was administered based on patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference.
8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the following is an example for consideration:
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization’s medication management policy (MM.04.01.01).
The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, or a lower dose of the same agent. If the policy allows a lower dose of the same medication, the reduced dose would have to be a part of an existing range order.
The practice described may be acceptable as long as an organization has determined ALL of the following:
1. That the medication order is written in a manner that supports deferring to patient preference when:
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.
2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.06.01.01 EP 3).
3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
5. The use of a protocol is not required. However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7. The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
7. The medical record must accurately reflect that the lesser potent medication was administered based on patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference.
8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the following is an example for consideration:
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization’s medication management policy (MM.04.01.01).
The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, or a lower dose of the same agent. If the policy allows a lower dose of the same medication, the reduced dose would have to be a part of an existing range order.
The practice described may be acceptable as long as an organization has determined ALL of the following:
1. That the medication order is written in a manner that supports deferring to patient preference when:
b. Requesting a lesser prescribed dose in a range order.
c. Requesting a less intrusive route of administration if both routes are prescribed by the provider.
2. The medication is administered in accordance with orders from the Licensed Independent Practitioner (MM.06.01.01 EP 3).
3. The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
4. The organization’s medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
5. The use of a protocol is not required. However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7. The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
6. That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
7. The medical record must accurately reflect that the lesser potent medication was administered based on patient preference (RC.02.01.01 EP 2). It is NEVER acceptable to administer a medication of stronger potency based on patient preference.
8. Each organization is responsible for determining how such orders are to be entered into the medical record. However, the following is an example for consideration:
Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization’s medication management policy (MM.04.01.01).
The policy must be explicit in that such an order is ONLY for administration of a different (lesser) agent, or a lower dose of the same agent. If the policy allows a lower dose of the same medication, the reduced dose would have to be a part of an existing range order.
The practice described may be acceptable as long as an organization has determined ALL of the following:
- That the medication order is written in a manner thatsupports deferring to patient preference when:
- Requesting a lesser potent medication.(Potency should be established with an evidence based tool i.e. morphine equivalents).
- Requesting a lesser prescribed dose in a range order.
- Requesting a less intrusive route of administration if both routes are prescribed by the provider.
- The medication is administered in accordance with orders from the LicensedPractitioner (MM.06.01.01 EP 3).
- The inclusion of patient preference into the medication order cannot subsequently create a therapeutic duplication with other prescribed medications.
- The organization's medication management policy (see MM.04.01.01 EP 1) identifies this type of medication order as deemed acceptable, and defines all required elements of such orders.
- The use of a protocol is not required.However if an organization chooses to utilize a protocol or standing order, the review and approval process must comply with the requirements found at MM.04.01.01 EP 7.The medical record must contain evidence of an order to implement the protocol as well as the protocol itself.
- That implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation,
Each organization is responsible for determining how such orders are to be entered into the medical record. The following are example for consideration:
- Acetaminophen 325 mg 2 tablets po every 4 hours prn mild pain.
- Hydromorphone 2 mg 1 tablet po every 4 hours prn moderate pain. May administer less potent prescribed medication based on patient request per the organization's medication management policy (MM.04.01.01).
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
When additives are included, the IV solution container must be labeled with the name, strength and amount of all additives, a revised expiration date and have the date prepared and diluents on the label. Additionally, when preparing individualized medications for multiple patients, the label also includes
the following:
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
The requirements for medication labeling are located in the Medication Management (MM) chapter of the accreditation manual at MM.05.01.09.
The requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
When additives are included, the IV solution container must be labeled with the name, strength and amount of all additives, a revised expiration date and have the date prepared and diluents on the label. Additionally, when preparing individualized medications for multiple patients, the label also includes
the following:
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
The requirements for medication labeling are located in the Medication Management (MM) chapter of the accreditation manual at MM.05.01.09.
The requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered‘individualized medication’. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer’s label, so relabelingis not necessary. ‘Individualized’ means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes
the following:
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
The requirements for medication labeling are located in the Medication Management (MM) chapter of the accreditation manual at MM.05.01.09.
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered‘individualized medication’. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer’s label, so relabelingis not necessary. ‘Individualized’ means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes
the following:
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
The requirements for medication labeling are located in the Medication Management (MM) chapter of the accreditation manual at MM.05.01.09.
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered‘individualized medication’. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer’s label, so relabelingis not necessary. ‘Individualized’ means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes
the following:
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
The requirements for medication labeling are located in the Medication Management (MM) chapter of the accreditation manual at MM.05.01.09.
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Upon discharge from an inpatient stay or outpatient encounter, organizations need to determine the disposition of unused or partially used medication. For example, an inhaler provided by the facility for administration during an inpatient stay contains additional doses at the time the patient is discharged. The options available would be for the facility to discard the inhaler or send the inhaler home with the patient. Another example might be sending a 'couple' antibiotics home just to get the patient started on the medication.
When determining policies regarding dispensing medications at discharge, organizations should work with their accreditation and pharmacy leadership and legal counsel to ensure all accreditation and regulatory requirements have been addressed.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
Organizations are required to establish a process for communicating medication shortages to Licensed Practitioners (LP) and staff who participate in medication management (MM.02.01.01). Examples of 'staff' may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources
Individual State Pharmacy Boards
Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all identified risk points. As a general rule, concentrated electrolytesare not be kept in patient care areas where access is not urgently needed.
The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served in each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadership would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets, dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device or storage location should also be evaluated as such storage areas may serve a mixed patient population.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards must be developed to prevent inadvertent administration of these medications without proper dilution.Examples of strategies to prevent errors may include:
- Segregation from all other medications stored in the device or area.
- Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amount necessary to meet patient care needs over a limited time period (for example, one day).
- A system for regularly checking and restocking to par level by pharmacy staff. .
- Prominent warning labels applied to the drug container.
- Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.
Expiration dating is based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA) approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the LOT number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Expiration dating is based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA) approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the LOT number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
If your state has implemented programs/processes that oversee the procurement, storage, and dispensing of opioid reversal agents, surveyors will evaluate compliance based on the requirements outlined per your state.
If your state has not implemented a program that has been adopted by your organization, you should consider the following:
Security
As with all medications, the security and integrity of such medications must be assured. Therefore, the medications must be stored in a manner to prevent tampering, theft or diversion at all times (see MM.03.01.01).While ֱ standards do not define what process must be followed to ensure medication security, organizations should consider conducting a risk assessment as a helpful way of identifying risks associated with various options being considered by the organization. The assessment must include all applicable accreditation, law and regulatory requirements.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
Storage
Medications must be stored in a manner consistent with the manufacturer's instructions for use to ensure stability. Therefore, a risk assessment should include environmental factors, such as temperature, light exposure, etc., that may impact medication integrity. NOTE -The guidance for storage listed in a package insert must be followed and cannot be superseded by an organization's risk assessment.
Orders
Protocols should include pre-established and approved patient assessment criteria in order to provide timely care and services to patients. The organization needs to define, in writing, who is authorized to administer medication in accordance with law and regulation (MM.06.01.01).The implementation of a protocol must be documented as an order in the patient's medical record and dated, timed and signed by the practitioner responsible for the care of the patient. However, the timing of such documentation should not be a barrier to providing timely and necessary care, or other patient safety advances.
Documentation
Once the organization chooses to treat an individual, they become a patient of the organization. Therefore, a medical record would be required that reflects all care, treatment and services provided in accordance with the requirements found in the Record of Care (RC) chapter of the accreditation manual, law and regulation.
Education and Training
Each organization determines education, training or competency requirements for those individuals involved in responding to patient emergencies.
Evaluating Medication Management Systems
Organizations are required to evaluate the effectiveness of their medication management systems (see MM.08.01.01). Therefore, organizations are encouraged to include emergency response processes, that include the safe medication practices, into their performance analysis activities. Such activities should include the collection and analysis of data that allows leadership to identify and implement performance improvement opportunities.
Therapeutic duplication occurs when practitioners order more than one medication for the same indication. When this occurs, there must be a process in place to determine whether the ordering of multiple agents for the same indications is either an accidental prescribing error or intentional multi-modal therapy.
Joint Commission standards for organization's that dispense medications require medication orders to be reviewed by a pharmacist. Part of the review is to identify whether or not therapeutic duplication exists. Once this is identified, it is required that the pharmacist and nurse or staff administering or observing self-administration of medications have a clear understanding of the intent of the prescriber. Organizations may utilize resources such as policies, technology within the electronic medical record or other means necessary to ensure such communication.
The intent is to ensure that medication orders are clear and accurate for all members of the treatment team involved in medication management. If the intent was that both medications are to be administered and the organizations policy allows for these orders, the pharmacist preparing the medication and the staff administering the medication need to have clear guidance provided.
For example: An individual served is prescribed multiple psychotropic agents from the same class. There must be a clear understanding of the following:
- Was the intent of the prescriber to have all ordered medications given known by the prescriber, pharmacist, and the staff administering or observing self-administration of medications?
- When does the staff administering or observing self-administration give each agent based upon the intent of the prescriber?
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Physical care is direct care provided by staff to the individual that is beyond casual social contact. Examples of physical care would include physical examinations, taking vitals, wound care, medication injections, specimen collection, etc.. This is not to be considered an exhaustive list of examples. If applicable, the organization must implement a program that follows categories IA, IB, or IC of either the current Centers for Disease Control and Prevention (CDC) or the current World Health Organization (WHO) hand hygiene guidelines. If NPSG.07.01.01 is not applicable to the organization because physical health care is not provided it should be noted that standard IC.01.04.01 EP 5 is still applicable to all accredited organizations. This requirement addresses the need to work on improvement in staff compliance with hand hygiene guidelines.
Yes, the health care equity leader(s) may be assigned at the corporate or system level as long as the leader is able to coordinate and implement health care equity activities at each location and address the site-specific health care disparities identified. However, larger organizations may still want to identify individuals to lead activities at the site level, but the overall responsibilities for system-wide health care equity initiatives can be assigned at the corporate or system level.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Any examples are for illustrative purposes only.
Protective factors may be described as individual, relationship, community, and societal characteristics or circumstances that can protect individuals from suicide.
Examples of protective factors include, but are not limited to:
Individual Protective Factors
- Skills in coping and problem solving
- Reasons for living, such as family, friends, pets, etc.
- Cultural identity
- Supportive partners, friends, and family
- Feeling connected to others
- Connections to school, community, or other social places
- Availability of consistent and high-quality healthcare
- Reduced access to lethal means
- Cultural, religious, or moral objections to suicide
References:
Additional Resources
Suicide Prevention Portal
Risk factors may be described as a combination of individual, relationship, community, and societal levels that can increase the possibility that a person will attempt suicide.
Examples of risk factors include, but are not limited to:
Individual Risk Factors
- Previous suicide attempt(s)
- History of mental illnesses, particularly depression
- Serious physical illness, such as chronic pain
- Criminal/legal issues
- Financial problems or job loss
- Impulsive or aggressive tendencies
- Substance use
- Current or prior history of adverse childhood experiences
- Feelings of hopelessness
- Violence victimization and/or perpetration
- ċċċċċBullying
- Family history of suicide
- Loss
- Violent or high conflict
- Isolation
- Lack of access to healthcare
- Suicide clusters
- Adopting and adjusting to a new environment
- Violence
- Discrimination
- Stigma associated with mental illness and seeking help
- Access to lethal means
- Media portrayals of suicide
Additional Resource
- No exposed components of the ceiling system can be used as a ligature attachment point (i.e. rails, tees, mains)
- Panels can in no way be removed by the patient.
- No impact will dislodge the panel(s)
Additional Resources:
Suicide Risk Reduction Resources
- No exposed components of the ceiling system can be used as a ligature attachment point (i.e. rails, tees, mains)
- Panels can in no way be removed by the patient.
- No impact will dislodge the panel(s)
Additional Resources:
Suicide Risk Reduction Resources
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
• Panels can in no way be removed by the patient.
• No impact will dislodge the panel(s)
Additional Resources:
Suicide Risk Reduction Resources
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
• Panels can in no way be removed by the patient.
• No impact will dislodge the panel(s)
Additional Resources:
Suicide Risk Reduction Resources
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
• Panels can in no way be removed by the patient.
• No impact will dislodge the panel(s)
Additional Resources:
Suicide Risk Reduction Resources
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
- There are no exposed components of the ceiling system that can be used as a ligature attachment point (i.e. exposed rails, tee connectors, couplers, or main rails)
- Panels can in no way be removed by the patient.
- No impact will dislodge the panel(s)
Additional Resource
Suicide Prevention Portal
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present, if there are no objects that patients could easily use to climb up to the drop ceiling, remove a panel, and gain access to ligature risk points in the space above the drop ceiling, andas allowable by the facility's environmental risk assessment. These areas do not need to be in constant view of staff but should be a part of the standard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor, an alcove, or other non-visible areas) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient's suicide attempt and prevent the attempt from occurring.
Additional Resource
Suicide Prevention Portal
No, ֱ does not mandate "safe rooms" in emergency departments.Spaces/rooms designated ONLY for the treatment of patients with behavioral health conditions within an emergency department or other area should follow the Recommendations for Suicide Prevention in Healthcare Settingsfor inpatient psychiatric units.
Note: TJC does not define "safe room" in its glossary, however in the context of the FAQ this moniker is used to describe a "designated space" as a room and/or area that is dedicated to the evaluation and/or treatment of patients with behavioral conditions. Designated and non-designated are the descriptors used to identify these spaces.
Additional Resource
Suicide Prevention Portal
Yes, as per NPSG.15.01.01 EP1, these organizations are required to conduct a risk assessment to identify elements in the environment that individuals served could use to harm themselves, visitors, and/or staff. Those items that have high potential to be used to harm oneself or others should be removed and placed in a secure location (for example, putting sharp cooking utensils in a locked drawer) when possible. Staff should be trained to be aware of the elements of the environment that may pose a serious risk to an individual who could develop serious suicidal ideation. Staff should be aware of how to keep an individual safe from these hazards until they are stabilized and/or able to be transferred to a higher level of care. The technical advisory panel recognized that a patient placed in this level of care may have a change in mental state based on some trigger within the environment or in their treatment, and staff should be prepared for this.
Furthermore, these organizations must have policies and procedures implemented to address how to manage an individual in these levels of care who may experience an increase in symptoms that could result in self-harm or suicidality.
Additional Resources
Suicide Prevention Portal
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers “serious” as equivalent to “high risk”. Please refer to NPSG 15.01.01 in the Hospital Accreditation Manual for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers “serious” as equivalent to “high risk”. Please refer to NPSG 15.01.01 in the Hospital Accreditation Manual for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers “serious” as equivalent to “high risk”. Please refer to NPSG 15.01.01 in the Hospital Accreditation Manual for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers "serious" as equivalent to "high risk". Please refer to NPSG 15.01.01 in the Accreditation Manuals for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
ֱneither discourages nor promotes the use of these devices.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
ֱneither discourages nor promotes the use of these devices.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
ֱneither discourages nor promotes the use of these devices.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
ֱ neither discourages nor promotes the use of these devices. If an organization chooses to use such devices, the organization must ensure the devices are installed, maintained, and tested per Manufacturer's Instructions for Use.
Additional Resources
Suicide Prevention Portal
There is no height requirement for a ligature risk. Information from various sources notes that death by suicide as a result of asphyxiation can occur at any height. Specifically, there have been reports of death by suicide or suicide attempts during which patients fixed a cord, rope, or other material to a low pipe and around their neck and then spun their body ("alligator roll") to twist until it asphyxiated them. Thus, low-to-the-ground exposed piping (such as piping near toilets or under the sink, for example) or any other apparatus protruding from the wall or another structure is considered a ligature risk if the patient is able to create a sustainable point of attachment with another material in order to inflict self-harm or cause loss of life.
Additional Resource
Suicide Prevention Portal
ֱ has not specified a requirement for the number of ligature resistant beds on any given unit. This will depend on the needs of the patient population. The type of medical bed should be balanced based on the medical needs and the patients' risk for suicide. If medical beds that contain ligature risks are being used within an inpatient and/or designated psychiatric unit, they must be identified on the organization's environmental risk assessment (as per NPSG.15.01.01 EP1). For patients who require medical beds that have ligature points, there must be appropriate mitigation plans and safety precautions in place, including 1:1 observation for patients determined to be at high risk for suicide who have access to the bed(s). Plans to mitigate risk must be documented within the patients' medical record (as per NPSG.15.01.01 EP4). The organization must consider these risks in patients' overall suicide/self-harm risk assessments and implement interventions to mitigate these risks.
ֱ will not advise on the type of medical beds or ligature-resistant beds that should be purchased for patients. These decisions should be balanced based on patient needs. Organizations must evaluate beds and be aware of the ligature and/or other safety risks the bed(s) may present.
In addition, if these medical beds are being used, safety provisions must be considered. Provisions may include, but are not limited to, locking the patient room door where a medical bed is being used when unoccupied, removing a medical bed from the unit if not in use, enacting the safety features of the bed, when appropriate, and/or enhanced environmental and safety rounding. These provisions must be addressed in the organization's environmental risk assessment and/or policies and procedures.
Additional Resource
Suicide Prevention Portal
Patients who are currently at high risk for suicide should remain in a ligature resistant environment. If a patient who is at high risk for suicide enters another unit/area/building that contains ligature and other safety risks, continuous monitoring with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient – is required. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
Additional Resource
Suicide Prevention Portal
ֱ will not advise or recommend any particular type of shower curtain, but shower curtains are considered a risk. The expectation is that shower curtains must be noted on an environmental risk assessment and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where this risk is present. Shower curtains must be installed, inspected, maintained, and tested per Manufacturer's Instructions for Use to ensure proper functioning (e.g. breakaway features).
Additional Resources
Suicide Prevention Portal
The recommendation states: "Nursing stations with an unobstructed view (so that a patient attempt at self-harm at the nursing station would be easily seen and interrupted) and areas behind self-closing/self-locking doors do not need to be ligature resistant and will not be cited for ligature risks." This refers to what can be seen within the nurses station, not what is being seen from the nurses station. If there is an unobstructed view of everything within a nurses station, then patients should not be able to attempt self-harm at the nurses station since this would be easily seen and interrupted.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
No, ֱ does not recommend products. Organizations should reviewRecommendations for Suicide Prevention in Healthcare Settings, conduct a risk assessment of the environment, determine which products to appropriately install (based on manufacturers' instructions), and ensure that they are functioning properly.
Ligature resistant is defined as: without points where a cord, rope, bedsheet, or other fabric/material can be looped or tied to create sustainable point of attachment that may result in self-harm or loss of life.
See also FAQ Titled "Is there a height requirement in order to consider something a "ligature risk"?"
Additional Resource
Suicide Prevention Portal
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
Suicide Prevention Portal
FAQ Ligatures and/or Suicide Risk Reduction – Video Monitoring of Patients at High Risk for Suicide
No, not all patients being evaluated or treated for a behavioral condition require 1:1 monitoring.
In units/areas that contain ligature and/or other safety risks, patients determined to be at high-risk for suicide must be under continuous observation with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
In inpatient psychiatric units/designated psychiatric areas that are ligature resistant and free from other safety risks, it is up to the organization to determine monitoring requirements for patients determined to be at high-risk for suicide and define such in their policy.
Additional Resources
Suicide Prevention Portal
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue 1 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Yes, the standard requires screening individuals served for suicidal ideation who are being evaluated or treated for behavioral health conditions as their primary reason for care using a validated screening
A validated screening tool is one that has been scientifically tested for reliability (the ability of the instrument to provide consistent results), validity (the degree to which the instrument is measuring the condition that it is designed to measure), sensitivity (the ability of the instrument to correctly identify individuals with the condition) and specificity (the ability of the instrument to correctly identify individuals without the condition).
Patients being evaluated or treated for behavioral health conditions often have suicidal ideation. Brief screening tools are an effective way to identify individuals who require further assessment to determine risk for suicide. Screening tools should be appropriate for the population to the extent possible (e.g., age-appropriate). When using validated screening tools, organizations should not change the wording of the questions because small changes can affect the accuracy of the tools.
In addition, it is important that organizations ensure that the chosen screening tool(s) are implemented and completed as directed by the creators of the tool(s). For example, the Columbia Suicide Severity Rating Scale (CSSRS) is a validated screening tool that contains six questions. Depending on the answer to the first two questions, additional questions apply. One or more questions may get missed if the tool is not implemented or completed as directed. Another example, the ASQ Suicide Risk Screen Tool, is a four-question validated screening tool, which also contains a fifth question to assess acuity. This question may get missed if the tool is not implemented or completed as directed. Therefore, if not completed as instructed, the validity of the tool to identify individuals who may be at risk for suicide is compromised. Ultimately, it is the responsibility of each organization to ensure that validated tool(s) are implemented and completed accurately.
Additional Resource
Suicide Prevention Portal
Organizations are required to develop and follow written policies and procedures addressing the care of patients identified as at risk for suicide, including guidelines for suicide risk reassessment. Reassessment guidelines should address how often reassessments will occur as well as additional criteria that would trigger a reassessment, for example, a change in patient status, endorsement of suicidal ideation, and/or suicidal or self-harm behaviors or gestures. An evidence-based process must be used to conduct suicide risk reassessments for individuals who have screened positive for suicidal ideation and were further assessed for suicide risk. At minimum, reassessments must directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of evidence-based tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population.
If the organization does not use an evidence-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their reassessment is based off
- The reassessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
Suicide Risk Reduction Resources
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Patients with suicidal ideation vary widely in their risk for a suicide attempt depending upon whether they have a plan, intent, history of attempts, etc. It is important to conduct an in-depth assessment of patients who screen positive for suicide risk to determine how to appropriately treat them.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of validated tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population, if the questions adhere to the intent of the original validated tool.
If the organization does not use an evidenced-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their assessment is based off
- The assessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
SuicidePrevention Portal
For patients identified as high risk for suicide who have access to ligature or other safety risks, constant 1:1 visual observation must be implemented (in which a qualified staff member is assigned to observe only one patient at all times) that would allow the staff member to immediately intervene should the patient attempt self-harm. The use of video monitoring or "electronic sitters" would generally not be acceptable in this situation because staff would not be immediately available to intervene. The use of video monitoring would be acceptable as a compliment to the 1:1 monitoring, but not acceptable as a stand-alone intervention, unless as described below.
For patients at high risk for suicide, video monitoring may only be used in place of direct line-of-sight monitoring when it is unsafe for a staff member to be physically located in the patient's room.In addition, for both direct line-of-sight and video monitoring of patients at high risk for suicide, the monitoring must be constant 1:1 at all times, including while the patient sleeps, toilets, bathes, etc. and the monitoring must be linked to the provision of immediate intervention, when needed, by the qualified staff member assigned to observe the high-risk patient.
The use of "electronic sitters" or video monitoring for patients who are NOT at high risk for suicide is up to the discretion of the organization. There are currently no leading practices on how to use video monitoring to monitor those at risk for suicide.It is important to reassess patients who are at risk for suicide, despite the monitoring method that is chosen.
Additional Resource
Suicide Prevention Portal
The goal is to ensure accurate identification of care recipients. In the home care setting, this is much easier and less prone to error than in other settings. Certainly, at the first encounter, the requirement for two identifiers is appropriate in a literal sense. Thereafter, and in any situation of continuing one-on-one care where the nurse "knows" the individual, one of the identifiers can be direct facial recognition. In the home, the correct address (an acceptable identifier when used in conjunction with another person-specific identifier) is also confirmed.However, on all initial visits for home care whether temporary or changing providers, two identifiers should occur.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
An Opioid Treatment Program (OTP) should select outcome measures that target behaviors outlined in the program goals and objectives, while taking into consideration the size, location, and population served. The focus of outcome measures is to monitor patients progress while on Medication Assisted Therapy (MAT) thus, selecting indicators that can assist in determining improved behavior is important. For example, if the program objective is designed to reduce or eliminating the use of illicit
Opioids, other illicit-drugs, and the problematic use of alcohol and prescription drugs, the OTP should collect data in these areas. ֱs Behavioral Health Manual (Performance Improvement) also outlines examples of outcome measures that OTPs may measure such as:
• Criminal activities and entry into the criminal justice system
• Behaviors contributing to the spread of infectious diseases
• Restoration of physical and mental health and functional status
• Retention in treatment
• Number of patients who are employed
• Abstinence from drugs of abuse
An Opioid Treatment Program (OTP) should select outcome measures that target behaviors outlined in the program goals and objectives, while taking into consideration the size, location, and population served. The focus of outcome measures is to monitor patients progress while on Medication Assisted Therapy (MAT) thus, selecting indicators that can assist in determining improved behavior is important. For example, if the program objective is designed to reduce or eliminating the use of illicit
Opioids, other illicit-drugs, and the problematic use of alcohol and prescription drugs, the OTP should collect data in these areas. ֱs Behavioral Health Manual (Performance Improvement) also outlines examples of outcome measures that OTPs may measure such as:
• Criminal activities and entry into the criminal justice system
• Behaviors contributing to the spread of infectious diseases
• Restoration of physical and mental health and functional status
• Retention in treatment
• Number of patients who are employed
• Abstinence from drugs of abuse
An Opioid Treatment Program (OTP) should select outcome measures that target behaviors outlined in the program goals and objectives, while taking into consideration the size, location, and population served. The focus of outcome measures is to monitor patients progress while on Medication Assisted Therapy (MAT) thus, selecting indicators that can assist in determining improved behavior is important. For example, if the program objective is designed to reduce or eliminating the use of illicit
Opioids, other illicit-drugs, and the problematic use of alcohol and prescription drugs, the OTP should collect data in these areas. ֱs Behavioral Health Manual (Performance Improvement) also outlines examples of outcome measures that OTPs may measure such as:
• Criminal activities and entry into the criminal justice system
• Behaviors contributing to the spread of infectious diseases
• Restoration of physical and mental health and functional status
• Retention in treatment
• Number of patients who are employed
• Abstinence from drugs of abuse
An Opioid Treatment Program (OTP) should select outcome measures that target behaviors outlined in the program goals and objectives, while taking into consideration the size, location, and population served. The focus of outcome measures is to monitor patients progress while on Medication Assisted Therapy (MAT) thus, selecting indicators that can assist in determining improved behavior is important. For example, if the program objective is designed to reduce or eliminating the use of illicit
OTPs may measure, such as:
- Use of illicit opioids, illegal drugs, and the problematic use of alcohol and prescription medications
- Criminal activities and entry into the criminal justice system
- Behaviors contributing to the spread of infectious diseases
- Restoration of physical and mental health and functional status
- Retention in treatment
- Number of patients who are employed
- Abstinence from drugs of abuse
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
The requirement to collect race and ethnicity has historically applied to hospitals (Standard RC.02.01.01, EP 25). As of January 1, 2023, it will also apply to organizations in the ambulatory health care (RC.02.01.01, EP 31), behavioral health and human services (RC.02.01.01, EP 26) and critical access hospital (RC.02.01.01, EP 25) programs.
The intent of the requirement is to collect race and ethnicity information to identify potential health care disparities, and organizations have the flexibility to determine which categories of race and ethnicity are appropriate for the population they serve. ֱ does not specify which categories an organization should use to collect race and ethnicity data.
While ֱ requirement is not prescriptive of which categories of race and ethnicity should be collected, many state reporting entities and payers do specify these requirements. Organizations are encouraged to use, at a minimum, the race and ethnicity categories from the Office of Management and Budget (OMB) and US Census Bureau, and to consider collecting ethnicity categories based on the population to obtain additional granularity. Resources such as the Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement and the Health Research and Educational Trust Disparities Toolkit provide additional guidance on collecting race and ethnicity information.
Resources
In respect to laboratory electronic health records (EHR), the determination of whether a hospital information system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains unchallenged in practice. ֱ's longstanding position is that the laboratory, an integrated and essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or electronic, appears in the organization's patient medical record in the intended format and with all required elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical record also appear to the end user in the intended format and with all required elements, even if these alternate versions are not considered a part of the patient's permanent medical record.
Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory results in other formats and that do not represent the official or an alternate distribution version of the laboratory report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to innovation and functionality. As such, these supporting clinical applications are not required to contain all of the required elements of the official or alternate distribution versions of the laboratory report. However, each supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary to ensure clarity and proper interpretation by the end user. This assessment should include review by representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications that rely upon the original and corrected laboratory results.
As the area of information technology is rapidly changing, please note that this interpretation could change in the future based upon updated regulations, case examples, and other pertinent developments associated with the implementation of the electronic medical record in a healthcare organization.
Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Practitioners (nurse, physician, etc) communicating directly with a patient in their preferred language while providing care without the presence of an interpreter
There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another language while providing care, treatment or services. However, it is recommended that the organization has a process to make sure that communication with the patient in the non-English language is effective and meets the patient’s needs. For example, theorganization can determine if a language proficiency assessment is necessary to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to validate the patient's understanding of the information provided by the bilingual provider and communicate further information as needed.
Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Applicability of HR.01.01.01 to providers (nurse, physician, etc) serving as an interpreter for a fellow provider
The requirement found at HR.01.01.01 'Note 4' applies to bilingual providers serving as an interpreter to bridge the communication between a fellow provider and a patient. For example, the patient and his/her provider speak different languages and a bilingual provider is facilitating communication between them.
Organizations surveyed under the Behavioral Health Care (BHC) manual:
RI.01.01.03 requires that individuals providing interpretative services are trained to provide such services. Examples may include:
- Trained bilingual staff
- Contract interpreting services
- Employed language interpreter
Additional Resources:
- ֱ's Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care: A Roadmap for Hospitals
- The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Practitioners (nurse, physician, etc) communicating directly with a patient in their preferred language while providing care without the presence of an interpreter
There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another language while providing care, treatment or services. However, it is recommended that the organization has a process to make sure that communication with the patient in the non-English language is effective and meets the patient’s needs. For example, theorganization can determine if a language proficiency assessment is necessary to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to validate the patient's understanding of the information provided by the bilingual provider and communicate further information as needed.
Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Applicability of HR.01.01.01 to providers (nurse, physician, etc) serving as an interpreter for a fellow provider
The requirement found at HR.01.01.01 'Note 4' applies to bilingual providers serving as an interpreter to bridge the communication between a fellow provider and a patient. For example, the patient and his/her provider speak different languages and a bilingual provider is facilitating communication between them.
Organizations surveyed under the Behavioral Health Care (BHC) manual:
RI.01.01.03 requires that individuals providing interpretative services are trained to provide such services. Examples may include:
- Trained bilingual staff
- Contract interpreting services
- Employed language interpreter
Additional Resources:
- ֱ's Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care: A Roadmap for Hospitals
- The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Practitioners (nurse, physician, etc) communicating directly with a patient in their preferred language while providing care without the presence of an interpreter
There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another language while providing care, treatment or services. However, it is recommended that the organization has a process to make sure that communication with the patient in the non-English language is effective and meets the patient’s needs. For example, theorganization can determine if a language proficiency assessment is necessary to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to validate the patient's understanding of the information provided by the bilingual provider and communicate further information as needed.
Additional Resources:
The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Applicability of HR.01.01.01 to providers (nurse, physician, etc) serving as an interpreter for a fellow provider
The requirement found at HR.01.01.01 'Note 4' applies to bilingual providers serving as an interpreter to bridge the communication between a fellow provider and a patient. For example, the patient and his/her provider speak different languages and a bilingual provider is facilitating communication between them.
Organizations surveyed under the Behavioral Health Care (BHC) manual:
RI.01.01.03 requires that individuals providing interpretative services are trained to provide such services. Examples may include:
- Trained bilingual staff
- Contract interpreting services
- Employed language interpreter
Additional Resources:
- ֱ's Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care: A Roadmap for Hospitals
- The American Medical Association’s Promoting Appropriate Use of Physicians’ Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Practitioners (nurse, physician, etc) communicating directly with a patient in their preferred language while providing care without the presence of an interpreter
There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another language while providing care, treatment or services. However, it is recommended that the organization has a process to make sure that communication with the patient in the non-English language is effective and meets the patient's needs. For example, theorganization can determine if a language proficiency assessment is necessary to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to validate the patient's understanding of the information provided by the bilingual provider and communicate further information as needed.
Additional Resources:
The American Medical Association's Promoting Appropriate Use of Physicians' Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Applicability of HR.01.01.01 to providers (nurse, physician, etc) serving as an interpreter for a fellow provider
The requirement found at HR.01.01.01 'Note 4' applies to bilingual providers serving as an interpreter to bridge the communication between a fellow provider and a patient. For example, the patient and his/her provider speak different languages and a bilingual provider is facilitating communication between them.
Organizations surveyed under the Behavioral Health Care (BHC) manual
RI.01.01.03 requires that individuals providing interpretative services are trained to provide such services. Examples may include:
- Trained bilingual staff
- Contract interpreting services
- Employed language interpreter
Additional Resources
The American Medical Association's Promoting Appropriate Use of Physicians' Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include but not be limited to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Critical Access Hospital
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include, but not be limited, to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
Reference EM.12.02.09 EP3.
The following are links to FAQs that address the new requirements:
Emergency Management – Hazard Vulnerability Analysis
Emergency Management - Human Resource (HR) Requirements for Volunteers
Emergency Management – Continuity of Operations Plan (COOP) and Disaster Recovery
Emergency Management - Requirements for Granting Privileges During a Disaster
Emergency Management - Duration for Continuing Disaster Privileges
Emergency Management – 96 Hour Plan
Emergency Management – Emergency Operations Plan Development and Participation
Emergency Management – Privileging Requirements When Providing Services via Telehealth Links During a Disaster
Emergency Management – Committee Expectations
Emergency Management – Incident Command Structure
Emergency Management – Inventory
Additional Resources:
Emergency Management Portal
R3 Report: Requirement, Rationale, Reference
For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation.
EM.10.01.01 requires senior leaders to participate in emergency management planning activities. Although it is up to the hospital to determine committee participants, the committee should be a multidisciplinary team which may include representatives from senior leadership, nursing services, medical staff, pharmacy services, infection prevention and control, facilities engineering, security and information technology. There are specific activities required of the committee (see EM.10.01.01, EP 4).
Reference EM.10.01.01
The requirements for a Continuity of Operations Plan (COOP) are defined in EM.13.01.01. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plant, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery (EM.14.01.01) after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. To evaluate effectiveness, the survey process will review the emergency operations plan, the continuity of operations and recovery plans, interview staff and review exercise evaluations.
Volunteer physicians and other licensed practitioners that have been granted disaster privileges may continue to provide care, treatment and services under the disaster privileging option (see EM.12.02.03) for the period of time the organization continues to operate under its Emergency Operations Plan (EOP). Organizations should periodically assess the number and specialty of those volunteer physicians and other licensed practitioners initially granted disaster privileges to ensure the ongoing needs of the patient population are being met and that the medical staff can maintain oversight over practitioner performance. If an important patient care need continues at the time the organization discontinues operation of the EOP, the medical staff could either grant temporary privileges or consider granting full privileges. NOTE: All Credentialing and Privileging must be consistent with applicable law, regulation and medical staff requirements.
A multidisciplinary committee that oversees the EM program should include medical staff or physician member as well as hospital executive leadership (e.g. individuals with decision-making authority). The multidisciplinary committee, including medical staff and hospital leadership, will be directly involved in the preparation, development, implementation, evaluation, and maintenance of the EM program, the emergency operations plan, policies, and procedures. Their input is essential to establish the expected capabilities and duties of these entities.
It is also important for medical staff and executive leadership to understand the duties and capabilities for the staff that will support the emergency operations plan, and the capabilities of community support entities. Many disaster scenarios involve patient care regarding management of current patients and managing influx of patients. Hospital leaders must understand the command structure and how it functions.
The HVA should be reviewed and updated based on after-action reports or opportunities for improvements that have been identified following real events and/or exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improve, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and an HVA performed for that site.
^Licensed volunteers are practitioners (physicians, nurses, therapists, etc.) who can provide direct patient care, treatment, and services who by law and regulation are required to have a license to practice. Other licensed volunteers (electricians, plumbers, inspectors) may provide unique services to help rebuild or restore a hospital or community.
ֱ's requirements for incident command at EM.12.01.01, EP 5 includes an incident command structure that describes the overall incident command operations, specific roles and responsibilities, and provides a structure that is flexible and scalable based on the needs of the organization during an emergency or disaster incident. Incident command staff are to be trained to be competent to effectively accomplish their assigned duties, command roles and responsibilities (EM.15.01.01, EP 4).
The hospital must have a written plan for how resources and assets are documented, tracked, and monitored and how they will locate (on-site and off-site inventories) during a disaster/emergency incident (EM.12.02.09, EP 1). The plan includes processes or procedures for how the hospital will manage and maintain critically needed resources such as personal protective equipment, water, fuel, and medical, surgical supplies and medications. It is up to the organization to determine what additional resources and assets may be needed during an emergency.
The written plan should include how the hospital will obtain, allocate, mobilize, replenish and conserve its resources and assets (see EM.12.02.09, EP 2). Memorandums of Understanding (MOUs) or other agreements may be formed with other entities to help the organization maintain its inventory during an emergency. However, MOUs are most useful during isolated emergencies, and are often not effective during large emergency events impacting a large region. Therefore, it is very important to test and/or document this along with the other five critical areas during an exercise or actual event to look for areas of risk.Additionally, hospitals are required to have a plan to sustain operations for up to 96 hours based on calculations of current resource consumptions (see EM.12.02.09, EP 3).
The applicable requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03. NOTE: The disaster privileging option ONLY applies when the organization has implemented their emergency management plan.
Physicians and other licensed practitioners CURRENTLY credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that telehealth be delineated as a separate privilege.
For volunteer physician and other licensed practitioners that are NOT currently credentialed and privileged by the organization, disaster privileges may be granted to volunteer physicians and other licensed practitioners by following the requirements outlined in the Emergency Management chapter of the accreditation manual. Additional Resources FAQ: Requirements for Granting Privileges During a Disaster.
The applicable requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03. NOTE: The disaster privileging option ONLY applies when the organization has implemented their emergency management plan.
Licensed Practitioners (LP)CURRENTLY credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that 'telehealth' be delineated as a separate privilege.
For volunteer Licensed Practitioners that are NOT currently credentialed and privileged by the organization, disaster privileges may be granted to volunteer LIPs by following the requirements outlined in the Emergency Management chapter of the accreditation manual.
Additional Resources
FAQ:Requirements for Granting Privileges During a Disaster.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Before granting emergency privileges, the organization must obtain a valid, government-issued photo ID (e.g. driver's license, passport) and at least one of the following:
- A current picture identification card from a health care organization that clearly identifies professional designation
- A current license to practice
- Primary source verification of licensure. (^) NOTE: Primary source verification of licensure occurs as soon as the disaster is under control or within 72 hours from the time the volunteer licensed practitioner presents to the hospital, whichever comes first. (see also EM.12.02.03 for additional information).
- Identification indicating that the individual is a member of a Disaster Medical Assistance Team (DMAT), the Medical Reserve Corps (MRC), the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), or other recognized state or federal response organization or group Identification indicating that the individual has been granted authority by a government entity to provide patient care, treatment, or services in disaster circumstances
- Confirmation by a licensed practitioner currently privileged by the hospital or by a staff member with personal knowledge of the volunteer practitioner's ability to act as a licensedpractitioner during a disaster
The medical staff must have a process in place to oversee the performance of each volunteer practitioner. Based on its oversight of each volunteer licensed practitioner, the hospital determines, within 72 hours of the practitioner's arrival, if granted disaster privileges should continue.
Note: The requirements for assigning disaster responsibilities to volunteer practitioners who are NOT licensed practitioners, but who are required by law and regulation to have a license, certification, or registration, are found in the Hospital and Critical Access Hospital Accreditation manual at EM.12.02.03. Examples of such practitioners may include, but are not limited to: Nurses, Physician Assistants, Nurse Practitioners, Respiratory Therapists, etc.
Organizations that use Joint Commission accreditation for deemed status purposes should monitor the as waivers are being approved frequently and may include state-specific waivers.
The requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03.
Disaster privileges can only be granted to volunteer licensed practitioners when the organization's Emergency Operations Plan has been activated. A disaster is an emergency that, due to its complexity, scope, or duration, threatens the organization's capabilities and requires outside assistance to sustain patient care, safety, or security functions.
Before granting emergency privileges, the organization must obtain a valid, government-issued photo ID (e.g. driver's license, passport) and at least one of the following:
Before granting emergency or disaster incident privileges, the organization must have a documented staffing plan for the management of volunteer licensed practitioners when the hospital is unable to meet its patient needs. The plan outlines the following:
- Verifies and documents the identify of all volunteer licensed practitioners
- Completes primary source verification of licensure as soon as the immediate situation is under control or within 72 hours from the time the volunteer licensed practitioner presents to the organization
- Provision of oversight of the care, treatment, and services provided by the volunteer licensed practitioner
- Note: If primary source verification of licensure cannot be completed within 72 hours, the hospital documents the reason(s) it could not be performed
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or the 2018 FGI Guidelines for Design and Construction of Hospitals.
Reference: EC.02.06.05 EP 1
Additional Resources
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or in their absence thelatest edition ofFGI Guidelines for the Design and Construction of Outpatient Facilities.
The FGI Guidelines documents state "the number and placement of both hand-washing stations and hand sanitation dispensers shall be determined by the ICRA." (Section 2.1-7.2.2.8) The ICRA or infection control risk assessment, which should be done at the programming stage of the project and should help guide the decisions on where to locate them. The individual facility chapters, though, have additional specific requirements for hand washing stations in certain locations. For example, each exam or treatment room is required to have one.
Additional Resources:
To access a read only copy of the FGI Guidelines for Design and Construction of Outpatient Facilities the hyperlink is provided here for your convenience:
Reference EC.02.06.05 EP1
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2010 edition of NFPA 10 Standard for Portable Fire Extinguishers which is a mandatory reference in chapter 2 of the 2012 edition of NFPA 99, Healthcare Facilities Code.
The organization is expected to determine and select an appropriate fire extinguisher based upon a site-specific risk assessment that would include but not limited to:
- potential fire size
- types of fuels present
- sources of ignition
- flammable skin prep products
- potential for chemical reactions with the extinguishing agent
- presence of electrical equipment
According to the NFPA, a water-mist or carbon dioxide extinguisher may be used in the OR. Water mist-extinguishers are rated Class 2A:C. ECRI Institute has published information that water-mist fire extinguishers may not be appropriate in the operating room due to infection control concerns if used on a patients open surgical site cavity. Alternatively, a close-by basin of sterile water with a sponge to quench a surgical site fire might be most appropriate.
Carbon dioxide extinguishers are rated Class B and Class C, and can also be used for Class A fires.
Electrical fires or Class C, once the equipment is unplugged and de-energized, the fuel source is considered to be either a class A or B, allowing a carbon dioxide extinguisher to be utilized.
Additional Resources
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
- Each facility should develop policies about the specific frequency and methods for wall box surface disinfection
- Wall box surfaces should be disinfected at least daily
- Cleaning and disinfection of the wall box should be performed after the patient has left the station
- Disinfectant should be applied to all surfaces of the wall box and any attached hoses
- Ensure high touch surfaces (e.g., connections for acid, bicarbonate, and reverse osmosis water) are disinfected
- Wipes or other supplies used to disinfect the wall box should be discarded after use and not used to disinfect other surfaces in the dialysis station
- More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
If your organization is using ֱ accreditation process for deemed status purposes, then all medical equipment is required to be included in the written inventory.
The written inventory identifies high-risk devices. High-risk medical equipment includes all life support equipment and any other device for which there is a risk of serious injury or death to a patient or staff member should it fail. The term high-risk equipment is equivalent in scope and nature to the CMS term critical equipment.
Maintenance activities and frequencies follow manufacturers' instructions and recommendations for maintaining, inspecting, and testing all medical equipment in the inventory. These maintenance activities and frequencies, including an alternative equipment maintenance (AEM) strategy, are documented in writing.
The alternative equipment maintenance (AEM) strategy program must not reduce safety and is based on accepted standards of practice such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of maintenance and run-to-fail strategies.
AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers' recommendations:
- Equipment subject to federal or state law or Medicare Conditions of Participation
- Imaging and radiologic equipment (diagnostic or therapeutic)
- Medical LASER devices
- New medical equipment with insufficient maintenance history to support the use of an AEM strategy
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
The labeling shall include:
- the name or chemical symbol for the specific medical gas or vacuum system
- room or areas served
- caution to not close or open the valve except in an emergency
Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its hidden location may be identified by a label, icon, etc., or on a utility system map in accordance with EC.02.05.01 EP 17.
Reference EC.02.05.09 EP11
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
ֱ references NFPA 99-2012 Chapter 9, that requires the use of ASHRAE 170-2008, Ventilation Table 7-1. This document provides allowances to exceed minimum temperature ranges. To use this exception, it must be done by following the established organizational policy. In accordance with the allowances, the policy or formal process must be limited to cases based on either surgeon, patient, or procedure. It is not acceptable to consistently maintain temperatures outside of the required ranges.
Reference EC.02.05.01 EP 15
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
ֱ standards are not prescriptive regarding testing frequencies for piped medical gas and vacuum systems. The facility may determine its testing frequency by policy and the surveyor will evaluate testing based on that policy.
In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and reliable condition.
The organization is required by EC.02.05.01 to develop a maintenance strategy based upon either manufacturer's recommendations or an alternative equipment maintenance (AEM) strategy. Piped medical gas and vacuum systems are considered high-risk utility systems.
Issues such as system complexity, system age/condition, patient acuity, etc. are to be used to assess maintenance strategies. NFPA 99-2012 Appendix B can be used as a guide for establishing a maintenance strategy, but appendix material is not required unless adopted by a controlling authority. The survey process will evaluate the maintenance strategy assessment process for effectiveness and validate that it has been properly implemented.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
- applicable staff
- type of training
- level of training
- required credentials
The security management plan may be a stand-alone document or may be combined with other Environment of Care plans (one overarching plan or combined with another, such as the safety management plan, for instance). Components of the plan are outlined in EC.02.01.01 EPs, which include but not limited to:
- how will security risks be assessed and mitigated
- staff roles in security management
- how the facility is secured
- how the organization contact external security forces if needed
- how the organization will control access to areas identified as security sensitive
- how physical or verbal threats, acts of violence, inappropriate behavior will be managed
- If the organization has an MRI, there is to be an assessment for safety and security risk that addresses patient comfort and safety, equipment safety and security, and staff safety
Any requirements from the local authority having jurisdiction (AHJ) are expected to be followed.
Reference:
EC.01.01.01 EP 5
EC.02.01.01.
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ is not prescriptive to monitor or log temperature for refrigerators provided for personal patient use. However, a process is required to be in place to ensure that the refrigerator functions properly to safely store its contents.
ֱs standards require that organizations store food and nutrition products, including those brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and security as per PC.02.02.03.
When nutritional products, such as breast milk or baby formula are stored in these refrigerators, refer to evidence-based guidelines from the formula manufacturer's instructions for use (IFU), the Centers for Disease Control and Prevention (CDC), etc. to ensure safe storage.
Organizations should also have processes that address cleaning between patients and identifies maintenance responsibilities.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Additional Resources:
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ standards do not require infant/child abduction drills. The standards do require that the organization identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable (see EC.02.01.01 EP 9). An exercise is one method to evaluate the effectiveness of the procedures regarding this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of the security procedures and that staff are knowledgeable of those procedures.
Conduct a risk assessment through a multi-disciplinary group that includes, for instance, OB, NICU, Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to address actual and potential risks.
Reference EC.02.01.01 EP 9
ֱ standards do not require infant/child abduction drills. The standards do require that the organization identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable (see EC.02.01.01 EP 9). An exercise is one method to evaluate the effectiveness of the procedures regarding this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of the security procedures and that staff are knowledgeable of those procedures.
Conduct a risk assessment through a multi-disciplinary group that includes, for instance, OB, NICU, Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to address actual and potential risks.
Reference EC.02.01.01 EP 9
ֱ standards do not require infant/child abduction drills. The standards do require that the organization identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable (see EC.02.01.01 EP 9). An exercise is one method to evaluate the effectiveness of the procedures regarding this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of the security procedures and that staff are knowledgeable of those procedures.
Conduct a risk assessment through a multi-disciplinary group that includes, for instance, OB, NICU, Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to address actual and potential risks.
Reference EC.02.01.01 EP 9
ֱ standards do not require infant/child abduction drills. The standards do require that the organization identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable (see EC.02.01.01 EP 9). An exercise is one method to evaluate the effectiveness of the procedures regarding this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of the security procedures and that staff are knowledgeable of those procedures.
Conduct a risk assessment through a multi-disciplinary group that includes, for instance, OB, NICU, Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to address actual and potential risks.
Reference EC.02.01.01 EP 9
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.). Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.). Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore, some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
For ambulatory surgical centers and outpatient surgical departments that use ֱ deemed status option, that were constructed, or had a change in occupancy type, or have undergone an electrical system upgrade since 1983, a Type 1 or Type 3 essential electrical system is required as defined in the 2012 edition of NFPA 99.
This essential electrical system must be divided into three branches, including the:
- life safety branch
- critical branch
- equipment branch
Type 1 essential electrical system is required for:
- Critical care areas are those special care units in which patients are intended to be subjected to invasive procedures using electrical patient care medical equipment. Type 1 systems should be installed where there would be a risk of death or serious injury to the patient in the event of power failure.
- To supply emergency power in facilities that do not provide electrical life support or use general anesthesia. Type 3 systems are permitted where equipment failure is less critical to human life and safety.
Additional Resources:
EC.02.05.03
NFPA 99-2012: 6.3.2.2.10, 6.4.1, 6.4.2.2, 6.6.3
CMS S&C 07-21
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
ֱ standard EC.02.05.01 EP 15 references NFPA 99-2012, which includes ANSI/ASHRAE/ASHE Standard 170-2008, or state design requirements if more stringent for temperature, pressure, and humidity requirements. This applies to hospital and outpatient facilities that were built, altered, or renovated after July 5, 2016. This document states that soiled workroom shall be negative with a temperature between 72-78 degrees Fahrenheit and no humidity requirement. The Clean workroom shall be positive, with temperature between 72-78 and a maximum relative humidity of 60%. For existing facilities (prior to July 5, 2016), you may comply with either these requirements, or the requirements that were in effect at the time of construction. In existing one-room layouts, the air flow within the room shall be from clean to dirty (with negative air flow overall).
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list toStandard 170-2008 Ventilation of Health Care Facilities.
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
•The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
•Current license, certification, or registration confirmed via primary source verification.
•Meets the educational and experience requirements defined by the organization.
•Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
•Orientation to the policies and procedures, key safety content and specific job duties.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
•Pharmacy
•Dietary
•Environmental Services
•Laundry Services
•Agency/traveling staff (nurses, therapists, etc)
•Mobile imaging (CT,PET, MRI, etc)
The following FAQs may also be informative in assisting contract service providers understand verification requirements:
•The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
•Current license, certification, or registration confirmed via primary source verification.
•Meets the educational and experience requirements defined by the organization.
•Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
•Orientation to the policies and procedures, key safety content and specific job duties.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
•Pharmacy
•Dietary
•Environmental Services
•Laundry Services
•Agency/traveling staff (nurses, therapists, etc)
•Mobile imaging (CT,PET, MRI, etc)
The following FAQs may also be informative in assisting contract service providers understand verification requirements:
•The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
•Current license, certification, or registration confirmed via primary source verification.
•Meets the educational and experience requirements defined by the organization.
•Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
•Orientation to the policies and procedures, key safety content and specific job duties.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
•Pharmacy
•Dietary
•Environmental Services
•Laundry Services
•Agency/traveling staff (nurses, therapists, etc)
•Mobile imaging (CT,PET, MRI, etc)
The following FAQs may also be informative in assisting contract service providers understand verification requirements:
•The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
•Current license, certification, or registration confirmed via primary source verification.
•Meets the educational and experience requirements defined by the organization.
•Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
•Orientation to the policies and procedures, key safety content and specific job duties.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
•Pharmacy
•Dietary
•Environmental Services
•Laundry Services
•Agency/traveling staff (nurses, therapists, etc)
•Mobile imaging (CT,PET, MRI, etc)
The following FAQs may also be informative in assisting contract service providers understand verification requirements:
•The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
•Current license, certification, or registration confirmed via primary source verification.
•Meets the educational and experience requirements defined by the organization.
•Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
•Orientation to the policies and procedures, key safety content and specific job duties.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
•Pharmacy
•Dietary
•Environmental Services
•Laundry Services
•Agency/traveling staff (nurses, therapists, etc)
•Mobile imaging (CT,PET, MRI, etc)
The following FAQs may also be informative in assisting contract service providers understand verification requirements:
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
ֱ's,expectation is thatthe organization is aware of anyoneentering the organizationand their purpose in order to maintain patient safety. Leadership is responsible to ensure that the processes are in place and implemented to ensure patient privacy and safety.
For non-licensed, non-employees that have a direct impact on patient care. E.g. HCIRs or Vendorsin procedure rooms/operating rooms providing guidance to the surgeon or staff, trainingof staff on equipment use, surgical assistants brought in by surgeons additional requirements include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information, as well as obtaining informed consent in accordance with organization policy and law/regulation.
- Awareness of applicable infection control and patient safe processes/procedures.
- For non-employees brought into the organization by licensedpractitioners,organizations must also addressqualifications, competency and performance evaluation.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master's Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as 'paper' or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Joint Commission standards require that when developing infection prevention and control activities, the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert consensus. The is published by the CDC's Healthcare Infection Control Practice Advisory Committee (HICPAC).
Recommendation V.B.3.b.i. from the HICPAC guideline states, "Wear a gown whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient. Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment."
Joint Commission surveyors will expect healthcare workers to wear a gown if their "clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient". The difficulty lies in "anticipating" when this may occur. For example, it is very probable that a nurses' aide preparing to perform a bed bath will have contact as described above, and therefore a gown would be expected. However, one of a large group of residents performing rounds with an attending physician would have a lower likelihood of clothing contamination.
Each organization may decide what guidance to provide to its healthcare workers within the parameters provided by HICPAC. However, ֱ would encourage organizations to consider the high morbidity and mortality of healthcare-associated infections in our nation when deciding what constitutes "anticipated contact" in each facility. Additionally, organizations may want to discourage non-essential personnel from entering the rooms of patients on isolation precautions.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
- For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensedpractitioners, screenings must be made available in some cases, but each organization may decide whether these screenings are mandatory if not required by state law/local regulatory requirements. The health status of an applicant for medical staff privileges is also addressed in the HR chapter (AHC, OBS) or MS chapter (HAP and CAH).
- Treatment or referral must be initiated if the organization becomes aware of any individual, including non- employed physicians and other licensedpractitioners, who "have, or are suspected of having, an infectious disease that puts others at risk".(Action is needed only if the organization becomes aware of such an exposure).
- Treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, who "have been occupationally exposed to an infectious disease". (Action is needed only if the organization becomes aware of such an exposure).
- The use of evidence-based national guidelines, such as the CDC, or, in the absence of such guidelines, expert consensus to develop an organizational plan for developing guidelines to prevent disease transmission in healthcare settings.
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
The R3 report Introduction to Standard IC.07.01.01 states:"While there is not a standardized definition for high-consequence infectious diseases (HCIDs) or special pathogens, expert consensus defines these as novel or reemerging infectious agents that are easily transmitted from person-to-person, have limited or no medical countermeasures (such as an effective vaccine or prophylaxis), have a high mortality, require prompt identification and implementation of infection control activities (for example, isolation, special personal protective equipment), and require rapid notification to public health authorities and special action. Examples of high-consequence infectious diseases or special pathogens include MERS, novel influenzas, and Ebola or other viral hemorrhagic fever diseases. This list may change, however, to reflect current regional or global outbreaks or to include future emerging agents."
The definitive list is not provided because the identity of the pathogen may not always be known or certain. The intent is routine screening using a syndromic-based approach (fever, rash, respiratory symptoms), and travel history to determine if the symptomatic patient traveled to an area with an active outbreak. Organizations should also examine information or definitions provided by local and state law and regulation.
What is meant by "points of entry"?
Points of entry are typically understood as the first point of contact, but the organization can operationalize the appropriate location or what constitutes the first point of contact (for example, front desk, triage area at the emergency room, electronic check-in prior to the appointment, etc.) Note that points of entry may include the emergency department, urgent care, and ambulatory clinics.
What are the expectations regarding the "identify" screening protocols at the points of entry?
The requirement for "Identify" protocols builds on the CDC Core Practice "Minimizing Potential Exposures" that includes the development and implementation of "systems for early detection and management (e.g., use of appropriate infection control measures, including isolation precautions, PPE) of potentially infectious persons at initial points of patient encounter in outpatient settings (e.g., triage areas, emergency departments, outpatient clinics, physician offices) and at the time of admission to hospitals and long-term care facilities (LTCF)."
The expectation is that screening is implemented at the point of entry for fever, respiratory symptoms, rash, and travel history. However, the Joint Commission is not prescriptive on the implementation details, leaving it to organizations to develop the screening protocols that best fit their care environments and resources. For example, hospitals and critical access hospitals may consider the following:
- Active and/or passive screening processes, such as staff at the point of entry asking specific questions, posting visual alerts at the entrances of clinics on signs and symptoms that patients/visitors should report to staff when they first register for care, etc.
- The organization can determine the threshold at which screening will escalate from passive (e.g., signs at the entrance) to active (e.g., direct questioning).
- The organization can definethe threshold at which travel screening will be initiated, such as after ascertaining that persons entering the facility present with fever, fever & rash, fever & respiratory symptoms.
The organization may revise or adjust screening protocols based on: The absence/or presence of known transmission locally, regionally, nationally or internationally; in the setting of suspected or identified special pathogen locally, regionally, nationally or internationally; the guidance of public health authorities.
What are the expectations regarding competencies?
Hospitals have the flexibility to define the competencies required by the organization, in accordance with HR.01.06 01 EP 1. This includes competencies associated with the practical applications of the Identify-Isolate-Inform protocols. In general, competencies must be based on observable and measurable methods, such as use of a written test or a demonstration of accurate completion of procedure or process. The organization decides what type of education and training must have a competency associated with it.
Is there an expectation to address each special pathogen separately?
There is no expectation to address each special pathogen separately since the identity of the pathogen may not always be known or certain. Hospitals should focus on screening using a syndromic-based approach (fever, rash, respiratory symptoms) and travel history to determine if the symptomatic patient traveled to an area with an identified active outbreak or known organism of concern.
Does IC.07.01.01 apply to psychiatric hospitals?
IC.07.01.01 applies to acute hospitals. The requirements under IC.07.01.01 are not applicable to psychiatric, surgical specialty, long term care acute hospitals or swing beds.
Additional Resources
Any examples are for illustrative purposes only.
Immediate-Use Steam Sterilization (IUSS), formerly termed "flash" sterilization, is described as "the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field". IUSS items are not intended to be stored for future use.
Considerations for IUSS
- Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the IFUs regarding cycle type, temperature setting, exposure time, and drying times.
- IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
- Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
- IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
Evidence-based guidelines should be adopted to minimize the use of IUSS.Scenarios when IUSS may be appropriate include:
- When a specific instrument is needed for an emergency procedure.
- When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
- When an item has dropped on the floor and is needed to continue a surgical procedure.
- When 'loaner' trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery occurssufficiently in advance of scheduled case(s)to allow complete reprocessing of trays by the organization.Such a requirement is an example of a performance expectation to include in a contract (seeLD.04.03.09).
- Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
- Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
- Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
- Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
- Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
- When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care.
- Ensure that sterilization practices, in all locations, have been fully incorporated into the organization's Quality Assessment Performance Improvement (QAPI) activities.
- Evaluate the IUSS process in all locations that it is being performed.Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization.
Resources
- The Association for Professionals in Infection Control and Epidemiology (APIC)
- The Association of periOperative Registered Nurses (AORN)
- The Association for the Advancement of Medical Instrumentation (AAMI).
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
NOTE: This FAQ does not apply to any clothing that has been designated by the organization as personal protective equipment (PPE) as defined by Occupational Safety and Health Department (OSHA): specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.)
ֱ standards do not require employers to launder surgical scrubs or other attire. However, ֱ's Leadership Standard LD.04.01.01 requires health care organizations to adhere to applicable federal (e.g. OSHA), state and local regulations (e.g., licensing requirements), and if deemed, Centers for Medicare and Medicaid Conditions of Participation and/or Conditions of Coverage. The hierarchical approach to infection control standards as described in ֱ Perspectives, April 2019, should be used to guide development of infection control related policies and procedures for laundering surgical scrubs or attire that is not designated as personal protective equipment and is worn in the healthcare setting.
Applicable elements to consider include the following:
- The OSHA Bloodborne Pathogen Standard requires that all clothing, including scrubs and personally owned attire such as uniforms or street clothing, which have been visibly soiled with blood or other potentially infectious materials, be laundered by the employer at no cost to the employee.
- For surgical scrubs, uniforms, or other attire not considered personal protective equipment and which are not visibly contaminated, organizations should determine if there any requirements that the facility provide clean attire to staff to perform their job duties. For example, some states, require that hospitals and ambulatory care facilities provide hospital laundered scrubs for healthcare workers working in the restricted or semi-restricted areas. State requirements may be more stringent and prescriptive than those from OSHA.
- To our knowledge, Center for Medicare and Medicaid Services (CMS) does not have any requirements for laundering surgical attire or uniforms. But as recommended by the Joint Commission and CMS, organizations should consult evidence-based guidelines for best practices and consider their adoption. Examples of guidelines include the Guideline for Surgical Attire (effective July 1, 2019) from the Association for periOperative Nursing (AORN), the AST Guidelines for Best Practices for Laundering Scrub Attire (revised April 14, 2017) from The Association of Surgical Technologists and the Statement on operating room attire (approved July 2016) from the American College of Surgeons.
Additional Resources:
See also the Perspectives®, April 2019, Volume 39, Issue 4 Page 15:Clarifying Infection Control Policy Requirements
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
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No, requirements for managing linen are notdefined within ֱ standards. Organizations are expected to develop their linen cleaning, storage and management requirements in accordance with evidence-based sources, such as the CDC, the National Association of Institutional Linen Management and/or the local or state authority having jurisdiction.
For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be used to store linens on patient-care areas (hallways) must have covers on them during transportation and storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."
If an organization is unsure whether their linen management processes are compliant with such guidelines, conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
The focus of the IC standards is prevention of transmission of infectious disease. If no patient or specimen contact occurs, no transmission is possible. While a risk assessment would not be required, if performed it would reveal no risk at all. As such, no surveillance or reporting would be required, even for staff.
If the organization receives back contaminated equipment, then all IC standards apply.
Please note, however, that interpretive reading services do play a critical role in disease detection and communication. These services bear the responsibility for notification of infectious disease-related results, especially those for which the differential diagnosis might necessitate isolation or public health action. Examples would be a radiology study showing a right upper lobe cavity lesion (suspicious for pulmonary tuberculosis), or mediastinal widening (suspicious for inhalation anthrax). Pathology studies would include those that identify pathogens considered reportable to a public health authority.
Therefore, interpretive reading providers must have clearly defined processes for communication of such results. An agreement should be in place with each organization for which services are provided. It should specify which results are to be communicated urgently, whom should be notified, and in what time frame. It is expected that many organizations will choose to have their infection control practitioner notified in addition to the provider who orders the test.
Employee health programs may or may not be required. If your organization determines that one is not needed, please check with your state's health department or healthcare licensing act, which may have further regulations.
In conclusion, Teleradiology services will only be evaluated for compliance as delineated above. They are encouraged, but not required, to incorporate practices for hand hygiene (please see NPSG.07.01.01).
ֱ does not determine which items are prohibited from a behavioral health setting. Items that are prohibited from use in an organization, due to the risk of harm to self or others, should be determined by the organization.
Source control involves having people wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions and thus reduce the dispersion of droplets from an infected individual.
TheCDC recommendsimplementing source control (use of masks) in a healthcare facility to prevent dispersal of respiratory droplets from known, asymptomatic and pre-symptomatic people with COVID when are high.Compliance with this recommendation should be based upon the organization's assessment, policies/procedures, individual care plans, and applicable state rules or regulations.
When evaluating the updated CDC recommendations for a patient with behavioral health needs, it is important to complete an assessment of the impact that wearing a face covering or mask would have on the safety of a patient(s), staff and visitors. The expectation is for organizations to complete a clinical risk assessment of the individual for possible self-harm or harm to others if they will wear a mask. The organization must have a process to determine if the patient is capable of wearing a face covering, or mask, based on clinical assessment.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
No, there is no requirement that all surgical procedures be included in an organization's surveillance for surgical site infections (SSI). We expect organizations to follow a hierarchical approach when establishing infection surveillance. We would first expect organizations to follow applicable federal and state law and regulation, then if deemed or required by state regulation, to follow CMS requirements. Some states have specified surgical procedures for which surveillance must be performed. If mandated by your state, then the Joint Commission would expect your organization to be compliant to that requirement.
In the absence of federal/state mandates for specific surgical site infection surveillance requirements, organizations may choose to target SSI surveillance based on the results of a risk assessment. If an organization's risk assessment shows that risk is greatest for certain procedures or settings, the surveillance program may be targeted to focus resources on those high-risk procedures. Organizations may wish to consider conducting periodic risk assessments to ensure that the scope of the targeted procedures included in surveillance activities remains current. Conducting a risk assessment is a helpful way of identifying risks associated with various procedures performed. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
The risk assessment should focus on all components of the surgical continuum, including – but not limited to - staff knowledge and competency, adoption of – and compliance with - evidence-based guidelines for reprocessing of instruments, policies and procedures, surgical attire, practitioner engagement, and patient education. Compliance with any state-specific reporting requirements should also be evaluated. From a quality and safety perspective, ensure that surgical procedures performed in all locations have been integrated into the organization-wide quality assessment and performance improvement (QAPI) program.
Additional Resources
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
ֱ standards require organizations to comply with applicable law and regulation to ensure the privacy and integrity of protected health information (PHI) are maintained. When an organization's staff is not present to monitor medical records storage areas, alternative approaches must be employed to protect privacy and confidentiality of this information. Keeping such information secure when staff is not present generally requires a process that includes a locking mechanism. The use of alternative approaches, such as a signed confidentiality statement in lieu of a locking mechanism, should be thoroughly evaluated by the organization's legal and risk management leadership to determine if such approaches comply with regulatory requirements (CMS, state law/regulation, etc.).
In conclusion, all areas should have a process in place for maintaining the security and integrity of PHI. The adopted processes should be subject to security audits that can identify system vulnerabilities and policy violations. Signed, confidentiality statements alone may not necessarily result in the proper security and integrity of PHI. Additionally, per IM.02.01.03, the hospital must follow their policy regarding security of health information. Such a policy may include who has access to medical records when staff is not present to monitor the records. The policy should also address all areas where medical records are stored.
Any examples are for illustrative purposes only.
Centers for Medicare & Medicaid Services (CMS) revised its position on the use of texting in a February 8, 2024, memorandum stating that texting patient information and orders is permissible in hospitals and critical access hospitals if accomplished through a Health Insurance Portability and Accountability Act (HIPAA)-compliant Secure Texting Platform (STP) and in compliance with the Conditions of Participation at 42 CFR 482.24 and 41 CFR 485.638.
Therefore, CMS states that when certain conditions are met, organizations may choose to text patient care information and orders. While there is no specific requirement that the secure text must be electronically transmitted into the electronic health record, these messages are still subject to HIPAA regulations.
According to the CMS memorandum, organizations that choose to use texting for patient information and orders are required to do the following:
- Utilize and maintain systems/platforms that are secure and encrypted and must ensure the integrity of author identification as well as minimize the risks to patient privacy and confidentiality, as per the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations.
- Confirm that texted orders are promptly placed in the medical record dated, timed, and authenticated.
- Make sure that the information transmitted into the EHR is accurately written, promptly completed, properly filed and retained, and accessible.
Additionally, providers should implement procedures/processes that routinely assess the security and integrity of the texting systems/platforms that are being utilized to avoid negative outcomes that could compromise the care of patients.
Please refer to the CMS memo for further details:
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(^).
Rules or regulation -States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states "Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas." and "Surgical masks are worn fully covering mouth and nose
Manufacturer instructions for use -Instructions for use of medical equipment or devices may include instructions for particular attire during use.
Evidence-based guidelines and consensus statements -If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
Facility policy -Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization's chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
- In the state of Illinois Hospital and Ambulatory Surgery Center regulations it states in the restricted area, "Cloth head coverings shall be laundered by the hospital. Additional garments shall be completely contained or covered within the scrub attire." According to organizational policy, the facility follows AORN guidelines 1.7.1 "Establish and implement a process for managing personal clothing that may be worn under scrub attire" and 5.3.1 "An interdisciplinary team, including members of the surgical team and infection preventionists, may determine the type of head covers that will be worn at the health care organization." The policy states that staff may wear long sleeve shirts under hospital scrub attire as long as they are not scrubbed into a case and cloth head coverings that they launder at home. This organization could be found out of compliance with Joint Commission standards because organizations must follow state licensing requirements.
- A non-deemed ambulatory surgery center creates a multidisciplinary team to create a dress code policy. They review state regulations, manufacturer instructions for us, and evidence-based guidelines. The team reaches consensus and establish a policy that staff may wear long sleeves shirts under scrub attire and cloth caps may be worn so long as staff are not scrubbed into a case and reference AORN guidelines. The organization would be found in compliance with Joint Commission standards.
Hierarchical approach
- Regulation
- Conditions of Participation
- Manufacturer's Instructions For Use
- Evidence-based Guidelines
- Consensus documents
- Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Any examples are for illustrative purposes only.
Providing staff and licensed practitioners (LP) with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Opioid treatment programs that can be used for patient referrals
Clinicians encountering patients dealing with possible opioid abuse or dependence need readily accessible, accurate information about available resources to which patients can be referred for treatment. It can be challenging for individual clinicians or departments to maintain current information about provider availability in the community, therefore leadership can play a role by identifying community resources, then communicating this information to staff and practitioners. To assist organizations, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has a directory of opioid treatment programs.
Compliance may be determined through interviews with leadership, staff, practitioners and patients, review of an organization's discharge and referral processes, discharge information provided to patients to support ongoing care following discharge, etc.
Leadership responsibilities for developing and monitoring performance improvement activities specific to pain management and safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities, e.g., on monitoring the use of opioids;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LP) on available services for consultation and referral of patients with complex pain management needs
The intent of this requirement is to ensure that staff and LPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, an organization's outpatient pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LPs, patients, etc.
Acceptable non-pharmacologic pain treatment modalities
Organizations are required to provide non-pharmacologic pain treatment modalities relevant to its patient population and assessed needs of the patient. These modalities serve as a complementary approach for pain management and may potentially reduce the need for opioid medication in some circumstances.
Additionally, it is important to have non-pharmacologic pain treatment modalities available for patients that refuse opioids or for whom physicians believe may benefit from complementary therapies. Non-pharmacologic strategies include, but are not limited to, acupuncture therapy, massage therapy, physical therapy, relaxation techniques, music therapy, cognitive behavioral therapy, etc. The level of evidence for these therapies is highly variable, and it is evolving. Therefore, our standards do not mandate that any specific complementary option(s) is provided, but allow organizations to determine what modality(s) to offer.
Organizations should ensure that patient preferences for pain management are considered, and, when a patient's preference for a safe non-pharmacologic therapy cannot be provided, provide education to patients on where the treatment may be accessed post-discharge. There is not an expectation that the hospital will fulfill any and all requested non-pharmacologic therapies during the inpatient stay.
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
Facilitating access to the PDMP means that leadership has implemented systems and processes that support both ease of access for practitioners and consistent access to the PDMP when required by law.
Examples may include:
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record (when state law requires accessing before hospital discharge )
Each organization determines who is responsible for accessing the PDMP. This may vary based on different patient care settings.
The requirement does NOT apply to patients receiving short term opioid medications DURING the hospital encounter (for example, opioids administered for a day or two following a surgical or invasive procedure). During survey, compliance with accessing the PDMP may be evaluated during tracer activities, interviews with staff, practitioners, pharmacists, etc.
NOTE: This requirementis only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
Monitoring of post-operative patients on opiates and/or on opiates combined with other pain medications
ֱ requires hospitals to monitor patients at high risk for adverse outcomes related to opioid treatment (for example, patients with sleep apnea, patients receiving continuous intravenous opioids, patients on supplemental oxygen, etc.) (See PC.01.02.07 EP 6). The intent of this requirement is to ensure adequate monitoring and timely detection of opioid-induced respiratory depression. Decisions on who is at high risk and monitoring requirements are determined by the clinical team responsible for providing care and based on evidence-based guidelines, accepted standards of practice, etc.
In addition, leadership commitment is required to ensure that appropriate equipment is available to monitor patients deemed at high risk for adverse outcomes from opioid treatment (See LD.04.03.13 EP 7). Refer to standards PC.03.01.01 through PC.03.01.07 regarding sedation and anesthesia care, specifically.
Review of evidence-based guidelines will assist leadership and the medical staff in developing policies, protocols, metrics and other quality indicators. During survey, clinicians may be asked to describe how they identify a patient that is high risk and how they would manage and monitor that patient.
Educating the patient and family on discharge related to pain management
It is the responsibility of each organization to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, and safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these topics. Each organization determines where this information will be documented in the medical record.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available and used appropriately. The tools required to adequately assess pain may differ depending on a patient's age, condition, and ability to understand and should be evidence-based. For example, adult intensive care unit (ICU) patients who are unable to self-report and pediatric patients require the use of alternative assessment tools. Hospitals are required to have defined criteria that they will use to screen, assess and reassess pain that are consistent with the patient's age, condition, and ability to understand. Organizations determine where these criteria are located and any documentation requirements when such screenings or assessments are completed.
Intent
Physical Presence
Advance Practice Nurses
Supervision or Collaborative Agreement Requirements
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
The requirements for the installation of smoke and fire dampers may be found in NFPA 90A Installation of Air Conditioning and Ventilating Systems, 2012 edition, Section 5.3 and 5.4.
Generally, fire dampers are required where air ducts penetrate walls that are rated for 2-hours or more. They are needed in all air transfer openings (non-ducted) in rated walls, regardless of the rating. And they are required at some, but not all penetrations of rated floor assemblies and shaft enclosures.
Smoke dampers are required at penetrations of smoke barriers, unless the HVAC system is fully ducted and there is a sprinkler system installed throughout the facility, in which case they are not required. Smoke dampers are also required in air transfer openings (non-ducted) in smoke partitions.
Where a penetration requires both a fire damper and a smoke damper, combination units that are both smoke responsive and heat responsive may be used.
Reference LS.02.01.10 EP13, LS.02.01.30 EP22 & EP23
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as "no exit".
Reference LS.02.01.20 EP 41
ֱ uses the 2012 edition of NFPA 101 Life Safety Code. For consistency, no equipment is allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance with section 7.1.3.2.3. This would include evacuation chairs/sleds.
Security cameras, card readers, Wi-Fi routers and repeaters can be in the exit enclosure, so long as it doesn't interfere with the use of the exit and is used for surveillance of the exit enclosure. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Any penetrations into the rated exit enclosure must be sealed with a fire stop material that is appropriate to the rating of the enclosure. Properly protected system penetrations into existing (prior to July 5, 2016) exit enclosures are acceptable as long as they were part of the original construction and no alterations have since been made; once an alteration has been made, the current code should be followed.
Reference LS.02.01.20 EP 13, LS.03.01.20 EP 11
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as “any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening.”
Assemblies include, but are not limited to, the following components:
Door frame | Latchset and/or lockset |
Hinges | Strike plate |
Door leaf including rating label | Closer |
Glazing (glass) and glazing frame | Coordinator |
Hinges | Astragal |
Transoms or side lights | Gasketing |
Protective Plates | Exit hardware |
Flush Bolt | Door holder / release device |
For same-product replacement of individual components (such as replacing a broken door closer with a new closer), as long as the new component is listed for use with the door in question, then the door assembly remains compliant. If not, then the resulting altered assembly must be validated by a field study of the assembly by a qualified entity.
Reference LS.02.01.10 EP9
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Doors in means of egress are required to be opened without the "use of a tool or key from the egress side". Occupant movement cannot be restricted during an emergency; however, locking certain doors may be necessary for the safety of the patient in certain situations.
When a healthcare facility determines that doors must be locked to protect patients the locking configuration must comply with one of the following:
- Delayed-egress locking system as defined by NFPA 101-2012: 7.2.1.6.1
- Access-controlled egress door assemblies as defined in NFPA 101-2012: 7.2.1.6.2
- Elevator lobby exit access door locking compliant with NFPA 101-2012: 7.2.1.6.3
Pediatric units, maternity units, and emergency departments are examples of areas where patients might have special needs that justify door locking. Patients that require additional protective measures to ensure safety and security are allowed to have door locking arrangements provided that all of 5 criteria of NFPA 101-2012: 18/19.2.2.2.5.2 are met, in summary these are:
- Staff can readily unlock all doors at all times
- A total (complete) smoke detection system is provided throughout the locked space, compliant with NFPA 101-2012: 9.6.2.9, or locked doors can be remotely unlocked at an approved, constantly attended location within the locked space.
- The building is protected throughout by an approved, supervised sprinkler system in accordance with NFPA 101-2012: 18/19.2.2.2.5.2
- Locks are electrical and fail safe to release upon loss of power
- The locks release by independent activation of each:
- Activation of the smoke detection system NFPA 101-2012: 18/19.2.2.2.5.2(2)
- Waterflow in the automatic sprinkler system NFPA 101-2012: 18/19.2.2.2.5.2(3)
Additional Resources
LS.02.01.20
NFPA 101-2012: 18/19.2.2.2.4; 19.2.2.2.5
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ's Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
ֱ describes a consultant as an LIP who was asked to evaluate a patient and provide consultation, by the way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
ֱ describes a consultant as an LIP who was asked to evaluate a patient and provide consultation, by the way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and privileged. Compliance with the organization's process for monitoring a practitioner's professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LP who was asked to evaluate a patient and provide consultation, by way of an order from another LP. The consultant's findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
The definition of a peer is someone from the same discipline. For example, physicians for physicians, dentists for dentists, podiatrists for podiatrists, etc. It does not have to be someone in the same specialty (orthopedist, etc.). To be able to provide a recommendation, the peermust be familiar with the individual's actual performance. For the nurse practitioner, physician assistant, and psychologist, or social worker, the peer should ideally be another individual from the same discipline and the organization should attempt to obtain such recommendation. This could be someone within the same organization or someone from outside the organization.
Peer recommendation includes written information regarding the practitioner's current:
- Medical/clinical knowledge
- Technical and clinical skills
- Clinical judgment
- Interpersonal skills
- Communication skills
- Professionalism
Yes, any provider recognized by state lawand providing services as a 'Licensed Practitioner (LP)^^or providing a medical level of care and decision-making(e.g. writing orders, directing care, etc) isrequired to be granted privileges prior to providing care, treatment or services. While Physician Assistants (PA) are generally not recognized by law/regulation as 'independent practitioners', they are subject to the same credentialing and privileging requirements outlined in the Medical Staff chapter of the manual.Examples of Care, Treatment or Services subject to the Medical Staff requirements may include, but are not limited to:
- Writing orders for medications, tests, and procedures
- Interpreting tests and treatments
- Performing history and physicals
- Wound debridement
- Central line insertions
- Assisting with interventional or surgical procedures
No, there is no requirement that privileges be granted for each individual location at which a practitioner may provide care. A multi-campus(^) organization may be described as having multiple locations - inpatient and/or outpatient - at which care, treatment and services are provided, and all locations operate under a single CMS Certification Number (CCN). Examples may include more than one hospital, ambulatory clinics, urgent care centers, physician office practices, etc.
The requirements found at MS.06.01.01 require that there is a process to determine the following resources are available:
- sufficient space
- sufficient equipment
- sufficient staffing
- financial resources are in place or available within a specified time period to support each requested privilege
- Emergency Department physicians may be privileged to perform laceration repair, splint, or cast application, administer moderate sedation, reduce dislocations, insert central lines, chest tubes, etc. However, some remote locations that only offer 'urgent care' services may not have the resources to insert central lines or chest tubes.
- A surgeon may be privileged to perform robotic procedures; however, robotic technology may only be available at the main hospital campus.
Each organization determines how this information will be tracked. This is generally an administrative document available to each location rather than being linked to a specific practitioner. The practitioner will be privileged once, and the document will identify where the privilege(s) can be performed.
^NOTE: For multi-entity systems in which each location operates under their own (separate) CCN number, each entity must fully credential and privilege practitioners.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
- To fulfill an important patient care, treatment, and service need, or
- When an applicant for new privileges^with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 14must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
- The care of a patient requires specialized skills that no currently privileged practitioner possesses
- Acurrently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- The patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
ֱ requires that organizations verify the identity of the applicant by viewing one of the following:
- A current picture organizational ID card
- A valid picture ID issued by a state or federal agency (for example, a driver's license or passport)
- Identity Assurance Level 2 (IAL2) credentials may be used as defined by the US Government's National Institute of Standards and Technology (NIST). The requirements to meet this standard are outlined in NIST Special Publication 800-63.
- To pick up the application
- For an interview by the department chair
- When arriving to first provide services
- When having their photo ID badge picture taken
- Use of a telecommunications link that includes both audio and video capabilities
If the verification is performed at a remote location, then the confirmation of the verification should be forwarded to the credentialing office for inclusion in the credentials file.It isNOT required or recommended that a copy of the photo ID be taken or placed in the credentials files due to potential for identity theft.
If the applicant provides only a copy of the photo ID, or a notarized document indicating the identity was verified by another entity, it would not satisfy the requirement for verification.
For telehealth service providers only
Applicant identity verification may be completed offsite at the distant (provider) location, as the practitioner never comes onsite where the patient is located. The organization determines the process for verifying practitioner identity.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Intent
The Focused Professional Practice Evaluation (FPPE) is a process whereby the medical staff evaluates the privilege-specific competence of the practitioner that lacks documented evidence of competently performing the requested privilege(s) at the organization. This process may also be used when a question arises of a currently-privileged practitioner's ability to provide safe, high quality patient care.
A period of FPPE is required for all new privileges. This includes privileges requested by new applicants and all newly-requested privileges for existing practitioners. There is no exemption based on board certification, documented experience, or reputation.
Design -The FPPE process must be pre-defined and consistently implemented for all newly requested privileges. The performance monitoring process must also be clearly defined and include, at a minimum, the following:
- criteria for conducting performance evaluations,
- method for establishing the monitoring plan specific to the requested privilege,
- method to determining the duration of performance monitoring, and
- circumstances under which monitoring by an external source is required.
Data -Both qualitative and quantitative criteria (data) should be considered when designing the process. For example, limiting criteria to quantitative data may only represent the presence or absence of information but may not reflect the quality of the information reviewed. Consider the following:
Qualitative Data -Qualitative or 'categorical' data, may be described as data that 'approximates and characterizes' and is often non-numerical in nature. This type of data may be collected through methods of observations, discussion with other individuals, chart review, monitoring of diagnostic and treatment techniques, etc.
• Periodic Chart Review
o appropriateness of tests ordered / procedures performed
o patient outcomes
• Code of conduct breaches
• Peer recommendations
• Discussion with other individuals involved in the care of patient(s), IE: consultants, surgical assistants, nursing, administration, etc.
- Length of stay trends
- Post-procedure infection rates
- Periodic Chart Review
- Dating/timing/signing entries
- T.O./V.O. authenticated within defined time frame
- Presence/absence of required information (H & P elements, etc)
- Number of H & P / updates completed within 24 hours after inpatient admission/registration
- Compliance with medical staff rules, regulations, policies, etc.
- Documenting the minimum required elements of an H & P / update.
- Compliance with core measures
Data Sources -The data source used for the FPPE process must include practitioner activities performed at the organization where privileges have been requested. This may include activities performed at any location that falls under the organization's single CMS Certification Number (CCN). For example, if an organization operates two hospitals that fall under the same CCN number, data from both hospital locations may be used.
Multi-hospital Systems -In multi-hospital systems where each hospital operates independently under separate CCN numbers, data from those entities may be used to supplement local data.
Low-volume Practitioners -When practitioner activity at the 'local' level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges. The use of supplemental data may NOT be used in lieu of a process to capture local data. Organizations choosing to use supplemental data should assess and determine the supplemental data's relevance, timeliness, and accuracy.
Examples where supplemental data could be used may include, but are not limited to:
- activity is limited to periodic on-call coverage for other physicians or groups
- occasional consultations for a clinical specialty
FPPE for non-inpatient areas -Privileges are required for any practitioner providing a medical level of care/decision-making, therefore, FPPE applies to all settings/locations included in the scope of the hospital survey. Examples of settings may include, but are not limited to: On and off-campus outpatient services, clinics, hospital owned physician office practices, free-standing emergency/urgent care centers, etc.
Additional Resources
ֱ Perspectives: The official newsletter of ֱ August 2019 / Volume 39 / Number 8
Content
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners
Practitioners Without Privileges
- review the history and physical examination document
- determine if the information is compliant with the organization's defined minimal content
- obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
Non-inpatient Services (e.g., Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc.)
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
- Patient age
- diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
- comorbidities, and the level of anesthesia required for the surgery or procedure
- Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
- Applicable state and local health and safety laws
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an 'entry'.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
There are no standards that require the medical staff to create policies that duplicate existing organizational policies, as long as it is clear that such policies also apply to the activities of the medical staff – whether employees of the organization or not. There shouldbe evidence that the medical staff participated in the review/approval of such policies.
There are requirements that are specific to the structure,functions and accountabilitiesof the medical staff that should be defined in medical staff rules, regulations or policies. These documents create a system of rights, responsibilities, and accountabilities between the organized medical staff, the governing body, and between the organized medical staff and its members.
The requirements found at MS.01.01.01 EPs 5–7 address requirements specific to medical staff and governing body compliance and enforcement of the bylaws, rules and regulations, and policies.A few examples of such policies may include:
- Required elements of a medical history, such as a psychological history, body systems review, past procedures, allergies, co-morbidities, etc.
- The detailed steps for credentialing and re-credentialing
- Responsibilities for oversight of professional graduate education program participants
- Medical staff health screening requirements
- On-call coverage requirements
For the purposes of 'policies' as referenced in the medical staff chapter, policies are documents other than medical staff bylaws. However, when such documents are adopted by the organized medical staff and approved by the governing body, pursuant to the provisions of Standard MS.01.01.01, these documents have the same force and effect as the medical staff bylaws.
Use of rules, regulations, and policiesmay beused to define those requirements that are subject to more frequent changes in the environment, law/regulation, expectations and functions of the medical staff. Therefore, review, revisions, and approvals can bemore expeditious than changes to bylaws as such changes cannot be delegated (see MS.01.01.01 EP 2).
When developing medical staff documents, organizations need to be mindful that there are requirements specific to the medical staff governance and framework that MUST be contained within the bylaws. These are defined in the Medical Staff chapter at MS.01.01.01 EP 12 - 38.
There is no medical staff standard that prescriptively requires use of a meeting format to review/revise/adopt/approve medical staff bylaws. Such a format would be an organizational decision. It is required, however, that the medical staff, as a whole, have the opportunity to review, amend and vote on any changes to the medical staff bylaws. Adoption or amendment of the bylaws cannot be delegated (see MS.01.01.01 EP 2) to a committee, such as the medical executive committee. Once any amendments or adoptions to the bylaws have been accepted by the medical staff, they must be submitted to the governing body for action.Bylaws become effective only upon governing body approval.
Intent
Goals
The goals include:
- A qualitative and quantitative data-driven process to identify performance trends that may require taking steps to improve performance (e.g. implementing an FPPE review).
- Establishing an objective, data-driven foundation for making re-privileging decisions.
- Responsibilities for data review, as defined by the medical staff that may include:
- Department chair or the department as a whole
- Credentialing committee
- Medical Executive Committee
- Special committee of the organized medical staff
- Frequency of review
- The process for using data for decision-making
- The decision process resulting from the review (continue/limit/deny privilege)
Data
Qualitative Data
• Periodic Chart Review
o appropriateness of tests ordered / procedures performed
o patient outcomes
• Code of conduct breaches
• Peer recommendations
• Discussion with other individuals involved in the care of patient(s), e.g. consultants, surgical assistants, nursing, administration, etc.
Quantitative Data
- Length of stay trends
- Post-procedure infection rates
- Periodic Chart Review
- Dating/timing/signing entries
- T.O./V.O. authenticated within defined time frame
- Presence/absence of required information (H & P elements, etc)
- Number of H & P / updates completed within 24 hours after inpatient admission/registration
- Compliance with medical staff rules, regulations, policies, etc.
- Documenting the minimum required elements of an H & P / update.
- Compliance with core measures
Data Sources
Multi-hospital Systems
In multi-hospital systems where each hospital operates independently under separate CMS Certification Numbers (CCN), data from those entities may be used to supplement local data.
Low-volume Practitioners
When practitioner activity at the 'local' level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges. The use of supplemental data may NOT be used in lieu of a process to capture local data. Organizations choosing to use supplemental data should assess and determine the supplemental data's relevance, timeliness, and accuracy.
Examples where supplemental data could be used may include, but are not limited to:
- activity is limited to periodic on-call coverage for other physicians or groups
- occasional consultations for a clinical specialty
OPPE for non-inpatient areas
- Privileges need to be granted to anyone providing a medical level of care, i.e., making medical diagnoses or medical treatment decisions, in any setting that is included within the scope of the hospital survey. The settings can include inpatient, on-campus outpatient, off campus clinics, hospital owned physician office practices, etc.
- OPPE applies to any privileges granted to be exercised in any setting and/or location included within the scope of the hospital survey. The privileges are often the same as those for inpatient care, treatment, and services, therefore, separate privileges based on 'location' would not be required. If the non-inpatient settings do not have the same clinical record system or information technology, collecting data may be more difficult, but if the privileges are the same, the data collected should be the same.
- determining that the practitioner is performing well or within desired expectations and that no further action is warranted
- determining that a performance issues exists and requires a focused evaluation – see MS.08.01.01 EP 5.
- revoking the privilege because it is no longer required
- suspending the privilege, which suspends the data collection, and notifying the practitioner that if they wish to reactivate it, they must request a reactivation
Intent
Physical Presence
Advance Practice Nurses
Supervision or Collaborative Agreement Requirements
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
While privileges are required to administer sedation (see MS.03.01.01 EP 2), it is not required that criteria for competence to perform "moderate" sedation be included in a separately delineated privilege. For example, competency criteria for "moderate" sedation may be defined and included in procedure-based privileges. Thus, a clinical privilege for endoscopy could be defined as including the use of sedation.
Organizations decide whether to use privileging as an appropriate approach to take based on the education, training, and experience of the clinicians requesting authorization perform procedures using sedation. Individuals who are privileged to administer sedation must be able to rescue patients at whatever level of sedation or anesthesia is achieved either intentionally or unintentionally, e.g., when the patient slips from moderate into deep sedation or from deep sedation into full anesthesia.
Organizations must define how it will determine that the individuals arecompetent to perform the required types of rescue. Acceptable examples may include, but are not limited to, ACLS certification, a satisfactory score on a written examination developed in concert with the department of anesthesiology (see LD.04.01.05 EP 7), a mock rescue exercise evaluated by an anesthesiologist, etc.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included in the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated as required per the standards in the Medical Staff Chapter of the manual. There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified of the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position
Additional Resources
Due Dates
Reappointment/re-privileging is due no later than three^ years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter. For example, if the reappointment period is July 1, 2021 through June 30, 2024, the reappointment date would be July 1, 2024.
Governing Body Approval Dates
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in June, the board would approve all July reappointments/reprivileging effective periods and in July the board would be approving all August reappointments/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
^ Additional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame. The change will also be reflected in a future release date of the accreditation manuals.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Optimizing the use of antibiotics is a patient safety priority, and antibiotic stewardship plays a critical role in supporting appropriate prescribing practices and reducing antibiotic resistance. ֱ is committed to helping organizations develop and implement successful antibiotic stewardship programs and activities in the hospital setting. As a result, ֱ has made several revisions to Standard MM.09.01.01, which include updates to align with federal regulations and current recommendations from scientific and professional organizations. The 12 new elements of performance (EPs) will be implemented for the Hospital (HAP) and Critical Access Hospital (CAH) accreditation programs on January 1, 2023.
Organizational Support (EP 10)
Dedicating the financial resources necessary for staffing and information technology to support the antibiotic stewardship program is essential to demonstrate the hospital's commitment to improving antibiotic prescribing practices. Hospital leaders should be prepared to discuss how antibiotic stewardship has been established as a patient safety priority, and the resources that have been allocated to the antibiotic stewardship program to support its activities.
Program Leadership (EPs 11, 12)
Qualifications:Hospitals are required to appoint a physician and/or pharmacist who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship as the leader(s) of the program. Organizations may determine whether to appoint a physician or pharmacist to lead the antibiotic stewardship program, or to have a physician and pharmacist co-lead the program, depending on the organization's size, structure, and complexity. The antibiotic stewardship program leader(s) may be assigned at the corporate or system level, as long as the leader is able to coordinate and implement antibiotic stewardship activities at each location.While documentation of the governing body's appointment of the antibiotic stewardship program leader(s) is not required, hospitals are expected to discuss how the governing body is involved in decisions about the program's leader(s).
Responsibilities:The appointed leader(s) of the program is responsible for the development and implementation of a hospital-wide antibiotic stewardship program that is based on national recognized guidelines. The program leader(s) is also responsible for documenting antibiotic stewardship activities, communicating and collaborating with individuals across the organization on antibiotic use issues, and providing competency-based training and education for staff. These expectations align with the Centers for Medicare and Medicaid Services Conditions of Participation for antibiotic stewardship (see §482.42 for hospitals and §485.640 for critical access hospitals for additional information).
When developing competency-based training and education for staff, it is important to note that ֱ describes competency as a combination of observable and measurable knowledge, skills, and abilities. Competence assessment lets the hospital know whether its staff have the ability to use specific skills and to employ the knowledge necessary to perform their jobs. Organizations have the flexibility to define the competencies associated with the practical applications of their antibiotic stewardship guidelines, policies, and procedures. Examples of competency-based training and education may include a combination of observable and measurable methods, such as use of a written test or demonstrate accurate completion of procedure/process.The competency-based training and education should be provided to staff with responsibilities related to antibiotic stewardship.
Multidisciplinary Committee (EP 13)
It is important for hospitals to establish a multidisciplinary committee to oversee the antibiotic stewardship program. The composition of the committee is determined by the hospital and may include part-time or consultant staff that are on site or they may participate in committee activities remotely. Examples of committee representation may include medical staff, pharmacy services, the infection prevention and control program, nursing services, microbiology, information technology, and the quality assessment and performance improvement program.
Program Coordination (EPs 14, 15)
The antibiotic stewardship program is expected to have a process in place that demonstrates coordination among all components of the hospital responsible for antibiotic use and resistance including, but not limited to, the infection prevention and control program the quality assessment and performance improvement program, the medical staff, nursing services, and pharmacy services. Additionally, the antibiotic stewardship program is responsible for documenting the evidence-based use of antibiotics in all departments and services of the hospital. The goal of this requirement is for the antibiotic stewardship program to document that all departments and services of the hospital are using antibiotics in a manner supported by evidence as determined by the hospital. Hospitals should be prepared to verify that the hospital's antibiotic use is consistent with the documented evidence-based antibiotic stewardship program recommendations. These expectations align with the Centers for Medicare and Medicaid Services Conditions of Participation for antibiotic stewardship (see §482.42 for hospitals and §485.640 for critical access hospitals for additional information).
Monitor Antibiotic Use (EP 16)
Measuring the hospital's antibiotic use is a critical first step to identifying improvement opportunities for antibiotic prescribing and can also help an organization determine whether its antibiotic stewardship activities are effective. Hospitals may monitor antibiotic use by analyzing days of therapy per 1000 days present or 1000 patient days or by reporting to the National Healthcare Safety Network Antimicrobial Use Option. While hospitals are encouraged to electronically submit data to the NHSN AU option so that they may benchmark their rates comparatively to national data, it is not required.For hospitals contracting with external pharmacy management organizations that may be unable to calculate days of therapy directly, an estimated metric for days of therapy may be used to identify opportunities to improve antibiotic prescribing practices.
Optimize Prescribing (EP 17)
The antibiotic stewardship program is required to implement strategies to optimize antibiotic prescribing practices. Organizations may determine how the strategies are implemented based on the antibiotic stewardship program's expertise and the organization's complexity. Organizations may choose to implement preauthorization for specific antibiotics that includes an internal review and approval process prior to use. Alternatively, organizations may implement prospective review and feedback regarding antibiotic prescribing practices, including the treatment of positive blood cultures. While the prospective review must be performed by a member of the antibiotic stewardship team, organizations should consider multiple pharmacists on the antibiotic stewardship team to minimize potential delays in patient care.
Implement Evidence-Based Guidelines (EPs 18, 19)
Hospitals are required to implement at least two evidence-based guidelines to improve antibiotic use for the most common indications. The two evidence-based guidelines implemented may be selected by the organization based on national guidelines and must also reflect local susceptibilities, formulary options, and the patient population served. Examples include, but are not limited to, community-acquired pneumonia, urinary tract infections, skin and soft tissue infections, Clostridioides difficile colitis, asymptomatic bacteriuria, plan for parenteral to oral antibiotic conversion, or use of surgical prophylactic antibiotics. Hospitals should be prepared to discuss how the evidence-based guidelines were selected and implemented.
The antibiotic stewardship program is required to evaluate adherence (including antibiotic selection, and duration of therapy, where applicable) to at least one of the evidence-based guidelines the hospital implements. Hospitals may measure adherence using a variety of methods, depending on the data and information technology resources available to the antibiotic stewardship program team. Organizations may evaluate adherence data at the group level (i.e., department, unit, clinician subgroup) or at the individual prescriber level. Adherence data may be obtained for a sample of patients from relevant clinical areas by analyzing the electronic health records or through chart review.
Data Collection and Reporting (EP 20)
It is critical to collect, analyze, and report data about the antibiotic stewardship program to hospital leadership and prescribers. Antibiotic stewardship program data may include antibiotic resistance patterns, antibiotic prescribing practices, or an evaluation of the antibiotic stewardship program's activities. Reporting antibiotic stewardship program data to hospital leadership and prescribers allows organizations to review the program's activities and its impact on prescribing practices.
Performance Improvement (EP 21)
When the antibiotic stewardship program identifies improvement opportunities, the hospital develops an action plan. The hospital should be prepared to discuss the actions taken to improve antibiotic prescribing practices.
Additional Resources
Perspectives NewsletterJuly 2022 Volume 42 Number 7
Requirement, Rationale, Reference (R3) Report
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
The recently published a resource titled "" which is consistent with our current accreditation requirements. Organizations are encouraged to review this document which provides guidance in shortage management and conservation.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LP controlled orders for the items listed at MM.05.01.01 EP 4.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
ֱ would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not beenapproved as an indication.
ֱ is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
Ideally, hazardous medications would be compounded in a negative pressure environment. Currently, according to USP 797, if an organization prepares a low volume of hazardous drugs, the use of two tiers of containment is acceptable in a non-negative pressure area. An example of 2-tier containment would be the use of a closed system transfer device utilized within a biological safety cabinet or compounding aseptic containment isolator.
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
The same personal protective equipment expected in a clean room when compounding in a laminar workflow bench are required when utilizing a CAI or CACI unless the manufacturer has written information based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This includes double gloving for the preparation of hazardous medications.
Allergens may be prepared outside of an ISO 5 environment as long as they are prepared with the following conditions:
- The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances
- All allergen extracts shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms.
- Perform thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water.
- Garb with hair covers, facial hair covers, gowns, and face masks.
- Perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity.
- Don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) be- fore beginning compounding manipulations.
- Disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen ex- tracts as CSPs.
- Ampule necks and vial stoppers must be disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.
- The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers).
- The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications.
- Single-dose allergen extracts may not be stored for subsequent additional use.
- ISO level of the primary engineering control
- Viable particle testing surface of the primary engineering control
- Viable particle testing air within the primary engineering control
- HEPA filter leak test of the primary engineering control
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals.Lack of testing of these items will result in non-compliance with Joint Commission standards.
- Air exchanges per hour of the buffer area
- Pressure differential (between buffer area/ante area; ante area/non-classified area)
- ISO level of the buffer area and ante area
- Viable particle testing surface of the buffer area and ante area
- Viable particle testing air—HEPA filter leak test of HVAC HEPA filter system
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Applicable only to organizations following USP 797 2008 Version:
The current standard of practice does not allow for alcohol swabs to touch another object prior to its use when cleaning a critical point (i.e. vial septum, ampule neck, or injection entry port on an IV bag). If this is identified during a survey, it will be scored as non-compliant with Joint Commission Standards as an infection control risk.
It is up to the organization to determine whether or not the compounding space is acceptable to continue producing sterile compounded medication products. Factors should include the pathogenicity of the organism grown in the positive growth viable sample; complexity level of the compounded product; any known/potential associated hospital acquired infections; and guidance from the infection control practitioner.
The practice described may be acceptable as long as an organization has determined that:
- The medication order is written in a manner that supports deferring to patient preference when the patient is:
- Requesting a lesserpotent medication.(Potency should be established with an evidence based tool i.e. morphine equivalents).
- Requesting alesser prescribed dose in a range order.
- Requestinga less intrusive route of administration if both routes are prescribed by the provider.
- The medication is administeredin accordance with orders from the LicensedPractitioner.
- The inclusion allowing patient preference is in the medication order and does not subsequently create a therapeutic duplication with other prescribed medications.
- The organization's medication management policy identifies this type of medication order as acceptable and defines all required elements of such orders.
- The use of a protocol is not required.However, if an organization chooses to utilize a protocol, the review and approval process must comply with the requirements found at MM.04.01.01 EP 15.The medical record must contain evidence of an order to implement the protocol, as well as the protocol itself.
- Implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation.
Per the requirements of the Record of Care, Treatment, and Services (RC) chapter, the medical record must accurately reflect that the lesser potent medication was administered based on patient preference. It isNEVER acceptable to administer a medication of stronger potency based on patient preference.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
Therapeutic duplication occurs when practitioners order more than one medication for the same indication. While this is an acceptable practice there must be clarity sought to determine when one agent should be administered over another, if both agents are to be given concurrently or if one therapy was to replace an existing therapy and wasn't discontinued properly. Such orders are commonly seen in orders for analgesics and anti-emetics but occurs other drug classifications as well (e.g. anti-hypertensives, anticoagulants, etc.)
When more than one medication is prescribed for the same indication, there must be a process in place to determine whether the ordering of multiple agents for the same indications is either an accidental prescribing error or intentional multi-modal therapy.
Joint Commission standards require medication orders to be reviewed by a pharmacist. Part of the review is to identify whether or not therapeutic duplication exists. Once this is identified, it is required that the pharmacist and nurse have a clear understanding of the intent of the prescriber. Organizations may utilize resources such as policies, technology within the electronic medical record or other means necessary to ensure such communication.
The intent is to ensure that medication orders are clear and accurate for all members of the patient care team involved in medication management. If the intent was that both medications be administered and the organizations policy allows for these orders, the pharmacy preparing the medication and the staff administering the medication need to have clear guidance provided.
For example, when a patient is prescribed multiple antiemetic agents, there must be a clear understanding of the following concerns:
- Was the intent of the prescriber to have all ordered medications given known by the prescriber, pharmacist, and the administering provider?
- When does the administering provider give each agent based upon the intent of the prescriber?
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Titration orders are generally defined as those in which the medication dose is either progressively increased or decreased in response to the patient's status. Organizations are required to define, by policy, if titration orders are deemed acceptable for use. The elements of performance found in the Medication Management (MM) chapter at MM.04.01.01 outline the policy requirements.
- Medication name
- Medication route
- Initial or starting rate of infusion (dose/min)
- Incremental units the rate can be increased or decreased
- Frequency for incremental doses (how often dose(rate) can be increased or decreased
- Maximum rate (dose) of infusion
- Objective clinical endpoint (RASS score, CAM score, etc). NOTE:This particular element does not have to reside in the titration order itself but instead may be a separate order in the medical record.
- Initial or starting rate of infusion (dose/min)
- Incremental units the rate can be increased or decreased
- Frequency for incremental doses (how often dose(rate) can be increased or decreased
- Objective clinical endpoint(RASS score, CAM score, etc).
- Compliance with manufacturer's Instructions For Use (IFU) for safe administration
- Consistent administration practices among nurses and other practitioners
- Ensure the patient response is achieved/sustained
- Nursing not placed in a position of making dosing/administration decisions that may conflict with their scope of practice
- Documentation accurately reflects order changes, patient assessments, etc.
Additional Resources
FAQ:Documentation During Rapid Titration
No, it would not be acceptable to establish a blanket practice that select medications ordered are auto-verified. ֱ requires that a pharmacist reviews all medication orders or prescriptions, with limited exceptions as described in the 'notes' at *MM.05.01.01 EP 1.
The requirement and 'notes' found at MM.05.01.01 EP 1 do allow for limited situations where prospective pharmacy review may not be feasible or required. For example, if waiting for pharmacy review would create a delay that could result in patient harm, prospective review would not be expected. However, organizations should have a process in place to review these scenarios to ensure such a practice is limited to urgent scenarios and not a standard practice for convenience.
Another example may be when a licensed practitioner (LP) controls the ordering, preparation, and administration of a medication, such as in an emergency department. In this example, use of auto-verification technology may be considered as the LP would be physically present.
*This does not apply to the discontinuation of orders.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Organizations are expected to have a process in place for providing medications to meet patient needs when pharmacy services are not available. Such a process generally requires non-pharmacist health care professionals to access medication storage areas, such as a designated medication storage area or the pharmacy.
When non-pharmacist health care professionals are allowed by law or regulation and hospital policies and procedures to obtain medications after the pharmacy is closed, the following occurs:
- Medications must only be accessed and removed from medication storage areas or pharmacy by trained prescribers and nurses designated by the organization and in accordance with Federal and State law.
- After-hours access to the pharmacy by non-pharmacists to obtain medications should be minimized and eliminated as much as possible.
- Use of well-designed night cabinets, after-hours medication carts, and other methods will reduce the need for non-pharmacist staff to enter the pharmacy.
- Quality control procedures (e.g., an independent second check by another qualified individual, secondary verification technology, such as barcoding, etc.) are to be in place to prevent medication retrieval errors.
- A qualified pharmacist must be available either on-call or at another location to answer questions or provide medications beyond those accessible to non-pharmacy staff.
^ This FAQ is intended to clarify the requirement found at MM.05.01.13 EP 2 regarding pharmacy access.
Upon discharge from an inpatient stay or outpatient encounter, organizations need to determine the disposition of unused or partially used medication. For example, an inhaler provided by the facility for administration during an inpatient stay contains additional doses at the time the patient is discharged. The options available would be for the facility to discard the inhaler or send the inhaler home with the patient. Another example might be sending a 'couple' antibiotics home just to get the patient started on the medication.
When determining policies regarding dispensing medications at discharge, organizations should work with their accreditation and pharmacy leadership and legal counsel to ensure all accreditation and regulatory requirements have been addressed.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
ֱ has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids is outside the scope of the USP 797 chapter. ֱ will survey to organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies, procedures, staff education/competencies, etc., should also take into account:
- Product and device manufacturer's instructions for use
- Evidence-based guidelines for safe administration practices
- Applicable law and regulation
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
When an organization permits patients to self-administer medications, the requirements found at MM.06.01.03 also apply. If the self-administered medications include medications brought in by the patient or family, the requirements found at MM.03.01.05 apply as well.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.; or combinations and variations.
The organization's individual responsible for accreditation readiness has a copy of the manual containing the full text of standards referenced in this FAQ as they are not published on our website.
When an organization permits patients to self-administer medications, the requirements found at MM.06.01.03 also apply. If the self-administered medications include medications brought in by the patient or family, the requirements found at MM.03.01.05 apply as well.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.; or combinations and variations.
The organization's individual responsible for accreditation readiness has a copy of the manual containing the full text of standards referenced in this FAQ as they are not published on our website.
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Practitioners (LP) and staff who participate in medication management (MM.02.01.01). Examples of 'staff' may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources
Individual State Pharmacy Boards
Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all identified risk points. As a general rule, concentrated electrolytesare not be kept in patient care areas where access is not urgently needed.
The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served in each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadership would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets, dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device or storage location should also be evaluated as such storage areas may serve a mixed patient population.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards must be developed to prevent inadvertent administration of these medications without proper dilution.Examples of strategies to prevent errors may include:
- Segregation from all other medications stored in the device or area.
- Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amount necessary to meet patient care needs over a limited time period (for example, one day).
- A system for regularly checking and restocking to par level by pharmacy staff. .
- Prominent warning labels applied to the drug container.
- Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a ‘meds-to-beds’ program
- etc.
** NOTE:
- A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.
- Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No, retail pharmacies are not subject to survey along with a hospital as there are no accreditation requirements in the hospital or critical access hospital accreditation manuals that address such entities**. This also applies to those situations when there are contractual agreements between a hospital and a retail pharmacy to provide services directly to patients preparing for discharge. Examples of such services may include delivery of:
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a ‘meds-to-beds’ program
- etc.
** NOTE:
- A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.
- Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No, retail pharmacies are not subject to survey along with a hospital as there are no accreditation requirements in the hospital or critical access hospital accreditation manuals that address such entities**. This also applies to those situations when there are contractual agreements between a hospital and a retail pharmacy to provide services directly to patients preparing for discharge. Examples of such services may include delivery of:
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a ‘meds-to-beds’ program
- etc.
** NOTE:
- A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.
- Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No, retail pharmacies are not subject to survey along with a hospital as there are no accreditation requirements in the hospital or critical access hospital accreditation manuals that address such entities**. This also applies to those situations when there are contractual agreements between a hospital and a retail pharmacy to provide services directly to patients preparing for discharge. Examples of such services may include delivery of:
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a ‘meds-to-beds’ program
- etc.
** NOTE:
- A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.
- Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No, retail pharmacies are not subject to survey along with a hospital as there are no accreditation requirements in the hospital or critical access hospital accreditation manuals that address such entities^. This also applies to those situations when there are contractual agreements between a hospital and a retail pharmacy to provide services directly to patients preparing for discharge. Examples of such services may include delivery of:
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a 'meds-to-beds' program
- etc.
^ NOTE:A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
If your state has implemented programs/processes that oversee the procurement, storage, and dispensing of opioid reversal agents, surveyors will evaluate compliance based on the requirements outlined per your state.
If your state has not implemented a program that has been adopted by your organization, you should consider the following:
Security
As with all medications, the security and integrity of such medications must be assured. Therefore, the medications must be stored in a manner to prevent tampering, theft or diversion at all times (see MM.03.01.01).While ֱ standards do not define what process must be followed to ensure medication security, organizations should consider conducting a risk assessment as a helpful way of identifying risks associated with various options being considered by the organization. The assessment must include all applicable accreditation, law and regulatory requirements.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
Storage
Medications must be stored in a manner consistent with the manufacturer's instructions for use to ensure stability. Therefore, a risk assessment should include environmental factors, such as temperature, light exposure, etc., that may impact medication integrity. NOTE -The guidance for storage listed in a package insert must be followed and cannot be superseded by an organization's risk assessment.
Orders
Protocols should include pre-established and approved patient assessment criteria in order to provide timely care and services to patients. The organization needs to define, in writing, who is authorized to administer medication in accordance with law and regulation (MM.06.01.01).The implementation of a protocol must be documented as an order in the patient's medical record and dated, timed and signed by the practitioner responsible for the care of the patient. However, the timing of such documentation should not be a barrier to providing timely and necessary care, or other patient safety advances.
Documentation
Once the organization chooses to treat an individual, they become a patient of the organization. Therefore, a medical record would be required that reflects all care, treatment and services provided in accordance with the requirements found in the Record of Care (RC) chapter of the accreditation manual, law and regulation.
Education and Training
Each organization determines education, training or competency requirements for those individuals involved in responding to patient emergencies.
Evaluating Medication Management Systems
Organizations are required to evaluate the effectiveness of their medication management systems (see MM.08.01.01). Therefore, organizations are encouraged to include emergency response processes, that include the safe medication practices, into their performance analysis activities. Such activities should include the collection and analysis of data that allows leadership to identify and implement performance improvement opportunities.
Influenza and Pneumococcal Vaccines
Unless your state is more specific, these vaccines are not required to have a physician's order in the medical record as long as certain conditions are met which are listed below:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and Pneumococcal Vaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing the patient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # and Expiration Date as well as the publication date of the vaccine information sheet (VIS) given to the patient.
- If all of these criteria are met, since an order would not be required then pharmacy would not be required to review.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Please note that MM.05.01.01EP 1 states Before dispensing or removing medications from floor stock or from an automated storage and distribution device, a pharmacist reviews all medication orders or prescriptions unless a licensed practitioner controls the ordering, preparation, and administration of the medication".
Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order. Your organization would need to determine if their state permits the use of such standing orders for vaccine administration as you describe. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Please note that while our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Again, your organization should research this within their state. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient's bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Yes, the health care equity leader(s) may be assigned at the corporate or system level as long as the leader is able to coordinate and implement health care equity activities at each location and address the site-specific health care disparities identified. However, larger organizations may still want to identify individuals to lead activities at the site level, but the overall responsibilities for system-wide health care equity initiatives can be assigned at the corporate or system level.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Any examples are for illustrative purposes only.
NPSG.15.01.01 applies to all patients in organizations surveyed under the Behavioral Healthcare and Human Services standards (CAMBHC), all patients in psychiatric hospitals, any patient in a general hospital who is being treated or evaluated for a behavioral condition as their primary reason for care, and all patients who express suicidal ideation during the course of care regardless of their registration status (IP, OP, ED, Obs, etc.).
At this time, suicide risk assessment of patients with secondary diagnoses or secondary complaints of emotional or behavioral disorders and/or conditions that are NOT part of the current assessment or treatment is encouraged but not required. For purposes of this requirement, the phrase "behavioral conditions" refers to any Diagnostic Statistical Manual (DSM) diagnosis or condition/symptomology, including those related to substance abuse. The phrase "being treated" is interpreted in terms of the patient's diagnosis or presenting complaint, condition, and/or symptomology. If a patient is being evaluated or treated for a behavioral compliant, condition, or symptomology, the standard applies whether a formal psychiatric diagnosis is present or not.
For additional information regarding environmental requirements in non-psychiatric settings review the following FAQ: Environmental Risk Assessment Expectations in Non-psychiatric Units/Areas in General Hospitals
Additional Resource
Suicide Prevention Portal
Any examples are for illustrative purposes only.
Protective factors may be described as individual, relationship, community, and societal characteristics or circumstances that can protect individuals from suicide.
Examples of protective factors include, but are not limited to:
Individual Protective Factors
- Skills in coping and problem solving
- Reasons for living, such as family, friends, pets, etc.
- Cultural identity
- Supportive partners, friends, and family
- Feeling connected to others
- Connections to school, community, or other social places
- Availability of consistent and high-quality healthcare
- Reduced access to lethal means
- Cultural, religious, or moral objections to suicide
References:
Additional Resources
Suicide Prevention Portal
Risk factors may be described as a combination of individual, relationship, community, and societal levels that can increase the possibility that a person will attempt suicide.
Examples of risk factors include, but are not limited to:
Individual Risk Factors
- Previous suicide attempt(s)
- History of mental illnesses, particularly depression
- Serious physical illness, such as chronic pain
- Criminal/legal issues
- Financial problems or job loss
- Impulsive or aggressive tendencies
- Substance use
- Current or prior history of adverse childhood experiences
- Feelings of hopelessness
- Violence victimization and/or perpetration
- ċċċċċBullying
- Family history of suicide
- Loss
- Violent or high conflict
- Isolation
- Lack of access to healthcare
- Suicide clusters
- Adopting and adjusting to a new environment
- Violence
- Discrimination
- Stigma associated with mental illness and seeking help
- Access to lethal means
- Media portrayals of suicide
Additional Resource
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
- There are no exposed components of the ceiling system that can be used as a ligature attachment point (i.e. exposed rails, tee connectors, couplers, or main rails)
- Panels can in no way be removed by the patient.
- No impact will dislodge the panel(s)
Additional Resource
Suicide Prevention Portal
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present as allowable by the facility’s safety risk assessment. These areas do not need to be in constant view of staff but should be a part of thestandard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient’s suicide attempt and prevent the attempt from occurring.
This FAQ was also published in the Perspectives® Newsletter, January 2019, Volume 39, Issue1 - The Official Newsletter ofֱ.
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present as allowable by the facility’s safety risk assessment. These areas do not need to be in constant view of staff but should be a part of thestandard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient’s suicide attempt and prevent the attempt from occurring.
This FAQ was also published in the Perspectives® Newsletter, January 2019, Volume 39, Issue1 - The Official Newsletter ofֱ.
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present as allowable by the facility’s safety risk assessment. These areas do not need to be in constant view of staff but should be a part of thestandard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient’s suicide attempt and prevent the attempt from occurring.
This FAQ was also published in the Perspectives® Newsletter, January 2019, Volume 39, Issue1 - The Official Newsletter ofֱ.
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present, if there are no objects that patients could easily use to climb up to the drop ceiling, remove a panel, and gain access to ligature risk points in the space above the drop ceiling, andas allowable by the facility's environmental risk assessment. These areas do not need to be in constant view of staff but should be a part of the standard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor, an alcove, or other non-visible areas) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient's suicide attempt and prevent the attempt from occurring.
Additional Resource
Suicide Prevention Portal
No, ֱ does not mandate "safe rooms" in emergency departments.Spaces/rooms designated ONLY for the treatment of patients with behavioral health conditions within an emergency department or other area should follow the Recommendations for Suicide Prevention in Healthcare Settingsfor inpatient psychiatric units.
Note: TJC does not define "safe room" in its glossary, however in the context of the FAQ this moniker is used to describe a "designated space" as a room and/or area that is dedicated to the evaluation and/or treatment of patients with behavioral conditions. Designated and non-designated are the descriptors used to identify these spaces.
Additional Resource
Suicide Prevention Portal
ֱ requires:
2. A plan, and
3. Available resources to guide staff when housing patients at risk for suicide in a patient room in a non-designated space.
The evaluation is meant to be a proactive process to, at a minimum, identify self-harm issues prior to the patient being placed in the room.
The plan needs to address who is responsible to remove any objects identified to be of a self-harm nature and resources to guide staff, which may include but are not limited to:
• Electronic flags (e.g. the patient you are placing in a medical/surgicalroom is high risk and you should sweep the room for items not essential for patient care which may pose a self-harm risk)
• Competency/training for all sitters who will be with high risk patients to do the environmental assessments
• Visual reminders (e.g., posters) of the most common items that are significant risks on the unit
• On-site psychiatric professional who is available to complete an environmental risk assessment in areas where staff do not have the training to do this independently
ֱ requires:
2. A plan, and
3. Available resources to guide staff when housing patients at risk for suicide in a patient room in a non-designated space.
The evaluation is meant to be a proactive process to, at a minimum, identify self-harm issues prior to the patient being placed in the room.
The plan needs to address who is responsible to remove any objects identified to be of a self-harm nature and resources to guide staff, which may include but are not limited to:
• Electronic flags (e.g. the patient you are placing in a medical/surgicalroom is high risk and you should sweep the room for items not essential for patient care which may pose a self-harm risk)
• Competency/training for all sitters who will be with high risk patients to do the environmental assessments
• Visual reminders (e.g., posters) of the most common items that are significant risks on the unit
• On-site psychiatric professional who is available to complete an environmental risk assessment in areas where staff do not have the training to do this independently
ֱ requires:
2. A plan, and
3. Available resources to guide staff when housing patients at risk for suicide in a patient room in a non-designated space.
The evaluation is meant to be a proactive process to, at a minimum, identify self-harm issues prior to the patient being placed in the room.
The plan needs to address who is responsible to remove any objects identified to be of a self-harm nature and resources to guide staff, which may include but are not limited to:
• Electronic flags (e.g. the patient you are placing in a medical/surgicalroom is high risk and you should sweep the room for items not essential for patient care which may pose a self-harm risk)
• Competency/training for all sitters who will be with high risk patients to do the environmental assessments
• Visual reminders (e.g., posters) of the most common items that are significant risks on the unit
• On-site psychiatric professional who is available to complete an environmental risk assessment in areas where staff do not have the training to do this independently
ֱ requires:
- Thoughtful evaluation of the environment,
- A plan, and
- Available resources to guide staff when housing patients at risk for suicide in a patient room in a non-designated space.
- Checklists identifying the self-harm objects to be removed
- Electronic flags (e.g. the patient you are placing in a medical/surgicalroom is high risk and you should sweep the room for items not essential for patient care which may pose a self-harm risk)
- Competency/training for all sitters who will be with high risk patients to do the environmental assessments
- Visual reminders (e.g., posters) of the most common items that are significant risks on the unit
- On-site psychiatric professional who is available to complete an environmental risk assessment in areas where staff do not have the training to do this independently
Suicide Prevention Portal
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers "serious" as equivalent to "high risk". Please refer to NPSG 15.01.01 in the Accreditation Manuals for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
ֱ neither discourages nor promotes the use of these devices. If an organization chooses to use such devices, the organization must ensure the devices are installed, maintained, and tested per Manufacturer's Instructions for Use.
Additional Resources
Suicide Prevention Portal
There is no height requirement for a ligature risk. Information from various sources notes that death by suicide as a result of asphyxiation can occur at any height. Specifically, there have been reports of death by suicide or suicide attempts during which patients fixed a cord, rope, or other material to a low pipe and around their neck and then spun their body ("alligator roll") to twist until it asphyxiated them. Thus, low-to-the-ground exposed piping (such as piping near toilets or under the sink, for example) or any other apparatus protruding from the wall or another structure is considered a ligature risk if the patient is able to create a sustainable point of attachment with another material in order to inflict self-harm or cause loss of life.
Additional Resource
Suicide Prevention Portal
ֱ has not specified a requirement for the number of ligature resistant beds on any given unit. This will depend on the needs of the patient population. The type of medical bed should be balanced based on the medical needs and the patients' risk for suicide. If medical beds that contain ligature risks are being used within an inpatient and/or designated psychiatric unit, they must be identified on the organization's environmental risk assessment (as per NPSG.15.01.01 EP1). For patients who require medical beds that have ligature points, there must be appropriate mitigation plans and safety precautions in place, including 1:1 observation for patients determined to be at high risk for suicide who have access to the bed(s). Plans to mitigate risk must be documented within the patients' medical record (as per NPSG.15.01.01 EP4). The organization must consider these risks in patients' overall suicide/self-harm risk assessments and implement interventions to mitigate these risks.
ֱ will not advise on the type of medical beds or ligature-resistant beds that should be purchased for patients. These decisions should be balanced based on patient needs. Organizations must evaluate beds and be aware of the ligature and/or other safety risks the bed(s) may present.
In addition, if these medical beds are being used, safety provisions must be considered. Provisions may include, but are not limited to, locking the patient room door where a medical bed is being used when unoccupied, removing a medical bed from the unit if not in use, enacting the safety features of the bed, when appropriate, and/or enhanced environmental and safety rounding. These provisions must be addressed in the organization's environmental risk assessment and/or policies and procedures.
Additional Resource
Suicide Prevention Portal
Patients who are currently at high risk for suicide should remain in a ligature resistant environment. If a patient who is at high risk for suicide enters another unit/area/building that contains ligature and other safety risks, continuous monitoring with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient – is required. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
Additional Resource
Suicide Prevention Portal
ֱ will not advise or recommend any particular type of shower curtain, but shower curtains are considered a risk. The expectation is that shower curtains must be noted on an environmental risk assessment and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where this risk is present. Shower curtains must be installed, inspected, maintained, and tested per Manufacturer's Instructions for Use to ensure proper functioning (e.g. breakaway features).
Additional Resources
Suicide Prevention Portal
The recommendation states: "Nursing stations with an unobstructed view (so that a patient attempt at self-harm at the nursing station would be easily seen and interrupted) and areas behind self-closing/self-locking doors do not need to be ligature resistant and will not be cited for ligature risks." This refers to what can be seen within the nurses station, not what is being seen from the nurses station. If there is an unobstructed view of everything within a nurses station, then patients should not be able to attempt self-harm at the nurses station since this would be easily seen and interrupted.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
No, ֱ does not recommend products. Organizations should reviewRecommendations for Suicide Prevention in Healthcare Settings, conduct a risk assessment of the environment, determine which products to appropriately install (based on manufacturers' instructions), and ensure that they are functioning properly.
Ligature resistant is defined as: without points where a cord, rope, bedsheet, or other fabric/material can be looped or tied to create sustainable point of attachment that may result in self-harm or loss of life.
See also FAQ Titled "Is there a height requirement in order to consider something a "ligature risk"?"
Additional Resource
Suicide Prevention Portal
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
Suicide Prevention Portal
FAQ Ligatures and/or Suicide Risk Reduction – Video Monitoring of Patients at High Risk for Suicide
No, not all patients being evaluated or treated for a behavioral condition require 1:1 monitoring.
In units/areas that contain ligature and/or other safety risks, patients determined to be at high-risk for suicide must be under continuous observation with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
In inpatient psychiatric units/designated psychiatric areas that are ligature resistant and free from other safety risks, it is up to the organization to determine monitoring requirements for patients determined to be at high-risk for suicide and define such in their policy.
Additional Resources
Suicide Prevention Portal
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue1 - The Official Newsletter of ֱ.
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue1 - The Official Newsletter of ֱ.
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue1 - The Official Newsletter of ֱ.
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue 1 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
No, the National Patient Safety Goal does not require organizations to universally screen all patients for suicidal ideation. Screening patients for suicide risk with secondary diagnoses or secondary complaints of emotional or behavioral disorders is encouraged but not required. It is important for clinicians to be aware that patients being treated primarily for a medical condition may also have behavioral tendencies that, if triggered, may lead to self-harm. For example, changes in health status resulting in a poor prognosis, chronic pain resulting from injury or illness, etc.
Psychosocial changes, such as sudden loss of a loved one, broken relationships, financial hardship, etc., can also trigger self-harm behaviors. These patients may also be at risk for suicide, therefore, it is important for clinicians to properly assess these individuals for suicidal ideation as part of their overall clinical evaluation, when indicated.
A validated screening tool is one that has been scientifically tested for reliability (the ability of the instrument to provide consistent results), validity (the degree to which the instrument is measuring the condition that it is designed to measure), sensitivity (the ability of the instrument to correctly identify individuals with the condition) and specificity (the ability of the instrument to correctly identify individuals without the condition).
Patients being evaluated or treated for behavioral health conditions often have suicidal ideation. Brief screening tools are an effective way to identify individuals who require further assessment to determine risk for suicide. Screening tools should be appropriate for the population to the extent possible (e.g., age-appropriate). When using validated screening tools, organizations should not change the wording of the questions because small changes can affect the accuracy of the tools.
In addition, it is important that organizations ensure that the chosen screening tool(s) are implemented and completed as directed by the creators of the tool(s). For example, the Columbia Suicide Severity Rating Scale (CSSRS) is a validated screening tool that contains six questions. Depending on the answer to the first two questions, additional questions apply. One or more questions may get missed if the tool is not implemented or completed as directed. Another example, the ASQ Suicide Risk Screen Tool, is a four-question validated screening tool, which also contains a fifth question to assess acuity. This question may get missed if the tool is not implemented or completed as directed. Therefore, if not completed as instructed, the validity of the tool to identify individuals who may be at risk for suicide is compromised. Ultimately, it is the responsibility of each organization to ensure that validated tool(s) are implemented and completed accurately.
Additional Resource
Suicide Prevention Portal
Organizations are required to develop and follow written policies and procedures addressing the care of patients identified as at risk for suicide, including guidelines for suicide risk reassessment. Reassessment guidelines should address how often reassessments will occur as well as additional criteria that would trigger a reassessment, for example, a change in patient status, endorsement of suicidal ideation, and/or suicidal or self-harm behaviors or gestures. An evidence-based process must be used to conduct suicide risk reassessments for individuals who have screened positive for suicidal ideation and were further assessed for suicide risk. At minimum, reassessments must directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of evidence-based tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population.
If the organization does not use an evidence-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their reassessment is based off
- The reassessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
Suicide Risk Reduction Resources
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Patients with suicidal ideation vary widely in their risk for a suicide attempt depending upon whether they have a plan, intent, history of attempts, etc. It is important to conduct an in-depth assessment of patients who screen positive for suicide risk to determine how to appropriately treat them.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of validated tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population, if the questions adhere to the intent of the original validated tool.
If the organization does not use an evidenced-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their assessment is based off
- The assessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
SuicidePrevention Portal
For patients identified as high risk for suicide who have access to ligature or other safety risks, constant 1:1 visual observation must be implemented (in which a qualified staff member is assigned to observe only one patient at all times) that would allow the staff member to immediately intervene should the patient attempt self-harm. The use of video monitoring or "electronic sitters" would generally not be acceptable in this situation because staff would not be immediately available to intervene. The use of video monitoring would be acceptable as a compliment to the 1:1 monitoring, but not acceptable as a stand-alone intervention, unless as described below.
For patients at high risk for suicide, video monitoring may only be used in place of direct line-of-sight monitoring when it is unsafe for a staff member to be physically located in the patient's room.In addition, for both direct line-of-sight and video monitoring of patients at high risk for suicide, the monitoring must be constant 1:1 at all times, including while the patient sleeps, toilets, bathes, etc. and the monitoring must be linked to the provision of immediate intervention, when needed, by the qualified staff member assigned to observe the high-risk patient.
The use of "electronic sitters" or video monitoring for patients who are NOT at high risk for suicide is up to the discretion of the organization. There are currently no leading practices on how to use video monitoring to monitor those at risk for suicide.It is important to reassess patients who are at risk for suicide, despite the monitoring method that is chosen.
Additional Resource
Suicide Prevention Portal
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still "critical" but moving in the desired direction it may be referred to as a "repeat critical result (RCR)" and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the "repeat critical value" procedure is described by the organization and would include how "improving labs" is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each health care organization may define for itself what constitutes "critical values". Provisions may be made for certain patient-specific situations in which values that would be "critical" for most patients are not critical for a particular patient or for patients with a particular diagnosis. The parameters must be objectively defined and are known to all staff who are involved in the process of reporting values.
The information provided in the ‘Note’ provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the ‘note’ at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
The information provided in the ‘Note’ provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the ‘note’ at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
The intent of the new requirement at NPSG.01.01.01 EP 3 is that organizations implement practices to prevent misidentification of newborns.The goal is to have a reliable process in place to ensure accurate identification of the newborn for whom the service or treatment is intended and to match the service or treatment to that neonate.
The information provided in the ‘Note’ provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the ‘note’ at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
The intent of the new requirement at NPSG.01.01.01 EP 3 is that organizations implement practices to prevent misidentification of newborns.The goal is to have a reliable process in place to ensure accurate identification of the newborn for whom the service or treatment is intended and to match the service or treatment to that neonate.
The information provided in the ‘Note’ provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the ‘note’ at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
The intent of the new requirement at NPSG.01.01.01 EP 3 is that organizations implement practices to prevent misidentification of newborns.The goal is to have a reliable process in place to ensure accurate identification of the newborn for whom the service or treatment is intended and to match the service or treatment to that neonate.
The information provided in the ‘Note’ provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the ‘note’ at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
The intent of the new requirement at NPSG.01.01.01 EP 3 is that organizations implement practices to prevent misidentification of newborns.The goal is to have a reliable process in place to ensure accurate identification of the newborn for whom the service or treatment is intended and to match the service or treatment to that neonate.
The information provided in the 'Note' provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the 'note' at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of the preprocedure verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the pre-procedure verification process will depend on the type and complexity of the procedure.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of the preprocedure verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the pre-procedure verification process will depend on the type and complexity of the procedure.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of the preprocedure verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the pre-procedure verification process will depend on the type and complexity of the procedure.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of the preprocedure verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the pre-procedure verification process will depend on the type and complexity of the procedure.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that "are" or "maybe" required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Resources:
ֱ Tools and Resources: Universal Protocol
Hospitals
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes outpatient locations as the Conditions of Participation require that the organization's outpatient services be consistent with the hospital's inpatient services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
NR.02.03.01 EP 9 also requires that hospitals that use Joint Commission accreditation for deemed status purposes have policies and procedures that establish which outpatient departments, if any, are not required to have a registered nurse present.
Critical Access Hospitals
NR.02.03.01 EP 7 applies only to critical access hospitals that have either an inpatient rehabilitation or psychiatric distinct part unit (DPU). The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term 'immediately available' has not been formally defined, an RN would not be considered 'immediately available' if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state's CMS office regarding a waiver (42 CFR §488.54(c)) option.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts^ in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
^The organization determines where emergency carts are located within the organization.
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
There are no specific Joint Commission standards that require an H & P, that has been dictated and placed into the record, to be authenticated prior to a procedure or prior to updating an H & P that was completed within 30 days prior to admission or registration.
Organizations are required to have a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature is considered an entry. However,State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing a policy, organizations should work with their regulatory leadership and legal counsel to determine any state-specific requirements that must be considered. When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
It is recognized that the prenatal patient is a special situation in that, in and of itself, the prenatal course of care is a planned, systematic updating of the history and physical performed at the first visit and throughout the pregnancy. As such, the entire prenatal record can be utilized as the history and physical, provided it is updated to reflect the patient's condition upon admission or prior to a high risk or operative procedure.
When a history and physical (H & P) is completed within 30 days PRIOR TO inpatient admission or registration of the patient, an update is required within 24 hours AFTER the patient physically arrives for admission/registration but prior to surgery or a procedure requiring anesthesia services. For example, if an H & P was completed in a physician's office at 3:00 pm today for a procedure to be performed at 9:00 am tomorrow, an update would be required AFTER the patient arrives for the procedure tomorrow morning but prior to the 9:00 am procedure time. The 24 hour time frame starts when the patient physically presents for admission/registration. NOTE: The term 'registration' generally applies to patients scheduled for same day or outpatient procedures. Any H & P completed greater than 30 days prior to inpatient admission or registration cannot be updated and a new H & P must be completed.
NOTE: A properly executed history and physical is valid for the entire length of stay. Any changes to the patient's condition would be documented in the daily progress notes. A new H & P or update to the H & P is not required when the patient remains continuously hospitalized. If the patient has been discharged, then readmitted, there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay. Any changes to the patient’s condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Accreditation requirements that apply to H & Ps and updates include:
- Medical Staff (MS): MS.01.01.01 EP 16
- Medical Staff (MS): MS.03.01.01 EP 6, 7, 10, 11
- Provision of Care (PC): PC.01.02.03 EP 4
- Record of Care (RC): RC.01.03.01 EP 4
- Record of Care (RC): RC.02.01.03 EP 3
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay. Any changes to the patient’s condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Accreditation requirements that apply to H & Ps and updates include:
- Medical Staff (MS): MS.01.01.01 EP 16
- Medical Staff (MS): MS.03.01.01 EP 6, 7, 10, 11
- Provision of Care (PC): PC.01.02.03 EP 4
- Record of Care (RC): RC.01.03.01 EP 4
- Record of Care (RC): RC.02.01.03 EP 3
Any examples are for illustrative purposes only.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay. Any changes to the patient’s condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Any examples are for illustrative purposes only.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay. Any changes to the patient’s condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Any examples are for illustrative purposes only.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay. Any changes to the patient’s condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Any examples are for illustrative purposes only.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay.Any changes to the patient's condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners
Practitioners Without Privileges
- review the history and physical examination document
- determine if the information is compliant with the organization's defined minimal content
- obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
Non-inpatient Services (e.g., Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc.)
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
- Patient age
- diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
- comorbidities, and the level of anesthesia required for the surgery or procedure
- Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
- Applicable state and local health and safety laws
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an 'entry'.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state's Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The standards for nutritional and functional screening clearly state that these are performed when warranted by the patient's needs or condition. Your organization would define in writing the criteria that identify when these screenings and more in-depth assessment are performed. When applicable for the patient's condition, these screenings must be completed within 24 hours after inpatient admission.
It is not required that nutritional or functional screening are completed for all patients at all encounters if it has not been defined by the organization's policy, a licensed practitioner with appropriate clinical privileges has determined that it is not necessary in emergency situations, or it is not warranted by the patient's needs or condition.
A comprehensive pain assessment would be conducted consistent with the scope of care, treatment and services and the patient's condition. Nutritional, functional or pain screening may be performed at the first visit for primary care, an ambulatory clinic or office practice. Thereafter, the screens and assessment would be needed only as appropriate to the reason the patient is presenting for care or services.
The terms 'room' and 'suite' are sometimes used interchangeably. Therefore, compliance will be evaluated based on the availability of the following equipment to areas in which operative procedures are performed. When evaluating equipment inventory requirements and location, organizations are encouraged to consider the procedures performed, population served, physical layout, resources available to retrieve equipment, hours of operation (scheduled and emergencies), etc.
At a minimum, operating room suites have the following equipment available:
- Call-in system:A process to summon or communicate with staff outside of the operating room when needed
- Cardiac monitor
- Resuscitator: A hand-held or mechanical device that provides positive airway pressure
- Defibrillator
- Aspirator: A hand-held or mechanical device used to suction out fluids or secretions
- Tracheotomy set: Disposable or non-disposable as determined by the organization
The requirement applies to Hospitals that use accreditation for deemed status purposes and Rehabilitation and Psychiatric Distinct Part Units (DPU) in Critical Access Hospitals.
No, there is no specific accreditation requirement that states all orders must be canceled, then rewritten following a procedure or when a patient is transferred from one level of care to the next. Such a requirement would be an organizational decision, or when specifically required by individual state law/regulation.
During transitions of care, there must be a process in place to ensure coordination of care among care providers and that the most recent orders are being followed.However, such a process may not include the use of summary (blanket) orders for resuming medication (see MM.04.01.01 EP 8). During transitions of care, discussions between caregivers is an important step in making sure the orders implemented are the most recent.
Consider conducting a risk assessment as such an assessment allows organizations to identify risk points associated with options being considered. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Any examples are for illustrative purposes only.
Providing staff and licensed practitioners (LP) with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Opioid treatment programs that can be used for patient referrals
Clinicians encountering patients dealing with possible opioid abuse or dependence need readily accessible, accurate information about available resources to which patients can be referred for treatment. It can be challenging for individual clinicians or departments to maintain current information about provider availability in the community, therefore leadership can play a role by identifying community resources, then communicating this information to staff and practitioners. To assist organizations, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has a directory of opioid treatment programs.
Compliance may be determined through interviews with leadership, staff, practitioners and patients, review of an organization's discharge and referral processes, discharge information provided to patients to support ongoing care following discharge, etc.
Leadership responsibilities for developing and monitoring performance improvement activities specific to pain management and safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities, e.g., on monitoring the use of opioids;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LP) on available services for consultation and referral of patients with complex pain management needs
The intent of this requirement is to ensure that staff and LPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, an organization's outpatient pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LPs, patients, etc.
Acceptable non-pharmacologic pain treatment modalities
Organizations are required to provide non-pharmacologic pain treatment modalities relevant to its patient population and assessed needs of the patient. These modalities serve as a complementary approach for pain management and may potentially reduce the need for opioid medication in some circumstances.
Additionally, it is important to have non-pharmacologic pain treatment modalities available for patients that refuse opioids or for whom physicians believe may benefit from complementary therapies. Non-pharmacologic strategies include, but are not limited to, acupuncture therapy, massage therapy, physical therapy, relaxation techniques, music therapy, cognitive behavioral therapy, etc. The level of evidence for these therapies is highly variable, and it is evolving. Therefore, our standards do not mandate that any specific complementary option(s) is provided, but allow organizations to determine what modality(s) to offer.
Organizations should ensure that patient preferences for pain management are considered, and, when a patient's preference for a safe non-pharmacologic therapy cannot be provided, provide education to patients on where the treatment may be accessed post-discharge. There is not an expectation that the hospital will fulfill any and all requested non-pharmacologic therapies during the inpatient stay.
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
Facilitating access to the PDMP means that leadership has implemented systems and processes that support both ease of access for practitioners and consistent access to the PDMP when required by law.
Examples may include:
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record (when state law requires accessing before hospital discharge )
Each organization determines who is responsible for accessing the PDMP. This may vary based on different patient care settings.
The requirement does NOT apply to patients receiving short term opioid medications DURING the hospital encounter (for example, opioids administered for a day or two following a surgical or invasive procedure). During survey, compliance with accessing the PDMP may be evaluated during tracer activities, interviews with staff, practitioners, pharmacists, etc.
NOTE: This requirementis only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
Monitoring of post-operative patients on opiates and/or on opiates combined with other pain medications
ֱ requires hospitals to monitor patients at high risk for adverse outcomes related to opioid treatment (for example, patients with sleep apnea, patients receiving continuous intravenous opioids, patients on supplemental oxygen, etc.) (See PC.01.02.07 EP 6). The intent of this requirement is to ensure adequate monitoring and timely detection of opioid-induced respiratory depression. Decisions on who is at high risk and monitoring requirements are determined by the clinical team responsible for providing care and based on evidence-based guidelines, accepted standards of practice, etc.
In addition, leadership commitment is required to ensure that appropriate equipment is available to monitor patients deemed at high risk for adverse outcomes from opioid treatment (See LD.04.03.13 EP 7). Refer to standards PC.03.01.01 through PC.03.01.07 regarding sedation and anesthesia care, specifically.
Review of evidence-based guidelines will assist leadership and the medical staff in developing policies, protocols, metrics and other quality indicators. During survey, clinicians may be asked to describe how they identify a patient that is high risk and how they would manage and monitor that patient.
Educating the patient and family on discharge related to pain management
It is the responsibility of each organization to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, and safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these topics. Each organization determines where this information will be documented in the medical record.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available and used appropriately. The tools required to adequately assess pain may differ depending on a patient's age, condition, and ability to understand and should be evidence-based. For example, adult intensive care unit (ICU) patients who are unable to self-report and pediatric patients require the use of alternative assessment tools. Hospitals are required to have defined criteria that they will use to screen, assess and reassess pain that are consistent with the patient's age, condition, and ability to understand. Organizations determine where these criteria are located and any documentation requirements when such screenings or assessments are completed.
The practice of providing discharge instructions or after-visit summaries via the electronic medical record (i.e. patient portal) in lieu of a paper copy provided at discharge would not be prohibited by Joint Commission accreditation requirements.
Prior to providing instructions and information electronically, organizations need to consider the individual patient's ability to access electronic devices (e.g. computers, smartphone, tablet, etc.) technical ability, and overall comfort in using such devices to access electronic information. When another individual will be responsible for ensuring ongoing care of the patient, the same considerations apply.
Organizations that have the capability to provide discharge instructions and after-visit summaries electronically, are encouraged to handle on a case-by-case basis and allow the patient to determine how to receive discharge information. If your organization has a written policy or procedure on your requirements for providing discharge information, consider including this process in that document.
Enclosure Bed
- Use of an enclosure bed or net bed that prevents a patient from freely exiting the bed is considered a restraint. (An exception is the age-appropriate use of an enclosed crib for infants and/or toddlers.)
Restricting a patient's freedom from exiting the bed
- If raising the side rails prevents a patient from voluntarily getting out of bed or attempting to exit the bed, this would be restricting the patient's freedom of movement and the side rails would be considered a restraint.
- The number of raised side rails used may also be a factor. When all four side rails are used to prevent a patient from exiting the bed, this would be a restraint, however, raising fewer than four side rails when the bed has segmented side rails would not necessarily immobilize or reduce the ability of a patient to move freely. For example, if the side rails are segmented and all but one segment are raised to allow the patient to freely exit the bed, the side rails are not acting as a restraint. On the contrary, if the bed has non-segmented rails that when both raised does not allow the patient to freely exit the bed, the side rails would be acting as a restraint.
- If a patient is not physically able to get out of bed, regardless of whether the side rails are raised or not, raising all four side rails for this patient would not be considered restraint because the side rails have no impact on the patient's freedom of movement.
The use of restraints for the prevention of falls should not be considered a routine part of a fall prevention program. Use of restraints as a fall prevention approach has major, serious drawbacks and can contribute to serious injuries.
Protecting a patient from falling out of bed
- If raising the side rails prevents the patient from inadvertently falling out of bed, then it is not considered a restraint. Examples include raising the side rails when a patient is on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from inadvertently falling out of the bed.
- The mitts are pinned or otherwise attached to the bed/bedding or are used in conjunction with wrist restraints and/or
- The mitts are applied so tightly that the patient's hands or fingers are immobilized, and/or
- The mitts are so bulky that the patient's ability to use their hands is significantly reduced, and/or
- The mitts cannot be easily removed intentionally by the patient in the same manner they were applied by staff considering the patient's physical condition and ability to accomplish the objective.
No. A telemedicine link does not fulfill the in-person requirement for the evaluation by a Licensed Practitioner (LP) of the individual in restraint or seclusion for the management of violent or self-destructive behavior. The in-person evaluation must be face-to-face and completed by a physician, clinical psychologist, or other licensed practitioner responsible for the care of the patient. A registered nurse may conduct the in-person evaluation within one hour of the initiation of restraint or seclusion as long as this individual is trained in accordance with the requirements in PC.03.05.17, EP 3.
When the in-person evaluation (performed within one hour of the initiation of restraint or seclusion) is done by a trained registered nurse, they must consult with the attending physician or other licensed practitioner responsible for the care of the patient as soon as possible after the evaluation, as determined by hospital policy. This evaluation must be completed within one hour of the initiation of restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff, or others.
Joint Commission standards require that a physician or other licensed practitioner responsible for the patient's care order restraint^ or seclusion^. When restraint or seclusion is used for the management of violent or self-destructive behavior an in-person (face-to-face) evaluation of the patient within one hour of the initiation of the restraint or seclusion is also required.
Four requirements must be met for a resident (a physician in a graduate medical education program) to order restraint or seclusion or conduct the required face-to-face evaluation of a patient in restraint or seclusion for the management of violent or self-destructive behavior:
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
^Please see the glossary of the accreditation manual for definition of terms.
Any examples are for illustrative purposes only.
Education and Training in Resuscitation versus Certification Requirements (e.g., BLS, ACLS, PALS, NRP)
The intent of PC.02.01.11, EP 4 is that organizations provide education and training in addition to any certifications. While certifications provide the necessary foundational knowledge in resuscitation, PC.02.01.11, EP 4 stresses institution-specific education and training to promote staff preparedness that certification courses may not provide (for example, training grounded in local policies, procedures, or protocols, equipment; and the staff's specific roles and expectations during a code event).
Policies versus Procedures or Protocols
The organization can decide whether it develops a policy(-ies), procedure(s) or protocol(s). The phrase "Policies, procedures, or protocols" in PC.02.01.20 EPs 1 and 2 is meant to convey that the organization may determine which format is used for such documents.The organization can also decide whether the processes for post-cardiac arrest care (e.g., on targeted temperature management (TTM), neuro-prognostication, cardiac arrest in the context of STEMI) will be formalized as a single policy, several policies or procedures, protocols, or a combination of several types of documents. The intent of the requirements is that interdisciplinary, post-cardiac arrest care is delivered in an organized manner. Periodic review of processes is expected (the frequency is determined by organizations) to ensure that care and treatment align with current scientific literature. Note: For hospitals that use Joint Commission accreditation for deemed status purposes: Preprinted and electronic standing orders, order sets, and protocols that contain medication orders must meet the requirement MM.04.01.01 EP 15.
Inter-facility Transfers
An inter-facility transfer (see PC.02.01.20 EP 3) is a transfer that occurs between any two healthcare facilities. Examples include hospital to hospital, ambulatory surgical center to hospital, etc. For the purposes of this requirement, 'inter-facility" does not include transfers between different departments within the same hospital if they are housed in the same building or within the same hospital complex.
In-hospital cardiac arrest (IHCA) versus out of hospital cardiac arrest (OHCA)
The scope of resuscitation requirements includes IHCA and OHCA. For IHCA, there is no particular area of focus in terms of location, e.g., ED, or ICU, general nursing floor, etc. OHCA management would include post-cardiac arrest care for survivors and, if indicated, inter-hospital transfer. Organization policy(-ies), procedure(s) or protocol(s) may address IHCA and OHCA together or separately. Organizations also have the flexibility to decide whether any of the above subcategories should receive priority in performance improvement, based on data, populations served, etc. (see PI.01.01.01, EP 10 and PI.03.01.01 EP 22).
Analysis for Performance Improvement
- average ventilation rate
- chest compression depth and rate
- chest compression fraction
- time to first shock ≤2 min for VF/pulseless VT first documented rhythm
- time to IV/IO epinephrine ≤5 min for asystole or pulseless electrical activity
- peri-shock pauses (pre-shock and post-shock)
Reference: Meaney, P. A., Bobrow, B. J., Mancini, M. E., Christenson, J., De Caen, A. R., Bhanji, F., ... & Leary, M. (2013). Cardiopulmonary resuscitation quality: improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation, 128(4), 417-435.
Additional Resources
Joint Commission Perspectives®, July 2021, Volume 41, Issue 7
Requirement, Rationale, Reference R3 Report
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions (see accreditation manual glossary)
• Deep sedation/analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance and maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.
• Anesthesia:Consists of general anesthesia and spinal or major regional anesthesia, does not include local anesthesia. General anesthesia is a drug-induced loss of consciousness during which patients are not arouse a ball even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuro-muscular function. Cardiovascular function may be impaired.
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LIP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no significant changes in the patient’s status since the initial assessment. This re-evaluation occur after the patient is on the procedure table and/or prior to the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by an anesthesia provider or aLIP with medical staff privileges consistent with state law and regulation.
- In deemed*organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LIP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LIP, or the patient may bedischarged upon a LIP’s order based on criteria established by the medical staff.
* Deemed Status:Status conferred by the Centers for Medicare & Medicaid Services (CMS) on an organization whose standards and survey process are determined by CMS to be equivalent to those of the Medicare program or other federal laws, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). Accreditation is voluntary and seeking deemed status through accreditation is an option, not a requirement.
Definitions^
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no changes in the patient's status since the initial assessment. This re-evaluation occurs immediately prior to (meaning without delay) the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by a qualified individual and consistent with state law and regulation.
- In deemed(^^)organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LP, or the patient may bedischarged upon a LP's order based on criteria established by the medical staff.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
The "qualified individual/ transfusionist" is determined by the organization considering any professional guidelines, state laws and regulations that define qualifications necessary to transfuse blood and blood products. The organization must also ensure the qualified individual/ transfusionist is competent in transfusing blood and blood products and the identification verification process defined by the organization.
The second individual involved in a two-person verification process is determined by the organization. This individual must be competent in conducting the identification verification process for blood and blood products defined and implemented by the organization.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LIP could authenticate for another LIP.
Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LIP responsible for the care of that patient, when the ordering LIP is not available, but NOT transcribed progress notes which can only be authenticated b the LIP who dictated the progress note.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LP could authenticate for another LP.Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP)/Conditions for Coverage(CfC), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LP responsible for the care of that patient, when the ordering LP is not available. This does not apply totranscribed progress notes as they can only be authenticated by the LP who dictated the progress note.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
There are no specific Joint Commission standards that require an H & P, that has been dictated and placed into the record, to be authenticated prior to a procedure or prior to updating an H & P that was completed within 30 days prior to admission or registration.
Organizations are required to have a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature is considered an entry. However,State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing a policy, organizations should work with their regulatory leadership and legal counsel to determine any state-specific requirements that must be considered. When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
No, an H & P that has only been dictated and not placed in the medical record would not be compliant, except in emergencies*.The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards as essential information needed to further assess and manage the patient is absent.
Standard RC.02.01.03 is specific in the requirement that the patient's medical history and physical examination are recorded in the medical record before an operative or other high-risk procedure is performed.
*In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
No, an H & P that has only been dictated and not placed in the medical record would not be compliant, except in emergencies*.The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards as essential information needed to further assess and manage the patient is absent.
Standard RC.02.01.03 is specific in the requirement that the patient's medical history and physical examination are recorded in the medical record before an operative or other high-risk procedure is performed.
*In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
No, an H & P that has only been dictated and not placed in the medical record would not be compliant, except in emergencies*.The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards as essential information needed to further assess and manage the patient is absent.
Standard RC.02.01.03 is specific in the requirement that the patient's medical history and physical examination are recorded in the medical record before an operative or other high-risk procedure is performed.
*In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
No, an H & P that has only been dictated and not placed in the medical record would not be compliant, except in emergencies^.The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards as essential information needed to further assess and manage the patient is absent.
Standard RC.02.01.03 is specific in the requirement that the patient's medical history and physical examination are recorded in the medical record before an operative or other high-risk procedure is performed.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
The requirement to collect race and ethnicity has historically applied to hospitals (Standard RC.02.01.01, EP 25). As of January 1, 2023, it will also apply to organizations in the ambulatory health care (RC.02.01.01, EP 31), behavioral health and human services (RC.02.01.01, EP 26) and critical access hospital (RC.02.01.01, EP 25) programs.
The intent of the requirement is to collect race and ethnicity information to identify potential health care disparities, and organizations have the flexibility to determine which categories of race and ethnicity are appropriate for the population they serve. ֱ does not specify which categories an organization should use to collect race and ethnicity data.
While ֱ requirement is not prescriptive of which categories of race and ethnicity should be collected, many state reporting entities and payers do specify these requirements. Organizations are encouraged to use, at a minimum, the race and ethnicity categories from the Office of Management and Budget (OMB) and US Census Bureau, and to consider collecting ethnicity categories based on the population to obtain additional granularity. Resources such as the Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement and the Health Research and Educational Trust Disparities Toolkit provide additional guidance on collecting race and ethnicity information.
Resources
In respect to laboratory electronic health records (EHR), the determination of whether a hospital information system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains unchallenged in practice. ֱ's longstanding position is that the laboratory, an integrated and essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or electronic, appears in the organization's patient medical record in the intended format and with all required elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical record also appear to the end user in the intended format and with all required elements, even if these alternate versions are not considered a part of the patient's permanent medical record.
Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory results in other formats and that do not represent the official or an alternate distribution version of the laboratory report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to innovation and functionality. As such, these supporting clinical applications are not required to contain all of the required elements of the official or alternate distribution versions of the laboratory report. However, each supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary to ensure clarity and proper interpretation by the end user. This assessment should include review by representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications that rely upon the original and corrected laboratory results.
As the area of information technology is rapidly changing, please note that this interpretation could change in the future based upon updated regulations, case examples, and other pertinent developments associated with the implementation of the electronic medical record in a healthcare organization.
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The practice described may be acceptable as long as an organization has determined that:
- The medication order is written in a manner that supports deferring to patient preference when the patient is:
- Requesting a lesserpotent medication.(Potency should be established with an evidence based tool i.e. morphine equivalents).
- Requesting alesser prescribed dose in a range order.
- Requestinga less intrusive route of administration if both routes are prescribed by the provider.
- The medication is administeredin accordance with orders from the LicensedPractitioner.
- The inclusion allowing patient preference is in the medication order and does not subsequently create a therapeutic duplication with other prescribed medications.
- The organization's medication management policy identifies this type of medication order as acceptable and defines all required elements of such orders.
- The use of a protocol is not required.However, if an organization chooses to utilize a protocol, the review and approval process must comply with the requirements found at MM.04.01.01 EP 15.The medical record must contain evidence of an order to implement the protocol, as well as the protocol itself.
- Implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation.
Per the requirements of the Record of Care, Treatment, and Services (RC) chapter, the medical record must accurately reflect that the lesser potent medication was administered based on patient preference. It isNEVER acceptable to administer a medication of stronger potency based on patient preference.
No. If there was no blood loss^ and/or no specimens removed, there is no requirement for the proceduralist to document those two items, unless the organization specifically requires this level of documentation. The word "any" was specifically chosen to reflect the need to only document those items when applicable to the procedure performed.
^As applicable to the procedure, it is acceptable to document 'quantitative blood loss' in lieu of 'estimated blood loss' which is common in OB/GYN procedures.
The report must be written or dictated immediately after an operative or other high risk procedure^ and entered into the medical record.This information could be entered as the operative report or as a hand-written progress note. If the operative or procedural report is not placed in the medical record immediately following the procedure, then a progress note must be immediately entered after the procedure to provide pertinent information to the next provider of care. The goal is to ensure there is sufficient information about the procedure in the record immediately after surgery or other high risk procedure to manage the patient throughout the post procedure period.
'Immediately after surgery or procedure' is defined as "upon completion of procedure, before the patient is transferred to the next level of care". This is to ensure that pertinent information is available to the next caregiver. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit or area of care, the report can be written or dictated in the new unit or area of care. For the purposes of this requirement, ֱ considers the Pre-Op, O.R. and PACU as the same level of care as the clinical team is essentially intact across these areas.
If the progress note option is used (see RC.02.01.03 EP 7), it must contain, at a minimum, comparable operative/procedural report information. The minimum required elements include; the name of the primary surgeon and assistants procedures performed and description of each procedure findings any estimated blood loss, any specimens removed, and the post operative diagnosis.
^ See definition in the glossary of the accreditation manual.
No, there is no specific accreditation requirement that states all orders must be canceled, then rewritten following a procedure or when a patient is transferred from one level of care to the next. Such a requirement would be an organizational decision, or when specifically required by individual state law/regulation.
During transitions of care, there must be a process in place to ensure coordination of care among care providers and that the most recent orders are being followed.However, such a process may not include the use of summary (blanket) orders for resuming medication (see MM.04.01.01 EP 8). During transitions of care, discussions between caregivers is an important step in making sure the orders implemented are the most recent.
Consider conducting a risk assessment as such an assessment allows organizations to identify risk points associated with options being considered. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO) agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient, there should be documentation of the patient's wishes according to the organization's policy and procedure. The organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life. The patient may need to be transferred and this should be in accordance with law/regulation and any applicable OPO agreement.
No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO) agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient, there should be documentation of the patient's wishes according to the organization's policy and procedure. The organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life. The patient may need to be transferred and this should be in accordance with law/regulation and any applicable OPO agreement.
No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO) agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient, there should be documentation of the patient's wishes according to the organization's policy and procedure. The organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life. The patient may need to be transferred and this should be in accordance with law/regulation and any applicable OPO agreement.
No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO) agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient, there should be documentation of the patient's wishes according to the organization's policy and procedure. The organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life. The patient may need to be transferred and this should be in accordance with law/regulation and any applicable OPO agreement.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the introduction to the Transplant Safety chapter found in the accreditation manual.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The source facility must be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.Each organization must check with their state for the status of Tissue License Requirements.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Disease Specific Care
Primary Source verification applies only to licensure/certification or registration required to practice a profession. Current licensure/certification or registration is verified at the time of hire or renewal via a secure electronic communication. Telephone verification is acceptable, if that verification is documented. Primary Source verification will be obtained from a state licensing board or another agency officially designated to provide such services. Primary Source verification is not required for organizational requirements such as cardiopulmonary resuscitation (CPR), advanced cardiac life support (ACLS), pediatric advanced life support (PALS), or clinical certifications such as peripherally inserted central catheter (PICC) line certification.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
You may follow the sampling methodology for measuring compliance with Elements of Standards Compliance (ESC) & Measures of Success (MOS) in our standards which can be found in thePerformance Improvement and Performance Measurement (PI) chapter located in the Disease Specific Care (DSC) manual.
Manual: Health Care Staffing Services
The HCSS certification process provides a comprehensive evaluation of key functional areas such as processes for verifying the credentials and competencies of health care staff. Program standards also address major content areas such as Leadership, Human Resources Management, Performance Measurement and Improvement, and Information Management.
To be reviewed by surveyors. Categories complete. Remember: Article Annual Review to be Completed
The HCSS certification process provides a comprehensive evaluation of key functional areas such as processes for verifying the credentials and competencies of health care staff. Program standards also address major content areas such as Leadership, Human Resources Management, Performance Measurement and Improvement, and Information Management.
The HCSS certification process provides a comprehensive evaluation of key functional areas such as processes for verifying the credentials and competencies of health care staff. Program standards also address major content areas such as Leadership, Human Resources Management, Performance Measurement and Improvement, and Information Management.
The HCSS certification process provides a comprehensive evaluation of key functional areas such as processes for verifying the credentials and competencies of health care staff. Program standards also address major content areas such as Leadership, Human Resources Management, Performance Measurement and Improvement, and Information Management.
The HCSS certification process provides a comprehensive evaluation of key functional areas such as processes for verifying the credentials and competencies of health care staff. Program standards also address major content areas such as Leadership, Human Resources Management, Performance Measurement and Improvement, and Information Management.
Additional Resources
HCSC Certification Resources
Competency assessment relies on many factors, including the command of knowledge and the ability to perform tasks. Current competency may be reviewed through information obtained from past and current employers, peer recommendations, validating specialty certifications, testing, ongoing performance data collection, and/or skills observation, either separately or in partnership with customers. In addition, the staffing firm's customers need to provide feedback regarding competency assessment to the staffing firm. However, the staffing firm chooses to measure competency, it should be done in a thorough and ongoing fashion, looking at significant, high risk activities or competencies that are new to the staff member.
Although competency assessments and performance evaluations are two different requirements, they are interrelated.The competency assessment looks at whether the clinical staff has the skills, knowledge, and abilities to perform the assigned job duties.Competency must be assessed by staff who understands the skills and knowledge required by the job responsibilities.Beyond the documented initialassessment to be finalized upon the completion of the staff's orientation, competency should be assessed on an on-going basis with documentation of such at least once every two years.
The performance evaluation looks at how well the clinical staff performs the assigned job responsibilities.This may also include any employee related functions such as communication and cooperation with the staffing office.A documented evaluation should be completed at least once every two years or more frequently as defined by organizational policy.
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The competency assessment can be accomplished through a variety of methods including the assessment of information from current and previous employers, collecting peer feedback, verifying certification and licensure, reviewing test results with a written or oral competency, and observation of skills. The assessment must be thorough and focus on the particular competency needs for the clinical staff's assignment. Use of a self-assessment, such as a skills checklist, as the sole assessment method does not constitute a competency assessment.
ֱ certified staffing firm must complete the credentialing process for all clinical staff that are assigned in the field. The hospital that contracts with the certified staffing firm may use the credentialing process of the staffing firm. The hospital should have confidence in the completeness, accuracy, and timeliness of the information. During the survey of an accredited organization that uses the credentialing information provided by a Joint Commission certified staffing agency, the survey team may request the credentialing information for review. The information will need to be provided during the survey. This should be discussed between the certified staffing agency and the accredited organization and agreed upon in advance to assure ongoing compliance.
ֱ certified staffing firm must complete the credentialing process for all clinical staff that are assigned in the field. The hospital that contracts with the certified staffing firm may use the credentialing process of the staffing firm. The hospital should have confidence in the completeness, accuracy, and timeliness of the information. During the survey of an accredited organization that uses the credentialing information provided by a Joint Commission certified staffing agency, the survey team may request the credentialing information for review. The information will need to be provided during the survey. This should be discussed between the certified staffing agency and the accredited organization and agreed upon in advance to assure ongoing compliance.
ֱ certified staffing firm must complete the credentialing process for all clinical staff that are assigned in the field. The hospital that contracts with the certified staffing firm may use the credentialing process of the staffing firm. The hospital should have confidence in the completeness, accuracy, and timeliness of the information. During the survey of an accredited organization that uses the credentialing information provided by a Joint Commission certified staffing agency, the survey team may request the credentialing information for review. The information will need to be provided during the survey. This should be discussed between the certified staffing agency and the accredited organization and agreed upon in advance to assure ongoing compliance.
ֱ certified staffing firm must complete the credentialing process for all clinical staff that are assigned in the field. The hospital that contracts with the certified staffing firm may use the credentialing process of the staffing firm. The hospital should have confidence in the completeness, accuracy, and timeliness of the information. During the survey of an accredited organization that uses the credentialing information provided by a Joint Commission certified staffing agency, the survey team may request the credentialing information for review. The information will need to be provided during the survey. This should be discussed between the certified staffing agency and the accredited organization and agreed upon in advance to assure ongoing compliance.
The staffing firm encourages on-going education of its staff by offering education directly, or making available any schedules, announcements and overviews of any formal educational activities offered by various professional organizations and/or healthcare organizations. In many cases of licensed staff there is a state requirement for the staff to pursue continuing education for renewal of the professional license. The staffing firm should track the continuing education of staff which occurs outside of the organization.
ֱ certified staffing firm orients their clinical staff to the following:
- Cultural diversity and sensitivity.
- National Patient Safety Goals.
- Infection control including either using the Centers for Disease Control Hand Hygiene guidelines or the World Health Organization's hand hygiene guidelines.
- Patient rights, the ethics of care, treatment and services and the process to address ethical issues.
- Procedures to follow in the event of unexpected patient incidents related to the care, treatment, and services provided (including errors, safety hazards, injuries and sentinel events) regardless of whether the incident resulted in an adverse patient outcome.
No, the customers’ orientation cannot replace the orientation that is the responsibility of the certified firm.Orientation to the healthcare staffing firmmust be documented prior totheir first assignment.
ֱ certified staffing firm orients their clinical staff to the following:
- Cultural diversity and sensitivity.
- National Patient Safety Goals.
- Infection control including either using the Centers for Disease Control Hand Hygiene guidelines or the World Health Organization's hand hygiene guidelines.
- Patient rights, the ethics of care, treatment and services and the process to address ethical issues.
- Procedures to follow in the event of unexpected patient incidents related to the care, treatment, and services provided (including errors, safety hazards, injuries and sentinel events) regardless of whether the incident resulted in an adverse patient outcome.
No, the customers’ orientation cannot replace the orientation that is the responsibility of the certified firm.Orientation to the healthcare staffing firmmust be documented prior totheir first assignment.
ֱ certified staffing firm orients their clinical staff to the following:
- Cultural diversity and sensitivity.
- National Patient Safety Goals.
- Infection control including either using the Centers for Disease Control Hand Hygiene guidelines or the World Health Organization's hand hygiene guidelines.
- Patient rights, the ethics of care, treatment and services and the process to address ethical issues.
- Procedures to follow in the event of unexpected patient incidents related to the care, treatment, and services provided (including errors, safety hazards, injuries and sentinel events) regardless of whether the incident resulted in an adverse patient outcome.
No, the customers’ orientation cannot replace the orientation that is the responsibility of the certified firm.Orientation to the healthcare staffing firmmust be documented prior totheir first assignment.
ֱ certified staffing firm orients their clinical staff to the following:
- Cultural diversity and sensitivity.
- National Patient Safety Goals.
- Infection control including either using the Centers for Disease Control Hand Hygiene guidelines or the World Health Organization's hand hygiene guidelines.
- Patient rights, the ethics of care, treatment and services and the process to address ethical issues.
- Procedures to follow in the event of unexpected patient incidents related to the care, treatment, and services provided (including errors, safety hazards, injuries and sentinel events) regardless of whether the incident resulted in an adverse patient outcome.
No, the customers' orientation cannot replace the orientation that is the responsibility of the certified firm.Orientation to the healthcare staffing firmmust be documented prior totheir first assignment.
ֱ certified staffing firm orients their clinical staff to the following:
- Cultural diversity and sensitivity.
- National Patient Safety Goals.
- Infection control including either using the Centers for Disease Control Hand Hygiene guidelines or the World Health Organization's hand hygiene guidelines.
- Patient rights, the ethics of care, treatment and services and the process to address ethical issues.
- Procedures to follow in the event of unexpected patient incidents related to the care, treatment, and services provided (including errors, safety hazards, injuries and sentinel events) regardless of whether the incident resulted in an adverse patient outcome.
In addition to addressing all the elements of performance at HSHR.3, the staffing firm's customers need to provide orientation to the organization, and any department specific and job specific information and training.
In addition to addressing all the elements of performance at HSHR.3, the staffing firm's customers need to provide orientation to the organization, and any department specific and job specific information and training.
In addition to addressing all the elements of performance at HSHR.3, the staffing firm's customers need to provide orientation to the organization, and any department specific and job specific information and training.
In addition to addressing all the elements of performance at HSHR.3, the staffing firm's customers need to provide orientation to the organization, and any department specific and job specific information and training.
Regularly scheduled performance evaluations provide an opportunity to offer feedback to clinical staff about their fulfillment of job responsibilities and quality of their efforts. The evaluationmustencompass:
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External:The quality of services the clinical staff member is providing tothefirm'sclients(clinicalclient feedback)
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Internal:How the staff member has functioned as a contributing member and representative of the HCSS firm
This process also provides the staff member with constructive feedback and education for professional and occupational development.
Analyzingbothcustomer feedback and competency reassessmentsresultsareimperative to the evaluation.This analysis should be consistent with the expectations outlined in the job description.Conclusionsfrom the performance evaluation should direct future assignments and the continued relationship with the staff member.
It is up to the organization to decide whether to maintain one file or to separate the personnel file into two sections. The primary issue related to this decision is the organization's ability to maintain confidentiality for the protected health information of the staff. For paper files this is usually easier to accomplish with two files since the organization can better control who has access to the protected health information, while allowing staff to have access to the more general personnel information. In electronic files, this can be accomplished by controlling access through passwords for authorized office staff. For either form of record keeping, the information should only be available to authorized staff in accordance with law and regulation.
It is up to the organization to decide whether to maintain one file or to separate the personnel file into two sections. The primary issue related to this decision is the organization's ability to maintain confidentiality for the protected health information of the staff. For paper files this is usually easier to accomplish with two files since the organization can better control who has access to the protected health information, while allowing staff to have access to the more general personnel information. In electronic files, this can be accomplished by controlling access through passwords for authorized office staff. For either form of record keeping, the information should only be available to authorized staff in accordance with law and regulation.
It is up to the organization to decide whether to maintain one file or to separate the personnel file into two sections. The primary issue related to this decision is the organization's ability to maintain confidentiality for the protected health information of the staff. For paper files this is usually easier to accomplish with two files since the organization can better control who has access to the protected health information, while allowing staff to have access to the more general personnel information. In electronic files, this can be accomplished by controlling access through passwords for authorized office staff. For either form of record keeping, the information should only be available to authorized staff in accordance with law and regulation.
It is up to the organization to decide whether to maintain one file or to separate the personnel file into two sections. The primary issue related to this decision is the organization's ability to maintain confidentiality for the protected health information of the staff. For paper files this is usually easier to accomplish with two files since the organization can better control who has access to the protected health information, while allowing staff to have access to the more general personnel information. In electronic files, this can be accomplished by controlling access through passwords for authorized office staff. For either form of record keeping, the information should only be available to authorized staff in accordance with law and regulation.
It is up to the organization to decide whether to maintain one file or to separate the personnel file into two sections. The primary issue related to this decision is the organization's ability to maintain confidentiality for the protected health information of the staff. For paper files this is usually easier to accomplish with two files since the organization can better control who has access to the protected health information, while allowing staff to have access to the more general personnel information. In electronic files, this can be accomplished by controlling access through passwords for authorized office staff. For either form of record keeping, the information should only be available to authorized staff in accordance with law and regulation.
No,acopy of the agreement or contract must be provided to the staffing firm's customers. At a minimum the agreement must address all theelementslisted in HSLD 5.
If the health care organization is unwilling to modify the language of the contract, the certified staffing firm may include the missing elements in an addendum to the contractora policy statement. The addendum or policy statement must address all requirements atHSLD.5andthenbesent to the health care organization.This will need to be done each time the contract is updated or renewed. The staffing firmmustmaintain verification that theaddendum/policy statementwas sent to the health care organization.
The identification of potential emergencies and the direct and indirect effects these emergencies may have on the staffing firm's operation and demand for its services.If the firm has multiple locations, each officelocationis required tohave its own HVA.A common, but not prescribed,practice is to utilizeagrid style HVA toolthat will comprehensively capture all the potential risks.
Performance Measure Data Report questions can be completed,updatedorrevised at any time; however, responses to all 4 questions should be enteredprior to theIntra-Cycle Review and reviewed,updatedorrevised for the recertification review visit. A performance measure data reportmustbe completed for each measure.
The electronic submission process,known as CMIP,stands for Certification Measure Information Process and is available through the HCSS firm's secure extranetsite.
In the field of health care, almost any process, patientorcustomer encounter can generate data. The challenge for HCSS firms is to know which data to collect to generate the most useful reportsforanalysis.When HCSS firms collect and analyze data over time, they can use their data to predict future trends, which will allow them to adapt to an ever-changing business environment.
In order to transform data into performance improvement,ֱdeveloped standardized performance measures to assistaccredited healthcarestaffing firmsin identifyingthe most usefuldata.
Standardized set of measures:
- HCSS -1 Do Not Return Clinical
- HCSS- 2 Do Not Return Professional
- HCSS- 3 Completeness of Personnel File
(These include all active direct clinical care providers)
Refer to the PM Implementation Guide located on your Extranetsitefor additional information.
The performance measure requirements for all HCSS firmsinclude:
- Collection of monthly data points(Numerator/Denominator) for the three standardized measures
- Performance improvement is a continuous study and adjustmentandshould be entered in CMIP as it becomes available
- HCSS firms are required to submit performance data no later than 45 days following the end of the calendar quarter
- Data submission is accomplished by enteringand saving monthly data points (numerator and denominator value for each measure). Saving the informationwill transmit the data to ֱ.
The data collection tools available in the implementation guide are optional. These forms are aids that can be used to guide data collection; however, other data collection tools, such as electronic reports and internally developed forms are other possible options for data collection. All data collection tools (e.g., forms, reports, etc.) utilized by the firm should be retained for the on-site review.
The firm can apply for certification in May and request an initial on-site review in August; however, four months of data for each performance measure must be available at the time of the on-site review. Data collection can be retrospective. If the firm wants to have an on-site in August, they should collect data for the months of March, April, May, and June, or if available, July to comprise the four months needed.
Sampling is allowed for HCSS-3: Completeness of Personnel File; however, measures HCSS-1: Do Not Return-Clinical and HCSS-2: Do Not Return-Professional require 100% review.
Sampling is an option; however, the firm may choose to review and collect data for more than the required sample size. When the firm chooses to use sampling, they must use the sampling methodology for performance measurement as outlined in theimplementation guide.
Monthly sample size based on population size # of active clinical staff:
- 1 - 9 = 100% of personnel files
- 10 - 49 = 10 personnel files
- 50 - 99 20 % of personnel files
- > 100 = 20 personnel files
The standards and standardized measures are not the same yet work together to improve performance. The standards are the principles and expectations for quality service in a well-run firm. The Performance Measurement and Improvement Standards guide firms in establishing a performance improvement process. The HCSS Standardized Performance Measures are precisely defined quantitative tools used to monitor and improve the firm's performance over time.
Manual: Home Care
ֱ has no prescribed list of recommended members for the emergency management committee, with the exception that participants should include the emergency program lead and others as identified by the organization (EM.10.01.01, EP 3). Based on the size and needs of the organization, the committee should consider including positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response, and recovery activities.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation.
The continuity of operations plan (COOP) outlines how the organization will continue to provide essential or critical services until full operations are restored. Based on the known or assessed risks (the HVA) the organization predicts what the consequences would be if they were to lose critical infrastructure (such as information technology, security systems, administrative/vital records) and develops plans and/or policies to identify actions the organization will implement to mitigate the effects of a potential emergency or disaster. The COOP also includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making. Testing the COOP for potential failures will be needed during emergency management exercises, which allows participants to identify gaps or weaknesses and provides opportunities to make improvements. Failure to recognize and plan for challenges may disrupt the organization's ability to provide essential services and functions that may result in the inability to remain fully operational, resulting in partial or even full evacuation. (For testing requirements, refer to Standard EM.16.01.01).
A disaster recovery plan is a documented, structured approach that describes how the organization will quickly restore services such as electricity, water, communications, and information technology and resume operations. Conducting an organization wide damage assessment occurs early in the recovery phase to begin identifying needs for recovery services or repairs and to begin restoring critical systems and essential services. Phases of recovery can vary depending on the incident and the damages or impacts to the organization. Response, continuity of operations, and recovery procedures are often conducted concurrently. Therefore, identifying connected functions, tasks, or activities in the post-emergency environment will facilitate a coordinated transition from response to recovery. Therefore, the disaster recovery plan is an essential part of continuity of operations and provides strategies to quickly handle incidents, reduce downtime, and minimize financial loss so that the organization can continue to operate or quickly resume critical functions after an emergency or disaster.
There are differences between the Emergency Operations Plan (EOP) and the COOP. The EOP is a plan for how the organization will function during the mitigation, preparedness, response, and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plant, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or the 2018 FGI Guidelines for Design and Construction of Hospitals.
Reference: EC.02.06.05 EP 1
Additional Resources
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or in their absence thelatest edition ofFGI Guidelines for the Design and Construction of Outpatient Facilities.
The FGI Guidelines documents state "the number and placement of both hand-washing stations and hand sanitation dispensers shall be determined by the ICRA." (Section 2.1-7.2.2.8) The ICRA or infection control risk assessment, which should be done at the programming stage of the project and should help guide the decisions on where to locate them. The individual facility chapters, though, have additional specific requirements for hand washing stations in certain locations. For example, each exam or treatment room is required to have one.
Additional Resources:
To access a read only copy of the FGI Guidelines for Design and Construction of Outpatient Facilities the hyperlink is provided here for your convenience:
Reference EC.02.06.05 EP1
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.
Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
The three main issues to oxygen storage in a patient’s residence are:
- Secured in an appropriate stand to prevent tipping and physical damage
- Placement away from heat sources
- Located with adequate ventilation
Placement under the patient's bed would be acceptable if there are no bed coverings which prevent airflow and there is no heat source such as a radiator or air register (central air heating).
Inappropriate storage locations would include; open porches or decks, near a furnace or water heater, and closets.
The three main issues to oxygen storage in a patient’s residence are:
- Secured in an appropriate stand to prevent tipping and physical damage
- Placement away from heat sources
- Located with adequate ventilation
Placement under the patient's bed would be acceptable if there are no bed coverings which prevent airflow and there is no heat source such as a radiator or air register (central air heating).
Inappropriate storage locations would include; open porches or decks, near a furnace or water heater, and closets.
The three main issues to oxygen storage in a patient’s residence are:
- Secured in an appropriate stand to prevent tipping and physical damage
- Placement away from heat sources
- Located with adequate ventilation
Placement under the patient's bed would be acceptable if there are no bed coverings which prevent airflow and there is no heat source such as a radiator or air register (central air heating).
Inappropriate storage locations would include; open porches or decks, near a furnace or water heater, and closets.
The three main issues to oxygen storage in a patient's residence are:
- Secured in an appropriate stand to prevent tipping and physical damage
- Placement away from heat sources
- Located with adequate ventilation
Inappropriate storage locations would include; open porches or decks, near a furnace or water heater, and closets.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
For ambulatory surgical centers and outpatient surgical departments that use ֱ deemed status option, that were constructed, or had a change in occupancy type, or have undergone an electrical system upgrade since 1983, a Type 1 or Type 3 essential electrical system is required as defined in the 2012 edition of NFPA 99.
This essential electrical system must be divided into three branches, including the:
- life safety branch
- critical branch
- equipment branch
Type 1 essential electrical system is required for:
- Critical care areas are those special care units in which patients are intended to be subjected to invasive procedures using electrical patient care medical equipment. Type 1 systems should be installed where there would be a risk of death or serious injury to the patient in the event of power failure.
- To supply emergency power in facilities that do not provide electrical life support or use general anesthesia. Type 3 systems are permitted where equipment failure is less critical to human life and safety.
Additional Resources:
EC.02.05.03
NFPA 99-2012: 6.3.2.2.10, 6.4.1, 6.4.2.2, 6.6.3
CMS S&C 07-21
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The organization must ensure that equipment with specific electrical needs is appropriately set up in the patients’ home. It would be up to the organization to determine how this will be done. ֱ does not require organizations to perform voltage or amperage checks. That would be the organization's decision. If the organization determines that the utility system in the home is inadequate or cannot be adapted such as adding a grounded 3 prong adapter, the organization should consult with the physician about further orders.
The determination considers the electrical and environmental requirements of the equipment that need to be met and is intended to bring to light any concerns about the equipment’s safe use in the patient’s home.
The organization must ensure that equipment with specific electrical needs is appropriately set up in the patients’ home. It would be up to the organization to determine how this will be done. ֱ does not require organizations to perform voltage or amperage checks. That would be the organization's decision. If the organization determines that the utility system in the home is inadequate or cannot be adapted such as adding a grounded 3 prong adapter, the organization should consult with the physician about further orders.
The determination considers the electrical and environmental requirements of the equipment that need to be met and is intended to bring to light any concerns about the equipment’s safe use in the patient’s home.
The organization must ensure that equipment with specific electrical needs is appropriately set up in the patients’ home. It would be up to the organization to determine how this will be done. ֱ does not require organizations to perform voltage or amperage checks. That would be the organization's decision. If the organization determines that the utility system in the home is inadequate or cannot be adapted such as adding a grounded 3 prong adapter, the organization should consult with the physician about further orders.
The determination considers the electrical and environmental requirements of the equipment that need to be met and is intended to bring to light any concerns about the equipment’s safe use in the patient’s home.
The organization must ensure that equipment with specific electrical needs is appropriately set up in the patients' home. It would be up to the organization to determine how this will be done. ֱ does not require organizations to perform voltage or amperage checks. That would be the organization's decision. If the organization determines that the utility system in the home is inadequate or cannot be adapted such as adding a grounded 3 prong adapter, the organization should consult with the physician about further orders.
The determination considers the electrical and environmental requirements of the equipment that need to be met and is intended to bring to light any concerns about the equipment's safe use in the patient's home.
In the home care setting, the infusion pump is out of the control of the organization while it is in the patient's home and could be subject to damage that could affect its operation. The damage may not be known to the organization. As such, before the pump can be reissued to a new patient after it has been picked up from a patient's home, the organization needs perform basic safety and operational checks, along with any routine and preventive maintenance according to manufacturers' guidelines that may include volumetric checks in addition to inspecting the pump for such things as cord condition, alarm function, lights, casing condition, etc.
If the manufacturer does not have guidelines for routine and/or preventive maintenance, the organization establishes such guidelines. For example, the organization may choose to have discussions with the manufacturer, observe its own failure rates for the equipment, examine maintenance schedules of like products, or use any other method that is effective.
In the home care setting, the infusion pump is out of the control of the organization while it is in the patient's home and could be subject to damage that could affect its operation. The damage may not be known to the organization. As such, before the pump can be reissued to a new patient after it has been picked up from a patient's home, the organization needs perform basic safety and operational checks, along with any routine and preventive maintenance according to manufacturers' guidelines that may include volumetric checks in addition to inspecting the pump for such things as cord condition, alarm function, lights, casing condition, etc.
If the manufacturer does not have guidelines for routine and/or preventive maintenance, the organization establishes such guidelines. For example, the organization may choose to have discussions with the manufacturer, observe its own failure rates for the equipment, examine maintenance schedules of like products, or use any other method that is effective.
In the home care setting, the infusion pump is out of the control of the organization while it is in the patient's home and could be subject to damage that could affect its operation. The damage may not be known to the organization. As such, before the pump can be reissued to a new patient after it has been picked up from a patient's home, the organization needs perform basic safety and operational checks, along with any routine and preventive maintenance according to manufacturers' guidelines that may include volumetric checks in addition to inspecting the pump for such things as cord condition, alarm function, lights, casing condition, etc.
If the manufacturer does not have guidelines for routine and/or preventive maintenance, the organization establishes such guidelines. For example, the organization may choose to have discussions with the manufacturer, observe its own failure rates for the equipment, examine maintenance schedules of like products, or use any other method that is effective.
In the home care setting, the infusion pump is out of the control of the organization while it is in the patient's home and could be subject to damage that could affect its operation. The damage may not be known to the organization. As such, before the pump can be reissued to a new patient after it has been picked up from a patient's home, the organization needs perform basic safety and operational checks, along with any routine and preventive maintenance according to manufacturers' guidelines that may include volumetric checks in addition to inspecting the pump for such things as cord condition, alarm function, lights, casing condition, etc.
If the manufacturer does not have guidelines for routine and/or preventive maintenance, the organization establishes such guidelines. For example, the organization may choose to have discussions with the manufacturer, observe its own failure rates for the equipment, examine maintenance schedules of like products, or use any other method that is effective.
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master's Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as 'paper' or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
- A decision that individuals who work in the organization may use any abbreviation, acronym, or symbol that is not on the list of unacceptable abbreviations. However, if multiple abbreviations, symbols, or acronyms exist for the same term, the organization identifies what will be used to eliminate ambiguity.
U,u
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
Note 1: A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
Note 2: The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as "no exit".
Reference LS.02.01.20 EP 41
ֱ uses the 2012 edition of NFPA 101 Life Safety Code. For consistency, no equipment is allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance with section 7.1.3.2.3. This would include evacuation chairs/sleds.
Security cameras, card readers, Wi-Fi routers and repeaters can be in the exit enclosure, so long as it doesn't interfere with the use of the exit and is used for surveillance of the exit enclosure. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Any penetrations into the rated exit enclosure must be sealed with a fire stop material that is appropriate to the rating of the enclosure. Properly protected system penetrations into existing (prior to July 5, 2016) exit enclosures are acceptable as long as they were part of the original construction and no alterations have since been made; once an alteration has been made, the current code should be followed.
Reference LS.02.01.20 EP 13, LS.03.01.20 EP 11
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization’s policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization “maintains documentation of any inspections and approvals made by state or local fire control agencies.” These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered “in use” when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Doors in means of egress are required to be opened without the "use of a tool or key from the egress side". Occupant movement cannot be restricted during an emergency; however, locking certain doors may be necessary for the safety of the patient in certain situations.
When a healthcare facility determines that doors must be locked to protect patients the locking configuration must comply with one of the following:
- Delayed-egress locking system as defined by NFPA 101-2012: 7.2.1.6.1
- Access-controlled egress door assemblies as defined in NFPA 101-2012: 7.2.1.6.2
- Elevator lobby exit access door locking compliant with NFPA 101-2012: 7.2.1.6.3
Pediatric units, maternity units, and emergency departments are examples of areas where patients might have special needs that justify door locking. Patients that require additional protective measures to ensure safety and security are allowed to have door locking arrangements provided that all of 5 criteria of NFPA 101-2012: 18/19.2.2.2.5.2 are met, in summary these are:
- Staff can readily unlock all doors at all times
- A total (complete) smoke detection system is provided throughout the locked space, compliant with NFPA 101-2012: 9.6.2.9, or locked doors can be remotely unlocked at an approved, constantly attended location within the locked space.
- The building is protected throughout by an approved, supervised sprinkler system in accordance with NFPA 101-2012: 18/19.2.2.2.5.2
- Locks are electrical and fail safe to release upon loss of power
- The locks release by independent activation of each:
- Activation of the smoke detection system NFPA 101-2012: 18/19.2.2.2.5.2(2)
- Waterflow in the automatic sprinkler system NFPA 101-2012: 18/19.2.2.2.5.2(3)
Additional Resources
LS.02.01.20
NFPA 101-2012: 18/19.2.2.2.4; 19.2.2.2.5
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ's Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Picture a horizontal plane parallel to the ceiling that is 18 inches below the sprinkler heads. Nothing should be in that area between the bottom of the sprinkler heads and the imaginary horizontal plane parallel to the ceiling that is 18 inches below. This is done to allow an even and unobstructed spray pattern from the sprinklers when triggered to extinguish the fire.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources:
LS.02.01.35
NFPA 13-2010
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
ֱ would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not beenapproved as an indication.
ֱ is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
Ideally, hazardous medications would be compounded in a negative pressure environment. Currently, according to USP 797, if an organization prepares a low volume of hazardous drugs, the use of two tiers of containment is acceptable in a non-negative pressure area. An example of 2-tier containment would be the use of a closed system transfer device utilized within a biological safety cabinet or compounding aseptic containment isolator.
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
• Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients
• Description of all ingredients and their quantities
• Compatibility and stability information, including references when available
• Equipment used for the preparation, when appropriate
• Mixing instructions including, but not limited to, order of mixing, temperature, duration of mixing, and related factors important to the replication of the compounded preparation
• Dispensing container used for nonsterile compounded preparation
• Packaging and storage requirements
• Description of final preparation
• Quality control procedures and expected results
• For sample labeling, in addition to legally required information, themanufacturer should include generic name, quantity/concentration of each active ingredient, assigned beyond-use date (BUD), storage conditions, and prescription or control number.
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
• Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients
• Description of all ingredients and their quantities
• Compatibility and stability information, including references when available
• Equipment used for the preparation, when appropriate
• Mixing instructions including, but not limited to, order of mixing, temperature, duration of mixing, and related factors important to the replication of the compounded preparation
• Dispensing container used for nonsterile compounded preparation
• Packaging and storage requirements
• Description of final preparation
• Quality control procedures and expected results
• For sample labeling, in addition to legally required information, themanufacturer should include generic name, quantity/concentration of each active ingredient, assigned beyond-use date (BUD), storage conditions, and prescription or control number.
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
• Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients
• Description of all ingredients and their quantities
• Compatibility and stability information, including references when available
• Equipment used for the preparation, when appropriate
• Mixing instructions including, but not limited to, order of mixing, temperature, duration of mixing, and related factors important to the replication of the compounded preparation
• Dispensing container used for nonsterile compounded preparation
• Packaging and storage requirements
• Description of final preparation
• Quality control procedures and expected results
• For sample labeling, in addition to legally required information, themanufacturer should include generic name, quantity/concentration of each active ingredient, assigned beyond-use date (BUD), storage conditions, and prescription or control number.
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
- Official or assigned name, strength, and dosage form of the nonsterile compounded preparation
- Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients
- Description of all ingredients and their quantities
- Compatibility and stability information, including references when available
- Equipment used for the preparation, when appropriate
- Mixing instructions including, but not limited to, order of mixing, temperature, duration of mixing, and related factors important to the replication of the compounded preparation
- Dispensing container used for nonsterile compounded preparation
- Packaging and storage requirements
- Description of final preparation
- Quality control procedures and expected results
- For sample labeling, in addition to legally required information, themanufacturer should include generic name, quantity/concentration of each active ingredient, assigned beyond-use date (BUD), storage conditions, and prescription or control number.
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
The same personal protective equipment expected in a clean room when compounding in a laminar workflow bench are required when utilizing a CAI or CACI unless the manufacturer has written information based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This includes double gloving for the preparation of hazardous medications.
- ISO level of the primary engineering control
- Viable particle testing surface of the primary engineering control
- Viable particle testing air within the primary engineering control
- HEPA filter leak test of the primary engineering control
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals.Lack of testing of these items will result in non-compliance with Joint Commission standards.
- Air exchanges per hour of the buffer area
- Pressure differential (between buffer area/ante area; ante area/non-classified area)
- ISO level of the buffer area and ante area
- Viable particle testing surface of the buffer area and ante area
- Viable particle testing air—HEPA filter leak test of HVAC HEPA filter system
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Applicable only to organizations following USP 797 2008 Version:
The current standard of practice does not allow for alcohol swabs to touch another object prior to its use when cleaning a critical point (i.e. vial septum, ampule neck, or injection entry port on an IV bag). If this is identified during a survey, it will be scored as non-compliant with Joint Commission Standards as an infection control risk.
The following definition of 'compounding' can be found in the glossary of the Home Care (OME) Accreditation Manual:
The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
- Preparation of drug dosage forms for both human and animal patients
- Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
- Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients
- Preparation of drugs or devices for the purposes of or incidental to chemical analysis, teaching, or research (clinical or academic)
- Preparation of drugs and devices for prescriber's office use where permitted by federal and state law
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
Applicable only to organizations following USP 797 2008 Version:
The current standard of practice does not allow for alcohol swabs to touch another object prior to its use when cleaning a critical point (i.e. vial septum, ampule neck, or injection entry port on an IV bag). If this is identified during a survey, it will be scored as non-compliant with Joint Commission Standards as an infection control risk.
It is up to the organization to determine whether or not the compounding space is acceptable to continue producing sterile compounded medication products. Factors should include the pathogenicity of the organism grown in the positive growth viable sample; complexity level of the compounded product; any known/potential associated hospital acquired infections; and guidance from the infection control practitioner.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
Organizations are required to establish a process for communicating medication shortages to Licensed Practitioners (LP) and staff who participate in medication management (MM.02.01.01). Examples of 'staff' may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources
Individual State Pharmacy Boards
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
National Patient Safety Goal.09.02.01-EP1 requires the organization to evaluate the patient's risk for falls and take action to reduce the risk of falling as well as the risk of injury, should a fall occur. The evaluation could include a patient's fall history; review of medications and alcohol consumption; gait and balance screening; assessment of walking aids, assistive technologies, and protective devices; and environmental assessments.
It is helpful to identify medications that are frequently associated with increased risk of falling. Some suggested classifications are: hypnotics, sedatives, analgesics, psychotropics, antihypertensives, laxatives and diuretics. Please consider not only the class of drug, but the number of drugs (polypharmacy) and the potential for additive effects when they accumulate in the body that also increases risk.
The organization's fall reduction program is expected to include all patient/resident care settings and populations. We don't prescribe what the program must include but there must be something to address the risk of harm from falls for all of the organization's settings and populations. That includes the possibility that a specific unit or population had been assessed and determined to have a minimal risk of patient/resident harm from falls and that nothing further needs to be done for that setting or population. However, if a particular setting or population was simply ignored in the organization's program, then it would not meet the requirement.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
It is expected that education related to the common causes of household fires, how oxygen enhances fires, and a comprehensive list of what preventive actions need to be taken by the patient using oxygen. This education can be provided orally, or in writing (such as in a pamphlet), or preferably both.
The goal is to ensure accurate identification of care recipients. In the home care setting, this is much easier and less prone to error than in other settings. Certainly, at the first encounter, the requirement for two identifiers is appropriate in a literal sense. Thereafter, and in any situation of continuing one-on-one care where the nurse "knows" the individual, one of the identifiers can be direct facial recognition. In the home, the correct address (an acceptable identifier when used in conjunction with another person-specific identifier) is also confirmed.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
In addition to obtaining Home Infusion Therapy (HIT) Accreditation from a CMS approved organization such as ֱ, in order to bill for the new HIT benefit, the organization must be a Medicare Part B provider. Some organizations may be asking if they are eligible for the Part B benefit.
Provider Criteria
To be eligible for the Home Infusion Therapy (HIT) Medicare Part B benefit, providers need to meet the following criteria:
- Be a home infusion therapy supplier which involves the provision of professional services (including nursing services) furnished in accordance with a physician established plan of care that describes the type, amount and duration of infusion therapy services that are to be furnished.
- Furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
- Provide training and education, and remote and other monitoring services.
- Ensure the safe and effective provisions and administration of home infusion therapy on a 7-day-a-week, 24 hour-a-day basis and
- Obtain accreditation with a CMS-approved accrediting organization (ֱ) by January 1, 2021
Organizations interested in becoming a supplier under the HIT benefit involving professional services, training and education are required to complete and submit an application to CMS.
After you become Medicare Part B certified, in order obtain Medicare reimbursement for HIT specifically for the nursing component, your organization will need to obtain accreditation by a CMS approved accrediting organization, such as ֱ.
The HIT benefit covers services provided that are separate from those reimbursed under the Durable Medical Equipment (DME). The service can only be billed if a professional is present on days the infusion drug is administered. The nursing component covers:
- Specific Training and Education on the care of venous access devices (VAD).
- Education regarding maintenance and troubleshooting
- Infection Control
- Site Care
- Ongoing patient assessments
- Medication Management
- Interdisciplinary Communication
ֱ’s ‘Provision of Care, Treatment and Services’ (PC) remain the same with the addition of two elements of performance (EP) specific to HIT which address the Plan of Care (POC)and remote monitoring. You will be accountable for the current existing standards specific to your home care program i.e.deemed or non-deemed and the new HIT specific EPs. The additional EPs are:
- PC.02.01.03, EP 2: The patient plan of care is established and periodically reviewed by a physician and includes the medication(s) route, dose, frequency and duration for home infusion.
- PC.02.02.05, EP 7: The organization provides the patient with access to nursing services, including nursing services, patient education and training, and remote monitoring services 24 hours a day, 7 days a week.
Organizations that achieve or maintain their existing home care accreditation for home infusion services by January 1, 2021 will not need to complete a new survey. Organizations not currently accredited but interested in obtaining Medicare reimbursement for the nursing component of the infusion therapy service must participate in an unannounced home care survey and achieve a decision of ‘Accredited’ prior to submitting requests for reimbursement.
ֱ HIT accreditation will satisfy the CMS reimbursement requirement. Your organization will still need to follow the CMS application process. Questions regarding this can be submitted to the following email address: HomeInfusionPolicy@cms.hhs.gov. Once the entire process is completed, your organization will be accredited to provide and bill for HIT services to Medicare patients.
HIT Accreditation
HIT accreditation is considered a new accreditation and separate from other accreditation programs. CMS is allowing organizations currently accredited to remain on their current survey schedule. These organizations are grandfathered in for HIT accreditation until the organization’s next scheduled survey. However, it is necessary to implement the new, unique HIT Elements of Performance for compliance with the program.
Resources:
In addition to obtaining Home Infusion Therapy (HIT) Accreditation from a CMS approved organization such as ֱ, in order to bill for the new HIT benefit, the organization must be a Medicare Part B provider. Some organizations may be asking if they are eligible for the Part B benefit.
Provider Criteria
To be eligible for the Home Infusion Therapy (HIT) Medicare Part B benefit, providers need to meet the following criteria:
- Be a home infusion therapy supplier which involves the provision of professional services (including nursing services) furnished in accordance with a physician established plan of care that describes the type, amount and duration of infusion therapy services that are to be furnished.
- Furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
- Provide training and education, and remote and other monitoring services.
- Ensure the safe and effective provisions and administration of home infusion therapy on a 7-day-a-week, 24 hour-a-day basis and
- Obtain accreditation with a CMS-approved accrediting organization (ֱ) by January 1, 2021
Organizations interested in becoming a supplier under the HIT benefit involving professional services, training and education are required to complete and submit an application to CMS.
After you become Medicare Part B certified, in order obtain Medicare reimbursement for HIT specifically for the nursing component, your organization will need to obtain accreditation by a CMS approved accrediting organization, such as ֱ.
The HIT benefit covers services provided that are separate from those reimbursed under the Durable Medical Equipment (DME). The service can only be billed if a professional is present on days the infusion drug is administered. The nursing component covers:
- Specific Training and Education on the care of venous access devices (VAD).
- Education regarding maintenance and troubleshooting
- Infection Control
- Site Care
- Ongoing patient assessments
- Medication Management
- Interdisciplinary Communication
ֱ’s ‘Provision of Care, Treatment and Services’ (PC) remain the same with the addition of two elements of performance (EP) specific to HIT which address the Plan of Care (POC)and remote monitoring. You will be accountable for the current existing standards specific to your home care program i.e.deemed or non-deemed and the new HIT specific EPs. The additional EPs are:
- PC.02.01.03, EP 2: The patient plan of care is established and periodically reviewed by a physician and includes the medication(s) route, dose, frequency and duration for home infusion.
- PC.02.02.05, EP 7: The organization provides the patient with access to nursing services, including nursing services, patient education and training, and remote monitoring services 24 hours a day, 7 days a week.
Organizations that achieve or maintain their existing home care accreditation for home infusion services by January 1, 2021 will not need to complete a new survey. Organizations not currently accredited but interested in obtaining Medicare reimbursement for the nursing component of the infusion therapy service must participate in an unannounced home care survey and achieve a decision of ‘Accredited’ prior to submitting requests for reimbursement.
ֱ HIT accreditation will satisfy the CMS reimbursement requirement. Your organization will still need to follow the CMS application process. Questions regarding this can be submitted to the following email address: HomeInfusionPolicy@cms.hhs.gov. Once the entire process is completed, your organization will be accredited to provide and bill for HIT services to Medicare patients.
HIT Accreditation
HIT accreditation is considered a new accreditation and separate from other accreditation programs. CMS is allowing organizations currently accredited to remain on their current survey schedule. These organizations are grandfathered in for HIT accreditation until the organization’s next scheduled survey. However, it is necessary to implement the new, unique HIT Elements of Performance for compliance with the program.
Resources:
In addition to obtaining Home Infusion Therapy (HIT) Accreditation from a CMS approved organization such as ֱ, in order to bill for the new HIT benefit, the organization must be a Medicare Part B provider. Some organizations may be asking if they are eligible for the Part B benefit.
Provider Criteria
To be eligible for the Home Infusion Therapy (HIT) Medicare Part B benefit, providers need to meet the following criteria:
- Be a home infusion therapy supplier which involves the provision of professional services (including nursing services) furnished in accordance with a physician established plan of care that describes the type, amount and duration of infusion therapy services that are to be furnished.
- Furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
- Provide training and education, and remote and other monitoring services.
- Ensure the safe and effective provisions and administration of home infusion therapy on a 7-day-a-week, 24 hour-a-day basis and
- Obtain accreditation with a CMS-approved accrediting organization (ֱ) by January 1, 2021
Organizations interested in becoming a supplier under the HIT benefit involving professional services, training and education are required to complete and submit an application to CMS.
After you become Medicare Part B certified, in order obtain Medicare reimbursement for HIT specifically for the nursing component, your organization will need to obtain accreditation by a CMS approved accrediting organization, such as ֱ.
The HIT benefit covers services provided that are separate from those reimbursed under the Durable Medical Equipment (DME). The service can only be billed if a professional is present on days the infusion drug is administered. The nursing component covers:
- Specific Training and Education on the care of venous access devices (VAD).
- Education regarding maintenance and troubleshooting
- Infection Control
- Site Care
- Ongoing patient assessments
- Medication Management
- Interdisciplinary Communication
ֱ’s ‘Provision of Care, Treatment and Services’ (PC) remain the same with the addition of two elements of performance (EP) specific to HIT which address the Plan of Care (POC)and remote monitoring. You will be accountable for the current existing standards specific to your home care program i.e.deemed or non-deemed and the new HIT specific EPs. The additional EPs are:
- PC.02.01.03, EP 2: The patient plan of care is established and periodically reviewed by a physician and includes the medication(s) route, dose, frequency and duration for home infusion.
- PC.02.02.05, EP 7: The organization provides the patient with access to nursing services, including nursing services, patient education and training, and remote monitoring services 24 hours a day, 7 days a week.
Organizations that achieve or maintain their existing home care accreditation for home infusion services by January 1, 2021 will not need to complete a new survey. Organizations not currently accredited but interested in obtaining Medicare reimbursement for the nursing component of the infusion therapy service must participate in an unannounced home care survey and achieve a decision of ‘Accredited’ prior to submitting requests for reimbursement.
ֱ HIT accreditation will satisfy the CMS reimbursement requirement. Your organization will still need to follow the CMS application process. Questions regarding this can be submitted to the following email address: HomeInfusionPolicy@cms.hhs.gov. Once the entire process is completed, your organization will be accredited to provide and bill for HIT services to Medicare patients.
HIT Accreditation
HIT accreditation is considered a new accreditation and separate from other accreditation programs. CMS is allowing organizations currently accredited to remain on their current survey schedule. These organizations are grandfathered in for HIT accreditation until the organization’s next scheduled survey. However, it is necessary to implement the new, unique HIT Elements of Performance for compliance with the program.
Resources:
In addition to obtaining Home Infusion Therapy (HIT) Accreditation from a CMS approved organization such as ֱ, in order to bill for the new HIT benefit, the organization must be a Medicare Part B provider. Some organizations may be asking if they are eligible for the Part B benefit.
Provider Criteria
- Be a home infusion therapy supplier which involves the provision of professional services (including nursing services) furnished in accordance with a physician established plan of care that describes the type, amount and duration of infusion therapy services that are to be furnished.
- Furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
- Provide training and education, and remote and other monitoring services.
- Ensure the safe and effective provisions and administration of home infusion therapy on a 7-day-a-week, 24 hour-a-day basis and
- Obtain accreditation with a CMS-approved accrediting organization (ֱ) by January 1, 2021
After you become Medicare Part B certified, in order obtain Medicare reimbursement for HIT specifically for the nursing component, your organization will need to obtain accreditation by a CMS approved accrediting organization, such as ֱ.
The HIT benefit covers services provided that are separate from those reimbursed under the Durable Medical Equipment (DME). The service can only be billed if a professional is present on days the infusion drug is administered. The nursing component covers:
- Specific Training and Education on the care of venous access devices (VAD).
- Education regarding maintenance and troubleshooting
- Infection Control
- Site Care
- Ongoing patient assessments
- Medication Management
- Interdisciplinary Communication
- PC.02.01.03, EP 2: The patient plan of care is established and periodically reviewed by a physician and includes the medication(s) route, dose, frequency and duration for home infusion.
- PC.02.02.05, EP 7: The organization provides the patient with access to nursing services, including nursing services, patient education and training, and remote monitoring services 24 hours a day, 7 days a week.
TJC HIT accreditation will satisfy the CMS reimbursement requirement. Your organization will still need to follow the CMS application process. Questions regarding this can be submitted to HomeInfusionPolicy@cms.hhs.gov. Once the entire process is completed your organization will be accredited to provide and bill for HIT services to Medicare patients.
Resources:
ֱ standards do not require an order for pulse oximetry.In addition, CMS does not have any requirements which prohibit the use of pulse oximetry without a physician's order.
The use of pulse oximetry on a PRN basis may be viewed as a part of vital signs.A therapist or nurse can use their clinical judgment to do an occasional pulse oximetry reading, and that would not need to be on the POC. However, if it is a regular part of their care, the nurse/therapist should put it on the POC/485.For example, in the case of a patient with known cardiopulmonary disease when pulse oximetry is being used for ongoing monitoring this should be included on the patient's plan of care.
There are no standards that prescriptively require temperature monitoring or maintaining a temperature log for refrigerators provided for personal patient use. However, a process is required to ensure the refrigerator functions properly to ensure safe storage of its food contents. Use of a temperature monitoring is one approach the organization may choose to ensure the unit is functioning properly.
ֱs standards require that organizations store food and nutrition products, including those brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and security. When nutritional products, such as breast milk or baby formula are stored in these units, evidence-based guidelines from sources, such as the CDC, the formula manufacturer, etc., are to be followed to ensure safe storage. Organizations should also have processes that address cleaning between patients and maintenance responsibilities. Consulting with local/state board of health agencies is recommended as there may be additional requirements to consider.
A risk assessment should be conducted to identify any risk points associated with this practice. Conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Leadership responsible for patient care practices, infection prevention and control, safe management of food and facilities maintenance should be encouraged to participate in the risk assessment process.
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
- PC.02.02.13 addresses providing care, to the extent possible, that accommodates spiritual needs during end-of-life care
- RI.01.01.01 addresses patient's right to access religious and other spiritual services
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
- PC.02.02.13 addresses providing care, to the extent possible, that accommodates spiritual needs during end-of-life care
- RI.01.01.01 addresses patient's right to access religious and other spiritual services
No. Your organization would define the content and scope of spiritual assessments and the qualifications of the individual(s) performing the assessment.
No. Your organization would define the content and scope of spiritual assessments and the qualifications of the individual(s) performing the assessment.
No. Your organization would define the content and scope of spiritual assessments and the qualifications of the individual(s) performing the assessment.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
Yes. Standard MM.04.01.01 requires that there be documented indication for all medications ordered. That indication can be in the form of lab values, diagnoses, progress note entries, etc. In other words, the indication must be evident somewhere in the medical record. This requirement is found in the Medication Management chapter at MM.04.01.01.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
Yes, all PRN medications the patient is actively using to treat existing health conditions must be documented. Examples would include Nitroglycerin for chest pain associated with coronary artery disease or ibuprofen for ongoing arthritis pain.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
Yes, all PRN medications the patient is actively using to treat existing health conditions must be documented. Examples would include Nitroglycerin for chest pain associated with coronary artery disease or ibuprofen for ongoing arthritis pain.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
Yes, all PRN medications the patient is actively using to treat existing health conditions must be documented. Examples would include Nitroglycerin for chest pain associated with coronary artery disease or ibuprofen for ongoing arthritis pain.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
Yes, all PRN medications the patient is actively using to treat existing health conditions must be documented. Examples would include Nitroglycerin for chest pain associated with coronary artery disease or ibuprofen for ongoing arthritis pain.
PRN medications the patient may have in the home but are not actively used to treat an existing health condition would not need to be documented. Examples would include pseudoephedrine without recent sinus congestion or acetaminophen without a recent headache. The patient should be informed not to self-administer any medications that have not been reviewed by the physician.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Hospital and Hospital Clinics
Health care organizations are not required to remain fully functional for 96-hours. Nor are they required to stock-pile supplies. They are required to develop an operational plan for 96-hour duration to fully understand capabilities and limitations in order to make effective decisions when under emergency conditions in an organized and prioritized manner.
Decisions would include, but not be limited, to maintaining emergency services, progressive curtailment of activities, stopping elective/non-emergency services, transfer of patients, evacuation of the facility, or returning to normal operations.
High priority incidents identified in the hazard vulnerability analysis are the issues to be considered in the 96-hour sustainability analysis. Issues include but are not limited to the anticipated actions, emergency supply inventory, access to emergency supplies, and emergency services based upon the assessment process. Exercises should be used to validate or adjust the sustainability plan.
For example, a hospital with a 72-hour supply of potable water at full capacity. Consideration of reducing patient load by early discharge and halting elective procedures, could reduce water demand by approximately 50%, thereby extending the hospitals potable water supply to 96 hours. The intent is to have a plan to stretch the supply on hand or to activate a Memoranda of Understanding (MOU) to receive more supplies, or a combination of both actions.
If any of the organization's controlling authorities, such as a local, state, region or federal charter requires the organization to remain open for a specified period, then the organization is expected to comply.
Reference EM.12.02.09 EP3.
The following are links to FAQs that address the new requirements:
Emergency Management – Hazard Vulnerability Analysis
Emergency Management - Human Resource (HR) Requirements for Volunteers
Emergency Management – Continuity of Operations Plan (COOP) and Disaster Recovery
Emergency Management - Requirements for Granting Privileges During a Disaster
Emergency Management - Duration for Continuing Disaster Privileges
Emergency Management – 96 Hour Plan
Emergency Management – Emergency Operations Plan Development and Participation
Emergency Management – Privileging Requirements When Providing Services via Telehealth Links During a Disaster
Emergency Management – Committee Expectations
Emergency Management – Incident Command Structure
Emergency Management – Inventory
Additional Resources:
Emergency Management Portal
R3 Report: Requirement, Rationale, Reference
For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation.
EM.10.01.01 requires senior leaders to participate in emergency management planning activities. Although it is up to the hospital to determine committee participants, the committee should be a multidisciplinary team which may include representatives from senior leadership, nursing services, medical staff, pharmacy services, infection prevention and control, facilities engineering, security and information technology. There are specific activities required of the committee (see EM.10.01.01, EP 4).
Reference EM.10.01.01
The requirements for a Continuity of Operations Plan (COOP) are defined in EM.13.01.01. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plant, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery (EM.14.01.01) after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. To evaluate effectiveness, the survey process will review the emergency operations plan, the continuity of operations and recovery plans, interview staff and review exercise evaluations.
Volunteer physicians and other licensed practitioners that have been granted disaster privileges may continue to provide care, treatment and services under the disaster privileging option (see EM.12.02.03) for the period of time the organization continues to operate under its Emergency Operations Plan (EOP). Organizations should periodically assess the number and specialty of those volunteer physicians and other licensed practitioners initially granted disaster privileges to ensure the ongoing needs of the patient population are being met and that the medical staff can maintain oversight over practitioner performance. If an important patient care need continues at the time the organization discontinues operation of the EOP, the medical staff could either grant temporary privileges or consider granting full privileges. NOTE: All Credentialing and Privileging must be consistent with applicable law, regulation and medical staff requirements.
A multidisciplinary committee that oversees the EM program should include medical staff or physician member as well as hospital executive leadership (e.g. individuals with decision-making authority). The multidisciplinary committee, including medical staff and hospital leadership, will be directly involved in the preparation, development, implementation, evaluation, and maintenance of the EM program, the emergency operations plan, policies, and procedures. Their input is essential to establish the expected capabilities and duties of these entities.
It is also important for medical staff and executive leadership to understand the duties and capabilities for the staff that will support the emergency operations plan, and the capabilities of community support entities. Many disaster scenarios involve patient care regarding management of current patients and managing influx of patients. Hospital leaders must understand the command structure and how it functions.
The HVA should be reviewed and updated based on after-action reports or opportunities for improvements that have been identified following real events and/or exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improve, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and an HVA performed for that site.
^Licensed volunteers are practitioners (physicians, nurses, therapists, etc.) who can provide direct patient care, treatment, and services who by law and regulation are required to have a license to practice. Other licensed volunteers (electricians, plumbers, inspectors) may provide unique services to help rebuild or restore a hospital or community.
ֱ's requirements for incident command at EM.12.01.01, EP 5 includes an incident command structure that describes the overall incident command operations, specific roles and responsibilities, and provides a structure that is flexible and scalable based on the needs of the organization during an emergency or disaster incident. Incident command staff are to be trained to be competent to effectively accomplish their assigned duties, command roles and responsibilities (EM.15.01.01, EP 4).
The hospital must have a written plan for how resources and assets are documented, tracked, and monitored and how they will locate (on-site and off-site inventories) during a disaster/emergency incident (EM.12.02.09, EP 1). The plan includes processes or procedures for how the hospital will manage and maintain critically needed resources such as personal protective equipment, water, fuel, and medical, surgical supplies and medications. It is up to the organization to determine what additional resources and assets may be needed during an emergency.
The written plan should include how the hospital will obtain, allocate, mobilize, replenish and conserve its resources and assets (see EM.12.02.09, EP 2). Memorandums of Understanding (MOUs) or other agreements may be formed with other entities to help the organization maintain its inventory during an emergency. However, MOUs are most useful during isolated emergencies, and are often not effective during large emergency events impacting a large region. Therefore, it is very important to test and/or document this along with the other five critical areas during an exercise or actual event to look for areas of risk.Additionally, hospitals are required to have a plan to sustain operations for up to 96 hours based on calculations of current resource consumptions (see EM.12.02.09, EP 3).
The applicable requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03. NOTE: The disaster privileging option ONLY applies when the organization has implemented their emergency management plan.
Physicians and other licensed practitioners CURRENTLY credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that telehealth be delineated as a separate privilege.
For volunteer physician and other licensed practitioners that are NOT currently credentialed and privileged by the organization, disaster privileges may be granted to volunteer physicians and other licensed practitioners by following the requirements outlined in the Emergency Management chapter of the accreditation manual. Additional Resources FAQ: Requirements for Granting Privileges During a Disaster.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Before granting emergency privileges, the organization must obtain a valid, government-issued photo ID (e.g. driver's license, passport) and at least one of the following:
- A current picture identification card from a health care organization that clearly identifies professional designation
- A current license to practice
- Primary source verification of licensure. (^) NOTE: Primary source verification of licensure occurs as soon as the disaster is under control or within 72 hours from the time the volunteer licensed practitioner presents to the hospital, whichever comes first. (see also EM.12.02.03 for additional information).
- Identification indicating that the individual is a member of a Disaster Medical Assistance Team (DMAT), the Medical Reserve Corps (MRC), the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP), or other recognized state or federal response organization or group Identification indicating that the individual has been granted authority by a government entity to provide patient care, treatment, or services in disaster circumstances
- Confirmation by a licensed practitioner currently privileged by the hospital or by a staff member with personal knowledge of the volunteer practitioner's ability to act as a licensedpractitioner during a disaster
The medical staff must have a process in place to oversee the performance of each volunteer practitioner. Based on its oversight of each volunteer licensed practitioner, the hospital determines, within 72 hours of the practitioner's arrival, if granted disaster privileges should continue.
Note: The requirements for assigning disaster responsibilities to volunteer practitioners who are NOT licensed practitioners, but who are required by law and regulation to have a license, certification, or registration, are found in the Hospital and Critical Access Hospital Accreditation manual at EM.12.02.03. Examples of such practitioners may include, but are not limited to: Nurses, Physician Assistants, Nurse Practitioners, Respiratory Therapists, etc.
Organizations that use Joint Commission accreditation for deemed status purposes should monitor the as waivers are being approved frequently and may include state-specific waivers.
The requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03.
Disaster privileges can only be granted to volunteer licensed practitioners when the organization's Emergency Operations Plan has been activated. A disaster is an emergency that, due to its complexity, scope, or duration, threatens the organization's capabilities and requires outside assistance to sustain patient care, safety, or security functions.
Before granting emergency privileges, the organization must obtain a valid, government-issued photo ID (e.g. driver's license, passport) and at least one of the following:
Before granting emergency or disaster incident privileges, the organization must have a documented staffing plan for the management of volunteer licensed practitioners when the hospital is unable to meet its patient needs. The plan outlines the following:
- Verifies and documents the identify of all volunteer licensed practitioners
- Completes primary source verification of licensure as soon as the immediate situation is under control or within 72 hours from the time the volunteer licensed practitioner presents to the organization
- Provision of oversight of the care, treatment, and services provided by the volunteer licensed practitioner
- Note: If primary source verification of licensure cannot be completed within 72 hours, the hospital documents the reason(s) it could not be performed
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
- Medical gas systems(training and certification or credentialing to the requirements of AASE 6030 or 6040)
- Fire alarm systems
- Fire door maintenance (certification is not required but demonstrated knowledge of the code and operating requirements)
- Boilers / High pressure vessels
- Fire/Smoke dampers
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or the 2018 FGI Guidelines for Design and Construction of Hospitals.
Reference: EC.02.06.05 EP 1
Additional Resources
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or in their absence thelatest edition ofFGI Guidelines for the Design and Construction of Outpatient Facilities.
The FGI Guidelines documents state "the number and placement of both hand-washing stations and hand sanitation dispensers shall be determined by the ICRA." (Section 2.1-7.2.2.8) The ICRA or infection control risk assessment, which should be done at the programming stage of the project and should help guide the decisions on where to locate them. The individual facility chapters, though, have additional specific requirements for hand washing stations in certain locations. For example, each exam or treatment room is required to have one.
Additional Resources:
To access a read only copy of the FGI Guidelines for Design and Construction of Outpatient Facilities the hyperlink is provided here for your convenience:
Reference EC.02.06.05 EP1
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Static load is typically a load bank brought on-site and connected to the generator to increase electrical load in order to achieve the 50% and 75% of nameplate rating loading.
Cooldown period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer’s recommended prime movers’ exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources:
NFPA 99-2012: 6.4.4.1
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2010 edition of NFPA 10 Standard for Portable Fire Extinguishers which is a mandatory reference in chapter 2 of the 2012 edition of NFPA 99, Healthcare Facilities Code.
The organization is expected to determine and select an appropriate fire extinguisher based upon a site-specific risk assessment that would include but not limited to:
- potential fire size
- types of fuels present
- sources of ignition
- flammable skin prep products
- potential for chemical reactions with the extinguishing agent
- presence of electrical equipment
According to the NFPA, a water-mist or carbon dioxide extinguisher may be used in the OR. Water mist-extinguishers are rated Class 2A:C. ECRI Institute has published information that water-mist fire extinguishers may not be appropriate in the operating room due to infection control concerns if used on a patients open surgical site cavity. Alternatively, a close-by basin of sterile water with a sponge to quench a surgical site fire might be most appropriate.
Carbon dioxide extinguishers are rated Class B and Class C, and can also be used for Class A fires.
Electrical fires or Class C, once the equipment is unplugged and de-energized, the fuel source is considered to be either a class A or B, allowing a carbon dioxide extinguisher to be utilized.
Additional Resources
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
- Each facility should develop policies about the specific frequency and methods for wall box surface disinfection
- Wall box surfaces should be disinfected at least daily
- Cleaning and disinfection of the wall box should be performed after the patient has left the station
- Disinfectant should be applied to all surfaces of the wall box and any attached hoses
- Ensure high touch surfaces (e.g., connections for acid, bicarbonate, and reverse osmosis water) are disinfected
- Wipes or other supplies used to disinfect the wall box should be discarded after use and not used to disinfect other surfaces in the dialysis station
- More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
If your organization is using ֱ accreditation process for deemed status purposes, then all medical equipment is required to be included in the written inventory.
The written inventory identifies high-risk devices. High-risk medical equipment includes all life support equipment and any other device for which there is a risk of serious injury or death to a patient or staff member should it fail. The term high-risk equipment is equivalent in scope and nature to the CMS term critical equipment.
Maintenance activities and frequencies follow manufacturers' instructions and recommendations for maintaining, inspecting, and testing all medical equipment in the inventory. These maintenance activities and frequencies, including an alternative equipment maintenance (AEM) strategy, are documented in writing.
The alternative equipment maintenance (AEM) strategy program must not reduce safety and is based on accepted standards of practice such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of maintenance and run-to-fail strategies.
AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers' recommendations:
- Equipment subject to federal or state law or Medicare Conditions of Participation
- Imaging and radiologic equipment (diagnostic or therapeutic)
- Medical LASER devices
- New medical equipment with insufficient maintenance history to support the use of an AEM strategy
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
The labeling shall include:
- the name or chemical symbol for the specific medical gas or vacuum system
- room or areas served
- caution to not close or open the valve except in an emergency
Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its hidden location may be identified by a label, icon, etc., or on a utility system map in accordance with EC.02.05.01 EP 17.
Reference EC.02.05.09 EP11
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
ֱ references NFPA 99-2012 Chapter 9, that requires the use of ASHRAE 170-2008, Ventilation Table 7-1. This document provides allowances to exceed minimum temperature ranges. To use this exception, it must be done by following the established organizational policy. In accordance with the allowances, the policy or formal process must be limited to cases based on either surgeon, patient, or procedure. It is not acceptable to consistently maintain temperatures outside of the required ranges.
Reference EC.02.05.01 EP 15
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
ֱ standards are not prescriptive regarding testing frequencies for piped medical gas and vacuum systems. The facility may determine its testing frequency by policy and the surveyor will evaluate testing based on that policy.
In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and reliable condition.
The organization is required by EC.02.05.01 to develop a maintenance strategy based upon either manufacturer's recommendations or an alternative equipment maintenance (AEM) strategy. Piped medical gas and vacuum systems are considered high-risk utility systems.
Issues such as system complexity, system age/condition, patient acuity, etc. are to be used to assess maintenance strategies. NFPA 99-2012 Appendix B can be used as a guide for establishing a maintenance strategy, but appendix material is not required unless adopted by a controlling authority. The survey process will evaluate the maintenance strategy assessment process for effectiveness and validate that it has been properly implemented.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
- applicable staff
- type of training
- level of training
- required credentials
The security management plan may be a stand-alone document or may be combined with other Environment of Care plans (one overarching plan or combined with another, such as the safety management plan, for instance). Components of the plan are outlined in EC.02.01.01 EPs, which include but not limited to:
- how will security risks be assessed and mitigated
- staff roles in security management
- how the facility is secured
- how the organization contact external security forces if needed
- how the organization will control access to areas identified as security sensitive
- how physical or verbal threats, acts of violence, inappropriate behavior will be managed
- If the organization has an MRI, there is to be an assessment for safety and security risk that addresses patient comfort and safety, equipment safety and security, and staff safety
Any requirements from the local authority having jurisdiction (AHJ) are expected to be followed.
Reference:
EC.01.01.01 EP 5
EC.02.01.01.
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ is not prescriptive to monitor or log temperature for refrigerators provided for personal patient use. However, a process is required to be in place to ensure that the refrigerator functions properly to safely store its contents.
ֱs standards require that organizations store food and nutrition products, including those brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and security as per PC.02.02.03.
When nutritional products, such as breast milk or baby formula are stored in these refrigerators, refer to evidence-based guidelines from the formula manufacturer's instructions for use (IFU), the Centers for Disease Control and Prevention (CDC), etc. to ensure safe storage.
Organizations should also have processes that address cleaning between patients and identifies maintenance responsibilities.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Additional Resources:
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
According to the Environmental Protection Agency (EPA) and Per OSHA, The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ standards do not require infant/child abduction drills. The standards do require that the organization identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable (see EC.02.01.01 EP 9). An exercise is one method to evaluate the effectiveness of the procedures regarding this issue. It is up to the organization to determine the appropriate actions to ensure successful implementation of the security procedures and that staff are knowledgeable of those procedures.
Conduct a risk assessment through a multi-disciplinary group that includes, for instance, OB, NICU, Pediatrics and other staff, such as the Safety Officer, Security Officer, Emergency Room staff, foster care personnel, direct child care staff, and the Risk Manager with each providing input in their area of expertise to address actual and potential risks.
Reference EC.02.01.01 EP 9
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
ֱ has no prescriptive requirement for daily monitoring or logging of temperature and relative humidity of a particular room type unless required by a controlling authority, such as the state health department or CMS, or by organizational policy. However, ASHRAE 170-2008, as referenced in NFPA 99-2012 must be complied with for new construction (designedafter July 5, 2016). Existing spaces must be maintained as originally designed unless hazards to health and safety exist.
Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore, some reliable strategy is to be implemented to insure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. Room temperature and humidity monitoring can be accomplished remotely by a building automation system, as long as there is a means to effectively identify an adverse condition (like a person at the monitoring station, an alarming mechanism, a paging system, etc.).
Daily monitoring can also be accomplished at the room site, by the occupants, as long as there is a process to periodically check readings (like a temperature/humidity reading device within the space). Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels. For other rooms assessed to be less critical, evidence of temperature and humidity levels may not be required, but are to be initially set-up properly when affected by new construction, alteration or renovation, and through methods such as regular environmental rounding, occupant feedback and through maintenance activities.
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
ֱ standard EC.02.05.01 EP 15 references NFPA 99-2012, which includes ANSI/ASHRAE/ASHE Standard 170-2008, or state design requirements if more stringent for temperature, pressure, and humidity requirements. This applies to hospital and outpatient facilities that were built, altered, or renovated after July 5, 2016. This document states that soiled workroom shall be negative with a temperature between 72-78 degrees Fahrenheit and no humidity requirement. The Clean workroom shall be positive, with temperature between 72-78 and a maximum relative humidity of 60%. For existing facilities (prior to July 5, 2016), you may comply with either these requirements, or the requirements that were in effect at the time of construction. In existing one-room layouts, the air flow within the room shall be from clean to dirty (with negative air flow overall).
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list toStandard 170-2008 Ventilation of Health Care Facilities.
- Medical gas systems(training and certification or credentialing to the requirements of AASE 6030 or 6040)
- Fire alarm systems
- Fire door maintenance (certification is not required but demonstrated knowledge of the code and operating requirements)
- Boilers / High pressure vessels
- Fire/Smoke dampers
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both ‘education’ and ‘training’ that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that ‘training’ focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by , "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, with the exception of nursing or other allied health licenses in states where non-waived laboratory testing in specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
ֱ's,expectation is thatthe organization is aware of anyoneentering the organizationand their purpose in order to maintain patient safety. Leadership is responsible to ensure that the processes are in place and implemented to ensure patient privacy and safety.
For non-licensed, non-employees that have a direct impact on patient care. E.g. HCIRs or Vendorsin procedure rooms/operating rooms providing guidance to the surgeon or staff, trainingof staff on equipment use, surgical assistants brought in by surgeons additional requirements include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information, as well as obtaining informed consent in accordance with organization policy and law/regulation.
- Awareness of applicable infection control and patient safe processes/procedures.
- For non-employees brought into the organization by licensedpractitioners,organizations must also addressqualifications, competency and performance evaluation.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
No, primary source verification of education is not required at this element of performance. Organizations are required to verify and document education and experience only when specific minimum requirements are written into the job description. For example, if the Nurse Manager job description specifically requires the incumbent to possess a Master's Degree in Nursing (MSN), the organization must verify the individual has this credential. Organizations determine how verification and documentation of education and experience will be managed. Examples may include, but are not limited to:
- Review of an original diploma or certification that demonstrates completion of an education course or degree, then retaining a copy as documentation of this education. Organizations also determine if documentation will be retained as 'paper' or in an electronic format, such as a scanned document.
- Alternatively, such a document could be reviewed (but not copied) and then a note of attestation by the person reviewing the document could be entered into an HR file. The date the document was reviewed should be documented.
- Use of an external service, such as a Credentials Verification Organization (CVO). The glossary of the accreditation manual contains a definition of a CVO.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Joint Commission standards require that when developing infection prevention and control activities, the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert consensus. The is published by the CDC's Healthcare Infection Control Practice Advisory Committee (HICPAC).
Recommendation V.B.3.b.i. from the HICPAC guideline states, "Wear a gown whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient. Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment."
Joint Commission surveyors will expect healthcare workers to wear a gown if their "clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient". The difficulty lies in "anticipating" when this may occur. For example, it is very probable that a nurses' aide preparing to perform a bed bath will have contact as described above, and therefore a gown would be expected. However, one of a large group of residents performing rounds with an attending physician would have a lower likelihood of clothing contamination.
Each organization may decide what guidance to provide to its healthcare workers within the parameters provided by HICPAC. However, ֱ would encourage organizations to consider the high morbidity and mortality of healthcare-associated infections in our nation when deciding what constitutes "anticipated contact" in each facility. Additionally, organizations may want to discourage non-essential personnel from entering the rooms of patients on isolation precautions.
No, ֱ does not publish standards specific to management of such devices. Any care, treatment or service provided needs to be well-designed, based on evidence-based guidelines, research and comply with law/regulation.While the following discussion focuses on ECMO circuits, the same concepts would apply to other such devices.
Although pre-priming an ECMO circuit and related activities are NOTsubject to USP 797, organizations must establish requirements for managing pre-primed systems based on evidence-based guidelines and accepted standards of practice. This would include compliance with instructions for use (IFU) for the machine, pump, circuit and fluid used for priming. Be sure to include your Infection Preventionist in establishing requirements.
ECMO circuits must be assembled and primed using strict, aseptic technique. Advance priming limits the length of time a circuit may be kept on standby. For example, a saline-primed circuit may be kept on standby for immediate deployment for a longer period of time than one primed with a hypertonic solution. It is the organization's responsibility to define an acceptable 'standby' timeframe based on all of the above factors.
Once an organization has established their requirements, close monitoring for compliance is critical to reduce the risk of patient harm. For example, documenting the date, time and initials of the individual completing the priming process. Consider also a process that ensures that the equipment is readily available and has not extended beyond the defined timeframe for use.
In addition to device and product manufacturers, organizations are encouraged to reach out to the FDA, professional organizations, such as The American Academy of Cardiovascular Perfusion (AACP), the American Society of Extra-corporeal Technology (AmSECT), the American Board of Cardiovascular Perfusion (ABCP), etc., for guidance. Additionally, conducting an internet search for examples of such policies, research studies, etc., may be helpful.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For IC.02.03.01 EP 1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.02.05 EP 5 (HAP and CAH). For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory. The health status of an applicant for medical staff privileges is also addressed under MS.4.20 EP 6 (HAP and CAH).
- For IC.02.03.01 EP 2, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Active surveillance is not required for either EP 2. Action is needed only if the organization becomes aware of such an exposure).
- For IC.02.03.01 EP 3, treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Active surveillance is not required for either EP 3. Action is needed only if the organization becomes aware of such an exposure).
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires the use of "evidence-based national guidelines or, in the absence of such guidelines, expert consensus".
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensed independent practitioners, screenings must be made available in some cases, but each organization may decide whether these screenings are mandatory if not required by state law/local regulatory requirements. The health status of an applicant for medical staff privileges is also addressed in the HR chapter (AHC, OBS) or MS chapter (HAP and CAH).
- Treatment or referral must be initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have, or are suspected of having, an infectious disease that puts others at risk". (Action is needed only if the organization becomes aware of such an exposure).
- Treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, who "have been occupationally exposed to an infectious disease". (Action is needed only if the organization becomes aware of such an exposure).
- The use of evidence-based national guidelines, such as the CDC, or, in the absence of such guidelines, expert consensus to develop an organizational plan for developing guidelines to prevent disease transmission in healthcare settings.
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
- For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensedpractitioners, screenings must be made available in some cases, but each organization may decide whether these screenings are mandatory if not required by state law/local regulatory requirements. The health status of an applicant for medical staff privileges is also addressed in the HR chapter (AHC, OBS) or MS chapter (HAP and CAH).
- Treatment or referral must be initiated if the organization becomes aware of any individual, including non- employed physicians and other licensedpractitioners, who "have, or are suspected of having, an infectious disease that puts others at risk".(Action is needed only if the organization becomes aware of such an exposure).
- Treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, who "have been occupationally exposed to an infectious disease". (Action is needed only if the organization becomes aware of such an exposure).
- The use of evidence-based national guidelines, such as the CDC, or, in the absence of such guidelines, expert consensus to develop an organizational plan for developing guidelines to prevent disease transmission in healthcare settings.
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
The R3 report Introduction to Standard IC.07.01.01 states:"While there is not a standardized definition for high-consequence infectious diseases (HCIDs) or special pathogens, expert consensus defines these as novel or reemerging infectious agents that are easily transmitted from person-to-person, have limited or no medical countermeasures (such as an effective vaccine or prophylaxis), have a high mortality, require prompt identification and implementation of infection control activities (for example, isolation, special personal protective equipment), and require rapid notification to public health authorities and special action. Examples of high-consequence infectious diseases or special pathogens include MERS, novel influenzas, and Ebola or other viral hemorrhagic fever diseases. This list may change, however, to reflect current regional or global outbreaks or to include future emerging agents."
The definitive list is not provided because the identity of the pathogen may not always be known or certain. The intent is routine screening using a syndromic-based approach (fever, rash, respiratory symptoms), and travel history to determine if the symptomatic patient traveled to an area with an active outbreak. Organizations should also examine information or definitions provided by local and state law and regulation.
What is meant by "points of entry"?
Points of entry are typically understood as the first point of contact, but the organization can operationalize the appropriate location or what constitutes the first point of contact (for example, front desk, triage area at the emergency room, electronic check-in prior to the appointment, etc.) Note that points of entry may include the emergency department, urgent care, and ambulatory clinics.
What are the expectations regarding the "identify" screening protocols at the points of entry?
The requirement for "Identify" protocols builds on the CDC Core Practice "Minimizing Potential Exposures" that includes the development and implementation of "systems for early detection and management (e.g., use of appropriate infection control measures, including isolation precautions, PPE) of potentially infectious persons at initial points of patient encounter in outpatient settings (e.g., triage areas, emergency departments, outpatient clinics, physician offices) and at the time of admission to hospitals and long-term care facilities (LTCF)."
The expectation is that screening is implemented at the point of entry for fever, respiratory symptoms, rash, and travel history. However, the Joint Commission is not prescriptive on the implementation details, leaving it to organizations to develop the screening protocols that best fit their care environments and resources. For example, hospitals and critical access hospitals may consider the following:
- Active and/or passive screening processes, such as staff at the point of entry asking specific questions, posting visual alerts at the entrances of clinics on signs and symptoms that patients/visitors should report to staff when they first register for care, etc.
- The organization can determine the threshold at which screening will escalate from passive (e.g., signs at the entrance) to active (e.g., direct questioning).
- The organization can definethe threshold at which travel screening will be initiated, such as after ascertaining that persons entering the facility present with fever, fever & rash, fever & respiratory symptoms.
The organization may revise or adjust screening protocols based on: The absence/or presence of known transmission locally, regionally, nationally or internationally; in the setting of suspected or identified special pathogen locally, regionally, nationally or internationally; the guidance of public health authorities.
What are the expectations regarding competencies?
Hospitals have the flexibility to define the competencies required by the organization, in accordance with HR.01.06 01 EP 1. This includes competencies associated with the practical applications of the Identify-Isolate-Inform protocols. In general, competencies must be based on observable and measurable methods, such as use of a written test or a demonstration of accurate completion of procedure or process. The organization decides what type of education and training must have a competency associated with it.
Is there an expectation to address each special pathogen separately?
There is no expectation to address each special pathogen separately since the identity of the pathogen may not always be known or certain. Hospitals should focus on screening using a syndromic-based approach (fever, rash, respiratory symptoms) and travel history to determine if the symptomatic patient traveled to an area with an identified active outbreak or known organism of concern.
Does IC.07.01.01 apply to psychiatric hospitals?
IC.07.01.01 applies to acute hospitals. The requirements under IC.07.01.01 are not applicable to psychiatric, surgical specialty, long term care acute hospitals or swing beds.
Additional Resources
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Any examples are for illustrative purposes only.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
- Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the IFUs regarding cycle type, temperature setting, exposure time, and drying times.
- IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
- Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
- IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
Evidence-based guidelines should be adopted to minimize the use of IUSS.Scenarios when IUSS may be appropriate include:
- When a specific instrument is needed for an emergency procedure.
- When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
- When an item has dropped on the floor and is needed to continue a surgical procedure.
- When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery occurssufficiently in advance of scheduled case(s)to allow complete reprocessing of trays by the organization.Such a requirement is an example of a performance expectation to include in a contract (seeLD.04.03.09).
- Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
- Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
- Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
- Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
- Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
- When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care.
- Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities.
- Evaluate the IUSS process in all locations that it is being performed.Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization.
Resources:
- The Association for Professionals in Infection Control and Epidemiology (APIC)
- The Association of periOperative Registered Nurses (AORN)
- The Association for the Advancement of Medical Instrumentation (AAMI).
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Any examples are for illustrative purposes only.
Immediate-Use Steam Sterilization (IUSS), formerly termed "flash" sterilization, is described as "the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field". IUSS items are not intended to be stored for future use.
Considerations for IUSS
- Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the IFUs regarding cycle type, temperature setting, exposure time, and drying times.
- IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
- Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
- IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
Evidence-based guidelines should be adopted to minimize the use of IUSS.Scenarios when IUSS may be appropriate include:
- When a specific instrument is needed for an emergency procedure.
- When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
- When an item has dropped on the floor and is needed to continue a surgical procedure.
- When 'loaner' trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery occurssufficiently in advance of scheduled case(s)to allow complete reprocessing of trays by the organization.Such a requirement is an example of a performance expectation to include in a contract (seeLD.04.03.09).
- Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
- Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
- Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
- Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
- Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
- When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care.
- Ensure that sterilization practices, in all locations, have been fully incorporated into the organization's Quality Assessment Performance Improvement (QAPI) activities.
- Evaluate the IUSS process in all locations that it is being performed.Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization.
Resources
- The Association for Professionals in Infection Control and Epidemiology (APIC)
- The Association of periOperative Registered Nurses (AORN)
- The Association for the Advancement of Medical Instrumentation (AAMI).
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
NOTE: This FAQ does not apply to any clothing that has been designated by the organization as personal protective equipment (PPE) as defined by Occupational Safety and Health Department (OSHA): specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.)
ֱ standards do not require employers to launder surgical scrubs or other attire. However, ֱ's Leadership Standard LD.04.01.01 requires health care organizations to adhere to applicable federal (e.g. OSHA), state and local regulations (e.g., licensing requirements), and if deemed, Centers for Medicare and Medicaid Conditions of Participation and/or Conditions of Coverage. The hierarchical approach to infection control standards as described in ֱ Perspectives, April 2019, should be used to guide development of infection control related policies and procedures for laundering surgical scrubs or attire that is not designated as personal protective equipment and is worn in the healthcare setting.
Applicable elements to consider include the following:
- The OSHA Bloodborne Pathogen Standard requires that all clothing, including scrubs and personally owned attire such as uniforms or street clothing, which have been visibly soiled with blood or other potentially infectious materials, be laundered by the employer at no cost to the employee.
- For surgical scrubs, uniforms, or other attire not considered personal protective equipment and which are not visibly contaminated, organizations should determine if there any requirements that the facility provide clean attire to staff to perform their job duties. For example, some states, require that hospitals and ambulatory care facilities provide hospital laundered scrubs for healthcare workers working in the restricted or semi-restricted areas. State requirements may be more stringent and prescriptive than those from OSHA.
- To our knowledge, Center for Medicare and Medicaid Services (CMS) does not have any requirements for laundering surgical attire or uniforms. But as recommended by the Joint Commission and CMS, organizations should consult evidence-based guidelines for best practices and consider their adoption. Examples of guidelines include the Guideline for Surgical Attire (effective July 1, 2019) from the Association for periOperative Nursing (AORN), the AST Guidelines for Best Practices for Laundering Scrub Attire (revised April 14, 2017) from The Association of Surgical Technologists and the Statement on operating room attire (approved July 2016) from the American College of Surgeons.
Additional Resources:
See also the Perspectives®, April 2019, Volume 39, Issue 4 Page 15:Clarifying Infection Control Policy Requirements
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
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FAQ Ligatures and/or Suicide Risk Reduction – Video Monitoring of Patients at High Risk for Suicide
No, requirements for managing linen are notdefined within ֱ standards. Organizations are expected to develop their linen cleaning, storage and management requirements in accordance with evidence-based sources, such as the CDC, the National Association of Institutional Linen Management and/or the local or state authority having jurisdiction.
For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be used to store linens on patient-care areas (hallways) must have covers on them during transportation and storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."
If an organization is unsure whether their linen management processes are compliant with such guidelines, conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
The focus of the IC standards is prevention of transmission of infectious disease. If no patient or specimen contact occurs, no transmission is possible. While a risk assessment would not be required, if performed it would reveal no risk at all. As such, no surveillance or reporting would be required, even for staff.
If the organization receives back contaminated equipment, then all IC standards apply.
Please note, however, that interpretive reading services do play a critical role in disease detection and communication. These services bear the responsibility for notification of infectious disease-related results, especially those for which the differential diagnosis might necessitate isolation or public health action. Examples would be a radiology study showing a right upper lobe cavity lesion (suspicious for pulmonary tuberculosis), or mediastinal widening (suspicious for inhalation anthrax). Pathology studies would include those that identify pathogens considered reportable to a public health authority.
Therefore, interpretive reading providers must have clearly defined processes for communication of such results. An agreement should be in place with each organization for which services are provided. It should specify which results are to be communicated urgently, whom should be notified, and in what time frame. It is expected that many organizations will choose to have their infection control practitioner notified in addition to the provider who orders the test.
Employee health programs may or may not be required. If your organization determines that one is not needed, please check with your state's health department or healthcare licensing act, which may have further regulations.
In conclusion, Teleradiology services will only be evaluated for compliance as delineated above. They are encouraged, but not required, to incorporate practices for hand hygiene (please see NPSG.07.01.01).
ֱ does not determine which items are prohibited from a behavioral health setting. Items that are prohibited from use in an organization, due to the risk of harm to self or others, should be determined by the organization.
Source control involves having people wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions and thus reduce the dispersion of droplets from an infected individual.
TheCDC recommendsimplementing source control (use of masks) in a healthcare facility to prevent dispersal of respiratory droplets from known, asymptomatic and pre-symptomatic people with COVID when are high.Compliance with this recommendation should be based upon the organization's assessment, policies/procedures, individual care plans, and applicable state rules or regulations.
When evaluating the updated CDC recommendations for a patient with behavioral health needs, it is important to complete an assessment of the impact that wearing a face covering or mask would have on the safety of a patient(s), staff and visitors. The expectation is for organizations to complete a clinical risk assessment of the individual for possible self-harm or harm to others if they will wear a mask. The organization must have a process to determine if the patient is capable of wearing a face covering, or mask, based on clinical assessment.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
No, there is no requirement that all surgical procedures be included in an organization's surveillance for surgical site infections (SSI). We expect organizations to follow a hierarchical approach when establishing infection surveillance. We would first expect organizations to follow applicable federal and state law and regulation, then if deemed or required by state regulation, to follow CMS requirements. Some states have specified surgical procedures for which surveillance must be performed. If mandated by your state, then the Joint Commission would expect your organization to be compliant to that requirement.
In the absence of federal/state mandates for specific surgical site infection surveillance requirements, organizations may choose to target SSI surveillance based on the results of a risk assessment. If an organization's risk assessment shows that risk is greatest for certain procedures or settings, the surveillance program may be targeted to focus resources on those high-risk procedures. Organizations may wish to consider conducting periodic risk assessments to ensure that the scope of the targeted procedures included in surveillance activities remains current. Conducting a risk assessment is a helpful way of identifying risks associated with various procedures performed. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
The risk assessment should focus on all components of the surgical continuum, including – but not limited to - staff knowledge and competency, adoption of – and compliance with - evidence-based guidelines for reprocessing of instruments, policies and procedures, surgical attire, practitioner engagement, and patient education. Compliance with any state-specific reporting requirements should also be evaluated. From a quality and safety perspective, ensure that surgical procedures performed in all locations have been integrated into the organization-wide quality assessment and performance improvement (QAPI) program.
Additional Resources
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The performance of a bronchoscopy procedure in a negative pressure room is a requirement established by ASHRAE 170-2008 ventilation table 7.1. This space provision has been determined by NFPA Code and as such an organization cannot risk assess out of a code requirement.
Recognizing that there are extenuating patient specific circumstances that may arise that would preclude a bronchoscopy from being performed in a space specifically designed for that purpose, an established process must be in place in the event the situation arises.These circumstances may include but are not limited to scenarios where patient safety concerns take precedence (e.g., due to immediacy of the procedure, inability to move the patient safely, etc.) or the need to perform the procedure along with other critical procedures in a positive pressure environment such as the Operating Room.
The organization's process must address items such as, but not limited to:
- The patient has been evaluated to determine the need to perform the bronchoscopy in a non-controlled environment
- The risks associated with unique situations where the need exists for performing bronchoscopies in an alternative location were evaluated, including specific patient risk factors (e.g., evaluation of the patient for a diagnosis of airborne communicable disease as a part of their differential diagnosis)
- Interventions and activities designed to mitigate the risks identified (e.g., the use of a HEPA unit to scrub the air space if indicated, scheduling the patient in the OR at the end of the day, etc.)
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
- A decision that individuals who work in the organization may use any abbreviation, acronym, or symbol that is not on the list of unacceptable abbreviations. However, if multiple abbreviations, symbols, or acronyms exist for the same term, the organization identifies what will be used to eliminate ambiguity.
U,u
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
Note 1: A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
Note 2: The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
No, IM.02.02.01 EP 2 requires that organizations use 'standardized' abbreviations but does not require organizations to maintain a list of acceptable abbreviations. Any reasonable approach to standardizing abbreviations, acronyms, and symbols is acceptable.
Examples of different approaches may include:
-Standardized abbreviations developed by the individual organization.
-Use of a published reference source. However, if multiple abbreviations, symbols or acronyms are used for the same term, the organization identifies what will be used to eliminate any ambiguity.
-If a standardized abbreviation list is created, staff should have knowledge and access to the list.
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
ֱ standards require organizations to comply with applicable law and regulation to ensure the privacy and integrity of protected health information (PHI) are maintained. When an organization's staff is not present to monitor medical records storage areas, alternative approaches must be employed to protect privacy and confidentiality of this information. Keeping such information secure when staff is not present generally requires a process that includes a locking mechanism. The use of alternative approaches, such as a signed confidentiality statement in lieu of a locking mechanism, should be thoroughly evaluated by the organization's legal and risk management leadership to determine if such approaches comply with regulatory requirements (CMS, state law/regulation, etc.).
In conclusion, all areas should have a process in place for maintaining the security and integrity of PHI. The adopted processes should be subject to security audits that can identify system vulnerabilities and policy violations. Signed, confidentiality statements alone may not necessarily result in the proper security and integrity of PHI. Additionally, per IM.02.01.03, the hospital must follow their policy regarding security of health information. Such a policy may include who has access to medical records when staff is not present to monitor the records. The policy should also address all areas where medical records are stored.
Any examples are for illustrative purposes only.
Centers for Medicare & Medicaid Services (CMS) revised its position on the use of texting in a February 8, 2024, memorandum stating that texting patient information and orders is permissible in hospitals and critical access hospitals if accomplished through a Health Insurance Portability and Accountability Act (HIPAA)-compliant Secure Texting Platform (STP) and in compliance with the Conditions of Participation at 42 CFR 482.24 and 41 CFR 485.638.
Therefore, CMS states that when certain conditions are met, organizations may choose to text patient care information and orders. While there is no specific requirement that the secure text must be electronically transmitted into the electronic health record, these messages are still subject to HIPAA regulations.
According to the CMS memorandum, organizations that choose to use texting for patient information and orders are required to do the following:
- Utilize and maintain systems/platforms that are secure and encrypted and must ensure the integrity of author identification as well as minimize the risks to patient privacy and confidentiality, as per the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations.
- Confirm that texted orders are promptly placed in the medical record dated, timed, and authenticated.
- Make sure that the information transmitted into the EHR is accurately written, promptly completed, properly filed and retained, and accessible.
Additionally, providers should implement procedures/processes that routinely assess the security and integrity of the texting systems/platforms that are being utilized to avoid negative outcomes that could compromise the care of patients.
Please refer to the CMS memo for further details:
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(^).
Rules or regulation -States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states "Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas." and "Surgical masks are worn fully covering mouth and nose
Manufacturer instructions for use -Instructions for use of medical equipment or devices may include instructions for particular attire during use.
Evidence-based guidelines and consensus statements -If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
Facility policy -Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization's chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
- In the state of Illinois Hospital and Ambulatory Surgery Center regulations it states in the restricted area, "Cloth head coverings shall be laundered by the hospital. Additional garments shall be completely contained or covered within the scrub attire." According to organizational policy, the facility follows AORN guidelines 1.7.1 "Establish and implement a process for managing personal clothing that may be worn under scrub attire" and 5.3.1 "An interdisciplinary team, including members of the surgical team and infection preventionists, may determine the type of head covers that will be worn at the health care organization." The policy states that staff may wear long sleeve shirts under hospital scrub attire as long as they are not scrubbed into a case and cloth head coverings that they launder at home. This organization could be found out of compliance with Joint Commission standards because organizations must follow state licensing requirements.
- A non-deemed ambulatory surgery center creates a multidisciplinary team to create a dress code policy. They review state regulations, manufacturer instructions for us, and evidence-based guidelines. The team reaches consensus and establish a policy that staff may wear long sleeves shirts under scrub attire and cloth caps may be worn so long as staff are not scrubbed into a case and reference AORN guidelines. The organization would be found in compliance with Joint Commission standards.
Hierarchical approach
- Regulation
- Conditions of Participation
- Manufacturer's Instructions For Use
- Evidence-based Guidelines
- Consensus documents
- Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Any examples are for illustrative purposes only.
Providing staff and licensed practitioners (LP) with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Opioid treatment programs that can be used for patient referrals
Clinicians encountering patients dealing with possible opioid abuse or dependence need readily accessible, accurate information about available resources to which patients can be referred for treatment. It can be challenging for individual clinicians or departments to maintain current information about provider availability in the community, therefore leadership can play a role by identifying community resources, then communicating this information to staff and practitioners. To assist organizations, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has a directory of opioid treatment programs.
Compliance may be determined through interviews with leadership, staff, practitioners and patients, review of an organization's discharge and referral processes, discharge information provided to patients to support ongoing care following discharge, etc.
Leadership responsibilities for developing and monitoring performance improvement activities specific to pain management and safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities, e.g., on monitoring the use of opioids;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LP) on available services for consultation and referral of patients with complex pain management needs
The intent of this requirement is to ensure that staff and LPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, an organization's outpatient pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LPs, patients, etc.
Acceptable non-pharmacologic pain treatment modalities
Organizations are required to provide non-pharmacologic pain treatment modalities relevant to its patient population and assessed needs of the patient. These modalities serve as a complementary approach for pain management and may potentially reduce the need for opioid medication in some circumstances.
Additionally, it is important to have non-pharmacologic pain treatment modalities available for patients that refuse opioids or for whom physicians believe may benefit from complementary therapies. Non-pharmacologic strategies include, but are not limited to, acupuncture therapy, massage therapy, physical therapy, relaxation techniques, music therapy, cognitive behavioral therapy, etc. The level of evidence for these therapies is highly variable, and it is evolving. Therefore, our standards do not mandate that any specific complementary option(s) is provided, but allow organizations to determine what modality(s) to offer.
Organizations should ensure that patient preferences for pain management are considered, and, when a patient's preference for a safe non-pharmacologic therapy cannot be provided, provide education to patients on where the treatment may be accessed post-discharge. There is not an expectation that the hospital will fulfill any and all requested non-pharmacologic therapies during the inpatient stay.
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
Facilitating access to the PDMP means that leadership has implemented systems and processes that support both ease of access for practitioners and consistent access to the PDMP when required by law.
Examples may include:
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record (when state law requires accessing before hospital discharge )
Each organization determines who is responsible for accessing the PDMP. This may vary based on different patient care settings.
The requirement does NOT apply to patients receiving short term opioid medications DURING the hospital encounter (for example, opioids administered for a day or two following a surgical or invasive procedure). During survey, compliance with accessing the PDMP may be evaluated during tracer activities, interviews with staff, practitioners, pharmacists, etc.
NOTE: This requirementis only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
Monitoring of post-operative patients on opiates and/or on opiates combined with other pain medications
ֱ requires hospitals to monitor patients at high risk for adverse outcomes related to opioid treatment (for example, patients with sleep apnea, patients receiving continuous intravenous opioids, patients on supplemental oxygen, etc.) (See PC.01.02.07 EP 6). The intent of this requirement is to ensure adequate monitoring and timely detection of opioid-induced respiratory depression. Decisions on who is at high risk and monitoring requirements are determined by the clinical team responsible for providing care and based on evidence-based guidelines, accepted standards of practice, etc.
In addition, leadership commitment is required to ensure that appropriate equipment is available to monitor patients deemed at high risk for adverse outcomes from opioid treatment (See LD.04.03.13 EP 7). Refer to standards PC.03.01.01 through PC.03.01.07 regarding sedation and anesthesia care, specifically.
Review of evidence-based guidelines will assist leadership and the medical staff in developing policies, protocols, metrics and other quality indicators. During survey, clinicians may be asked to describe how they identify a patient that is high risk and how they would manage and monitor that patient.
Educating the patient and family on discharge related to pain management
It is the responsibility of each organization to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, and safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these topics. Each organization determines where this information will be documented in the medical record.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available and used appropriately. The tools required to adequately assess pain may differ depending on a patient's age, condition, and ability to understand and should be evidence-based. For example, adult intensive care unit (ICU) patients who are unable to self-report and pediatric patients require the use of alternative assessment tools. Hospitals are required to have defined criteria that they will use to screen, assess and reassess pain that are consistent with the patient's age, condition, and ability to understand. Organizations determine where these criteria are located and any documentation requirements when such screenings or assessments are completed.
Intent
Physical Presence
Advance Practice Nurses
Supervision or Collaborative Agreement Requirements
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
ֱ allows the installation of alcohol-based hand rub (ABHR) dispensers in corridors and rooms provided the requirements of NFPA 101-2012, 18/19.3.2.6 are met. Please note that there are eleven criteria, and ALL criteria must be met in order to be in compliance. LS.02.01.30 EP6 lists 10 of the requirements, plus one dispenser per room may be excluded from the 10-gallon maximum. The 10-gallon limit per smoke compartment is applicable to the aggregate of all alcohol-based products mounted in unprotected locations within a smoke compartment. For consistency, the volume of the ABHR container (typically ounces converted to gallons) would be used in the aggregate calculation, regardless of the amount contained within at the time of review.
Additionally, there is an allowance to exclude one dispenser from the aggregate volume when located in a room, so caution should be taken when calculating volume where ABHR dispensers are located in a suite versus an individual room; that is, only one dispenser in a suite will be excluded from the aggregate volume limitations. One dispenser complying with 18/19.3.2.6 (2) or (3) per room and located in that room shall not be included in the aggregated quantity addressed in 18/19.3.2.6(5).
Alcohol-based hand wipes are not included in the 10-gallon limit per smoke compartment due to some products not listing the alcohol content and others do not actually have alcohol as their disinfecting ingredient. However, caution should be used in adding wipes to areas as they are still potentially adding to the combustible fire load and/or increase the amount of flammable materials in the area. Additionally, depending on the disinfecting ingredient, the wipes could be reviewed as a hazardous chemical; the SDS should be reviewed and appropriate actions taken. A risk assessment is not a requirement but is a recommendation.
Reference LS.02.01.30 EP6
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
The requirements for the installation of smoke and fire dampers may be found in NFPA 90A Installation of Air Conditioning and Ventilating Systems, 2012 edition, Section 5.3 and 5.4.
Generally, fire dampers are required where air ducts penetrate walls that are rated for 2-hours or more. They are needed in all air transfer openings (non-ducted) in rated walls, regardless of the rating. And they are required at some, but not all penetrations of rated floor assemblies and shaft enclosures.
Smoke dampers are required at penetrations of smoke barriers, unless the HVAC system is fully ducted and there is a sprinkler system installed throughout the facility, in which case they are not required. Smoke dampers are also required in air transfer openings (non-ducted) in smoke partitions.
Where a penetration requires both a fire damper and a smoke damper, combination units that are both smoke responsive and heat responsive may be used.
Reference LS.02.01.10 EP13, LS.02.01.30 EP22 & EP23
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
There are circumstances when a No Exit sign is an effective means of providing clarity to the means of egress. The Annex A guidance for NFPA 101-2012 is helpful. "The likelihood of occupants mistaking passageways or stairways that lead to dead-end spaces for exit doors and becoming trapped governs the need for No Exit signs."
Another consideration is in a space with multiple doors leading out (such as in an operating room area or kitchen). If there are doors which are not exits, but which people may refer to as exits and could potentially become trapped, consideration should be given to marking those doors as "no exit".
Reference LS.02.01.20 EP 41
ֱ uses the 2012 edition of NFPA 101 Life Safety Code. For consistency, no equipment is allowed in an exit enclosure (exit stairwell) that could interfere with its function as an area of refuge in accordance with section 7.1.3.2.3. This would include evacuation chairs/sleds.
Security cameras, card readers, Wi-Fi routers and repeaters can be in the exit enclosure, so long as it doesn't interfere with the use of the exit and is used for surveillance of the exit enclosure. In accordance with 7.1.3.2.1, systems in an exit enclosure are limited to systems that support the functionality of the exit enclosure in new health care and ambulatory health care occupancies.
Any penetrations into the rated exit enclosure must be sealed with a fire stop material that is appropriate to the rating of the enclosure. Properly protected system penetrations into existing (prior to July 5, 2016) exit enclosures are acceptable as long as they were part of the original construction and no alterations have since been made; once an alteration has been made, the current code should be followed.
Reference LS.02.01.20 EP 13, LS.03.01.20 EP 11
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
The criteria for determining the occupancy of free-standing emergency departments depends on whether the organization is deemed by CMS (accepts funding from Medicare and/or Medicaid).
For non-deemed organizations, ֱ uses the definition of NFPA 101 (2012 edition) Life Safety Code which defines Ambulatory Health Care Occupancy as facilities that provide care to patients with less than a 24-hour stay wherein there are 4 or more patients mostly incapable of self-preservation. This includes emergency or urgent care for patients who, due to the nature of their injury or illness, are incapable of taking action for self-preservation under emergency conditions without the assistance of others.
For non-deemed organizations where fewer than 4 patients are mostly incapable of self-preservation in a freestanding emergency department, the facility would be classified as a Business Occupancy.
For deemed organizations, CMS uses the same definitions as described above, except that the threshold is 1 or more patients mostly incapable of self-preservation. Effectively for deemed organizations, all freestanding emergency departments would be considered Ambulatory Health Care Occupancy.
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aersols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aersols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aersols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
Alcohol-based hand rub (ABHR) gel dispensers can be installed in egress corridors as follows:
- The corridor width is 6 feet or greater
- Dispensers are installed no less than 4 feet apart (horizontal spacing)
- Dispensers are not installed directly above an electrical outlet or switch
- Dispensers are not installed less than 1 inch adjacent to an electrical outlet or switch
- Dispensers installed directly over carpeted surfaces are permitted only in sprinklered smoke compartments
- ABHR does not contain more than 95 percent alcohol content by volume
- Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
- Each smoke compartment may contain a maximum aggregate of 10 gallons (37.8 liters) of ABHR gel, in dispensers and a maximum of 5 gallons (18.9 liters) in storage
- Maximum individual dispenser fluid capacity is 0.32 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors
- Maximum dispenser size for individual dispensers in areas designated as suites of rooms is 0.53 gallons (2.0 liters)
- And also with other requirements contained in NFPA 101-2012: 18/19.3.2.6
- Maximum capacity of the aerosol dispenser is 18 ounces (0.51 kg) and limited to Level 1 aerosols defined by NFPA 30B
- A maximum of 1135 ounces (32.2 kg) of Level 1 aerosols, or a combination of gel and Level 1 aerosols not to exceed, in total, the equivalent of 10 gallons (37.8 L) in use in a single smoke compartment
Reference NFPA 101-2012: 18/19.3.2.6
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Doors in means of egress are required to be opened without the "use of a tool or key from the egress side". Occupant movement cannot be restricted during an emergency; however, locking certain doors may be necessary for the safety of the patient in certain situations.
When a healthcare facility determines that doors must be locked to protect patients the locking configuration must comply with one of the following:
- Delayed-egress locking system as defined by NFPA 101-2012: 7.2.1.6.1
- Access-controlled egress door assemblies as defined in NFPA 101-2012: 7.2.1.6.2
- Elevator lobby exit access door locking compliant with NFPA 101-2012: 7.2.1.6.3
Pediatric units, maternity units, and emergency departments are examples of areas where patients might have special needs that justify door locking. Patients that require additional protective measures to ensure safety and security are allowed to have door locking arrangements provided that all of 5 criteria of NFPA 101-2012: 18/19.2.2.2.5.2 are met, in summary these are:
- Staff can readily unlock all doors at all times
- A total (complete) smoke detection system is provided throughout the locked space, compliant with NFPA 101-2012: 9.6.2.9, or locked doors can be remotely unlocked at an approved, constantly attended location within the locked space.
- The building is protected throughout by an approved, supervised sprinkler system in accordance with NFPA 101-2012: 18/19.2.2.2.5.2
- Locks are electrical and fail safe to release upon loss of power
- The locks release by independent activation of each:
- Activation of the smoke detection system NFPA 101-2012: 18/19.2.2.2.5.2(2)
- Waterflow in the automatic sprinkler system NFPA 101-2012: 18/19.2.2.2.5.2(3)
Additional Resources
LS.02.01.20
NFPA 101-2012: 18/19.2.2.2.4; 19.2.2.2.5
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
Suites are groups of rooms that for the purposes of life safety, function as one big room. The 2012 edition ofNFPA 101 Life Safety Code lists the requirements for suites in health care occupancies at 18/19.2.5.7. They are limited in size based on whether they are sprinkled, used for patient care, and used for sleeping.
Sleeping suites greater than 1000 square feet and patient care non-sleeping suites greater than 2500 square feet require two means of egress. One of these means of egress shall be directly into a corridor, but the other means of egress may be into an adjacent suite, so long as the perimeter wall and door between the two suites meet corridor requirements (smoke resistive and the door must be positive latching). Either of these required means of egress may be substituted with a door that goes directly into an exit stair, exit passageway, or exit door to the exterior.
Reference LS.02.01.20 EP 30 & 31
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ’s Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions required to be followed by other of the organization's controlling authorities (like their state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ’s Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions required to be followed by other of the organization's controlling authorities (like their state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ’s Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions required to be followed by other of the organization's controlling authorities (like their state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ’s Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
For deemed organizations, the Centers for Medicare & Medicaid Services (CMS) requires compliance with NFPA 101-2012 Life Safety Code and NFPA 99-2012 Health Care Facilities Code, including the mandatory references in each edition, for fire safety, construction and operations requirements.
ֱ's Elements of Performance in the Accreditation Manuals reference these same editions of the NFPA documents.
Variations in adopted code editions are required to be followed by the organization's controlling authorities (e.g. the state health care licensing entity) can be handled by reconciling the requirements of the code editions and complying with the most strict requirements.
For other federal organizations like the Veterans Administration, the Department of Defense, the Indian Health Service, etc., those entities decide the NFPA code editions that they will use and TJC will survey to those standards.
For non-CMS deemed organizations, like a state institution, they must arrange with TJC for the editions of NFPA to be used; if there is no previous arrangement, the 2012 edition of NFPA 101 and NFPA 99 is used.
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and privileged. Compliance with the organization's process for monitoring a practitioner's professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LP who was asked to evaluate a patient and provide consultation, by way of an order from another LP. The consultant's findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
The definition of a peer is someone from the same discipline. For example, physicians for physicians, dentists for dentists, podiatrists for podiatrists, etc. It does not have to be someone in the same specialty (orthopedist, etc.). To be able to provide a recommendation, the peermust be familiar with the individual's actual performance. For the nurse practitioner, physician assistant, and psychologist, or social worker, the peer should ideally be another individual from the same discipline and the organization should attempt to obtain such recommendation. This could be someone within the same organization or someone from outside the organization.
Peer recommendation includes written information regarding the practitioner's current:
- Medical/clinical knowledge
- Technical and clinical skills
- Clinical judgment
- Interpersonal skills
- Communication skills
- Professionalism
Yes, any provider recognized by state lawand providing services as a 'Licensed Practitioner (LP)^^or providing a medical level of care and decision-making(e.g. writing orders, directing care, etc) isrequired to be granted privileges prior to providing care, treatment or services. While Physician Assistants (PA) are generally not recognized by law/regulation as 'independent practitioners', they are subject to the same credentialing and privileging requirements outlined in the Medical Staff chapter of the manual.Examples of Care, Treatment or Services subject to the Medical Staff requirements may include, but are not limited to:
- Writing orders for medications, tests, and procedures
- Interpreting tests and treatments
- Performing history and physicals
- Wound debridement
- Central line insertions
- Assisting with interventional or surgical procedures
No, there is no requirement that privileges be granted for each individual location at which a practitioner may provide care. A multi-campus(*) organization may be described as having multiple locations - inpatient and/or outpatient - at which care, treatment and services are provided, and all locations operate under a single CMS Certification Number (CCN). Examples may include more than one hospital, ambulatory clinics, urgent care centers, physician office practices, etc.
The requirements found at MS.06.01.01 require that there is a process to determine the following resources are available:
- sufficient space
- sufficient equipment
- sufficient staffing
- financial resources are in place or available within a specified time period to support each requested privilege
- Emergency Department physicians may be privileged to perform laceration repair, splint, or cast application, administer moderate sedation, reduce dislocations, insert central lines, chest tubes, etc. However, some remote locations that only offer ‘urgent care’ services may not have the resources to insert central lines or chest tubes.
- A surgeon may be privileged to perform robotic procedures; however, robotic technology may only be available at the main hospital campus.
Each organization determines how this information will be tracked. This is generally an administrative document available to each location rather than being linked to a specific practitioner. The practitioner will be privileged once, and the document will identify where the privilege(s) can be performed.
* NOTE: For multi-entity systems in which each location operates under their own (separate) CCN number, each entity must fully credential and privilege practitioners.
No, there is no requirement that privileges be granted for each individual location at which a practitioner may provide care. A multi-campus(^) organization may be described as having multiple locations - inpatient and/or outpatient - at which care, treatment and services are provided, and all locations operate under a single CMS Certification Number (CCN). Examples may include more than one hospital, ambulatory clinics, urgent care centers, physician office practices, etc.
The requirements found at MS.06.01.01 require that there is a process to determine the following resources are available:
- sufficient space
- sufficient equipment
- sufficient staffing
- financial resources are in place or available within a specified time period to support each requested privilege
- Emergency Department physicians may be privileged to perform laceration repair, splint, or cast application, administer moderate sedation, reduce dislocations, insert central lines, chest tubes, etc. However, some remote locations that only offer 'urgent care' services may not have the resources to insert central lines or chest tubes.
- A surgeon may be privileged to perform robotic procedures; however, robotic technology may only be available at the main hospital campus.
Each organization determines how this information will be tracked. This is generally an administrative document available to each location rather than being linked to a specific practitioner. The practitioner will be privileged once, and the document will identify where the privilege(s) can be performed.
^NOTE: For multi-entity systems in which each location operates under their own (separate) CCN number, each entity must fully credential and privilege practitioners.
2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 17 must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
As noted at MS.06.01.13, new applicant temporary privileges are granted when the applicant is awaiting review and approval by the organized medical staff, or if delegated to the MEC, etc.
The second, and most common reason for use of temporary privileges is to meet an important patient care need. The need must be documented in the credentials file at the time privileges are granted. It typically appears as a recommendation from the medical staff president or designee to the CEO who grants the privileges. It could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s).
Examples of important patient care needs may include, but are not limited to:
- the care of a patient requires specialized skills that no currently privileged practitioner possesses
- a currently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- the patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 17 must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
As noted at MS.06.01.13, new applicant temporary privileges are granted when the applicant is awaiting review and approval by the organized medical staff, or if delegated to the MEC, etc.
The second, and most common reason for use of temporary privileges is to meet an important patient care need. The need must be documented in the credentials file at the time privileges are granted. It typically appears as a recommendation from the medical staff president or designee to the CEO who grants the privileges. It could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s).
Examples of important patient care needs may include, but are not limited to:
- the care of a patient requires specialized skills that no currently privileged practitioner possesses
- a currently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- the patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 17 must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
As noted at MS.06.01.13, new applicant temporary privileges are granted when the applicant is awaiting review and approval by the organized medical staff, or if delegated to the MEC, etc.
The second, and most common reason for use of temporary privileges is to meet an important patient care need. The need must be documented in the credentials file at the time privileges are granted. It typically appears as a recommendation from the medical staff president or designee to the CEO who grants the privileges. It could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s).
Examples of important patient care needs may include, but are not limited to:
- the care of a patient requires specialized skills that no currently privileged practitioner possesses
- a currently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- the patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 17 must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
As noted at MS.06.01.13, new applicant temporary privileges are granted when the applicant is awaiting review and approval by the organized medical staff, or if delegated to the MEC, etc.
The second, and most common reason for use of temporary privileges is to meet an important patient care need. The need must be documented in the credentials file at the time privileges are granted. It typically appears as a recommendation from the medical staff president or designee to the CEO who grants the privileges. It could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s).
Examples of important patient care needs may include, but are not limited to:
- the care of a patient requires specialized skills that no currently privileged practitioner possesses
- a currently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- the patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
2. When an applicant for new privileges* with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 14must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
As noted at MS.06.01.13, new applicant temporary privileges are granted when the applicant is awaiting review and approval by the organized medical staff, or if delegated to the MEC, etc.Temporary privileges for applicants for new privileges are granted for no more than 120 days.
The second, and most common reason for use of temporary privileges is to meet an important patient care need. The need must be documented in the credentials file at the time privileges are granted. It typically appears as a recommendation from the medical staff president or designee to the CEO who grants the privileges. It could also appear in a statement by the CEO as to the reason for granting the temporary privilege(s).
Examples of important patient care needs may include, but are not limited to:
- the care of a patient requires specialized skills that no currently privileged practitioner possesses
- a currently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- the patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
There are two circumstances in which temporary privileges (See MS.06.01.13) may be granted. Each circumstance has different criteria for granting privileges. The acceptable circumstances for which granting temporary privileges include:
- To fulfill an important patient care, treatment, and service need, or
- When an applicant for new privileges^with a complete application that raises no concerns is awaiting review and approval bythe Medical Executive Committee (MEC) and the governing body.
The medical staff bylaws at MS.01.01.01 EP 14must include a description of the privileging process including temporary and disaster privileges (see EM.02.02.13). The description of temporary privileges would need to include the elements of performance outlined at MS.06.01.13 for the two acceptable reasons, i.e., important patient care need and new applicant temporary privileges.
- The care of a patient requires specialized skills that no currently privileged practitioner possesses
- Acurrently privileged practitioner will be absent from the organization and someone is needed to cover the associated patients during the absence (commonly termed locum tenems)
- The patient care volume exceeds the level that can be handled by currently privileged practitioners and additional practitioners are needed to handle the volume
- Requiring an anesthesiologist to stop practicing at reappointment, when the organization only has three anesthesiologists which results in a backlog of surgeries, would be an important patient care need issue and would justify the use of temporary privileges at reappointment.
- However, requiring a pediatrician to stop practicing at reappointment, when the organization has ten other pediatricians that could admit the children, would probably not result or meet the definition of an 'important patient care need', therefore, may not justify the use of temporary privileges at reappointment.
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
ֱ requires that organizations verify the identity of the applicant by viewing one of the following:
- A current picture organizational ID card
- A valid picture ID issued by a state or federal agency (for example, a driver's license or passport)
- Identity Assurance Level 2 (IAL2) credentials may be used as defined by the US Government's National Institute of Standards and Technology (NIST). The requirements to meet this standard are outlined in NIST Special Publication 800-63.
- To pick up the application
- For an interview by the department chair
- When arriving to first provide services
- When having their photo ID badge picture taken
- Use of a telecommunications link that includes both audio and video capabilities
If the verification is performed at a remote location, then the confirmation of the verification should be forwarded to the credentialing office for inclusion in the credentials file.It isNOT required or recommended that a copy of the photo ID be taken or placed in the credentials files due to potential for identity theft.
If the applicant provides only a copy of the photo ID, or a notarized document indicating the identity was verified by another entity, it would not satisfy the requirement for verification.
For telehealth service providers only
Applicant identity verification may be completed offsite at the distant (provider) location, as the practitioner never comes onsite where the patient is located. The organization determines the process for verifying practitioner identity.
Yes. Each practitioner privileged through the medical staff process is expected to participate in hospital-sponsored continuing education (see MS.12.01.01). Such education is based on performance improvement^ activities that focus, at least in part, on the nature of care, treatment, and services offered by the hospital. The organized medical staff, then, determines the curriculum and prioritizes the time frames for completion.
The organized medical staff also determines participation requirements, such as required hours or activities to be completed, the time frame for completing (e.g., annually, each reappointment cycle, etc.), and how participation is documented. Participation is also considered in decisions about reappointment to medical staff membership or renewal/revisions of individual clinical privileges.
Additional examples of hospital-sponsored education requirements for privileged practitioners may be foundat:
- HR.01.05.03
- MM.09.01.01
- NPSG.06.01.01
The organization's accreditation coordinator has access to the manual containing the full text of the standards referenced.
The applicable requirements that address disaster privileging are found in the Emergency Management (EM) chapter of the Hospital and Critical Access Hospital Accreditation Manuals at EM.12.02.03. NOTE: The disaster privileging option ONLY applies when the organization has implemented their emergency management plan.
Licensed Practitioners (LP)CURRENTLY credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that 'telehealth' be delineated as a separate privilege.
For volunteer Licensed Practitioners that are NOT currently credentialed and privileged by the organization, disaster privileges may be granted to volunteer LIPs by following the requirements outlined in the Emergency Management chapter of the accreditation manual.
Additional Resources
FAQ:Requirements for Granting Privileges During a Disaster.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Intent
The Focused Professional Practice Evaluation (FPPE) is a process whereby the medical staff evaluates the privilege-specific competence of the practitioner that lacks documented evidence of competently performing the requested privilege(s) at the organization. This process may also be used when a question arises of a currently-privileged practitioner's ability to provide safe, high quality patient care.
A period of FPPE is required for all new privileges. This includes privileges requested by new applicants and all newly-requested privileges for existing practitioners. There is no exemption based on board certification, documented experience, or reputation.
Design -The FPPE process must be pre-defined and consistently implemented for all newly requested privileges. The performance monitoring process must also be clearly defined and include, at a minimum, the following:
- criteria for conducting performance evaluations,
- method for establishing the monitoring plan specific to the requested privilege,
- method to determining the duration of performance monitoring, and
- circumstances under which monitoring by an external source is required.
Data -Both qualitative and quantitative criteria (data) should be considered when designing the process. For example, limiting criteria to quantitative data may only represent the presence or absence of information but may not reflect the quality of the information reviewed. Consider the following:
Qualitative Data -Qualitative or 'categorical' data, may be described as data that 'approximates and characterizes' and is often non-numerical in nature. This type of data may be collected through methods of observations, discussion with other individuals, chart review, monitoring of diagnostic and treatment techniques, etc.
• Periodic Chart Review
o appropriateness of tests ordered / procedures performed
o patient outcomes
• Code of conduct breaches
• Peer recommendations
• Discussion with other individuals involved in the care of patient(s), IE: consultants, surgical assistants, nursing, administration, etc.
- Length of stay trends
- Post-procedure infection rates
- Periodic Chart Review
- Dating/timing/signing entries
- T.O./V.O. authenticated within defined time frame
- Presence/absence of required information (H & P elements, etc)
- Number of H & P / updates completed within 24 hours after inpatient admission/registration
- Compliance with medical staff rules, regulations, policies, etc.
- Documenting the minimum required elements of an H & P / update.
- Compliance with core measures
Data Sources -The data source used for the FPPE process must include practitioner activities performed at the organization where privileges have been requested. This may include activities performed at any location that falls under the organization's single CMS Certification Number (CCN). For example, if an organization operates two hospitals that fall under the same CCN number, data from both hospital locations may be used.
Multi-hospital Systems -In multi-hospital systems where each hospital operates independently under separate CCN numbers, data from those entities may be used to supplement local data.
Low-volume Practitioners -When practitioner activity at the 'local' level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges. The use of supplemental data may NOT be used in lieu of a process to capture local data. Organizations choosing to use supplemental data should assess and determine the supplemental data's relevance, timeliness, and accuracy.
Examples where supplemental data could be used may include, but are not limited to:
- activity is limited to periodic on-call coverage for other physicians or groups
- occasional consultations for a clinical specialty
FPPE for non-inpatient areas -Privileges are required for any practitioner providing a medical level of care/decision-making, therefore, FPPE applies to all settings/locations included in the scope of the hospital survey. Examples of settings may include, but are not limited to: On and off-campus outpatient services, clinics, hospital owned physician office practices, free-standing emergency/urgent care centers, etc.
Additional Resources
ֱ Perspectives: The official newsletter of ֱ August 2019 / Volume 39 / Number 8
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content:
It is the responsibility of the organized medical staff to determine the minimum required content of medical history and physical (H & P) examinations (see MS.03.01.01 EP 6). The required content is relevant and includes sufficient information necessary to provide the care, treatment and services required addressing the patient's condition, planned care and assessed needs.
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners:
The H & P must be completed and documented by a qualified and privileged physician or other qualified licensed practitioner privileged to do so in accordance with state law and organizational policy.
Other qualified licensed practitioners could include nurse practitioners and physician assistants. More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When more than one practitioner participates in completing the H & P, each entry must be signed, dated and timed by the author of that entry.
Podiatrists and Dentists
The medical staff must determine, based on state-specific law and regulation (Scope of Practice), the extent to which a Dentist or Podiatrist may complete a history and physical. Typically, the Dentist or Podiatrist is only authorized to perform aspects of the History and Physical that are applicable to either Dentistry or Podiatry.
Practitioners Without Privileges
The organization can have a policy that would permit the use of a history and physical examination performed by any practitioner permitted by state law. In this situation a practitioner who is privileged by the organization (see MS.03.01.01 EP 8), as permitted by state law and organization policy and familiar with the organization's policy for the defined minimal content of the history (see MS.03.01.01 EP 6) and physical must:
• determine if the information is compliant with the organization's defined minimal content;
• obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
• inclusion of absent or incomplete required information,
• a description of the patient's condition and course of care since the history and physical examination was performed, and
• a signature and date on any document with updated or revised information as an attestation that it is current.
Medical Students
A medical student has no legal status as a provider of health care services, therefore, a medical History and Physical (H&P) conducted by a medical student would not fulfill the requirements.
Non-inpatient Services (e.g. Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc).
MS.03.01.01 EP 11 (HAP only) requires that "the organized medical staff defines the scope of the medical history and physical examination when required for non-inpatient services". The intent is that the medical staff defines only certain circumstances, such as certain type of outpatient surgeries or procedures such as angiograms, that require a history and physical.
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
• diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
• comorbidities, and the level of anesthesia required for the surgery or procedure
• Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
• Applicable state and local health and safety laws
Authentication Timeframe:
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an ‘entry’.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed:
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Content
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners
Practitioners Without Privileges
- review the history and physical examination document
- determine if the information is compliant with the organization's defined minimal content
- obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
Non-inpatient Services (e.g., Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc.)
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
- Patient age
- diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
- comorbidities, and the level of anesthesia required for the surgery or procedure
- Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
- Applicable state and local health and safety laws
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an 'entry'.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
There are no standards that require the medical staff to create policies that duplicate existing organizational policies, as long as it is clear that such policies also apply to the activities of the medical staff – whether employees of the organization or not. There shouldbe evidence that the medical staff participated in the review/approval of such policies.
There are requirements that are specific to the structure,functions and accountabilitiesof the medical staff that should be defined in medical staff rules, regulations or policies. These documents create a system of rights, responsibilities, and accountabilities between the organized medical staff, the governing body, and between the organized medical staff and its members.
The requirements found at MS.01.01.01 EPs 5–7 address requirements specific to medical staff and governing body compliance and enforcement of the bylaws, rules and regulations, and policies.A few examples of such policies may include:
- Required elements of a medical history, such as a psychological history, body systems review, past procedures, allergies, co-morbidities, etc.
- The detailed steps for credentialing and re-credentialing
- Responsibilities for oversight of professional graduate education program participants
- Medical staff health screening requirements
- On-call coverage requirements
For the purposes of 'policies' as referenced in the medical staff chapter, policies are documents other than medical staff bylaws. However, when such documents are adopted by the organized medical staff and approved by the governing body, pursuant to the provisions of Standard MS.01.01.01, these documents have the same force and effect as the medical staff bylaws.
Use of rules, regulations, and policiesmay beused to define those requirements that are subject to more frequent changes in the environment, law/regulation, expectations and functions of the medical staff. Therefore, review, revisions, and approvals can bemore expeditious than changes to bylaws as such changes cannot be delegated (see MS.01.01.01 EP 2).
When developing medical staff documents, organizations need to be mindful that there are requirements specific to the medical staff governance and framework that MUST be contained within the bylaws. These are defined in the Medical Staff chapter at MS.01.01.01 EP 12 - 38.
There is no medical staff standard that prescriptively requires use of a meeting format to review/revise/adopt/approve medical staff bylaws. Such a format would be an organizational decision. It is required, however, that the medical staff, as a whole, have the opportunity to review, amend and vote on any changes to the medical staff bylaws. Adoption or amendment of the bylaws cannot be delegated (see MS.01.01.01 EP 2) to a committee, such as the medical executive committee. Once any amendments or adoptions to the bylaws have been accepted by the medical staff, they must be submitted to the governing body for action.Bylaws become effective only upon governing body approval.
Intent
Goals
The goals include:
- A qualitative and quantitative data-driven process to identify performance trends that may require taking steps to improve performance (e.g. implementing an FPPE review).
- Establishing an objective, data-driven foundation for making re-privileging decisions.
- Responsibilities for data review, as defined by the medical staff that may include:
- Department chair or the department as a whole
- Credentialing committee
- Medical Executive Committee
- Special committee of the organized medical staff
- Frequency of review
- The process for using data for decision-making
- The decision process resulting from the review (continue/limit/deny privilege)
Data
Qualitative Data
• Periodic Chart Review
o appropriateness of tests ordered / procedures performed
o patient outcomes
• Code of conduct breaches
• Peer recommendations
• Discussion with other individuals involved in the care of patient(s), e.g. consultants, surgical assistants, nursing, administration, etc.
Quantitative Data
- Length of stay trends
- Post-procedure infection rates
- Periodic Chart Review
- Dating/timing/signing entries
- T.O./V.O. authenticated within defined time frame
- Presence/absence of required information (H & P elements, etc)
- Number of H & P / updates completed within 24 hours after inpatient admission/registration
- Compliance with medical staff rules, regulations, policies, etc.
- Documenting the minimum required elements of an H & P / update.
- Compliance with core measures
Data Sources
Multi-hospital Systems
In multi-hospital systems where each hospital operates independently under separate CMS Certification Numbers (CCN), data from those entities may be used to supplement local data.
Low-volume Practitioners
When practitioner activity at the 'local' level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges. The use of supplemental data may NOT be used in lieu of a process to capture local data. Organizations choosing to use supplemental data should assess and determine the supplemental data's relevance, timeliness, and accuracy.
Examples where supplemental data could be used may include, but are not limited to:
- activity is limited to periodic on-call coverage for other physicians or groups
- occasional consultations for a clinical specialty
OPPE for non-inpatient areas
- Privileges need to be granted to anyone providing a medical level of care, i.e., making medical diagnoses or medical treatment decisions, in any setting that is included within the scope of the hospital survey. The settings can include inpatient, on-campus outpatient, off campus clinics, hospital owned physician office practices, etc.
- OPPE applies to any privileges granted to be exercised in any setting and/or location included within the scope of the hospital survey. The privileges are often the same as those for inpatient care, treatment, and services, therefore, separate privileges based on 'location' would not be required. If the non-inpatient settings do not have the same clinical record system or information technology, collecting data may be more difficult, but if the privileges are the same, the data collected should be the same.
- determining that the practitioner is performing well or within desired expectations and that no further action is warranted
- determining that a performance issues exists and requires a focused evaluation – see MS.08.01.01 EP 5.
- revoking the privilege because it is no longer required
- suspending the privilege, which suspends the data collection, and notifying the practitioner that if they wish to reactivate it, they must request a reactivation
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
The team must include a doctor of medicine or doctor of osteopathy. Physician participation on interdisciplinary teams may be obtained either through an employment or referral relationship such as a contract. The intent of this requirement is that while a Doctor of Medicine or doctor of osteopathy is always available to be part of the interdisciplinary team, his or her involvement in a patient's care would be determined by the needs of the patient.
Physical Presence
There is no expectation that physicians or any other individuals participating on a patient's interdisciplinary team be physically present in the PCMH or interact with the patient at each encounter. Although some PCMHs may bring together large and diverse interdisciplinary teams to meet the needs of their patients, many others, such as smaller rural organizations may choose to establish virtual teams using telehealth communication processes. For example, a cardiologist might be included on interdisciplinary team of a patient with heart disease or an endocrinologist on the interdisciplinary team of a diabetic patient.
Advance Practice Nurses
ֱ does certify PCMHs that are led by advanced practice nurses serving as primary care clinicians. The standards do not impose any additional restrictions on the scope of practice of individuals qualified to serve as primary care clinicians (PCC).
Supervision or Collaborative Agreement Requirements
PCMH standards do not require physician supervision over advance practice nurses or formal collaborative agreements between the two groups if it is not required by state law. If physician supervision or a formal collaborative agreement is required by state law, then the surveyors would expect to see evidence of that supervision. It is expected that advanced practice nurses serving in the role of primary care clinicians (PCC) will continue to collaborate with physicians as needed, to meet the needs of the patients on their panels.
Intent
Physical Presence
Advance Practice Nurses
Supervision or Collaborative Agreement Requirements
The issues that can relate to verification vary and include but are not limited to:
- The date of the education the name of the educational institution and its reputation the location of the educational institution. If the date of the education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school. e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education the name of the educational institution and its reputation the location of the educational institution. If the date of the education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school. e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
Any examples are for illustrative purposes only.
The issues that can relate to verification vary and include but are not limited to:
- The date of the education, the name of the educational institutionand its reputation and the location of the educational institution. If the date of education is important to know to determine how the practitioner has kept current with changes in their field, then primary source verification would be required. For example, if the education was at some time in the distant past, e.g., twenty or thirty years, then additional information on subsequent training might need to be obtained before granting privileges or assigning job responsibilities.
- If it is important to the organization to be able to market the educational status of their practitioners, e.g., having graduates of specific institutions, then primary source verification would be required. If it is important to know the location of the school;e.g., U.S. vs. foreign to determine if there could be a difference in level of the education or possible language barrier issues that need to be considered, then primary source verification would be required.
- If none of these issues are of importance then, verification of licensure alone could suffice of evidence that the individual had completed the requisite education. In addition, there may be an occasion when the educational institution is no longer in existence and the information does not appear on the AMA profile or ECFMG. In those instances verification of licensure would suffice since the licensing board would have had to verify the education before granting the license.
While privileges are required to administer sedation (see MS.03.01.01 EP 2), it is not required that criteria for competence to perform "moderate" sedation be included in a separately delineated privilege. For example, competency criteria for "moderate" sedation may be defined and included in procedure-based privileges. Thus, a clinical privilege for endoscopy could be defined as including the use of sedation.
Organizations decide whether to use privileging as an appropriate approach to take based on the education, training, and experience of the clinicians requesting authorization perform procedures using sedation. Individuals who are privileged to administer sedation must be able to rescue patients at whatever level of sedation or anesthesia is achieved either intentionally or unintentionally, e.g., when the patient slips from moderate into deep sedation or from deep sedation into full anesthesia.
Organizations must define how it will determine that the individuals arecompetent to perform the required types of rescue. Acceptable examples may include, but are not limited to, ACLS certification, a satisfactory score on a written examination developed in concert with the department of anesthesiology (see LD.04.01.05 EP 7), a mock rescue exercise evaluated by an anesthesiologist, etc.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
No. Transport Teams, such as for Neonatal ICU patients, trauma victims, long-term care facility residents, or burn patients, and Donor Surgical Teams, often includelicensed practitioners who would otherwise require clinical privileges to work within the facility. These teams often consist of individuals who are on rotational assignments, who may only infrequently visit the health care organization for a very brief period specifically for the purpose of transporting a patient. They often cover large territories and a large number of health care organizations. The Teams work as part of the health care organization's plan for continuity of care.
Their work is too limited to undergo effective performance improvement activity review at each site that would be meaningful for the renewal of clinical privileges.
The patient, although still in the health care organization, is transferred to the responsibility of the Team. When that occurs, the responsibility for the performance of the Team members as it applies to the patient (and as required by Joint Commission standards), passes to the Team.
Teams work in health care organizations on the basis of an agreement, whether a contract, memorandum of understanding, or regional governmental authority. It is the health care organization's responsibility to ensure that the agreement provides for qualified individuals who are properly authorized by their organizations.
Note: While this answer provides an exception to the usual procedures required for credentials review, privileging, competency, and job descriptions, it does not remove the health care organization from its obligation to ensure that it enters into agreements that comply with Joint Commission standards.
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process:
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation:
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated (MS.06.01.05, MS.06.01.07). There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified as to the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position:
In November 2004, CMS issued their position on privileging which addresses the concept of core/bundle privileging and remains current as of 2019. It is in line with the Joint Commission expectation. Organizations are also encouraged to determine if any state-specific law/regulation exist that address the use of a core/bundled privileging model.
Resources:
Centers for Medicare & Medicaid Services (CMS) Requirements for Hospital MedicalStaff Privileging.Ref: S&C-05-04
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process:
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation:
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated (MS.06.01.05, MS.06.01.07). There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified as to the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position:
In November 2004, CMS issued their position on privileging which addresses the concept of core/bundle privileging and remains current as of 2019. It is in line with the Joint Commission expectation. Organizations are also encouraged to determine if any state-specific law/regulation exist that address the use of a core/bundled privileging model.
Resources:
Centers for Medicare & Medicaid Services (CMS) Requirements for Hospital MedicalStaff Privileging.Ref: S&C-05-04
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process:
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation:
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated (MS.06.01.05, MS.06.01.07). There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified as to the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position:
In November 2004, CMS issued their position on privileging which addresses the concept of core/bundle privileging and remains current as of 2019. It is in line with the Joint Commission expectation. Organizations are also encouraged to determine if any state-specific law/regulation exist that address the use of a core/bundled privileging model.
Resources:
Centers for Medicare & Medicaid Services (CMS) Requirements for Hospital MedicalStaff Privileging.Ref: S&C-05-04
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process:
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included in the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation:
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated as required per the standards in the Medical Staff Chapter of the manual. There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified of the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position:
In November 2004, CMS issued their position on privileging which addresses the concept of core/bundle privileging and remains current. It is in line with the Joint Commission expectation. Organizations are also encouraged to determine if any state-specific law/regulation exist that address the use of a core/bundled privileging model.
Additional Resources:
Centers for Medicare & Medicaid Services (CMS) Requirements for Hospital MedicalStaff Privileging.Ref: S&C-05-04
ֱ does not define or prohibit the use of a core/bundled privileging model. Organizations adopting this model must consider the following:
Defining the process
The core/bundled privilege must clearly and accurately define the specific activities/procedures/privileges to be included in the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.
Implementation
The applicant's education, training and current competence to perform each activity listed in the core/bundle must be evaluated as required per the standards in the Medical Staff Chapter of the manual. There also needs to be a clearly defined method for the applicant to request deletion of specific privileges if they don't wish for them to be granted.
If the organization's evaluation determines that the applicant is not competent to perform certain activities, then they must modify the core/bundle that is granted to reflect only the specific privileges granted to the applicant.
In accordance with the medical staff standards, the applicant and all appropriate internal and/or external persons or entities (as defined by the organization and applicable law) are to be notified of the granting decision, i.e., whether the full core/bundle or a modified bundle has been granted (see MS.06.01.09 EP 3). If the core/bundle was modified, the notification must detail the specific modifications.
CMS Position
Additional Resources
Due Dates
Reappointment/re-privileging is due no later than three^ years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter. For example, if the reappointment period is July 1, 2021 through June 30, 2024, the reappointment date would be July 1, 2024.
Governing Body Approval Dates
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in June, the board would approve all July reappointments/reprivileging effective periods and in July the board would be approving all August reappointments/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
^ Additional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame. The change will also be reflected in a future release date of the accreditation manuals.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Optimizing the use of antibiotics is a patient safety priority, and antibiotic stewardship plays a critical role in supporting appropriate prescribing practices and reducing antibiotic resistance. ֱ is committed to helping organizations develop and implement successful antibiotic stewardship programs and activities in the hospital setting. As a result, ֱ has made several revisions to Standard MM.09.01.01, which include updates to align with federal regulations and current recommendations from scientific and professional organizations. The 12 new elements of performance (EPs) will be implemented for the Hospital (HAP) and Critical Access Hospital (CAH) accreditation programs on January 1, 2023.
Organizational Support (EP 10)
Dedicating the financial resources necessary for staffing and information technology to support the antibiotic stewardship program is essential to demonstrate the hospital's commitment to improving antibiotic prescribing practices. Hospital leaders should be prepared to discuss how antibiotic stewardship has been established as a patient safety priority, and the resources that have been allocated to the antibiotic stewardship program to support its activities.
Program Leadership (EPs 11, 12)
Qualifications:Hospitals are required to appoint a physician and/or pharmacist who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship as the leader(s) of the program. Organizations may determine whether to appoint a physician or pharmacist to lead the antibiotic stewardship program, or to have a physician and pharmacist co-lead the program, depending on the organization's size, structure, and complexity. The antibiotic stewardship program leader(s) may be assigned at the corporate or system level, as long as the leader is able to coordinate and implement antibiotic stewardship activities at each location.While documentation of the governing body's appointment of the antibiotic stewardship program leader(s) is not required, hospitals are expected to discuss how the governing body is involved in decisions about the program's leader(s).
Responsibilities:The appointed leader(s) of the program is responsible for the development and implementation of a hospital-wide antibiotic stewardship program that is based on national recognized guidelines. The program leader(s) is also responsible for documenting antibiotic stewardship activities, communicating and collaborating with individuals across the organization on antibiotic use issues, and providing competency-based training and education for staff. These expectations align with the Centers for Medicare and Medicaid Services Conditions of Participation for antibiotic stewardship (see §482.42 for hospitals and §485.640 for critical access hospitals for additional information).
When developing competency-based training and education for staff, it is important to note that ֱ describes competency as a combination of observable and measurable knowledge, skills, and abilities. Competence assessment lets the hospital know whether its staff have the ability to use specific skills and to employ the knowledge necessary to perform their jobs. Organizations have the flexibility to define the competencies associated with the practical applications of their antibiotic stewardship guidelines, policies, and procedures. Examples of competency-based training and education may include a combination of observable and measurable methods, such as use of a written test or demonstrate accurate completion of procedure/process.The competency-based training and education should be provided to staff with responsibilities related to antibiotic stewardship.
Multidisciplinary Committee (EP 13)
It is important for hospitals to establish a multidisciplinary committee to oversee the antibiotic stewardship program. The composition of the committee is determined by the hospital and may include part-time or consultant staff that are on site or they may participate in committee activities remotely. Examples of committee representation may include medical staff, pharmacy services, the infection prevention and control program, nursing services, microbiology, information technology, and the quality assessment and performance improvement program.
Program Coordination (EPs 14, 15)
The antibiotic stewardship program is expected to have a process in place that demonstrates coordination among all components of the hospital responsible for antibiotic use and resistance including, but not limited to, the infection prevention and control program the quality assessment and performance improvement program, the medical staff, nursing services, and pharmacy services. Additionally, the antibiotic stewardship program is responsible for documenting the evidence-based use of antibiotics in all departments and services of the hospital. The goal of this requirement is for the antibiotic stewardship program to document that all departments and services of the hospital are using antibiotics in a manner supported by evidence as determined by the hospital. Hospitals should be prepared to verify that the hospital's antibiotic use is consistent with the documented evidence-based antibiotic stewardship program recommendations. These expectations align with the Centers for Medicare and Medicaid Services Conditions of Participation for antibiotic stewardship (see §482.42 for hospitals and §485.640 for critical access hospitals for additional information).
Monitor Antibiotic Use (EP 16)
Measuring the hospital's antibiotic use is a critical first step to identifying improvement opportunities for antibiotic prescribing and can also help an organization determine whether its antibiotic stewardship activities are effective. Hospitals may monitor antibiotic use by analyzing days of therapy per 1000 days present or 1000 patient days or by reporting to the National Healthcare Safety Network Antimicrobial Use Option. While hospitals are encouraged to electronically submit data to the NHSN AU option so that they may benchmark their rates comparatively to national data, it is not required.For hospitals contracting with external pharmacy management organizations that may be unable to calculate days of therapy directly, an estimated metric for days of therapy may be used to identify opportunities to improve antibiotic prescribing practices.
Optimize Prescribing (EP 17)
The antibiotic stewardship program is required to implement strategies to optimize antibiotic prescribing practices. Organizations may determine how the strategies are implemented based on the antibiotic stewardship program's expertise and the organization's complexity. Organizations may choose to implement preauthorization for specific antibiotics that includes an internal review and approval process prior to use. Alternatively, organizations may implement prospective review and feedback regarding antibiotic prescribing practices, including the treatment of positive blood cultures. While the prospective review must be performed by a member of the antibiotic stewardship team, organizations should consider multiple pharmacists on the antibiotic stewardship team to minimize potential delays in patient care.
Implement Evidence-Based Guidelines (EPs 18, 19)
Hospitals are required to implement at least two evidence-based guidelines to improve antibiotic use for the most common indications. The two evidence-based guidelines implemented may be selected by the organization based on national guidelines and must also reflect local susceptibilities, formulary options, and the patient population served. Examples include, but are not limited to, community-acquired pneumonia, urinary tract infections, skin and soft tissue infections, Clostridioides difficile colitis, asymptomatic bacteriuria, plan for parenteral to oral antibiotic conversion, or use of surgical prophylactic antibiotics. Hospitals should be prepared to discuss how the evidence-based guidelines were selected and implemented.
The antibiotic stewardship program is required to evaluate adherence (including antibiotic selection, and duration of therapy, where applicable) to at least one of the evidence-based guidelines the hospital implements. Hospitals may measure adherence using a variety of methods, depending on the data and information technology resources available to the antibiotic stewardship program team. Organizations may evaluate adherence data at the group level (i.e., department, unit, clinician subgroup) or at the individual prescriber level. Adherence data may be obtained for a sample of patients from relevant clinical areas by analyzing the electronic health records or through chart review.
Data Collection and Reporting (EP 20)
It is critical to collect, analyze, and report data about the antibiotic stewardship program to hospital leadership and prescribers. Antibiotic stewardship program data may include antibiotic resistance patterns, antibiotic prescribing practices, or an evaluation of the antibiotic stewardship program's activities. Reporting antibiotic stewardship program data to hospital leadership and prescribers allows organizations to review the program's activities and its impact on prescribing practices.
Performance Improvement (EP 21)
When the antibiotic stewardship program identifies improvement opportunities, the hospital develops an action plan. The hospital should be prepared to discuss the actions taken to improve antibiotic prescribing practices.
Additional Resources
Perspectives NewsletterJuly 2022 Volume 42 Number 7
Requirement, Rationale, Reference (R3) Report
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources:
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
The recently published a resource titled "" which is consistent with our current accreditation requirements. Organizations are encouraged to review this document which provides guidance in shortage management and conservation.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LP controlled orders for the items listed at MM.05.01.01 EP 4.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
The following competencies are expected to be completed for all compounding staff:
- Media fill testing (representing the highest complexity level of compounding performed)
- Gloved fingertip sampling (initial and ongoing testing)
- Written didactic testing
- Evaluation of hand washing and donning PPE
- Low-Riskand Medium-Risk^Sterile Compounding: Annually for staff performing (defined as every 12 months +/- one month.)
- High-Risk Sterile Compounding*: Every 6 months
ֱ would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not beenapproved as an indication.
ֱ is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
Ideally, hazardous medications would be compounded in a negative pressure environment. Currently, according to USP 797, if an organization prepares a low volume of hazardous drugs, the use of two tiers of containment is acceptable in a non-negative pressure area. An example of 2-tier containment would be the use of a closed system transfer device utilized within a biological safety cabinet or compounding aseptic containment isolator.
No, immediate-use compounding is reserved for situations where an immediate/urgent need for medications is present and a delay in waiting for the pharmacy to compound items could delay care, as well as items with limited stability, once compounded. Therefore, ֱ will not require fingertip or media fill competencies for nurses performing immediate-use compounding outside of the pharmacy.
The same personal protective equipment expected in a clean room when compounding in a laminar workflow bench are required when utilizing a CAI or CACI unless the manufacturer has written information based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This includes double gloving for the preparation of hazardous medications.
Allergens may be prepared outside of an ISO 5 environment as long as they are prepared with the following conditions:
- The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances
- All allergen extracts shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms.
- Perform thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water.
- Garb with hair covers, facial hair covers, gowns, and face masks.
- Perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity.
- Don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) be- fore beginning compounding manipulations.
- Disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen ex- tracts as CSPs.
- Ampule necks and vial stoppers must be disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.
- The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers).
- The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications.
- Single-dose allergen extracts may not be stored for subsequent additional use.
- ISO level of the primary engineering control
- Viable particle testing surface of the primary engineering control
- Viable particle testing air within the primary engineering control
- HEPA filter leak test of the primary engineering control
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
The following items are expected to be tested at a minimum with a frequency not to exceed 6 month intervals.Lack of testing of these items will result in non-compliance with Joint Commission standards.
- Air exchanges per hour of the buffer area
- Pressure differential (between buffer area/ante area; ante area/non-classified area)
- ISO level of the buffer area and ante area
- Viable particle testing surface of the buffer area and ante area
- Viable particle testing air—HEPA filter leak test of HVAC HEPA filter system
- Evidence of remediation/retesting if assessed levels were not in compliance with those listed in USP 797
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours.Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
A pharmacist is responsible for supervising all compounding, packaging, and dispensing of drugs and biologicals except in urgent situations in which a delay could harm the patient or when the product's stability is short. Additionally, all compounding, packaging, and dispensing of drugs and biologicals must be performed in accordance with state and federal law and regulation. This requirement is based on the CMS Conditions of Participation.
Organizations are required to develop a remediation program to address the identified issue which must include retesting the tested components which were out of range.The remediation process should include an overall review of compliance with procedures including those of compounding staff, cleaning processes and products, and air filtration efficiency. These should be evaluated to identify any potential adverse impact affecting testing results.
Applicable only to organizations following USP 797 2008 Version:
The current standard of practice does not allow for alcohol swabs to touch another object prior to its use when cleaning a critical point (i.e. vial septum, ampule neck, or injection entry port on an IV bag). If this is identified during a survey, it will be scored as non-compliant with Joint Commission Standards as an infection control risk.
It is up to the organization to determine whether or not the compounding space is acceptable to continue producing sterile compounded medication products. Factors should include the pathogenicity of the organism grown in the positive growth viable sample; complexity level of the compounded product; any known/potential associated hospital acquired infections; and guidance from the infection control practitioner.
The practice described may be acceptable as long as an organization has determined that:
- The medication order is written in a manner that supports deferring to patient preference when the patient is:
- Requesting a lesserpotent medication.(Potency should be established with an evidence based tool i.e. morphine equivalents).
- Requesting alesser prescribed dose in a range order.
- Requestinga less intrusive route of administration if both routes are prescribed by the provider.
- The medication is administeredin accordance with orders from the LicensedPractitioner.
- The inclusion allowing patient preference is in the medication order and does not subsequently create a therapeutic duplication with other prescribed medications.
- The organization's medication management policy identifies this type of medication order as acceptable and defines all required elements of such orders.
- The use of a protocol is not required.However, if an organization chooses to utilize a protocol, the review and approval process must comply with the requirements found at MM.04.01.01 EP 15.The medical record must contain evidence of an order to implement the protocol, as well as the protocol itself.
- Implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation.
Per the requirements of the Record of Care, Treatment, and Services (RC) chapter, the medical record must accurately reflect that the lesser potent medication was administered based on patient preference. It isNEVER acceptable to administer a medication of stronger potency based on patient preference.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
Therapeutic duplication occurs when practitioners order more than one medication for the same indication. While this is an acceptable practice there must be clarity sought to determine when one agent should be administered over another, if both agents are to be given concurrently or if one therapy was to replace an existing therapy and wasn't discontinued properly. Such orders are commonly seen in orders for analgesics and anti-emetics but occurs other drug classifications as well (e.g. anti-hypertensives, anticoagulants, etc.)
When more than one medication is prescribed for the same indication, there must be a process in place to determine whether the ordering of multiple agents for the same indications is either an accidental prescribing error or intentional multi-modal therapy.
Joint Commission standards require medication orders to be reviewed by a pharmacist. Part of the review is to identify whether or not therapeutic duplication exists. Once this is identified, it is required that the pharmacist and nurse have a clear understanding of the intent of the prescriber. Organizations may utilize resources such as policies, technology within the electronic medical record or other means necessary to ensure such communication.
The intent is to ensure that medication orders are clear and accurate for all members of the patient care team involved in medication management. If the intent was that both medications be administered and the organizations policy allows for these orders, the pharmacy preparing the medication and the staff administering the medication need to have clear guidance provided.
For example, when a patient is prescribed multiple antiemetic agents, there must be a clear understanding of the following concerns:
- Was the intent of the prescriber to have all ordered medications given known by the prescriber, pharmacist, and the administering provider?
- When does the administering provider give each agent based upon the intent of the prescriber?
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single “block” charting episode does not extend beyond a four-hour time frame. If a patient’s urgent/emergent situation extends beyond four hours and block charting is continued, a new charting “block” period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Titration orders are generally defined as those in which the medication dose is either progressively increased or decreased in response to the patient's status. Organizations are required to define, by policy, if titration orders are deemed acceptable for use. The elements of performance found in the Medication Management (MM) chapter at MM.04.01.01 outline the policy requirements.
- Medication name
- Medication route
- Initial or starting rate of infusion (dose/min)
- Incremental units the rate can be increased or decreased
- Frequency for incremental doses (how often dose(rate) can be increased or decreased
- Maximum rate (dose) of infusion
- Objective clinical endpoint (RASS score, CAM score, etc). NOTE:This particular element does not have to reside in the titration order itself but instead may be a separate order in the medical record.
- Initial or starting rate of infusion (dose/min)
- Incremental units the rate can be increased or decreased
- Frequency for incremental doses (how often dose(rate) can be increased or decreased
- Objective clinical endpoint(RASS score, CAM score, etc).
- Compliance with manufacturer's Instructions For Use (IFU) for safe administration
- Consistent administration practices among nurses and other practitioners
- Ensure the patient response is achieved/sustained
- Nursing not placed in a position of making dosing/administration decisions that may conflict with their scope of practice
- Documentation accurately reflects order changes, patient assessments, etc.
Additional Resources
FAQ:Documentation During Rapid Titration
No, it would not be acceptable to establish a blanket practice that select medications ordered are auto-verified. ֱ requires that a pharmacist reviews all medication orders or prescriptions, with limited exceptions as described in the 'notes' at *MM.05.01.01 EP 1.
The requirement and 'notes' found at MM.05.01.01 EP 1 do allow for limited situations where prospective pharmacy review may not be feasible or required. For example, if waiting for pharmacy review would create a delay that could result in patient harm, prospective review would not be expected. However, organizations should have a process in place to review these scenarios to ensure such a practice is limited to urgent scenarios and not a standard practice for convenience.
Another example may be when a licensed practitioner (LP) controls the ordering, preparation, and administration of a medication, such as in an emergency department. In this example, use of auto-verification technology may be considered as the LP would be physically present.
*This does not apply to the discontinuation of orders.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
Organizations are expected to have a process in place for providing medications to meet patient needs when pharmacy services are not available. Such a process generally requires non-pharmacist health care professionals to access medication storage areas, such as a designated medication storage area or the pharmacy.
When non-pharmacist health care professionals are allowed by law or regulation and hospital policies and procedures to obtain medications after the pharmacy is closed, the following occurs:
- Medications must only be accessed and removed from medication storage areas or pharmacy by trained prescribers and nurses designated by the organization and in accordance with Federal and State law.
- After-hours access to the pharmacy by non-pharmacists to obtain medications should be minimized and eliminated as much as possible.
- Use of well-designed night cabinets, after-hours medication carts, and other methods will reduce the need for non-pharmacist staff to enter the pharmacy.
- Quality control procedures (e.g., an independent second check by another qualified individual, secondary verification technology, such as barcoding, etc.) are to be in place to prevent medication retrieval errors.
- A qualified pharmacist must be available either on-call or at another location to answer questions or provide medications beyond those accessible to non-pharmacy staff.
^ This FAQ is intended to clarify the requirement found at MM.05.01.13 EP 2 regarding pharmacy access.
Upon discharge from an inpatient stay or outpatient encounter, organizations need to determine the disposition of unused or partially used medication. For example, an inhaler provided by the facility for administration during an inpatient stay contains additional doses at the time the patient is discharged. The options available would be for the facility to discard the inhaler or send the inhaler home with the patient. Another example might be sending a 'couple' antibiotics home just to get the patient started on the medication.
When determining policies regarding dispensing medications at discharge, organizations should work with their accreditation and pharmacy leadership and legal counsel to ensure all accreditation and regulatory requirements have been addressed.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
ֱ has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids is outside the scope of the USP 797 chapter. ֱ will survey to organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies, procedures, staff education/competencies, etc., should also take into account:
- Product and device manufacturer's instructions for use
- Evidence-based guidelines for safe administration practices
- Applicable law and regulation
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required.
After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required.
After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required.
After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required.
After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required. After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The timeframe for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult, therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Independent Practitioners (LIP) and staff who participate in medication management (MM.02.01.01). Examples of ‘staff’ may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LIPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources:
Individual State Pharmacy Boards
Organizations are required to establish a process for communicating medication shortages to Licensed Practitioners (LP) and staff who participate in medication management (MM.02.01.01). Examples of 'staff' may include those responsible for ordering, preparing, stocking, storing, and administering medications. Each organization determines the most effective means of communicating this information to key constituents.
While not required, organizations may wish to consider several different means of communicating this information. Examples may include emails, medical staff newsletters, daily staff briefings and huddles, alerts posted in dictation/documentation stations often used by LPs, medication dispensing stations, etc. Periodic assessment of the effectiveness of the communication process should be conducted to ensure compliance with organizational requirements.
The time frame for receiving notice of medication shortages is often short and preparing for shortages can be time-consuming and difficult. Therefore, advanced planning is crucial. If the organization intends to automatically substitute medications during times of shortage, organizations are required to develop written medication substitution protocols. Such protocols must be approved by leadership and the medical staff. The intent of these protocols is to allow for automatic substitutions which would be utilized if the ordering practitioner had not indicated an alternative medication to an individual patient order. If providers are expected to determine and order an alternative medication or dosage form, then the protocol would not be required.
If the substitution is made to items located in floor stock or crash carts, where an individual might retrieve a product different than what would be typically used, an approved substitution protocol would also be required. This would apply to substituting: dosage form; route; concentration (strength); or medication. Staff education should be conducted for those assigned to those areas affected by medication shortages and where the substitution may occur.
To ensure reduction of risk from variations introduced as a result of shortages, compliance with substitution practices should be included when evaluating the effectiveness of all medication management systems (see MM.08.01.01). One example may be to review medication errors/adverse drug events to determine if a medication shortage was directly or indirectly associated withthe event. The focus of this evaluation would be to identify performance improvement opportunities and implement risk reduction strategies that can be applied to subsequent shortages. Organizations may also find it helpful to develop a safety checklist that addresses each step of medication management systems when dealing with medication shortages.
Additional Resources
Individual State Pharmacy Boards
Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all identified risk points. As a general rule, concentrated electrolytesare not be kept in patient care areas where access is not urgently needed.
The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served in each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadership would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets, dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device or storage location should also be evaluated as such storage areas may serve a mixed patient population.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards must be developed to prevent inadvertent administration of these medications without proper dilution.Examples of strategies to prevent errors may include:
- Segregation from all other medications stored in the device or area.
- Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amount necessary to meet patient care needs over a limited time period (for example, one day).
- A system for regularly checking and restocking to par level by pharmacy staff. .
- Prominent warning labels applied to the drug container.
- Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.
Expiration dating is based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA) approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the LOT number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Expiration dating is based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA) approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the LOT number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer’s instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
If your organization chooses to use temperature monitoring to achieve this, the process must be effective to ensure appropriate temperatures are being maintained within the required ranges for all medications stored. Organization should also have a defined process outlining disposition of medication from a refrigerator or freezer which has deviated from the recommended temperature range.
The frequency of temperature monitoring (daily, continuous, etc.) is determined by the organization and in a manner consistent with the medication manufacturer's safe storage guidelines.
For temperature log retention requirements, see the FAQ titled "Records and Documentation - Retention" under the Leadership.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
No, retail pharmacies are not subject to survey along with a hospital as there are no accreditation requirements in the hospital or critical access hospital accreditation manuals that address such entities^. This also applies to those situations when there are contractual agreements between a hospital and a retail pharmacy to provide services directly to patients preparing for discharge. Examples of such services may include delivery of:
- durable medical equipment (canes, crutches, wheelchairs, etc)
- prosthetics, orthotics, dressings, etc.
- prescription medications, sometimes referred to as a 'meds-to-beds' program
- etc.
^ NOTE:A retail pharmacy may be visited when seekingaccreditation under the Home Care Accreditation Program for eligible services.Business occupancies located within the boundaries of a hospital may be evaluated by a life safety code surveyor for compliance with EC and LS standards. This would include a retail pharmacy that may or maynot be owned or operated by the hospital.
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
If your state has implemented programs/processes that oversee the procurement, storage, and dispensing of opioid reversal agents, surveyors will evaluate compliance based on the requirements outlined per your state.
If your state has not implemented a program that has been adopted by your organization, you should consider the following:
Security
As with all medications, the security and integrity of such medications must be assured. Therefore, the medications must be stored in a manner to prevent tampering, theft or diversion at all times (see MM.03.01.01).While ֱ standards do not define what process must be followed to ensure medication security, organizations should consider conducting a risk assessment as a helpful way of identifying risks associated with various options being considered by the organization. The assessment must include all applicable accreditation, law and regulatory requirements.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
Storage
Medications must be stored in a manner consistent with the manufacturer's instructions for use to ensure stability. Therefore, a risk assessment should include environmental factors, such as temperature, light exposure, etc., that may impact medication integrity. NOTE -The guidance for storage listed in a package insert must be followed and cannot be superseded by an organization's risk assessment.
Orders
Protocols should include pre-established and approved patient assessment criteria in order to provide timely care and services to patients. The organization needs to define, in writing, who is authorized to administer medication in accordance with law and regulation (MM.06.01.01).The implementation of a protocol must be documented as an order in the patient's medical record and dated, timed and signed by the practitioner responsible for the care of the patient. However, the timing of such documentation should not be a barrier to providing timely and necessary care, or other patient safety advances.
Documentation
Once the organization chooses to treat an individual, they become a patient of the organization. Therefore, a medical record would be required that reflects all care, treatment and services provided in accordance with the requirements found in the Record of Care (RC) chapter of the accreditation manual, law and regulation.
Education and Training
Each organization determines education, training or competency requirements for those individuals involved in responding to patient emergencies.
Evaluating Medication Management Systems
Organizations are required to evaluate the effectiveness of their medication management systems (see MM.08.01.01). Therefore, organizations are encouraged to include emergency response processes, that include the safe medication practices, into their performance analysis activities. Such activities should include the collection and analysis of data that allows leadership to identify and implement performance improvement opportunities.
Influenza and Pneumococcal Vaccines
Unless your state is more specific, these vaccines are not required to have a physician's order in the medical record as long as certain conditions are met which are listed below:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and Pneumococcal Vaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing the patient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # and Expiration Date as well as the publication date of the vaccine information sheet (VIS) given to the patient.
- If all of these criteria are met, since an order would not be required then pharmacy would not be required to review.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Please note that MM.05.01.01EP 1 states Before dispensing or removing medications from floor stock or from an automated storage and distribution device, a pharmacist reviews all medication orders or prescriptions unless a licensed practitioner controls the ordering, preparation, and administration of the medication".
Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order. Your organization would need to determine if their state permits the use of such standing orders for vaccine administration as you describe. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Please note that while our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Again, your organization should research this within their state. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient's bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. The guidelines describe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Yes, the health care equity leader(s) may be assigned at the corporate or system level as long as the leader is able to coordinate and implement health care equity activities at each location and address the site-specific health care disparities identified. However, larger organizations may still want to identify individuals to lead activities at the site level, but the overall responsibilities for system-wide health care equity initiatives can be assigned at the corporate or system level.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource:
Suicide Prevention Portal
Organizations providing inpatient substance abuse detox treatment (as the primary focus of treatment) should follow the recommendations applicable to general acute care inpatient settings, given the complexity of physical health care required to care for these patients. These units do not need to meet the same recommendations as psychiatric inpatient units. As with any patient receiving treatment for mental health, screening, assessment, and reassessment are critical when determining the appropriate level of care.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Any examples are for illustrative purposes only.
NPSG.15.01.01 applies to all patients in organizations surveyed under the Behavioral Healthcare and Human Services standards (CAMBHC), all patients in psychiatric hospitals, any patient in a general hospital who is being treated or evaluated for a behavioral condition as their primary reason for care, and all patients who express suicidal ideation during the course of care regardless of their registration status (IP, OP, ED, Obs, etc.).
At this time, suicide risk assessment of patients with secondary diagnoses or secondary complaints of emotional or behavioral disorders and/or conditions that are NOT part of the current assessment or treatment is encouraged but not required. For purposes of this requirement, the phrase "behavioral conditions" refers to any Diagnostic Statistical Manual (DSM) diagnosis or condition/symptomology, including those related to substance abuse. The phrase "being treated" is interpreted in terms of the patient's diagnosis or presenting complaint, condition, and/or symptomology. If a patient is being evaluated or treated for a behavioral compliant, condition, or symptomology, the standard applies whether a formal psychiatric diagnosis is present or not.
For additional information regarding environmental requirements in non-psychiatric settings review the following FAQ: Environmental Risk Assessment Expectations in Non-psychiatric Units/Areas in General Hospitals
Additional Resource
Suicide Prevention Portal
Any examples are for illustrative purposes only.
Protective factors may be described as individual, relationship, community, and societal characteristics or circumstances that can protect individuals from suicide.
Examples of protective factors include, but are not limited to:
Individual Protective Factors
- Skills in coping and problem solving
- Reasons for living, such as family, friends, pets, etc.
- Cultural identity
- Supportive partners, friends, and family
- Feeling connected to others
- Connections to school, community, or other social places
- Availability of consistent and high-quality healthcare
- Reduced access to lethal means
- Cultural, religious, or moral objections to suicide
References:
Additional Resources
Suicide Prevention Portal
Risk factors may be described as a combination of individual, relationship, community, and societal levels that can increase the possibility that a person will attempt suicide.
Examples of risk factors include, but are not limited to:
Individual Risk Factors
- Previous suicide attempt(s)
- History of mental illnesses, particularly depression
- Serious physical illness, such as chronic pain
- Criminal/legal issues
- Financial problems or job loss
- Impulsive or aggressive tendencies
- Substance use
- Current or prior history of adverse childhood experiences
- Feelings of hopelessness
- Violence victimization and/or perpetration
- ċċċċċBullying
- Family history of suicide
- Loss
- Violent or high conflict
- Isolation
- Lack of access to healthcare
- Suicide clusters
- Adopting and adjusting to a new environment
- Violence
- Discrimination
- Stigma associated with mental illness and seeking help
- Access to lethal means
- Media portrayals of suicide
Additional Resource
An allowable alternative to a solid ceiling such as dry wall is a concealed grid system. This is a system of interlocking panels. Typically, the ceiling panels lock into one another and the grid with the use of small strips of metal called 'splines', this prevents removal of the panels by patients attempting to gain access above the ceiling.
There are various manufacturers of concealed grid ceiling systems, when selecting a system, or confirming an existing installation, ensure that the it meets the following requirements:
- There are no exposed components of the ceiling system that can be used as a ligature attachment point (i.e. exposed rails, tee connectors, couplers, or main rails)
- Panels can in no way be removed by the patient.
- No impact will dislodge the panel(s)
Additional Resource
Suicide Prevention Portal
Yes, dropped ceilings are allowed in corridors and common areas where staff are regularly present, if there are no objects that patients could easily use to climb up to the drop ceiling, remove a panel, and gain access to ligature risk points in the space above the drop ceiling, andas allowable by the facility's environmental risk assessment. These areas do not need to be in constant view of staff but should be a part of the standard safety rounds conducted by staff (for example, 15-minute patient safety checks, shift-to-shift environmental rounds, and so on).
Dropped ceilings in areas that are not fully visible to staff (for example, a right-angle curve of a corridor, an alcove, or other non-visible areas) should be noted on the risk assessment and have some additional steps taken to make it more difficult for a patient to attempt to access the space above the dropped ceiling (such as, gluing or clipping tiles), which would allow staff to hear or see the patient's suicide attempt and prevent the attempt from occurring.
Additional Resource
Suicide Prevention Portal
No, ֱ does not mandate "safe rooms" in emergency departments.Spaces/rooms designated ONLY for the treatment of patients with behavioral health conditions within an emergency department or other area should follow the Recommendations for Suicide Prevention in Healthcare Settingsfor inpatient psychiatric units.
Note: TJC does not define "safe room" in its glossary, however in the context of the FAQ this moniker is used to describe a "designated space" as a room and/or area that is dedicated to the evaluation and/or treatment of patients with behavioral conditions. Designated and non-designated are the descriptors used to identify these spaces.
Additional Resource
Suicide Prevention Portal
Yes, as per NPSG.15.01.01 EP1, these organizations are required to conduct a risk assessment to identify elements in the environment that individuals served could use to harm themselves, visitors, and/or staff. Those items that have high potential to be used to harm oneself or others should be removed and placed in a secure location (for example, putting sharp cooking utensils in a locked drawer) when possible. Staff should be trained to be aware of the elements of the environment that may pose a serious risk to an individual who could develop serious suicidal ideation. Staff should be aware of how to keep an individual safe from these hazards until they are stabilized and/or able to be transferred to a higher level of care. The technical advisory panel recognized that a patient placed in this level of care may have a change in mental state based on some trigger within the environment or in their treatment, and staff should be prepared for this.
Furthermore, these organizations must have policies and procedures implemented to address how to manage an individual in these levels of care who may experience an increase in symptoms that could result in self-harm or suicidality.
Additional Resources
Suicide Prevention Portal
ֱ requires:
- Thoughtful evaluation of the environment,
- A plan, and
- Available resources to guide staff when housing patients at risk for suicide in a patient room in a non-designated space.
- Checklists identifying the self-harm objects to be removed
- Electronic flags (e.g. the patient you are placing in a medical/surgicalroom is high risk and you should sweep the room for items not essential for patient care which may pose a self-harm risk)
- Competency/training for all sitters who will be with high risk patients to do the environmental assessments
- Visual reminders (e.g., posters) of the most common items that are significant risks on the unit
- On-site psychiatric professional who is available to complete an environmental risk assessment in areas where staff do not have the training to do this independently
Suicide Prevention Portal
Organizations should use an evidence-based process to conduct a suicide assessment of patients who exhibit suicidal behavior or who have screened positive for suicidal ideation. The assessment should directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors. After this assessment, patients should be classified as high, medium, or low risk of suicide. ֱ considers "serious" as equivalent to "high risk". Please refer to NPSG 15.01.01 in the Accreditation Manuals for information relevant to screening and assessment of patients at risk for suicide.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource:
Suicide Prevention Portal
If curtains are used in place of a bathroom door, analysis of this risk should be noted on the environmental risk assessment, and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where the risk is present.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
ֱ neither discourages nor promotes the use of these devices. If an organization chooses to use such devices, the organization must ensure the devices are installed, maintained, and tested per Manufacturer's Instructions for Use.
Additional Resources
Suicide Prevention Portal
There is no height requirement for a ligature risk. Information from various sources notes that death by suicide as a result of asphyxiation can occur at any height. Specifically, there have been reports of death by suicide or suicide attempts during which patients fixed a cord, rope, or other material to a low pipe and around their neck and then spun their body ("alligator roll") to twist until it asphyxiated them. Thus, low-to-the-ground exposed piping (such as piping near toilets or under the sink, for example) or any other apparatus protruding from the wall or another structure is considered a ligature risk if the patient is able to create a sustainable point of attachment with another material in order to inflict self-harm or cause loss of life.
Additional Resource
Suicide Prevention Portal
ֱ has not specified a requirement for the number of ligature resistant beds on any given unit. This will depend on the needs of the patient population. The type of medical bed should be balanced based on the medical needs and the patients' risk for suicide. If medical beds that contain ligature risks are being used within an inpatient and/or designated psychiatric unit, they must be identified on the organization's environmental risk assessment (as per NPSG.15.01.01 EP1). For patients who require medical beds that have ligature points, there must be appropriate mitigation plans and safety precautions in place, including 1:1 observation for patients determined to be at high risk for suicide who have access to the bed(s). Plans to mitigate risk must be documented within the patients' medical record (as per NPSG.15.01.01 EP4). The organization must consider these risks in patients' overall suicide/self-harm risk assessments and implement interventions to mitigate these risks.
ֱ will not advise on the type of medical beds or ligature-resistant beds that should be purchased for patients. These decisions should be balanced based on patient needs. Organizations must evaluate beds and be aware of the ligature and/or other safety risks the bed(s) may present.
In addition, if these medical beds are being used, safety provisions must be considered. Provisions may include, but are not limited to, locking the patient room door where a medical bed is being used when unoccupied, removing a medical bed from the unit if not in use, enacting the safety features of the bed, when appropriate, and/or enhanced environmental and safety rounding. These provisions must be addressed in the organization's environmental risk assessment and/or policies and procedures.
Additional Resource
Suicide Prevention Portal
Patients who are currently at high risk for suicide should remain in a ligature resistant environment. If a patient who is at high risk for suicide enters another unit/area/building that contains ligature and other safety risks, continuous monitoring with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient – is required. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
Additional Resource
Suicide Prevention Portal
ֱ will not advise or recommend any particular type of shower curtain, but shower curtains are considered a risk. The expectation is that shower curtains must be noted on an environmental risk assessment and the organization must have a mitigation plan for monitoring any high-risk patients near the curtain or area where this risk is present. Shower curtains must be installed, inspected, maintained, and tested per Manufacturer's Instructions for Use to ensure proper functioning (e.g. breakaway features).
Additional Resources
Suicide Prevention Portal
The recommendation states: "Nursing stations with an unobstructed view (so that a patient attempt at self-harm at the nursing station would be easily seen and interrupted) and areas behind self-closing/self-locking doors do not need to be ligature resistant and will not be cited for ligature risks." This refers to what can be seen within the nurses station, not what is being seen from the nurses station. If there is an unobstructed view of everything within a nurses station, then patients should not be able to attempt self-harm at the nurses station since this would be easily seen and interrupted.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
No, ֱ does not recommend products. Organizations should reviewRecommendations for Suicide Prevention in Healthcare Settings, conduct a risk assessment of the environment, determine which products to appropriately install (based on manufacturers' instructions), and ensure that they are functioning properly.
Ligature resistant is defined as: without points where a cord, rope, bedsheet, or other fabric/material can be looped or tied to create sustainable point of attachment that may result in self-harm or loss of life.
See also FAQ Titled "Is there a height requirement in order to consider something a "ligature risk"?"
Additional Resource
Suicide Prevention Portal
In the context of transmission-based precaution, if observation occurs outside of the room, the 1:1 observer must be able to maintain full continuous view of the patient, with the door closed, and be able to intervene without delay when necessary. This means that the observer would have to maintain the appropriate (clean) PPE to ensure entry into the room without delay if necessary. If this is not possible, the 1:1 observer would have to remain in the room, with the door closed, donning the appropriate PPE with full continuous view of the patient and within a distance to be able to immediately intervene if necessary.
ֱ does not prescribe a specific distance from which the observer must be to the patient. This is determined by the organization. The observer must always have full continuous view of the patient and be able to intervene without delay if necessary.
ֱ requires organizations to follow the current CDC guidelines for Transmission-based Precautions which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.When deciding which observation strategy to deploy, the organization must consider the following:
- Implement interventions based on the following principles:
- Route(s) of transmission of the known or suspected infectious agent
- Risk factors for transmission in the infected patient (e.g., patient's willingness to observe precautions to prevent transmission to other patients)
- Risk factors for adverse outcomes resulting from an HAI in other patients in the area or room being considered for patient-placement
- Availability of single-patient rooms
- Patient options for room-sharing (e.g., cohorting patients with the same infection)
- The observer must have received training on and demonstrate an understanding of how to properly don, doff, dispose of, and maintain PPE.
- Ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material and/or the organization's policy/process/procedure.
- Gloves, gowns, protective eyewear, mask, face shield N95 respirator that are appropriate to the suspected or confirmed infectious agent should be selected and can be worn individually or in combination.
Suicide Prevention Portal
FAQ Ligatures and/or Suicide Risk Reduction – Video Monitoring of Patients at High Risk for Suicide
No, not all patients being evaluated or treated for a behavioral condition require 1:1 monitoring.
In units/areas that contain ligature and/or other safety risks, patients determined to be at high-risk for suicide must be under continuous observation with the ability to immediately intervene through the use of 1:1 observation - 1 qualified staff member to 1 high risk patient. A qualified staff member is one that has been trained and has demonstrated competence in working with suicidal patients and performing 1:1 observation.
In inpatient psychiatric units/designated psychiatric areas that are ligature resistant and free from other safety risks, it is up to the organization to determine monitoring requirements for patients determined to be at high-risk for suicide and define such in their policy.
Additional Resources
Suicide Prevention Portal
No, ֱ does not determine the items to be prohibited from an inpatient psychiatric unit. Items that are prohibited to be brought into organizations, due to the risk of harm to self or others, should be determined by the organization. Compliance of such safety measures is based upon organizational policies/procedures, individual care plans, and applicable state rules or regulations.
This FAQ was also published in the Perspectives® Newsletter, January 2018, Volume 39, Issue 1 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
No, the National Patient Safety Goal does not require organizations to universally screen all patients for suicidal ideation. Screening patients for suicide risk with secondary diagnoses or secondary complaints of emotional or behavioral disorders is encouraged but not required. It is important for clinicians to be aware that patients being treated primarily for a medical condition may also have behavioral tendencies that, if triggered, may lead to self-harm. For example, changes in health status resulting in a poor prognosis, chronic pain resulting from injury or illness, etc.
Psychosocial changes, such as sudden loss of a loved one, broken relationships, financial hardship, etc., can also trigger self-harm behaviors. These patients may also be at risk for suicide, therefore, it is important for clinicians to properly assess these individuals for suicidal ideation as part of their overall clinical evaluation, when indicated.
A validated screening tool is one that has been scientifically tested for reliability (the ability of the instrument to provide consistent results), validity (the degree to which the instrument is measuring the condition that it is designed to measure), sensitivity (the ability of the instrument to correctly identify individuals with the condition) and specificity (the ability of the instrument to correctly identify individuals without the condition).
Patients being evaluated or treated for behavioral health conditions often have suicidal ideation. Brief screening tools are an effective way to identify individuals who require further assessment to determine risk for suicide. Screening tools should be appropriate for the population to the extent possible (e.g., age-appropriate). When using validated screening tools, organizations should not change the wording of the questions because small changes can affect the accuracy of the tools.
In addition, it is important that organizations ensure that the chosen screening tool(s) are implemented and completed as directed by the creators of the tool(s). For example, the Columbia Suicide Severity Rating Scale (CSSRS) is a validated screening tool that contains six questions. Depending on the answer to the first two questions, additional questions apply. One or more questions may get missed if the tool is not implemented or completed as directed. Another example, the ASQ Suicide Risk Screen Tool, is a four-question validated screening tool, which also contains a fifth question to assess acuity. This question may get missed if the tool is not implemented or completed as directed. Therefore, if not completed as instructed, the validity of the tool to identify individuals who may be at risk for suicide is compromised. Ultimately, it is the responsibility of each organization to ensure that validated tool(s) are implemented and completed accurately.
Additional Resource
Suicide Prevention Portal
Organizations are required to develop and follow written policies and procedures addressing the care of patients identified as at risk for suicide, including guidelines for suicide risk reassessment. Reassessment guidelines should address how often reassessments will occur as well as additional criteria that would trigger a reassessment, for example, a change in patient status, endorsement of suicidal ideation, and/or suicidal or self-harm behaviors or gestures. An evidence-based process must be used to conduct suicide risk reassessments for individuals who have screened positive for suicidal ideation and were further assessed for suicide risk. At minimum, reassessments must directly ask about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of evidence-based tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population.
If the organization does not use an evidence-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their reassessment is based off
- The reassessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
Suicide Risk Reduction Resources
The recommendations for a ligature-resistant environment for inpatient psychiatric units (in both a psychiatric hospital and a general acute care hospital) apply to closed or secure/locked psychiatric units in which entrance to and exit from the unit are controlled by unit staff and a patient could not independently leave the unit without supervision. The recommendations would not apply to an open or unlocked psychiatric unit in which patients are able to enter and exit of their own accord.
This FAQ was also published in the Perspectives® Newsletter, July 2018, Volume 38, Issue 7 - The Official Newsletter of ֱ.
Additional Resource
Suicide Prevention Portal
Patients with suicidal ideation vary widely in their risk for a suicide attempt depending upon whether they have a plan, intent, history of attempts, etc. It is important to conduct an in-depth assessment of patients who screen positive for suicide risk to determine how to appropriately treat them.
The use of an evidence-based assessment tool, in conjunction with clinical evaluation, is an evidenced-based process effective in determining overall risk for suicide. The use of validated tools is strongly encouraged, and it is acceptable for organizations to use language that is more appropriate for their patient population, if the questions adhere to the intent of the original validated tool.
If the organization does not use an evidenced-based tool, the following conditions must be met:
- Organization can demonstrate what evidenced based resource(s) their assessment is based off
- The assessment asks directly about suicidal ideation, plan, intent, suicidal or self-harm behaviors, risk factors, and protective factors
- How level of risk was determined is clearly documented
Additional Resources
SuicidePrevention Portal
For patients identified as high risk for suicide who have access to ligature or other safety risks, constant 1:1 visual observation must be implemented (in which a qualified staff member is assigned to observe only one patient at all times) that would allow the staff member to immediately intervene should the patient attempt self-harm. The use of video monitoring or "electronic sitters" would generally not be acceptable in this situation because staff would not be immediately available to intervene. The use of video monitoring would be acceptable as a compliment to the 1:1 monitoring, but not acceptable as a stand-alone intervention, unless as described below.
For patients at high risk for suicide, video monitoring may only be used in place of direct line-of-sight monitoring when it is unsafe for a staff member to be physically located in the patient's room.In addition, for both direct line-of-sight and video monitoring of patients at high risk for suicide, the monitoring must be constant 1:1 at all times, including while the patient sleeps, toilets, bathes, etc. and the monitoring must be linked to the provision of immediate intervention, when needed, by the qualified staff member assigned to observe the high-risk patient.
The use of "electronic sitters" or video monitoring for patients who are NOT at high risk for suicide is up to the discretion of the organization. There are currently no leading practices on how to use video monitoring to monitor those at risk for suicide.It is important to reassess patients who are at risk for suicide, despite the monitoring method that is chosen.
Additional Resource
Suicide Prevention Portal
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still “critical” but moving in the desired direction it may be referred to as a “repeat critical result (RCR)” and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the “repeat critical value” procedure is described by the organization and would include how “improving labs” is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still “critical” but moving in the desired direction it may be referred to as a “repeat critical result (RCR)” and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the “repeat critical value” procedure is described by the organization and would include how “improving labs” is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still “critical” but moving in the desired direction it may be referred to as a “repeat critical result (RCR)” and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the “repeat critical value” procedure is described by the organization and would include how “improving labs” is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still “critical” but moving in the desired direction it may be referred to as a “repeat critical result (RCR)” and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the “repeat critical value” procedure is described by the organization and would include how “improving labs” is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still "critical" but moving in the desired direction it may be referred to as a "repeat critical result (RCR)" and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the "repeat critical value" procedure is described by the organization and would include how "improving labs" is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each health care organization may define for itself what constitutes "critical values". Provisions may be made for certain patient-specific situations in which values that would be "critical" for most patients are not critical for a particular patient or for patients with a particular diagnosis. The parameters must be objectively defined and are known to all staff who are involved in the process of reporting values.
The intent of the new requirement at NPSG.01.01.01 EP 3 is that organizations implement practices to prevent misidentification of newborns.The goal is to have a reliable process in place to ensure accurate identification of the newborn for whom the service or treatment is intended and to match the service or treatment to that neonate.
The information provided in the 'Note' provides examples on how an organization can meet the intent of the requirement.The naming convention listed in the 'note' at NPSG.01.01.01 EP 3 is not prescriptive. The organization may use any naming convention that works for them as long as it meets the intent of the requirement.
The naming convention selected is only to be utilized during the initial admission following delivery. This would not apply to a pediatric, neonatal intensive care, and/or special care unit settings if the newborn has been re-admitted following discharge from delivery and given an official name.
Regarding standardized practices for banding, while the practice of applying identification (ID) bands to two limbs is common, organizations may elect to use other devices and/or technologies designed to support accurate patient identification. Whatever device(s) is selected, organizations should give consideration to any risks of them separating from the infant.
The use of communications tools, such as visual prompts/alerts, are intended to alert all staff providing care that there may be infants with similar names, twins, etc., that may contribute to ID ambiguity. During survey, staff should be able to speak to how they handle a situation in which there is a baby with a name alert.
Click here to review the R-3 report for this new requirement.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient’s identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Yes, in cases where the patient is not held in a pre-procedure area for preparation, it would be acceptable to complete the verifications and checklist in the operating room. Hospitals should identify the timing and location of the preprocedure verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the pre-procedure verification process will depend on the type and complexity of the procedure.
Keep in mind that the final time-out (see UP.01.03.01) must occur immediately prior to making the incision with involvement of all immediate members of the procedure team. The final time-out participants MUSTinclude, for example, the individual performing the procedure, the anesthesia providers, the circulating nurse, the operating room technician(s), and other active participants who will be participating in the procedure from the beginning.
The Universal Protocol is based on the following principles:
- Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
- A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
- Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
- To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety.
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that "are" or "maybe" required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Resources:
ֱ Tools and Resources: Universal Protocol
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes any outpatient locations in which surgical services are provided as the Conditions of Participation require that the hospital’s outpatient surgical services must be consistent in quality with the hospital’s inpatient surgical services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
For distinct part rehabilitation and psychiatric distinct part units in critical access hospitals, NR.02.03.01 EP 7 applies only to these inpatient units. The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Click here to view the full text of the revised requirements for 2019.
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes any outpatient locations in which surgical services are provided as the Conditions of Participation require that the hospital’s outpatient surgical services must be consistent in quality with the hospital’s inpatient surgical services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
For distinct part rehabilitation and psychiatric distinct part units in critical access hospitals, NR.02.03.01 EP 7 applies only to these inpatient units. The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Click here to view the full text of the revised requirements for 2019.
While the requirement regarding the provision or supervision of care delivery by a Registered Nurse (RN) is not a new requirement, the ‘note’ clarifies CMS’s expectation regarding the availability of an RN.
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes any outpatient locations in which surgical services are provided as the Conditions of Participation require that the hospital’s outpatient surgical services must be consistent in quality with the hospital’s inpatient surgical services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
For distinct part rehabilitation and psychiatric distinct part units in critical access hospitals, NR.02.03.01 EP 7 applies only to these inpatient units. The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Click here to view the full text of the revised requirements for 2019.
While the requirement regarding the provision or supervision of care delivery by a Registered Nurse (RN) is not a new requirement, the ‘note’ clarifies CMS’s expectation regarding the availability of an RN.
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes any outpatient locations in which surgical services are provided as the Conditions of Participation require that the hospital’s outpatient surgical services must be consistent in quality with the hospital’s inpatient surgical services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
For distinct part rehabilitation and psychiatric distinct part units in critical access hospitals, NR.02.03.01 EP 7 applies only to these inpatient units. The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Click here to view the full text of the revised requirements for 2019.
While the requirement regarding the provision or supervision of care delivery by a Registered Nurse (RN) is not a new requirement, the ‘note’ clarifies CMS’s expectation regarding the availability of an RN.
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes any outpatient locations in which surgical services are provided as the Conditions of Participation require that the hospital’s outpatient surgical services must be consistent in quality with the hospital’s inpatient surgical services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
For distinct part rehabilitation and psychiatric distinct part units in critical access hospitals, NR.02.03.01 EP 7 applies only to these inpatient units. The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Click here to view the full text of the revised requirements for 2019.
Hospitals
While the requirement regarding the provision or supervision of care delivery by a Registered Nurse (RN) is not a new requirement, the ‘note’ clarifies CMS’s expectation regarding the availability of an RN.
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes outpatient locations as the Conditions of Participation require that the organization’s outpatient services be consistent with the hospital’s inpatient services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
NR.02.03.01 EP 9 also requires that hospitals that use Joint Commission accreditation for deemed status purposes have policies and procedures that establish which outpatient departments, if any, are not required to have a registered nurse present.
Critical Access Hospitals
NR.02.03.01 EP 7 applies only to critical access hospitals that have either an inpatient rehabilitation or psychiatric distinct part unit (DPU). The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term ‘immediately available’ has not been formally defined, an RN would not be considered ‘immediately available’ if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state’s CMS office regarding a waiver (42 CFR §488.54(c)) option.
Hospitals
For hospitals that use Joint Commission accreditation for deemed status purposes, NR.02.03.01 EP 7 applies to all inpatient units, departments and locations in which the provision of nursing care occurs. This includes outpatient locations as the Conditions of Participation require that the organization's outpatient services be consistent with the hospital's inpatient services. The Emergency Department(ED) would also be included as patients may be boarded in the ED while awaiting admission or transfer.
NR.02.03.01 EP 9 also requires that hospitals that use Joint Commission accreditation for deemed status purposes have policies and procedures that establish which outpatient departments, if any, are not required to have a registered nurse present.
Critical Access Hospitals
NR.02.03.01 EP 7 applies only to critical access hospitals that have either an inpatient rehabilitation or psychiatric distinct part unit (DPU). The requirement does not apply to clinic settings, such as Family Practice, Internal Medicine, etc.
Although the term 'immediately available' has not been formally defined, an RN would not be considered 'immediately available' if he/she was working on more than one unit, building, floor in a building, etc, at the same time.
Small organizations and those located in rural areas may consider contacting their state's CMS office regarding a waiver (42 CFR §488.54(c)) option.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
ֱ requires that medications are stored in a secure manner to prevent tampering, theft or diversion in accordance with law and regulation. Considering the intended nature and use of emergency carts, organizations must balance security with the requirement that emergency medications and their associated supplies are readily available (see MM.03.01.03) when needed.
While organizations are responsible for ensuring the security of the contents of an emergency cart, use of devices (padlocks, etc.) that could create delays or barriers to immediate access to emergency medications and supplies is discouraged and could potentially be interpreted as 'not readily accessible for use' (see PC.02.01.11). When security devices are used, the intent would be to use an appropriate device that allows the organization to detect tampering while not creating a barrier or delay in the staff's ability to access the emergency supplies contained within the cart. Therefore, use of a breakaway tag with a numeric identification number is acceptable as long as there was a defined process in place to monitor the integrity of the breakaway lock.
It is most helpful for organizations to conduct a risk assessment in order to identify risks associated with various options available for securing emergency cart contents. The results of the risk assessment will enable leaders to make decisions and design processes that best serve the delivery of safe, quality emergency care while maintaining the integrity of emergency medication and supplies. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
Since emergency departments and nursing units are staffed 24/7, yes, it would be acceptable to place emergency carts^ in these locations as long as there was a defined process in place to monitor the integrity of the breakaway lock and cart contents. Constant visual surveillance of emergency carts is not required when such systems are in place. However, if there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current emergency cart security policies and procedures, then implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. NOTE: Emergency carts containing medication located in departments that are not staffed 24/7 must be secured in a locked location.
^The organization determines where emergency carts are located within the organization.
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
There are no specific Joint Commission standards that require an H & P, that has been dictated and placed into the record, to be authenticated prior to a procedure or prior to updating an H & P that was completed within 30 days prior to admission or registration.
Organizations are required to have a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature is considered an entry. However,State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing a policy, organizations should work with their regulatory leadership and legal counsel to determine any state-specific requirements that must be considered. When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
It is recognized that the prenatal patient is a special situation in that, in and of itself, the prenatal course of care is a planned, systematic updating of the history and physical performed at the first visit and throughout the pregnancy. As such, the entire prenatal record can be utilized as the history and physical, provided it is updated to reflect the patient's condition upon admission or prior to a high risk or operative procedure.
When a history and physical (H & P) is completed within 30 days PRIOR TO inpatient admission or registration of the patient, an update is required within 24 hours AFTER the patient physically arrives for admission/registration but prior to surgery or a procedure requiring anesthesia services. For example, if an H & P was completed in a physician's office at 3:00 pm today for a procedure to be performed at 9:00 am tomorrow, an update would be required AFTER the patient arrives for the procedure tomorrow morning but prior to the 9:00 am procedure time. The 24 hour time frame starts when the patient physically presents for admission/registration. NOTE: The term 'registration' generally applies to patients scheduled for same day or outpatient procedures. Any H & P completed greater than 30 days prior to inpatient admission or registration cannot be updated and a new H & P must be completed.
NOTE: A properly executed history and physical is valid for the entire length of stay. Any changes to the patient's condition would be documented in the daily progress notes. A new H & P or update to the H & P is not required when the patient remains continuously hospitalized. If the patient has been discharged, then readmitted, there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Any examples are for illustrative purposes only.
If the history and physical (H & P) is completed as required (see PC.01.02.03 EP 4), then a surgical procedure or other procedure requiring anesthesia services is to be completed at a later point during the admission, anupdate to the H & P is not required as the daily progress notes serve as the updates. The medical staff is responsible for determining who is responsible for entering daily progress notes as well as the required contents of such notes.
To summarize,a properly executedhistory and physical is valid for the entire length of stay.Any changes to the patient's condition would be documented in the daily progress notes.A new H & P orupdate tothe H & P is not requiredwhenthe patient remainscontinuouslyhospitalized. If the patient hasbeen discharged,then readmitted,there must be a valid history and physical (no greater than 30 days) and updated within 24 hours after re-admission/registration but prior to a surgical procedure or other procedure requiring anesthesia.
Content
The specific content may vary based on services provided and patient population served by the care setting. An H & P must be completed and entered into the medical record for any high-risk procedure, surgical procedure and any procedure that involves anesthesia services.
Qualified Practitioners
Practitioners Without Privileges
- review the history and physical examination document
- determine if the information is compliant with the organization's defined minimal content
- obtain missing information through further assessment update information and findings as necessary, which may include, but are not limited to:
- inclusion of absent or incomplete required information,
- a description of the patient's condition and course of care since the history and physical examination was performed, and
- a signature and date on any document with updated or revised information as an attestation that it is current.
Non-inpatient Services (e.g., Outpatient surgery, interventional and diagnostic procedures, therapy services, infusion centers, wound care centers, laboratory, etc.)
For hospitals that use Joint Commission accreditation for deemed status purposes, the medical staff may choose to develop and maintain a policy for the identification of specific patients to whom the assessment requirements would apply, in lieu of a comprehensive medical history and physical examination (see MS.03.01.01 EP 19). The policy must be based on the following:
- Patient age
- diagnoses, the type and number of surgeries and procedures scheduled to beperformed,
- comorbidities, and the level of anesthesia required for the surgery or procedure
- Nationally recognized guidelines and standards of practice for assessment of particular types of patients prior to specific outpatient surgeries and procedures
- Applicable state and local health and safety laws
There are no specific Joint Commission standards that require a dictated/transcribed H & P to be authenticated prior to surgery, a procedure requiring anesthesia services or prior to an update being completed. However, organizations are expected to have a written policy (see RC.01.03.01) requiring timely entry of information into a medical record that does not exceed 30 days. A signature (authentication) is considered an 'entry'.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Dictated but not transcribed
The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the requirements as essential information needed to further assess and manage the patient would not be available to the patient care team.
Intent
Organizations that do not provide obstetric services
- Standard PC.06.01.01 does not apply. Rationale: Most hemorrhages occur immediately after delivery while the patient is in the obstetrical unit.
- Standard PC.06.03.01 applies as it requires the development of role-specific education for postpartum severe hypertension/preeclampsia for emergency department staff. Rationale: There have been multiple instances of postpartum women seeking care in emergency departments for symptoms of high blood pressure or preeclampsia that have been discharged home who later experience severe harm or even death.
Additional Resources
R3 Report: Maternal Safety
No, use of the word 'kit' does not require organizations to separate supplies and medications needed to respond to a maternal hemorrhage emergency and store them in their own container. The intent is that organizations have identified the supplies and medications needed to respond to an emergency and that they are organized and readily accessible to minimize any delays in treatment.
For example, to ensure emergency medications are securely stored, and in a manner consistent with the manufacturer, such medications may be kept in an automated dispensing cabinet (ADC). The ADC is then programmed to release all emergency medication at once by entering a key word, an acronym, etc. Supplies could be managed in a similar manner. This option is sometimes referred to as a 'virtual' kit.Since emergency medications and supplies may not be used very often, organizations should have a process in place to ensure supplies needed to manage hemorrhage emergencies have not expired. This should include a process for prompt restocking should the emergency supplies and medication be used.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state’s Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The hospital standards are specific to only a Registered Nurse (RN) performing the nursing assessment within 24 hours after admission. It may be possible for an LPN to collect the data and then have an RN review the data and complete the assessment to determine the patient's needs and developing the plan of care.
An LPN may collect data if allowed by the nurse scope of practice act as defined by the state's Nurse Practice Act, however, the RN must complete the nursing assessment. Based on the Nurse Practice Act, it may be possible for an LPN to perform partial or full assessment in only specific situations, such as personal care and support services.
The Nurse Practice Act varies from one state to the next, therefore, organizations need to work with their nursing leadership and legal counsel to determine the scope of practice as defined by state-specific law and regulation. ֱ does not define the scope of practice for any discipline.
The standards for nutritional and functional screening clearly state that these are performed when warranted by the patient's needs or condition. Your organization would define in writing the criteria that identify when these screenings and more in-depth assessment are performed. When applicable for the patient's condition, these screenings must be completed within 24 hours after inpatient admission.
It is not required that nutritional or functional screening are completed for all patients at all encounters if it has not been defined by the organization's policy, a licensed practitioner with appropriate clinical privileges has determined that it is not necessary in emergency situations, or it is not warranted by the patient's needs or condition.
A comprehensive pain assessment would be conducted consistent with the scope of care, treatment and services and the patient's condition. Nutritional, functional or pain screening may be performed at the first visit for primary care, an ambulatory clinic or office practice. Thereafter, the screens and assessment would be needed only as appropriate to the reason the patient is presenting for care or services.
The terms 'room' and 'suite' are sometimes used interchangeably. Therefore, compliance will be evaluated based on the availability of the following equipment to areas in which operative procedures are performed. When evaluating equipment inventory requirements and location, organizations are encouraged to consider the procedures performed, population served, physical layout, resources available to retrieve equipment, hours of operation (scheduled and emergencies), etc.
At a minimum, operating room suites have the following equipment available:
- Call-in system:A process to summon or communicate with staff outside of the operating room when needed
- Cardiac monitor
- Resuscitator: A hand-held or mechanical device that provides positive airway pressure
- Defibrillator
- Aspirator: A hand-held or mechanical device used to suction out fluids or secretions
- Tracheotomy set: Disposable or non-disposable as determined by the organization
The requirement applies to Hospitals that use accreditation for deemed status purposes and Rehabilitation and Psychiatric Distinct Part Units (DPU) in Critical Access Hospitals.
No, there is no specific accreditation requirement that states all orders must be canceled, then rewritten following a procedure or when a patient is transferred from one level of care to the next. Such a requirement would be an organizational decision, or when specifically required by individual state law/regulation.
During transitions of care, there must be a process in place to ensure coordination of care among care providers and that the most recent orders are being followed.However, such a process may not include the use of summary (blanket) orders for resuming medication (see MM.04.01.01 EP 8). During transitions of care, discussions between caregivers is an important step in making sure the orders implemented are the most recent.
Consider conducting a risk assessment as such an assessment allows organizations to identify risk points associated with options being considered. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Any examples are for illustrative purposes only.
Providing staff and licensed practitioners (LP) with educational programs and resources regarding pain management and safe use of opioid medication
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each organization determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Opioid treatment programs that can be used for patient referrals
Clinicians encountering patients dealing with possible opioid abuse or dependence need readily accessible, accurate information about available resources to which patients can be referred for treatment. It can be challenging for individual clinicians or departments to maintain current information about provider availability in the community, therefore leadership can play a role by identifying community resources, then communicating this information to staff and practitioners. To assist organizations, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has a directory of opioid treatment programs.
Compliance may be determined through interviews with leadership, staff, practitioners and patients, review of an organization's discharge and referral processes, discharge information provided to patients to support ongoing care following discharge, etc.
Leadership responsibilities for developing and monitoring performance improvement activities specific to pain management and safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities, e.g., on monitoring the use of opioids;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in pain management and opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LP) on available services for consultation and referral of patients with complex pain management needs
The intent of this requirement is to ensure that staff and LPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, an organization's outpatient pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LPs, patients, etc.
Acceptable non-pharmacologic pain treatment modalities
Organizations are required to provide non-pharmacologic pain treatment modalities relevant to its patient population and assessed needs of the patient. These modalities serve as a complementary approach for pain management and may potentially reduce the need for opioid medication in some circumstances.
Additionally, it is important to have non-pharmacologic pain treatment modalities available for patients that refuse opioids or for whom physicians believe may benefit from complementary therapies. Non-pharmacologic strategies include, but are not limited to, acupuncture therapy, massage therapy, physical therapy, relaxation techniques, music therapy, cognitive behavioral therapy, etc. The level of evidence for these therapies is highly variable, and it is evolving. Therefore, our standards do not mandate that any specific complementary option(s) is provided, but allow organizations to determine what modality(s) to offer.
Organizations should ensure that patient preferences for pain management are considered, and, when a patient's preference for a safe non-pharmacologic therapy cannot be provided, provide education to patients on where the treatment may be accessed post-discharge. There is not an expectation that the hospital will fulfill any and all requested non-pharmacologic therapies during the inpatient stay.
Practitioner and pharmacist access to the Prescription Drug Monitoring Program (PDMP) databases
Facilitating access to the PDMP means that leadership has implemented systems and processes that support both ease of access for practitioners and consistent access to the PDMP when required by law.
Examples may include:
- Shortcuts on designated computer desktops to the PDMP database
- Links from the organization's intranet site and/or electronic health record (EHR)
- Staff and practitioner education that includes access to and when the PDMP is to be queried
- Demonstration/return demonstration
- Periodic monitoring of compliance as defined
- Periodic refreshers with staff, as defined by the organization
- Creating prompts in an electronic medical record (when state law requires accessing before hospital discharge )
Each organization determines who is responsible for accessing the PDMP. This may vary based on different patient care settings.
The requirement does NOT apply to patients receiving short term opioid medications DURING the hospital encounter (for example, opioids administered for a day or two following a surgical or invasive procedure). During survey, compliance with accessing the PDMP may be evaluated during tracer activities, interviews with staff, practitioners, pharmacists, etc.
NOTE: This requirementis only applicable in states that have a fully functioning Prescription Drug Monitoring Program (PDMP).
Monitoring of post-operative patients on opiates and/or on opiates combined with other pain medications
ֱ requires hospitals to monitor patients at high risk for adverse outcomes related to opioid treatment (for example, patients with sleep apnea, patients receiving continuous intravenous opioids, patients on supplemental oxygen, etc.) (See PC.01.02.07 EP 6). The intent of this requirement is to ensure adequate monitoring and timely detection of opioid-induced respiratory depression. Decisions on who is at high risk and monitoring requirements are determined by the clinical team responsible for providing care and based on evidence-based guidelines, accepted standards of practice, etc.
In addition, leadership commitment is required to ensure that appropriate equipment is available to monitor patients deemed at high risk for adverse outcomes from opioid treatment (See LD.04.03.13 EP 7). Refer to standards PC.03.01.01 through PC.03.01.07 regarding sedation and anesthesia care, specifically.
Review of evidence-based guidelines will assist leadership and the medical staff in developing policies, protocols, metrics and other quality indicators. During survey, clinicians may be asked to describe how they identify a patient that is high risk and how they would manage and monitor that patient.
Educating the patient and family on discharge related to pain management
It is the responsibility of each organization to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, and safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these topics. Each organization determines where this information will be documented in the medical record.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Organizations are responsible for ensuring that appropriate screening and assessment tools are readily available and used appropriately. The tools required to adequately assess pain may differ depending on a patient's age, condition, and ability to understand and should be evidence-based. For example, adult intensive care unit (ICU) patients who are unable to self-report and pediatric patients require the use of alternative assessment tools. Hospitals are required to have defined criteria that they will use to screen, assess and reassess pain that are consistent with the patient's age, condition, and ability to understand. Organizations determine where these criteria are located and any documentation requirements when such screenings or assessments are completed.
The practice of providing discharge instructions or after-visit summaries via the electronic medical record (i.e. patient portal) in lieu of a paper copy provided at discharge would not be prohibited by Joint Commission accreditation requirements.
Prior to providing instructions and information electronically, organizations need to consider the individual patient's ability to access electronic devices (e.g. computers, smartphone, tablet, etc.) technical ability, and overall comfort in using such devices to access electronic information. When another individual will be responsible for ensuring ongoing care of the patient, the same considerations apply.
Organizations that have the capability to provide discharge instructions and after-visit summaries electronically, are encouraged to handle on a case-by-case basis and allow the patient to determine how to receive discharge information. If your organization has a written policy or procedure on your requirements for providing discharge information, consider including this process in that document.
Enclosure Bed
- Use of an enclosure bed or net bed that prevents a patient from freely exiting the bed is considered a restraint. (An exception is the age-appropriate use of an enclosed crib for infants and/or toddlers.)
Restricting a patient's freedom from exiting the bed
- If raising the side rails prevents a patient from voluntarily getting out of bed or attempting to exit the bed, this would be restricting the patient's freedom of movement and the side rails would be considered a restraint.
- The number of raised side rails used may also be a factor. When all four side rails are used to prevent a patient from exiting the bed, this would be a restraint, however, raising fewer than four side rails when the bed has segmented side rails would not necessarily immobilize or reduce the ability of a patient to move freely. For example, if the side rails are segmented and all but one segment are raised to allow the patient to freely exit the bed, the side rails are not acting as a restraint. On the contrary, if the bed has non-segmented rails that when both raised does not allow the patient to freely exit the bed, the side rails would be acting as a restraint.
- If a patient is not physically able to get out of bed, regardless of whether the side rails are raised or not, raising all four side rails for this patient would not be considered restraint because the side rails have no impact on the patient's freedom of movement.
The use of restraints for the prevention of falls should not be considered a routine part of a fall prevention program. Use of restraints as a fall prevention approach has major, serious drawbacks and can contribute to serious injuries.
Protecting a patient from falling out of bed
- If raising the side rails prevents the patient from inadvertently falling out of bed, then it is not considered a restraint. Examples include raising the side rails when a patient is on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from inadvertently falling out of the bed.
- The mitts are pinned or otherwise attached to the bed/bedding or are used in conjunction with wrist restraints and/or
- The mitts are applied so tightly that the patient's hands or fingers are immobilized, and/or
- The mitts are so bulky that the patient's ability to use their hands is significantly reduced, and/or
- The mitts cannot be easily removed intentionally by the patient in the same manner they were applied by staff considering the patient's physical condition and ability to accomplish the objective.
No. A telemedicine link does not fulfill the in-person requirement for the evaluation by a Licensed Practitioner (LP) of the individual in restraint or seclusion for the management of violent or self-destructive behavior. The in-person evaluation must be face-to-face and completed by a physician, clinical psychologist, or other licensed practitioner responsible for the care of the patient. A registered nurse may conduct the in-person evaluation within one hour of the initiation of restraint or seclusion as long as this individual is trained in accordance with the requirements in PC.03.05.17, EP 3.
When the in-person evaluation (performed within one hour of the initiation of restraint or seclusion) is done by a trained registered nurse, they must consult with the attending physician or other licensed practitioner responsible for the care of the patient as soon as possible after the evaluation, as determined by hospital policy. This evaluation must be completed within one hour of the initiation of restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff, or others.
Joint Commission standards require that a physician or other licensed practitioner responsible for the patient's care order restraint^ or seclusion^. When restraint or seclusion is used for the management of violent or self-destructive behavior an in-person (face-to-face) evaluation of the patient within one hour of the initiation of the restraint or seclusion is also required.
Four requirements must be met for a resident (a physician in a graduate medical education program) to order restraint or seclusion or conduct the required face-to-face evaluation of a patient in restraint or seclusion for the management of violent or self-destructive behavior:
- State law permits residents to perform these two activities under the auspices of a graduate medical education program.
- The graduate medical education program has provided relevant education and training for the resident in performing these two activities. Graduate medical education programs accredited by the Accreditation Council on Graduate Medical Education would be expected to be in compliance with this requirement; the organization should be able to demonstrate compliance with any residency review committee citations related to this requirement.
- In the judgment of the graduate medical education program, the resident is able to competently perform these two activities.
- The health care organization in which the resident provides patient care permits residents to perform these two activities.
^Please see the glossary of the accreditation manual for definition of terms.
Any examples are for illustrative purposes only.
Education and Training in Resuscitation versus Certification Requirements (e.g., BLS, ACLS, PALS, NRP)
The intent of PC.02.01.11, EP 4 is that organizations provide education and training in addition to any certifications. While certifications provide the necessary foundational knowledge in resuscitation, PC.02.01.11, EP 4 stresses institution-specific education and training to promote staff preparedness that certification courses may not provide (for example, training grounded in local policies, procedures, or protocols, equipment; and the staff's specific roles and expectations during a code event).
Policies versus Procedures or Protocols
The organization can decide whether it develops a policy(-ies), procedure(s) or protocol(s). The phrase "Policies, procedures, or protocols" in PC.02.01.20 EPs 1 and 2 is meant to convey that the organization may determine which format is used for such documents.The organization can also decide whether the processes for post-cardiac arrest care (e.g., on targeted temperature management (TTM), neuro-prognostication, cardiac arrest in the context of STEMI) will be formalized as a single policy, several policies or procedures, protocols, or a combination of several types of documents. The intent of the requirements is that interdisciplinary, post-cardiac arrest care is delivered in an organized manner. Periodic review of processes is expected (the frequency is determined by organizations) to ensure that care and treatment align with current scientific literature. Note: For hospitals that use Joint Commission accreditation for deemed status purposes: Preprinted and electronic standing orders, order sets, and protocols that contain medication orders must meet the requirement MM.04.01.01 EP 15.
Inter-facility Transfers
An inter-facility transfer (see PC.02.01.20 EP 3) is a transfer that occurs between any two healthcare facilities. Examples include hospital to hospital, ambulatory surgical center to hospital, etc. For the purposes of this requirement, 'inter-facility" does not include transfers between different departments within the same hospital if they are housed in the same building or within the same hospital complex.
In-hospital cardiac arrest (IHCA) versus out of hospital cardiac arrest (OHCA)
The scope of resuscitation requirements includes IHCA and OHCA. For IHCA, there is no particular area of focus in terms of location, e.g., ED, or ICU, general nursing floor, etc. OHCA management would include post-cardiac arrest care for survivors and, if indicated, inter-hospital transfer. Organization policy(-ies), procedure(s) or protocol(s) may address IHCA and OHCA together or separately. Organizations also have the flexibility to decide whether any of the above subcategories should receive priority in performance improvement, based on data, populations served, etc. (see PI.01.01.01, EP 10 and PI.03.01.01 EP 22).
Analysis for Performance Improvement
- average ventilation rate
- chest compression depth and rate
- chest compression fraction
- time to first shock ≤2 min for VF/pulseless VT first documented rhythm
- time to IV/IO epinephrine ≤5 min for asystole or pulseless electrical activity
- peri-shock pauses (pre-shock and post-shock)
Reference: Meaney, P. A., Bobrow, B. J., Mancini, M. E., Christenson, J., De Caen, A. R., Bhanji, F., ... & Leary, M. (2013). Cardiopulmonary resuscitation quality: improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation, 128(4), 417-435.
Additional Resources
Joint Commission Perspectives®, July 2021, Volume 41, Issue 7
Requirement, Rationale, Reference R3 Report
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
Definitions^
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no changes in the patient's status since the initial assessment. This re-evaluation occurs immediately prior to (meaning without delay) the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by a qualified individual and consistent with state law and regulation.
- In deemed(^^)organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LP, or the patient may bedischarged upon a LP's order based on criteria established by the medical staff.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
The "qualified individual/ transfusionist" is determined by the organization considering any professional guidelines, state laws and regulations that define qualifications necessary to transfuse blood and blood products. The organization must also ensure the qualified individual/ transfusionist is competent in transfusing blood and blood products and the identification verification process defined by the organization.
The second individual involved in a two-person verification process is determined by the organization. This individual must be competent in conducting the identification verification process for blood and blood products defined and implemented by the organization.
Organizations would need to develop policies and procedures, consistent with law and regulation, which define the circumstance and mechanisms under which one LP could authenticate for another LP.Consistent with Joint Commission Standards and CMS Conditions of Participation (CoP)/Conditions for Coverage(CfC), it would be acceptable for an organization to develop and implement a policy allowing verbal orders to be authenticated by an LP responsible for the care of that patient, when the ordering LP is not available. This does not apply totranscribed progress notes as they can only be authenticated by the LP who dictated the progress note.
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Suggested Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed independent practitioners (LIPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LIPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LIPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LIPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of “scribe” for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
During its research, ֱ identified the following potential quality and safety issues:
• Unclear role and responsibilities when providing documentation assistance
• Documentation assistants using the physician log-in rather than independently logging in to the EMR
• Failure of physician or LIP to verify orders or other documentation entered during clinical encounter
Based on the recent efforts to better understand the evolution of this role and its different models, ֱ provides the following guidance:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Competency: At a minimum, all persons performing documentation assistance have the education or training on the following:
• Medical terminology
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Principles of billing, coding, and reimbursement
• Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
• Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
The amount of training required in these areas will vary depending upon the person’s past training and experience.
Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:
Policy and procedure: Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LIP’s log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description: All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
• Orientation and ongoing training and education to the role must be provided.
• Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
• CMS meaningful use requirements including , , and the
• American College of Medical Scribe Specialists (ACMSS)
• American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Accreditation requirements that apply:
• Record of Care (RC): RC.01.03.01
The organization's individual responsible for accreditation readiness has a copy of the manual containing the full text of standards referenced in this FAQ as they are not published on our website.
When developing such a policy, organizations should involve their legal and regulatory leadership to determine any state, federal or other regulatory requirements that may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure. Where state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
Accreditation requirements that apply:
• Record of Care (RC): RC.01.03.01
The organization's individual responsible for accreditation readiness has a copy of the manual containing the full text of standards referenced in this FAQ as they are not published on our website.
There are no specific Joint Commission standards that require an H & P to be authenticated prior to surgery, a procedure requiring anesthesia services,or prior to an update being completed.
The standards do require a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature isconsidered an entry.
State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing policy, organizations are advised to involve their legal and regulatory leadership to be compliant with these requirements.
When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
There are no specific Joint Commission standards that require an H & P to be authenticated prior to surgery, a procedure requiring anesthesia services,or prior to an update being completed.
The standards do require a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature isconsidered an entry.
State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing policy, organizations are advised to involve their legal and regulatory leadership to be compliant with these requirements.
When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
There are no specific Joint Commission standards that require an H & P to be authenticated prior to surgery, a procedure requiring anesthesia services,or prior to an update being completed.
The standards do require a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature isconsidered an entry.
State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing policy, organizations are advised to involve their legal and regulatory leadership to be compliant with these requirements.
When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
There are no specific Joint Commission standards that require an H & P, that has been dictated and placed into the record, to be authenticated prior to a procedure or prior to updating an H & P that was completed within 30 days prior to admission or registration.
Organizations are required to have a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature is considered an entry. However,State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing a policy, organizations should work with their regulatory leadership and legal counsel to determine any state-specific requirements that must be considered. When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
There are no specific Joint Commission standards that require an H & P, that has been dictated and placed into the record, to be authenticated prior to a procedure or prior to updating an H & P that was completed within 30 days prior to admission or registration.
Organizations are required to have a written policy regarding timely entry of information into a medical record that does not exceed 30 days. A signature is considered an entry. However,State, federal or other regulatory requirements may be more prescriptive when authenticating documents, such as an H & P, in advance of a procedure.
When developing a policy, organizations should work with their regulatory leadership and legal counsel to determine any state-specific requirements that must be considered. When state or federal law is silent, hospital policy and medical staff rules/regulations should define such requirements.
No, an H & P that has only been dictated and not placed in the medical record would not be compliant, except in emergencies^.The mere existence of a dictated history and physical that has not been transcribed and entered in the patient's medical record is not in compliance with the intent of the standards as essential information needed to further assess and manage the patient is absent.
Standard RC.02.01.03 is specific in the requirement that the patient's medical history and physical examination are recorded in the medical record before an operative or other high-risk procedure is performed.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
The requirement to collect race and ethnicity has historically applied to hospitals (Standard RC.02.01.01, EP 25). As of January 1, 2023, it will also apply to organizations in the ambulatory health care (RC.02.01.01, EP 31), behavioral health and human services (RC.02.01.01, EP 26) and critical access hospital (RC.02.01.01, EP 25) programs.
The intent of the requirement is to collect race and ethnicity information to identify potential health care disparities, and organizations have the flexibility to determine which categories of race and ethnicity are appropriate for the population they serve. ֱ does not specify which categories an organization should use to collect race and ethnicity data.
While ֱ requirement is not prescriptive of which categories of race and ethnicity should be collected, many state reporting entities and payers do specify these requirements. Organizations are encouraged to use, at a minimum, the race and ethnicity categories from the Office of Management and Budget (OMB) and US Census Bureau, and to consider collecting ethnicity categories based on the population to obtain additional granularity. Resources such as the Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement and the Health Research and Educational Trust Disparities Toolkit provide additional guidance on collecting race and ethnicity information.
Resources
In respect to laboratory electronic health records (EHR), the determination of whether a hospital information system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains unchallenged in practice. ֱ's longstanding position is that the laboratory, an integrated and essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or electronic, appears in the organization's patient medical record in the intended format and with all required elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical record also appear to the end user in the intended format and with all required elements, even if these alternate versions are not considered a part of the patient's permanent medical record.
Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory results in other formats and that do not represent the official or an alternate distribution version of the laboratory report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to innovation and functionality. As such, these supporting clinical applications are not required to contain all of the required elements of the official or alternate distribution versions of the laboratory report. However, each supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary to ensure clarity and proper interpretation by the end user. This assessment should include review by representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications that rely upon the original and corrected laboratory results.
As the area of information technology is rapidly changing, please note that this interpretation could change in the future based upon updated regulations, case examples, and other pertinent developments associated with the implementation of the electronic medical record in a healthcare organization.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.*
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
*Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources:
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The intent of the Joint Commission requirement to collect the patient's preferred language is to record the language the patient would like to use when discussing health care. The term "preferred" language is consistent with the Centers for Medicare & Medicaid Services Meaningful Use criteria, the Office of Minority Health's National Standards for Culturally and Linguistically Appropriate Services (CLAS), and the Institute of Medicine's Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement report.
The term "primary" language has been used by several organizations, including the Office for Civil Rights (OCR) and the Health Research and Educational Trust Disparities Toolkit. Primary language has been defined by OCR as the language that a Limited English Proficient individual identifies as the language he or she uses to communicate effectively and would prefer to use to communicate (1). Although the terms "preferred" language and "primary" language differ slightly, the intent behind collecting these data is similar - to identify which language the patient wants to use to communicate with his or her provider.^
Regardless of the term used by the organization, the goal is to identify the language needs of the patient to determine whether an interpreter is required at the patient-level or whether language access services need to be modified at the organization-level. If an organization collects "primary" language, and its policies and staff describe that as the language the patient wants to use to communicate with his or her provider, the organization would be in compliance with the Joint Commission's requirement for collecting preferred language data. If an alternate or abbreviated term is used, for example "pref lang" to accommodate character limitations in an EHR, that would also be acceptable as long as the organization's policies and staff were able to describe the information being collected as the patient's language for discussing health care.
^Of note, ֱ's rationale behind collecting language data is to identify patients that may be limited English proficient and need language access services, not necessarily to document the native or first language of the patient. Although some organizations may choose to collect additional language data based on their services and/or patient population, the intent of the Joint Commission requirement is to determine the language the patient is comfortable using to communicate health care information, which may differ from the patient's native language.
(1) HHS (U.S. Department of Health and Human Services). 2008. Civil rights: Hawaii Department of Human Services Resolution Agreement. Washington, DC: U.S. Department of Health and Human Services.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care
The practice described may be acceptable as long as an organization has determined that:
- The medication order is written in a manner that supports deferring to patient preference when the patient is:
- Requesting a lesserpotent medication.(Potency should be established with an evidence based tool i.e. morphine equivalents).
- Requesting alesser prescribed dose in a range order.
- Requestinga less intrusive route of administration if both routes are prescribed by the provider.
- The medication is administeredin accordance with orders from the LicensedPractitioner.
- The inclusion allowing patient preference is in the medication order and does not subsequently create a therapeutic duplication with other prescribed medications.
- The organization's medication management policy identifies this type of medication order as acceptable and defines all required elements of such orders.
- The use of a protocol is not required.However, if an organization chooses to utilize a protocol, the review and approval process must comply with the requirements found at MM.04.01.01 EP 15.The medical record must contain evidence of an order to implement the protocol, as well as the protocol itself.
- Implementing such orders or protocols is not outside of the RN scope of practice as defined by state law/regulation.
Per the requirements of the Record of Care, Treatment, and Services (RC) chapter, the medical record must accurately reflect that the lesser potent medication was administered based on patient preference. It isNEVER acceptable to administer a medication of stronger potency based on patient preference.
No. If there was no blood loss^ and/or no specimens removed, there is no requirement for the proceduralist to document those two items, unless the organization specifically requires this level of documentation. The word "any" was specifically chosen to reflect the need to only document those items when applicable to the procedure performed.
^As applicable to the procedure, it is acceptable to document 'quantitative blood loss' in lieu of 'estimated blood loss' which is common in OB/GYN procedures.
The report must be written or dictated immediately after an operative or other high risk procedure^ and entered into the medical record.This information could be entered as the operative report or as a hand-written progress note. If the operative or procedural report is not placed in the medical record immediately following the procedure, then a progress note must be immediately entered after the procedure to provide pertinent information to the next provider of care. The goal is to ensure there is sufficient information about the procedure in the record immediately after surgery or other high risk procedure to manage the patient throughout the post procedure period.
'Immediately after surgery or procedure' is defined as "upon completion of procedure, before the patient is transferred to the next level of care". This is to ensure that pertinent information is available to the next caregiver. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit or area of care, the report can be written or dictated in the new unit or area of care. For the purposes of this requirement, ֱ considers the Pre-Op, O.R. and PACU as the same level of care as the clinical team is essentially intact across these areas.
If the progress note option is used (see RC.02.01.03 EP 7), it must contain, at a minimum, comparable operative/procedural report information. The minimum required elements include; the name of the primary surgeon and assistants procedures performed and description of each procedure findings any estimated blood loss, any specimens removed, and the post operative diagnosis.
^ See definition in the glossary of the accreditation manual.
Practitioners (nurse, physician, etc) communicating directly with a patient in their preferred language while providing care without the presence of an interpreter
There are no standards that prohibit a bilingual practitioner from communicating directly with a patient in another language while providing care, treatment or services. However, it is recommended that the organization has a process to make sure that communication with the patient in the non-English language is effective and meets the patient's needs. For example, theorganization can determine if a language proficiency assessment is necessary to make sure the bilingual provider is able to communicate effectively or may consider using an interpreter to validate the patient's understanding of the information provided by the bilingual provider and communicate further information as needed.
Additional Resources:
The American Medical Association's Promoting Appropriate Use of Physicians' Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
Applicability of HR.01.01.01 to providers (nurse, physician, etc) serving as an interpreter for a fellow provider
The requirement found at HR.01.01.01 'Note 4' applies to bilingual providers serving as an interpreter to bridge the communication between a fellow provider and a patient. For example, the patient and his/her provider speak different languages and a bilingual provider is facilitating communication between them.
Organizations surveyed under the Behavioral Health Care (BHC) manual
RI.01.01.03 requires that individuals providing interpretative services are trained to provide such services. Examples may include:
- Trained bilingual staff
- Contract interpreting services
- Employed language interpreter
Additional Resources
The American Medical Association's Promoting Appropriate Use of Physicians' Non-English Language Skills in Clinical Care: A White Paper of the Commission to End Health Care Disparities provides guidance for physicians on the appropriate use of their non-English language skills when caring for patients with limited English proficiency.
No. Hospitals and critical access hospitals are not required to ask patients about their organ donation wishes unless it is required by law/regulation, organization policy/procedure or Organ Procurement Organization (OPO) agreement. If organ donation is specified in the patient's advance directive or verbally expressed by the patient, there should be documentation of the patient's wishes according to the organization's policy and procedure. The organization must honor the patient's wishes within the limits of the law or hospital capacity. Some organizations may not be capable of fully honoring the patient's wishes since they do not have the capability of sustaining life. The patient may need to be transferred and this should be in accordance with law/regulation and any applicable OPO agreement.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
- Reporting Adverse Patient Reactions to the Donor Source Facility:
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the introduction to the Transplant Safety chapter found in the accreditation manual.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The source facility must be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.Each organization must check with their state for the status of Tissue License Requirements.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Laboratory
Standards require the placement of the intraoperative pathology report in the clinical record of the patient but there is no defined time period for the inclusion of the report in the clinical record. Standards require that the laboratory director ensures the reporting of test results within a defined time frame. They also require the laboratory director to develop a process for clinical staff to receive results on an emergency or STAT basis. National Patient Safety Goals require a definition of the acceptable length of time between the availability and reporting of critical results of tests and diagnostic procedures.
All of these requirements must be considered in the development of policies relating to the inclusion of intraoperative pathology consultation results in clinical records. Requirements must be consistent in all policies. Laboratories will be surveyed for compliance with the policies.
The results of the interpretation of frozen section examinations are interim results which are used for patient care decisions during surgical procedures. Although these results may be communicated verbally to surgeons, it is preferable to include the original frozen interpretive report (manual or electronic)in the clinical record to officially document the laboratory result in a time frame concurrent with application of the information in patient care decisions.
No, you will not fail the ESC. The long term objective should be to ensure all versions of the laboratory report (hard copy or electronic) contain all the required fields. As it may be a challenge to comply with the specific requirement to print the date and time of reporting on the laboratory report, we have two approaches to support realistic options for laboratories. First, we will accept the standard as compliant if the date and time of reporting is present on any single version of the report in the patient's permanent medical record (hardcopy or electronic). Second, when the corrective action involves a software solution, we will accept an ESC as compliant if the laboratory has an implementation plan, provides a reasonable timeline for implementing the plan (depending on the cost, anticipated software upgrades, etc.), and the date and time of reporting is electronically retrievable in the interim through the Laboratory Information System. This is acceptable even if implementation exceeds the usual timeline for an ESC. If the plan cannot be fully implemented before the ESCis due, we will advise your account executive to accept the ESC in anticipation that the corrective action will be implemented as set out in the timeline of the approved ESC.
On a related topic, hospital leaders should also be aware of the various elements required by federal regulation to be present in the patient record (electronic or hardcopy) when displaying a laboratory report. Information on this topic is available in the hospital FAQ titled "Laboratory Report Requirements in the Medical Record."
Note: This interpretation was first published in ֱ's Lab Focus newsletter, 2009 Issue #4.
The name and address of the laboratory where the test is performed and a final result is generated must appear on the report. When a pathologist travels to multiple locations or reference laboratory computers are interfaced, this requirement may be overlooked. Below are some common scenarios to consider:
- A 'traveling" pathologist keeps offices at more than one laboratory. If cytology or histopathology slides are taken from one office to another, the name and address of the laboratory where the final interpretation is rendered must appear on the report. This applies even if that location is different from the specimen's originating laboratory.
- Laboratory A contracts with a pathologist from Laboratory B to perform frozen sections. While Laboratory B may issue the report, Laboratory A's name and address must be on the report as the testing facility. In addition, Laboratory A would be required to have a CLIA certificate for the histopathology specialty.
- A reference laboratory's computer is interfaced with the referring laboratory's computer and test results are downloaded directly into the referring laboratory's information system. While reports may be issued from the referring laboratory's information system, the requirement to clearly identify the name and address of the reference laboratory on each of their results still applies. In any of the above cases, the report may be printed on either the testing or the reporting facility's letterhead. If the latter, there must be clear notation on the report indicating the name and address of the testing laboratory, such as an appended comment or footnote.
In respect to laboratory electronic health records (EHR), the determination of whether a hospital information system is considered an agent of the laboratory to deliver laboratory reports to the authorized user remains unchallenged in practice. ֱ's longstanding position is that the laboratory, an integrated and essential service within a hospital, has an obligation to ensure the laboratory report, whether hardcopy or electronic, appears in the organization's patient medical record in the intended format and with all required elements. To ensure patient safety and correct interpretation by the end user, it is our further opinion that all alternate distribution versions of the laboratory report (such as portals) derived from the data in the medical record also appear to the end user in the intended format and with all required elements, even if these alternate versions are not considered a part of the patient's permanent medical record.
Other supporting clinical applications in the patient record that may extract, manipulate and redisplay laboratory results in other formats and that do not represent the official or an alternate distribution version of the laboratory report in the record are not subject to the CLIA requirements. Examples include physician notes, wishbone diagrams to support decision making, and nursing flow sheets, all of which may readily integrate laboratory report data for various purposes and in which requiring the presence of all the CLIA required fields may be limiting to innovation and functionality. As such, these supporting clinical applications are not required to contain all of the required elements of the official or alternate distribution versions of the laboratory report. However, each supporting clinical application should be assessed by the organization for inclusion of any and all fields necessary to ensure clarity and proper interpretation by the end user. This assessment should include review by representatives from both the laboratory and the intended end users. At a minimum, it is recommended that the analyte' s name and units of measure always be included with the discrete laboratory result(s), either individually or in title for aggregated data. The date and time of collection may also be necessary in a majority of uses. The use of hyperlinks and hover capabilities to connect the extracted data to the original source laboratory report is strongly encouraged. And lastly, healthcare professionals and software developers must consider the implications associated with corrected laboratory reports and how to manage their effect on all supporting clinical applications that rely upon the original and corrected laboratory results.
As the area of information technology is rapidly changing, please note that this interpretation could change in the future based upon updated regulations, case examples, and other pertinent developments associated with the implementation of the electronic medical record in a healthcare organization.
For non-waived testing, laboratory instrument printout data must be retained at least two years. These records may be paper or electronic, however they must be comprehensive. An acceptable example would be a data management system interfaced with the analyzer that provides retrievability of all information printed on the original hardcopy generated at the time of testing. If information printed on the hardcopy would not be retrievable from the computer system, then the hardcopy should be retained. Laboratories should also consider applicable state regulations which may be more stringent.
For non-waived testing, laboratory instrument printout data must be retained at least two years. These records may be paper or electronic, however they must be comprehensive. An acceptable example would be a data management system interfaced with the analyzer that provides retrievability of all information printed on the original hardcopy generated at the time of testing. If information printed on the hardcopy would not be retrievable from the computer system, then the hardcopy should be retained. Laboratories should also consider applicable state regulations which may be more stringent.
For non-waived testing, laboratory instrument printout data must be retained at least two years. These records may be paper or electronic, however they must be comprehensive. An acceptable example would be a data management system interfaced with the analyzer that provides retrievability of all information printed on the original hardcopy generated at the time of testing. If information printed on the hardcopy would not be retrievable from the computer system, then the hardcopy should be retained. Laboratories should also consider applicable state regulations which may be more stringent.
For non-waived testing, laboratory instrument printout data must be retained at least two years. These records may be paper or electronic, however they must be comprehensive. An acceptable example would be a data management system interfaced with the analyzer that provides retrievability of all information printed on the original hardcopy generated at the time of testing. If information printed on the hardcopy would not be retrievable from the computer system, then the hardcopy should be retained. Laboratories should also consider applicable state regulations which may be more stringent.
ֱ standard for an organization's recovery and continuity of operations is performance based (EM.02.01.01). The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness, the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
The requirements for a Continuity of Operations Plan (COOP) is defined in EM.02.01.01 EP12. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plan, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Someone from the medical staff or physician member and someone from the hospital executive leadership (as opposed to middle management) team should participate in planning activities prior to the development of the Emergency Operations Plan. Medical staff and hospital leadership will be directly involved in the management of an implementation of the emergency operations plan, so their input is essential to establish the expected capabilities and duties of these entities.
It is also important for medical staff and executive leadership to understand the duties and capabilities for the staff that will support the emergency operations plan, and the capabilities of community support entities. Many disaster scenarios involve patient care regarding management of current patients and managing influx of patients. Hospital leaders must understand the command structure and how it functions.
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
A hazardous material inventory is required by all employers in order to provide information to their employees about hazardous materials to which they may be exposed to in their workplaces as stated in the OSHA Hazard Communication Standard, 29 CFR 1910.1200 (see 29 CFR 1910, Subpart Z, Toxic and Hazardous Substances).
Any hazardous material or waste that is regulated by local, state, or federal law (including OSHA, EPA, DOT, etc.) are required to be part of your organization's current inventory of hazardous materials and waste. This inventory may either be consolidated into one document or decentralized. Consumer products (such as turpentine, gasoline or white out) that are used in a workplace in such a way that the duration and frequency of use are the same as that of a consumer, are not required to be included in the hazardous material and waste inventory. However, it is the responsibility of the employer to make the determination for their workplace by assessing the exposure potential of the consumer products that staff may encounter and ensuring that the frequency and duration of use are not greater than that of normal consumer use.
A good rule-of-thumb would be, for a given product, review the Safety Data Sheet (prior MSDS) and determine if the organization's method of use could result in adverse exposure. If the SDS contains any storage or usage warnings, like special storage, special criteria for the use environment, critical emergency actions to take if exposed, etc. then those products should be included in the hazardous materials inventory. Hazardous wastes are typically tracked by manifest, and that acts as an inventory.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization’s leadership.
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
- applicable staff
- type of training
- level of training
- required credentials
The security management plan may be a stand-alone document or may be combined with other Environment of Care plans (one overarching plan or combined with another, such as the safety management plan, for instance). Components of the plan are outlined in EC.02.01.01 EPs, which include but not limited to:
- how will security risks be assessed and mitigated
- staff roles in security management
- how the facility is secured
- how the organization contact external security forces if needed
- how the organization will control access to areas identified as security sensitive
- how physical or verbal threats, acts of violence, inappropriate behavior will be managed
- If the organization has an MRI, there is to be an assessment for safety and security risk that addresses patient comfort and safety, equipment safety and security, and staff safety
Any requirements from the local authority having jurisdiction (AHJ) are expected to be followed.
Reference:
EC.01.01.01 EP 5
EC.02.01.01.
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The qualifications of the individual(s) who can perform test and maintenance direct observations for the competence assessment on non-waived testing personnel are defined by CLIA regulations and CMS guidance. The qualifications of the observer of high complexity testing differ from those who observe moderate complexity testing.
The competence for performing high complexity testing including direct observations must be performed and assessed by an individual qualified as a technical supervisor or delegated in writing to an individual qualified as general supervisor.
The competence for performing moderate complexity tests including direct observations must be performed and assessed by an individual qualified as a technical consultant. Responsibilities may not be delegated to a general supervisor.
References:
- The qualifications required for the role of technical supervisor can be found at CLIA regulation 42 CFR 493.1449.
- The qualifications required for the role of general supervisor can be found at CLIA regulation 42 CFR 493.1461.
- The qualifications required for the role of technical consultant can be found at CLIA regulation 42 CFR 493.1411.
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489.
In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). Competence will be assessed annually using all applicable methods referenced in Joint Commission Human Resources (HR) standards and CLIA regulations. In addition, the pathologist must define, in writing, the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services the organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
There are additional expectations for non-licensed, non-employees that have a direct impact on patient care. Some examples of these individuals are HCIRs in procedure rooms/operating rooms providing guidance to the surgeon, HCIRs providing training to staff on equipment use, and surgical assistants brought in by surgeons. Additional requirements related to these individuals include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy (RI.01.01.01), and privacy of health information (IM.02.01.01) Obtaining informed consent in accordance with organization policy (RI.01.03.01)
- Implementation of infection control precautions (IC.02.01.01)
- Implementation of the patient safety program (LD.04.04.05)
- For non-employees brought into the organization by licensed independent practitioners,organizations must also addressqualifications (HR.01.0.01) competency (HR.01.06.01) and performance(HR.01.07.01 EP 5of these individuals.
ֱ's,expectation is thatthe organization is aware of anyoneentering the organizationand their purpose in order to maintain patient safety. Leadership is responsible to ensure that the processes are in place and implemented to ensure patient privacy and safety.
For non-licensed, non-employees that have a direct impact on patient care. E.g. HCIRs or Vendorsin procedure rooms/operating rooms providing guidance to the surgeon or staff, trainingof staff on equipment use, surgical assistants brought in by surgeons additional requirements include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information, as well as obtaining informed consent in accordance with organization policy and law/regulation.
- Awareness of applicable infection control and patient safe processes/procedures.
- For non-employees brought into the organization by licensedpractitioners,organizations must also addressqualifications, competency and performance evaluation.
Yes, competency assessment for non-waived testing must include all six methods, as applicable to the test system.
The six elements include:
- Direct observation of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing and testing.^
- Monitoring, recording, and reporting test results.
- Review of intermediate test results or worksheets, quality control, proficiency testing, and preventive maintenance performance.
- Direct observation of instrument maintenance function checks and calibration.
- Test performance as defined by laboratory policy (for example, testing previously analyzed specimens, internal blind testing samples, external proficiency, or testing samples).
- Problem-solving skills as appropriate to the job.
^Due to the significant challenges associated with performing direct observation of patient testing,maintenance function checks, and calibrationfor either a large number of point-of-care testing personnel or for testing performed in a surgical area, the use of a skills demonstration is an acceptable option in these cases.
Competence to perform moderate complexity testing must be assessed by an individual qualified as a technical consultant. Please refer to the CLIA regulation 42 CFR 493.1405 for additional information.
Competence to perform high complexity tests must be assessed by an individual qualified as a technical supervisor.
Please refer to the CLIA regulation 42 CFR 493.1443 for additional information.
This FAQ does not apply to waived testing. Please refer to the Waived Testing standards for the specific competency assessment requirements.
Primary source verification of an employee's credentials refers to verifying a state or federally required license, certification, or registration with the issuing agency or the designated agent, both upon hire and when the credential is renewed .. This can be accomplished by mail, secure electronic communication (including secure websites), or by telephone if the details of the verification are documented. When primary source verification is required, an organization cannot accept evidence of the required credential directly from the employee.
Primary source verification has limited applicability to individuals performing non-waived laboratory and point-of-care testing and does not apply to individuals performing waived testing unless there is a state law specifying otherwise. Applicability of primary source verification for non-waived testing is as follows:
- License - Yes. Primary source verification is expressly required for licensure, certification, and registration when there is a state or federal regulation requiring the specific license, certification or registration to perform testing. Thus, primary source verification applies in states that have a licensure or registrationrequirement for testing personnel. Testing personnel licensure is currently required in 12 states and one territory: California, Hawaii, Florida, New York, North Dakota, Rhode Island, Tennessee, Louisiana, Nevada, West Virginia, Montana, Georgia, and Puerto Rico. Registration by a national certification agency is required by Georgia.
- Education - No. While the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) at Subpart M, the standards requirement for primary source verification does not apply to education and the CLIA regulations are silent. Thus, education can be verified in the manner the organization determines appropriate. CMS document S&C-10-07-CLIA indicates that appropriate documents substantiating the education must be provided within "a reasonable time frame (the time it takes to complete the survey or within one week afterwards). These will include: diplomas, certificates, licenses, degrees, transcripts, training, experience, continuing education (CE), competency assessment, duties and responsibilities."
- Professional credentials - No, with the exception of the state of Georgia, certifications and registrations, such as MT(ASCP) or CLS(NCA), are usually voluntary credentials not required by state or federal regulation. For employers that specify a certification or registration as a requirement for the position, the credentials may be verified according to the organization's policy. However, there may be exceptions. Primary source verification is applicable if the credential is required by state or federal regulation. As example, cytotechnologists and cytology general supervisors qualifying under CLIA at 42 CFR 493.1483(b)(2) are required to have a certification (i.e. American Society of Clinical Pathology (ASCP) certification). As a regulatory requirement, the credential must be primary source verified.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
ֱ has no standard that prohibits wood pallets in clean areas, to include storerooms and supply break-down rooms. Wood pallets that are contaminated should be segregated based on condition, and not introduced to patient care areas or areas that support patient care, like laboratories.
The organization should conduct a risk assessment to determine the appropriateness of having wood pallets within any area of clean storage. Wood pallets should not be used in sterile areas, to include sterile storage areas, since their surfaces are not conducive to the level of cleanliness required in a sterile area; this prohibition does not apply to sterile supply breakdown areas; plastic pallets would be acceptable in sterile storage areas.
Large quantities of wood pallets should not be used in non-fire sprinklered areas. When conducting the risk assessment, the organization should involve an infection control representative, as well as the primary occupant of the area being evaluated.
Organizations should define their requirements, such as in a policy that addresses the acceptable use of wooden pallets. The organization is expected to adhere to its requirements and evaluate the assessed practice for effectiveness and compliance. The survey process will review the established process for effectiveness and tracer activity will validate proper implementation.
See also: Boxes and Shipping Containers
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
Leaders should verify that all specialties and sub-specialties for non-waived testing performed by the laboratory service are listed on both the award letter from ֱ and their new CLIA Certificate of Accreditation. Both documents should accurately reflect the specialties and sub-specialties included in the laboratory services' application for accreditation, and reviewed during the laboratory's most recent survey. If either the award letter or the CLIA Certificate of Accreditation does not list all specialties or sub-specialties for which the laboratory reports patient results then the laboratory should immediately contact their laboratory Account Executive at ֱ to verify that the specialty or sub-specialty was included on the most recent survey. This will enable ֱ to correct the information sent to the Centers for Medicare and Medicaid Services (CMS). CLIA certificates are not routinely re-issued between biennial surveys therefore the laboratory should retain a copy of the revised award letter from ֱ as evidence of accreditation for all specialties and sub-specialties.
Note: This FAQ does not apply to CLIA Certificates of Waiver or Provider Performed Microscopy Procedures (PPMP). The laboratory is not required to declare specialties or sub-specialties on these types of certificates. Specialties and sub-specialties are also not listed on the certificate issued to a new laboratory before it is inspected, which is identified as a CLIA Certificate of Registration.
Additional Resources:
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Organizations should consult the intended use described in the Letter of Authorization for the test:
- For tests approved for use in high- and moderate-complexity laboratories, and organizations need to follow the requirements for nonwaived testing.
- For tests that are intended to be used in patient care settings (including hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings), such tests can be performed in patient care settings that have a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.
Organizations that use Joint Commission accreditation for deemed status purposes should monitor the CMS website as waivers are being approved frequently and may include state-specific waivers.
Additional Resources
Coronavirus (COVID-19) Guidance and Resources
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
The timeliness of accessibility to required documentation is at the surveyor's discretion and is an evaluative determination. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made. If an asked-for document is incomplete and requires some time to retrieve additional documentation, then the surveyor will likely provide additional time (LD.04.01.05).
The 2017Accreditation Survey Activity Guide (SAG)for Health Care Organizations,available toorganizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizationsoperating in a highbrid environment (both paper andelectronic) orare in the process of migrating to an EMR platform may wish to consider having a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Effective January 2017:
The following information regarding changes to the clarification process for 2017 were communicated to organizations on December 22, 2016. “Findings of ‘lack of required documentation at the time of survey’ will no longer be eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. If the documentation is provided within the time frame agreed upon by the organization and surveyor, the organization will be compliant for document availability. However, if the documentation is not provided, the organization is not compliant and an RFI is created. The RFI remains in the survey report. Following the survey, the organization will need to provide ESC that the required documentation is addressed through corrective actions."
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Etc.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Each organization defines for itself the circumstances under which a test result is considered "critical" and when/how it will be reported. It is permissible to define repeat "critical results" differently especially if they are improving. For example: If a patient is undergoing treatment and a certain test result is still "critical" but moving in the desired direction it may be referred to as a "repeat critical result (RCR)" and the reporting process may be limited or changed after consulting the practitioner. The default, however, should be to treat the repeat result as a critical result. Please note, the "repeat critical value" procedure is described by the organization and would include how "improving labs" is defined, which results are applicable and/or if an individual order is required to execute the policy for certain results.
Each health care organization may define for itself what constitutes "critical values". Provisions may be made for certain patient-specific situations in which values that would be "critical" for most patients are not critical for a particular patient or for patients with a particular diagnosis. The parameters must be objectively defined and are known to all staff who are involved in the process of reporting values.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
Blood banks must retain samples of both the transfused unit(s) and recipient blood for at least seven days following transfusion. Further, guidelines state patient samples for antibody screening and compatibility testing are acceptable to use for a maximum of three (3) days following the date of collection, at which time a new patient sample would be necessary^. As such, a transfusion may be given up to three days after the sample's original collection date. In order to meet the requirement to retain samples for at least seven days after transfusion, samples would need to be retained for at least 10 days after the original collection date.
^If a patient's history is known and they have definitely not been transfused or pregnant in the preceding three months, protocols can be established for frozen retention of the patient's serum for a longer period.
Semiannual calibration verification is not required when the laboratory performs a calibration protocol using 3 or more levels of calibration materials that include a low, mid, and high value at least once every 6 months. After calibration, quality control should be performed and documented to verify the calibration protocol was successful. Please see 'Note 1' and 'Note 2' at QSA.02.03.01 EP 3 in the Quality System Assessment chapter of the Laboratory Accreditation Manual for additional information regarding calibration verification.
Semiannual calibration verification is not required when the laboratory performs a calibration protocol using 3 or more levels of calibration materials that include a low, mid, and high value at least once every 6 months. After calibration, quality control should be performed and documented to verify the calibration protocol was successful. Please see 'Note 1' and 'Note 2' at QSA.02.03.01 EP 3 in the Quality System Assessment chapter of the Laboratory Accreditation Manual for additional information regarding calibration verification.
Semiannual calibration verification is not required when the laboratory performs a calibration protocol using 3 or more levels of calibration materials that include a low, mid, and high value at least once every 6 months. After calibration, quality control should be performed and documented to verify the calibration protocol was successful. Please see 'Note 1' and 'Note 2' at QSA.02.03.01 EP 3 in the Quality System Assessment chapter of the Laboratory Accreditation Manual for additional information regarding calibration verification.
Semiannual calibration verification is not required when the laboratory performs a calibration protocol using 3 or more levels of calibration materials that include a low, mid, and high value at least once every 6 months. After calibration, quality control should be performed and documented to verify the calibration protocol was successful. Please see 'Note 1' and 'Note 2' at QSA.02.03.01 EP 3 in the Quality System Assessment chapter of the Laboratory Accreditation Manual for additional information regarding calibration verification.
Organizations should consult the intended use described in the Letter of Authorization for the test:
- For tests approved for use in high- and moderate-complexity laboratories, and organizations need to follow the requirements for nonwaived testing.
- For tests that are intended to be used in patient care settings (including hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings), such tests can be performed in patient care settings that have a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.
Organizations that use Joint Commission accreditation for deemed status purposes should monitor the CMS website as waivers are being approved frequently and may include state-specific waivers.
Additional Resources
Coronavirus (COVID-19) Guidance and Resources
During the COVID-19 emergency, external quality control for COVID-19 tests may be performed less frequently than ֱ and CLIA normally require. Quality control for COVID-19 testing must be performed at least as frequently as stated in the manufacturer's package insert, and an individual quality control plan (IQCP) is not required at this time.
After the emergency is resolved and the Emergency Use Authorizations (EUA) are rescinded, laboratories MUST return to the full frequency required for quality control by ֱ standards and CLIA regulations.
Laboratories who elect to conduct COVID-19 testing must follow the guidance released by the FDA, CDC, and CLIA (CMS). Since this is an emergent and changing situation, it's best to review those websites often. The FDA is allowing for an abbreviated validation process, but laboratories must follow those FDA guidelines. The manufacturer should also be able provide additional information.
ֱ is following the guidance from FDA, CDC, and CLIA (CMS) as follows:
- If the laboratory is using a CDC-developed Emergency Use Authorization (EUA) assay, the instructions provided with the procedure must be followed.
- If the laboratory is using an Emergency Use Authorization (EUA) assay not developed by CDC but approved by the FDA, the laboratory director must determine the number of positive and negative specimens needed to verify performance and must follow manufacturer's instructions.
Additional Resources
Joint Commission standards refer to the Food and Drug Administration (FDA) regulations for blood product labeling requirements. Effective July 2, 2012 and current as of 2016, the FDA regulations will allow the infusion of thawed fresh frozen plasma for up to 24 hours after thawing. The need for a variance from the FDA to transfuse plasma beyond the original six-hour limit will no longer be required. The scheduled regulation change was published in the Federal Register, Vol. 77, No. 1, Tuesday January 3, 2012/Rules and Regulations 7. When frozen plasma is thawed, the product is still considered to be fresh frozen plasma for up to the 24 hours. After 24 hours, the product should be labeled as thawed plasma. The license number should be struck, because this is no longer a licensed product according to the FDA. For more information on product modifications, an excellent resource is found on the ,
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489.
In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). Competence will be assessed annually using all applicable methods referenced in Joint Commission Human Resources (HR) standards and CLIA regulations. In addition, the pathologist must define, in writing, the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity.Please the.
- Perform the type and frequency of quality control equal to or more stringent than that required by CLIA regulations. Quality control type and frequency may not be less stringent than the manufacturer’s recommendations.
- Develop a laboratory-specific Quality Control Plan using the risk assessment process of IQCP. The type and frequency of the quality control may not be less stringent than the manufacturer’s recommendations.
No. The development of laboratory-specific quality control plans using the risk assessment process of IQCP is optional. Laboratories have the following two options for all quality control except for those methods classified as Pathology and Cytology: (Some individual states apply additional restrictions.) IQCP is not an option for Pathology and Cytology.
- Perform the type and frequency of quality control equal to or more stringent than that required by CLIA regulations. Quality control type and frequency may not be less stringent than the manufacturer’s recommendations.
- Develop a laboratory-specific Quality Control Plan using the risk assessment process of IQCP. The type and frequency of the quality control may not be less stringent than the manufacturer’s recommendations.
No. The development of laboratory-specific quality control plans using the risk assessment process of IQCP is optional. Laboratories have the following two options for all quality control except for those methods classified as Pathology and Cytology: (Some individual states apply additional restrictions.) IQCP is not an option for Pathology and Cytology.
- Perform the type and frequency of quality control equal to or more stringent than that required by CLIA regulations. Quality control type and frequency may not be less stringent than the manufacturer’s recommendations.
- Develop a laboratory-specific Quality Control Plan using the risk assessment process of IQCP. The type and frequency of the quality control may not be less stringent than the manufacturer’s recommendations.
No. The development of laboratory-specific quality control plans using the risk assessment process of IQCP is optional. Laboratories have the following two options for all quality control except for those methods classified as Pathology and Cytology: (Some individual states apply additional restrictions.) IQCP is not an option for Pathology and Cytology.
- Perform the type and frequency of quality control equal to or more stringent than that required by CLIA regulations. Quality control type and frequency may not be less stringent than the manufacturer’s recommendations.
- Develop a laboratory-specific Quality Control Plan using the risk assessment process of IQCP. The type and frequency of the quality control may not be less stringent than the manufacturer’s recommendations.
No. The development of laboratory-specific quality control plans using the risk assessment process of IQCP is optional. Laboratories have the following two options for all quality control except for those methods classified as Pathology and Cytology: (Some individual states apply additional restrictions.) IQCP is not an option for Pathology and Cytology.
- Perform the type and frequency of quality control equal to or more stringent than that required by CLIA regulations. Quality control type and frequency may not be less stringent than the manufacturer's recommendations.
- Develop a laboratory-specific Quality Control Plan using the risk assessment process of IQCP. The type and frequency of the quality control may not be less stringent than the manufacturer's recommendations.
Although it is not necessary to repeat the extensive verification study performed when the method was originally evaluated, at a minimum, studies should be performed to determine the accuracy, reproducibility, and the reportable range of the "loaner" instrument. The accuracy can be verified by testing materials with known values for the analyte(s) such as quality control materials, calibration materials, or proficiency samples. The same materials, if properly selected, can be used to verify that the instrument is capable of accurate results across the reportable range(s) of the analyte(s). At least the low, middle, and high levels of the reportable range(s) should be checked. Reproducibility can be determined by replicate testing of quality control materials.
A sufficient number of replicates should be performed to determine the precision of the method. For those instruments with internal quality control capability, the reliability of the internal quality control must be evaluated. This can be accomplished concurrently with the reproducibility studies if external quality control materials are used for those studies in parallel with the internal quality control. The laboratory director or technical supervisor must approve the results of the abbreviated validation study before the instrument is used for patient testing and must determine the frequency of the external quality control requirements.
NOTE: This FAQ does not apply to waived instruments or methods. Verification of waived instruments or methods should be conducted to the extent determined by the laboratory director or technical supervisor.
Although it is not necessary to repeat the extensive verification study performed when the method was originally evaluated, at a minimum, studies should be performed to determine the accuracy, reproducibility, and the reportable range of the "loaner" instrument. The accuracy can be verified by testing materials with known values for the analyte(s) such as quality control materials, calibration materials, or proficiency samples. The same materials, if properly selected, can be used to verify that the instrument is capable of accurate results across the reportable range(s) of the analyte(s). At least the low, middle, and high levels of the reportable range(s) should be checked. Reproducibility can be determined by replicate testing of quality control materials.
A sufficient number of replicates should be performed to determine the precision of the method. For those instruments with internal quality control capability, the reliability of the internal quality control must be evaluated. This can be accomplished concurrently with the reproducibility studies if external quality control materials are used for those studies in parallel with the internal quality control. The laboratory director or technical supervisor must approve the results of the abbreviated validation study before the instrument is used for patient testing and must determine the frequency of the external quality control requirements.
NOTE: This FAQ does not apply to waived instruments or methods. Verification of waived instruments or methods should be conducted to the extent determined by the laboratory director or technical supervisor.
Although it is not necessary to repeat the extensive verification study performed when the method was originally evaluated, at a minimum, studies should be performed to determine the accuracy, reproducibility, and the reportable range of the "loaner" instrument. The accuracy can be verified by testing materials with known values for the analyte(s) such as quality control materials, calibration materials, or proficiency samples. The same materials, if properly selected, can be used to verify that the instrument is capable of accurate results across the reportable range(s) of the analyte(s). At least the low, middle, and high levels of the reportable range(s) should be checked. Reproducibility can be determined by replicate testing of quality control materials.
A sufficient number of replicates should be performed to determine the precision of the method. For those instruments with internal quality control capability, the reliability of the internal quality control must be evaluated. This can be accomplished concurrently with the reproducibility studies if external quality control materials are used for those studies in parallel with the internal quality control. The laboratory director or technical supervisor must approve the results of the abbreviated validation study before the instrument is used for patient testing and must determine the frequency of the external quality control requirements.
NOTE: This FAQ does not apply to waived instruments or methods. Verification of waived instruments or methods should be conducted to the extent determined by the laboratory director or technical supervisor.
Although it is not necessary to repeat the extensive verification study performed when the method was originally evaluated, at a minimum, studies should be performed to determine the accuracy, reproducibility, and the reportable range of the "loaner" instrument. The accuracy can be verified by testing materials with known values for the analyte(s) such as quality control materials, calibration materials, or proficiency samples. The same materials, if properly selected, can be used to verify that the instrument is capable of accurate results across the reportable range(s) of the analyte(s). At least the low, middle, and high levels of the reportable range(s) should be checked. Reproducibility can be determined by replicate testing of quality control materials.
A sufficient number of replicates should be performed to determine the precision of the method. For those instruments with internal quality control capability, the reliability of the internal quality control must be evaluated. This can be accomplished concurrently with the reproducibility studies if external quality control materials are used for those studies in parallel with the internal quality control. The laboratory director or technical supervisor must approve the results of the abbreviated validation study before the instrument is used for patient testing and must determine the frequency of the external quality control requirements.
NOTE: This FAQ does not apply to waived instruments or methods. Verification of waived instruments or methods should be conducted to the extent determined by the laboratory director or technical supervisor.
ֱ, as an accrediting agency, will follow the guidance from the FDA, CMS and CLIA regarding this issue. CMS/CLIA has updated their FAQ on this topic and they have stated that facilities can continue to use the Abbott cTnI moderate complexity i-STAT cartridge.
Here is the link to the CMS/CLIA FAQ: .
ֱ suggests that your organization continue to work with your CLIA laboratory director, risk manager and legal team to determine your further course of action. We also recommend that you frequently check the which assigns complexity to tests.
There are standards regarding submission of tissue from surgery to pathology in the laboratory manual. QSA.13.01.01 EP1, requires that all specimens, except those identified by the clinical staff as part of EP2, are routinely sent to a pathologist for evaluation. QSA.13.01.01 EP2 states that the clinical staff, in consultation with a pathologist, decides the exceptions to submitting specimens removed during a surgical procedure to the laboratory.
The medical staff and pathologist(s) should approve the tissue exemption list for the institution in writing. Exceptions are made only when the quality of care has not been compromised by the exception, when another suitable means of verifying the removal has been routinely used, and when there is an authenticated operative or other official report that documents the removal.
Unsatisfactory Status:
- Definition: A single proficiency testing event with a score of less than 100% for ABO, Rh, and compatibility testing, or less than 80% for all other testing.
- Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a Plan of Action to ֱ. The records will be reviewed during the laboratory's next on-site survey.
- Definition: A cumulative event in which the laboratory has had an Unsatisfactory score on two out of three consecutive proficiency testing events.
- Action: Document investigation and remedial action sufficient to prevent recurrence. ֱ will identify the unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in ֱ's Central Office. You are not required to contact ֱ prior to receiving this request.
- Definition: A cumulative event in which the laboratory has had Unsuccessful proficiency testing status two times in the past five years.
- Action: Document investigation and remedial action sufficient to prevent recurrence. Consider voluntarily ceasing testing for the involved analyte(s) and proactively contacting the Joint Commission in writing to formally report this action. ֱ will identify the subsequent unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. If the laboratory has not already ceased testing, a formal notification to cease testing may be issued by ֱ and be in effect for a minimum of six months. The Plan of Action will be reviewed by staff in ֱ's Central Office. When a laboratory chooses to voluntarily cease testing before being formally notified to do so, the Joint Commission has additional discretion to work with the laboratory and permit reinstatement in an shorter timeframe once the Plan of Action has been determined acceptable.
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in CLIA brochure #8:
Information about ֱ's proficiency testing monitoring, including contact information, can be found at the following website:
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status:
• Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a Plan of Action to ֱ. The records will be reviewed during the laboratory's next on-site survey.
• Action: Document investigation and remedial action sufficient to prevent recurrence. ֱ will identify the unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in ֱ's Central Office, and the laboratory will be given further instructions of documents to be submitted. ֱ need not be contacted prior to receiving this request.
Subsequent Unsuccessful Status:
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in
Information about ֱ's proficiency testing monitoring, including contact information, can be found at the following website:
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status:
• Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a Plan of Action to ֱ. The records will be reviewed during the laboratory's next on-site survey.
• Action: Document investigation and remedial action sufficient to prevent recurrence. ֱ will identify the unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in ֱ's Central Office, and the laboratory will be given further instructions of documents to be submitted. ֱ need not be contacted prior to receiving this request.
Subsequent Unsuccessful Status:
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in
Information about ֱ's proficiency testing monitoring, including contact information, can be found at the following website:
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status:
• Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a Plan of Action to ֱ. The records will be reviewed during the laboratory's next on-site survey.
• Action: Document investigation and remedial action sufficient to prevent recurrence. ֱ will identify the unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in ֱ's Central Office, and the laboratory will be given further instructions of documents to be submitted. ֱ need not be contacted prior to receiving this request.
Subsequent Unsuccessful Status:
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in
Information about ֱ's proficiency testing monitoring, including contact information, can be found at the following website:
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status
- Definition: A single proficiency testing event with a score of less than 100% for ABO, Rh, and compatibility testing, or less than 80% for all other testing.
- Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a Plan of Action to ֱ. The records will be reviewed during the laboratory's next on-site survey.
- Definition: A cumulative event in which the laboratory had an Unsatisfactory score on two out of three consecutive proficiency testing events.
- Action: Document investigation and remedial action sufficient to prevent recurrence. ֱ will identify the unsuccessful status through its routine proficiency testing monitoring activities and contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in ֱ's Central Office, and the laboratory will be given further instructions of documents to be submitted. ֱ need not be contacted prior to receiving this request.
Definition:Subsequent or repeated unsuccessful proficiency testing is when a laboratory has unsuccessful proficiency testing and then fails to achieve satisfactory performance on one of the next two events. (see APR.10.03.01 EP4)
- Action: Document investigation and remedial action sufficient to prevent recurrence. Consider voluntarily ceasing testing for the involved analyte(s) and proactively contacting the Joint Commission in writing to formally report this action. ֱ will identify the subsequent unsuccessful status through its routine proficiency test monitoring activities and contact the laboratory to request a Plan of Action. If the laboratory has not already ceased testing, a formal notification to cease testing may be issued by ֱ and be in effect for a minimum of six months. The Plan of Action will be reviewed by staff in ֱ's Central Office. When a laboratory chooses to voluntarily cease testing before being formally notified to do so, the Joint Commission has discretion to work with the laboratory and permit reinstatement in a shorter timeframe once the Plan of Action has been determined acceptable.
- Note that the recommendations stated above apply to the regulated analytes for non-waived testing. Regulated analytes are those specified in the Clinical Laboratory Improvement Amendments (CLIA), Subpart I. For waived testing and other non-waived unregulated analytes, participation in proficiency testing is a voluntary best practice. If unsuccessful status or subsequent unsuccessful status is obtained, the laboratory should conduct and document an internal investigation and remedial action sufficient to prevent recurrence, or may voluntarily cease testing based on the Laboratory Director's decision.
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in the
For non-waived testing, the minimum retention requirement is two years for both Joint Commission standards and regulatory compliance. However, non-waived proficiency testing performance is monitored for subsequent unsuccessful status for up to a five year period. In rare instances, a laboratory could be required to provide a Plan of Action for a current unsuccessful event that also addresses any unsuccessful events that occurred in the prior five year period. For this reason, it is recommended that laboratories retain non-waived proficiency testing records by specialty and subspecialty for a five year period, particularly if there has been unsatisfactory or unsuccessful status within that timeframe. If all proficiency testing performance was satisfactory beyond the minimum two year regulatory retention period, then there is probably little value in retaining it longer than the required two years. Note that this recommendation is specifically intended for non-waived testing. Participation in proficiency testing for waived testing is voluntary. Thus the value of retaining waived proficiency testing records beyond two years is at the determination of the laboratory director.
For non-waived testing, the minimum retention requirement is two years for both Joint Commission standards and regulatory compliance. However, non-waived proficiency testing performance is monitored for subsequent unsuccessful status for up to a five year period. In rare instances, a laboratory could be required to provide a Plan of Action for a current unsuccessful event that also addresses any unsuccessful events that occurred in the prior five year period. For this reason, it is recommended that laboratories retain non-waived proficiency testing records by specialty and subspecialty for a five year period, particularly if there has been unsatisfactory or unsuccessful status within that timeframe. If all proficiency testing performance was satisfactory beyond the minimum two year regulatory retention period, then there is probably little value in retaining it longer than the required two years. Note that this recommendation is specifically intended for non-waived testing. Participation in proficiency testing for waived testing is voluntary. Thus the value of retaining waived proficiency testing records beyond two years is at the determination of the laboratory director.
For non-waived testing, the minimum retention requirement is two years for both Joint Commission standards and regulatory compliance. However, non-waived proficiency testing performance is monitored for subsequent unsuccessful status for up to a five year period. In rare instances, a laboratory could be required to provide a Plan of Action for a current unsuccessful event that also addresses any unsuccessful events that occurred in the prior five year period. For this reason, it is recommended that laboratories retain non-waived proficiency testing records by specialty and subspecialty for a five year period, particularly if there has been unsatisfactory or unsuccessful status within that timeframe. If all proficiency testing performance was satisfactory beyond the minimum two year regulatory retention period, then there is probably little value in retaining it longer than the required two years. Note that this recommendation is specifically intended for non-waived testing. Participation in proficiency testing for waived testing is voluntary. Thus the value of retaining waived proficiency testing records beyond two years is at the determination of the laboratory director.
The standards require each laboratory to establish its own control ranges through repetitive testing. However, there is an allowance to use manufacturers' ranges when all of the following conditions are met:
- the stated values correspond to the method and instrument used by the laboratory,
- the mean obtained by the laboratory reflects the manufacturer's stated mean, and
- the Laboratory Medical Director assures the range arenarrow enough to detect clinically significant errors.
It is at the determination of the Laboratory Medical Director to approve quality control ranges after giving consideration to the clinically significant variance as compared to the statistically derived SD.
Joint Commission Standards require that laboratories report the results of acid-fast stains, both positive and negative, within 24 hours of specimen receipt. The intent is to require the TESTING laboratory to report results of acid-fast stains within 24 hours of specimen receipt. For laboratories that perform acid-fast stains, the expected turnaround time for result reporting is 24 hours.
For laboratories that refer acid-fast stains to reference laboratories, ֱ recommends that the reference laboratories be informed of the 24 hour turnaround time expectation for result reporting by the testing laboratory. In addition, laboratories are encouraged to establish a 24 hour turnaround time for the processing and transport of acid-fast staining specimens to the reference laboratories.
Joint Commission Standards require that laboratories report the results of acid-fast stains, both positive and negative, within 24 hours of specimen receipt. The intent is to require the TESTING laboratory to report results of acid-fast stains within 24 hours of specimen receipt. For laboratories that perform acid-fast stains, the expected turnaround time for result reporting is 24 hours.
For laboratories that refer acid-fast stains to reference laboratories, ֱ recommends that the reference laboratories be informed of the 24 hour turnaround time expectation for result reporting by the testing laboratory. In addition, laboratories are encouraged to establish a 24 hour turnaround time for the processing and transport of acid-fast staining specimens to the reference laboratories.
Joint Commission Standards require that laboratories report the results of acid-fast stains, both positive and negative, within 24 hours of specimen receipt. The intent is to require the TESTING laboratory to report results of acid-fast stains within 24 hours of specimen receipt. For laboratories that perform acid-fast stains, the expected turnaround time for result reporting is 24 hours.
For laboratories that refer acid-fast stains to reference laboratories, ֱ recommends that the reference laboratories be informed of the 24 hour turnaround time expectation for result reporting by the testing laboratory. In addition, laboratories are encouraged to establish a 24 hour turnaround time for the processing and transport of acid-fast staining specimens to the reference laboratories.
Joint Commission Standards require that laboratories report the results of acid-fast stains, both positive and negative, within 24 hours of specimen receipt. The intent is to require the TESTING laboratory to report results of acid-fast stains within 24 hours of specimen receipt. For laboratories that perform acid-fast stains, the expected turnaround time for result reporting is 24 hours.
For laboratories that refer acid-fast stains to reference laboratories, ֱ recommends that the reference laboratories be informed of the 24 hour turnaround time expectation for result reporting by the testing laboratory. In addition, laboratories are encouraged to establish a 24 hour turnaround time for the processing and transport of acid-fast staining specimens to the reference laboratories.
*National Institute of Standards and Technology
Water and saline are generally not acceptable as a negative control for qualitative urinalysis performed by an instrument. Laboratories should follow manufacturer instructions for quality control. Past contact with urine dipstick vendors has shown that they do not recommend use of water or saline as a negative control. The specifications of the commercial controls have been determined by methods traceable to NIST* standards and it would be impractical for most laboratories to demonstrate comparable analysis.
*National Institute of Standards and Technology
Water and saline are generally not acceptable as a negative control for qualitative urinalysis performed by an instrument. Laboratories should follow manufacturer instructions for quality control. Past contact with urine dipstick vendors has shown that they do not recommend use of water or saline as a negative control. The specifications of the commercial controls have been determined by methods traceable to NIST* standards and it would be impractical for most laboratories to demonstrate comparable analysis.
*National Institute of Standards and Technology
Water and saline are generally not acceptable as a negative control for qualitative urinalysis performed by an instrument. Laboratories should follow manufacturer instructions for quality control. Past contact with urine dipstick vendors has shown that they do not recommend use of water or saline as a negative control. The specifications of the commercial controls have been determined by methods traceable to NIST* standards and it would be impractical for most laboratories to demonstrate comparable analysis.
*National Institute of Standards and Technology
Water and saline are generally not acceptable as a negative control for qualitative urinalysis performed by an instrument. Laboratories should follow manufacturer instructions for quality control. Past contact with urine dipstick vendors has shown that they do not recommend use of water or saline as a negative control. The specifications of the commercial controls have been determined by methods traceable to NIST* standards and it would be impractical for most laboratories to demonstrate comparable analysis.
*National Institute of Standards and Technology
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellullar through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7and TS-8.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the introduction to the Transplant Safety chapter found in the accreditation manual.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The source facility must be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.Each organization must check with their state for the status of Tissue License Requirements.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual*. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
*Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
Water and saline are generally not acceptable as a negative control for qualitative urinalysis performed by an instrument. Laboratories should follow manufacturer instructions for quality control. Past contact with urine dipstick vendors has shown that they do not recommend use of water or saline as a negative control. The specifications of the commercial controls have been determined by methods traceable to NIST* standards and it would be impractical for most laboratories to demonstrate comparable analysis.
*National Institute of Standards and Technology
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Nursing Care Center
ֱ standard for an organization's recovery and continuity of operations is performance based (EM.02.01.01). The organization will use its emergency operations plan to define its response to emergencies and to help position it for recovery after the emergency has passed. Various aspects of a recovery effort could take place during an event or after an event. Recovery strategies and actions are designed to help restore the systems that are critical to providing care, treatment, and services in the most expeditious manner possible.
Emergency operations plans are to be designed to provide optimum flexibility to restore critical services as soon as possible to meet community needs. Recovery strategies are to maintain a focus on continuity of operations. For example: smooth transition from emergency to regular supply chains; effective decoupling of services shared with other entities during an event; use or return of stockpiled supplies; staff relief without affecting continuity of operations; creating the most seamless environment possible for patients and patient care. In order to evaluate effectiveness, the survey process will review the emergency operations plan, interview staff and review exercise evaluations.
The requirements for a Continuity of Operations Plan (COOP) is defined in EM.02.01.01 EP12. Think of the COOP as your emergency operations plan after the initial response to an incident. The COOP outlines how the organization will continue to provide services until full operations are restored. The COOP includes a strategy for a succession plan for key leaders if they are not able or available to carry out duties (for instance, if they are stranded away from the organization or have a communications interruption), as well as a delegation of authority plan for policy and decision making.
There are differences between the EOP and the COOP. Essentially, the EOP is a plan for how the organization will function during the mitigation, preparedness, response and recovery phases of a given emergency, or the emergency response to an event/incident. The COOP should detail all the procedures that define how the organization will continue to operate within the emergency and/or recover the minimum essential functions in the event of a disaster. The focus of a COOP is often protecting the physical plan, information technology systems, business and financial operations, and other infrastructure from direct disruption or damage so that the organization can continue to function through or shortly after an emergency.
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Volunteer Licensed Practitioners that have been granted disaster privileges may continue to provide care, treatment and services under the disaster privileging option (see EM.02.02.13) for the period of time the organization continues to operate under its Emergency Operations Plan (EOP). Organizations should periodically assess the number and specialty of those volunteer practitioners initially granted disaster privileges to ensure the ongoing needs of the patient population are being met and that the medical staff can maintain oversight over practitioner performance.
If an important patient care need continues at the time the organization discontinues operation of the EOP, the medical staff could either grant temporary privileges or consider granting full privileges.
NOTE: All Credentialing and Privileging must be consistent with applicable law, regulation and medical staff requirements.
Additional Resources:
FAQ: Emergency Management - Requirements for Granting Privileges During a Disaster
FAQ:Credentialing and Privileging - Temporary Privileges
An organization needs to establish a process to manage its emergency inventory, however there is no requirement for centralization of the inventory. The inventory must be itemized. The emergency inventory includes, but is not limited to, personal protective equipment, water, fuel, and medical, surgical and medication related resources and assets. The organization should conduct an annual inventory review to determine if all items assessed are available for use during an emergency. The inventory and annual review must be documented.
ֱ recognizes that it can be problematic with "just in time" purchasing and recognizes it is important to use stock with a shelf-life. Tracking assets and inventory for a year is recommended in order to accurately ascertain what the capabilities and needs are for the organization. Many organizations consider emergency requirements when establishing par levels. Some healthcare systems create a process by which to store and transport emergency inventory between system locations.
Memorandums of Understanding (MOUs) or other agreements may be formed with other entities to help the organization maintain its inventory during an emergency. However, MOUs are most useful during isolated emergencies, and are often not effective during large emergency events impacting a large region. Therefore, it is very important to test and/or document this along with the other five critical areas during an exercise or actual event to look for areas of risk. If an event or exercise is initiated, one of the initial responses should be for those entities holding emergency inventories to report available inventories to the incident commander.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
During times of utility interruptions, clinical procedures and processes may need to be changed or modified due to lack of utility support. EC.02.05.01 EP 10 requires organizations to have written procedures for responding to utility system disruptions. In the event of power loss, HVAC system shut-down, loss of running water, etc. emergency clinical interventions may be required to continue to provide necessary patient care.
As clinical interventions vary based on the needs of the organization, there must be an assessment made relative to the type of utility interruption. Written clinical procedures must be available for implementation should a utility system disruption happen. Staff should be aware of these procedures and how to access them in the event of a utility system disruption.
Procedures to consider may include utilizing alternative spaces for patient care or procedures due to a power outage, rescheduling cases if an operating room does not have working HVAC, relocating patients/staff due to no potable water available. This is different from the 96-hour sustainability plan, but the sustainability plan could be helpful in creating the clinical procedures and processes to manage utility systems disruption.
Reference EC.02.05.01 EP 10, EP 12
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
For new, altered, or renovated space, organizations are expected to comply with either state rules or regulations (if applicable), or the 2018 FGI Guidelines for Design and Construction of Hospitals.
Reference: EC.02.06.05 EP 1
Additional Resources
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
ֱ standards do not require an environment of care (or safety) committee.Specific tools used to maintain compliance, like a multidisciplinary committee or environmental tours, are no longer specifically required.
EC.01.01.01 requires an individual or individuals to manage risk, coordinate risk reduction activities in the physical environment, collect deficiency information, and disseminate summaries of actions and results.This is typically accomplished by a committee of appropriately qualified and responsible personnel with expertise in the applicable portions of the environment of care chapter, to include safety, security, hazardous material and waste, fire safety, medical equipment management and utility systems management.
Depending upon the size and complexity of the organization, these duties may be performed by one-person, multiple persons, or persons assigned multiple duties. By identifying one or more individuals to coordinate and manage risk assessment and reduction activities, organizations can be more confident that they have minimized the potential for harm and have effectively managed the required aspects of the environment of care.
The Leadership Chapter establishes reporting relationships between leadership and responsible entities. If used, the make-up of the EOC committee, the frequency of meeting, the agenda items, and the reporting requirements are to be assessed based upon the circumstances of the organization to effectively monitor, analyze and improve the environment.The organization must be able to demonstrate on-going activity throughout the reporting period to remain aware of the dynamic circumstances of a health care organization, to be able to assess situations and make needed changes, and to make an accurate evaluation of effectiveness at the end of the reporting period.
Although not prescriptive, if the responsible group meets less frequently than quarterly, the survey process would likely require a satisfactory explanation of how it can effectively manage the dynamic character of a healthcare organization. The survey process will also validate that meetings are conducted in accordance with established policies, to include established frequencies and attendance requirements.
An annual evaluation of the management plans provides a systematic approach that the organization can use to ensure that the plans are still relevant, effective, and useful.
Organizations are required to have a written plan for managing the following:
- Environmental safety of patients and everyone else who enters the facility
- Security of everyone who enters the facility
- Hazardous materials and waste
- Fire safety
- Medical equipment
- Utility systems
Review of the plan since the last annual evaluation would include a determination of:
- effectiveness of the plan
- whether the previous year's objectives were achieved
- new services, programs, or sites added
- services, programs, or sites that have been eliminated
- new hazards that have been introduced
- critique of fire drills
- review of incident reports
- need for new objectives areas for improvement
Additional Resources:
EC.01.01.01
EC.04.01.01
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ standards requires transmission of a fire signal during every fire drill requiring the fire alarm to be activated.
There is an allowance for a coded announcement to replace audible alarms for fire drills conducted between the hours of 9:00 pm and 6:00 am. This allows for only silencing the audible signals not the transmission of the fire alarm signal.
Reference:
NFPA 101-2012 18/19.7.1.7;7.1; 7.2; 7.3
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2011 edition of NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, where all actuation components, including remote manual pull stations, mechanical or electrical devices, detectors, actuators, and fire-actuated dampers, shall be checked for proper operation during the inspection in accordance with the manufacturer's listed procedures. This includes annual replacement of the fusible link.
ֱ is not prescriptive for the procedures to be used to clean and maintain kitchen extinguishing systems. The organization is expected to have a plan in place for cleaning based upon the manufacturer's instructions for use.
The organization must also be able to demonstrate on-going compliance with required system design components described in LS.02.01.35 that include:
- portable fire extinguishers in the vicinity
- grease removal devices
- fire alarm system activation
- deactivation of the cooking fuel source
- proper operation of the exhaust system
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cooldown period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources:
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
Unrated flammable plastic sheets (such as Visqueen), do not constitute acceptable temporary barriers. Even though flammable plastic sheets taped across an opening may form a dust seal, they are incapable of controlling fire. The only thing they can do is keep air and particulate from moving to unwanted locations. Therefore, they are good for infection control, and on a limited basis, for resisting smoke passage caused by a fire, friction or welding/brazing in the construction zone. But these sheet types do nothing to stop the fire itself.
ֱ standards require that temporary construction partitions be smoke tight and built of noncombustible or limited combustible materials (sheet rock, gypsum board) that will not contribute to the development or spread of fire." Ensure that evidence of "limited combustibility" can be furnished if questioned during survey or other inspection.
Reference EC.02.06.05 EP3
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
A common issue during the survey process is that the organization is not adequately familiar with the content of the report and the configuration of their fire safety systems. An effective way to accomplish this is for the testing entity to closely review the report with the organization's representative.
Additional Resources:
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
The labeling shall include:
- the name or chemical symbol for the specific medical gas or vacuum system
- room or areas served
- caution to not close or open the valve except in an emergency
Hidden shut-off valves, such as those above the ceiling, are to be labeled on or near the valve; its hidden location may be identified by a label, icon, etc., or on a utility system map in accordance with EC.02.05.01 EP 17.
Reference EC.02.05.09 EP11
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
ֱ standards are not prescriptive regarding testing frequencies for piped medical gas and vacuum systems. The facility may determine its testing frequency by policy and the surveyor will evaluate testing based on that policy.
In accordance with EC.02.05.09, for each piped medical gas and vacuum system, the source, distribution, inlets/outlets, and the alarms that protect the systems are to be maintained in a safe and reliable condition.
The organization is required by EC.02.05.01 to develop a maintenance strategy based upon either manufacturer's recommendations or an alternative equipment maintenance (AEM) strategy. Piped medical gas and vacuum systems are considered high-risk utility systems.
Issues such as system complexity, system age/condition, patient acuity, etc. are to be used to assess maintenance strategies. NFPA 99-2012 Appendix B can be used as a guide for establishing a maintenance strategy, but appendix material is not required unless adopted by a controlling authority. The survey process will evaluate the maintenance strategy assessment process for effectiveness and validate that it has been properly implemented.
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
Specific to expiration dating and discarding unused food, organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable law/regulation that may be defined by your local authority having jurisdiction (i.e., local or state health department, etc.).
Specific to expiration dating and discarding unused food, organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable law/regulation that may be defined by your local authority having jurisdiction (i.e., local or state health department, etc.).
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ does not specifically require temperature logs for refrigerators and freezers used for patient food. The organization is expected to have a plan in place to ensure that food and nutrition products are stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security. The refrigeration equipment must be properly maintained.
Organizations are expected to comply with the product manufacturer's guidelines for safe storage as well as applicable requirements by local authority having jurisdiction. Unused food and expired products are discarded.
ֱ is not prescriptive to monitor or log temperature for refrigerators provided for personal patient use. However, a process is required to be in place to ensure that the refrigerator functions properly to safely store its contents.
ֱs standards require that organizations store food and nutrition products, including those brought in by patients or their families, using proper sanitation, temperature, light, moisture, ventilation, and security as per PC.02.02.03.
When nutritional products, such as breast milk or baby formula are stored in these refrigerators, refer to evidence-based guidelines from the formula manufacturer's instructions for use (IFU), the Centers for Disease Control and Prevention (CDC), etc. to ensure safe storage.
Organizations should also have processes that address cleaning between patients and identifies maintenance responsibilities.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Additional Resources:
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference:
EC.02.06.01
MM.03.01.01
Additional Resources:
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
ֱ does not require a Safety Officer position. ֱ standard EC.01.01.01 EP 1 does require the organization to identify an individual or individuals to perform specified risk reduction activities and threat intervention responsibilities, so that all environment of care activities are effectively managed and to intervene when situations threaten people or property.
The organization is expected to demonstrate that the environment of care activities is effectively coordinated from the perspective of assessment, management, implementation, monitoring, analysis, and program improvement.
Reference: EC.01.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
Competency requires a third attribute – ability. Ability is simply described as being able to ‘do something’. The ability to do something 'competently' is based on an individual’s capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency (see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources:
FAQ: Competency Assessment vs Orientation
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO's leadership, does not substitute for the surveyor's request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed practitioners (see alsoLD.01.03.01 and LD.03.04.01).
ֱ, similar to organization’s themselves, has expectations regarding anyone entering a health care organization. In order to maintain patient safety, accredited health care organizations need to be aware of who is entering the organization and their purpose at the organization (EC.02.01.01). Accredited health care organization leaders need to also make sure they oversee operations and that responsibilities are assigned for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3); this includes processes for knowing who is entering the organization and their purpose. For non-employees brought into the organization by licensed independent practitioners, there are two additional requirements regarding qualifications and competence of these individuals (HR.01.01.01, EP 7 and HR.01.07.01, EP 5).
ֱ, similar to organization’s themselves, has expectations regarding anyone entering a health care organization. In order to maintain patient safety, accredited health care organizations need to be aware of who is entering the organization and their purpose at the organization (EC.02.01.01). Accredited health care organization leaders need to also make sure they oversee operations and that responsibilities are assigned for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3); this includes processes for knowing who is entering the organization and their purpose. For non-employees brought into the organization by licensed independent practitioners, there are two additional requirements regarding qualifications and competence of these individuals (HR.01.01.01, EP 7 and HR.01.07.01, EP 5).
ֱ, similar to organization’s themselves, has expectations regarding anyone entering a health care organization. In order to maintain patient safety, accredited health care organizations need to be aware of who is entering the organization and their purpose at the organization (EC.02.01.01). Accredited health care organization leaders need to also make sure they oversee operations and that responsibilities are assigned for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3); this includes processes for knowing who is entering the organization and their purpose. For non-employees brought into the organization by licensed independent practitioners, there are two additional requirements regarding qualifications and competence of these individuals (HR.01.01.01, EP 7 and HR.01.07.01, EP 5).
ֱ, similar to organization's themselves, has expectations regarding anyone entering a health care organization. In order to maintain patient safety, accredited health care organizations need to be aware of who is entering the organization and their purpose at the organization (EC.02.01.01). Accredited health care organization leaders need to also make sure they oversee operations and that responsibilities are assigned for administrative and clinical direction of programs, services, sites, and departments (LD.04.01.05, EPs 1 and 3); this includes processes for knowing who is entering the organization and their purpose. For non-employees brought into the organization by licensed practitioners, there are two additional requirements regarding qualifications(HR.01.01.01) and competence (HR.01.06.01) for these individuals.
ֱ describes a consultant as an LIP who was asked to evaluate a patient and provide consultation, by the way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
ֱ describes a consultant as an LIP who was asked to evaluate a patient and provide consultation, by the way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and/or privileged. Compliance with the organization's process for monitoring a practitioner’s professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LIP who was asked to evaluate a patient and provide consultation, by way of an order from another LIP. The consultant’s findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Yes, consultants that evaluate patients and recommend care, treatment, or services are required to be credentialed and privileged. Compliance with the organization's process for monitoring a practitioner's professional performance, clinical/technical skills, etc. is also required.
ֱ describes a consultant as a LP who was asked to evaluate a patient and provide consultation, by way of an order from another LP. The consultant's findings are entered into the medical record and may be used by other practitioners to determine the ongoing course of care, treatment, or services.
Additionally, the requirements found at RC.02.01.01 EP 2 require that the medical record contain documentation of any consultation reports. Therefore, organizations need to ensure that consultants have been identified as authorized to make entries into the medical record (see RC.01.02.01 EP 1).
Organizationsare free todecide tohaveeithera separate process or to integrate with the hospital's medical staff and processes. Whicheveris selected,the approach must meet therequirementsof the NCC(Nursing Care Center)manual,including the role of the NCC Medical Director. See LD.01.06.01 EPs 1-5andHR. 02.01.04 EP10and13.Fororganizationsthat elect the Post-Acute Care Certification,please alsoseeLD. 01.06.01EPs6, 7, and 16.
When thelicensed practitioneris receiving privileges/authorization/clinical responsibilities in multiple settings using a single credentialing and privileging process, it must be clear as to what the practitionercando inthe Nursing Care Center.(HR. 02.01.04 EP 10and11). For example, some hospital based NCCs will have a separate list of privileges for the physicians whopracticein the NCC unit.
If the Licensed Practitioneris new to theorganizationand not currently privileged at any Joint Commission-Accredited Organization, such as the Dentist, Optometrist, orPodiatrist, theMedicalDirectormust monitortheLicensed Practitioner'sperformancein the Nursing Care Center.This monitoring continues untilthe Medical Director is satisfied the newLicensed Practitionercanprovidesafe and effective carethat he or she is being permitted to providein the Nursing Care Center.
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
If an established provider's privileges are scheduled to expire during the time of the declared national emergency, ֱ will allow an automatic extension of medical staff reappointment beyond the 2-year period under the following conditions:
- A national emergency has officially been declared
- The organization has activated its emergency management plan
- Extending the duration of providers' privileges during an emergency is NOT prohibited by State Law
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
For IC.02.03.01 EP.1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.01.01 EP.5. For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory.
For IC.02.03.01 EP.2, referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, " When licensed independent practitioners or staff have, or are suspected of having, an infectious disease that puts others at risk".
For IC.02.03.01 EP.3, referral is initiated if the organization becomes aware of any individual, including non-employed physicians and other licensed independent practitioners, “when licensed independent practitioners or staff have been occupationally exposed to an infectious disease". Active surveillance is not required and action is needed only if the organization becomes aware of such an exposure
When making a decision as to how to address these issues, organizations are encouraged to consider the following factors:
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires “When developing infection prevention and control activities, the organization.”
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
For IC.02.03.01 EP.1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.01.01 EP.5. For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory.
For IC.02.03.01 EP.2, referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, " When licensed independent practitioners or staff have, or are suspected of having, an infectious disease that puts others at risk".
For IC.02.03.01 EP.3, referral is initiated if the organization becomes aware of any individual, including non-employed physicians and other licensed independent practitioners, “when licensed independent practitioners or staff have been occupationally exposed to an infectious disease". Active surveillance is not required and action is needed only if the organization becomes aware of such an exposure
When making a decision as to how to address these issues, organizations are encouraged to consider the following factors:
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires “When developing infection prevention and control activities, the organization.”
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
For IC.02.03.01 EP.1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.01.01 EP.5. For non-employed physicians and other licensed independent practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory.
For IC.02.03.01 EP.2, referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed independent practitioners, " When licensed independent practitioners or staff have, or are suspected of having, an infectious disease that puts others at risk".
For IC.02.03.01 EP.3, referral is initiated if the organization becomes aware of any individual, including non-employed physicians and other licensed independent practitioners, “when licensed independent practitioners or staff have been occupationally exposed to an infectious disease". Active surveillance is not required and action is needed only if the organization becomes aware of such an exposure
When making a decision as to how to address these issues, organizations are encouraged to consider the following factors:
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires “When developing infection prevention and control activities, the organization.”
- Many states require such screenings for all healthcare workers, including physicians and licensed independent practitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
For IC.02.03.01 EP.1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.01.01 EP.5. For non-employed physicians and other licensed practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory.
For IC.02.03.01 EP.2, referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, " When licensed practitioners or staff have, or are suspected of having, an infectious disease that puts others at risk".
For IC.02.03.01 EP.3, referral is initiated if the organization becomes aware of any individual, including non-employed physicians and other licensed practitioners, "when licensed practitioners or staff have been occupationally exposed to an infectious disease". Active surveillance is not required and action is needed only if the organization becomes aware of such an exposure
When making a decision as to how to address these issues, organizations are encouraged to consider the following factors:
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires "When developing infection prevention and control activities, the organization."
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
Due Dates
Reappointment/re-privileging is due no later than three^ years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter. For example, if the reappointment period is July 1, 2021 through June 30, 2024, the reappointment date would be July 1, 2024.
Governing Body Approval Dates
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in June, the board would approve all July reappointments/reprivileging effective periods and in July the board would be approving all August reappointments/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
^ Additional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame. The change will also be reflected in a future release date of the accreditation manuals.
There is no requirement that organizations obtain transcripts as part of the education verification process. Such a requirement would be an organizational decision.
The FAQ titled "Verification - Education" provides examples of ways organizations may verify education.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner’s reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a ‘designated equivalent source’. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also requires PSV of the applicant’s relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)."The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence that primary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the accreditation manuals at HR.01.01.01. For the Behavioral Health program, see HRM.01.02.01. The Hospital and Critical Access Hospital manuals contain a Medical Staff (MS) chapter that also require PSV of the applicant's relevant training and current competence. These requirements are found at MS.06.01.03 EP 6 and MS.06.01.05 EP 2.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
For IC.02.03.01 EP.1, the standard requires that screening "is available". For employees, and others to whom the HR standards apply, health screenings are a requirement under HR.01.01.01 EP.5. For non-employed physicians and other licensed practitioners, screenings must be made available, but each organization may decide whether these screenings are mandatory.
For IC.02.03.01 EP.2, referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, " When licensed practitioners or staff have, or are suspected of having, an infectious disease that puts others at risk".
For IC.02.03.01 EP.3, referral is initiated if the organization becomes aware of any individual, including non-employed physicians and other licensed practitioners, "when licensed practitioners or staff have been occupationally exposed to an infectious disease". Active surveillance is not required and action is needed only if the organization becomes aware of such an exposure
When making a decision as to how to address these issues, organizations are encouraged to consider the following factors:
- Physicians are specifically included by the CDC in the documents entitled "Immunization of Health-Care Workers" and "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005". IC.01.05.01 EP 1 requires "When developing infection prevention and control activities, the organization."
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
No, requirements for managing linen are notdefined within ֱ standards. Organizations are expected to develop their linen cleaning, storage and management requirements in accordance with evidence-based sources, such as the CDC, the National Association of Institutional Linen Management and/or the local or state authority having jurisdiction.
For example, the CDC's guidelines state, "Clean linen should be transported and stored by methods that will ensure its cleanliness." According to the NAILM, (National Association of Institutional Linen Management) the carts or hampers that deliver laundered linens must be cleaned prior to accepting processed linens. A clean liner within the cart is acceptable, and the linens should be covered. The guidelines state: "Carts that are going to be used to store linens on patient-care areas (hallways) must have covers on them during transportation and storage time. The covers shall protect the linens at all time during storage. They cannot be removed or adjusted in a manner that will expose linens to common traffic. Open carts that are going to be used just to dispense linens on patient- care areas need not be covered for this purpose. They cannot be used to store linens on the floors."
If an organization is unsure whether their linen management processes are compliant with such guidelines, conducting a risk assessment is a helpful way of identifying risks associated with various options being considered by the organization. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
ֱ does not determine which items are prohibited from a behavioral health setting. Items that are prohibited from use in an organization, due to the risk of harm to self or others, should be determined by the organization.
Source control involves having people wear a cloth face covering or facemask over their mouth and nose to contain their respiratory secretions and thus reduce the dispersion of droplets from an infected individual.
TheCDC recommendsimplementing source control (use of masks) in a healthcare facility to prevent dispersal of respiratory droplets from known, asymptomatic and pre-symptomatic people with COVID when are high.Compliance with this recommendation should be based upon the organization's assessment, policies/procedures, individual care plans, and applicable state rules or regulations.
When evaluating the updated CDC recommendations for a patient with behavioral health needs, it is important to complete an assessment of the impact that wearing a face covering or mask would have on the safety of a patient(s), staff and visitors. The expectation is for organizations to complete a clinical risk assessment of the individual for possible self-harm or harm to others if they will wear a mask. The organization must have a process to determine if the patient is capable of wearing a face covering, or mask, based on clinical assessment.
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
When developing Infection Prevention related policies and practices, it's important that you refer to the Infection Prevention Hierarchy, published in the April 2019 Perspectives.
The first level of the hierarchy is that you ensure your organization is compliant with all building code requirements. Deemed organizations must fulfill, Centers for Medicare and Medicaid (CMS) ventilation requirements which outline criteria for new or renovated existing facilities (constructed or plans approved on or after July 5, 2016). These are provided in the 2012 edition of NFPA 99 which references the 2008 edition of ASHRAE 170 table 7.1. If your local authority has published building codes, then your organization must meet the most restrictive requirement.
ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
- Positive air pressure relationship to adjacent areas
- Minimum outdoor air exchange 2 per hour
- Minimum total air exchange 4 per hour
- Maximum relative humidity 60%
- Temperature range 72 to 78 F or 22 to 26 C
Organizations with existing facilities, constructed or plans approved prior to July 5, 2016, may comply with the 2012 ventilation requirements in NFPA 99 or the version of NFPA 99 in effect at the time of the ventilation system installation.
The next level of the hierarchy is the CMS Infection Control Worksheet for the Hospital (HAP) and Ambulatory Surgical Center (ASC). Depending on the type of facility surveyed, these organizations must meet Conditions of Participation (CoP) or Conditions for Coverage (CfC). The worksheet provides the following guidance for surveyors for reusable items sterilized on site:
- (HAP) After sterilization, medical devices and instruments are stored so that sterility is not compromised.
- (ASC) After sterilization, medical devices and instruments are stored in a designated clean area so that sterility is not compromised
- (ASC and HAP) Sterile packages are inspected for integrity and compromised packages are repackaged and reprocessed prior to use.
Next, organizations must be compliant the manufacturer's instructions for storage. If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met. ֱ does not specifically require that these parameters be documented, however your staff should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.
Finally, your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from contamination, moisture, dust, temperature extremes, and humidity extremes. Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage. Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.06.01.01 EP 3.
References and applicable standards:
NFPA 99-2012: 9.3.1
ASHRAE 170-2008
2018 FGI Guidelines
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Yes, accredited organization's are expected to demonstrate compliance with all accreditation or certification requirements for their respective program. In general, the contractual agreements that are reviewed during survey are those that relatemost directlyto resident safety, care,andtreatment (see also LD.04.03.09 and HR.01.02.07).Contracts that relate to other support issues(lawn care, snow removal, and plant technology maintenance)arelower priorities during survey.
Contractual agreementsmust give theaccredited organization's therightto enrollthe direct care and supportcontract employees intothe orientation, competency assessment, on-going education, performance evaluation, health screening, and emergency and fire prevention programs that are established by the organization.To these ends, the contracted service/agency/vendor deploys properly trained and credentialed staff andmaterials. The compliance of all staff, including contracted staffmust bedocumentedbut this documentation may reside with the employer.
Theaccredited organization policies and procedures must be followed by all staff, even if the contract company does nothave comparable requirements. For example,if the organization or the local government or public health entity requires tuberculosis testing and the contract company does not, the contract staff must comply with tuberculosis screening.The screening can be done by the contractor or by the accredited organizationand must be documented.
Yes, accredited organization's are expected to demonstrate compliance with all accreditation or certification requirements for their respective program. In general, the contractual agreements that are reviewed during survey are those that relatemost directlyto resident safety, care,andtreatment (see also LD.04.03.09 and HR.01.02.07).Contracts that relate to other support issues(lawn care, snow removal, and plant technology maintenance)arelower priorities during survey.
Contractual agreementsmust give theaccredited organization's therightto enrollthe direct care and supportcontract employees intothe orientation, competency assessment, on-going education, performance evaluation, health screening, and emergency and fire prevention programs that are established by the organization.To these ends, the contracted service/agency/vendor deploys properly trained and credentialed staff andmaterials. The compliance of all staff, including contracted staffmust bedocumentedbut this documentation may reside with the employer.
Theaccredited organization policies and procedures must be followed by all staff, even if the contract company does nothave comparable requirements. For example,if the organization or the local government or public health entity requires tuberculosis testing and the contract company does not, the contract staff must comply with tuberculosis screening.The screening can be done by the contractor or by the accredited organizationand must be documented.
Yes, accredited organization's are expected to demonstrate compliance with all accreditation or certification requirements for their respective program. In general, the contractual agreements that are reviewed during survey are those that relatemost directlyto resident safety, care,andtreatment (see also LD.04.03.09 and HR.01.02.07).Contracts that relate to other support issues(lawn care, snow removal, and plant technology maintenance)arelower priorities during survey.
Contractual agreementsmust give theaccredited organization's therightto enrollthe direct care and supportcontract employees intothe orientation, competency assessment, on-going education, performance evaluation, health screening, and emergency and fire prevention programs that are established by the organization.To these ends, the contracted service/agency/vendor deploys properly trained and credentialed staff andmaterials. The compliance of all staff, including contracted staffmust bedocumentedbut this documentation may reside with the employer.
Theaccredited organization policies and procedures must be followed by all staff, even if the contract company does nothave comparable requirements. For example,if the organization or the local government or public health entity requires tuberculosis testing and the contract company does not, the contract staff must comply with tuberculosis screening.The screening can be done by the contractor or by the accredited organizationand must be documented.
Yes, accredited organization's are expected to demonstrate compliance with all accreditation or certification requirements for their respective program. In general, the contractual agreements that are reviewed during survey are those that relatemost directlyto resident safety, care,andtreatment (see also LD.04.03.09 and HR.01.02.07).Contracts that relate to other support issues(lawn care, snow removal, and plant technology maintenance)arelower priorities during survey.
Contractual agreementsmust give theaccredited organization's therightto enrollthe direct care and supportcontract employees intothe orientation, competency assessment, on-going education, performance evaluation, health screening, and emergency and fire prevention programs that are established by the organization.To these ends, the contracted service/agency/vendor deploys properly trained and credentialed staff andmaterials. The compliance of all staff, including contracted staffmust bedocumentedbut this documentation may reside with the employer.
Theaccredited organization policies and procedures must be followed by all staff, even if the contract company does nothave comparable requirements. For example,if the organization or the local government or public health entity requires tuberculosis testing and the contract company does not, the contract staff must comply with tuberculosis screening.The screening can be done by the contractor or by the accredited organizationand must be documented.
There may be instances, e.g., during tracer activities, where the surveyor requests to review the personnel file of a contracted staff or an independent contractor. Under these circumstances, the surveyor should review the organization’s process for monitoring the contracted services. If a concern is not sufficiently addressed, then the surveyor may request the personnel record of the contracted staff or independent contractor. The requested personnel record, from the contracted service or staffing firm, must be provided to the hospital in a timeframe sufficient for surveyor review during the survey.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed independent practitioners
There may be instances, e.g., during tracer activities, where the surveyor requests to review the personnel file of a contracted staff or an independent contractor. Under these circumstances, the surveyor should review the organization’s process for monitoring the contracted services. If a concern is not sufficiently addressed, then the surveyor may request the personnel record of the contracted staff or independent contractor. The requested personnel record, from the contracted service or staffing firm, must be provided to the hospital in a timeframe sufficient for surveyor review during the survey.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed independent practitioners
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO’s leadership, does not substitute for the surveyor’s request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed independent practitioners (see alsoLD.01.03.01 and LD.03.04.01).
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO’s leadership, does not substitute for the surveyor’s request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed independent practitioners (see alsoLD.01.03.01 and LD.03.04.01).
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO’s leadership, does not substitute for the surveyor’s request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed independent practitioners (see alsoLD.01.03.01 and LD.03.04.01).
ֱ does nottypicallyrequestaccreditedorganizationstosummonthe entire set of personnel files fromaccredited or certified contracted organizations.Contractedaccreditedorganizationswill undergotheirown accreditation or certification surveyby the Joint Commission andwilldemonstrate compliancewithintheir personnel recordsat that time.If personnel recordsare requested for review, theymust be provided in a timeframe sufficient for surveyor review during survey. The evaluation of the contract itself by the HCO's leadership, does not substitute for the surveyor's request to see a specific employee file.
Please note: This FAQ applies only to staff and independent contractors of accredited or certified organizations and not to licensed practitioners (see alsoLD.01.03.01 and LD.03.04.01).
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the organization's residents. This standard does not apply to contracted services that are not directly related to resident care. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their organization to oversee the quality and safety of services provided through contractual agreement. Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and residents.
- Review of resident satisfaction studies.
- Review of results of risk management activities.
Note: This FAQ applies only to staff and contractors of accredited or certified organizations and not to licensed practitioners.
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
- Joint Commission Resources publishes Environment of Care News (the official TJC environment of care, emergency management and life safety news source), ֱ Perspectives (the official newsletter of TJC), and E-Alerts.
- Accredited organizationsmay access the TJC Leading Practices Library on the intranet.
- Other publications for purchase are available through .
- Frequently Asked Questions for various standards can be found on the .
- For additional detail concerning specific standards, see ֱ Physical Environment Portal (JCPEP), which is a partnership with .
- A helpful source for clarification of terms found in the standards chapters is the Glossary section of the organization's applicable accreditation manual.
- Joint Commission Resources publishes Environment of Care News (the official TJC environment of care, emergency management and life safety news source), ֱ Perspectives (the official newsletter of TJC), and E-Alerts.
- Accredited organizationsmay access the TJC Leading Practices Library on the intranet.
- Other publications for purchase are available through .
- Frequently Asked Questions for various standards can be found on the .
- For additional detail concerning specific standards, see ֱ Physical Environment Portal (JCPEP), which is a partnership with .
- A helpful source for clarification of terms found in the standards chapters is the Glossary section of the organization's applicable accreditation manual.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
- Frequently Asked Questions
- The Physical Environment Portal
- Emergency Management Portal
- The Suicide Prevention Portal
- E-Alerts, a free newsletter subscription
- Definition of terms can be found in the Glossary section of the Comprehensive Accreditation Manual
Publications for purchase are available through
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
Agencies and Professional Organizations
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
Many of the Categorical Waivers (CW) that CMS issued in the past related to the Life Safety Code became no longer needed when they adopted NFPA 101-2012 and NFPA 99-2012, effective July 5, 2016.
ֱ still recognizes S&C 13-25-LSC & ASC related to Relative Humidity in Anesthetizing Locations.
The organization must strictly comply with the provisions of the CMS waiver document. The organization is to document invocation of the CW in their EC Committee meeting minutes or in the applicable management plan(s). When documenting invocation of a CW, the CW must be identified (S&C letter/subject), the locations of applicability, and there is to be an attestation that the organization has reviewed and is in compliance with the referenced content of the of the applicable NFPA code.
The S&C letter requires the organization to notify the survey team of the CW at the beginning of the survey (the entrance conference). The survey process will field-validate that the requirements of the CW have been met.
Additional Resources
For the text of S&C 13-25-LSC & ASC
For a full list of CMS S&C letters
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
ֱ references NFPA 101-2012 to limit the volume of combustible decorations in a health care environment:
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
- Health Care Occupancies 18/19.7.5.6
- Ambulatory Health Care Occupancies 20/21.7.5.4
Reference LS.02.01.70 EP5 | LS.03.01.70 EP5
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
CLEAN WASTE: Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
HAZARDOUS WASTE: In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
Clean Waste
Recycling containers used for clean waste (e.g., bottles, cans, paper) pose a lower fire risk than trash containing grease, oil, or flammable liquids. Allowing the size of container used for recycling to increase will reduce the number of trash receptacles and hazardous storage areas required, which will reduce undue cost burden. Containers used solely for recycling clean waste or for patient records awaiting destruction which are located outside a hazardous storage area shall be a maximum capacity of 96-gallons but only if in compliance with sections 18/19.7.5.7.2 of the NFPA 101 (2012). These recycle containers for clean waste or patient records awaiting destruction are to be labeled with FM Approval Standard 6921, Containers for Combustible Waste. Anything above 96-gallons shall be located in a room protected as a hazardous area when not attended.
Hazardous Waste
In accordance with Life Safety Code NFPA 101 Chapters 18/19.7.5.7 there are restrictions on deployment of soiled linen and trash collection receptacles in health care occupancies. When located outside of hazardous protected rooms, container capacity is not to exceed 32 gallons, and when there are multiple containers, the density of soiled linen or trash is not to exceed 0.5 gallons per square foot. Container size and density restrictions are not required within hazardous rooms.
Reference LS.02.01.70 EP 6, LS.03.01.70 EP 6
ֱ allows gaps which do not exceed 1/8 inch for the meeting edges of door pairs as a compliant smoke resistant corridor door. The door undercut is not to exceed 1 inch. Gaskets may be used to reduce or close the gap and can also be used if the door is not a fire rated door.
Note that the Life Safety Code NFPA 101-2012: 18/19.3.6.3 only requires that the door is smoke resistant. The 1/8 inch gap criteria has been adapted by ֱ to provide an objective measurement for uniform and consistent survey results.
Additional Resources
NFPA 101 – 2012: 18/19.3.6.3
The requirements for the installation of smoke and fire dampers may be found in NFPA 90A Installation of Air Conditioning and Ventilating Systems, 2012 edition, Section 5.3 and 5.4.
Generally, fire dampers are required where air ducts penetrate walls that are rated for 2-hours or more. They are needed in all air transfer openings (non-ducted) in rated walls, regardless of the rating. And they are required at some, but not all penetrations of rated floor assemblies and shaft enclosures.
Smoke dampers are required at penetrations of smoke barriers, unless the HVAC system is fully ducted and there is a sprinkler system installed throughout the facility, in which case they are not required. Smoke dampers are also required in air transfer openings (non-ducted) in smoke partitions.
Where a penetration requires both a fire damper and a smoke damper, combination units that are both smoke responsive and heat responsive may be used.
Reference LS.02.01.10 EP13, LS.02.01.30 EP22 & EP23
Fire-rated doors should have approved protective plates (i.e. fire-rated kick plates) no greater than 16 inches from the bottom of the door unless they have a rating label. ֱ uses NFPA 80 (2010) 6.4.5 regarding Protection Plates which states that: Factory-installed protection plates shall be installed in accordance with the listing of the door. Field-installed protection plates shall be labeled and installed in accordance with their listing.
Labeling is not required where the top of the protection plate is not more than 16 in. (406 mm) above the bottom of the door. Labeling is required for field installed protective plates greater than higher 16 in. from the bottom of the door. Per NFPA 80, Door Protection Plate is defined as: Protective material applied to the face of a door and generally made of approximately 0.05-in. (1.2-mm) thick brass, bronze, aluminum, or stainless steel or 1/8-in. (3.2-mm) thick laminated plastic.
Reference LS.02.01.10 EP11
Evacuation maps and life safety drawings may be confused as the same, and sometimes the terms used interchangeably. These are in fact 2 different drawings. Life safety drawings which are part of the floor plans for a facility include all the details of the building construction and infrastructure, but do not indicate emergency egress routes.
Evacuation maps are a basic floor plan indicating rooms, exits and stairwells, and include the emergency escape route that is easy to follow-up in an emergency. These are no longer required by ֱ. Way finding has been proven highly effective through the use of lighted exit signage.
If you choose to continue to use evacuation maps be sure to keep them up-to-date and accurate, so they reflect the current state of the area.
In some cases, local or state fire marshals have required evacuation maps. Check with them prior to removing the evacuation maps. If your local authority having jurisdiction (AHJ) mandates the posting of such maps, then the Joint Commission would expect compliance.
Where an exit sign is required, they may be either externally illuminated or internally illuminated.
Photoluminescent signs are a type of internally illuminated exit sign sometimes used to mark the means of egress, and as such, must meet certain criteria to ensure that they are reliable and readable by occupants of the facility. Using photoluminescence, light is absorbed from the surroundings onto the sign surface, stored and then re-emitted, making the signs glow when the building is dark.
NFPA 101 (2012 edition) The Life Safety Code, Section 7.10.7.2 requires that "the face of a photoluminescent sign shall be continually illuminated while the building is occupied. The illumination levels on the face of the photoluminescent sign shall be in accordance with its listing. The charging illumination shall be a reliable light source, as determined by the authority having jurisdiction. The charging light source, shall be of a type specified in the product markings." Per Section 7.10.7.1, internally illuminated signs shall be listed in accordance with ANSI/UL 924, Standard for Emergency Lighting and Power Equipment.
Some jurisdictions require photoluminescent egress path markers, typically in high-rise buildings. It should be noted that these signs may not meet the requirements of exit signs and are used in addition to, but not in place of exit signs.
Reference LS.02.01.20 EP38, EP40
NFPA 80 (2010 edition) Standard for Fire Doors and Other Opening Protectives defines a fire door assembly as "any combination of a fire door, a frame, hardware, and other accessories that together provide a specific degree of fire protection to the opening."
Assemblies include, but are not limited to, the following components:
- Door frame
- Latch set and/or lockset
- Hinges
- Strike plate
- Door leaf including rating label
- Closer
- Glazing(glass) and glazing frame
- Coordinator
- Hinges
- Astragal
- Transoms or side lights
- Gasketing
- Protective Plates
- Exit hardware
- Flush Bolt
- Door holder/release device
Reference LS.02.01.10 EP9
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
For fire rated door assemblies in new horizontal exits, vision panels are required, according to section 18.2.2.5.6 of the Life Safety Code NFPA 101-2012.
If wired glass is used, and the vision opening is sized correctly according to NFPA 101-2012, Table 8.3.4.2 (does not exceed the area and dimension limits), then the wired glass is considered to be compliant. If glazed glass is used, regardless of whether the vision opening is sized correctly, the glass is to be labeled since that is the only way to determine if it is fire rated glass.
NFPA 13 (2012 edition) Standard for the Installation of Sprinkler Systems requires that "a building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers." The installation requirements may be found in Chapter 8 of that document.
Sprinklers are permitted to be omitted from some skylights (see 8.5.7.1); some concealed spaces (See 8.15.1.2); some spaces under ground floors, exterior docks, and platforms (see 8.15.6); some exterior roofs, canopies, porte-cocheres, balconies, decks, or similar projections (see 8.15.7); and some electrical equipment rooms (see 8.15.10.3). All of these exceptions have specific criteria that must be met in order to utilize them.
NFPA 101 (2012 edition) Life Safety Code allows some additional exceptions specific to Health Care Occupancies. From Section 18/19.3.5.5:
From Section 18/19.3.5.10:
Reference LS.02.01.35
Annex A in NFPA 25 (2011 edition) Standard for the Inspection, testing, and Maintenance of Water-Based Fire Protection Systems defines what is needed for a fire watch:
For organizations seeking CMS deemed status, from Federal Register Vol. 81, No. 86 Wednesday, May 4, 2016 Rules and Regulations, CMS states:
ֱ does not allow cameras to be used instead of on-site fire watches performed by personnel as described above. Cameras may be used as a supplement to fire watches by personnel, but not as a sole substitute. Cameras cannot replace human smell and hearing senses, and sight scanning and focusing abilities to identify smoldering, fire and smoke development in their early stages.
Reference LS.01.02.01 EP2
In order to evaluate and implement an effective plan for Life Safety code deficiency mitigation, an Interim Life Safety Measure
(ILSM) policy must consist of the following:
- State that the process is applicable to construction related situations and situations of non-compliance with the Life Safety Code.
- State circumstances that would require ILSM assessment, to include a statement that at all Statement of Condition, Plans for Improvement (PFIs) are to be assessed for ILSM.
- Describe how the organization will respond to situations described in LS.01.02.01.
- Describe how occupants are to be protected by using the available menu of interim life safety measures described in LS.01.02.01, as applicable to the situation.
- Describe the ILSM assessment process, to include an assessment tool to document which measure(s) will be implemented.
- Describe the ILSM implementation process, to be effective throughout the duration of the deficiency(s), and to include an implementation tool to document each implemented ILSM for the duration of its application.
The context of "immediate" is to allow for a fire-safe facility, either by correction of the identified Life Safety Code deficiency, or by implementing mitigating activities to compensate for the deficiency.
ֱ allows the organization to use their professional judgement and their knowledge of their facility's unique circumstances to determine the timeline associated with "immediate." That judgement would determine the timeline on "immediate" based upon the criticality and severity of the identified deficiency.
An Interim Life Safety Measures (ILSM) assessment must be made for any deficiency when it becomes apparent (immediately) to the organization. Survey-related Plans for Improvement (SPFIs) may be used when the organization cannot complete a deficiency related to NFPA 101-2012 of NFPA 99-2012 within 60 days of the survey event. The ILSM assessment must be identified in the SPFI once entered in the Statement of Conditions (SOC). If ILSMs are implemented, the validation documentation must demonstrate that the risks identified by the SPFIs are being mitigated.
Reference LS.01.01.01 EP 4
The requirements for interior finish in Health Care Occupancies may be found in NFPA 101 (2012 edition) Life Safety Code at Section 18/19.3.3 and are amended by Section 10.2.8.1 for sprinkled facilities.
In non-sprinkled Health Care facilities, the requirement for ASTM E 84 Class A or B wall finishes applies:
- Existing Health Care Occupancy may be either Class A or Class B
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016
- New Health Care Occupancy requires Class A with two exceptions:
- In individual rooms with a capacity up to 4 people, Class A or B is permitted
- Corridor wall finish up to a height of 48" above the floor may be either Class A or B
For sprinkled Health Care facilities, Section 10.2.8.1 allows Class C in any location where Class B is required as described above, or Class B in any location where Class A is required as described above.
For Ambulatory Health Care occupancies, the code points to Chapters 38 & 39 (Business Occupancy) for interior finish requirements. Both existing and New Ambulatory Health Care occupancies require Class A or B wall finishes in exits and exit access corridors and Class A, B, or C everywhere else. Similar to Health Care occupancy, the requirements are amended for sprinkled facilities by Section 10.2.8.1.
Beginning July 5, 2016 the Center for Medicare and Medicaid Services (CMS) adopted NFPA 101 (2012 edition) Life Safety Code and NFPA 99 (2012 edition) Health Care Facilities Code. Facilities that were designed and approved for construction by the authority having jurisdiction (AHJ) before this date are considered "existing" occupancies by the Life Safety Code. Facilities that were approved after that date are considered "new" occupancies. These codes include other NFPA documents by reference which are enforced as long as there is a code path from NFPA 101 or NFPA 99.
ֱ standards in the Comprehensive Accreditation Manuals are based on CMS's Conditions of Participation and have been approved by CMS. The Conditions of Participation that relate to the Life Safety Code standards are §482.41 for Hospitals, §482.41 and §485.623 for Critical Access Hospitals, §416.44 for Ambulatory facilities, §483.90 for Nursing Care Centers, and §418.110 for Home Care. Even though Behavioral Health facilities have life safety standards in ֱ Comprehensive Accreditation Manual, there are no CoPs for these standards.
You may view the Joint Commission standards that apply to your organization, and view whether each standard is related to a CMS CoP on your Extranet site under the Resources and Tools tab, E-dition. The standards may be filtered by the Life Safety Chapter on the left side. By clicking on the CoP number that is listed next to the Element of Performance (EP), you will see the language of the CoP.
LS.01.01.01 EP3 requires a hospital/organization to maintain "current and accurate drawings denoting features of fire safety and related square footage."
Where the entire building is considered business occupancy by the definition of NFPA 101 (2012 edition) Life Safety Code, life safety drawings are not required . For mixed occupancy buildings where portions of the building are business occupancy, and other portions are either health care occupancy or ambulatory health care occupancy, life safety drawings are required for the whole building, including the sections that are business occupancy.
For hospitals and ambulatory health care facilities, LS.01.01.01 EP 7 requires that "the hospital/organization maintains current Basic Building Information (BBI) within the Statement of Conditions (SOC)." Organizations that have free-standing business occupancy buildings shall list them in the SOC under "Sites and Buildings."
Reference LS.01.01.01 EP3, EP7
ֱ does not mandate a specific frequency for inspections by the Fire Marshal or other fire safety authority. It is up to the organization to determine the frequency, in cooperation with the fire marshal or other authority having jurisdiction. However, the Joint Commission will evaluate whether inspections are being done per the organization's policy. Insurance companies may have a frequency requirement, so that should be considered when determining the policy.
Standard LS.01.01.01 EP5 requires that the organization "maintains documentation of any inspections and approvals made by state or local fire control agencies." These will be reviewed during survey to determine whether the organization acts upon identified deficiencies in a timely manner.
- a legend that clearly identifies features of fire safety;
- areas of the building that are fully sprinklered (if the building is partially sprinklered; areas covered, not individual sprinkler heads);
- locations of all hazardous storage areas (both fire rated barrier types and smoke resistive barrier types);
- locations of all fire-rated barriers; locations of all smoke barriers;
- suite boundaries, including the sizes of the identified suites;
- locations of designated smoke compartments;
- locations of chutes and vertical (elevator and utility) shafts; and
- any approved equivalencies or waivers.
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that “the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers”
Life Safety drawings are floor plans of the building that identify life safety features as required by NFPA 101 (2012 edition) Life Safety Code. They are used during the survey as a reference tool by the life safety code surveyor to determine whether the built conditions are in compliance with (and are maintained to) the way the building was designed to protect occupants from being harmed due to fire. Because many health care facilities have occupants that are mostly incapable of self-preservation because of age or illness, the buildings require several types of fire safety features which are identified on the drawings.
LS.01.01.01 EP3 requires that "the hospital/organization maintains current and accurate drawings denoting features of fire safety and related square footage. Fire safety features include the following:
- Areas of the building that are fully sprinklered (if the building is partially sprinklered)
- Locations of all hazardous storage areas
- Locations of all fire-rated barriers
- Locations of all smoke-rated barriers
- Sleeping and non-sleeping suite boundaries, including the size of the identified suites
- Locations of designated smoke compartments
- Locations of chutes and shafts
- Any approved equivalencies or waivers
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as “existing” if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
Portions of buildings that are considered hazardous by the definition of NFPA 101 (2012 edition) Life Safety Code, shall be identified on the life safety drawings per the requirements of LS.01.01.01 EP3. There is no specific required method of identification. Some organizations identify them with a symbol, some use a hatch overlay. The method used should be shown on the drawing legend as identifying hazardous areas.
Even though many hazardous areas are required by code to have either 1-hr rated or smoke partition walls, it is not enough to simply have the walls of the hazardous area shown with the rating, as walls are often rated for other reasons.
The life safety drawings should also indicate whether the area is sprinkled and whether it is considered new or existing. Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Hazardous areas in health care occupancies are defined in Section 18.3.2 for new and 19.3.2 for existing. Hazardous areas in ambulatory health care occupancies are defined in Section 20.3.2 for new and 21.3.2 for existing and refer to 38/39.3.2 (business occupancy) for requirements.
The requirements for items stored in the corridor may be found at NFPA 101 (2012 edition) Life Safety Code, Section 18/19.2.3.4.
Computers on wheels are allowed in the corridor only when they are in use. When a staff member finishes using a computer on wheels in the corridor, the expectation is that it be relocated out of the corridor when not in use. Items are no longer considered "in use" when they have not been used or moved for at least 30 minutes. Although the Life Safety Code has not set this as a code requirement ֱ has established this as a timeline reference. They are not allowed to be parked in the corridor for charging.
The fire response plan and staff education should include relocating items in the corridor such as computers on wheels in the event of a fire to clear the way for egress.
Reference LS.02.01.20 EP14
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
Hospital Occupancy; LS.02.01.20/EP 14
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Items cannot be stored in corridors designated as egress access corridors no matter the width of the corridor.
The exception are crash carts, which are considered permanently in-use emergency medical equipment, and carts containing PPE for isolation when associated for a specific patient(s), which are also considered permanently in-use.
Wheeled items that are in-use, such as mobile computer on wheels, linen and housekeeping carts can be in the egress access corridor, if these are moved within 30-minutes.
In the event of an emergency in-use carts and equipment must be moved to provide unobstructed egress.
Alcoves in corridors can be used for storage as long as the stored items do not project into the corridor.
Dead-end corridors may be used for storage or sitting areas as long as it occupies less than 50 square feet of space and does not inhibit egress.
Additional Resources:
NFPA 101-2012: 18/19.2.2.3; 7.1.3.2.3; 7.2.2.5.3.1
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
Doors in means of egress are required to be opened without the "use of a tool or key from the egress side". Occupant movement cannot be restricted during an emergency; however, locking certain doors may be necessary for the safety of the patient in certain situations.
When a healthcare facility determines that doors must be locked to protect patients the locking configuration must comply with one of the following:
- Delayed-egress locking system as defined by NFPA 101-2012: 7.2.1.6.1
- Access-controlled egress door assemblies as defined in NFPA 101-2012: 7.2.1.6.2
- Elevator lobby exit access door locking compliant with NFPA 101-2012: 7.2.1.6.3
Pediatric units, maternity units, and emergency departments are examples of areas where patients might have special needs that justify door locking. Patients that require additional protective measures to ensure safety and security are allowed to have door locking arrangements provided that all of 5 criteria of NFPA 101-2012: 18/19.2.2.2.5.2 are met, in summary these are:
- Staff can readily unlock all doors at all times
- A total (complete) smoke detection system is provided throughout the locked space, compliant with NFPA 101-2012: 9.6.2.9, or locked doors can be remotely unlocked at an approved, constantly attended location within the locked space.
- The building is protected throughout by an approved, supervised sprinkler system in accordance with NFPA 101-2012: 18/19.2.2.2.5.2
- Locks are electrical and fail safe to release upon loss of power
- The locks release by independent activation of each:
- Activation of the smoke detection system NFPA 101-2012: 18/19.2.2.2.5.2(2)
- Waterflow in the automatic sprinkler system NFPA 101-2012: 18/19.2.2.2.5.2(3)
Additional Resources
LS.02.01.20
NFPA 101-2012: 18/19.2.2.2.4; 19.2.2.2.5
ֱ references the following National Fire Protection Agency (NFPA) editions in our standards and are used during surveys:
- NFPA 99 (2012) – as of July 5, 2016
- NFPA 101 (2012) – as of July 5, 2016
- Other NFPA resource editions can be found in Chapter 2 of NFPA 101 (2012) or NFPA 99 (2012)
If there is an impairment of a fire alarm or sprinkler system (see EC.02.03.05 for related systems), the clock starts at the time of the impairment. If the system is restored within the four hours for fire alarm systems or 10 hours (cumulative) for fire sprinkler systems, the clock stops. The time-frame noted for each system is a cumulative period of time over 24 hours rather than an individual occurrence. In other words, if the sprinkler system is taken offline for a repair for 8 hours, then later in evening it needs to go down for additional repairs for another 3 hours, then this meets the cumulative 10 hours in a 24 hour period.
LS.01.02.01 EP 2 requires notification and fire watch times to be documented. Additionally, according to the appendix in NFPA 101 (2012) for 9.6.1.6, those assigned to the fire watch should be specially trained in fire prevention, in fire department notification, and understand fire safety. Most State AHJs have specified that the person assigned to the fire watch should have no other duties and the area should be monitored consistently. Refer to your AHJ for further guidance.
Reference LS.01.02.01 EP 2
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as “fire block,” such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
NFPA 101 (2012 edition) Life Safety Code requires penetrations in fire-rated walls and assemblies to be sealed with a product that is UL-Listed for the appropriate fire rating of the wall or assembly.
Products that are marketed as "fire block," such as polyurethane expandable foam, are typically not UL listed for firestop application in a fire rated wall. These products are used in residential construction to restrict air movement in a wall cavity.
When choosing a fire stop product, look for products that are marketed for commercial use. Keep documentation on hand of the fire stop product and its UL Listing for surveyor review and inspection.
Reference LS.02.01.10 EP14
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
While ֱ does not survey for the requirements of Chapter 28/29 of the Life Safety Code pertaining to Hotels and Dormitories, within Health Care or Ambulatory Health Care occupancies, non-patient sleep rooms that are used by on-call staff fall under that description. The principals contained in those chapters are used to accommodate a non-patient overnight stay condition. Therefore, the Joint Commission requires a single-station smoke alarm in all staff/physician sleeping rooms in accordance with NFPA 101 (2012 edition) Sections 28/29.3.4.5 and 9.6.2.10.
The required single-station smoke alarm need not be a smoke detector that is interconnected to the fire alarm system. Per 9.6.2.10.4, alarms shall sound only within the individual area, and not activate the building fire alarm system unless otherwise required by the local AHJ. Remote annunciation is permitted.
Reference LS.02.01.34 EP10
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
NFPA 101 (2012 edition) The Life Safety Code requires that smoke barrier doors are self-closing or automatic-closing, constructed of 1 3/4-inch or thicker solid bonded wood core or rated for a minimum of 20-minutes, and fitted to resist the passage of smoke. The code does not require that smoke barrier doors have latching hardware.
Where latching hardware is installed on a smoke barrier door, it must be maintained so that it is functional or be removed.
Reference LS.02.01.30 EP20, LS.02.01.10 EP11
Smoke barrier walls in existing health care and ambulatory health care occupancies are required to have a ½-hour fire rating. In new health care and ambulatory health care occupancies, smoke barrier walls are required to have a 1-hour fire rating. When sealing penetrations in these walls, a material that is UL listed for the appropriate fire rating must be used.
- Facilities are classified as "existing" if final plans for construction, additions, renovations, or changes in occupancy were approved by the local authority having jurisdiction before July 5, 2016.
Reference LS.02.01.30 EP19
The 18-inch applies only to areas that have sprinklers installed.
Perimeter wall shelving and storage are allowed to extend from floor to ceiling level.
Additional Resources
LS.02.01.35
NFPA 13-2010
Once a new site (address) has been added to your Joint Commission E-App (General Application), within a few days the new site will automatically appear in your electronic Statement of Conditions, on the Sites and Building page.Once the site appears, or if the new building is at an existing site, building information can be created by selecting Manage SOC.If the site is not downloaded to your eSOC within four days, please contact your Account Executive.Instructions for completing the Statement of Conditions (SOC) and Basic Building Information (BBI) may be found by clicking on.
Reference LS.01.01.01 EP 7
The inappropriate use of antimicrobial medications contributes to antibiotic resistance and adverse drug events and improving antimicrobial prescribing practices is a patient safety priority. As a result, ֱ implemented an antimicrobial stewardship standard (MM.09.01.01) for the Nursing Care Center (NCC) accreditation programs on January 1, 2017.
Organizational Priority and Leadership Commitment
Organization leaders should be prepared to discuss how antimicrobial stewardship has been established as an organizational priority. Documents such as strategic plans, budget plans, and performance improvement plans may be helpful to illustrate the organization's efforts. Leadership commitment may also be reflected in an accountability document that describes the formal chain of responsibility for the antimicrobial stewardship program.
Education
Although Joint Commission surveyors will not be reviewing staff or medical staff/licensed practitioner records on education received regarding antimicrobial resistance and antimicrobial stewardship, they will inquire about the type of education provided by the organization. During patient tracers, surveyors may ask staff and licensed practitioners about the education they have received. Organizations may consider providing written material such as the organization's antibiogram (if available) to demonstrate compliance.
Antimicrobial Stewardship Multidisciplinary Team
ֱ is aware that the composition of the multidisciplinary team may vary based on the type of organization being surveyed, as well as the geographic location of the organization. This is the reason MM.09.01.01, EP 4 indicates that the four practitioners listed should be on the multidisciplinary team "when available in the setting." However, it would not be acceptable for an organization to have a team consisting of only a pharmacist and a nurse when physicians and other licensed practitioners are available in the organization (e.g., an infectious disease consultation team exists).
Antimicrobial Stewardship Program Components
The organization needs to have a document indicating how each of the core elements listed MM.09.01.01, EP 5 is addressed in its antimicrobial stewardship program. This information can be located in a separate document or can be included in other antimicrobial stewardship documents. Documentation does not have to be provided in a lengthy format but needs to describe how the core elements are addressed in the antimicrobial stewardship program.
A list of multidisciplinary protocols is provided for organizations to consider based on the care, treatment, and services delivered; they are not requirements.
Data Collection and Analysis
ֱ does not specify the type of antimicrobial stewardship data that organizations should collect. It is the organization's responsibility to identify which antimicrobial stewardship data it will collect, analyze, and report. Organizations are encouraged to review the CDC's Core Elements of Antibiotic Stewardship for Nursing Homes at for examples of measures that can be used to collect antimicrobial stewardship data.
Improvement Opportunities
Organizations need to use the antimicrobial stewardship data they have collected and analyzed to identify improvement opportunities for their antimicrobial stewardship program. If the data demonstrate that antimicrobial stewardship improvements are not necessary, the organization should share the data with the surveyor. If improvements are identified, the organization should be prepared to discuss the actions taken to improve the program.
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
Before a medication is added to an accredited organization's list or formulary, both staff and Licensed Practitioners are trained on the effects of the medication and the monitoring requirements. In addition, the healthcare provider must have access to laboratory and other diagnostic testingwhich may be required to monitor effectiveness and/or adverse events.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LIP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LIP controlled orders for the items listed at MM.05.01.01 EP 4.
No. Per MM 05.01.01 EP 1, retrospective review is not required when medications are ordered, prepared, and administered under LP control. Organizations should, however, consider the requirements at MM 08.01.01 in evaluating it's medication management system and assess risk points by randomly sampling and reviewing LP controlled orders for the items listed at MM.05.01.01 EP 4.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization’s medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by hospital policy.
The glossary of the accreditation manual describes a ‘range order’ as “Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual’s status.”
Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Organizations are responsible for determining the implementation process forhow range orders are entered into the medical recordand that staffare properly trained to ensure consistent implementation.It is alsothe responsibility of the organization’s leadership and medical staff to determine how these orders are interpreted. For example, if an order is written ‘Morphine 2mg-4mg every 6 hours’ and the patient is given 2mg, must the nurse wait until the 6 hours has passed to give another dose or may they give the remaining 2mg if the pain is not adequately controlled prior to the 6-hour interval ?
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization’s medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by hospital policy.
The glossary of the accreditation manual describes a ‘range order’ as “Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual’s status.”
Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Organizations are responsible for determining the implementation process forhow range orders are entered into the medical recordand that staffare properly trained to ensure consistent implementation.It is alsothe responsibility of the organization’s leadership and medical staff to determine how these orders are interpreted. For example, if an order is written ‘Morphine 2mg-4mg every 6 hours’ and the patient is given 2mg, must the nurse wait until the 6 hours has passed to give another dose or may they give the remaining 2mg if the pain is not adequately controlled prior to the 6-hour interval ?
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization’s medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by hospital policy.
The glossary of the accreditation manual describes a ‘range order’ as “Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual’s status.”
Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Organizations are responsible for determining the implementation process forhow range orders are entered into the medical recordand that staffare properly trained to ensure consistent implementation.It is alsothe responsibility of the organization’s leadership and medical staff to determine how these orders are interpreted. For example, if an order is written ‘Morphine 2mg-4mg every 6 hours’ and the patient is given 2mg, must the nurse wait until the 6 hours has passed to give another dose or may they give the remaining 2mg if the pain is not adequately controlled prior to the 6-hour interval ?
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
No, there are no Joint Commission standards that prohibit the use of range orders as long as such orders are permitted by the organization's medication management policy (see MM.04.01.01). In addition, range orders may be a component of other order types, such as taper orders and titration orders, unless prohibited by organizational policy.
The glossary of the accreditation manual describes a 'range order' as "Orders in which the dose or dosing interval varies over a prescribed range, depending on the situation or the individual's status."
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 hours prn severe pain.
- Hydromorphone 2mg tablets 1 – 2 tablets PO every 4 – 6 hours prn mild pain.
- Morphine 2 mg to 4 mg IV every 4 - 6 hours prn severe pain.
Compliance withapplicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.
Therapeutic duplication occurs when practitioners order more than one medication for the same indication. While this is an acceptable practice there must be clarity sought to determine when one agent should be administered over another, if both agents are to be given concurrently or if one therapy was to replace an existing therapy and wasn't discontinued properly. Such orders are commonly seen in orders for analgesics and anti-emetics but occurs other drug classifications as well (e.g. anti-hypertensives, anticoagulants, etc.)
When more than one medication is prescribed for the same indication, there must be a process in place to determine whether the ordering of multiple agents for the same indications is either an accidental prescribing error or intentional multi-modal therapy.
Joint Commission standards require medication orders to be reviewed by a pharmacist. Part of the review is to identify whether or not therapeutic duplication exists. Once this is identified, it is required that the pharmacist and nurse have a clear understanding of the intent of the prescriber. Organizations may utilize resources such as policies, technology within the electronic medical record or other means necessary to ensure such communication.
The intent is to ensure that medication orders are clear and accurate for all members of the patient care team involved in medication management. If the intent was that both medications be administered and the organizations policy allows for these orders, the pharmacy preparing the medication and the staff administering the medication need to have clear guidance provided.
For example, when a patient is prescribed multiple antiemetic agents, there must be a clear understanding of the following concerns:
- Was the intent of the prescriber to have all ordered medications given known by the prescriber, pharmacist, and the administering provider?
- When does the administering provider give each agent based upon the intent of the prescriber?
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
No. Standard MM.04.01.01 requires that a diagnosis, condition, or indication for use exists for each medication ordered. However, the indication can be anywhere in the medical record and need not be part of the order itself. For example, the indication may be part of the medical history, in the form of lab values, diagnoses, progress note entries, etc.
However, standard MM.04.01.01. EP2 requires organizational policy to designate when an indication for use is required as an element of a specific medication order. For example, an order written as 'Acetaminophen 650 mg po q4h prn for fever greater than 101' clearly definesthe indication when it would be appropriate to administer this medication.
ֱ has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids is outside the scope of the USP 797 chapter. ֱ will survey to organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies, procedures, staff education/competencies, etc., should also take into account:
- Product and device manufacturer's instructions for use
- Evidence-based guidelines for safe administration practices
- Applicable law and regulation
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
ֱ standards do not prescriptively require medications kept at the bedside to be locked, unless required by law and regulation. Organizations must ensure the medications are secure – meaning protected from unauthorized access, tampering, theft, or diversion. The requirements that address medication security are found in the Medication Management (MM) chapter of the accreditation manual at MM.03.01.01.
The requirementswill also apply to sample medications, and if permitted by the organization, to medications brought in by a patient or family.
Conducting a risk assessment is a helpful way of identifying risks associated with various options under consideration for securing medication. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability. The risk assessment prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a proactive risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Examples may include: root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
Intent
The intent of the requirement is to understand that anticoagulant medications are high-risk medications that may cause severe bleeding when not administered or monitored appropriately. Complex dosing requirements, insufficient monitoring, and inconsistent patient compliance can all contribute to adverse drug events or even death. The introduction of direct oral anticoagulants, as alternatives to heparin and warfarin, requires organizations to modify existing protocols and use evidence-based practice guidelines to address the initiation and maintenance of all anticoagulant medications and their associated risk factors. These requirements will promote patient safety and quality of care and are aligned with current recommendations from professional and scientific organizations.
The new and revised requirements address concepts related to:
- the use of approved protocols and evidence-based guidelines
- monitoring
- patient education
- family education
The revision of NPSG.03.05.01 applies to several programs. Hospital (HAP), Critical Access Hospital (CAH), Nursing Care Center (NCC), and Ambulatory Health Care (AHC) accreditation programs. It is important to acknowledge that not all EPs are applicable to all programs.
Within the AHC program, this NPSG only applies to organizations providing medical services, specifically those that an initiate, manage, and dose anticoagulant medications. NPSG.03.05.01 does not apply to Ambulatory Surgical Centers (ASCs).
Prophylactic Treatment
Patients taking oral anticoagulation medications need to be managed appropriately during the perioperative period to minimize bleeding risks during surgery. The decision to stop an anticoagulant, use a bridging medication, or to restart an anticoagulant should be based on organization-approved protocols and evidence-based practice guidelines that address the patient's bleeding risk and renal function, as well as the half-life of the medication.
This NPSG does not apply to routine situations in which short-term prophylactic anticoagulation is used for venous-thromboembolism prevention (VTE) (for example, related to procedures or hospitalization). However, NPSG.03.05.01 does apply to pharmacologic VTE treatment.
Anticoagulation Therapy
NPSG.03.05.01 only applies to patient's receiving "anticoagulation therapy". Thus, it only applies to patients receiving these drugs for therapeutic purposes, and not for flushes, etc. Subcutaneous heparin is used for therapeutic purposes; therefore, subcutaneous heparin is included.
In addition, this NPSG applies to all classes of anticoagulants with the exception of Antiplatelet Agents-GP IIb/IIIa inhibitors. The examples provided in the requirements are not an exhaustive list (Heparin, Low Molecular Weight Heparin, Warfarin, Direct Oral Anticoagulants).
Education
Non-adherence with anticoagulation therapy places patients at risk for bleeding and/or clotting that can lead to severe adverse drug events. It is important for patient and family education to emphasize medication adherence, dose and schedule compliance, drug and food interactions, and the need for follow-up appointments and ongoing laboratory tests. It is important to educate patients taking anticoagulants that some foods and medicines can cause adverse interactions that can lead to an increase risk of bleeding while others can lead to an increase risk of developing blood clots.
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
National Patient Safety Goal.09.02.01-EP1 requires the organization to evaluate the patient's risk for falls and take action to reduce the risk of falling as well as the risk of injury, should a fall occur. The evaluation could include a patient's fall history; review of medications and alcohol consumption; gait and balance screening; assessment of walking aids, assistive technologies, and protective devices; and environmental assessments.
It is helpful to identify medications that are frequently associated with increased risk of falling. Some suggested classifications are: hypnotics, sedatives, analgesics, psychotropics, antihypertensives, laxatives and diuretics. Please consider not only the class of drug, but the number of drugs (polypharmacy) and the potential for additive effects when they accumulate in the body that also increases risk.
The organization's fall reduction program is expected to include all patient/resident care settings and populations. We don't prescribe what the program must include but there must be something to address the risk of harm from falls for all of the organization's settings and populations. That includes the possibility that a specific unit or population had been assessed and determined to have a minimal risk of patient/resident harm from falls and that nothing further needs to be done for that setting or population. However, if a particular setting or population was simply ignored in the organization's program, then it would not meet the requirement.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
"Pressure ulcer" is a broader term that includes decubitus ulcers but also includes any ulcerations associated with pressure (e.g. prosthetic limbs or dental prostheses). "Decubitus ulcer" refers to the breakdown of skin and subcutaneous tissue due to prolonged, unrelieved pressure over a bony prominence, often associated with malnutrition, paralysis, or physical deformity.
"Pressure ulcer" is a broader term that includes decubitus ulcers but also includes any ulcerations associated with pressure (e.g. prosthetic limbs or dental prostheses). "Decubitus ulcer" refers to the breakdown of skin and subcutaneous tissue due to prolonged, unrelieved pressure over a bony prominence, often associated with malnutrition, paralysis, or physical deformity.
"Pressure ulcer" is a broader term that includes decubitus ulcers but also includes any ulcerations associated with pressure (e.g. prosthetic limbs or dental prostheses). "Decubitus ulcer" refers to the breakdown of skin and subcutaneous tissue due to prolonged, unrelieved pressure over a bony prominence, often associated with malnutrition, paralysis, or physical deformity.
"Pressure ulcer" is a broader term that includes decubitus ulcers but also includes any ulcerations associated with pressure (e.g. prosthetic limbs or dental prostheses). "Decubitus ulcer" refers to the breakdown of skin and subcutaneous tissue due to prolonged, unrelieved pressure over a bony prominence, often associated with malnutrition, paralysis, or physical deformity.
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
A multi-component approach is recommended. The plan of care for a resident at risk for developing a pressure ulcer should include the following:
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
A multi-component approach is recommended. The plan of care for a resident at risk for developing a pressure ulcer should include the following:
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
A multi-component approach is recommended. The plan of care for a resident at risk for developing a pressure ulcer should include the following:
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
A multi-component approach is recommended. The plan of care for a resident at risk for developing a pressure ulcer should include the following:
- Skin inspection, skin cleansing, care for dry skin, use of moisture barriers and massage
- Nutritional support based on an individualized nutritional needs assessment
- Avoidance of skin injury from friction or shear forces through the use of positioning, transferring and turning techniques
- A plan to maintain and, when appropriate, to increase mobility and activity level
- Improvement in positioning, repositioning, transferring and turning techniques to reduce skin injury caused by friction and shear force
- Use of repositioning devices, and mechanical loading and support surfaces to reduce skin injury caused by friction or shear force
- Staff educational programs on the assessment, prevention, and treatment protocols.
A validated risk assessment tool such as the Braden Scale or the Norton Scale should be used to identify residents at risk for developing pressure ulcers, NPSG.14.01.01 EP 3. Initial assessment should be done on the resident at the time of admission to the long term care facility. Recommendations for subsequent reassessment are weekly as well as whenever the resident's condition changes or deteriorates.
A validated risk assessment tool such as the Braden Scale or the Norton Scale should be used to identify residents at risk for developing pressure ulcers, NPSG.14.01.01 EP 3. Initial assessment should be done on the resident at the time of admission to the long term care facility. Recommendations for subsequent reassessment are weekly as well as whenever the resident's condition changes or deteriorates.
A validated risk assessment tool such as the Braden Scale or the Norton Scale should be used to identify residents at risk for developing pressure ulcers, NPSG.14.01.01 EP 3. Initial assessment should be done on the resident at the time of admission to the long term care facility. Recommendations for subsequent reassessment are weekly as well as whenever the resident's condition changes or deteriorates.
A validated risk assessment tool such as the Braden Scale or the Norton Scale should be used to identify residents at risk for developing pressure ulcers, NPSG.14.01.01 EP 3. Initial assessment should be done on the resident at the time of admission to the long term care facility. Recommendations for subsequent reassessment are weekly as well as whenever the resident's condition changes or deteriorates.
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
No. Each patient must have a history and physical performed and documented within 72 hours of admission as an inpatient. This includes weekend and holidays. History and physicals are dictated, transcribed, authenticated and placed in the medical/clinical record, based on organizational policy. When there is a transcription delay, a handwritten note signed by the licensed practitioner and placed in the record containing pertinent findings, (i.e., enough information record within 72 hours of admission for clinicians to manage the patient and guide the plan of) care would be acceptable.
A history and physical examination is to be performed by a Physician or a Licensed Practitioner (LP). However, this responsibility can be delegated to any qualified individual consistent with law and regulation and organization's policy. Before allowing the delegation of responsibilities the organization must determine - and be able to demonstrate -whether state law and regulation and professional practice acts allowssuch delegation and under what circumstances. The definition of LIP can be found in the glossary of the Accreditation Manual.
If state law and regulation and professional practice acts allows delegation of a history and physical examination then, the organization must have a process to ensure:
- Only authorized staff conduct history and physicals.
- Only authorized staff perform the components of a history and physical examination that have been delegated by a Physician or LP.
- The medical history and physical examination is performed under the supervision of, or through appropriate delegation by, a specific qualified physician who countersigns in accordance with law, regulation and organizational policy, and retains accountability for the patient's medical history and physical examination.
Enclosure Bed
- Use of an enclosure bed or net bed that prevents a patient from freely exiting the bed is considered a restraint. (An exception is the age-appropriate use of an enclosed crib for infants and/or toddlers.)
Restricting a patient's freedom from exiting the bed
- If raising the side rails prevents a patient from voluntarily getting out of bed or attempting to exit the bed, this would be restricting the patient's freedom of movement and the side rails would be considered a restraint.
- The number of raised side rails used may also be a factor. When all four side rails are used to prevent a patient from exiting the bed, this would be a restraint, however, raising fewer than four side rails when the bed has segmented side rails would not necessarily immobilize or reduce the ability of a patient to move freely. For example, if the side rails are segmented and all but one segment are raised to allow the patient to freely exit the bed, the side rails are not acting as a restraint. On the contrary, if the bed has non-segmented rails that when both raised does not allow the patient to freely exit the bed, the side rails would be acting as a restraint.
- If a patient is not physically able to get out of bed, regardless of whether the side rails are raised or not, raising all four side rails for this patient would not be considered restraint because the side rails have no impact on the patient's freedom of movement.
The use of restraints for the prevention of falls should not be considered a routine part of a fall prevention program. Use of restraints as a fall prevention approach has major, serious drawbacks and can contribute to serious injuries.
Protecting a patient from falling out of bed
- If raising the side rails prevents the patient from inadvertently falling out of bed, then it is not considered a restraint. Examples include raising the side rails when a patient is on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from inadvertently falling out of the bed.
- The mitts are pinned or otherwise attached to the bed/bedding or are used in conjunction with wrist restraints and/or
- The mitts are applied so tightly that the patient's hands or fingers are immobilized, and/or
- The mitts are so bulky that the patient's ability to use their hands is significantly reduced, and/or
- The mitts cannot be easily removed intentionally by the patient in the same manner they were applied by staff considering the patient's physical condition and ability to accomplish the objective.
It is important that the spiritual needs, beliefs, values and preferences be evaluated for patients receiving psychosocial services to treat alcoholism or other substance use disorders and those receiving end-of-life care. Each organization would determine how these needs will be identified as our standards do not define such elements. Examples to consider - but not prescriptively required by ֱ - may include the following questions directed to the patient or his/her family:
- Who or what provides the patient with strength and hope?
- Does the patient use prayer in their life?
- How does the patient express their spirituality?
- How would the patient describe their philosophy of life?
- What type of spiritual/religious support does the patient desire?
- What is the name of the patient's clergy, ministers, chaplains, pastor, rabbi?
- What does suffering mean to the patient?
- What does dying mean to the patient?
- What are the patient's spiritual goals?
- Is there a role of church/synagogue in the patient's life?
- How does your faith help the patient cope with illness?
- How does the patient keep going day after day?
- What helps the patient get through this health care experience?
- How has illness affected the patient and his/her family?
The complexity and pace of medical practice have increased greatly over the last few decades. At the same time, financial constraints have increased the pressure on physicians and other licensed practitioners (LPs) to see more patients in less time. Yet the most dramatic change in practice for many physicians and LPs has been the introduction of electronic medical records (EMRs).
While EMRs hold great potential as tools for improving the quality, safety, and coordination of care, the most immediate effect has been to increase the time required for documentation and order entry. To address the burden of using an EMR for routine recording of history and physical examination findings, retrieval of laboratory and radiography results, and order entry, many physicians, LPs, and health care organizations have begun to involve various health care professionals in assisting physicians and LPs with documentation.
Based on the request of stakeholders, ֱ reviewed the literature and conducted learning visits at two organizations to understand different models for providing documentation assistance. The goal for these activities was to identify potential quality and safety issues regarding current practices of documentation assistance. The Centers for Medicare & Medicaid Services (CMS) does not provide official guidance on the use of documentation assistance.
ֱ has previously defined scribes as unlicensed personnel and prohibited them from entering orders. However, due to the emergence of models including both licensed and unlicensed personnel of varying levels of skill and clinical knowledge, that previous definition is no longer valid or appropriate. There are individuals with the official title of "scribe" for whom documentation assistance is their only role, and there are individuals who perform dual roles that include clinical responsibilities as well as documentation assistance.
Quality and Safety
- Unqualified staff performing documentation assistance
- Unclear role and responsibilities when providing documentation assistance
- Documentation assistants using the physician log-in rather than independently logging in to the EMR
- Failure of physician or LP to verify orders or other documentation entered during clinical encounter
Competency -At a minimum, all persons performing documentation assistance have the education or training on the following:
- Medical terminology
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Principles of billing, coding, and reimbursement
- Electronic medical record (EMR) navigation and functionality, as appropriate based on job description
- Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
Policy and procedure -Each organization should develop a policy/procedure regarding processes associated with personnel providing documentation assistance. Policies may include proper log-in procedures (such as prohibition of documentation assistants from using the physician or LP's log-in), the scope of documentation that may be entered, requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
Job description -All organizations utilizing personnel to provide documentation assistance must have job descriptions that define the minimum qualifications to perform this function and the allowable scope of activities that can be performed. Job descriptions should also specify plans to periodically assess performance and continued competence.
- Orientation and ongoing training and education to the role must be provided.
- Organizations that contract for the services of a documentation assistant must ensure that the quality of the service is the same regardless of whether it is provided directly or through a contractual agreement. At a minimum, the organization should ensure the scribe meets all of the same competency and training described above.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
ֱ will continue to monitor the evolving use of documentation assistants in the field and recommends that organizations consult available resources for guidance.
Additional Resources
American College of Medical Scribe Specialists (ACMSS)
American Health Information Management Association ()
This information waspublished in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ֱ.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Any examples are for illustrative purposes only.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Dx and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control:
- Adults:
- Pediatrics:
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Dx and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control:
- Adults:
- Pediatrics:
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Dx and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control:
- Adults:
- Pediatrics:
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Office Based Surgery
ֱ has no prescribed list of recommended members for the emergency management committee. The organization should consider positions or persons that have primary responsibility and expertise associated with the phases of emergency management, as well as anyone who would have responsibilities in incident command for the organization. This includes mitigation, preparedness, response and recovery activities. For example, if the National Incident Management System (NIMS) is used, there should be representation at least from the areas of command, command staff, operations, planning, logistics, and finance/administration. Membership consideration could come from on-call lists, such as emergency medicine on-call, administrator on-call, house supervisor on-call, medical staff on-call and physical plant content experts on-call.
Just like the hazard vulnerability analysis (HVA) is used to establish the content of an emergency operations plan, the HVA can also be used to establish the expertise needed for the emergency management committee. Also, if the community emergency operations structure requires certain representation in an emergency management committee, then the organization should take that into consideration when setting up committee representation. EM.01.01.01 requires leaders of the medical staff to participate in emergency management planning activities, there it is recommended to have medical staff participation on the committee.
Volunteer Licensed Practitioners that have been granted disaster privileges may continue to provide care, treatment and services under the disaster privileging option (see EM.02.02.13) for the period of time the organization continues to operate under its Emergency Operations Plan (EOP). Organizations should periodically assess the number and specialty of those volunteer practitioners initially granted disaster privileges to ensure the ongoing needs of the patient population are being met and that the medical staff can maintain oversight over practitioner performance.
If an important patient care need continues at the time the organization discontinues operation of the EOP, the medical staff could either grant temporary privileges or consider granting full privileges.
NOTE: All Credentialing and Privileging must be consistent with applicable law, regulation and medical staff requirements.
Additional Resources:
FAQ: Emergency Management - Requirements for Granting Privileges During a Disaster
FAQ:Credentialing and Privileging - Temporary Privileges
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA,) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Ideally, the HVA should be adjusted each year based on real events and exercises conducted. For instance, an organization with frequent severe winter weather (snowstorms or blizzards) on their HVA, due to activation of the Emergency Operations Plan (EOP) most winters, should improve their EM plans as they learn lessons and improve their response/recovery for severe winter weather. Therefore, as their plans and response improves, the risk rating of severe winter weather should decrease, allowing other risks and vulnerabilities to become a focus.
The need for site-unique hazard vulnerability analysis (HVA) depends upon whether the off-site facility has different internal or external circumstances that would affect its ability to manage emergencies. If a site is in close proximity to the main facility, and participates in the main facility's emergency operations plan, then the organization may combine the off-site HVA with the main facility's HVA; the off-site facility must be identified. If the off-site facility has its own unique vulnerabilities in the context of its ability to provide services, then those vulnerabilities are to be assessed and are required to perform an HVA for that site.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
Reference EM.01.01.01 EP2, EM.03.01.01 EP1
Organizations are expected to have a hazard vulnerability analysis (HVA) which identify potential emergencies, for locations within the organization/facility and the community. The potential emergencies could affect demand for services and/or the ability to provide services. The HVA should take into account the likelihood of those events occurring and the consequences of those events. The HVA is documented and reviewed annually.
Although it is not uncommon for a unique hazard vulnerability to be identified for a remote facility, often the emergency operation plan is simply a documented process for temporarily stopping services since the off-site facility does not provide emergency services or any other care that cannot be deferred.
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
ֱ standard EC.02.05.07 EP7 requires that all automatic transfer switches are tested monthly. Testing activities are to be conducted in accordance with the manufacturer's instructions for use. There must be documentation of the result.
The monthly generator load test must include a complete simulated cold start along with automatic and manual transfer of all essential electrical system loads. It is best practice, but not a requirement, to initiate the load test with a different ATS each month.
The weekly inspection of the emergency power supply system (EPSS) as per EC.02.05.07 EP 4 requires that all associated components and batteries be inspected which include all ATS, battery chargers, radiator, fuel pumps, etc.
Each ATS is uniquely identified in the equipment inventory so that testing for each unique piece of equipment or device is tested to demonstrate that the testing and inspections have been completed as required.
The essential electrical system must be maintained to supply emergency power within 10 seconds of loss of normal power. If the 10-second criteria is not met during regular testing, the organization must have a process to confirm on an annual basis that the 10-second criteria can be met.
Reference:
NFPA 99-2012, 6.4.4.1.1
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.
System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
Utility system maps are important tools to be used when trouble-shooting a system problem and to isolate portions of the system when needed. Maps may be drawings, diagrams, tables, or other effective means that identify the location where a control device or equipment resides. When mapping a utility system, label components in accordance with their actual labeling in the field so they may be easily identified.
These maps often consist of construction as-built drawings, but many facilities have been altered in phases after the original construction, therefore it is important to have accurate, up to date information that includes how the various generations of these systems interconnect.System equipment that is to be identified may include but is not limited to:
- Heating Ventilating and Air Conditioning Systems
- Plumbing Systems
- Fire Protection Systems
- Med gas systems
- Electrical Systems
- Fire alarm systems
- Lighting
When planning for new, altered, or renovated space, the applicable standard is EC.02.06.05. The hospital manages its environment during demolition, renovation, or new construction to reduce risk to those in the organization.
ֱ expects organizations to assess building design and construction requirements based on local, state, and federal regulations and codes. Typically, an organization's controlling authority for this issue is their state health department licensing entity. The organization would have to check their licensing rules to determine their criteria and whether retroactive compliance is allowed.
When these entities are silent on a particular design criterion, ֱ recognizes the most recent edition of the Facility Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals for new construction and renovation.
Additional resources:
ֱ environment of care standard prohibits smoking, in all buildings. The scope of this element of performance prohibits all smoking regardless of type; tobacco, electronic, or other.
Smoking is a source of ignition regardless of the type, electronic smoking devices contain a heating element to develop the smoke or vapor. Additionally, electronic cigarettes typically contain lithium batteries which can pose a fire hazard.
ֱ standards provide provisions for allowing smoking in specific circumstances, which may include a designated smoking room with appropriate exhaust and fire safety features that are physically separated from patient care, treatment and service areas.
Emergency call stations are not required for restrooms designated for public use, such as those found in waiting and reception areas.
Nurse call device requirements are addressed in the most current edition of the FGI Guidelines for Design and Construction of Hospitals; Table 2.1-2 Locations for Nurse Call Devices in Hospitals.
There are several factors to consider when determining how much fuel a facility should have stored on site for running a generator.
If the generator serves as a component of an Essential Electrical System (EES) as required for critical care rooms and general care rooms by NFPA 99 (2012 edition) Health Care Facilities Code, Chapter 6, then the licensing authority (typically the state health department) should be consulted for applicable requirements.
"Basic Care" patient rooms in facilities, such as those used for inpatient behavioral health, do not require an EES. However, in many of these facilities, the generator is the alternate source of power for the illumination of the means of egress, emergency (task) lighting, exit lights, and/or the fire alarm system. NFPA 101 Life Safety Code requires these all to have a minimum duration of 1-1/2 hours (Class 1.5) (which may also be from a battery source).
ֱ Emergency Management Standard requires that hospitals plan for managing its resources and assets describing in writing the actions that will be taken to sustain the needs of the hospital for up to 96 hours based on calculations of current resource consumptions.The facility should assess how it would be affected if outside emergency support could not be obtained for 96 hours. This does not mean that they need to have 96 hours worth of fuel on site. The plan could include memoranda of understanding (MOUs) with suppliers to replenish fuel as needed during the emergency period. Additionally, the plan could be to operate without normal branch of power to reduce fuel consumption, to extend run-time of the available fuel. If the generator is used as the backup power source for the life safety branch of the electrical system, the facility should have enough fuel to run the generator for a least 1-1/2 hours for as long as the building is occupied.
The testing for an annual load bank test and the triennial exercise may be combined according to NFPA 110-2010: 8.4.9.7.
Summary of testing
Monthly load testing of at least 30% of the nameplate rating for 30 minutes for diesel powered emergency power supplies (EPS), see NFPA 110-2010: 8.4.9.1, EC.02.05.07 EP5 and EP6. The cool-down period (load disconnected) does not count as part of the 30 minutes test.
Annual load test (for situations not meeting monthly testing requirements) for diesel powered EPS
- at least 50% of the nameplate rating for 30 minutes
- at least 75% of the nameplate rating for 1 hour
- Total test duration of not less than 1.5 continuous hours, see EC.02.05.07 EP6
When combining both tests for diesel powered EPS, the first three hours of the test is required to be not less than 30% of the emergency generator nameplate kW rating or the minimum exhaust gas temperature. The last hour cannot be less than 75% of the emergency generator nameplate kW rating for a total of 4 continuous hours.
References:
- NFPA 110-2010 edition
- EC.02.05.07
When conducting the monthly test of a diesel-powered emergency generator as required by EC.02.05.07/EP 5; test of each emergency generator beginning with a cold start under load for at least 30 continuous minutes.
When conducting the monthly tests for diesel-powered emergency generators the dynamic load that is applied to the generator is at least 30% of the nameplate rating of the generator or meets the manufacturer's recommended prime movers' exhaust gas temperature.
If either the dynamic load is less than 30% of nameplate rating or the recommended exhaust gas temperature is not reached during the monthly test, then the diesel-powered emergency generator must be tested every 12 months using supplemental loads either dynamic or static.
This annual test is conducted for a total of 90 continuous minutes as follows:
- 30 minutes with a connected load of at least 50% of nameplate rating
- 60 minutes with a connected load of at least 75% of nameplate rating
Cool down period is not part of the 30 and 90 continuous minutes test duration.
Tests for non-diesel-powered generators need only be conducted with available load.
Additional Resources
NFPA 99-2012: 6.4.4.1
ֱ standard EC.02.05.07 EP 1 requires functional testing be performed on battery-powered emergency lighting systems used for exit signs, egress, and task lighting, at least monthly for at least 30 seconds in duration. Visual inspections of other exit signs are also required at least monthly.
In addition to the monthly 30 second test, the battery-powered emergency lights are tested every 12 months for a minimum duration of 90 minutes.
In locations that have undergone renovation, or modernization, and in new construction, where deep sedation and general anesthesia are administered the battery-powered lighting are tested annually for a duration not less than 30 minutes.
The test results and completion dates are documented.
Additional Resources:
EC.02.05.07
LS.02.01.20
NFPA 101-2012, 7.9, 7.9.3, 7.70.9,
NFPA 99-2012: 6.3.2.2.11.5
An emergency generator can be defined as a stationary device, driven by a reciprocating internal combustion engine or turbine that serves solely as a secondary source of mechanical or electrical power whenever the primary energy supply is disrupted or discontinued.
A stored emergency power supply system (SEPSS) is a system consisting of an uninterruptible power supply (UPS), or a motor generator, powered by a stored electrical energy source, together with a transfer switch designed to monitor preferred and alternate load power source and provide desired switching of the load, and all necessary control equipment to make the system(s) for which it is connected functional.
An uninterruptible power supply (UPS) is a device that powers equipment, nearly instantaneously allowing it to keep running for at least a short time when incoming power is interrupted. As long as utility power is flowing, it also replenishes and maintains the energy storage.
The decision to use one type over the other is usually determined by the required time for the emergency power systems to deliver electrical power. Engine driven generators can provide as long as the fuel supply is maintained. Hospitals with heavy electrical loads for critical care patient care requiring life support equipment, lighting, HVAC and other critical systems and the need to remain functional during uncertain emergencies opt for the engine driven electrical generators. SEPSS are typically used in smaller outpatient clinics, surgical centers and ambulatory facilities due to the lower acuity of the patients and that the duration that emergency power is required to be supplied is much shorter than an in-patient facility. Emergency power is required to allow staff and patients to exit the facility, and to treatments or therapy in progress to be halted and evacuate the patients. Runtimes for a SEPSS can be as short as a few minutes to as long as 90 minutes. Utilization of a UPS is typically to bridge the 10 second gap from power interruption to generator start time and is not to be considered a SEPSS.
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
Eyewash stations and emergency showers are flushing devices required in locations where workers are handling injurious corrosive or caustic chemicals. Any chemicals that have a pH less than 2.0 or greater than 11.5. Common corrosive chemicals used in health care, include but not limited to; glutaraldehyde, formaldehyde, bleach and sodium hydroxide (caustic soda).
These flushing devices are required by the Occupational Safety and Health Administration (OSHA). OSHA's requirements for emergency eyewashes and showers can be found in 29 CFR 1910.151(c): "Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use." OSHA refers employers to ANSI Z358.1-2014.
Requirements of this standard for an eye wash station include:
- assembled and installed in accordance with the manufacturer's instructions
- in accessible locations that require no more than 10 seconds to reach. The eyewash shall be located on the same level as the hazard and the path of travel shall be free of obstructions (no doors) that may inhibit its immediate use
- located in an area identified with a highly visible sign positioned so the sign shall be visible within the area served by the eyewash
- area around the eyewash shall be well-lit
- connected to a supply of flushing fluid to produce the required spray pattern for a minimum period of 15 minutes, 1.5 liters per minute (0.4 gallons per minute)
- flushing fluid is tepid, 16 to 38degrees Celsius (60 to 100 degrees Fahrenheit)
- if the possibility of freezing conditions exists, the eyewash shall be protected from freezing or freeze-protected equipment shall be installed
- if shut off valves are installed in the supply line for maintenance purposes, provisions shall be made to prevent unauthorized shut off
- The actuating valve once activated the valve shall remain open without requiring further use of the operator's hands (single action operation)
No, ֱ does not have an official definition of a 'fall', however a uniform definition is needed throughout the organization.Organizations are encouraged to check national guidelines (see "Additional Resources" below) and to check with their state to determine if any law/regulation exist defining a fall within the individual state.The organization should choose a definition appropriate for the patient/client population served.
For consideration, a fall may be described as an unintentional change in position coming to rest on the ground, floor, or onto the next lower surface (e.g. onto a bed, chair or bedside mat). The fall may be witnessed, reported by a patient, an observer, or identified when the patient is found on the floor or ground. Falls include any fall whether it occurred at home, out in the community, in an acute hospital, or ambulatory setting.
Additional Resources
Sentinel Event Alert: Preventing Falls and Fall-related Injuries in Health Care Facilities
There are no specificJoint Commission standardsthat prohibit the use of fans. While fans may be used for additional comfort of the patient, such as those with respiratory distress or post cardiac surgery, they may indicate to surveyors that a temperature control or ventilation problem exists, as described by EC.02.05.01. Space temperature issues can impact equipment, patient testing results, and overall patient care. This concern usually arises after adding equipment or use of the space without increasing the capability of space cooling/ventilation. The organization should perform a risk assessment per EC.02.01.01 that includes the most appropriate persons available to the organization.
Examples of assessment concerns could include:
- Risks pertinent to the needs of the patient
- Ventilation and/or temperature concerns for equipment
- Airborne particles/contamination that may impact patient care, procedure/treatment processes or equipment operation; maintaining the cleanliness of fan blades/housing; possible tripping hazard(s) created by cords; etc.
ֱ requirement for inspection of fire extinguishers is once per calendar month. There is no minimum and maximum requirement for the interval of days between monthly inspections, but best practice is to maintain an interval as close to 30 days as reasonably possible.
The date (MMDDYYYY) the inspection was performed and the initials of the person performing the inspection shall be recorded.
Reference EC.02.03.05
ֱ references the 2010 edition of NFPA 10 Standard for Portable Fire Extinguishers which is a mandatory reference in chapter 2 of the 2012 edition of NFPA 99, Healthcare Facilities Code.
The organization is expected to determine and select an appropriate fire extinguisher based upon a site-specific risk assessment that would include but not limited to:
- potential fire size
- types of fuels present
- sources of ignition
- flammable skin prep products
- potential for chemical reactions with the extinguishing agent
- presence of electrical equipment
According to the NFPA, a water-mist or carbon dioxide extinguisher may be used in the OR. Water mist-extinguishers are rated Class 2A:C. ECRI Institute has published information that water-mist fire extinguishers may not be appropriate in the operating room due to infection control concerns if used on a patients open surgical site cavity. Alternatively, a close-by basin of sterile water with a sponge to quench a surgical site fire might be most appropriate.
Carbon dioxide extinguishers are rated Class B and Class C, and can also be used for Class A fires.
Electrical fires or Class C, once the equipment is unplugged and de-energized, the fuel source is considered to be either a class A or B, allowing a carbon dioxide extinguisher to be utilized.
Additional Resources
The monthly emergency power system load test is to be initiated by a simulated or actual loss of normal electrical power.
There are 2 methods both of which are acceptable means of initiating the monthly test:
- A TEST Switch may be included on the automatic transfer switch (ATS) to simulate loss of normal power
- Alternatively, a circuit breaker feeding an ATS is opened resulting in a loss of normal electrical power
The duration of the test is to be at least 30-continuous minutes with a minimum dynamic load of at least 30% of the nameplate rating. The cool down period for the generator is not included as part of the 30-minute run time.
The monthly test is invalid if the generator is started and allowed to run for a period before activating the ATS to transfer the load to the generator. This does not fully test the generators ability to respond in actual emergency conditions, which require sensing loss of normal power and providing emergency power within 10 seconds from a cold start.
Additional Resources
EC.02.05.07 EP 5 and EP 6
NFPA 99-2012: 6.4.4.1
Grounds maintenance is to be in the context of safe ingress and egress to the health care facilities from where customers enter the campus. These include:
- Entry ways into the facility
- Emergency exits
- Vehicle parking
- Pedestrian walkways, sidewalks, ramps and stairs
- Patient drop-off zones
- Shuttle and bus stops
- Exterior lighting and signage
- Loading dock and equipment
- Helicopter landing pad
- Ambulance parking
ֱ is not prescriptive to a specific format for fire safety system inspection records and reports. Standard EC.02.03.05/EP 28 specifies the required information that must be included on the report documenting the maintenance, testing, and inspection activities for fire alarm and fire protection systems.
The required information for each service record must include the following:
- Name of the activity
- Date of the activity
- Inventory of devices, equipment, or other items
- Required frequency of the activity
- Name and contact information, including affiliation, of the person who performed the activity
- NFPA standard(s) referenced for the activity (including the edition and section)
- Results of the activity
Additional Resources
NFPA 25-2011: 4.3; 4.4;
NFPA 72-2010: 14.2.1; 14.2.2; 14.2.3; 14.2.4.
ֱ is not prescriptive regarding the temperature setting for blanket warmers.
Best practice would utilize evidence-based guidelines and recommendations by organizations such as but not limited to AORN and ECRI to determine optimal and safe temperatures for blankets to be warmed to. Both AORN and ECRI recommend maximum temperature setting of 130 degrees Fahrenheit (54 degrees Celsius) for blanket warming cabinets
Blanket warming equipment should be:
- maintained in accordance with manufacturer's recommendations
- loaded correctly and not exceed the level or quantity specified by the manufacturer's instructions for use (over-loading can be a source of fire)
- only contain items that the warming cabinet was designed for, blankets and fluids are not to be commingled in a warming cabinet unless specifically designed for that purpose
Crash carts and defibrillators are considered high risk medical equipment. ֱ does not require battery powered crash cart and defibrillator on standby to be plugged into an emergency power receptacle to maintain charging of the batteries. This is considered best practice. ֱ does require a process to be in-place to maintain the battery charge during a prolonged normal electrical power outage for battery powered crash cart and defibrillator on standby that are plugged into a normal power receptacle.Non-battery powered crash cart and defibrillator are required to be plugged into an emergency power receptacle during use.
Prior to initial use and following any major repair or upgrade to a fixed or portable medical device an electrical safety test is performed in accordance with NFPA 99 -2012: 10.3 Testing Requirements. Additionally, an operational or functional test is performed to ensure that the device performs as per manufacturer specifications, in accordance with test procedures in the manufacturer's instructions for use.
Any equipment transported between sites should be tested to ensure that the device the electrical safety and proper operation has not been compromised while in transit.
Reference
EC.02.04.03
NFPA 99 -2012: Chapter 10 Electrical Equipment
ֱ references OSHA's Bloodborne Pathogen Standard (1910.1030) that applies to occupational exposure to blood or other potentially infectious materials in healthcare settings. All organizations must follow this requirement.
Additionally, ֱ standard EC.02.01.01 requires organizations to conduct a comprehensive risk assessment to determine but not limited to:
- Type of containment devices
- Locations
- Patient population
- Secure storage and transit (access control)
- Procedures and controls to be implemented
- Potential adverse impact of equipment
- Potential risk to the occupants
- Potential risk to visitors (perhaps with small children)
NIOSH recommended wall mounting height:
- Standing workstation: 52 to 56 inches above the standing surface of the user
- Seated workstation: 38 to 42 inches above the floor on which the chair rests
Additional Resources:
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying risks associated with various options being considered to ensure safe storage of syringes and needles.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The services provided, patient population served and applicable law and regulation should be included in the assessment process. Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying risks associated with various options being considered to ensure safe storage of syringes and needles.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The services provided, patient population served and applicable law and regulation should be included in the assessment process. Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
ֱ does not have a standard to address needle and syringe storage. These items should be kept secure to protect from tampering or theft. A secure area may be described as an area where the staff is providing patient care, or staff is present and effectively ensures that access to the area or storage device is restricted to authorized individuals, and patients and visitors are not allowed access without the supervision or presence of a health care professional.
Organizations are expected to implement a process to identify safety and security risks associated with the environment of care that could affect patients, staff, and other individuals. Conducting a risk assessment is a helpful way of identifying associated risks and to assist you with developing and implementing a storage process specific to your organization's specific situation.
Based on risks identified, organizations may determine that use of a locking device or storage unit may be needed to prevent unauthorized access to these supplies. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
Reference EC.02.06.01 EP 1
NFPA 99 does not prohibit various medical gas cylinders from being stored in the same room as long as flammable and non-flammable gasses are not comingled. Typical medical gases whose storage can be comingled with oxygen include: Carbon Dioxide, Medical Air, Nitrogen, Nitrous Oxide, Helium, Argon, and Xenon. All criteria as specified in EC.02.05.09 applies as well as NFPA 99-2012 11.6.5.2 requiring full and empty cylinders to be segregated from each other.
As previously indicated, non-flammable medical gas cylinders cannot be comingled with; flammable materials, cylinders containing flammable gases, or containers containing flammable liquids. Typical flammable gases may include but are not limited to: Acetylene, Butane, Ammonia, Ethane, and Propane. This prohibition is addressed in NFPA 99-2012; 5.1.3.2.4.
Medical gas cylinders are also not allowed to be stored in an enclosure containing motor driven devices with the exception of cylinders intended for instrument air reserve headers that must comply with NFPA 99-2012; 5.1.3.9.5. This reference can be found at NFPA 99-2012; 5.1.3.3.4.2
Ice machines are appliances that require regularly scheduled maintenance.
The organization evaluates and determines maintenance activities and intervals of maintenance based upon manufacturer's recommendations and instructions for use.
Ice machines have an infection control risk due to waterborne pathogens. Particular attention to regularly scheduled cleaning, disinfection, and maintenance to prevent build-up of water deposits, mold, and other biologics.
Effective July 5, 2016, the Centers for Medicare and Medicaid (CMS) adopted the 2012 edition of NFPA 99, Health Care Facilities Code.
Facilities in which final plans were approved by the Authority Having Jurisdiction (AHJ) before July 5, 2016, are considered "existing." Section 1.3 of NFPA 99 does not require retroactive compliance in existing facilities unless alteration, renovation, or modernization has occurred or any of the organization's controlling authorities have specific requirements. Where a CMS Condition of Participation (CoP) or a Joint Commission Standard and Element of Performance (EP) refer to a specific requirement from NFPA 99, compliance is expected regardless of whether the facility is new or existing.
- Example: Section 5.1.4.8.4 of NFPA 99 requires that "Zone valve boxes shall be installed where they are visible and accessible at all times." This requirement also applies to existing installations because the requirements are referenced in the language of EC.02.05.09 EP 11 and CMS Tag K909.
The first NFPA 99 edition was published in 1984. The 1999 edition was adopted by ֱ and CMS in 2003. For the years between, use the edition required by the organization's controlling authority for health care construction. In order to be relieved of the 1999 edition requirements, the organization must know the applicable requirements of construction for their facilities.
ֱ references NFPA 99-2012 Chapter 9, that requires the use of ASHRAE 170-2008, Ventilation Table 7-1. This document provides allowances to exceed minimum temperature ranges. To use this exception, it must be done by following the established organizational policy. In accordance with the allowances, the policy or formal process must be limited to cases based on either surgeon, patient, or procedure. It is not acceptable to consistently maintain temperatures outside of the required ranges.
Reference EC.02.05.01 EP 15
Additional Resources:
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
Storing oxygen cylinders, as per NFPA 99-2012, 11.6.5.2, is about ensuring full and empty cylinders are not comingled. Those cylinders defined as 'empty' by the organization shall be segregated from all other cylinders that are intended for patient care use. Partials without an integral pressure gauge and those equipped with gauges with depleted volume content (as determined by the organization's policy) are to be stored with empty cylinders.
Full and partially full cylinders, as determined by organizational policy are permitted to be stored together. Empty cylinders shall be marked as such by either individual tagging, as indicated by the integral gauge (and defined by policy), or group signage, as appropriate.
For example, if a rack containing twelve cylinders are in an area and four of the cylinders are determined to be empty, they must be segregated from the other cylinders and labeled as empty to avoid confusion or delay if a full cylinder is needed in a rapid manner, per NFPA 99-2012, 11.6.5.2 and 11.6.5.3. If there is a separate rack designated for empty cylinders, the designation of this rack, would accomplish the "marking" of the cylinders by the nature of the rack being labeled.
Reference EC.02.05.09
Yes, management plans are required to cover each of the Environment of Care (EC) and Emergency Management (EM) chapters and are to cover all the functional areas of an organization. If care and service is provided in business occupancy sites then the plan must address any particulars that may differ from other occupancies within the organization.
The content of the organization's EC & EM plans and policies for those plans that address business occupancies should be designed to meet the needs of the organization. These will vary based on the nature and complexity of operations.Some standards may not apply to the business occupancy location at all, and this needs to be noted. The intent is to assure reasonable programs are in place and designed to meet the needs of the organization for all occupancies where patients are seen or treated.
Reference EC.01.01.01
There is no specific Joint Commission standard that requires the organization's governing board to approve environment of care management plans. EC.04.01.01 EP15 requires that the environment of care management plans be evaluated annually.This may be conducted by the governing board or another body such as the environment of care committee and the organization's leadership.
Management plans are not operational policies but provide a high-level framework for managing the environment of care (the physical environment). In other words, management plans should be a roadmap/outline to describe how the standards apply to the organization, and then describe how the organization will comply with the applicable standards.
Management plans should include, at a minimum:
- All facilities, spaces, equipment, people
- How risk is managed through planning, implementing, evaluating and evaluation of results
- Specific risks and unique conditions
- Scope, objectives, staff responsibilities and time frame for identified activities
- How leased spaces are addressed if care, treatment and services are conducted in those spaces
Policies are a set of rules around which work is accomplished. Plans provide the overview for the work done considering the policy.
For example, some organizations create a single, overarching policy to provide authority for and enforcement of the management plans. These management plans are dynamic documents which can be modified more readily than a policy. Additionally, management plans may reference several policies, procedures or other documents. Some organizations choose to have all plans in policy form. It is up to the organization to determine the best structure and format of their management plans to address their individual needs and circumstances.
Reference: EC.01.01.01
Standard EC.02.06.05 requires the organization to have a pre-construction risk assessment process in place, ready to be applied at any time if planned or unplanned demolition, construction or renovation occurs. Additionally, organizations must have a process that allows for minor work tasks to be performed in established locations or under particular low risk circumstances using predetermined levels of protective practices. The assessment covers potential risks to patients, staff, visitors or assets for air quality, infection control, utility requirements, noise, vibration and any other hazards applicable to the work.
ֱ does not prescribe a particular risk assessment and implementation process. Recommendations can be found in the most recent edition of the FGI Guidelines for Design and Construction of Hospitals and the Centers for Disease Control and Prevention (CDC).
Many organizations use an assessment matrix that applies the construction intensity to the risk level of the construction planned as well as the location of the project, resulting in specific protective practices to be implemented for the duration of the construction project.
Staff and contractors performing the work are to have working knowledge of the specific protective practices being implemented. The organization monitors the project to ensure that the implemented protective practices are being followed and adjusted to meet any unforeseen conditions.
ֱ does not require specific design or quality criteria for refrigerators that organizations decide to purchase.
It is recognized that medication or laboratory refrigerators would likely require a significantly higher level of design quality than a food refrigerator in order to maintain specific temperature ranges. Although not specifically required, refrigerators marketed by manufacturers to be medical grade typically are designed provide precise temperature control, and are constructed of more durable components (like metal construction, typically stainless steel).
Starting with an assessment of the items and products to be stored, the organization would be able to select the most appropriate level of quality and functionality for refrigerators to ensure proper consistent temperature conditions.
ֱ concurs with the Center for Disease Control (CDC) recommendation not to store vaccines in a dormitory-style or bar-style refrigerator. A dormitory-style refrigerator is defined as a combination refrigerator and freezer unit that is typically outfitted with one exterior door and an evaporator plate (cooling coil), which is usually located inside the freezer compartment. Performance testing revealed that this type of design results in generally unacceptable levels performance in maintaining a consistent temperature regardless of where vaccines were placed in the refrigerator
Additional Resources:
EC.02.06.01
ֱ does not require staff only refrigerators to have a thermometer installed or that temperature monitoring logs be documented.
It is always recommended to contact your state or local health department to confirm if there are any code requirements to your geographic location.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
- liquid or semi-liquid blood or other potentially infectious materials
- contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed
- items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling
- contaminated sharps
- and pathological and microbiological wastes containing blood or other potentially infectious materials.
Reference EC.02.02.01
The use of a Relocatable Power Tap (RPT) or power strip is addressed by standard EC.02.05.01 EP 23. These devices may also be called by other names such as power strips, multiple outlet connection and multiple outlet strip. These devices are not to be confused or considered electrical extension cords.
Per Condition of Participation (CoP) §482.41(d)(2):
- RPT in the patient care vicinity^are only used on movable patient care medical equipment and are permanently attached to the equipment and meet UL 1363A or UL 60601-1.
- RPT in the patient care vicinity may not be used for non-patient care electrical equipment, such as personal electronics, except in long-term care resident rooms that do not use patient care medical equipment.
- assembled by qualified personnel and meet the conditions of NFPA 99: 10.2.3.6.
- Power strips for non-patient care electrical equipment in the patient care rooms, but outside of the patient care vicinity, must meet UL 1363.
- In non-patient care rooms, power strips meet other UL standards.
- The RPT is permanently attached to the equipment assembly.
- The sum of the ampacity of all appliances connected to the RPT does not exceed 75% of the ampacity of the flexible cord supplying the RPT.
- The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.
- The electrical and mechanical integrity of the assembly is regularly verified and documented.
^ The "patient care vicinity" is defined as a space, within a location intended for the examination and treatment of patients, extending 6 feet beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7-foot 6-inches above the floor. For full text refer to NFPA 99-2012: 3.3.139
Reference EC.02.05.01/EP 23
ֱ is not prescriptive as to how risk assessments are performed. ֱ allows organizations to develop assessment methods that best suit their circumstances and preferences. Organizations may use assessment tools that they consider appropriate to achieve an outcome that will mitigate or eliminates the risk.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use and modify to their specific needs.
Examples of other tools are, but not limited to:
- Root Cause Analysis
- Failure Mode and Effect Analysis
- Strength Weakness Opportunities and Threat Analysis (SWOT)
- Gap Analysis
- Delphi Technique
- Outputs to Identify Risks
- Probability and Impact Matrix
Best practice approach is to report the results and recommended actions to a multi-disciplinary team such as the Safety, Environment of Care, or Infection Control Committee, to facilitate implementation of the actions required to minimize or eliminate risks in the physical environment.
Reference: EC.02.01.01
Environment of care standards do not require safety and security risk assessments to be done at any particular frequency, but reassessment is to be done when significant changes to the environment of care occur. It is a good practice to schedule assessments for high risk issues on a regular frequency in order to incorporate new tools or knowledge that may have become available.
EC.02.01.01 EP 1 requires organizations to implement a process to identify safety and security risks. Additionally, the risks should come from internal sources such as ongoing monitoring of the environment, results from root cause analyses and results of proactive risk assessments (see the EP for more information). Furthermore, EP 3 states the organization takes action to minimize or eliminate identified safety and security risks in the physical environment; meaning it's not enough to just identify, there needs to be follow up action.
An annual evaluation of safety and security management plans is a requirement, so annual risk assessments are helpful tools to identify goals and objectives, and to recognize changes that have occurred in the environment. Compliance with all elements of performance within the EC.02.01.01 standard for safety and security issues lend themselves to the assessment process because effective management depends upon analysis of the organization's particular circumstances. If an organizational policy establishes frequencies of assessment, then the established schedule is to be followed.
Reference EC.02.01.01 EP 1, EP 3
ֱ standard EC.02.01.01 requires that the organization identifies individuals entering its facilities. The organization is expected to determine who requires identification and how the process is implemented. There is also a requirement to control access to and from areas identified as security sensitive. The organization is held accountable for their policy on ID badges.
If the policy requires all staff and independent practitioners to wear ID badges, then all staff (including Physicians) would need to comply. Photo IDs, names on badges (first, last, both, one or the other, etc.) may be necessary as some states have specific standards.
There is no specific Joint Commission requirement for photo identification, nor is there required badge information. Check with the local or state Authority Having Jurisdiction for additional guidance. Surveyors will survey based on the organization policy.
Reference EC.02.01.01
ֱ defines "secure" as locked in containers, in a locked room, or under constant surveillance. Furthermore, in many cases, monitoring remotely via camera is not adequate in meeting constant surveillance if there is an opportunity for something to occur without the means to immediately react to minimize the risk.
Organizations are to conduct a risk assessment regarding unique security issues in accordance with standard EC.02.01.01. A course of action should be established that is both defensible and rational. The organization is expected to implement the course of action, then analyze if the desired effect was achieved.
Reference EC.02.01.01
ֱ does not require soiled utility rooms to be locked. Rooms that store more than 64 gallons of trash or soiled linen have doors that are self-closing and latching. Soiled utility rooms in behavioral health units are required to be self-closing and self-locking.
Organizations should conduct a risk assessment to determine whether locking is warranted for soiled utility rooms, other than those located in behavioral health units, to prevent unauthorized individuals access to potentially hazardous items.
Typical criteria used to evaluate the need for the door to lock may include:
- patient and visitor population, geriatric or pediatric patients and visitors
- risks residing within the room
- trash and linen chutes
- hazardous materials and waste
- sharps containers
- dangerous equipment
- soiled and contaminated items
Best practice in conducting a comprehensive risk assessment would include input from infection control, risk management, the safety officer, and consulting with your local authority having jurisdiction.
The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens regulation 1910.1030 states, "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure" and "Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present". ֱ expects organizations to follow applicable licensure requirements, laws and regulations. This includes OSHA's Bloodborne Pathogen regulations.
Health care organizations retain the ability to define and establish safe eating areas for staff members. An evaluation will determine what work areas represent the risks for contamination to food and drinks. Based on this assessment, organizations can designate a safe space for staff to eat or drink.
For example, an organization may determine that a nurse or physician station or other location is physically separated from other work areas subject to contamination and therefore reasonable to anticipate that occupational exposure is not likely.
Keep in mind that while OSHA regulations apply to all health care facilities, local health departments may have additional requirements that health care organizations must comply with.
Additional Resources
ֱ references NFPA 99-2012, Chapter 9, requires ventilation, temperature, and relative humidity to comply with ASHRAE 170-2008 for new, renovated, altered, or modernized areas of the facility.
Additional Resources
A read only copy of the ASHRAE standard can be accessed from this hyperlink:
Then scroll down the list to Standard 170-2008 Ventilation of Health Care Facilities.
The Environment of Care chapter applies to all facilities where the organization's patients are seen or treated. This includes leased facilities and business occupancies.
In leased facilities, the lease agreement should include a requirement for the availability of documentation associated with all applicable elements of the EC chapter. There should also be a process for regular compliance reporting by the host organization to the leasing organization.
Fire safety system maintenance requirements are found in EC.02.03.05. This standard does not require organizations to have the types of fire safety equipment and building features described by the elements of performance, however if these types of equipment or features exist within the building, then maintenance, testing, and inspection is be conducted and documented.
Reference EC.02.03.05
ֱ standards do not specifically prohibit all under-sink storage, a risk assessment should be performed to determine the organization's accepted practices, with a resulting policy established and disseminated to staff for implementation. The survey process will assess the policy for effectiveness and verify through tracer activity that the policy is being followed.
The risk assessment shall establish if anything stored under a sink could be damaged by a sink plumbing leak or the moist environment, and under-sink storage of those items shall be prohibited by the resulting policy. CDC guidelines do not support the storage of medical or surgical supplies under a sink. Other examples include reagent and chemicals that could have an adverse reaction if exposed to water/sewer/moisture, cleaned patient care equipment, etc. Trash bins or cleaning supplies located under sinks would typically not be an issue.
The organization should also determine if their local health department or state licensing/health organization has any prohibitions.
ֱ does not require electrical panels to be locked. The organization is to conduct a risk assessment, per EC.02.01.01, to determine the most appropriate policies for their circumstances.
Generally, electrical panels in certain patient care areas, such as pediatrics, geriatrics and behavioral health units, public spaces and corridors not under direct supervision are to be secure. This is the information to be considered on the risk assessment. Although emergency power panels should be given heightened scrutiny during the assessment process, there is no particular requirement to treat them differently. Electrical panels located in secure areas that are accessible to authorized staff may not need to be locked.
If an electrical panel is found to be unlocked during the survey process, and the surveyor evaluates the condition to be at-risk, then the organization should share their risk assessment with the surveyor. If the surveyor determines that the risk is still valid, then the organization would receive an observation(s) under EC.02.05.05.
NFPA 110 (2010 edition) Emergency and Standby Power Systems (EPSS) contains a Maintenance Schedule in Annex A that outlines the procedure and frequency for testing, inspection, and maintenance of the various components of an Emergency Power Supply System.
The requirements for the weekly emergency generator inspection required by EC.02.05.07 EP4 include an inspection of the prime mover, fuel system, lubrication system, cooling system, exhaust system, battery system, and electrical distribution system up to the automatic transfer switches. Running unloaded is not required and is discouraged because it can result in long-term problems such as wet stacking.
The requirements found in the Human Resources (HR or HRM) chapter of the accreditation manual found at HR.01.05.03 or HRM.01.05.01 (BHC)speak to both 'education' and 'training' that provide the foundation for competency. Education is the process of receiving systematic instruction resulting in the acquisition of theoretical knowledge. Training differs from education in that 'training' focuses on gaining specific – often manually performed – technical skills.
Competency requires a third attribute – ability. Ability is simply described as being able to 'do something'. The ability to do something 'competently' is based on an individual's capability to synthesize and correctly apply the knowledge and technical skills to a task.
Competency(see HR.01.06.01) differs from education and training in that competency incorporates all three attributes: Knowledge, technical skills, and ability - all are required to deliver safe care, correctly perform technical tasks, etc. Assessing competency, then, is the process by which the organization validates, via a defined process, that an individual has the ability to perform a task, consistent with the education and training provided.
Additional Resources
FAQ: Competency Assessment vs Orientation
Orientation
Orientation may be further described as an introductory program and/or activities intended to guide a person in adjusting to new surroundings, employment, policies/procedures, essential job functions, etc. Each organization is responsible for determining when and how long a person is considered to be in orientation.
The requirements found at HR.01.04.01 outline specific topicstobe included in an employee's orientation process and documented. For example, orientation to Key Safety Content that must be completed before staff provides care, treatment, and servicesoften include:
- Fire Safety and response
- Infection prevention and control
- Emergency response (code blue, rapid response, etc.)
- Active shooter
- Bomb threats
- Personal safety
- Emergency Management (internal/external disaster plans)
- Medical equipment failure and reporting process
- Utility system disruptions and reporting process
- Work schedule
- Employee attendance, time and resource management expectations
- Employee responsibilities in the event of an internal or external disaster
- Managing a patient's pain
- Sensitivity to cultural diversity
- Patient Rights
- Code of conduct expectations
- Infection prevention and control
- Maintaining privacy and security of protected health information; sometimes referred to as HIPAA training.
Competency assessment timeframes may vary greatly based on the individual's entry skill level and the complexity of the task(s) the individual will be required to safely perform.For example,demonstrating competency on performing a bedside glucometer test will takeless time to achieve than caring for a patient who has just undergone an open heart procedure that involves managing/monitoring complex equipment and highly refined assessment skills.
Because of the variability involved in both the number and complexity of competencies an individual must be deemed competent, organizations often give consideration to these factors rather than assigning a finite period of time in which competency must be achieved, however, this would be an organizational decision.
Whendetermining competency requirements, consideration should be given to needs of its patient population, the types of procedures conducted, conditions or diseases treated, the kinds of equipment it uses, and applicable law/regulations. Competency assessment then focuses on specific knowledge, technical skills, and abilities required to deliver safe, quality care.
Competency assessments for knowledge and technical skills intrinsic to an individual's professional education are generally not required. For example:
- Administration of oral, IM or sub-q medications may be intrinsic to professional education, but the use of a programmable infusion pump for IV administration may be a required competency.
- Basic assessment skills, such as heart/lung sounds may be part of education, but assessment skills required to care for patients on a neuro-surgical unit may require advanced competency assessments in evaluating a patient's neurological status.
- Basic infection prevention and control knowledge may be part of education, however, knowledge and skills related to sterile technique, sterilization, and high-level disinfection would be competenciesexpected of an OR Nurse, surgical assistants and sterile processing staff.
All standards in the Human Resource (HR) chapter apply to contract staff providing patient care, treatment or services.A well-written contract should specify that the contract organization will provide only staff who are qualified by education, training, licensure, and competence as defined by the organization. Simply contracting for services provided by another Joint Commission accredited organization does not assure compliance with the HR standards.
Examples of compliance may include (when applicable):
- The individual possesses the knowledge, experience and competence appropriate for his or her assigned responsibilities.
- Current license, certification, or registration confirmed via primary source verification.
- Meets the educational and experience requirements defined by the organization.
- Completion of health screenings and criminal background checks as required by law, regulation and organizational policy.
- Orientation to the policies and procedures, key safety content and specific job duties.
During a survey, the surveyor may ask to review files of contract staff to evaluate compliance. Only the information needed to demonstrate compliance should be provided. Organizations are NOT required to maintain redundant HR files on contracted staff or share the actual results of health screenings or criminal background checks, only that such requirements have been completed.
Through the contractual agreement, organizations determine which entity is responsible for obtaining and maintaining the required HR documentation. Accredited organizations are also required to monitor the provision of the contracted services provided based on the defined performance expectations. The requirements that address contracted services are found in the Leadership (LD) chapter of the accreditation manual at LD.04.03.09.
Examples of clinical contracted services may include, but are not limited to:
- Dialysis
- Pharmacy
- Dietary
- Environmental Services
- Laundry Services
- Agency/traveling staff (nurses, therapists, etc)
- Mobile imaging (CT, PET, MRI, etc)
The definition of a peer (see HR 02.01.03 EP 6) is someone from the same discipline. For example, physicians for physicians, dentists for dentists, podiatrists for podiatrists, etc. It does not have to be someone in the same specialty (orthopedist, etc.).
To be able to provide a recommendation, the peer must be familiar with the individual's actual performance. For a nurse practitioner, physician assistant, psychologist or social worker, ideally, this would be an individual from the same discipline. Therefore, the organization should attempt to obtain such recommendations. This could be an individual from within the same organization or someone from outside the organization. The organization determines the number of required peer recommendations.
In situations where there is no nurse practitioner, physician assistant, psychologist, or social worker to provide a peer recommendation, it is acceptable for a physician with like qualifications that is familiar with the practitioner's performance, to provide the recommendation. For example, an internist could provide a recommendation for a physician assistant, an anesthesiologist for a nurse anesthetist, a psychiatrist for a psychologist, and a psychologist, with similar responsibilities, could provide a recommendation for a social worker.
Practitioner credentialing is a critical safety issue for healthcare organizations that ensures clinicians have the necessary training and experience to provide safe care. ֱ standards for credentialing do not specify the methods by which credentials are obtained. Therefore, the use of Distributed Ledger Technology(DLT) to improve the efficiency of the credentialing process may be acceptable. However, should an organization choose to use technology such as DLT, it must evaluate their entire credentialing process to assure that all aspects of the accreditation requirements are included within the process. The use of DL technology does not guarantee full compliance with accreditation requirements, which can only be assessed on survey.
ֱ requires that organizations verify the identity of the applicant by viewing one of the following:
- A current picture organizational ID card
- A valid picture ID issued by a state or federal agency (for example, a driver's license or passport)
- Identity Assurance Level 2 (IAL2) credentials may be used as defined by the US Government's National Institute of Standards and Technology (NIST). The requirements to meet this standard are outlined in NIST Special Publication 800-63.
- To pick up the application
- For an interview by the department chair
- When arriving to first provide services
- When having their photo ID badge picture taken
- Use of a telecommunications link that includes both audio and video capabilities
If the verification is performed at a remote location, then the confirmation of the verification should be forwarded to the credentialing office for inclusion in the credentials file.It isNOT required or recommended that a copy of the photo ID be taken or placed in the credentials files due to potential for identity theft.
If the applicant provides only a copy of the photo ID, or a notarized document indicating the identity was verified by another entity, it would not satisfy the requirement for verification.
For telehealth service providers only
Applicant identity verification may be completed offsite at the distant (provider) location, as the practitioner never comes onsite where the patient is located. The organization determines the process for verifying practitioner identity.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., and organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., and organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., and organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., and organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., and organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Staff, students and volunteers who work in the same capacity as staff who provide care, treatment, and services, would be expected to have criminal background checks verified when required by law and regulation and organization policy. This means that if state law, regulation or organization policy requires background checks on all employees, volunteers and students, Joint Commission expects them to be done on all three categories.
If state law requires background checks on only specified types of health care providers (e.g. nursing assistants/child care workers), then Joint Commission would require background checks on only those specified in state law (unless organization policy goes beyond state law). If state law requires background checks on all "employees", the organization should seek an opinion from the state on what categories of health care workers are considered "employees". If the state clearly does not consider volunteers or students to be employees, then Joint Commission would not require background checks on them (unless organization policy goes beyond state law and requires it).
If state law is ambiguous as to the definition of employee, the organization can define the scope of background checks to fit its own definition. As such, they may include or exclude students and volunteers, and Joint Commission would survey toorganization's policy. In the absence of a state law on criminal background checks, each organization can develop its own expectations, e.g., an organization elects to screen employees and not students/volunteers. Joint Commission would evaluate compliance with the organization's internal policy only. There would be no Joint Commission expectation that an organization check categories of providers beyond what is required in their own policy, which must comply with law and regulation. All criminal background checks must be documented by the organization.
Yes. The standards in the human resource chapter apply tocontract and volunteerstaff providing patient care, treatment or services in the organization.
Contracted Staff: Organizations must manage contracted staff just as they must manage staff who are employees.The contract should specify that the contracted organization will provide only staff who are qualified in relation to their education, training, licensure, and competence as defined by the organization.
Volunteers: When volunteers perform patient care or services, organizations must manage volunteer staff just as they must manage staff who are employees.
Verification of Contract/Volunteer Information(when applicable):
- Education and training that is consistent with state law and regulation and organization policy.
- Evidence of license, certification, or registration.
- Evidence that individual's knowledge and experience and competence are appropriate for his or her assigned responsibilities.
ֱ standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.
For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions.
For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*. The moderate and high complexity personnel qualifications are located at 42CFR 493.1423(b)(1-4) and 42CFR 493.1489(b)(1-7), respectively. The regulations require specific levels of education, experience or both. In general terms, high complexity testing requires an Associate's degree or higher in a chemical, physical or biological science. Moderate complexity testing requires a high school diploma or an Associate's degree or higher in a chemical, physical or biological science. Note that there are also grandfathering routes specified at 42 CFR 493.1491 that may apply to some individuals.
When there is a State laboratory testing personnel license requirement, evidence of the individual's State license is acceptable to demonstrate the academic achievement. No further academic documentation (diplomas, degrees, transcripts) is required. This applies to physicians (MD, DO, DPM, DDS), midlevel practitioners, and testing personnel. Note that a State license must be primary source verified per Joint Commission standard HR.01.02.05. Also, evidence of laboratory credentials formerly granted by the federal government under the Department of Health Education and Welfare (HEW) are also acceptable and no further academic documentation is required.
Note that while other credentials may require an advanced degree, such as MT(ASCP), CLS(NCA) or an RN. license, these credentials are not specified as qualification routes in the federal CLIA regulations. Evidence of such credentials will not be considered a substitute for evidence of the education and experience required for testing personnel, except for nursing or other allied health licenses in states where non-waived laboratory testing is specified in the regulatory scope of practice.
Per the Survey and Certification guidance provided by CMS CLIA to its State Agencies, "If a high school is closed, it is possible for the individual to solicit documentation from the local school board or State Board of Education to verify graduation."
In summary, examples of acceptable evidence of qualification for non-waived testing include:
- Degrees, diplomas, G.E.D. or transcripts (Associate's degree and above for high complexity, high school diploma and above for moderate complexity)
- HEW Certification
- State laboratory personnel license
- Nursing or other state allied health license if laboratory testing (moderate or high complexity) is specified within the scope of practice
ֱ's,expectation is thatthe organization is aware of anyoneentering the organizationand their purpose in order to maintain patient safety. Leadership is responsible to ensure that the processes are in place and implemented to ensure patient privacy and safety.
For non-licensed, non-employees that have a direct impact on patient care. E.g. HCIRs or Vendorsin procedure rooms/operating rooms providing guidance to the surgeon or staff, trainingof staff on equipment use, surgical assistants brought in by surgeons additional requirements include:
- Taking steps to ensure that patient rights are respected, including communication, dignity, personal privacy and privacy of health information, as well as obtaining informed consent in accordance with organization policy and law/regulation.
- Awareness of applicable infection control and patient safe processes/procedures.
- For non-employees brought into the organization by licensedpractitioners,organizations must also addressqualifications, competency and performance evaluation.
After the organization obtains an initial NPDB query for each practitioner, use of "Continuous Query" (aka Proactive Disclosure Service) is acceptable for the ongoing NPDB information. To demonstrate compliance,the organization would need to have record of a baseline query and then share with the surveyors that no updates have been received from the NPDB. There does not need to be documentation in the record that no further communication has been received.
As with any NPDB information, the organization would review theinformation received (or confirm that no new information had been received) whenever they are granting a new privilege or renewing existing privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates:
Reappointment/re-privileging is due no later than two years from the same date from the previous appointment or reappointment. For example, if the reappointment period is July 15, 2017 through July 14, 2019, the reappointment date would be July 15, 2019.
Governing Body Approval Dates:
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in May, the board would approve all June reappointment/re privileging effective periods and in June the board would be approving all July reappointment/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
Due Dates
Reappointment/re-privileging is due no later than three^ years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter. For example, if the reappointment period is July 1, 2021 through June 30, 2024, the reappointment date would be July 1, 2024.
Governing Body Approval Dates
The reappointment/re-privileging dates do not need to match the governing body approval dates. The governing body should be approving effective periods in advance of the expiration date. For example, in June, the board would approve all July reappointments/reprivileging effective periods and in July the board would be approving all August reappointments/re-privileging effective periods. It would not be necessary to keep changing the effective period to match the date the board actually met and approved the appointment/reappointment or privileges.
^ Additional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame. The change will also be reflected in a future release date of the accreditation manuals.
Primary Source Verification (PSV) is required for confirming that an individual possesses a valid license, certification or registration to practice a profession when required by law or regulation. It is the responsibility of the accredited organization to complete PSV, not the licensed individual. The glossary of ֱ Accreditation Manual defines PSV as:
"Verification of an individual practitioner's reported qualifications by the original source or an approved agent of that source. Methods for conducting primary source verification of credentials include direct correspondence, documented telephone verification, secure electronic verification from the original qualification source, or reports from credentials verification organizations (CVOs) that meet Joint Commission requirements. See also credentials verification organization (CVO)." The definition of a CVO may be found in the glossary of the accreditation manual.
Selected agencies that have been determined to maintain a specific item(s) of credential(s) information that is identical to the information at the primary source are referred to as a 'designated equivalent source'. The glossary of the accreditation manual provides examples of such sources. Organizations are responsible for determining what method will be used to document that PSV was completed and must include the date the verification was conducted, who conducted the verification, what was specifically verified and the results of the verification. At the time of survey, surveyors evaluate compliance with completing primary source verification of licensure, certification, etc. Simply presenting a copy of a license in lieu of evidence thatprimary source verification was complete by the organization does not meet the intent of the requirement.
The requirements for completing PSV are found in the Human Resources chapter of the Ambulatory accreditation manual at HR 02.01.03 EP 3,(for training) EP 4 (for license) Also HR 02.01.05 EP 2 for Temporary privileges.
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Joint Commission standards require that when developing infection prevention and control activities, the organization uses evidence-based national guidelines or, in the absence of such guidelines, expert consensus. The is published by the CDC's Healthcare Infection Control Practice Advisory Committee (HICPAC).
Recommendation V.B.3.b.i. from the HICPAC guideline states, "Wear a gown whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient. Don gown upon entry into the room or cubicle. Remove gown and observe hand hygiene before leaving the patient-care environment."
Joint Commission surveyors will expect healthcare workers to wear a gown if their "clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient". The difficulty lies in "anticipating" when this may occur. For example, it is very probable that a nurses' aide preparing to perform a bed bath will have contact as described above, and therefore a gown would be expected. However, one of a large group of residents performing rounds with an attending physician would have a lower likelihood of clothing contamination.
Each organization may decide what guidance to provide to its healthcare workers within the parameters provided by HICPAC. However, ֱ would encourage organizations to consider the high morbidity and mortality of healthcare-associated infections in our nation when deciding what constitutes "anticipated contact" in each facility. Additionally, organizations may want to discourage non-essential personnel from entering the rooms of patients on isolation precautions.
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
- For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensedpractitioners, screenings must be made available in some cases, but each organization may decide whether these screenings are mandatory if not required by state law/local regulatory requirements. The health status of an applicant for medical staff privileges is also addressed in the HR chapter (AHC, OBS) or MS chapter (HAP and CAH).
- Treatment or referral must be initiated if the organization becomes aware of any individual, including non- employed physicians and other licensedpractitioners, who "have, or are suspected of having, an infectious disease that puts others at risk".(Action is needed only if the organization becomes aware of such an exposure).
- Treatment or referral is initiated if the organization becomes aware of any individual, including non- employed physicians and other licensed practitioners, who "have been occupationally exposed to an infectious disease". (Action is needed only if the organization becomes aware of such an exposure).
- The use of evidence-based national guidelines, such as the CDC, or, in the absence of such guidelines, expert consensus to develop an organizational plan for developing guidelines to prevent disease transmission in healthcare settings.
- Many states require such screenings for all healthcare workers, including physicians and licensedpractitioners.
- Biologically, all persons providing services in healthcare organizations are equally capable of transmitting disease.
- Legal and ethical considerations exist related to potential outbreak situations.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Immediate-Use Steam Sterilization (IUSS), formerly termed “flash” sterilization, is described as “the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field”. IUSS items are not intended to be stored for future use.
Considerations for IUSS:
• Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the
IFUs regarding cycle type, temperature setting, exposure time, and drying times.
• IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
• Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
• IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
• Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:
o When a specific instrument is needed for an emergency procedure.
o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
o When an item has dropped on the floor and is needed to continue a surgical procedure.
Identifying Gaps and Risk reduction strategies to consider:
• When ‘loaner’ trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery
occurssufficiently in advance of scheduled case(s)
to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract (see
LD.04.03.09).
• Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
• Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
o Review of manufacturer’s IFUs for both the device used for IUSS as well as the equipment/instruments being reprocessed to ensure compliance with
their guidelines.
o Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
o Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
• Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
• When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care (see LD.03.03.01).
• Ensure that sterilization practices, in all locations, have been fully incorporated into the organization’s Quality Assessment Performance Improvement (QAPI) activities (see LD.01.03.01 EP 21 and PI.01.01.01 EP 4).
• Evaluate the IUSS process in all locations that it is being performed. Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization (see IC.02.02.01 EP 2).
• Conducting a risk assessment is a helpful way of identifying risks and gaps in compliance with evidence-based guidelines and product manufacturer’s instructions for use. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided. The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization.
Resources:
• The Association for Professionals in Infection Control and Epidemiology (APIC)
• The Association of periOperative Registered Nurses (AORN)
• The Association for the Advancement of Medical Instrumentation (AAMI).
• CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
Any examples are for illustrative purposes only.
Immediate-Use Steam Sterilization (IUSS), formerly termed "flash" sterilization, is described as "the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field". IUSS items are not intended to be stored for future use.
Considerations for IUSS
- Review and adhere to manufacturer instructions for use (IFU) to determine if the device or instrument may be reprocessed via IUSS. If so, follow the IFUs regarding cycle type, temperature setting, exposure time, and drying times.
- IUSS does not imply that reprocessing steps, such as appropriate cleaning and transport, may be omitted. ,.
- Items are to be reprocessed in approved/validated containers/trays suitable for IUSS.
- IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.
Evidence-based guidelines should be adopted to minimize the use of IUSS.Scenarios when IUSS may be appropriate include:
- When a specific instrument is needed for an emergency procedure.
- When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.
- When an item has dropped on the floor and is needed to continue a surgical procedure.
- When 'loaner' trays or instruments (including those brought in by a provider)are used, establish an agreement with the vendor/provider requiring that delivery occurssufficiently in advance of scheduled case(s)to allow complete reprocessing of trays by the organization.Such a requirement is an example of a performance expectation to include in a contract (seeLD.04.03.09).
- Develop policies, procedures, staff orientation and competencies based on evidence-based guidelines.
- Regular rounding by Leadership experienced in sterilization practices to all areas where instruments are used and reprocessed is critical.Such rounds should include:
- Allowing sufficient time to actually observe reprocessing activities, including a review of any documentation requirements.
- Soliciting questions/concerns from staff responsible for performing IUSS and implement plans to reduce/eliminate concerns.
- Ensure there is a defined, evidence-based process in place for the premature release of items, to include documentation of IUSS.
- When limited resources are identified, work with Leadership to develop a plan to ensure sufficient resources are available to support the delivery of safe, quality of care.
- Ensure that sterilization practices, in all locations, have been fully incorporated into the organization's Quality Assessment Performance Improvement (QAPI) activities.
- Evaluate the IUSS process in all locations that it is being performed.Surveyors evaluate compliance based on the evidence-based guidelines, policies, procedures, practices and competencies adopted by the organization.
Resources
- The Association for Professionals in Infection Control and Epidemiology (APIC)
- The Association of periOperative Registered Nurses (AORN)
- The Association for the Advancement of Medical Instrumentation (AAMI).
- CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
NOTE: This FAQ does not apply to any clothing that has been designated by the organization as personal protective equipment (PPE) as defined by Occupational Safety and Health Department (OSHA): specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.)
ֱ standards do not require employers to launder surgical scrubs or other attire. However, ֱ's Leadership Standard LD.04.01.01 requires health care organizations to adhere to applicable federal (e.g. OSHA), state and local regulations (e.g., licensing requirements), and if deemed, Centers for Medicare and Medicaid Conditions of Participation and/or Conditions of Coverage. The hierarchical approach to infection control standards as described in ֱ Perspectives, April 2019, should be used to guide development of infection control related policies and procedures for laundering surgical scrubs or attire that is not designated as personal protective equipment and is worn in the healthcare setting.
Applicable elements to consider include the following:
- The OSHA Bloodborne Pathogen Standard requires that all clothing, including scrubs and personally owned attire such as uniforms or street clothing, which have been visibly soiled with blood or other potentially infectious materials, be laundered by the employer at no cost to the employee.
- For surgical scrubs, uniforms, or other attire not considered personal protective equipment and which are not visibly contaminated, organizations should determine if there any requirements that the facility provide clean attire to staff to perform their job duties. For example, some states, require that hospitals and ambulatory care facilities provide hospital laundered scrubs for healthcare workers working in the restricted or semi-restricted areas. State requirements may be more stringent and prescriptive than those from OSHA.
- To our knowledge, Center for Medicare and Medicaid Services (CMS) does not have any requirements for laundering surgical attire or uniforms. But as recommended by the Joint Commission and CMS, organizations should consult evidence-based guidelines for best practices and consider their adoption. Examples of guidelines include the Guideline for Surgical Attire (effective July 1, 2019) from the Association for periOperative Nursing (AORN), the AST Guidelines for Best Practices for Laundering Scrub Attire (revised April 14, 2017) from The Association of Surgical Technologists and the Statement on operating room attire (approved July 2016) from the American College of Surgeons.
Additional Resources:
See also the Perspectives®, April 2019, Volume 39, Issue 4 Page 15:Clarifying Infection Control Policy Requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer’s technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Examples are for illustrative purposes only:
Scenarios - These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer’s instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis.
For deemed organizations, the Centers for Medicare and Medicaid Services requires that “Hospital policies address steps to take when there are discrepancies between a device manufacturer’s instructions and automated high-level disinfection equipment manufacturer’s instruction for completing high-level disinfection” or “the sterilizer manufacturer’s instruction for completing sterilization.” ***
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
***Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
- Promote and administer recommended vaccines for healthcare workers and patients (e.g., seasonal influenza, COVID-19 primary series and recommended booster doses)
- Take steps to minimize potential exposures within the healthcare setting.For example, before arrival to the healthcare setting, consider exploring alternatives to face-to-face triage and visits, such as the use of telehealth, when clinically appropriate.Triage/screen patients and provide clear instructions on preventive actions to take upon arrival for patients with symptoms of respiratory infection.
- Upon arrival and during the healthcare visit, post visual alerts to provide patients and healthcare workers with instructions about respiratory hygiene, cough etiquette and any requirements for masks as source control (e.g., strategically placed posters, handouts, etc.).
- Ensure supplies (e.g., tissues, masks, hand sanitizer, etc.) to implement respiratory hygiene, cough etiquette, hand hygiene and source control if applicable are available for patients, visitors and healthcare providers at strategic locations (e.g., entrances of facility, waiting rooms, at patient check-in, etc.)
- Follow organizational processes for the management of ill healthcare providers
- Adhere to infection control precautions for all patient-care activities including standard precautions and transmission-based precautions
- Perform environmental cleaning and disinfection
- Consider implementing engineering infection control measures to reduce or eliminate exposures by shielding healthcare workers and other patients from infected individuals (e.g., curtains, solid barriers, etc.)
- Enforce administrative policies that promote and facilitate adherence to the recommendations among the various people within the healthcare setting, including patients, visitors, and healthcare providers
Local or state department of public health may require healthcare settings to implement additional strategies to prevent transmission of respiratory viruses during periods of increased burden of respiratory viruses in the community. Organizations should have a routine way of identifying added requirements such as enrollment in their local alert system and\or the CDC's Health Alert Network.
Links to the website referenced in this FAQ contain additional information that may be helpful in the development of organizational processes to prevent the spread of respiratory viruses in healthcare settings, however, organizations should ensure they are accessing the most recent publication prior to implementation.
Resources:
No, there is no requirement that all surgical procedures be included in an organization's surveillance for surgical site infections (SSI). We expect organizations to follow a hierarchical approach when establishing infection surveillance. We would first expect organizations to follow applicable federal and state law and regulation, then if deemed or required by state regulation, to follow CMS requirements. Some states have specified surgical procedures for which surveillance must be performed. If mandated by your state, then the Joint Commission would expect your organization to be compliant to that requirement.
In the absence of federal/state mandates for specific surgical site infection surveillance requirements, organizations may choose to target SSI surveillance based on the results of a risk assessment. If an organization's risk assessment shows that risk is greatest for certain procedures or settings, the surveillance program may be targeted to focus resources on those high-risk procedures. Organizations may wish to consider conducting periodic risk assessments to ensure that the scope of the targeted procedures included in surveillance activities remains current. Conducting a risk assessment is a helpful way of identifying risks associated with various procedures performed. A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
The risk assessment should focus on all components of the surgical continuum, including – but not limited to - staff knowledge and competency, adoption of – and compliance with - evidence-based guidelines for reprocessing of instruments, policies and procedures, surgical attire, practitioner engagement, and patient education. Compliance with any state-specific reporting requirements should also be evaluated. From a quality and safety perspective, ensure that surgical procedures performed in all locations have been integrated into the organization-wide quality assessment and performance improvement (QAPI) program.
Additional Resources
Intent
Standardized formats and terminology help ensure consistency in use and understanding of information when used by different individuals for various purposes. Standardization also adds clarity to information when dealing with symbols and abbreviations that may have different meanings, depending on the context of use. Use of standardized formats for numeric values, such as medication dose designations and laboratory values add precision that reduces the risk of error when interpreting such information.ֱ does not publish a list of approved abbreviations, etc.
Standardization
Organizations are expected to use standardized terminology, definitions, abbreviations,acronyms, symbols, and dose designations. Any reasonable approach to standardizing abbreviations, acronyms, symbols, etc. is acceptable. Examples include:
- Standardized abbreviations developed by the individual organization.
- Use of a published reference source. However, if multiple abbreviations, symbols, or acronyms are used for the same term, the organization clarifies what will be acceptable.
Prohibited Abbreviations (^)
IU
Q.D., QD, q.d., qd
Q.O.D., QOD, q.o.d, qod
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
MS
MSO4
MgSO4
The prohibited list applies to all orders, preprinted forms, and medication-related documentation. Medication-related documentation can be either handwritten or electronic. Organizations may also wish to review other sources that have identified additional error-prone abbreviations, such as those published by the
Use of a trailing zero
A trailing zero may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report the size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.
^NOTE: Prohibited abbreviations that are hard-coded into electronic health records by the software vendor in a manner that prevents the organization from editing, is acceptable. However, any user-defined or customizable fields/forms created by the organization must not include prohibited abbreviations, acronyms, etc. Medication labels that contain prohibited abbreviations from the manufacturer are acceptable.Organizations contemplating adding or upgrading CPOE/EMR systems should strive to eliminate prohibited abbreviations as well as acronyms, symbols and dose designations that may create risk from the software.
ֱ standards require organizations to comply with applicable law and regulation to ensure the privacy and integrity of protected health information (PHI) are maintained. When an organization's staff is not present to monitor medical records storage areas, alternative approaches must be employed to protect privacy and confidentiality of this information. Keeping such information secure when staff is not present generally requires a process that includes a locking mechanism. The use of alternative approaches, such as a signed confidentiality statement in lieu of a locking mechanism, should be thoroughly evaluated by the organization's legal and risk management leadership to determine if such approaches comply with regulatory requirements (CMS, state law/regulation, etc.).
In conclusion, all areas should have a process in place for maintaining the security and integrity of PHI. The adopted processes should be subject to security audits that can identify system vulnerabilities and policy violations. Signed, confidentiality statements alone may not necessarily result in the proper security and integrity of PHI. Additionally, per IM.02.01.03, the hospital must follow their policy regarding security of health information. Such a policy may include who has access to medical records when staff is not present to monitor the records. The policy should also address all areas where medical records are stored.
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(*).
1. Rules or regulation: States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
2. Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states “Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas.” and “Surgical masks are worn fully covering mouth and nose
by all personnel in restricted areas where open sterile supplies or scrubbed personnel are located.”
3. Manufacturer instructions for use:Instructions for use of medical equipment or devices may include instructions for particular attire during use.
4. Evidence-based guidelines and consensus statements: If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
5. Facility policy:Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization’s chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
(*) Excerpt fromApril 2019 edition of the PerspectivesNewsletter:
Infection Control needs vary across the United States because of different state and local regulations, devices and equipment, and patient care practices. ֱ’s Leadership (LD) standards require organizations to adhere to applicable federal, state, and local regulations and laws. ֱ recommends that health care organizations, when creating or revising IC–related policies, apply a hierarchical method to address the various IC requirements relevant to the organization. The following graphic illustrates the hierarchy of various references that organizations should use as they draft and/or revise their IC–related policies. Not all references will have information an organization needs to include in its policies, but all required references should be reviewed and considered.
Hierarchical approach:
2. Conditions of Participation
3. Manufacturer's Instructions For Use
4. Evidence-based Guidelines
5. Consensus documents
6. Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(*).
1. Rules or regulation: States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
2. Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states “Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas.” and “Surgical masks are worn fully covering mouth and nose
by all personnel in restricted areas where open sterile supplies or scrubbed personnel are located.”
3. Manufacturer instructions for use:Instructions for use of medical equipment or devices may include instructions for particular attire during use.
4. Evidence-based guidelines and consensus statements: If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
5. Facility policy:Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization’s chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
(*) Excerpt fromApril 2019 edition of the PerspectivesNewsletter:
Infection Control needs vary across the United States because of different state and local regulations, devices and equipment, and patient care practices. ֱ’s Leadership (LD) standards require organizations to adhere to applicable federal, state, and local regulations and laws. ֱ recommends that health care organizations, when creating or revising IC–related policies, apply a hierarchical method to address the various IC requirements relevant to the organization. The following graphic illustrates the hierarchy of various references that organizations should use as they draft and/or revise their IC–related policies. Not all references will have information an organization needs to include in its policies, but all required references should be reviewed and considered.
Hierarchical approach:
2. Conditions of Participation
3. Manufacturer's Instructions For Use
4. Evidence-based Guidelines
5. Consensus documents
6. Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(*).
1. Rules or regulation: States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
2. Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states “Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas.” and “Surgical masks are worn fully covering mouth and nose
by all personnel in restricted areas where open sterile supplies or scrubbed personnel are located.”
3. Manufacturer instructions for use:Instructions for use of medical equipment or devices may include instructions for particular attire during use.
4. Evidence-based guidelines and consensus statements: If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
5. Facility policy:Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization’s chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
(*) Excerpt fromApril 2019 edition of the PerspectivesNewsletter:
Infection Control needs vary across the United States because of different state and local regulations, devices and equipment, and patient care practices. ֱ’s Leadership (LD) standards require organizations to adhere to applicable federal, state, and local regulations and laws. ֱ recommends that health care organizations, when creating or revising IC–related policies, apply a hierarchical method to address the various IC requirements relevant to the organization. The following graphic illustrates the hierarchy of various references that organizations should use as they draft and/or revise their IC–related policies. Not all references will have information an organization needs to include in its policies, but all required references should be reviewed and considered.
Hierarchical approach:
2. Conditions of Participation
3. Manufacturer's Instructions For Use
4. Evidence-based Guidelines
5. Consensus documents
6. Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
ֱ standards do not prescribe operating room dress\surgical attire. To determine the appropriate requirements for a given organization, surveyors will review facility practices and policies to determine if they have followed the hierarchical approach to infection control standards that was published in the April 2019 edition of Perspectives(^).
Rules or regulation -States may have established their own dress code requirements or adopted a version of Association of periOperative Registered Nurses (AORN) or other guidelines. Organizations are advised to contact their local health authority for further information about state specific requirements.
Centers for Medicare and Medicaid Services(CMS) requirements if the organization is deemed. For example, the states "Surgical attire (e.g., scrubs) and surgical caps/hoods covering all head and facial hair are worn by all personnel and visitors in semi restricted and restricted areas." and "Surgical masks are worn fully covering mouth and nose
Manufacturer instructions for use -Instructions for use of medical equipment or devices may include instructions for particular attire during use.
Evidence-based guidelines and consensus statements -If none of the situations above apply and are not specifically required by a Joint Commission standard (e.g., standard precautions or transmission-based precautions), organizations can choose which guidelines or consensus statements they will follow based on their own evaluation process. For example, the Association of periOperative Registered Nurses (AORN) publishes Guidelines on Surgical Attire, the Association of Surgical Technologists (AST) has published Standards of Practice for Surgical Attire, and the American College of Surgeons have a Statement on Operating Room Attire.
Facility policy -Surveyors will survey to facility policy. It is expected that the policy is in compliance with the first three items stated above and, as applicable, the organization's chosen evidence-based guidelines and consensus statements.
The following examples are meant to be helpful and may not necessarily be required by Joint Commission standards:
- In the state of Illinois Hospital and Ambulatory Surgery Center regulations it states in the restricted area, "Cloth head coverings shall be laundered by the hospital. Additional garments shall be completely contained or covered within the scrub attire." According to organizational policy, the facility follows AORN guidelines 1.7.1 "Establish and implement a process for managing personal clothing that may be worn under scrub attire" and 5.3.1 "An interdisciplinary team, including members of the surgical team and infection preventionists, may determine the type of head covers that will be worn at the health care organization." The policy states that staff may wear long sleeve shirts under hospital scrub attire as long as they are not scrubbed into a case and cloth head coverings that they launder at home. This organization could be found out of compliance with Joint Commission standards because organizations must follow state licensing requirements.
- A non-deemed ambulatory surgery center creates a multidisciplinary team to create a dress code policy. They review state regulations, manufacturer instructions for us, and evidence-based guidelines. The team reaches consensus and establish a policy that staff may wear long sleeves shirts under scrub attire and cloth caps may be worn so long as staff are not scrubbed into a case and reference AORN guidelines. The organization would be found in compliance with Joint Commission standards.
Hierarchical approach
- Regulation
- Conditions of Participation
- Manufacturer's Instructions For Use
- Evidence-based Guidelines
- Consensus documents
- Organization's Infection Prevention and Control Policy (Note:Facility policy cannot be used to justify non-compliance with regulatory or device\ product use requirements. Also see FAQ on Manufacturer Instructions for Use).
- Establish performance expectations
- Communicate the performance expectations, in writing, to the service provider
- Monitor performance based on the expectations, and
- Take steps to improve contracted services that do not meet expectations
- Evidence the contract applies to the 'local' organization
- Leadership awareness of the requirements listed in the Leadership chapter at LD.04.03.09 EP 4 – 6 and has knowledge of the established performance expectations
- Reviews data to support the above elements of performance
- Takes action to improve contracted services that do not meet performance expectations
Leaders must oversee contracted services to make sure that they are provided safely and effectively. The only contractual agreements subject to the requirements at Standard LD.04.03.09 are those for the provision of care, treatment, and services provided to the hospital's (organization's) patients. This standard does not apply to contracted services that are not directly related to patient care, treatment, or services. The EPs do not prescribe the methods for evaluating contracted services; leaders are expected to select the best methods for their hospital (organization) to oversee the quality and safety of services provided through contractual agreement.
Examples of sources of information that may be used for evaluating contracted services include the following:
- Review of information about the contractor's Joint Commission accreditation or certification status.
- Direct observation of the provision of care.
- Audit of documentation, including medical records.
- Review of incident reports.
- Review of periodic reports submitted by the individual or hospital providing services under contractual agreement.
- Collection of data that address the efficacy of the contracted service.
- Review of performance reports based on indicators required in the contractual agreement.
- Input from staff and patients.
- Review of patient satisfaction studies.
- Review of results of risk management activities
Effective October 15, 2020,ֱ is only evaluating the reporting of SARS-CoV-2 test results in the Laboratory Accreditation Program. We continue to communicate with CMS to determine the impact of these new CLIA regulations on the other accreditation programs. Joint Commission surveyors will review the documentation of SARS-CoV-2 test result reporting during the Regulatory Review session of the survey. Noncompliance with the new CLIA SARS-CoV-2 test reporting requirements will be documented at Standard LD.04.01.01, EP 2.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
Manufacturers are the experts on their products and, for certain devices or products, are required to submit their instructions for use to the FDA or EPA for approval. ֱ expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility. When contacting a manufacture to determine if alternative products may be used, organizations should include a discussion of biological, chemical, and functional compatibilities. Organizations may also wish to consider the impact of their decision on liability, warranty and long-term maintenance of the item. If clear compatibility information is not able to be obtained, the organization should clearly identify the risks, the strategies to mitigate those risks, and implement their risk mitigation plan.
Scenarios
These scenarios are meant to be helpful and may not necessarily be required by Joint Commission standards:
An organization has contacted the manufacturer to determine if an alternative high-level disinfectant can be used. They received correspondence that the alternative product is acceptable, and the organization provides it to the surveyor. The manufacturer has stated that the alternative has been validated and is compatible but also provided important safety information to its customers. The manufacturer states that if soaking exceeds the alternative product instructions for use, temporary structural changes to the item may occur and organizations are advised not to use the equipment until the item is completely dry. The surveyor could ask what systems or processes have been put in place to ensure risk to the patient is mitigated.
The manufacturer instructions state that a specific cleaning chemical may result in damage to the surface of the equipment. However, the item cannot be used on subsequent patients without using the cleaning chemical in question because it would not be adequately disinfected if the manufacturer's instructions were followed. The organization contacts the manufacturer to determine what type of damage could be anticipated, reads FDA MAUDE reports, ECRI alerts, etc. They form a multidisciplinary team and determine that although they will need to replace the item in a shorter time it is the only way to protect patients from exposure to potential pathogens. To mitigate the risk, they identify clear rejection criteria for use of the equipment and staff is trained on those criteria. In addition, the item is added to a checklist for biomedical engineering to review on a quarterly basis. For deemed organizations, the Centers for Medicare and Medicaid Services requires that "Hospital policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection" or "the sterilizer manufacturer's instruction for completing sterilization."^
Please note: All organizations are responsible to meet the minimum reprocessing requirements as specified by how the device is used (e.g., per Spaulding classification system, a device that enters the vascular system must be sterilized).
^Centers for Medicare & Medicaid Services. Hospital Infection Control Worksheet. Cite at 42 CFR 482.42(a) (Tag A-0749)
IFUs for Medical Instruments and Devices:
ֱ requires organizations to provide access to information needed to support the Infection Prevention and Control program. The FDA requires manufacturers of medical instruments and devices to provide specific instructions on how to properly clean and/or disinfect these items. These Instructions for Use (IFUs) include the steps required for cleaning, disinfection, the level of disinfection required (e.g., sterilization, high level disinfection, low or intermediate level disinfection), the frequency of disinfection, and the products which are compatible for use on device. IFUs may include information about maximum number of times the item may be reprocessed as well as storage requirements. It is important to understand that each patient care item has its own IFUs for cleaning and disinfection and the expectation is that the organization will follow those instructions. Failure to follow such instructions or misuse creates significant risk to safe, quality care.
IFUs for Cleaning, Disinfection and Sterilization Products:
Products used during cleaning, disinfection and sterilization include specific IFUs to ensure efficacy and/or confirmation that cleaning, disinfection or sterilization cycles are successful. Accredited organizations must follow instructions for quality control of the process, including dilution of products, efficacy testing of the solution or process, exposure times, and acceptable temperature and pressure ranges.
Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
- Resource manuals provided by product and device manufacturers
- Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
- Copies of IFUs maintained electronically
- Subscribing to web-based resources that maintain IFUs
- Educating staff on how to conduct internet searches to retrieve product IFUs
- Educating staff on how to read and implement IFUs
- Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Providing staff and licensed practitioners with educational programs and resources regarding pain management and safe use of opioid medication.
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each practice determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Leadership responsibilities for developing and monitoring performance improvement activities specific to safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LIP) on available services for consultation and referral of patients with complex pain management needs.
The intent of this requirement is to ensure that staff and LIPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LIPs, patients, etc.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Practices are responsible for ensuring that appropriate screening and (re)assessment criteria and procedures are readily available and used appropriately. The approach to assessing pain may differ depending on a patient's age, condition, and ability to understand. For example, different tools are used for pediatric patients compared to adult patients. For an episode of acute pain from an identified cause, brief assessment of pain intensity and characteristics may be sufficient.
Chronic pain generally requires more extensive patient assessment, including various domains of physical and functional impairment.
Educating the patient and family on discharge related to pain management
It is the responsibility of each practice to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these requirements. Each practice determines where this information will be documented in the medical record.
Pain Assessment and Management Resources
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
The timeliness of accessibility to required documentation is at the surveyor's discretion and is an evaluative determination. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made. If an asked-for document is incomplete and requires some time to retrieve additional documentation, then the surveyor will likely provide additional time (LD.04.01.05).
The 2017Accreditation Survey Activity Guide (SAG)for Health Care Organizations,available toorganizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizationsoperating in a highbrid environment (both paper andelectronic) orare in the process of migrating to an EMR platform may wish to consider having a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Effective January 2017:
The following information regarding changes to the clarification process for 2017 were communicated to organizations on December 22, 2016. “Findings of ‘lack of required documentation at the time of survey’ will no longer be eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. If the documentation is provided within the time frame agreed upon by the organization and surveyor, the organization will be compliant for document availability. However, if the documentation is not provided, the organization is not compliant and an RFI is created. The RFI remains in the survey report. Following the survey, the organization will need to provide ESC that the required documentation is addressed through corrective actions."
The timeliness of accessibility to required documentation is at the surveyor's discretion and is an evaluative determination. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made. If an asked-for document is incomplete and requires some time to retrieve additional documentation, then the surveyor will likely provide additional time (LD.04.01.05).
The 2017Accreditation Survey Activity Guide (SAG)for Health Care Organizations,available toorganizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizationsoperating in a highbrid environment (both paper andelectronic) orare in the process of migrating to an EMR platform may wish to consider having a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Effective January 2017:
The following information regarding changes to the clarification process for 2017 were communicated to organizations on December 22, 2016. “Findings of ‘lack of required documentation at the time of survey’ will no longer be eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. If the documentation is provided within the time frame agreed upon by the organization and surveyor, the organization will be compliant for document availability. However, if the documentation is not provided, the organization is not compliant and an RFI is created. The RFI remains in the survey report. Following the survey, the organization will need to provide ESC that the required documentation is addressed through corrective actions."
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Question What form of documentation is acceptable by ֱ, electronic or paper? How quickly must documentation be accessible during a survey?
Answer:
Any examples are for illustrative purposes only.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
•A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
•If the documents are not in English then a translator should be available to interpret.
The timeliness of accessibility to required documentation is an evaluative determination. The surveyor will work collaboratively with your organizations to establish a time frame to submit requested documents. If the organization demonstrates a consistent pattern where requested documents are not readily available, then a Leadership finding (LD.04.01.05) may be made in addition to the requirement for improvement (RFI) for the missing documentation.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Regarding Medical Records:
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Regarding Clarifications and Lack of Required Documentation During Survey:
Findings resulting from ‘lack of required documentation at the time of survey’ are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
ֱ surveyors will accept evidence of standards compliance in either a paper format or an electronic format. In either case, the documentation must be organized or accessible in such a way as to allow for timely review. For example, electronic medical records, environment of care records, emergency management and life safety documentation can be completed by reviewing a computer screen or wall projection.
Please note:
- A person from the organization must be available and have knowledge on how to efficiently navigate the electronic format.
- If the documents are not in English then a translator should be available to interpret.
The Accreditation Survey Activity Guide (SAG) for Health Care Organizations, available to organizations via their secure extranet site or our website, includes a list of the documents required to be available to the survey team. Organizations may find it helpful to conduct 'mock surveys' that include evaluating timely access and availability of these documents.
Medical Records
There is no prescribed, required or recommended format for medical records. At the time of survey, medical records are evaluated for content, based on the applicable accreditation Elements of Performance (EP), not format. Organizations operating in a hybrid environment (both paper and electronic) or are in the process of migrating to an Electronic Medical Record (EMR) platform should have a 'super-user' available to staff during the survey to assist in navigating the record to locate information requested by the surveyor.
Clarifications and Lack of Required Documentation During Survey
Findings resulting from 'lack of required documentation at the time of survey' are not eligible for the clarification process. When an organization does not have required documentation available at the time of survey, the organization can expect that the surveyor will give the organization a reasonable amount of time to produce missing documents. Following the survey, the organization will need to provide Evidence of Standards Compliance (ESC) that the required documentation has been addressed through corrective actions.
Retention of medical records is generally determined by state and/or federal law. Organizations should work with their legal and risk management leadership to determine state-specific medical record retention requirements. Likewise, legal and risk management leadership should determine retention requirements for documents NOT considered part of the permanent patient medical record. Examples of documents not considered part of the patient's medical record may include, but are not limited to:
- Crash cart daily checks
- Temperature monitoring logs,
- Human Resource/employee file documents,
- meeting agendas and minutes,
- sign-in sheets for attendance at meetings,
- educational events,
- Sterilizer logs
- Etc.
Such an assessment is only required when explicitly noted in the language of the element of performance. Here are two examples from the HospitalManual:
LD.03.09.01 EP7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Additionally, organizationsare toassess forriskwhenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example,environmental ligature points, infection prevention/control, vesicant infusions,etc.While failing tocomplete a risk assessmentmay notresult in a recommendation for improvement,conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
Such an assessment is only required when explicitly noted in the language of the element of performance. Here are two examples from the HospitalManual:
LD.03.09.01 EP7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Additionally, organizationsare toassess forriskwhenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example,environmental ligature points, infection prevention/control, vesicant infusions,etc.While failing tocomplete a risk assessmentmay notresult in a recommendation for improvement,conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
A *proactive risk assessment is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is not prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization’
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01, EP 1)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
* A risk assessment is defined as “An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.”
A *proactive risk assessment is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is not prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization’
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01, EP 1)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
* A risk assessment is defined as “An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.”
A *proactive risk assessment is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is not prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization’
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01, EP 1)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
* A risk assessment is defined as “An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.”
A proactive risk assessment^ is required when explicitly noted in the language of the element of performance. A risk assessment would be highly encouraged when a process is problematic or there is no prescriptive guidance in the language of the EP or law and regulation. Additionally, organizations are to assess for risk whenever there is a process vulnerability or high risk procedure that could result in a poor outcome. For example, environmental ligature points, infection prevention/control, elopement, etc. While failing to complete a risk assessment may not result in a recommendation for improvement (RFI), conducting a risk assessment cannot be used to supersede requirements listed in the accreditation requirements or what is required by law and regulation.
Some Hospital manual examples:
EC.02.06.01 EP 2 states "When planning for demolition, construction, or renovation, the hospital conducts a preconstruction risk assessment for air quality requirements, infection control, utility requirements, noise, vibration, and other hazards that affect care, treatment, and services."
LD.03.09.01 EP 7 states "At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment."
Some Behavioral Health Care manual examples:
EC.02.01.01 EP 1. The organization implements its process to identify safety and security risks associated with the environment of care that could affect individuals served, staff, and other people coming to the organization'
s facilities.
Note: Risks are identified from internal sources such as ongoing monitoring of the environment, results of root cause analyses, results of proactive risk assessments of high-risk processes, and from credible external sources such as Sentinel Event Alerts.
To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments. (See also LD.03.08.01)
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations of such tools.
^A risk assessment is defined as "An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."
Infection Prevention and Control
Containers that are contaminated should be removed based upon the cleanliness requirements of the storage area. Many suppliers have paper or cardboard distribution boxes that are designed for use in laboratory, pharmacy, patient care areas or sterile storage areas.
ֱ recommends that when creating or revising IC–related policies, health care organizations apply a hierarchical method as described in ֱ Perspectives, April 2019, to address the various IC requirements on managing cardboard or corrugated boxes and shipping containers. As discussed in the Perspectives, health care organizations must first comply with the Rules and Regulations as described in Standard LD. 04.01.01, Conditions of Participation or Conditions for Coverage for those organizations that use Joint Commission Accreditation for deemed status purposes, and Manufacturers' Instructions for Use. Other components of the hierarchical method include evidence-based guidelines and national standards such as those promulgated by the US Centers for Disease Control and Prevention, and consensus documents, for example, those developed by national trade organizations.
Shipping containers, especially those made of a corrugated material, serve as generators of and reservoirs for dust. Corrugated cardboard boxes are susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. Boxes and containers may have been exposed to unknown and potentially high microbial contamination.
When organizations are making a determination as to whether these boxes and containers are appropriate to be located in a certain area, they should consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.
Other considerations might include, for example, where to load or unload supplies, criteria for content break-down areas, and what level of packaging to keep within the area in question. The process could also address the use of boxes that came out of the shipping container where box labeling is essential to proper use (for example, expiration dates, contents, ingredients, directions for use, etc.).
Once a process for managing cardboard or corrugated boxes and shipping containers is developed, health care organizations should ensure compliance.
AAMI ST 79 5.2.1 General Considerations:
Clean or sterile items to be transported to central processing and storage areas within the facility should be removed from their external shipping containers before they enter the storage areas of the department. Any instructions for use accompanying the items should be kept with the items.
Additional Resources
Dead-end corridors may be used for storage only past the last door opening into the corridor so that it does not impede the means of egress. If combustible items are stored, the area used for storage is limited to a 50 square feet footprint.
Reference LS.02.01.20 EP14
The Life Safety (LS) chapter of the Accreditation Manual has not been applicable for non-deemed status Joint Commission accredited office-based surgery practices since January 1, 2015. The criteria limits office-based surgery practices to a business occupancy, which is an occupancy having three or fewer patients at the same time who are undergoing treatment or anesthesia that renders them incapable of taking action for self-preservation under emergency conditions without the assistance of others.
The LS chapter applies to office-based surgery organizations classified as an ambulatory health care occupancy, which is an occupancy having at least four patients at the same time who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia. Note: CMS considers the Life Safety code applicable to ambulatory health care occupancies with at least one person who is either rendered incapable of self-preservation or undergoing general anesthesia; therefore, TJC will survey the LS standards if there is only one person meeting this criteria.
Reference LS.01.01.01
The following publications are available through ֱ to help with compliance with the Environment of Care, Emergency Management and Life Safety:
The Physical Environment Portal
Emergency Management Portal
The Suicide Prevention Portal
E-Alerts, a free newsletter subscription
- Perspectives, the official newsletter of ֱ
- Environment of Care News, ֱ official news source for the Environment of Care
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (*), whether or not an aromatherapy product is considered a ‘medication’ is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create “a healing environment” or some other non-specific purpose, then it would not be classified as a medication.
* ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Resources:
According to the FDA (^), the determination if an aromatherapy product is considered a 'medication' is based on the intended use. If a product is intended for therapeutic purposes, such as treating or preventing disease, it would be considered a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or as a sleep aid, these would be drug claims. If the aromatherapy is being used to create "a healing environment" or some other non-specific purpose, then it would not be classified as a medication.
^ ֱ Accreditation Manual utilizes the FDA classification for a product as part of its definition of a medication.
Additional Resources
The recently published a resource titled "" which is consistent with our current accreditation requirements. Organizations are encouraged to review this document which provides guidance in shortage management and conservation.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
For potassium chloride, strengths of 2 mEq/ml or greater (specifically, vials of 20mEq/10ml and 40mEq/20ml) are considered concentrated. The bags noted in the question are not considered concentrated and may be stored in patient care areas. For sodium chloride (NaCl), strengths greater than 0.9% are considered concentrated.
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources:
Use of block charting is a documentation option that may be used when rapid titration of medication is necessary in specific, urgent/emergent situations. It is permissible to use block charting to document the multiple dose/rate changes made to an infusion over a period of time and within the parameters of the glossary definition.
Block charting is defined as a documentation method that can be used when rapid titration of medication is necessary in specific urgent/emergent situations defined in an organization's policy. A single "block" charting episode does not extend beyond a four-hour time frame. If a patient's urgent/emergent situation extends beyond four hours and block charting is continued, a new charting "block" period must be started.The following minimum elements must be documented in each block charting episode:
- Time of initiation of the charting block
- Name(s) of medications administered during the block
- Starting rates and ending rates of medications administered during the charting block
- Maximum rate (dose) of medications administered during the charting block
- Time of completion of the charting block
- Physiological parameters evaluated to determine the administration of titratable medications during the charting block
This information was also published in the June 2020 edition of Perspectives.
Plain IV solutions retrieved from a stock supply (e.g. an automated dispensing device, floor stock supply, etc) arenotconsidered'individualized medication'. The only requirements for labeling include the name, strength, amount, and expiration date that are already on the manufacturer's label, so relabelingis not necessary. 'Individualized' means only drugs prepared for a specific patient - not floor stock.
When additives are included, the IV solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Additionally, when preparing individualized medications for multiple patients, the label also includes the following:
- The patient's name
- The location where the medication is to be delivered (e.g. patient room)
- Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.).
If applicable, the requirements for labeling medication containers used during procedures are located in the National Patient Safety Goal chapter of the accreditation manual at NPSG.03.04.01.
ֱ has no specific requirement regarding the pre-spiking of IV bags. USP released an FAQ on November 1, 2022, stating that a facility's policies and procedures regarding spiking IV fluids is outside the scope of the USP 797 chapter. ֱ will survey to organization's policies and procedures regarding the pre-spiking of IV bags.
Organization policies, procedures, staff education/competencies, etc., should also take into account:
- Product and device manufacturer's instructions for use
- Evidence-based guidelines for safe administration practices
- Applicable law and regulation
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No, simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to develop its own lists of high-alert and hazardous medications.
When developing a list, the following should be evaluated:
• Internal data about medication errors, sentinel events, known safety issues, etc.
• Information available from sources, such as:
• State pharmacy boards
• Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
• Institute for Safe Medication Practices, (ISMP) and other professional resources
• Applicable law and regulation
• Services provided and patient population served
The organization determines where and how the list of medications is documented and made available to practitioners/staff involved in medication ordering, management and administration practices. Examples may include, but not limited to:
• Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources:
No. Simply posting a list of high-alert and hazardous medication printed off the internet does not meet the intent of the requirements found at MM.01.01.03. While review of such a list assists in identifying medications known to have a heightened risk of causing harm, organizations need to have a process that identifies which medications on such a list indicate those medications that are available within the organization.
When developing a list, the following should be evaluated:
- Medication utilization patterns that may be unique to the organization
- Internal data about medication errors, sentinel events, known safety issues, etc.
- The medication manufacturer
- State pharmacy boards
- Regulatory agencies, such as the CDC, FDA, OSHA, USP, etc.
- Institute for Safe Medication Practices, (ISMP) and other professional resources
- Applicable law and regulation
- Services provided and patient population served
- Indicating on a pre-populated list obtained from an external source which medications are available for administration
- Developing separate lists for medications identified as high-alert and/or hazardous
Organizations determine how staff and practitioners will be educated regarding processes for managing these medications.
Additional Resources
If the individual operating room (OR) is part of a larger OR unit that is secured at all times, there is monitored access to the OR that assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, then locking of the cart between cases would not be required. After hours, when the OR unit is not secured/monitored in a like manner, the carts must be properly secured. Whether the carts are locked or unlocked, they must be stored in a secured area which prohibits access and tampering by unauthorized individuals (e.g., in a separate locked room or in the secured OR unit where unauthorized access is prohibited.)
Under limited circumstances, it may be necessary to store concentrated electrolytes in specific patient care areas. Such decisions should be based on the results of a robust risk assessment followed by implementation of appropriate safeguards that address all identified risk points. As a general rule, concentrated electrolytesare not be kept in patient care areas where access is not urgently needed.
The foundation for conducting a proactive risk assessment would be based on the services provided and patient population served in each respective patient care area being considered for storage of such solutions. If it is determined that they are required, leadership would need to designate the appropriate locations for storage (i.e. emergency carts, automated medication dispensing cabinets, dialysis unit, etc.) as well as which concentrated electrolytes would be appropriate. The population served by each storage device or storage location should also be evaluated as such storage areas may serve a mixed patient population.
A proactive risk assessment examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided.
The introductory section of the Leadership (LD) chapter provides an example of a pro-active risk assessment model that an organization may use. However, this specific approach is not mandated as there are other risk assessment tools available that may better meet the needs of the organization. Other examples may include a root cause analysis, failure mode and effect analysis, plan/do/check/act process, etc., or combinations and variations.
When an organization determines that concentrated electrolytes will be stored outside of the pharmacy, appropriate safeguards must be developed to prevent inadvertent administration of these medications without proper dilution.Examples of strategies to prevent errors may include:
- Segregation from all other medications stored in the device or area.
- Determine an appropriate par level of the medication so that the amount maintained on the unit does not exceed the amount necessary to meet patient care needs over a limited time period (for example, one day).
- A system for regularly checking and restocking to par level by pharmacy staff. .
- Prominent warning labels applied to the drug container.
- Restricted access to concentrated electrolyte medications and solutions to specially qualified staff.
Medication storage practices and conditionsare required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2).When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. ֱ is aware of published resourcesthat may provide alternative stability data which may not reflect what is stated by the manufacturer. However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.
Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.
ֱ is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling. The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication.
NOTE: This FAQ only addresses the stability of the product andNOT the sterility. An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.
Storage and Expiration Dating:
Vaccines are exempt from the 28-day requirement. The CDC Immunization Program states that vaccines are to be discarded per the manufacturer's expiration date. ֱ applies this approach to all vaccines - whether a part of the CDC or state immunization program or purchased by healthcare facilities - with the expectation that vaccines are managed in accordance with the product manufacturer's instructions for use (correct temperature, frequency of temperature checks, etc.) and any applicable regulatory requirements.
IMPORTANT: If you are a Vaccine for Children (VFC) provider or receive other vaccines purchased with public funds, consult your state or local immunization program to ensure you are meeting all mandatory storage and handling requirements that are specific or tailored to your jurisdiction
Preparation:
The setting in which vaccines are prepared and administered should have adequate space to prepare a vaccine using aseptic technique to prevent vial contamination.Consider the following:
- There is clear physical separation of the medication storage / preparation area from the administration area. A barrier, such as a wall, etc., is NOT required.
- The multi-dose vaccine vial remains in the medication preparation area and does not cross into the patient administration area.
- Any item taken into the administration area (e.g. needle, syringe, medication vial, band-aid, etc.) does not return to the medication storage/preparation area.
- Staff utilizing the room have been trained on procedures required to prevent cross contamination.
- All vaccination and administration supplies are secured or under constant visual surveillance to ensure cross contamination does not occur.
Unless your state is more specific, these two vaccines are not required to have a physician's order in the medical record as long as the following conditions are met:
- There must be a hospital policy and procedure approved by the medical staff which allows Influenza and PneumococcalVaccines to be given without a physician's order.
- There must be an evidence-based evaluation of the patient to ensure that no contraindications exist preventing thepatient from the receiving the vaccine.
- The medical record must contain evidence of the vaccination administration to include the Manufacturer Lot # andexpiration date as well as the publication date of the Vaccine Information Statement(VIS) given to the patient.
Since vaccines are considered medications, they are subject to the requirements found in the Medication Management (MM) chapter of the accreditation manual. Regarding patient-specific orders and pharmacy review, there are a number of states that allow vaccines to be administered based on a standing order that can be implemented when a patient meets certain pre-defined criteria (age, medical condition, etc), thus eliminating the need for an individual physician order.
Each organization would need to determine if their state permits the use of such standing orders for vaccine administration. However, a pharmacist will still need to review this standing order in regards to the particular patient in which it was ordered for evaluation of contraindications, etc.
Our standards do not address issues related to payer source, when patients are covered under entitlement programs, such as Medicare, an order to implement a protocol may be required to be entered into the medical record. Regardless of the payer source, to ensure compliance with RC.02.01.01, a copy of the standing order/protocol etc., should be included in the medical record.
Documentation Requirements:
The following information must be documented on the patient's paper or electronic medical record OR on a permanent log: (The HCO determines if documentation will be in the medical record OR on a permanent accessible log).
- The vaccine manufacturer
- The lot number of the vaccine
- The date the vaccine is administered
- The name, office address, and title of the healthcare provider administering the vaccine
- The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
- The date the VIS is given to the patient, parent, or guardian.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Center for Disease Control (CDC)
A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case, procedure, injection.
Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.
Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients.
Joint Commission Requirements
In April 2019, Joint Commission clarified that organizations should follow a hierarchical approach to compliance which includes manufacturer instructions for use (IFU).Organizations must comply with the ORIGINAL product manufacturer's IFUs. ֱ Infection Control standards require organizations follow standard precautions which include medication and injection safety.Standard precautions are also summarized in a table on the CDC Core Practices website. Organizations policies, procedures and practices are expected to incorporate these requirements.
Preparation and Use
- A patient is brought into the procedural room and the nurse accesses a multi-dose vial to administer a dose of medication to the patient receiving care and places it on the counter in case subsequent doses are needed. Any remaining medications are immediately disposed of at the end of the procedure.
- During a procedure, the physician performs hand hygiene and removed a multi-dose vial from the medication drawer of the procedure cart, after the procedure the multi-dose vial is discarded, and the top of the anesthesia cart and handles are cleaned with a disinfectant.
The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the 'date opened' does not meet the intent of this requirement
- If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer's expiration date which is generally printed on the label by the manufacturer.
- For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.
ֱ does not specifically require temperature logs for refrigerators and freezers used for to store medications. Standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use.
A process must be in place to ensure appropriate temperatures are being maintained within the required ranges for the medications stored and identifies maintenance responsibilities.
Organization should also have a defined process for the disposal of medication from a refrigerator or freezer which has deviated from the specified temperature range.
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.
Reference
EC.02.06.01
Additional Resources
No. The FDA reclassified all forms of pre-filled heparin and pre-filled saline flushes as medical devices. Previously, they were classified as either a device or a drug depending on how the manufacturer submitted its application to the FDA. Their reasoning was that these products act to keep lines open as a result of a physical effect and not as a result of a chemical or therapeutic effect. In addition, the flush has no therapeutic action on the body of the patient when used as directed.
Based on this reasoning and the fact that the FDA reclassified these as devices, they no longer meet ֱ's definition of a medication and do not have to meet the Medication Management standards. Storage of IV flushes must be in compliance with the organization's policies for safe storage. Caution must be taken to ensure that heparin flushes are not confused with therapeutic doses of heparin. If you have any questions regarding a specific product please check the FDA website to determine if the product is considered a device or a medication.
Organizations should contact the manufacturer of the IV bag toobtain written approval prior to implementingany process inconsistent with its intended use, otherwise it would not be considered an acceptable practice.
Another option is to have pharmacy prepare flushes in a controlled environment (e.g., USP 797).Please note that syringes prepared in this way would be subject to the Medication Management standards as they would be considered medications and no longer a medical device.
It may also be helpful to research evidence-based sources, such as ISMP or your state pharmacy board for additional guidance.
Additional Resources
Each organization must follow the IA, IB and IC recommendations from the guideline it chooses (CDC or WHO). Therefore, if WHO is chosen, no direct care providers should have artificial nails or extenders. If CDC is chosen, providers in high-risk areas must not wear artificial nails.
Many organizations following CDC guidelines have chosen to expand the ban on artificial nails, nail gels, gel colors, etc., to all care providers in the interest of safety. Regarding the length of natural nails, each organization may choose its own approach since the level of recommendation in both the CDC and WHO guidelines is "II", thereby making compliance optional.
In addition to the CDC and WHO, organization's requirements should incorporate evidence-based guidelines for specialized and/or procedural areas. AORN, AAMI and APIC are additional examples of resources for such guidelines.
Accredited organizations are required to provide health care workers with a readily accessible alcohol-based hand product. However, use of such a product by any individual health care worker is not required. Both the Centers for Disease Control and Prevention and World Health Organization hand hygiene guidelinesdescribe when this type of cleaner may be used instead of soap and water. If a healthcare worker chooses not to use it, then soap and water should be used instead.
If the person passing the food tray has, or is likely to have, direct contact with the patient, the answer is yes because both the CDC and WHO guidelines state that hand hygiene is required after direct contact (category IB). Both guidelines also say that individuals should decontaminate hands after contact with inanimate objects in the immediate vicinity of the patient, but this is identified as a Category II by the CDC recommendation. As such, while compliance with the CDC Guidelines is recommended for individuals passing meal trays who do not make direct contact with the patients, it is not required. In contrast, the WHO guidelines require hand hygiene after contact with the patient's environment (category IB).
For all healthcare programs to be fully compliant with NPSG.07.01.01 and standard precautions, organizations must implement a hand hygiene program that follows categories IA, IB, and IC of either the current Centers for Disease Control and Prevention (CDC) and/ or the current World Health Organization (WHO) hand hygiene guidelines, set goals for improving compliance with hand hygiene guidelines and improve compliance with hand hygiene guidelines based on established goals.
When developing infection prevention and control activities, including the hand hygiene program, the organization must follow the hierarchical approach to infection control standards. This includes following local, state and federal regulations which includes following OSHA Bloodborne Pathogen Standards, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation or Conditions for Coverage if deemed, and ensure that the manufacturer's instructions for use of hand hygiene products or supplies are followed. You may also choose to evaluate current evidence-based guidance and new products for incorporation into your hand hygiene program
Goal Setting
Organizations must set goals for improving compliance with hand hygiene guidelines.
The healthcare organization determines how the goal for improving hand hygiene compliance will be described. The goal may be a narrative description of activities or a numeric value, such as percent compliance.
ֱ does not determine the goals or the scope of the goal. It should be based on the organization's risk assessment, organizational priorities, resources, etc. There is no specific numerical target for this goal (e.g., 85%, 90%, 95% compliance) and no requirement for "organization-wide surveillance".
Goals for improving compliance with hand hygiene guidelines do not have to be confined solely to outcome metrics, but may include process measures for specific tasks or opportunities for hand hygiene, or may target metrics for specific areas or opportunities identified during your organization's risk assessment.
Hand hygiene goals must be documented. The organization determines where the hand hygiene goal(s) will be documented. Some organizations choose to include hand hygiene goals in the organization's overall performance improvement plan and then include sub-goals at the department level while others choose to place the goal(s) in the Infection Control Plan.
Examples of goals for improving hand hygiene guideline compliance may include (these are examples only: organizations may choose their specific goals based on their needs):
- Increase overall hand hygiene compliance in all inpatient units by at least 10% or maintain hand hygiene compliance rate of at least 80% by the end of the calendar year, whether through electronic and/or manual surveillance (NOTE: ֱ does not require organization-widehand hygiene surveillance and does not require capture of all hand hygiene opportunities).
- By the end of the fiscal year, improve compliance with hand hygiene prior to entering home care bag after touching the patient or their environment by 15%.
- By the end of the calendar year, increase compliance with hand hygiene upon leaving the work bench in the laboratory by 5%.
- Improve compliance with hand hygiene for entry/exit into the operating rooms 15% by the end of the year.
- Improve compliance with correct use of alcohol based surgical scrub.
- Improve compliance with organizational artificial nail policy in the operating room during FY21.
- Increase availability of hand lotion in patient care areasby auditing to ensure product is available and not expired.
Local, state or federal law and regulations may require your organization to follow a specific evidence based guideline, or may require specific elements of hand hygiene to be followed, so ensure you review all law and regulations when developing your hand hygiene program.
In addition to regulations, ֱ expects organizations to use CDC and/or WHO evidence-based hand hygiene guidance, or other evidence based national guidelines or, in the absence of such guidelines, expert consensus to develop infection prevention and control activities.
When developing hand hygiene activities, keep in mind that monitoring is a general term that refers to active or passive observations of activities while surveillance is the method of collecting, consolidating, and analyzing data. You should determine which activities require surveillance, so adequate data can be collected to support your goals and evaluate outcomes.
Implementation of the hand hygiene program is dependent on several important factors:
- Alcohol based hand sanitizer available and accessible in all areas where patient care is performed as per standard precautions.
- Ensure that placement of alcohol based hand sanitizer meets building code requirements.
- Soap and water or an OSHA approved alternative process are provided in a location where temporary healthcare services are provided and contact with blood or bodily fluids is anticipated.
- Hand hygiene monitoring and feedback on non-compliant hand hygiene opportunities is provided in real time (note: there is no requirement for data collection for all opportunities).
- All healthcare workers perform hand hygiene prior to touching a patient.
- All healthcare workers follow manufacturer's instructions for use when using surgical scrub products.
- Healthcare workers in the sterile compounding pharmacy perform hand hygiene as specified in USP 797.
See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
Intent
The intent of the requirement is to reliably identify the individual as the person for whom the service or treatment is intended and to match the service or treatment to that individual. The glossary of the accreditation manual defines a patient identifier as "Information directly associated with an individual that reliably identifies the individual as the person for whom the service or treatment is intended. Acceptable identifiers may be the individual's name, an assigned identification number, telephone number, date of birth or other person-specific identifier." Use of a room number would NOT be considered an example of a unique patient identifier.
Additional examples of identifiers may include, but not limited to:
- An assigned identification number (e.g. medical record number, etc).
- Telephone number or another person-specific identifier
- Electronic identification technology coding, such as bar coding or RFID, that includes two or more person-specific identifiers
Armbands
An armband in and of itself is not a patient identifier, rather an example of a source where patient identification information may be located. It is the person-specific information that is the "identifier," not the medium on which that information resides.
ֱ does not require the use of arm bands. However, when armbands are used as a means of conveying patient/resident identification information, the band must be attached to the patient/resident at all times. Simply placing it on the bedside table or taping it to the bed would not be acceptable.
Non-communicative Patients/Residents
For those individuals who are non-communicative or are confused, each organization determines what process will be used to safely identify these individuals. Such expectations must be clearly communicated to staff, and should be based on promotion of individual safety, not convenience or workflow.
Applicability to Nutrition Services
At a minimum, the requirement applies whenever the patient/resident requires a special diet or the meal/snack that is being delivered is part of a special diet. To ensure consistency, organizations have found it easier to implement this requirement by applying it to all patients/residents receiving diets or snacks.
Containers used for blood and other specimens
The intent of the goal is met when the patient is correctly identified using two identifiers and the containers are labeled with two identifiers in the presence of the patient. In practice, it is relatively common to label a urine container prior to giving it to the patient for collection, as long as the individual collecting the specimen verifies the identity of the patient using two patient identifiers and then labels the container while in the presence of the patient. Labeled containers which are not used due to failure of the patient to provide a urine specimen must be IMMEDIATELY discarded. The practice of pre-labeling blood tubes prior to seeing the patient and matching them at the time of collection is not acceptable.
Use of temporary names
Under some circumstances, a patient's identity may not be able to be verified and a temporary means of identification must be used. An example of such circumstances may include an injured, unresponsive patient presenting to the emergency department. Although not addressed in the requirements, a temporary "name" (e.g., John Doe) and an emergency department number or medical record number may be assigned.
These identifiers could then be used to identify the patient and match against specimen labels, medication orders, blood product labels, etc. In this process, formal identification of the patient should occur as soon as possible and once confirmed this identifying information should be used instead of the temporary identification. Ultimately, the organization determines how such scenarios should be managed.
Use of an alias to protect anonymity
There are no Joint Commission standards that address this practice. Organizations should evaluate risks associated with this practice. However, if an organization implements use of an alias, two patient identifiers must still be used, as defined by policy.
UP.01.01.01 EP3 is a step in the pre-procedural verification process in which (prior to the start of the procedure) information and items such as implants, blood products, x-rays and/or medical devices that "are" or "maybe" required for the procedure are present and verified to ensure they are the correct items for the procedure.
EP 1 requires that a pre-procedure process is defined by the organization to verify the correct procedure, for the correct patient, at the correct site. It is up to the organization to determine when this information is collected, such as at the time of scheduling or pre-admission testing, and by which team member. Whenever possible, consideration should be given to involving the patient in this process.
EP 2 requires a standardized pre-procedure verification list of items that, at a minimum, are - or may be required -at the time of the operative or invasive procedure. Activities to address such items may start days – or perhaps weeks – prior to the actual procedure. Such activities may include ordering medical devices, implants or special equipment, ordering blood products, and/or obtaining copies of reports or radiographic images to ensure their availability at the time of the procedure. Working from a standardized verification list reduces variability and thus the potential for error. The location of the standardized list is determined by the organization. For example, in a policy/procedure, a pre-procedure checklist that may become part of the patient medical record, etc.
EP 3 is the process of comparing information about the patient and procedure with the items identified in EP 2 that are required to proceed with the procedure. The final verification process generally occurs before the patient leaves the pre-procedure area or enters the procedure room. Missing information, supplies or discrepancies are addressed before starting the procedure.
Additional Resources:
ֱ Tools and Resources: Universal Protocol
No, except in emergencies^, an H & P that has been dictated, but not entered into the medical record would not be compliant. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination (see PC.03.01.03 ). The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
Providing staff and licensed practitioners with educational programs and resources regarding pain management and safe use of opioid medication.
Research and clinical guidance on pain management are evolving. The intent of the requirement is to provide up-to-date information to practitioners who are involved in patient care. Each practice determines what educational resources and programs to have readily available to staff and licensed practitioners, giving consideration to staff needs, services provided, and patient population served. Educational resources available to staff may include academic detailing, workshops, online resources and/or clinical guidelines that include content related to safe opioid prescribing, modalities of treatment, multi-modal pain management^, patient assessment and reassessment criteria.
^ Multimodal analgesia may be described as combining 2 or more analgesic agents or techniques that act by different mechanisms to provide analgesia resulting in improved pain relief while use of fewer opioids.
Leadership responsibilities for developing and monitoring performance improvement activities specific to safe opioid prescribing
Whether an individual 'leader' is assigned this responsibility, or a 'leadership team' model is used, responsible leader(s):
- participate in defining the goals and metrics for performance improvement activities;
- allocate resources to conduct performance improvement activities;
- review performance improvement data;
- promote improvement in practices and accountability across disciplines and services involved in opioid prescribing.
Survey activities may include staff interviews, review of applicable meeting minutes, discussions with leadership, practitioners, governing body members, review of performance improvement data, etc.
Providing information to staff and licensed practitioners (LIP) on available services for consultation and referral of patients with complex pain management needs.
The intent of this requirement is to ensure that staff and LIPs are knowledgeable about available services and resources. Available sources for consultation and referral may include 'internal' resources (such as a qualified provider with a specific expertise, pain management program or addiction treatment program) or external healthcare services and community resources. Compliance with this requirement is determined through interviews with staff, LIPs, patients, etc.
Screening vs. assessing pain
A 'screening' is a process for evaluating the possible presence of a problem. An 'assessment' gathers more detailed information through collection of data, observation, and physical examination. Assessments are completed by individuals deemed qualified through education, training, licensure, etc., to conduct such evaluations. Pain assessment tools are generally evidence-based and often include, at a minimum, an evaluation of pain intensity, location, quality, and associated symptoms. An accurate pain screening and assessment is the foundation on which an individualized, effective pain management plan is developed.
For example, a pain 'screening' may be used to determine if the patient has pain or not. If the patient answers "yes", a comprehensive pain assessment would be indicated. If the patient answers "no" no further pain assessment would be expected, unless required by organizational policy.
Practices are responsible for ensuring that appropriate screening and (re)assessment criteria and procedures are readily available and used appropriately. The approach to assessing pain may differ depending on a patient's age, condition, and ability to understand. For example, different tools are used for pediatric patients compared to adult patients. For an episode of acute pain from an identified cause, brief assessment of pain intensity and characteristics may be sufficient.
Chronic pain generally requires more extensive patient assessment, including various domains of physical and functional impairment.
Educating the patient and family on discharge related to pain management
It is the responsibility of each practice to determine who is qualified and responsible to educate the patient and family at discharge regarding the pain management plan, side effects of treatment, impact on activities of daily living, safe use, storage, and disposal of opioids when prescribed. PC.01.02.07 EP 8 requires written documentation that the patient and family were educated on these requirements. Each practice determines where this information will be documented in the medical record.
Pain Assessment and Management Resources
The practice of providing discharge instructions or after-visit summaries via the electronic medical record (i.e. patient portal) in lieu of a paper copy provided at discharge would not be prohibited by Joint Commission accreditation requirements.
Prior to providing instructions and information electronically, organizations need to consider the individual patient's ability to access electronic devices (e.g. computers, smartphone, tablet, etc.) technical ability, and overall comfort in using such devices to access electronic information. When another individual will be responsible for ensuring ongoing care of the patient, the same considerations apply.
Organizations that have the capability to provide discharge instructions and after-visit summaries electronically, are encouraged to handle on a case-by-case basis and allow the patient to determine how to receive discharge information. If your organization has a written policy or procedure on your requirements for providing discharge information, consider including this process in that document.
No. These standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards. A "code team" would only be considered as an additional resource.
Definitions^
Medications
Irrespective of the medications administered, the level of sedation/anesthesia achieved determines the applicability of the accreditation requirementsas discussed in this FAQ.
Assessments
Pre-sedation or pre-anesthesia (deep sedation, regional or general anesthesia):
- ֱ is not specific as to the required elements of the assessment, the expectation is that the assessment is based on established or recommended professional practices. (Examples of professional organizations that provide guidance for clinical practice are the American Society of Anesthesiologists, American Association of Nurse Anesthetist, American Dental Association.) Typically, the assessment includes, vital signs, status of the airway and response to any pre-procedure medications.
- Moderate Sedation: The organization determines who is qualified toperform the assessment consistent with competencies of staff, scope of practice, rules and regulation and State.
- Deep Sedation/Regional Blocks/General Anesthesia: must be performed by an anesthesia provider or LP with medical staff privileges to administer deep sedation, regional or general anesthesia in accordance with hospital policy and state scope of practice laws. This assessment may not be delegated to a non-privileged individual.
- The purpose is to confirm that there have been no changes in the patient's status since the initial assessment. This re-evaluation occurs immediately prior to (meaning without delay) the initiation of the moderate, deep or general anesthesia. The organization determines the required elements and documentation format. (Examples may include vital signs, status of the airway and response to any pre-procedure medications.) This assessment is most often the first entry on the procedure or anesthesia record.
- Moderate Sedation: the organization may determine who can perform this assessment based on staff competencies scope of practice and law and regulation.
- Deep Sedation, Regional anesthesia and Anesthesia: assessments must be performed by a qualified individual and consistent with state law and regulation.
- In deemed(^^)organizations, completion of the post- anesthesia assessment for both inpatient and outpatient must be completed within 48 hours by an anesthesia practitioner or credentialed LP. This assessment may not be delegated
- The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally should not be performed immediately at the point of movement from the operative area to the recovery area. The assessment should not begin until the patient is sufficiently recovered from the administration of the anesthesia so as to participate in the evaluation, e.g., answer questions appropriately, perform simple tasks, etc.
- Components of the evaluation may include, but are not limited to:respiratory function, including respiratory rate, airway patencyand oxygen saturation; cardiovascular function, including pulse rate and blood pressure; mental status; temperature; presence of nausea and/or vomiting; pain' and post-operative hydration. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
- In non-deemed organization post-anesthesia assessments for patients receiving moderate, deep, regional and general anesthesia care are evaluated by criteria established by the medical staff based on State law and professional organizations recommended practices. e.g. American Society of Anesthesiologists.
- Discharge assessments are completed by a LP, or the patient may bedischarged upon a LP's order based on criteria established by the medical staff.
These analyzers are approved by the FDA as monitoring devices and are not considered laboratory tests. Therefore, they are not regulated by the Joint Commission's specific laboratory standards. As monitoring devices, they should at a minimum be managed following manufacturer's guidelines. This includes performance of calibration, controls, and maintenance, as applicable. Written policies and procedures should be readily available to the staff using the equipment. In addition, staff should have evidence of training and competence, as required by the HR standards.
The "qualified individual/ transfusionist" is determined by the organization considering any professional guidelines, state laws and regulations that define qualifications necessary to transfuse blood and blood products. The organization must also ensure the qualified individual/ transfusionist is competent in transfusing blood and blood products and the identification verification process defined by the organization.
The second individual involved in a two-person verification process is determined by the organization. This individual must be competent in conducting the identification verification process for blood and blood products defined and implemented by the organization.
No, except in emergencies^, an H & P that has been dictated, but not entered into the medical record would not be compliant. The intent of the ambulatory standards related to Operative or Other High-Risk Procedures and/or the Administration of Moderate, Deep Sedation or Anesthesia is, the organization performs and documents a history and physical examination (see PC.03.01.03 ). The organization must complete this within 30 days before the procedure.
The mere existence of a dictated history and physical, not transcribed and entered in the patient's medical record, is not in compliance with the intent of the standard. The history and physical is essential information needed to further assess and manage the patient.
^In an emergency, when there is no time to record the complete history and physical examination, a progress or admission note describing a brief history and appropriate physical findings and the preoperative diagnosis is recorded in the medical record before surgery.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.
ֱ standards do not specify the time frame for authentication of documentation. The organization is free to determine the time frame for completion of authentication. The timeframe must comply with any applicable laws or regulations. If the organization is silent on the issue for specific types of documentation, the time frame defaults to the time frame that the organization adheres to for completion of the medical record.The requirements found at RC.01.02.01 address authentication requirements. The requirements found at RC.01.03.01 address timeliness for completing medical records.
No. If there was no blood loss^ and/or no specimens removed, there is no requirement for the proceduralist to document those two items, unless the organization specifically requires this level of documentation. The word "any" was specifically chosen to reflect the need to only document those items when applicable to the procedure performed.
^As applicable to the procedure, it is acceptable to document 'quantitative blood loss' in lieu of 'estimated blood loss' which is common in OB/GYN procedures.
The report must be written or dictated immediately after an operative or other high risk procedure^ and entered into the medical record.This information could be entered as the operative report or as a hand-written progress note. If the operative or procedural report is not placed in the medical record immediately following the procedure, then a progress note must be immediately entered after the procedure to provide pertinent information to the next provider of care. The goal is to ensure there is sufficient information about the procedure in the record immediately after surgery or other high risk procedure to manage the patient throughout the post procedure period.
'Immediately after surgery or procedure' is defined as "upon completion of procedure, before the patient is transferred to the next level of care". This is to ensure that pertinent information is available to the next caregiver. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit or area of care, the report can be written or dictated in the new unit or area of care. For the purposes of this requirement, ֱ considers the Pre-Op, O.R. and PACU as the same level of care as the clinical team is essentially intact across these areas.
If the progress note option is used (see RC.02.01.03 EP 7), it must contain, at a minimum, comparable operative/procedural report information. The minimum required elements include; the name of the primary surgeon and assistants procedures performed and description of each procedure findings any estimated blood loss, any specimens removed, and the post operative diagnosis.
^ See definition in the glossary of the accreditation manual.
Policies addressing the investigation of adverse tissue reactions should define two essential processes:
- Reporting Potential Disease Transmission From the Donor Source Facility to the Patient:
The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus. Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased. References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27(c)(4-8)] and the FDA's Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.
- Reporting Adverse Patient Reactions to the Donor Source Facility:
When developing theprocess, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis). Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue. Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate in MedWatch, the FDA's reporting system for adverse events, product use errors and product quality problems associated with medical products.
The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore,the tissue standards do applybased on FDA classification.
Products that are derived from human or non-human tissue and cellular materials, butrendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process.They are acellular at the time of patient useare not classified by the FDA as tissues, therefore,the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell productscan also be found in the introduction to the Transplant Safety chapter found in the accreditation manual.
The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products.These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes. Records should permit bidirectional tracing of any tissue in order to:
- Report potential disease transmission to the recipient when notified by the donor source facility
- Report adverse patient reactions to the donor source facility
- Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.
Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility. In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
The source facility must be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.
Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent.Each organization must check with their state for the status of Tissue License Requirements.
ֱ standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.
For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.
Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the :
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed independent practitioner (LIP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate** to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed independent practitioner (LIP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
** The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
When a licensed practitioner (LP) performs waived testing that does not involve an instrument, there is no Joint Commission requirement for documentation of competency when the test is a logical part of his or her specialty and the organization has specifically privileged the provider to perform the test(s). Through the medical staff credentialing process, individual practitioners may be privileged for those specific waived tests appropriate^^ to their scope of practice and no further assessment of skills or documentation of competence is required. At the discretion of the Director of Laboratory Services designated on the CLIA certificate or by organizational policy, more stringent competency requirements may be implemented. When a licensed practitioner (LP) performs waived testing that involves an instrument, competence to perform testing must be documented after training prior to performing patient tests and annually thereafter. Any two of the following four procedures may be used for competence assessment:
- Performance of a test on a blind specimen.
- Periodic observation of routine work by the supervisor or qualified designee.
- Monitoring of each user's quality control performance.
- Use of a written test specific to the test assessed.
^^ The appropriateness of the waived tests to the scope of practice is determined through the mechanisms of the credentialing process.
No. While it is preferred to have the reference range documented on the same page and adjacent to the laboratory result, the requirement is flexible enough to accommodate different information management systems when it is impractical to do so. For both waived and non-waived testing, two criteria must be met when reference ranges are not supplied on the same page along with the laboratory result: The reference range must be located elsewhere within the permanent medical/clinical record. The result must have a notation directing the reader to the location of the reference range(s) in the medical/clinical record.
ֱ standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. ֱ will survey each organization according to its own policies relative to proficiency testing for waived testing.
Only a provider may perform microscopy procedures under a Provider Performed Microscopy Procedure (PPMP) certificate. Providers include physicians, nurse practitioners, nurse midwives, and physician assistants. No other individuals may perform microscopy procedures under a PPMP certificate, including laboratory and nursing professionals, even though they may be qualified to perform microscopy procedures under a moderately complex license. Waived tests performed under a PPMP certificate may be performed by a competent individual and are not required to be performed by a provider.
Proficiency testing is not required for laboratories with a Provider Performed Microscopy Procedure certificate. Laboratories may elect to participate in proficiency testing in order to satisfy other standards requirements for competency (as applicable) and semiannual verification of the test method, although other mechanisms that demonstrate compliance would also be acceptable.
Joint Commission requirements for Provider Performed Microscopy Procedures (PPMP) are located in the laboratory program manual^. PPMP is specified in the federal regulations as a subset of moderately complex tests. On-site review by an accrediting agency is not federally required, however, Joint Commission laboratory surveyors will review a sampling of these services. Federal requirements for PPMP testing may be found in the Clinical Laboratory Improvement Amendments (CLIA), which are located in the Code of Federal Regulations at 42CFR493.
^Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
ֱ standards do not specifically require either visual acuity or color-blind testing for employees. The HR standards require assessment of the employees' abilities to fulfill the expectations of their job descriptions. Color-blind testing may be utilized as part of an organization's initial or ongoing competency assessment program, but other mechanisms that evaluate an individual's ability to interpret colorimetric determinations would also be acceptable.
Yes. Laboratory reagents may be stored in the same refrigerator as laboratory specimens. In both cases, there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves. Temperature monitoring and security requirements should be followed in accordance with manufacturer's instructions for use, accepted laboratory standards of practice and any regulatory requirements.
NOTE: Medications may not be stored in the same refrigerator as reagents and specimens.However, if the organization checks with their Board of Pharmacy and State Licensing Agency for the lab and get clear guidance that your process is compliant with law and regulation, that would be acceptable.
The manufacturer's package insert recommends that all negative rapid Group A Strep screens be followed-up with a culture. ֱ surveys compliance with following these manufacturer instructions. Thus, culture follow-up should be performed unless the laboratory has performed a study that justifies discontinuing such testing.
An acceptable study consists of age-specific (adults vs. children) parallel testing that demonstrates acceptable correlation of results from rapid testing against cultures for the laboratory's setting. The study may be simple (20 - 100 samples) and rely upon existing data. Correlations tend to be better for the adult population as compared to children as specimens are easier to collect and they have a higher colonization rate. Specimens from children have a higher potential for a false negative rapid test (low colonization, difficult collection) and a higher risk of further disease (such as rheumatic or scarlet fever), thus culture follow-up is recommended for this population.
This approach is consistent with the American Pediatric Association Guidelines (Pediatric Redbook 2002), the IDSA Guidelines for Diagnosis and Management of GAS and current recommendations for acute pharyngitis from the Centers for Disease Control.
A laboratory will be considered compliant if an age based study was performed and the laboratory director and physicians have considered these guidelines in developing the approved laboratory policy.
Laboratory tests classified as waived may be approved for professional use, home use (sold over-the-counter), or both. Tests approved for "home use only" are not appropriate for use by healthcare professionals in a Joint Commission accredited organization.
To determine if a test is approved for professional use, the information can sometimes be found in the manufacturer's package insert or by calling the manufacturer directly. You may also check the that was submitted to the FDA by the manufacturer for approval. Many of these are available electronically through the following website:
Follow the following steps to determine if the test is intended for professional use:
- Enter the name of the device in the search field.
- Locate the device in the list produced by the search.
- Click on the "Summary" for the device to open the 510(k) document.
- Read the 510(k) summary, particularly the section titled "Intended Use".
- If there is language indicating the instrument may be used in professional settings or by healthcare professionals, it meets the standards requirement.
All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert or checking the FDA web database.
The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.
For a urine drug test classified as waived, the following applies:
- The organization must have a current Certificate of Waiver (COW) obtained from their state CLIA office.
- The testing is surveyed under the waived testing standards in the PC chapter (PC.16.10 to PC.16.60) of the Comprehensive Accreditation Manual for Behavioral Health Care (CAMBHC).
- The testing is reviewed during the organization's routine triennial survey.
- The organization must have a current license for moderate complexity testing obtained from their state CLIA office.
- The CLIA license must have the following specialty/subspecialty listing: Chemistry/Toxicology.
- The testing is surveyed under the standards in the Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB), which are more stringent than the waived testing standards.
- The testing is reviewed during a biennial survey, which is separate from the organizational triennial survey.
^Clinical Laboratory Improvement Act, a section of the federal Center for Medicare & Medicaid Services (CMS) regulations
^^Note: A test designated as CLIA waived does not mean it is CLIA exempt.
The standards do not require a log sheet to be maintained for waived tests. The organization is required to be able to correlate the quality control results with the individual test results. Examples of typical correlated information would include the following:
- client identifier
- date of testing
- test kit lot number
- test result, QC lot numbers
- QC results
- testing personnel identifier
Yes, if the medical staff/leaders are informed of such a process, understands the risks, and the process is approved in written policy by the organization's leadership. Such a practice bears similarities to use of a reference laboratory. When using a reference laboratory, organizations must verify that the laboratory is compliant with applicable law and regulation. This is evidenced by having a current CLIA certificate and a successful biennial inspection. When using a patient/resident/client's result from self-testing, the healthcare provider does not have the same types of assurance provided by compliant reference laboratories, such as adequate competency, successful quality control or proper equipment maintenance.
The following processes are not specific Joint Commission requirements and are only provided as examples of how organizations have dealt with these concerns in practice. Verify competency by either confirming the patient/resident/client has been previously trained or observing the patient/resident/client perform their first test. Require the patient/resident/client to perform quality control, if available for the meter, each day results are used. Correlate the patient/resident/client's first glucose result with testing by a main laboratory. Confirm all critical and nonlinear instrument values with testing by the main laboratory.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
ֱ further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Within an organization, waived testing must be defined as either screening or definitive. The intention of the requirement is for the organization to promote a uniform standard of care and set expectations as to when confirmatory testing should be performed.
A test is considered definitive when the organization determines that a clinical treatment decision or diagnosis may be made based upon the result. For example, bedside glucose checks performed in order to adjust sliding scale insulin would be considered definitive. Although a test may be considered definitive, it does not preclude performance of additional testing to support medical diagnosis or treatment. Confirmatory testing may still be ordered. This is often done for critical glucose levels, even when the result may be within the linear (i.e. reportable) range of the glucose analyzer.
A test is considered screening when an organization determines that additional information from testing or other procedures would be required to make a treatment decision or diagnosis. An example of this would be a physician office that performs rapid Group A Strep testing, but follows up with cultures prior to determining whether or not to administer antibiotics.
When a test is considered screening, the organization's policies should state that additional information must be obtained through further testing or other procedures before any treatment or diagnostic decisions are made. For the purpose of promoting a uniform standard of care, confirmatory testing must be specified in the written procedure, if it is required.
Yes – organizations performing waived tests with any reagents/cartridges/instruments/kits that are not FDA approved for waived testing would be out of compliance with ֱ requirement to follow the manufacturer's instructions for use.
If an organization chooses to use reagents/cartridges/instruments/kits that are not FDA approved for waived testing, the following are required:
- Obtain a CLIA certificate for high complexity testing.Performing a waived test with any modifications other than those approved by the FDA (e.g., any changes in specimen type, reagents, instrument, procedural steps, or other components) elevates the test complexity from waived to high complexity.
- Apply for accreditation in the laboratory program.ֱ standards addressing high complexity testing are only evaluated by the laboratory accreditation program.
- Comply with the standards for laboratory developed tests outlined in the laboratory accreditation program manual.
Manual: Rural Health Clinic
Any examples are for illustrative purposes only.
ֱ is aware of the substantial impact Hurricane Helene had on the IV solution supply chain. These impacts will likely continue for some time as alternate manufacturing options are determined. ֱ understands the impact these shortages can have on patient care and overall operations. ֱ encourages organizations to implement conservation strategies for these shortages. Healthcare organizations must ensure that implemented conservation strategies preserve patient safety. The American Society of Health-System Pharmacy (ASHP) website has strategies for consideration and those can be found at
ֱ has received questions from organizations regarding the ability to circumvent long standing guidance from both Centers for Disease Control (CDC) or the Food and Drug Administration (FDA). As an accreditation organization, the Joint Commission does not have the ability to alter federal guidelines from CDC or the FDA related to sterile medications. However, ֱ will ensure that none of our accreditation standards preclude healthcare organizations from adopting any interim guidance provided by the CDC or FDA (for example, use of FDA-approved imported sterile medications, or FDA-approved extended expiration dating).
Additional Resources: