����ֱ��

While ����ֱ�� does not survey against specific HIPAA regulations, the standards do require compliance with applicable law and regulation. Standard DSCT.1 requires organizations to maintain the privacy and confidentiality of information. When an organization's staff is not present to monitor medical records storage areas, alternative approaches may be employed to protect privacy and confidentiality. Examples of such approaches may include ensuring that any individuals who are authorized to perform their duties in areas where medical records are stored, including contracted staff, understand their role in maintaining security and confidentiality, having such individuals sign a confidentiality statement, and ensuring that all medical records are closed and stored appropriately so that patient information would not be visible to unauthorized individuals. The organization needs to ensure that the medical records area is secured once the cleaning crew members have completed their duties.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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®.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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

��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.
��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

• Core stroke team members,��as defined by the organization, are required to��have 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, are��required to��have 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 for����complex stroke patients, endovascular catheterization laboratory, patient care units, a rehabilitation unit, etc.

��

��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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®.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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

��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

If the above practitioners are qualified and able to manage the diabetes, then that would meet the requirement. DSDF.6 EP.1.a

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

No.��This would not be required for Gestational Diabetes patients.

Any examples are for illustrative purposes only.

Blood Glucose level less than 70 mg/dL.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.
��

Any examples for for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.
��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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®.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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

��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only. ��
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.��

��

Any examples are for illustrative purposes only. ��

����ֱ�� 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.��

��

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.��
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.

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.��

��

Any examples are for illustrative purposes only.

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
��

Any examples are for illustrative purposes only.
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���� ��within��72 hours from the time the volunteer licensed��practitioner 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 licensed��practitioner currently privileged by the ��organization or by a staff member with personal knowledge of the volunteer practitioner's ability to act as a licensed��practitioner during a disaster

��

Any examples are for illustrative purposes only. �� ��
��

Any examples are for illustrative purposes only.

The following publications are available through ����ֱ�� to help with compliance with the Environment of Care, Emergency Management and Life Safety: 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��

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.
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

Reference EC.02.05.01

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.

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:

Any examples are for illustrative purposes only.
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.��

Any examples are for illustrative purposes only.

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.
��

Any examples are for illustrative purposes only.��
"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.

Any examples are for illustrative purposes only.

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

Triennial or 36-month generator test 30% of nameplate rating for 4 continuous hours for diesel powered EPs, see EC.02.05.07 EP and EP10.

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

Any examples are for illustrative purposes only.

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:

1. 30 minutes with a connected load of at least 50% of nameplate rating
2. 60 minutes with a connected load of at least 75% of nameplate rating

Additional Resources
NFPA 99-2012: 6.4.4.1

Any examples are for illustrative purposes only.

����ֱ�� 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

��

Any examples are for illustrative purposes only. Additional Resources
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
��

Any examples are for illustrative purposes only.
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.  ��
��

Any examples are for illustrative purposes only.

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

It is not necessary to have a separate plan for each of these environments of care risk categories, they may all be contained in a single document. ��

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

Any examples are for illustrative purposes only.

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 38��degrees 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)

Reference standard EC.02.02.01: The hospital minimizes risks associated with selecting,��handling, storing, transporting, using, and disposing of hazardous chemicals.

Any examples are for illustrative purposes only.

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



��

Any examples are for illustrative purposes only.

There are no specific��Joint Commission standards��that 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.

Infection control should be a key element in the assessment process. The survey process will evaluate the risk assessment for effectiveness and validate proper implementation of the resulting policy/practice. Adjustments to the implemented process are to be made as needed.

Any examples are for illustrative purposes only. ��

����ֱ�� 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��

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

����ֱ�� 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

The rating of a fire extinguisher is determined by the type of fuel that is being burned. ��The operating room typically has Class A fuels which would include; drapes, paper, and human tissue. Class B fuel would include flammable skin prep products. Class C fires involve energized 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

��

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

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

In either case both will result in activating the starter for the generator and activation of the ATS transferring the load from normal power to emergency generator 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

Any examples are for illustrative purposes only.
��
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��

This may also include exterior support equipment such as:

• Loading dock and equipment
• Helicopter landing pad
• Ambulance parking

Reference EC.02.01.01

Any examples are for illustrative purposes only. ��
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.��

��

Any examples are for illustrative purposes only.��
�� �� �� ��

• 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��

��

Any examples are for illustrative purposes only.��

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 ��

Any examples are for illustrative purposes only.��

• 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.

Any examples are for illustrative purposes only.

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
��

Any examples are for illustrative purposes only.

����ֱ�� 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

Additional Resources



��

Any examples are for illustrative purposes only.

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.��

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.

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

For organizations that do not use ����ֱ�� accreditation process for deemed status purposes, then you may maintain a written inventory of either, all medical equipment, or an inventory of selected equipment categorized by physical risk that includes all life-support equipment. ��New equipment is evaluated prior to initial use to determine if it will be included in the inventory.

��

Any examples are for illustrative purposes only.

����ֱ�� 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)

Multi-disciplinary input should include; infection control, risk management, and the safety officer.

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

These height installation recommendations from NIOSH will comfortably accommodate 95% of all adult female workers.

Additional Resources:


��

Any examples are for illustrative purposes only.

����ֱ�� 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��

Any examples are for illustrative purposes only.��

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

��

Any examples are for illustrative purposes only.
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

Each room served by the piped medical gas and vacuum zone valves is to be identified. Grouping of consecutive rooms served, like "Procedure Rooms 1-6" should be used with caution to ensure that no unserved location is included with the identification. General statements about the area are not acceptable.��

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

Any examples are for illustrative purposes only.��

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.
��

Any examples are for illustrative purposes only.��

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.��

For other NFPA 99 requirements that are not expressly identified in the language of a CoP or an EP, facilities will be held to the code requirements that were in effect at the time of construction and maintain compliance with that version.

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.

Any examples are for illustrative purposes only.

����ֱ�� 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.

Any examples are for illustrative purposes only.��

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

��

Any examples are for illustrative purposes only.

����ֱ�� 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.
��

Any examples are for illustrative purposes only.��

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��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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��

Any examples are for illustrative purposes only.

• applicable staff
• type of training
• level of training
• required credentials

The security management plan should take into consideration how the organization manages workplace violence and manages security during an emergency or disaster.

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

For example, hospitals with newborn nurseries and pediatric units (pediatric security risk assessment) would have very different criteria than a forensic behavioral health environment or geriatric health environment. Based upon their duties, staff may be assessed to require physical restraint training, self-defense training, situation de-escalation training, etc. Once the required skillset and type/level of training is established, the organization is to create applicable policies, implement the security program, assess for effectiveness, and adjust the strategy if needed.

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.

Any examples are for illustrative purposes only.
����ֱ�� 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.

��

Any examples are for illustrative purposes only.��

����ֱ�� 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

��

Any examples are for illustrative purposes only.

����ֱ�� 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.

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only. ��
��

• 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. ��

Organizations should also check with their state regulatory agencies as some states have additional items which is considered regulated waste or regulated medical waste. ����
��
Reference EC.02.02.01��

Any examples are for illustrative purposes only.
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.

In addition to CMS requirements, the following NFPA code requirements also apply:

• 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.

For full text, refer to NFPA 99-2012: 10.2.3.6; 10.2.4; NFPA 70-2011: 400-8; 590.3(D); Tentative Interim Amendment (TIA) 12-5)

^ 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

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

����ֱ�� 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��

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only
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��

Any examples are for illustrative purposes only.
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 ��

Any examples are for illustrative purposes only.

����ֱ�� 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.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

����ֱ�� 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 (designed��after 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.

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

����ֱ�� 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.
��

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.
This essential electrical system must be divided into three branches, including the:

• life safety branch
• critical branch
• equipment branch

Both the life safety branch and the critical branch are kept independent of all other wiring and equipment, and transfer within 10 seconds of an electrical interruption. ��Each branch has at least one automatic transfer switch.

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.

Type 3 essential electrical system is permitted:

• 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.

A Type 3 system is not permitted where a Type I system is required.

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

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

����ֱ�� 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.

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

• 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.)

Additional Resources:

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.

• 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.

• 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 competencies��expected of an OR Nurse, surgical assistants and sterile processing staff.

Any examples are for illustrative purposes only.

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)

��

Any examples are for illustrative purposes only.

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.



��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

����ֱ�� 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.

Examples may include:

• 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

��

Any examples are for illustrative purposes only.

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 to��organization'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.

Any examples are for illustrative purposes only.

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
��

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

����ֱ��'s,��expectation is that��the organization is aware of anyone��entering the organization��and 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 Vendors��in procedure rooms/operating rooms providing guidance to the surgeon or staff, training��of 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 licensed��practitioners,��organizations must also address��qualifications, competency and performance evaluation.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

��

Any examples are for illustrative purposes only.

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 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.

Any examples included in this response are for illustrative purposes only. An organization may determine, for example, that it is - or is not appropriate - for such boxes and containers to be located in food storage (State Food Sanitation Code), a pharmacy (e.g. USP 797) or in sterile storage (e.g. AAMI ST79).

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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-wide��hand 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 areas��by auditing to ensure product is available and not expired.��

The organization provides supplies to support the infection prevention and control program. ��Examples may include:

• 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.

Health care staff perform hand hygiene and observe other hand hygiene guidelines as per the organization's hand hygiene program. Examples may include:

• 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.

Additional Resources



See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
��

Any examples are for illustrative purposes only.

• For employees, and others to whom the HR standards apply, health screenings are a requirement. For non-employed physicians and other licensed��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��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 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��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.

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 occurs��sufficiently 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:

• 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.

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��

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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)

Any examples are for illustrative purposes only.

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. ��

Any examples are for illustrative purposes only.

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.

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).��

Any examples are for illustrative purposes only.

����ֱ�� 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.

The��CDC recommends��implementing 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.��

��

Any examples are for illustrative purposes only.
��

• 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

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.��

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.

Additional Resources��
��

��

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

• 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.)

Additional Resources:

Any examples are for illustrative purposes only
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.��

Organizations are required to follow a list of prohibited abbreviations, acronyms, symbols, and��dose designations, which, at a minimum, includes the following:
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.

��

Any examples are for illustrative purposes only

Examples are provided for illustrative purposes only. by all personnel in restricted areas where open sterile supplies or scrubbed personnel are located."

• 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.

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.

• 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).

Any examples are for illustrative purposes only.

• 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

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.
Please refer to the Guidance from the Department of Health and Human Services (HHS) for more information regarding additional requirements
��

Any examples are for illustrative purposes only.

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)

Any examples are for illustrative purposes only.

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. ��

Any examples are for illustrative purposes only.

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.​​�ċ�ċ�ċ�ċ�ċ
^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.��

Facilitating access to the Prescription Drug Monitoring Program (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��

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.
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.��
Pain Assessment and Management Resources

Any examples are for illustrative purposes only.

Intent
Physical Presence ����ֱ�� 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).�� 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.

Any examples are for illustrative purposes only.

The following publications are available through ����ֱ�� to help with compliance with the Environment of Care, Emergency Management and Life Safety: 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��

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.

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.

����

Any examples are for illustrative purposes only.

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.

From a survey perspective,��organizations are required to have records available��during the survey process that goes back to their last��full survey.����Compliance with more stringent requirements of��local/state/federal controlling authorities is also expected.


��

Any examples are for illustrative purposes only.

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."
��

Any examples are for illustrative purposes only.

����ֱ�� 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��

Any examples included in this response are for illustrative purposes only. An organization may determine, for example, that it is - or is not appropriate - for such boxes and containers to be located in food storage (State Food Sanitation Code), a pharmacy (e.g. USP 797) or in sterile storage (e.g. AAMI ST79).

Any examples are for illustrative purposes only.
����ֱ�� 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

Any examples are for illustrative purposes only.

• 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

Any examples are for illustrative purposes only.

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��

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.��
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.

Any examples are for illustrative purposes only.��

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��

Any examples are for illustrative purposes only.

����ֱ�� 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 ��

Any examples are for illustrative purposes only.
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

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��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

• 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

Any examples are for illustrative purposes only.��

An Interim Life Safety Measures (ILSM) assessment must be completed for any Life Safety Code deficiency when it becomes apparent to the organization.��

Survey-related Plans for Improvement (SPFIs)^ are developed when the organization cannot correct a deficiency related to NFPA 101-2012 or NFPA 99-2012 within 60 days of the survey event. This SPFI is the basis for requesting a Time Limited Waiver (TLW). The ILSM assessment must be identified in the SPFI entered into the Statement of Conditions (SOC).��The validation documentation must clearly demonstrate that the risks identified are being mitigated.��

^The Survey Related PFI (SPFI) tab is located on the Statement of Conditions page accessed via the organization's secure extranet site.

��

Any examples are for illustrative purposes only. 

• 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. ��

Reference LS.01.02.01

Any examples are for illustrative purposes only.��

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

Any examples are for illustrative purposes only.

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

Class A requires a flame spread index of 0-25, Class B 26-75. ��For plywood applied to the walls (such as in IT closets or electrical rooms), either a visible "fire-treated" stamp or a coating of intumescent paint is required. If the intumescent paint option is used, then keep on record specifications that show the flame spread rating of the product. ��Untreated or unpainted (intumescent paint) plywood is considered a Class C finish.

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.

Any examples are for illustrative purposes only.
��
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.��

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.��

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

Any examples are for illustrative purposes only.

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.
��

Any examples are for illustrative purposes only.

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��

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.

• 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)��

Reference LS.01.01.01��

Any examples are for illustrative purposes only.��

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.

Any examples are for illustrative purposes only.

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
��

Any examples are for illustrative purposes only.

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��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

The following publications are available through ����ֱ�� to help with compliance with the Environment of Care, Emergency Management and Life Safety: 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��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.
��

• 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. ��

Where ductwork penetrates a smoke barrier wall, a smoke damper is not required if the HVAC system is fully ducted. Air transfer openings (non-ducted) shall have a smoke damper installed.

Reference LS.02.01.30 EP19
��

Any examples are for illustrative purposes only. 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

Any examples are for illustrative purposes only.��

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��

Any examples are for illustrative purposes only.
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.��
��

Any examples are for illustrative purposes only.��

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.
��

Any examples are for illustrative purposes only.
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.��
��

Any examples are for illustrative purposes only.

Yes. The formulary should be a resource for prescribers and staff to know which products, strengths, and dosage forms are available within the organization.

Any examples are for illustrative purposes only.

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:

��

Any examples are for illustrative purposes only.

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.
  ��

Any examples are for illustrative purposes only.

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.

Organizations are responsible for determining the implementation process for��how range orders are entered into the medical record��and that staff��are properly trained to ensure consistent implementation.����It is also��the 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 with��applicable law/regulation, recommendations from professional organizations (state pharmacy boards, , etc) and evidence-based resources should be incorporated into applicable policies, procedures, etc.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.
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.


��

Any examples are for illustrative purposes only.��

Any examples are for illustrative purposes only.

����ֱ�� 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. ����

• Product and device manufacturer's instructions for use
• Evidence-based guidelines for safe administration practices
• Applicable law and regulation

Any examples are for illustrative purposes only.

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


��

Any examples are for illustrative purposes only.

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.)

Any examples are for illustrative purposes only.

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 with��the 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


��

Any examples are for illustrative purposes only. ��

• 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.

Any examples are for illustrative purposes only.

Medication storage practices and conditions��are 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 resources��that 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 and��NOT the sterility.�� An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.

Any examples are for illustrative purposes only.

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.

Influenza and Pneumococcal Vaccines:��
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 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 Statement��(VIS) given to the patient.��

If all criteria are met and an order would not be required, then pharmacy would not be required to review.

• 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.��

Resources:
Center for Disease Control (CDC)

��

Any examples are for illustrative purposes only.
��
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.

• 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.

��

Any examples are for illustrative purposes only.

����ֱ�� 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
��


��

Any examples are for illustrative purposes only.
Additional Resources

Any examples are for illustrative purposes only.

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.�� Organizational and medical staff leadership are responsible for determining the type and location of emergency medications and supplies (see MM.03.01.03). ��An order is required to administer any medication. In emergent situations, organizations may consider use of protocols, approved by the medical staff and in accordance with MM.04.01.01 EP 15 (deemed surveys), to guide the administration of urgently-needed medications.

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.��
��

Any examples are for illustrative purposes only.

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 ��

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. ����
��

Any examples are for illustrative purposes only.

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.
��

Any examples are for illustrative purposes only.

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 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.

Any examples are for illustrative purposes only.

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).

Any examples are for illustrative purposes only.

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-wide��hand 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 areas��by auditing to ensure product is available and not expired.��

The organization provides supplies to support the infection prevention and control program. ��Examples may include:

• 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.

Health care staff perform hand hygiene and observe other hand hygiene guidelines as per the organization's hand hygiene program. Examples may include:

• 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.

Additional Resources



See also Perspectives®, April 2019, Volume 39, Issue 4 p. 15 for additional information on infection control policy requirements
��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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��

While standardization of the identifiers used is beneficial, there are settings and situations when variations may need to be employed. For example, in an outpatient setting where ID bands may not be used as an information source, an infant or toddler, an unresponsive patient, etc. The organization determines how accurate patient identification will be completed in these types of situations. �� The two patient identifiers should be consistent within each setting, not just whatever the individual practitioner or staff person wishes to use

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.
��

Any examples are for illustrative purposes only
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

Any examples are for illustrative purposes only.
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.��
��

Any examples are for illustrative purposes only.
^The organization determines where emergency carts are located within the organization.





��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

The organization can have a��requirement, 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's��requirements for the history and physical��must 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.

Any examples are for illustrative purposes only.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care

Any examples are for illustrative purposes only.

No. Moderate and��deep sedation��are not without risks. As such, ����ֱ�� includes these in its glossary definition of anesthesia and sedation. As a result, the��requirements��found at��PC.03.01.07��apply to these levels of sedation, regardless of less stringent interpretation by organizational policy or interpretive guidelines.
��

Any examples are for illustrative purposes only.​​�ċ�ċ�ċ�ċ�ċ
^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.��

Facilitating access to the Prescription Drug Monitoring Program (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��

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.
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.��
Pain Assessment and Management Resources

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only. ��

• ����ֱ�� 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 to��perform 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 patency��and 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 be��discharged upon a LP's order based on criteria established by the medical staff.��

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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. ����

Any examples are for illustrative purposes only.



��

Any examples are for illustrative purposes only. ��

• 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

• 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

Role/Responsibilities—In addition, organizations should consider the following components to ensure clarity regarding role and responsibilities:

• 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.

This information was��published in the Perspectives® Newsletter, August 2018, Volume 38, Issue 8 - The Official Newsletter of ����ֱ��.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

����ֱ�� 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.
��

Any examples are for illustrative purposes only.
Resources

Any examples are for illustrative purposes only.
Additional Resources
Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care

Any examples are for illustrative purposes only.

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.
��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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:

• Reporting Adverse Patient Reactions to the Donor Source Facility:

Any examples are for illustrative purposes only.

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 apply��based on FDA classification.

Products that are derived from human or non-human tissue and cellular materials, but��rendered 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 use��are 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 products��can 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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.
��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

����ֱ�� 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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.��

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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.

• 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.

Appendix B of the Laboratory Accreditation Manual includes the standards that apply to laboratory developed tests.

Any examples are for illustrative purposes only. ��
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.��

��

Any examples are for illustrative purposes only. ��

����ֱ�� 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.��

��

Any examples are for illustrative purposes only.��
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.

��

��

Any examples are for illustrative purposes only. �� ��
��

Any examples are for illustrative purposes only.

The following publications are available through ����ֱ�� to help with compliance with the Environment of Care, Emergency Management and Life Safety: 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��

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.
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��

Any examples are for illustrative purposes only.

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:

Any examples are for illustrative purposes only.
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.��

Any examples are for illustrative purposes only.

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.
��

Any examples are for illustrative purposes only.��
"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.

Any examples are for illustrative purposes only.

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

Triennial or 36-month generator test 30% of nameplate rating for 4 continuous hours for diesel powered EPs, see EC.02.05.07 EP and EP10.

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

Any examples are for illustrative purposes only.

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:

1. 30 minutes with a connected load of at least 50% of nameplate rating
2. 60 minutes with a connected load of at least 75% of nameplate rating

Additional Resources
NFPA 99-2012: 6.4.4.1

Any examples are for illustrative purposes only.

����ֱ�� 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

��

Any examples are for illustrative purposes only. Additional Resources
NFPA 111 – 2010: 8.3.1; 8.3.3; 8.3.4; 8.4.1
��

Any examples are for illustrative purposes only.

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 38��degrees 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)

Reference standard EC.02.02.01: The hospital minimizes risks associated with selecting,��handling, storing, transporting, using, and disposing of hazardous chemicals.

Any examples are for illustrative purposes only. ��

����ֱ�� 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��

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

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

In either case both will result in activating the starter for the generator and activation of the ATS transferring the load from normal power to emergency generator 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

Any examples are for illustrative purposes only.
��
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��

This may also include exterior support equipment such as:

• Loading dock and equipment
• Helicopter landing pad
• Ambulance parking

Reference EC.02.01.01

Any examples are for illustrative purposes only.��

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 ��

Any examples are for illustrative purposes only.��

• 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.

Any examples are for illustrative purposes only.

����ֱ�� 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

Additional Resources



��

Any examples are for illustrative purposes only.

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.��

Any examples are for illustrative purposes only.
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

Any examples are for illustrative purposes only.

����ֱ�� 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)

Multi-disciplinary input should include; infection control, risk management, and the safety officer.

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

These height installation recommendations from NIOSH will comfortably accommodate 95% of all adult female workers.

Additional Resources:


��

Any examples are for illustrative purposes only.

����ֱ�� 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��

Any examples are for illustrative purposes only.��

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.��

For other NFPA 99 requirements that are not expressly identified in the language of a CoP or an EP, facilities will be held to the code requirements that were in effect at the time of construction and maintain compliance with that version.

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.

Any examples are for illustrative purposes only.��

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��

Any examples are for illustrative purposes only.

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��

Any examples are for illustrative purposes only.
����ֱ�� 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.

��

Any examples are for illustrative purposes only.��

����ֱ�� 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

��

Any examples are for illustrative purposes only.��
Consult with state and local authorities having jurisdiction to address regulations and requirements specific to your geographic location.

Additional Resources:

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

����ֱ�� 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
��


��

Any examples are for illustrative purposes only. ��
��

• 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. ��

Organizations should also check with their state regulatory agencies as some states have additional items which is considered regulated waste or regulated medical waste. ����
��
Reference EC.02.02.01��

Any examples are for illustrative purposes only.
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.

In addition to CMS requirements, the following NFPA code requirements also apply:

• 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.

For full text, refer to NFPA 99-2012: 10.2.3.6; 10.2.4; NFPA 70-2011: 400-8; 590.3(D); Tentative Interim Amendment (TIA) 12-5)

^ 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

Any examples are for illustrative purposes only.

����ֱ�� 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

Any examples are for illustrative purposes only.

����ֱ�� 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��

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.
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 ��

Any examples are for illustrative purposes only.

����ֱ�� 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.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

����ֱ�� 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.

��

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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

Any examples are for illustrative purposes only.

• 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.

• 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 competencies��expected of an OR Nurse, surgical assistants and sterile processing staff.

Any examples are for illustrative purposes only.

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)

��

Any examples are for illustrative purposes only.

����ֱ�� does not��typically��request��accredited��organizations��to��summon��the entire set of personnel files from��accredited or certified contracted organizations.��Contracted��accredited��organizations��will undergo��their��own accreditation or certification survey��by the Joint Commission and��will��demonstrate compliance��within��their personnel records��at that time.��If personnel records��are requested for review, they��must 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 also��LD.01.03.01 and LD.03.04.01).����

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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 to��organization'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.

Any examples are for illustrative purposes only.
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.

Any examples are for illustrative purposes only.

Any examples are for illustrative purposes only.

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.

Any examples are for illustrative purposes only.

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 hy