Healthcare Compliance Updates – February 2022

ACCREDITATION UPDATES

 

Surveyors to Focus On Immediate Threat to Health and Safety Hazards

The Joint Commission (TJC) surveyors have been identifying more Immediate Threat to Health and Safety (ITHS) hazards during the recent cycles of the accreditation process. The TJC defines an ITHS “as a threat that represents immediate risk and has or may potentially have serious adverse effects on the health or safety of patients, residents, or individuals served or on other occupants in the facility”. This citation will appear at the top of the TJC’s SAFER Matrix and can trigger a Preliminary Denial of Accreditation (PDA).

After being notified of a PDA decision, an organization must do the following:

  • Take immediate actions to eliminate the ITHS situation
  • Should an ITHS situation not be completely eliminated immediately, the organization must implement emergency interventions
  • Survey team will not leave the organization until sufficient mitigation is in place

To assist in the survey process, the TJC has provided Life Safety Code surveyors new policy documents and tools for better identifying severe hazards in the Environment of Care (EC) and Life Safety (LS) chapters of the Physical Environment. This new guidance clarified equipment, systems, and situations which would trigger an ITHS and gives more attention to ligature risks.

An ITHS may be declared only on site, during the survey process when a hazard is identified, such as:

  • Serious safety or quality concerns
  • High-risk issues
  • Questionable situations
  • Potential threats to health and safety

Before identifying an ITHS, a surveyor assesses the following:

  • Degree of noncompliance
  • Extent of harm or potential harm
  • Immediacy of the situation
  • Organization’s knowledge and responsiveness
  • Systemic issues

There are specific hazards in the physical environment which may trigger an ITHS situation. The TJC states that “typically, egregious issues and escalating levels of risk are observed during on-site surveys” in the following areas:

  • High-level disinfection and sterilization processes
  • Ligature and self-harm risks in settings which care for individuals at risk for suicide
  • Medication compounding processes and rooms
  • Physical environment systems

Some examples provided of significantly compromised physical environment systems that may trigger ITHS situations include the following:

  • Fire alarm system – notification devices are not working, the fire alarm system is not communicating with the fire department, and the fire alarm system is not connected to emergency power
  • Sprinkler system – fire pump is not functioning or not connected to emergency power
  • Emergency power supply system – emergency generator fails repeatedly during monthly load testing and emergency power system is not connected to the essential systems
  • Medical gas system – not connected to a master alarm panel, the master panel is not functional, a manifold system is not functional, improper category of the medical gas system is installed for the type of procedures conducted
  • Compromised exits – exits are blocked due to construction or other barriers, no directions for alternate exits or ILSMs in place
  • Ligature risks in a behavioral health environment – mitigation plan to reduce risks of harm to patients or individuals served is not or inconsistently implemented after risks are identified in an assessment. Adverse events related to ligature/self-harm have occurred without a comprehensive analysis or without corrective actions being implemented based on the analysis
  • Lapses in maintaining high-risk utilities systems and medical equipment – lacks inspection, testing, and maintenance (ITM) activities and ITM handled improperly, which could lead to catastrophic failure.
  • Infection prevention and control issues in the environment
  • Other situations which place patients, staff, or visitors in extreme danger

Maintaining a current compliance program that addresses the requirements in the environment of care and Life Safety standards provides the best way to prevent any ITHS citations. Conducting the required ITM activities of fire protection systems, utility system components, and medical equipment is essential. Maintaining the appropriate documentation to verify compliance will make the survey process much easier with a substantially better outcome. For further information, please see EC News January 2022 Volume 25 Issue 1.

 

Revised Survey Process for Hospital Business and Ambulatory Health Care Occupancies

In recent years, hospitals (HAP) and critical access hospitals (CAH) have obtained spaces or buildings on and off their campuses which are classified as ambulatory health care occupancy (AHCO) or business occupancy. These facilities are listed in their Centers for Medicare & Medicaid Services (CMS) certification number. During a Joint Commission (TJC) survey, all AHCOs and a sample of business occupancy sites that were attached to the hospital are inspected by the clinical surveyor. Recently, the TJC clarified the survey process in EC New, January 2022, Volume 25, Issue 1.

Effective July 1, 2020, the TJC Life Safety Code (LSC) surveyors became responsible for surveying off-site freestanding emergency departments and hospital-based ambulatory surgery locations, which are classified as AHCOs by the CMS Final Rule for physical environment issues. These buildings and spaces are predominantly business occupancies and must comply with TJC’s new “05” Life Safety (LS) standards, which applies to HAP, CAH, and behavioral health care and human services (BHC) organizations. The Life Safety standards for business occupancies took effect July 1, 2021, and includes five standards:

  • LS.05.01.10: Building and fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat.
  • LS.05.01.20: The [organization] maintains the integrity of the means of egress.
  • LS.05.01.30: The [organization] provides and maintains building features to protect individuals from the hazards of fire and smoke.
  • LS.05.01.34: The [organization] provides and maintains fire alarm systems.
  • LS.05.01.35: The [organization] provides and maintains equipment for extinguishing fires

The hospital AHCOs and business occupancies must be prepared to demonstrate compliance with all applicable Life Safety and Environment of Care (EC) requirements. Additionally, the sites must have an Environment of Care Management Plan to manage the EC risks (EC.01.01.01). The following are activities conducted:

  • Evaluate the physical environment
  • Conduct building tour assessments of critical life safety and environment of care areas, such as egress corridors and emergency generators
  • Review documents, such as life safety drawings; fire drill reports; and inspection, testing, and maintenance (ITM) records for key systems.

The TJC also answered essential questions about requirements for complying with a survey. These included:

  • Are life safety drawings required for business occupancies?

If an entire building is classified as a business occupancy per the NFPA, then life safety drawings need not be shown to Joint Commission surveyors. However, if a business occupancy is part of a building that includes health care occupancy or AHCO spaces, then surveyors will ask to see life safety drawings.”

  • Do surveyors inspect the above-ceiling space in business occupancies?

HAP and CAH business occupancies are expected to be compliant with LS.05.01.10, EP 5: “The space around pipes, conduits, bus ducts, cables, wire, air ducts, or pneumatic tubes penetrating the walls or floors are protected with an approved fire-rated material.” In addition, in spaces that are sprinklered, nothing can be draped over, attached to, or touching sprinkler pipes above the ceiling per the Life Safety Code (NFPA 101-2012). However, Joint Commission surveyors at this time do not ask to inspect above-ceiling spaces in business occupancies.”

  • If a hospital business occupancy is in a multitenant building, what parts of the building will Joint Commission surveyors examine beyond the accredited space?

“Inspect the means of egress and any fire safety features for use by the public. Both sides of fire barriers are inspected if there is a difference in occupancy type between adjacent spaces occupied by different tenants, such as when the accredited space is a business occupancy while the adjoining space leased by another tenant is an ambulatory health care or health care occupancy”.

 “If the accredited space is on the ground-level floor in a multistory building, the survey will not include stairways serving upper floors. However, surveyors will need to ensure that the stairwell does not contain combustible storage, such as a trash can or boxes of paper for a copier, and that nothing is in the stairwell that hinders its function, such as a bike rack in the exit discharge or “wet floor” signs”.

 “If the accredited space is on an upper floor of a multistory, multitenant building, the survey will include the stairways serving the upper floors as well as the path of exit from the building. If the path of exit is on the second floor, surveyors will examine that plus the exit discharge on the first floor”.

Include the ACHO and business occupancy facilities in the environmental tour and life safety audit programs conducted for the primary organization. Document the date, results, and any corrective actions taken for deficiencies identified. If Interim Life Safety Measures (ILSM) are implemented which require a fire drill, include the drill day, date, and time on the Fire Drill Matrix (EC.02.03.03). For further information on the survey process for ACHO and healthcare business occupancies, refer to EC New, January 2022, Volume 25, Issue 1, for complete details.

 

STANDARD REQUIREMENT UPDATES

 

Managing Alcohol-based Hand Rubs in Healthcare Areas (LS.02.01.30)

 Associated with the ramification of the pandemic, Alcohol-Based Hand Rubs (ABHR) were placed in a variety of locations throughout the healthcare facility, especially waiting areas. The Joint Commission (TJC) clarified the installation of ABHR dispensers in waiting areas, corridors, and rooms to minimize the fire risk from a flammable liquid. These requirements are in accordance with the requirements of the Life Safety Code, NFPA 101-2012, 18/19.3.2.6. & 8.7.3.1 (LS.02.01.30 EP6):

  • Corridor is at least six feet wide
  • ABHR does not exceed 95% alcohol
  • Maximum individual dispenser capacity is 0.32 gallon of fluid (0.53 gallon in suites) or 18 ounces of NFPA Level 1 -classified aerosols
  • Dispensers have a minimum of four feet of horizontal spacing between them
  • Dispensers are not installed within one inch of an ignition source
  • If floor is carpeted, the building is fully sprinkler protected
  • Operation of the dispenser complies with NFPA 101-2012: 18/19.3.2.6(11)
  • ABHR is protected against inappropriate access
  • Not more than an aggregate of 10 gallons of fluid or 1135 ounces of aerosol are used in a single smoke compartment outside a storage cabinet, excluding one individual dispenser per room
  • Storing more than five gallons of fluid in a single smoke compartment complies with the requirements of NFPA 30

Importantly, one dispenser of ABHR located in a room is excluded from the 10 gallon limit maximum for a smoke compartment. Remember, the 10 gallon maximum includes all alcohol-based products which are not properly protected from the risk of a fire within that smoke compartment, such as alcohol solutions used for dressings. Only one ABHR dispenser located in a suite is excluded from total amount of the quantity of alcohol-based products for the total space of a suite, not one for each individual bay.

According to TJC, Alcohol-based hand “wipes” are not included in the 10-gallon limit of ABHR in a smoke compartment. Many of the “wipes” do not list the quantity of alcohol on the label or use a non-alcohol-based material as the disinfectant. These non-alcohol-based disinfectants may, however, contain a hazardous material and the review of the Safety Data Sheet is required to provide adequate precaution and warning labels for use (EC.02.02.01 EP11-12). The wipes should also be included in the inventory of hazardous materials (EC.02.02.01 EP1).

Calculating the amount of flammable liquid can be difficult, but it is best to convert ounces to gallons and do the math. Taking an inventory of the quantity of ABHR stored outside a flammable storage cabinet or approved space should also be conducted frequently and “documented” for reference during a survey. For further information, see Joint Commission Frequently Asked Question, October 26, 2021.

  

Emergency Depressurization and Evacuation of Hyperbaric Facility (EC.02.04.03)

The Joint Commission (TJC) requires all occupancies containing hyperbaric facilities used for Hyperbaric Oxygen Therapy to comply with construction, equipment, administration, and maintenance requirements of NFPA 99-2012: Chapter 14 (EC.02.04.03 EP10).

Hyperbaric oxygen therapy (HBOT) is a type of treatment used to treat such conditions as sick scuba divers and people suffering from carbon monoxide poisoning. Patients enter a special chamber to breathe in “pure” oxygen in air pressure levels 1.5 to 3 times higher than average. The goal is to fill the blood with enough oxygen to repair tissues and restore normal body function. It has also been approved for more than a dozen conditions including:

  • Carbon monoxide poisoning
  • Cyanide poisoning
  • Crush injuries
  • Gas gangrene
  • Decompression sickness

Hyperbaric chambers are becoming commonplace in Wound Centers located inside a healthcare facility or in an offsite clinic, which may involve a single or several hyperbaric chambers in a space. The installation and operation of the hyperbaric chambers are covered in NFPA 99-2021 Chapter 14 Hyperbaric Facilities. Chambers are classified according to occupancy in order to establish appropriate minimum essentials in construction and operation as follows (14.1.2.2):

  • Class A — Human, multiple occupancies
  • Class B — Human, single occupancy
  • Class C — Animal, no human occupancy

These spaces must comply with the fire safety requirements for construction identified in the section “Housing for Hyperbaric Facilities” (14.2.1).

Recent TJC survey findings include citations for failure to demonstrate compliance for the “Emergency Depressurization and Evacuation of Hyperbaric Chambers” (14.2.4.5.1-.5). According to NFPA 99, these requirements include the following:

  • Class A chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 6 minutes (14.2.4.5.1)
  • Class B chambers shall be capable of depressurizing from 3 ATA (304.0 kPa) to ambient pressure in not more than 2 minutes (14.2.4.5.2)

Additionally, a source of breathable gas allowing unrestricted mobility shall be available outside a Class A or Class B chamber for use by personnel in the event that the air in the vicinity of the chamber is fouled by smoke or other combustion products of fire (14.2.4.5.3). The location and compliance testing documentation for these breathable gas systems should be readily available and current.

Key survey items which are required to document compliance include:

  • The time required to evacuate all persons from a hyperbaric area with a full complement of chamber occupants all at “treatment pressure”.
  • This time is required to be measured annually during the fire training drill requirements (14.3.1.4.5).
  • The code also states the occupants for this training drill shall be permitted to be simulated (14.2.4.5.4.1).

Even though this requirement is found in the Medical Equipment standard, compliance will involve several departments. Having clear procedures for conducting these exercises and documenting the results is important during a survey.

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