Healthcare Compliance Updates – July 2021

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Healthcare Compliance Updates – July 2021



Determining a Safe Environment: Necessity for an Environmental Tour Program

In the past, “environmental tours” were required semi-annually for patient care spaces, and annually for non-patient care spaces to evaluate the risks in the internal environment. Fortunately, requirements for the tour and frequency no longer exist, but a tour “program” is still a realistic process to demonstrate a safe and appropriate environment for patients, staff, and visitors (EC.02.06.01). Tours of the “grounds” monitor the external environment (EC.02.01.01).

Eliminating the “required” frequency allows the staff to focus on high-risk spaces or noted deficiencies. Some patient care spaces may require a tour quarterly, while other spaces require an annual tour based on data from previous tours, patient or staff activities, deficiency histories, and incident reports. The key elements of a successful environmental tour program include:

  • Realistic “frequency” based on risk in the space
  • Appropriate “checklist” which identifies risks or concerns
  • Tour “team” with expertise in the areas reviewed
  • Data “analysis” which results in corrective actions in order to minimize identified risks

Determining the appropriate tour “frequency” requires the organization to perform the following procedures:

  • List all the spaces in the facility, including mechanical spaces, gift shops, administrative office, vacant floors, and the like
  • Analyze the data from previous tours, safety, security, hazmat, and fire safety risk assessments, incident reports, and other items of interest (EC.02.01.01 & EC.04.01.03)
  • Determine spaces repurposed or incorporating personnel, procedural, or product changes
  • Identify high-risk spaces requiring frequent inspections based on patient or staff activities, such as operating rooms, pharmacy compounding enclosures, and neonatal intensive care units

A concise tour “checklist” should include essential items, which provide evidence of a safe environment. These should include:

  • Specific Elements of Performance for the six major chapters of the Environment of Care
  • Items considered as “hot button” from current accreditation survey “rumors”
  • Items identified by the organization as concerns from incident reports, etc.
  • Common life safety and infection control items, such as corridor clutter and uncovered clean linen, but not a strict evaluation of these disciplines

The tour “team” should focus on deficiencies, not just check the box for acceptable items. Tour data is not only essential in demonstrating a safe environment but also to discover “opportunities for improvements” by identifying the deficiencies most commonly found, as well as the spaces with the largest number of deficiencies. Based on the information, the following mitigation activities can be implemented to address the deficiencies:

  • Increase or revise staff training
  • Improve procedures, processes, or material
  • Modify the space to meet the need
  • Eliminate a procedure or the materials used

The tour data “analysis” should be discussed by the Environment of Care or other Committees and forwarded to leadership for support. Focus on the high-risk or most often occurring deficiencies, and adjust the tour frequency of those spaces until the deficiencies are corrected. Addressing corrective actions for tour deficiencies are great “objectives” and “performance measures” for the Environment of Care Management Plans.


FDA Announcement: Do Not Use Decontaminated N95’s Now!

 In a May 27, 2021 letter to healthcare workers and facilities, the Food and Drug Administration (FDA) recommended not using decontaminated or bio-burdened reduced N95 and other filtered face-piece respirators (FFR). The announcement also suggests the transition from “crisis capacity” conservation strategies, implemented during the pandemic, to a “conventional” strategy for FFR usage. Based on the increased domestic supply of new, approved FFRs, the FDA and Centers for Disease Control and Prevention (CDC) believe an adequate supply of FFRs is available to stop the use of decontamination and bioburden reduction systems introduced because of limited supplies during the pandemic.

The FDA announcement recommends some of the following procedures for meeting the current requirements for using FFRs:

  • Limit decontamination of disposable respirators.
  • Use a new FFR, if available, before decontaminating or reducing the bioburden on a “preferred” or personal preference, disposable respirator.
  • Only use decontaminated FFRs when there are insufficient supplies of new FFRs.
  • Do not continue to use “stored” FFRs which were previously used and decontaminated
  • Increase inventory of available NIOSH-approved respirators, including powered air-purifying respirators (PAPRs).
  • Stop purchasing non-NIOSH approved respirators for use as respiratory protection.

Since the long-term stability of non-NIOSH approved respirators and respirators is not known, FDA stated that healthcare facilities should not use these FFRs which have been decontaminated. For more information, see “FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.”


EC Management Plans: Required in Business Occupancies

Facilities classified as “Business Occupancy” per NFPA 101, Life Safety Code, have been mostly neglected for years during the Environment of Care (EC) Standards review as part of a Joint Commission (TJC) accreditation survey. However, there appears to be an increased focus on compliance for this part of the organization’s overall healthcare system. Each EC Standard has Elements of Performance (EP) to define and to “promote a safe, functional, and supportive environment within the hospital so that quality and safety are preserved.” The EC Management Plan provides information to demonstrate compliance with the EPs.

In a recent FAQ publication, the TJC clarified the need for Management Plans, which include the following:

  • Coverage for all the “functional” areas of an organization
  • Coverage for care and service provided in Business Occupancy locations
  • Addressing the nature and complexity of operations, which may differ from other occupancies within the organization
  • Addressing specific risks and the unique conditions at each location

The intent of the Management Plan is to provide a “framework” with the “Cliff Note” version of policies and procedures to demonstrate the process for meeting the requirements listed in the EPs. The EC standards requiring Management Plans are Safety, Security, Hazardous Materials and Waste, Medical Equipment, and Utility Systems (EC.01.01.01 EP4-9). To provide the required information, an organization can:

  • Address all required EPs for all the EC Standards in a single Plan
  • Address all required EPs in separate Plans for each EC Standard
  • Develop separate Plans for each location listing only the policies and procedures for the appropriate EPs
  • Provide one comprehensive set of Plans identifying the requirements for all locations

Since the Management Plans are usually requested during the initial document review session of an accreditation survey, presentation of “accurate” documents is important to set the tone for further documentation reviews. Of course, the Annual Evaluation of each Plan should be available, which includes the evaluation of the Scope, Objectives, and Program Indicators listed in each Plan (EC.04.01.01 EP15).




Conducting the Monthly Portable Fire Extinguishers Inspection – EC.02.03.05

A primary focus of the Joint Commission (TJC) survey process is the monthly inspection of the portable fire extinguisher located throughout the facility (EC.02.03.05 EP15). An essential piece of the inspection process is a current inventory which should contain the location, hydrostatic test, monthly inspection, and the annual maintenance activity dates for each fire extinguisher. This also includes those extinguishers designated as “spares.”

The organization should also have a “policy” that lists the procedures used for the monthly inspection conducted in accordance with the NFPA 10-2010: 7.2.2. The inspection procedures should include, at a minimum, the following requirements:

  1. The appropriate fire extinguisher is in the designated place.
  2. Access and visibility of the fire extinguisher is not obstructed.
  3. Pressure reading on a gauge or indicator appears in the operable range or position.
  4. Fullness of the self-expelling (i.e., CO2), cartridge-operated, and pump tank type extinguishers is determined by weighing or hefting.
  5. Condition of tires, wheels, carriage, hose, and nozzle for wheeled extinguishers is observed as in good condition.
  6. Status of push-to-test pressure indicator for non-rechargeable extinguishers is correct.

 A fire extinguisher in some locations may require that additional inspection activities be conducted in accordance with NFPA 10-, based on the conditions including:

  1. High frequency of fires in the past
  2. Severe hazards, such as open flames
  3. Fire extinguisher’s location is susceptible to mechanical injury or physical damage
  4. Exposure to abnormal temperatures or corrosive atmospheres

 If the space meets the above criteria, additional visual inspections are required in accordance with NFPA 10-, including:

  1. Verifying that operating instructions on nameplates are legible and face outward
  2. Checking for broken or missing safety seals and tamper indicators
  3. Examining for physical damage, corrosion, leakage, or clogged nozzles

Since the conditions in spaces containing fire extinguishers change frequently, the procedures should include all the inspection activities listed above. If the monthly inspection is conducted by a vendor, document that the vendor’s technicians are qualified to conduct the inspection, and that their inspection procedures meet the requirements presented above. Have this information available for survey review.


Vinyl Wrap on Elevator Doors Prohibited – LS.02.01.01

As recently noticed, healthcare organizations are using elevator doors as advertising billboards for a variety of items, ranging from marketing new services to congratulating well-deserving staff. However, the vinyl wrap can “negate” the fire rating of the fire door and jeopardize fire protection requirements for elevators. As of January 1, 2021, The Joint Commission (TJC) will not allow “wrapping” of elevator doors, unless it:

  • Meets the Underwriters Laboratory (UL) requirement for fire-rated doors – UL 10B, Fire Tests of Door Assemblies (neutral or negative pressure) and UL 10C, Positive Fire Pressure Tests of Door Assemblies.
  • Covers no more than 5% of the door’s surface
  • Is attached only with an adhesive, no screws, nails, nor glazing
  • Does not impair the operation of the door

To minimize this fire risk, the organization should implement a program that includes the following:

  • Documentations of elevators on the inventory which have wrapping
  • Reviewing documentation for vinyl wraps on elevator doors
  • Obtaining wrap documentation for NFPA 101 and UL-10B and UL-10C requirements if not currently available
  • Removing wrapping if the information is not available to ensure the fire rating of the door is not compromised
  • Reviewing the wrapping on elevator doors during the environmental tour process.

Should wrapping be found on the elevator doors during a survey and the rating documentation is not available or appropriate, a Requirement for Improvement (RFI) will be issued under Life Safety Chapter requirements, (LS.02.01.01 EP2). Since things happen overnight in a hospital, reviewing the wrapping on elevator doors frequently during the environmental tour process makes sense.


More Spares Sprinkler Heads Required – LS.02.01.35

Beginning January 1, 2021, TJC requires hospitals, critical access hospitals, and behavioral health care organizations to have specific “spare” sprinkler heads of each type and also to have required wrenches (LS.02.01.35 EP7 & NFPA 25-2011 & .6). Going forward, an organization should:

  • Have at least six spare heads for “each” type of sprinkler head design for all “temperature” ranges
  • Maintain the associated wrench for each sprinkler head type and temperature range
  • Store spare heads and wrenches in a wall-mounted cabinet located in a space that does not exceed 100o F
  • Conduct annual sprinkler heads inspection to update sprinkler head inventory and spare heads
  • Examine sprinkler heads during environmental tours as an “on-going” quality process

Have the spares available in a “clean, red, wall-mounted” cabinet for inspection during an accreditation survey. This location may be one of the first places a surveyor may visit.

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