Healthcare Compliance Updates – March 2022

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Healthcare Compliance Updates – March 2022



New Emergency Management Program Required for July 2022

As discussed earlier in Cohan Healthcare Compliance Updates; December 2021, the Joint Commission (TJC) has developed new standards for the Emergency Management (EM) Chapter which are based on the “all hazards approach” to emergency preparedness. Due to the pandemic, the primary goal stated by TJC for revising the EM standards was to: “provide more comprehensive, robust, and useful guidance on EM to health care facilities at a time when natural and human-caused disasters and public health emergencies are on the increase”. These standards were issued on December 17 in the TJC’s Prepublication Requirements publication for survey beginning in July 2022.

The new EM standards focus on the development and management of a “Program” based on the “all-hazards approach” for mitigation, preparedness, response, and recovery for emergency response, rather than on just an Emergency Operation Plan (EOP). The format of the new EM Program is similar to a Program for managing risks in the Environment of Care (EC). These Programs involve four elements:

  • Manage the risks of an emergency
  • Implement actions to minimize the risks
  • Develop and measure the competency of staff
  • Analyze the Program to provide opportunities for improvement

Much of the information required for compliance to the previous standards can be incorporated into the new EM Program. However, each standard has new Elements of Performance (EP) which will require additional procedures or other documentation. The standard numbering sequence for the new EM Chapter also is different than previous EM standards beginning with EM.09.01.01 – EM.16.01.01, so not to be confused with the old standards (EM.01.01.01 – EM.04.01.01).

The first four standards provide guidance for developing and managing the Program, including involvement of Leadership, conducting the hazard vulnerability analysis (HVA), and developing the EOP. These requirements are similar to the first standards in the previous edition.

Managing Risk of the Emergency

  • 09.01.01 – develop a comprehensive emergency management
  • 10.01.01 – document oversight and support from leadership
  • 11.01.01 – conduct a hazard vulnerability analysis
  • 12.01.01 – develop an EOP based on an all-hazards approach

The second group of standards provides guidance in developing various Plans needed for an emergency or disaster incident, including the six critical functions as shown:

Developing and Maintaining Plans to Minimize the Risks

  • 12.02.01 – initiating and maintaining communications during an emergency
  • 12.02.03 – managing all staff and volunteers
  • 12.02.05 – providing patient care and clinical support
  • 12.02.07 – providing safety and security measures
  • 12.02.09 – managing resources and assets, including sustainability
  • 12.02.11 – managing essential or critical utilities
  • 13.01.01 – developing Continuity of Operations Planning (COOP).
  • 14.01.01 – managing disaster recovery

The third group includes only one standard, which involves educating and training the staff on emergency management based on an all-hazards approach:

Increasing Staff Competency on Emergency Management

  • 15.01.01 – provide emergency management education and training program

The final group deals with testing of the Plans, evaluating the Program elements, and providing opportunities for improvement utilizing a multidisciplinary committee that is responsible for overseeing the EM Program. This committee reviews and evaluates all planned exercises, actual emergencies, or disaster incidents.

Analyzing and Improving of the Program

  • 16.01.01 – plan and conduct exercises to test its EOP and response procedures
  • 17.01.01 – evaluate the EM Program, EOP, and COOP and other plans
  • 04.01.10 – review leadership’s oversight for emergency management activities

Additionally, the new EM Program references changes to two EC standards for emergency power systems (EC.02.05.07) and demolition, renovation, or new construction activities (EC.02.06.05).

  • 02.05.07 EP11 – meets all other emergency power system requirements (NFPA 99-2012, 110-2010, & 101-2012)
  • 02.06.05 EP1 – emergency generator must be located in accordance with the location requirements for new structures or renovation (NFPA 99-2012, NFPA 101-2012, NFPA 110-2010 & Tentative Interim Amendments)

The new EM standards focus on the development of an EM Program based on the “all-hazards” approach to emergency preparedness. This requires the development of a plan for managing the risks identified in the EM Program. Many of the documents referenced in the previous EM standards can be utilized with the addition of the new requirements.


Top-Cited Physical Environment Standards for Office-Based

Surgery Practices

Recently, the Joint Commission (TJC) has focused more on Office-Based Surgery (OBS) practices to provide a safe physical environment and to minimize the risk of infections. According to the TJC, the most commonly cited findings for the full-year 2020 and the first half of 2021 fall under the requirements for the Environment of Care (EC) and Infection Control (IC) standards (EC News December 2021 Volume 24, Issue 12). An OBS practice, which is accredited by the TJC, must have an EC Management Plan and an Infection Control Plan to minimize the risk associated with these programs.

Standard Reference Requirement Percent Citation
IC.02.02.01 EP2 The practice is performing intermediate and high-level disinfection and sterilization of medical equipment devices, and supplies. 50%
EC.02.04.03 EP4 The practice conducts performance testing of and maintains all sterilizers. 33%
EC.02.03.01 EP12 The practice is managing flammable germicides or antiseptics used during surgeries utilizing electro-surgery, cautery, or lasers, are required 33%
EC.02.05.07 EP1-6 The practice inspects, tests, and maintains emergency power systems. 33%

Disinfection and Sterilization of Medical Equipment and Supplies (IC.02.02.01 EP2)

The reason given for citations covering the disinfection and sterilization procedures of medical equipment and supplies in the OBS practices is the limited staff which may not be properly trained in techniques required (IC.02.02.01 EP2). Understanding all the requirements in the manufacturers’ Information for Use (IFU) document was a concern. Some practices may have a single sterilizer for all procedures without adjusting the requirements for the various medical equipment and supplies resulting in improperly sterilized products.

Performing Inspection, Testing, and Maintenance of Sterilizers (EC.02.04.03 EP4)

Many OBS practices have a small “table-top” autoclave, especially for dental surgery, for sterilizing small surgical instruments and supplies. These units should receive varied inspecting, testing and maintaining (ITM) activities required by the manufacturer, which may not be performed on time or as required by a manufacturer (EC.02.03.04 EP3-4). Because of the size of the practice, an acceptable alternative equipment maintenance (AEM) program may not have been developed (EC.02.04.01 EP5).

Reducing the Fire Risk from Flammable Materials in Surgery (EC.02.03.03 EP12)

The risk of fire in a surgical setting is always a concern when flammable, alcohol-based liquids and electrical equipment, especially lasers, are involved. An assessment should be conducted to identify and minimize the fire safety risks (EC.02.03.01 EP 11). A surgical fire safety checklist should be developed with specific requirements, including a “timeout”, when witnessing a situation involving fire hazards (EC.02.03.01 EP12).

Inspecting, Testing, and Maintaining Emergency Power Systems (EC.02.05.07)

All OBS practices have life safety EXIT signs which can be self-illuminated or powered by the emergency generator or a battery. Regardless, these life safety devices must be tested, and the results documented on a monthly basis. The EXIT signs must also be inspected for proper function, operation, and direction. The other challenge is that these inspections and tests must be documented and an inventory maintained (EC.02.05.07 EP1-2).

An OBS practice could require emergency electrical power in case of failure of the normally provided electrical services. This emergency electrical service may be provided by a stored emergency power supply systems (SEPSS), as in lots of batteries, which requires a monthly or quarterly test based on the type of the device (EC.02.05.07 EP3). Conducting the ITM activities require trained staff or vendors.

However, emergency electrical power is usually provided by an emergency electric generator, which requires routine ITM activities, including a monthly load test (EC.02.05.07 EP6). Failure to properly test the emergency generator under a load needed to support the patient care activities can jeopardize patient safety during an emergency incident, which includes the loss of normal service. There are specific requirements for the generator test which may not be followed by the staff or even a local vendor. Carefully prepared documentation is also needed.

Regardless of the size of the OBS practice, compliance with the EC and IC requirements should be assigned to an appropriate staff member. If the practice is part of a hospital system, the ITM activities and surveillance round should be coordinated with that organization. Documenting compliance with the EC Management Plans and Infection Control Plan is also essential. For more details on the citation found from OBS, review EC News December 2021 Volume 24, Issue 12.




Illumination of EXIT Signs for Means of Egress (LS.02.01.20)

Proper illumination of EXIT signs, which identify “means of egress” in a healthcare facility, is essential for minimizing risks of injury to patients, staff, or visitors in case of a fire or other emergency incident, requiring evacuation of a space. The Joint Commission (TJC) requires the “means of egress” to be adequately illuminated for exit access and discharge pathways (LS.02.01.20 EP38 & 40). The “means of egress” include designated stairs, aisles, corridors, etc., leading to a public way (NFPA-

An EXIT sign can be illuminated in two methods:

  • Externally illuminated – illumination source comes from outside the exit sign
  • Internally illuminated – illumination source comes from inside the exit sign

The level of illumination is also important so that the sign may be seen in emergency situations. The illumination requirements are:

  • Externally illuminated signs – illuminated by not less than five foot-candles (54 lux) at the surface of the sign.
  • Internally illuminated signs – illuminated to a surface value of at least five-foot candles (54 lux) by a reliable light source and be distinctive in color.
  • Self-luminous or photo-luminescent signs illuminated to a minimum luminance surface value of at least .06-foot-lamberts are permitted.

Photo-luminescent signs sometimes referred to as “glow-in-the-dark” signs are illuminated without a dedicated power source. The material in the sign stores incident light (electromagnetic radiation), typically from ambient light sources in well-lit surroundings, and releases the radiation in the form of visible light as a glow. Photo-luminescent signs must be continually illuminated while the building is occupied. The light source which provides the electromagnetic radiation to the sign must also be reliable, such as on emergency power, as determined by the Authority Having Jurisdiction (NFPA 101.

Some EXIT signs which glow in the dark may contain a radioactive gas called “tritium” and may be referred to as “nuclear” powered signs. These signs do not require electricity or batteries and can be used where it is hard to install electric signs, such as above doors. Some of the characteristics of “nuclear” signs are:

  • Tritium gas is contained in sealed glass tubes lined with a light-emitting compound
  • Permanent warning label is attached identifying “tritium” (designated as “H-3” or “H3”)
  • Attached, three-bladed radiation warning symbol states “caution-radioactive materials”
  • All four letters in EXIT are fully lit when working properly
  • All four letters not fully lit indicates that the sign may be damaged or have reached the end of its working life

Regardless of the type of EXIT sign in use, the monthly inspection of the device must occur which reviews functionality, direction notation, condition, and other key indicators (EC.02.05.07 EP1). The inventory of each sign and documentation of the inspection status should be readily available for presentation during an accreditation survey.


Importance of a Current Hazardous Materials and Waste Inventory (EC.02.02.01)

The Occupational Safety and Health Administration (OSHA) requires all employers to maintain a written inventory of hazardous materials and waste (OSHA Hazard Communication Standard, 29 CFR 1910.1200). This requirement is based on the fact that an employer must have the proper safety information, such as a Safety Data Sheet (SDS) or other related documents, to alert employees of the hazards of possible exposure. A current inventory is not considered the list of Safety Data Sheets (SDS) the organization maintains but is the actual list of materials and waste located throughout the facility.

The Joint Commission (TJC) addresses hazardous materials and waste under the Environment of Care (EC) Standard. This standard requires “all types of health care organizations to maintain a written, current inventory of hazardous materials and waste which they use, store, or generate” (EC.02.02.01 EP1). This applies only to materials for which the handling, use, and storage are regulated by local, state, or federal law, such as the Environmental Protection Agency (EPA), Department of Transportation (DOT), and Nuclear Regulatory Commission (NRC). Such hazardous materials and waste identified by TJC include:

  • Chemicals (disinfectants, solvents, pesticides, etc.)
  • Hazardous medication (chemotherapeutics, drugs on the NIOSH hazardous drugs list, etc.)
  • Radioactive materials (both radioisotopes for nuclear medicine and sealed sources such a gamma knife, etc.)
  • Hazardous gases and vapors (smoke plume created during electrocautery surgical procedures, pharmacy and laboratory procedures, etc.)
  • Biohazardous waste (blood, sharps, and other potentially infectious substances)

The TJC also includes requirements to minimize risks associated with selecting and using hazardous energy sources, which include ionizing equipment (x-ray equipment) and non-ionizing equipment (lasers and MRIs) in this standard (EC.02.02.01 EP7). This EP does not require an inventory of this equipment, because this is covered in the Medical Equipment Standard (EC.02.04.01-.03). Additionally, the Infection Prevention Department is responsible for “minimizing the risk of infection when storing and disposing of infectious, biohazardous waste, but not maintaining the inventory” (IC.02.01.01 EP6). Of course, based on the inventory, the proper SDS or other hazard-related information should be available (EC.02.02.01 EP11).

A program to demonstrate compliance with the requirements for the proper inventory to manage hazardous materials and waste should include the following:

  • Describe the process for maintaining the current, written inventory
  • Demonstrate that the inventory is maintained in appropriate locations
  • Document that the inventory is current

The policy for managing hazardous materials and waste should describe the process for maintaining the inventory. This can be accomplished in several ways, such as:

  • Accounting for hazardous materials and waste in all locations periodically
  • Requiring those departments using a hazardous material or generating waste to maintain a current inventory
  • Relying on shipping and receiving manifest to document the quantity
  • Verifying the process during the environmental tour process

This inventory may also be maintained in several forms to demonstrate compliance with these requirements, which include:

  • Consolidated into one document maintained by the Chapter Leader for the Hazardous Material and Waste Program
  • Decentralized and maintained by the department using the material or generating the waste
  • Combined with the large user of hazardous materials, such as the laboratory, pharmacy, and engineering departments, to maintain their inventory, while a list of other departments is maintained by the Chapter Leader.
  • Be sure that Bulk Oxygen tanks are included on someone’s inventory!!!

Confusion comes when trying to determine the items which should be included in the inventory. The TJC states that “consumer products that are used in a workplace in such a way that the duration and frequency of use are the same as for consumer use, need not be included in the hazardous material and waste inventory”. This would include items such as liquid correction material, printer toner, furniture polish, etc. However, an assessment should be made of the exposure potential to the staff from consumer products. This includes ensuring that the use frequency and duration are not greater than that of normal consumer use. For further information about the TJC requirements, see TJC’s EC News, February 2022, Volume 25, Issue 2, for details.


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