Healthcare Compliance Updates – December 2021

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Healthcare Compliance Updates – December 2021



CMS Review of New TJC Emergency Management Standards

In the December edition of its EC News, the Joint Commission’s (TJC) announced that new Emergency Management (EM) Standards for Hospital and Critical Access Hospitals are under review by the Center for Medicare and Medicaid Services (CMS) for survey as soon as July 2022. The overarching goal of revising the EM standards is stated to be: “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”.

Unlike the existing EM chapter, the proposed new EM standards are not just centered on the existing Emergency Operations Plan (EOP) concept and the six critical areas of emergency management (Communication, Resources and Assets, Security and Safety, Staff Responsibilities, Utility systems and Patient Management). The focus now embraces factors associated with recent emergencies, such as cyberattacks and pandemics, and utilizing Continuity of Operation Planning (COOP). Some of the new emphasis includes the following:

  • Comprehensive EM program to utilize the “all-hazards” approach to emergencies and disasters, but not just focused on the current EOP process.
  • Leadership to provide oversight and support of the EM program, including allocation of resources for the program.
  • Senior leaders to identify a qualified individual to lead the EM program.
  • A multidisciplinary committee to provide input into the emergency management program and to assist with its preparation, development, implementation, evaluation, and maintenance.
  • Program to provide education and training on EM preparedness and response.
  • Process tor evaluating the EM program as well as the EOP and COOP documents.

Additionally, the organization will be required to develop a “Disaster Recovery Plan.” The plan will contain more detailed information than in the current EOP for disaster recovery and use strategies outlined in the COOP for continuing operations. The Plan will contain the following procedures:

  • Conducting an organization-wide damage assessment
  • Restoring critical systems and essential services
  • Returning to full operations

Additional requirements will necessitate the organization to use the “all-hazards” approach for emergency response to develop the following:

  • Facility-based, Hazard Vulnerability Analysis (HVA) which focuses on natural, human, and technology hazards, as well as hazardous material incidents and emerging diseases.
  • Written EOP with supporting policies and procedures, which focus on activities in addition to “current six critical functions”, such as mobilizing incident command; maintaining, expanding, curtailing, or closing operations; and securing information and records.
  • Communication plan, which addresses maintaining a contact list used for establishing and maintaining communications to deliver coordinated messaging and information to key individuals and entities, for notification in response to an emergency or disaster.
  • COOP program, which comprises participation from key executive, business, finance, and departmental leadership to provide guidance to continue delivering essential or critical services which cannot be deferred during an emergency.

For more information regarding the proposed EM standards and preparing the required documentation, review the article in TJC’s EC News December 2021 Volume 24, Issue 12. Never too early to be prepared for the next emergency!


Maintaining Current Inventories to Demonstrate Compliance

Maintaining a “written” and “current” inventory of equipment, systems components, materials, etc. is important in documenting compliance with many Joint Commission (TJC) standards in the Environment of Care (EC) Chapters. Most inventories are developed, updated, and maintained through a work order or another “asset” tracking system. Failure to provide an accurate inventory, which contains a possible component found during a building tour, could result in a citation during a survey.

Twenty-seven Elements of Performances (EP) in the EC standards actually cite the need for an “inventory” in the requirements. The number (-) of EPs in the standards includes:

  • 02.02.02 (1) – Hazardous Material and Waste Management, i.e., hazardous material and waste inventory
  • 02.03.05 (8) – Fire Protection System Testing, i.e., tamper switches, water flow devices, initiating and alarming devices, portable fire extinguisher, etc.
  • 02.04.01 & .03 (7) – Medical Equipment Management & Testing, i.e., medical equipment testing, high risk identification, AEM maintenance program
  • 02.05.01 & .05 (8) – Utility System Management & Testing, i.e., utility system component testing, high risk identification, AEM maintenance program
  • 02.05.07 (2) – Emergency Power Supply Testing, i.e., battery powered emergency egress and task lighting, and automatic transfer switches
  • 02.05.09 (1) – Medical Gas Systems Testing, i.e., critical components including source subsystems, control valves, alarms, etc.

The inventory for hazardous materials is usually maintained by the department using these items and updated each time a shipment of new materials is received or waste removed. A common activity conducted during a survey involves locating a container of hazardous material, requesting to verify it is on the departmental inventory, and asking for the Safety Data Sheet used to minimize the risks. Again, failure to have a current inventory of hazardous material can result in a citation.

Most organizations maintain a current inventory for medical equipment and utility system components through the use of a work order system which tracks the various assets for initial testing, routine inspections, testing and maintenance (ITM) activities, and repair actions. The inventory should contain, for example, at least the following information:

  • Asset Name: Air Handler, IV Pump
  • Manufacturer: Recall Engineering, Flow-fast, Inc.
  • Item Number: US – 12345, ME – 67890
  • Function: Infection Control, Medication Dispensing
  • Location: Mechanical Room 5, 4th Floor Clean Storage
  • Space Served: Operating Room 1, 4th Floor ICU
  • Maintenance Program: Alternative Equipment Maintenance (AEM), Manufacture’s Recommendation (MR)
  • Failure Risk Level: High Risk, Non-high Risk

The inventory should be updated using a standard format which is flexible, allowing changes in compliance requirements and additional information when necessary. Many current inventories developed through a work order system do not identify the “Maintenance Program” or “Failure Risk Level” required for medical equipment and utility system components (EC.02.04.01 & EC.02.05.01). Providing a consistence process for entering the initial information is key to a successful current inventory.




Storage Under a Sink in a Healthcare Environment (EC.02.06.01)

The storage of items “under a sink” in a healthcare environment usually raises concerns during the compliance rounding process for a safe environment (EC.02.06.01 EP1). Neither the Joint Commission (TJC) nor Occupational Safety and Health Administration (OSHA) specifically prohibit “all” under-sink storage, but TJC requires a risk assessment be performed to determine the allowance of storage in various settings. The Center for Disease Control and Prevention (CDC) guidelines do not support the storage of medical or surgical supplies under any sink!

Organizations often do not have a policy defining and identifying the requirements for approved locations for under sink storage. In most instances, an organization does not allow the placement of items under sinks in the patient care rooms and often that requirement is assumed to be enforced throughout the facility. This can become a concern when items are found stored under a sink in a non-patient care area during an accreditation survey. Without a policy, an organization may be cited based on the surveyor’s preference.

The policy should be established and the staff trained during the compliance rounding process based on the risk assessment. In some locations, under sink storage may be permissible based on the materials being stored and the activities conducted. The assessment should include the impact on the contents of a potential plumbing leak or a moist environment. Additionally, safety may be the concern with accessibility of the contents to patients or visitors.

Storage under a sink located in space managed by trained staff may be permissible, such as in a laboratory, soiled utility room, or medication room. Plastic trash bins or cleaning supplies located under sinks would typically not be an issue in certain areas. However, a product that is inherently ‘clean’ or which can be damaged by, or react to water should not be stored under a sink, such as the following:

  • Paper towels and toilet tissue
  • Reagent and chemicals – adverse reaction to water
  • Medical supplies (towels, gowns, gloves, etc.)
  • Charts or manuals
  • Soap (powdered or bar soap in cardboard boxes or paper container)
  • Medical equipment

The organization should conduct the assessment to identify spaces which could allow under sink storage. Based on this assessment, develop the policy which defines the storage requirements, train the staff on the policy, and review its effectiveness during the rounding process. After reviewing the results of the rounding process, determine if the “under sink storage” policy provides the proper guidance.


Managing Cardboard and Corrugated Boxes in Healthcare Facility (IC.02.01.01)

A question which frequently arises during a tour of the environment in a healthcare facility is the management of cardboard and corrugated boxes. Of course, there is a fire risk from the storage of large amounts of combustible materials and empty boxes blocking a means of egress, addressed in the Life Safety Chapter (LS.02.01.30 & LS.02.01.20). However, a greater concern may come from the risk of infections.

This requires implementing infection prevention and control precautions to minimize the risk of transmission of pathogens on medical equipment, devices, and supplies. (IC.02.01.01 EP3 & IC.02.02.01 EP4). Other requirements govern the placement of cardboard and corrugated boxes in a healthcare facility including the following:

  • Food storage and preparation areas (State Food Sanitation Code)
  • Pharmacy and medication rooms (e.g. USP 797)
  • Sterile storage (e.g. AAMI ST79)

Cardboard and corrugated boxes, especially exterior shipping containers, pose additional risk and extra precautions such as:

  • Reservoirs for dust
  • Susceptible to moisture, water, vermin and bacteria
  • Exposed to unknown and potentially high microbial contamination during the transportation process

Therefore, an organization should develop a policy which contains essential elements for the management of boxes from the time of arrival until disposal. This includes:

  • List of locations to load or unload supplies from shipping containers
  • Process to inspect shipping containers upon arrival for contamination
  • Procedure for removal, inspection, salvage, or disposal of contents from a visible soiled shipping container, based on the overall condition of contents
  • Distribution of content intended for patient care and service spaces, including placement of contents in clean containers or bags
  • Procedures for removal of clean or sterile items for the kitchen, central processing, pharmacy, etc. from their external shipping containers before they are placed in a storage areas
  • Criteria for allowing certain types of boxes (boxboard, compressed boards, etc.) in specific areas based on level of cleanliness required
  • Requirements for placement of boxes on the floors in storage or utility areas
  • Procedure and frequency for removal of boxes on a regular basis to avoid clutter and accumulation of combustible material in corridors

Once a process for managing cardboard or corrugated boxes is developed, organizations should demonstrate compliance with the policy during surveillance or rounding process. Review of the results of the compliance rounding process should demonstrate the effectiveness of the policy and could provide “opportunities for improvement” to minimize the risk of infections.



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