Healthcare Compliance Updates – October 2021



TJC to Increase Focus on Workplace Violence

Healthcare organizations are reporting an increase in workplace violence events, partially a result of the impact of the pandemic. The Occupational Safety and Health Administration (OSHA) identifies workplace violence “as any act or threat of physical violence, harassment, intimidation, or other threatening disruptive behavior that occurs at the worksite. These workplace violence events can range from threats and verbal abuse to physical assaults which can affect and involve staff, patients and visitors”.

The American Journal of Managed Care® (AJMC® May 2019) reported that “while 75% of nearly 25,000 workplace assaults occur annually in healthcare settings, only 30% of nurses and 26% of emergency department physicians have reported incidents of violence.  Those unfamiliar with daily events in healthcare institutions may be shocked to learn that violent altercations are so common that most employees in the field consider them to be simply part of the job.

To address this issue, The Joint Commission (TJC) has announced new requirements for developing a strong “workplace preventions system” for hospitals they accredit. Currently, there are no Elements of Performance in the Environment of Care standards which specifically address “workplace violence”. The new and revised requirements become effective in January 2022 and are applicable to all hospitals and critical access hospitals. These requirements are intended to provide a framework for assisting hospitals and critical access hospitals develop strong workplace violence prevention systems. These new requirements will be identified within the Environment of Care (EC.02.01.01 & EC.04.01.01), Human Resources (HR.01.05.03), and Leadership (LD.03.01.01) standards.

The requirements include the following:

  • Defining workplace violence for the facility
  • Including a formal definition
  • Involving leadership oversight
  • Analyzing the worksite for potential risk factors
  • Developing policies and procedures for the prevention of workplace violence
  • Creating reporting, data collection, and analysis systems
  • Identifying and implementing “post-incident” strategies
  • Developing training and education sessions to decrease workplace violence

By identifying risk factors in the workplace, workplace violence events can be minimized, or even prevented with the appropriate precautions in place and the staff properly trained. Any policy developed to address workplace violence should have “zero-tolerance” for staff, patients, visitors, contractors, etc., who may come in contact with workers of the facility.


2020 Survey Results for Ambulatory Healthcare Facilities

According to The Joint Commission, Ambulatory Healthcare (AHC) facilities have had problems complying with accreditation requirements of the Physical Environment (EC News June 2021). Many top-scored citations from the surveys conducted in 2020 were from the Environment of Care (EC) and Life Safety (LS) chapters. The reasons cited by TJC for the citations included:

  • On site staff lacks safety and engineering expertise to conduct document reviews and environmental tours.
  • Sites located in multi-tenant buildings lack landlords with awareness of compliance requirements for inspection, testing, and maintenance of fire protection and utility systems.
  • Utility systems shared in a multi-tenant building have varied shutdown sequences which may not be likely coordinated and documented.

For those AHC facilities surveyed in 2020, the TJC reports that the standards making the list of the most frequently cited were in the AHC Environment of Care (EC) and AHC Life Safety (LS) standards. These were identified as:

  • EC.02.05.01 EP 7: In areas designed to control airborne contaminants, the ventilation system provides appropriate pressure relationships, air-exchange rates, filtration efficiencies, relative humidity, and temperature.
  • EC.02.04.03 EP 4: The organization conducts performance testing of and maintains all sterilizers.
  • EC.02.05.07 EP 4: Every week, the hospital inspects the emergency power supply system (EPSS), including all associated components and batteries.
  • EC.02.02.01 EP 5: The organization minimizes risks associated with selecting, handling, storing, transporting, using, and disposing of hazardous chemicals.
  • LS.03.01.35 EP 6: There are 18 inches or more of open space maintained below a sprinkler deflector to the top of storage.
  • LS.03.01.10 EP 6: The fire protection rating for opening protectives in fire barriers, fire-rated smoke barriers, and fire-rated smoke partitions is as follows:
    • Three hours in three-hour barriers and partitions
    • Ninety minutes in two-hour barriers and partitions
    • Forty-five minutes in one-hour barriers and partitions
    • Twenty minutes in ½-hour barriers and partitions
    • Labels on fire door assemblies must be maintained in legible condition

To minimize the difficulties of maintaining compliance with the required standards and providing the appropriate physical environment for staff, patients, and visitors, the organization responsible for the AHC facilities should consider the following:

  • Develop a planned approach to review documentation and conduct environmental tours in conjunction with the activities conducted at all of the organization’s facilities.
  • Identify a point person for maintaining the documentation for the AHC facility.
  • Conduct scheduled meetings with individuals assigned the responsibility for maintaining the utility and fire protection systems and the safety of the environment.
  • Review lease agreement with AHC landlords to ensure the requirements for testing fire protection systems are included for the spaces in question.
  • Develop a mechanism to receive inspection, testing and maintenance data for fire protection and utility systems conducted by vendors.
  • Conduct frequent tours to document the status of the physical environment for EC and LS concerns.
  • Maintain current documentation for the AHC facilities in same manner as for the rest of the organization.



Continuity of Operation Planning for Emergencies (EM.02.01.01)

With the increased number of major events which can reduce the capacity and capabilities of a healthcare organization; such as weather, pandemics, and cyber-attacks, it is important to have an updated Continuity of Operations Planning (COOP) Plan. This Plan provides the flexibility to continue essential operations, including patient care services and ancillary support functions, while responding to a wide range of potential emergencies. The COOP Plan is usually activated as part of the Emergency Operation Plan (EOP) by the Incident Commander (EM.02.01.01 EP12).

The essential operation for each potential emergency identified in the organization’s Hazards Vulnerability Analysis (HVA) should be assessed with continuity and contingency plans developed. Based on recent major emergencies facing the healthcare community for such events as hurricanes and COVID-19, The Joint Commission is focusing on the organization’s Continuity of Operations Planning (COOP) Plan during the survey process.

Since the COOP Plan is a “stand-alone” document, it can be reviewed and updated periodically. Some of the major components of the COOP Plan include:

Activation Activities and Termination Procedures

  • Activation by Incident Commander as part of the EOP
  • Notification of staff as to plan for activation and process
  • Evaluation of resource needs based on existing sustainability
  • Termination when imminent emergency threat no longer exists, and staffing and resources levels have returned to normal levels

Delegations and Succession Process of Leadership Authority

  • Authority being delegated
  • Title of the incumbent being delegated the authority
  • Date or event which activates delegation
  • Order of succession (CEO, COO, Medical Director, etc.)

Essential Functions Assessment

  • Vital patient care and service requirements necessary to meet patient care needs during the current emergency
  • Staffing requirements and contingency plan for each essential operation
  • Procedures to acquire necessary resources to continue and sustain essential operations for an extended period

Mitigation Activities

  • Investment in resources needed for events identified in the HVA
  • Procedures outlined for curtailing or closing certain services (i.e., elective surgeries, clinic access)
  • Fortifications necessary of physical environment in advance of or during specific emergencies
  • Resource utilization for non-essential operations (i.e., cleaning administrative offices)

Communications Requirements for Compromised Service

  • Back-up technologies or procedures established for an event
  • Alternative communication methods, cell phones, email, pagers, etc.
  • New contact information established for re-deployed staff
  • Necessary information from outside agencies necessary for internal use and continuity of operations

Recovery Procedures

  • Restoration and reconstruction priorities for critical parts of the physical environment and utility systems used for maintaining essential services
  • Staff management from response to recovery
  • Resources needed and availability for the continuation of essential services

Alternate Care Sites

  • Assessment of accommodation to meet specific requirements of patients, and even staff
  • Selection criteria used to determine appropriate and safe Alternate Care Sites for current patient occupancy
  • Assessment of available staff, patient safety conditions, and resources; i.e. supplies, transportation, and communication
  • Implementation of special waivers, if needed

Instruction on use of the COOP Plan should be part of all staff orientation and annual training, especially the impact on their department. Training exercises are carried out regularly, or at least annually, to evaluate the COOP Plan and to improve the ability to execute the COOP Plan effectively. A resource of information for the COOP may be found in The Joint Commission Quick Safety article: “Emergency management: Need for continuity of operations planning, Issue 41 | May 2018.


FDA Request Medical Devices Remanufacturing Guidance (EC.02.04.03)

On June 24, 2021, The Food and Drug Administration (FDA) requested comments on a draft document, “Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff”. The FDA’s Center for Devices and Radiological Health (CDRH) is distributing the document to help “clarify” whether activities performed on medical devices are likely “remanufacturing (21CFR830.3(w))”. Most notably, remanufacturing has implications for the regulatory responsibilities of entities performing these activities.

Medical devices currently found in healthcare facilities utilize various technologies, have different useful lifecycles, and are used by a variety of individuals in various conditions. Certain types of medical devices are reusable, which require proper preventive maintenance and repair during their usefulness.

The FDA draft guidance raises the question about the difference between “servicing” and “remanufacturing” of a medical device. The FDA provided the following definitions:

  • Servicing – the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.
  • Remanufacturing – the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device which significantly changes the finished device’s performance or safety specifications, or intended use.

Some of the concern cited by the FDA for the remanufacturing of medical devices is whether there is significant change to the performance or safety. These concerns include:

  • Add, remove, or change a component/part/material which directly or indirectly contacts body tissue
  • Add or remove component/part/material or change the dimensional or performance specifications of a component/part/material
  • Add new or modified risk or change the performance or safety specifications

The FDA states that the guidance on remanufacturing will clarify applicable statutory and regulatory requirements. The determination of whether the activities performed on a device are considered remanufacturing which affects the applicability and enforcement of regulatory requirements. The FDA has consistently enforced these activities under the Federal Food, Drug, and Cosmetic (FD&C) Act. This draft guidance also includes recommendations for information which should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. Comments may be submitted to


New Workplace Violence Requirements (EC.02.01.01 & EC.04.01.01)

To address the rising concerns from workplace violence in healthcare organizations, The Joint Commission (TJC) has announced new requirements in the Environment of Care (EC) standards to minimize the risks and minimize the impact of workplace violence on staff, patients, and visitors. There are either new or revised requirements in two EC standards to provide a framework to guide the development of strong workplace violence “prevention systems”.

There are currently no Elements of Performance in the Environment of Care standards which specifically address “workplace” violence. The new requirements become effective in January 2022, and are applicable to all hospitals and critical access hospitals.

The new Element of Performance for workplace violence in the Safety and Security standard is:

  • EC.02.01.01 – The hospital manages safety and security risks.

Element(s) of Performance (EP) 17: (New)

The hospital conducts an annual worksite analysis related to its workplace violence prevention program. The hospital takes actions to mitigate or resolve the workplace violence safety and security risks based upon findings from the analysis.

Note: A worksite analysis includes a proactive analysis of the worksite, an investigation of the hospital’s workplace violence incidents, and an analysis of how the program’s policies and procedures, training, education, and environmental design reflect best practices and conform to applicable laws and regulations. (See also EC.04.01.01, EP1)

The revised language in the Elements of Performance for workplace violence in the Safety and Security standard is underlined below:

  • EC.04.01.01 – The hospital collects information to monitor conditions in the environment.

Element(s) of Performance (EP) 1: (Revised)

The hospital establishes a process(es) for continually monitoring, internally reporting, and investigating the following:  

Safety and security incidents involving patients, staff, or others within its facilities, including those related to workplace violence

Element(s) of Performance (EP) 6: (Revised)

Based on its process(es), the hospital reports and investigates the following:

Safety and security incidents involving patients, staff, or others within its facilities, including those related to workplace violence.

Additionally, there are two new requirements concerning workplace violence identified in the announcement dealing with other TJC Standards. One is in the Human Resources (HR) chapter covering staff training on defining workplace violence, de-escalating, and properly reporting an incident (HR.01.05.03 EP2). The second requirement is located in the Leadership (LD) chapter which requires the designation of an individual and a multi-disciplinary team to develop a “workplace violence prevention program,” including policies and procedures to prevent and respond to workplace violence, a process to report incidents in order to analyze incidents and trends, as well as a process for follow up and to support to victims and witnesses affected by workplace violence (LD.03.01.01 EP9).

These new requirements also become effective in January 2022. Additional information is available in the TJC document: Prepublication Requirements; New and Revised Workplace Violence Prevention Requirements, June 18, 2021.

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