[author: Robyn Hoffmann*]
Compliance Today (January 2025)
On May 11, 2023, the U.S. Department of Health and Human Services (HHS) issued a news release on behalf of HHS Secretary Xavier Becerra, announcing the end of the COVID-19 public health emergency (PHE).[1] The duration of the COVID-19 PHE was 1,200 days, extending from January 27, 2020, through May 11, 2023.
The unparalleled nature of the COVID-19 PHE challenged the flexibility and responsiveness of healthcare organizations’ emergency preparedness systems, including those of safety net providers, such as federally qualified health centers (FQHCs) and rural health centers (RHCs). During the pandemic, health centers (i.e., FQHCs and RHCs) modified their emergency plans due to evolving infection control guidelines, state-mandated lockdowns, the temporary closure of some clinical service settings (such as dental clinics and school-based health centers), and the need to rapidly credential volunteer clinicians. The expiration of the PHE was a key temporal event that warranted the need for health centers to reassess their emergency preparedness plans.
Federal emergency preparedness requirements for FQHCs and RHCs
The Centers for Medicare & Medicaid Services (CMS) has set forth federal emergency preparedness regulations for FQHCs and RHCs within the Code of Federal Regulations, Title 42, Section 491.12.[2] Health centers must comply with all applicable federal, state, and local emergency preparedness requirements. To ensure ongoing compliance, health centers must establish and maintain an emergency preparedness program that includes, but is not limited to, the following elements:
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An emergency plan
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Policies and procedures
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A communication plan
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A training and testing program
Emergency plan ( 42 C.F.R. § 491.12(a) )
The emergency plan provides the framework to guide the health center in addressing the needs of its patients in concert with its ability to sustain full or partial continuity of business operations. The emergency plan also supports the health center’s ability to collaborate with local, regional, and state emergency preparedness officials.
This plan must be reviewed and updated at least every two years and:
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“Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
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“Include strategies for addressing emergency events identified by the risk assessment.
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“Address patient population, including, but not limited to, the type of services the RHC/FQHC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
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“Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation.”[3]
Hazard vulnerability assessment
To document that the emergency plan is facility-based, the health center should describe its geographic location, patient population, and potential community assets accessible within the surrounding area. For example, is the health center located in a rural or an urban area? Does its service area cover a wide catchment area? Does the health center have locations that cross state borders? Are there any accessible community hospitals or tertiary institutions nearby?
To demonstrate that it has conducted a systematic risk assessment or “all hazards” evaluation, a health center may select from hazard vulnerability assessment (HVA) tools in the public domain. In January 2024, the Federal Administration for Strategic Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) updated its evaluation of hazard vulnerability assessment tools.[4] This evaluation provides links to a variety of HVA assessment tools and the intended audience for each tool, such as long-term care facilities, healthcare facilities, hospitals, and public health departments.
Organizing the health center’s emergency plan
This author was formerly responsible for analyzing the emergency preparedness plan at an urban FQHC in southern New England. As a result of its facility-based and community-based risk assessment—as well as the review of ambulatory accreditation standards issued by The Joint Commission—the FQHC organized its plan to address the following components:
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The risk assessment process
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The service area, patient population, and local and regional community assets
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The results from the HVA (the FQHC selected and used Kaiser Permanente’s HVA)
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How and when to activate the emergency plan
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Definitions of the healthcare incident command system roles
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Incident Command Center responsibilities (“live” versus “virtual”)
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Relevant policies and procedures (listed within the appendices)
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The communications plan, including contacts for federal, state, and local emergency management agencies, public health departments, hospitals, in-state FQHCs, the Bureau of Primary Health Care, and the state’s Primary Care Association (listed within the appendices)
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Site/building maps (listed within the appendices)
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Overhead paging codes by site and enterprise-wide
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The training and testing program
Storing the health center’s emergency plan
The emergency plan should be stored electronically for ease of access. To ensure redundancy in the event of power outages or a cybersecurity attack, a printed copy of the emergency plan should be stored at each clinical site and each administrative building. This author recommends storing these documents in an incident command lockbox at each location. When orienting new staff and during annual safety fairs, a “find your building’s emergency plan lockbox” exercise is recommended.
Policies and procedures ( 42 C.F.R. § 491.12(b) )
“The RHC or FQHC must develop and implement emergency preparedness policies and procedures, based on its facility-based and community-based emergency plan [. . .] risk assessment [. . .] and communication plan [. . . ]. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the [emergency preparedness] policies and procedures must address the following:
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“Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and the needs of the patients.
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“A means to shelter in place for patients, staff, and volunteers who remain in the facility.
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“A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
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“The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency.”[3]
It is important to note that CMS stated “at a minimum” when enumerating the mandatory set of emergency preparedness policies listed above. As previously mentioned, this author was formerly responsible for analyzing the emergency preparedness plan, including policies and procedures, at an urban FQHC in southern New England. Based on that analysis, as well as the review of emergency management accreditation standards issued by The Joint Commission, the FQHC developed and maintained emergency preparedness policies that addressed the following:
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Active shooter
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Annual emergency preparedness training
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Bomb threat
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Building lockdown
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Chemical, biological, radiological, nuclear, and explosive incidents
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Credentialing and privileging
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Electronic health record downtime
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Evacuation
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Fire response
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Fire safety plan
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Hazardous materials
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Inclement weather
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Infection control plan and associated policies
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IT disaster
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Shelter in place
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Transmission-based precautions: use of personal protective equipment
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Utility management
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Vaccine storage
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Workplace violence
The emergency preparedness communication plan ( 42 C.F.R. § 491.12(c) )
The health center “must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years.” The communication plan must include all of the following:
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“Names and contact information for the following:
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“Staff.
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“Entities providing services under arrangement.
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“Patients’ physicians.
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“Other RHCs/FQHCs.
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“Volunteers.
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“Contact information for the following:
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“Federal, state, tribal, regional, and local emergency preparedness staff.
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“Other sources of assistance.
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“Primary and alternate means for communicating with the following:
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“RHC/FQHC’s staff.
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“Federal, State, tribal, regional, and local emergency management agencies.
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“A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4) .
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“A means of providing information about the RHC/FQHC’s needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.”[6]
Training and testing ( 42 C.F.R. § 491.12(d) )
The health center “must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan [. . .] risk assessment [. . .] policies and procedures [. . .] and communication plan [. . .]. The training and testing program must be reviewed and updated at least every 2 years.”
In addition:
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“Training program. The RHC/FQHC must do all of the following:
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“Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles,
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“Provide emergency preparedness training at least every 2 years.
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“Maintain documentation of the training.
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“Demonstrate staff knowledge of emergency procedures.
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“If the emergency preparedness policies and procedures are significantly updated, the RHC/FQHC must conduct training on the updated policies and procedures.
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“Testing. The RHC or FQHC must conduct exercises to test the emergency plan at least annually. The RHC or FQHC must do the following:
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“Participate in a full-scale exercise that is community-based every 2 years; or
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“When a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years; or
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“If the RHC or FQHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC or FQHC is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
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“Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise [. . .] is conducted, that may include, but is not limited to [the] following:
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“A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
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“A mock disaster drill; or
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“A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
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“Analyze the RHC or FQHC’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC or FQHC’s emergency plan, as needed.”[7]
Education and training records
Each employee’s orientation record should document when the new employee received training about the health center’s emergency plan. If an employee transfers to a new role within the health center or another site, then additional on-site training should be provided and documented in the employee’s training record.
It is equally vital to train temporary or per diem staff, locum tenens, or volunteer clinicians.
Emergency preparedness training and testing: Build staff engagement
The biannual training requirement offers an opportunity to engage staff from across the health center in planning and executing the session. Consider soliciting employee volunteers willing to serve as emergency preparedness champions by collaborating in planning and conducting the health center’s training session. To enhance active learning, here are a few ideas for your health center’s consideration:
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Host a scavenger hunt at each site to locate the emergency preparedness kit or “find the red phone” (if your health center has Government Emergency Telecommunications Service telephones)
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Demonstrate how to use the overhead paging system
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Play “Emergency Preparedness Jeopardy”
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In an outdoor setting, show how to use a fire extinguisher
A health center’s safety officer might also contact the state or regional Primary Care Association to solicit fresh ideas about how other health centers conduct emergency preparedness training.
The Federal Emergency Management Agency, U.S. Department of Homeland Security offers a wide array of materials that can be used for staff training and patient education. Examples of these materials—which can be accessed online at https://www.fema.gov—include:
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Emergency Supply List (available in Arabic, Chinese, French, Haitian Creole, Japanese, Korean, Russian, Spanish, Tagalog, and Vietnamese)
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Take Control in 1, 2, 3: Disaster Preparedness for Older Adults (available in Arabic, Chinese, French, Haitian Creole, Japanese, Korean, Russian, Spanish, Tagalog, and Vietnamese)
Integrated healthcare systems ( 42 C.F.R. § 491.12(e) )
“If a RHC/FQHC is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the RHC/FQHC may choose to participate in the healthcare system’s coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
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“Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
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“Be developed and maintained in a manner that takes into account each separately certified facility’s unique circumstances, patient populations, and services offered.
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“Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
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“Include a unified and integrated emergency plan that meets the requirements of [ 42 C.F.R. § 491.12(a)(2)-(4) ]. The unified and integrated emergency plan must also be based on and include all of the following:
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“A documented community-based risk assessment, utilizing an all-hazards approach.
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“A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
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“Include integrated policies and procedures that meet the requirements set forth in [ 42 C.F.R. § 491.12(b) ], a coordinated communication plan, and training and testing programs that meet the requirements of [ 42 C.F.R. § 491.12(c)–(d) ], respectively.”[8]
Conclusion
Due to the length of the COVID-19 PHE, it is highly advisable that health centers reevaluate their emergency preparedness plan, including relevant policies and procedures, communications plan, and training and testing program—if that did not occur at the close of the PHE. Health centers can select from the HVA tools posted by the Federal Administration for ASPR TRACIE to conduct an updated, systematic, all-hazards risk assessment. The compliance officer and the health center’s HR director should consider whether to conduct an audit of staff orientation records to confirm that emergency preparedness content was documented, particularly for staff hired during the PHE.
Takeaways
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The health center’s emergency plan should be based on a risk assessment to document potential hazards within the geographic area.
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The Administration for Strategic Preparedness and Response Technical Resources, Assistance Center, Information Exchange evaluation tool is a helpful resource for determining which Hazard Vulnerability Assessment best meets your health center’s risk assessment needs.
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For redundancy and accessibility, maintain a current printed copy of your health center’s emergency plan at each location in the event the power or computers are down.
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Build workforce engagement by including staff when developing, testing, and training about the health center’s emergency plan.
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Sign up for online alerts and receive emergency preparedness training resources for patients and staff from the Federal Emergency Management Agency.
*Robyn Hoffmann is a Senior Manager, Compliance and Credentialing at BerryDunn in Glastonbury, CT.
1 U.S. Department of Health and Human Services, “HHS Secretary Xavier Becerra Statement on End of the COVID-19 Public Health Emergency,” news release, May 11, 2023, https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html.
2 42 C.F.R. § 491.12 .
3 42 C.F.R. § 491.12(a) .
4 The Administration for Strategic Preparedness and Response, “ASPR TRACIE Evaluation of Hazard Vulnerability Assessment Tools,” updated January 2024, https://files.asprtracie.hhs.gov/documents/aspr-tracie-evaluation-of-hva-tools-3-10-17.pdf.
5 42 C.F.R. § 491.12(b) .
6 42 C.F.R. § 491.12(c) .
7 42 C.F.R. § 491.12(d) .
8 42 C.F.R. § 491.12(e) .
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