This federal CMS emergency preparedness regulation requires covered facilities to develop, maintain, and update an emergency preparedness plan based on documented facility-based and community-based risk assessments using an all-hazards approach. Facilities must identify potential hazards specific to their geographic location and patient population, and develop strategies to address those risks. Special requirements apply to long-term care facilities (annual review, missing residents), ICF/IIDs (missing clients), and hospices (power failures and natural disasters). This tag applies across a broad range of Medicare/Medicaid provider types, including ICF/IIDs, and governs emergency planning standards rather than clinical care standards.
View official sourceE-0006 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. Interpretive Guidelines applies to: §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2). NOTE: This does not apply to Transplant Programs. Risk Assessments Using All-Hazards Approach Facilities are expected to develop an emergency preparedness plan that is based on the facility-based and community-based risk assessment using an “all-hazards” approach. Though a format is not specified, facilities must document the risk assessment. An example consideration may include, but is not limited to, natural disasters prevalent in a facility’s geographic region such as wildfires, tornados, flooding, etc. An all-hazards approach is an integrated approach to emergency preparedness planning that focuses on capacities and capabilities that are critical to preparedness for a full spectrum of emergencies or disasters, including pandemics and EIDs as noted under E-0004. This approach is specific to the location of the facility considering the types of hazards most likely to occur in the area, but should also include unforeseen widespread communicable diseases. Thus, all-hazards planning does not specifically address every possible threat or risk but ensures the facility will have the capacity to address a broad range of related emergencies. Also, a risk assessment is facility-based, which, among other things, considers a facility’s patient population and vulnerabilities. Facility-based and community-based risk assessments are intended to assist a facility in addressing the needs of their patient populations, along with identifying the continuity of business operations which will provide support during an actual emergency (81 FR 63876). For instance, if a facility has a population which is primarily dependent on medical equipment and is not located near a nuclear power plant, the risk assessment would identify a higher risk for emergencies due to power failures than a potential for a nuclear disaster. Facilities are encouraged to utilize the concepts outlined in the National Preparedness System, published by the United States Department of Homeland Security’s Federal Emergency Management Agency (FEMA), as well as guidance provided by the Agency for Healthcare Research and Quality (AHRQ). Understanding Community-Based “Community” is not defined in order to afford facilities the flexibility in deciding which healthcare facilities and agencies it considers to be part of its community for emergency planning purposes. However, the term could mean entities within a state or multi-state region. The goal of the provision is to ensure that healthcare providers collaborate with other entities within a given community to promote an integrated response. Conducting integrated planning with state and local entities could identify potential gaps in state and local capabilities that can then be addressed in advance of an emergency. Facilities may rely on a community-based risk assessment developed by other entities, such as public health agencies, emergency management agencies, and regional health care coalitions or in conjunction with conducting its own facility-based assessment. If this approach is used, facilities are expected to have a copy of the community-based risk assessment and to work with the entity that developed it to ensure that the facility’s emergency plan is in alignment. Development of Risk Assessments based on the Plan When developing an emergency preparedness plan, facilities are expected to consider, among other things, the following: • Identification of all business functions essential to the facility’s operations that should be continued during an emergency; • Identification of all risks or emergencies that the facility may reasonably expect to confront; • Identification of all contingencies for which the facility should plan; • Consideration of the facility’s location; • Assessment of the extent to which natural or man-made emergencies may cause the facility to cease or limit operations; and, • Determination of what arrangements may be necessary with other health care facilities, or other entities that might be needed to ensure that essential services could be provided during an emergency. Risk Assessment Considerations: Based on the community threat and hazard identification process, facilities should select a comprehensive risk assessment tool that evaluates their risk and potential for hazards.. The comprehensive risk assessment should include all risks that could disrupt the facility’s operations and necessitate emergency response planning to address the risk mitigation requirements and ensure continuity of care. Using an all-hazards approach helps facilities consider and prepare for a variety of risks which may impact their healthcare settings. Facilities should categorize the various probable risks and hazards identified by likelihood of occurrence and further create supplemental risk assessments based on the disaster or public health emergency. For example: • For power loss and potential disruptions of services: Facilities can consider using a heat index or heat risk assessment to identify situations which present concerns related to patient care and safety. Facilities are required to maintain safe temperatures under (b) policies and procedures (see Tag E-0015), therefore a heat risk assessment can be considered as an additional risk assessment, but is not required. Facilities may find it helpful to refer to ASPR TRACIE for the Natural Disasters Topic Collection at https://asprtracie.hhs.gov/technical- resources/36/natural-disasters/27. NOTE: In situations where the facility does not own the structure(s) where care is provided, it is the facility’s responsibility to discuss emergency preparedness concerns with the landlord to ensure continuation of care if the structure of the building and its utilities are impacted. • For public health emergencies, such as EIDs or pandemics: Facilities should consider risk assessments to include the needs of the patient population they serve in relation to a communicable or emerging infectious disease outbreak. Planning should include a process to evaluate the facility’s needs based on the specific characteristics of an EID that includes, but is not limited to: o Influx in need for PPE; o Considerations for screening patients and visitors; which may also include testing considerations for staff, visitors and patients for infectious diseases; o Transfers and discharges of patients; o Home-based healthcare settings; o Physical Environment, including but not limited to changes needed for distancing, isolation, or capacity/surge. Planning for Staffing in Emergencies: Facilities must develop strategies for addressing emergency events that were identified during the development of the facility- and community-based risk assessments. Examples of these strategies may include, but are not limited to, developing a staffing strategy if staff shortages were identified during the risk assessment or developing a surge capacity strategy if the facility has identified it would likely be requested to accept additional patients during an emergency. Facilities will also want to consider evacuation plans. For example, a facility in a large metropolitan city may plan to utilize the support of other large community facilities as alternate care sites for its patients if the facility needs to be evacuated. The facility is also expected to have a backup evacuation plan for instances in which nearby facilities are also affected by the emergency and are unable to receive patients. Additional Specific Requirements for LTC, ICF/IIDs and Hospice: • For LTC facilities and ICF/IIDs, written plans and the procedures are required to also include missing residents and clients, respectively, within their emergency plans. • Hospices must include contingencies for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. Survey Procedures • Ask to see the written documentation of the facility’s risk assessments and associated strategies. • Interview the facility leadership and ask which hazards (e.g. natural, man-made, facility, geographic) were included in the facility’s risk assessment, why they were included and how the risk assessment was conducted. • Verify the risk-assessment is facility-based and community-based, and based on an all-hazards approach specific to the geographic location of the facility and encompasses potential hazards, such as EIDs. NOTE: Surveyors are not expected to analyze a facility’s risk assessment to determine whether the identified risks are appropriate. Surveyors may take into consideration the geographic location and review the remaining standards to determine that the facility has addressed the hazards within their risk assessment through their policies and procedures. However, the intent is that surveyors review the risk assessments to determine if the facility has a risk assessment which is facility-based and also community-based. The facility’s risk assessment should describe a process facilities use to assess and document potential hazards that are likely to impact their geographical region, community, facility and patient population. The ranking of priority of the hazards and the format of the risk assessment is at the discretion and expertise of the facility.