CMS SOM App. Z, Tag E-0006

§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.