CMS SOM App. Z, Tag E-0004

§483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a),

§486.360(a), §491.12(a), §494.62(a).

The [facility] must comply with all applicable Federal, State and local emergency

preparedness requirements. The [facility] must develop establish and maintain a

comprehensive emergency preparedness program that meets the requirements of

this section. The emergency preparedness program must include, but not be limited

to, the following elements:

(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 all of the following:

* [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital

or CAH] must comply with all applicable Federal, State, and local emergency

preparedness requirements. The [hospital or CAH] must develop and maintain a

comprehensive emergency preparedness program that meets the requirements of

this section, utilizing an all-hazards approach.

* [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.

* [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must

develop and maintain an emergency preparedness plan that must be [evaluated],

and updated at least every 2 years.

Interpretive Guidelines applies to: §403.748(a), §416.54(a), §418.113(a), §441.184(a),

§460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a),

§485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a).

NOTE: This does not apply to Transplant Programs.

Emergency Plan- General

Facilities are required to develop and maintain an emergency preparedness plan. The

plan must include all of the required elements under the standard. The plan must be

reviewed and updated at least every 2 years, with the exception for LTC facilities which

must review and update their plan on an annual basis. This periodic review must be

documented to include the date of the review and any updates made to the emergency

plan based on the review. The format of the emergency preparedness plan that a facility

uses is at its discretion. While this 2-year review process (except for LTC facilities)

provides more flexibilities for providers to update their program as they see fit, facilities

are encouraged to continue to review and update their emergency preparedness plans

and train their staff accordingly as the plan may change on a more frequent basis (84 FR

at 51756).

An emergency plan is one part of a facility's emergency preparedness program. The plan

provides the framework, which includes conducting facility-based and community-based

risk assessments that will 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.

Elements of the Emergency Plan

In addition, the emergency plan supports, guides, and ensures a facility's ability to

collaborate with local emergency preparedness officials. This approach is specific to the

location of the facility and considers particular hazards most likely to occur in the

surrounding area. These include, but are not limited to:

• Natural disasters

• Man-made disasters,

• Facility-based disasters that include but are not limited to:

o Care-related emergencies;

o Equipment and utility failures, including but not limited to power, water, gas, etc.;

o Interruptions in communication, including cyber-attacks;

o Loss of all or portion of a facility; and

o Interruptions to the normal supply of essential resources, such as water, food, fuel

(heating, cooking, and generators), and in some cases, medications and medical

supplies (including medical gases, if applicable).

• Emerging infectious diseases (EIDs) such as Influenza, Ebola, Zika Virus and others.

o These EIDs may require modifications to facility protocols to protect the health

and safety of patients, such as isolation and personal protective equipment (PPE)

measures.

Emerging Infectious Diseases (EIDs)

As facilities develop or make revisions to their emergency preparedness plans, EID’s are

a potential threat which can impact the operations and continuity of care within a

healthcare setting and should be considered. The type of infectious diseases to consider

or the care-related emergencies that are a result of infectious diseases are not specified.

Adding EID’s within a facility’s risk assessment ensures that facilities consider having

infection prevention personnel involved in the planning, development and revisions to the

emergency preparedness program, as these individuals would likely be coordinating

activities within the facility during a potential surge of patients.

Some examples of EID’s may include, but are not limited to:

o Hazardous Waste

o Bioterrorism

o Pandemic Flu

o Highly Communicable Diseases (such as Ebola, Zika Virus, SARS, or

novel COVID-19 or SARS-CoV-2)

EID’s may be localized to a certain community or be widespread (as seen with the

COVID-19 PHE) and therefore plans for coordination with local, state, and federal

officials are essential. Facilities should engage and coordinate with their local

healthcare systems and healthcare coalitions, and their state and local health

departments when deciding on ways to meet surge needs in their community.

Understanding the Terminology

CMS recognizes that there are differences in terminology used within the emergency

preparedness industry pertaining to “continuity of operations” and “business

continuity.” We consider “continuity of business” to incorporate all continuity

operations and business continuity, which involves planning to ensure business

operations will continue even during a disaster. The concept of continuity is the facility’s

ability to continue operations or services related to patient care and to ensure patient

safety and quality of care is continued in an emergency event. The emergency plan

provides the framework, which includes conducting facility-based and community-based

risk assessments that will assist a facility in addressing the needs of their patient

populations, along with identifying the continuity of business operations which will

provide support to services that are necessary during an actual emergency (81 FR

63875-63876). For additional information related to continuity of operations, please

visit the Federal Emergency Management Agency’s (FEMA’s) Continuity Guidance

Circular at

https://www.fema.gov/sites/default/files/2020-07/Continuity-Guidance-

Circular_031218.pdf.

Essential Services and Continuity of Care

When evaluating potential interruptions to the normal supply of essential services, the

facility should take into account the likely durations of such interruptions. Arrangements

or contracts to re-establish essential utility services during an emergency should describe

the timeframe within which the contractor is required to initiate services after the start of

the emergency, how they will be procured and delivered in the facility’s local area, and

that the contractor will continue to supply the essential items throughout and to the end of

emergencies of varying duration. However, we recognize that contracts may be subject

to some issues in itself as there are no guarantees in the event of a disaster that the

contractor would be able to fulfill contract terms.

Facilities should also be prepared to continue to provide care in a safe setting in the

event that a contract is not able to be fulfilled during the event. The emergency plan

should take into account contingency planning, such as evacuation triggers in the event

essential resources provided by the contractor cannot be fulfilled.

Finally, facilities should also include in their planning and revisions of existing plans,

contracts and inventory of supply needs; availability of personal protective equipment

(PPE); critical care equipment; and transportation options/needs to be prepared for

surge events. NOTE: This is also further elaborated under the facility policies and

procedures required by facilities under the emergency preparedness program.

Survey Procedures

• Verify the facility has an emergency preparedness plan by asking to see a copy of the

plan.

• Ask facility leadership to identify the hazards (e.g. natural, man-made, facility,

geographic, etc.) that were identified in the facility’s risk assessment and how the risk

assessment was conducted.

• Review the plan to verify it contains all of the required elements.

• Verify that the plan is reviewed and updated every 2 years (annually for LTC

facilities) by looking for documentation of the date of the review and updates that

were made to the plan based on the review