CMS SOM App. Z, Tag E-0042

§484.102(e), §485.68(e), §485.625(f), §485.727(e), §485.920(e), §486.360(f),

§491.12(e), §494.62(e).

(e) [or (f)]Integrated healthcare systems. If a [facility] 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 [facility] 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:]

(1) Demonstrate that each separately certified facility within the system actively

participated in the development of the unified and integrated emergency

preparedness program.

(2) Be developed and maintained in a manner that takes into account each

separately certified facility's unique circumstances, patient populations, and services

offered.

(3) 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].

(4) Include a unified and integrated emergency plan that meets the requirements of

paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency

plan must also be based on and include the following:

(i) A documented community-based risk assessment, utilizing an all-hazards

approach.

(ii) A documented individual facility-based risk assessment for each

separately certified facility within the health system, utilizing an all-hazards

approach.

(5) Include integrated policies and procedures that meet the requirements set forth

in paragraph (b) of this section, a coordinated communication plan, and training

and testing programs that meet the requirements of paragraphs (c) and (d) of this

section, respectively.

Interpretive Guidelines Applies to: §482.15(f), §416.54(e), §418.113(e),

§441.184(e),

§460.84(e), §482.78(f), §483.73(f), §483.475(e), §484.102(e), §485.68(e), §485.625(f),

§485.727(e), §485.920(e), §486.360(f), §491.12(e), §494.62(e).

* [For ASCs at §416.54, PRTFs at §418.113, PACE organizations at §460.84, ICF/IIDs

at §483.475, HHAs at §484.102, CORFs at §485.68, Clinics and Rehab facilities at

§485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD facilities at

§494.62], the requirements for Integrated health systems are cited as substandard (e),

not (f).

NOTE: This does not apply to Transplant Programs.

Healthcare systems that include multiple facilities that are each separately certified as a

Medicare-participating provider or supplier have the option of developing a unified and

integrated emergency preparedness program that includes all of the facilities within the

healthcare system instead of each facility developing a separate emergency preparedness

program. If an integrated healthcare system chooses this option, each certified facility in

the system may elect to participate in the system’s unified and integrated emergency

program or develop its own separate emergency preparedness program. It is important to

understand that healthcare systems are not required to develop a unified and integrated

emergency program. Rather it is a permissible option. In addition, the separately

certified facilities within the healthcare system are not required to participate in the

unified and integrated emergency preparedness program. It is simply an option for each

facility. If this option is taken, the healthcare system’s unified emergency preparedness

program should be updated each time a facility enters or leaves the healthcare system’s

program.

If a healthcare system elects to have a unified emergency preparedness program, the

integrated program must demonstrate that each separately certified facility within the

system that elected to participate in the system’s integrated program actively participated

in the development of the program. Therefore, each facility should designate personnel

who will collaborate with the healthcare system to develop the plan. The unified and

integrated plan should include documentation that verifies each facility participated in the

development of the plan. This could include the names of personnel at each facility who

assisted in the development of the plan and the minutes from planning meetings. All

components of the emergency preparedness program that are required to be reviewed and

updated at least every 2 years (annually for LTC facilities) must include all participating

facilities. Again, each facility must be able to prove that it was involved in the annual

reviews and updates of the program. The healthcare system and each facility must

document each facility’s active involvement with the reviews and updates, as applicable.

A unified program must be developed and maintained in a manner that takes into account

the unique circumstances, patient populations, and services offered at each facility

participating in the integrated program. For example, for a unified plan covering both a

hospital and a LTC facility, the emergency plan must account for the residents in the LTC

facility as well as those patients within a hospital, while taking into consideration the

difference in services that are provided at a LTC facility and a hospital. The unique

circumstances that should be addressed at each facility would include anything that

would impact operations during an emergency, such as the location of the facility,

resources such as the availability of staffing, medical supplies, subsistence, patients' and

residents’ varying acuity and mobility at the different types of facilities in a unified

healthcare system, etc.

Each separately certified facility must be capable of demonstrating during a survey that it

can effectively implement the emergency preparedness program and demonstrate

compliance with all emergency preparedness requirements at the individual facility level.

Compliance with the emergency preparedness requirements is the individual

responsibility of each separately certified facility.

The unified emergency preparedness program must include a documented community–

based risk assessment and an individual facility-based risk assessment for each separately

certified facility within the health system, utilizing an all-hazards approach. This is

especially important if the facilities in a healthcare system are located across a large

geographic area with differing weather conditions.

Lastly, the unified program must have a coordinated communication plan and training

and testing program. For example, if the unified emergency program incorporates a

central point of contact at the “system” level who assists in coordination and

communication, such as during an evacuation, each facility must have this information

outlined within its individual plan.

This type of integrated healthcare system emergency program should focus the training

and exercises to ensure communication plans and reporting mechanisms are seamless to

the emergency management officials at state and local levels to avoid potential

miscommunications between the system and the multiple facilities under its control.

The training and testing program in a unified emergency preparedness program must be

developed considering all of the requirements of each facility type. For example, if a

healthcare system includes, hospitals, LTC facilities, ESRD facilities and ASCs, then the

unified training and testing programs must meet all of the specific regulatory

requirements for each of these facility types.

Because of the many different configurations of healthcare systems, from the different

types of facilities in the system, to the varied locations of the facilities, it is not possible

to specify how unified training and testing programs should be developed. There is no

“one size fits all” model that can be prescribed. However, if the system decides to

develop a unified and integrated training and testing program, the training and testing

must be developed based on the community and facility based hazards assessments at

each facility that is participating in the unified emergency preparedness program. Each

facility must maintain individual training records of staff and records of all required

training exercises.

Survey Procedures

• Verify whether or not the facility has opted to be part of its healthcare system’s

unified and integrated emergency preparedness program. Verify that they are by

asking to see documentation of its inclusion in the program.

• Ask to see documentation that verifies the facility within the system was actively

involved in the development of the unified emergency preparedness program.

• Ask to see documentation that verifies the facility was actively involved in the

reviews of the program requirements and any program updates.

• Ask to see a copy of the entire integrated and unified emergency preparedness

program and all required components (emergency plan, policies and procedures,

communication plan, training and testing program).

• Ask facility leadership to describe how the unified and integrated emergency

preparedness program is updated based on changes within the healthcare system such

as when facilities enter or leave the system.