This federal CMS regulation (E-0042) establishes requirements for integrated healthcare system emergency preparedness programs, allowing multiple separately certified Medicare facilities to develop a unified emergency preparedness program in lieu of individual plans. Participating facilities must demonstrate active involvement in program development, account for each facility's unique circumstances and patient populations, and maintain coordinated communication, training, and testing programs. Compliance remains the individual responsibility of each separately certified facility, and each must be able to demonstrate effective implementation during a survey. The regulation explicitly names PRTFs (§418.113) and CMHCs (§485.920) among the covered facility types.
View official sourceE-0042 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §416.54(e), §418.113(e), §441.184(e), §460.84(e), §482.15(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). (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. E-043 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §482.15(g) (g) Transplant hospitals. If a hospital has one or more transplant programs (as defined in § 482.70)— (1) A representative from each transplant program must be included in the development and maintenance of the hospital’s emergency preparedness program; and (2) The hospital must develop and maintain mutually agreed upon protocols that address the duties and responsibilities of the hospital, each transplant program, and the OPO for the DSA where the hospital is situated, unless the hospital has been granted a waiver to work with another OPO, during an emergency. Interpretive Guidelines for §482.15(g). Hospitals which have transplant programs must include within their emergency planning and preparedness process one representative, at minimum, from the transplant program. If a hospital has multiple transplant programs, each center must have at least one representative who is involved in the development and maintenance of the hospital’s emergency preparedness process. The hospital must include the transplant program in its emergency plan’s policies and procedures, communication plans, as well is the training and testing programs. The hospital must also collaborate with each OPO in its designated service area (DSA) or other OPO if the hospital was granted a waiver to develop policies and procedures (protocols) that address the duties and responsibilities of each entity during an emergency. Both the hospital and the transplant program are required to demonstrate during a survey that they have collaborated in the planning and development of the emergency program. Both are required to have written documentation of the emergency preparedness plans. However, the transplant program is not individually responsible for the emergency preparedness requirements under §482.15 (see Tag E-005 at §482.78). Survey Procedures • Verify the hospital has written documentation to demonstrate that a representative of each transplant program participated in the development of the emergency program. • Ask to see documentation of emergency protocols that address transplant protocols that include the hospital, the transplant program and the associated OPOs. E-044 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §486.360(e) (e) Continuity of OPO operations during an emergency. Each OPO must have a plan to continue operations during an emergency. (1) The OPO must develop and maintain in the protocols with transplant programs required under § 486.344(d), mutually agreed upon protocols that address the duties and responsibilities of the transplant program, the hospital in which the transplant program is operated, and the OPO during an emergency. (2) The OPO must have the capability to continue its operation from an alternate location during an emergency. The OPO could either have: (i) An agreement with one or more other OPOs to provide essential organ procurement services to all or a portion of its DSA in the event the OPO cannot provide those services during an emergency; (ii) If the OPO has more than one location, an alternate location from which the OPO could conduct its operation; or (iii) A plan to relocate to another location as part of its emergency plan as required by paragraph (a) of this section. Interpretive Guidelines for §486.360(e). An OPO may choose to relocate to an alternate location within its DSA. For instance, if a tornado threat or major flooding was anticipated within one area, however there is another location 20 miles away for the OPO to relocate to, we would anticipate the OPO would address this within its emergency plan. Additionally, OPOs must develop mutually-agreed upon protocols that address the duties and responsibilities of the hospital, transplant programs and OPO during emergencies as previously outlined (Reference Tags: 0002, 0012, 0014, 0042). Therefore, these three facility types must work together to develop and maintain policies and programs which address emergency preparedness. Survey Procedures • Verify that the OPO has mutually-agreed upon protocols with every certified transplant program it is associated with which includes the duties and responsibilities of the hospital, transplant program and OPO during emergencies. • Verify that the OPO has a plan in place to ensure continuity of its operation from an alternate location during an emergency. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R204SOMA 04/16/2021 Revisions to the State Operations Manual (SOM) Appendix Z - Emergency Preparedness) 04/16/2021 N/A R200SOMA 02/21/2020 Revisions to the State Operations Manual (SOM) Appendix A - Hospitals, Appendix AA – Psychiatric Hospitals, Appendix B – Home Health Agency, Appendix D - Portable X-Ray, Appendix G - Rural Health Clinics/Federally Qualified Health Centers, Appendix H- End Stage Renal Disease Facilities (ESRD), Appendix K – Comprehensive Outpatient Rehabilitation Facility, Appendix L - Ambulatory Surgical Centers, Appendix M – Hospice, Appendix U - Religious Nonmedical Healthcare Institutions, Appendix W - Critical Access Hospitals (CAHs), Appendix X-Organ Transplant Program and Appendix Z - Emergency Preparedness 02/21/2020 N/A R186SOMA 03/04/2019 Revisions to State Operations Manual (SOM) Appendix Z, Emergency Preparedness for All Provider and Certified Supplier Types 03/04/2019 N/A R169SOM 06/09/2017 New to State Operations Manual (SOM) Appendix Z, Emergency Preparedness for All Provider and Certified Supplier Types 06/09/2017 N/A