This regulation requires a broad range of Medicare/Medicaid-certified facilities to establish, maintain, and document a comprehensive emergency preparedness program using an all-hazards approach. Facilities must address the health, safety, and security needs of staff and patients during natural, man-made, or facility emergencies, including emerging infectious diseases and pandemics. Programs must be reviewed every two years (annually for long-term care), kept in writing, and coordinated with state and local emergency plans. Surveyors will interview leadership and review written documentation to verify compliance.
View official sourceE-0001 (Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must 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: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all- hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: Interpretive Guidelines applies to: §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12. NOTE: This does not apply to Transplant Programs. NOTE: The word comprehensive is not used in the language for ASCs. NOTE: The emergency preparedness program and its elements must be reviewed and updated annually for LTC facilities at §483.73(a). We’ve identified the differences in regulatory text for LTC facilities. Under this condition/requirement, facilities are required to develop an emergency preparedness program that meets all of the standards specified within the condition/requirement. The emergency preparedness program must describe a facility's comprehensive approach to meeting the health, safety, and security needs of their staff and patient population during an emergency or disaster situation. The program must also address how the facility would coordinate with other healthcare facilities, as well as the whole community during an emergency or disaster (natural, man-made, facility). The emergency preparedness program must be reviewed every two years for all providers and suppliers, with the exception of LTC providers who must review their emergency program annually. All facilities are expected to make the appropriate changes to their emergency program in the event changes are required more frequently outside of their update cycles. (“Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” Final Rule, 84 FR 51732, 51735, Sept. 30, 2019) (“Burden Reduction Rule”). A comprehensive approach to meeting the health and safety needs of a patient population should encompass the elements for emergency preparedness planning based on the “all- hazards” definition and specific to the location of the facility. For instance, a facility in a large flood zone, or tornado prone region, should have included these elements in their overall planning in order to meet the health, safety, and security needs of the staff and of the patient population. Additionally, if the patient population has limited mobility, facilities should have an approach to address these challenges during emergency events. The term “comprehensive” in this requirement is to ensure that facilities do not only choose one potential emergency that may occur in their area, but rather consider a multitude of events and be able to demonstrate that they have considered this during their development of the emergency preparedness plan. As emerging infectious disease outbreaks may affect any facility in any location across the country, a comprehensive emergency preparedness program should include emerging infectious diseases and pandemics during a public health emergency (PHE). The comprehensive emergency preparedness program emerging infectious disease planning should encompass how facilities will plan, coordinate and respond to a localized and widespread pandemic, similar to what is occurring with the 2019 Novel Coronavirus (COVID-19) PHE. Facilities should ensure their emergency preparedness programs are aligned with their State and local emergency plans/pandemic plans. Documentation and Requirements The emergency preparedness program must be in writing. The requirements under the emergency preparedness Final Rule allow for documentation flexibility. While facilities are required to meet all of the provisions applicable to their provider/supplier type, how they document their efforts is subject to their discretion. We are not requiring a hard copy/paper, electronic or any particular system for meeting the requirements. It is up to each individual facility to be able to demonstrate in writing their emergency preparedness program. We would also recommend, but are not requiring, facilities to develop a crosswalk as applicable for where their documents are located. For instance, if their emergency plan is located in a binder, specify this for surveyors. If there are policies and procedures to specific standards/requirements, identify where these are located. Providers and suppliers are encouraged to keep documentation and their written emergency preparedness program for a period of at least 2 years for inpatient providers and at least 4 years for outpatient providers. We are recommending this process due to the requirements related to training and testing exercises. Inpatient providers are required to have 2 exercises per year, therefore surveyors will review the current year and the previous year to determine compliance. For outpatient providers, testing exercises are required annually, however require full-scale exercises every other year, with the opposite years allowing for the exercise of choice. In order to determine compliance, surveyors will be required to review at least the past 2 cycles (generally 4 years) of emergency testing exercises. Additionally, we are not requiring approval of the Emergency Program or official “sign- off,” however, we do recommend facilities check with their State Agencies and local emergency planning coordinators (LEPCs) as some states require approval of the emergency preparedness plans as part of state licensure. Survey Procedures • Interview the facility leadership and ask him/her/them to describe the facility’s emergency preparedness program. • Ask to see the facility’s written policy and documentation on the emergency preparedness program. • For hospitals and CAHs only: Verify the hospital’s or CAH’s program was developed based on an all-hazards approach by asking their leadership to describe how the facility used an all-hazards approach when developing its program.