Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.84 Emergency preparedness. The Program for the All-Inclusive Care for the Elderly (PACE) organization must comply with all applicable Federal, State, and local emergency preparedness requirements. The PACE organization must establish and maintain an 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 PACE organization 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.
( 3 ) Address participant population, including, but not limited to, the type of services the PACE organization has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
( 4 ) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
( b ) *Policies and procedures.* The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. Policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following: ( 1 ) The provision of subsistence needs for staff and participants, whether they evacuate or shelter in place, include, but are not limited to the following: ( i ) Food, water, and medical supplies.
( ii ) Alternate sources of energy to maintain the following: ( A ) Temperatures to protect participant health and safety and for the safe and sanitary storage of provisions.
( B ) Emergency lighting.
( C ) Fire detection, extinguishing, and alarm systems.
( D ) Sewage and waste disposal.
( 2 ) A system to track the location of on-duty staff and sheltered participants under the PACE center(s) care during and after an emergency. If on-duty staff and sheltered participants are relocated during the emergency, the PACE must document the specific name and location of the receiving facility or other location.
( 3 ) Safe evacuation from the PACE center, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
( 4 ) The procedures to inform State and local emergency preparedness officials about PACE participants in need of evacuation from their residences at any time due to an emergency situation based on the participant's medical and psychiatric conditions and home environment.
( 5 ) A means to shelter in place for participants, staff, and volunteers who remain in the facility.
( 6 ) A system of medical documentation that preserves participant information, protects confidentiality of participant information, and secures and maintains the availability of records.
( 7 ) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
( 8 ) The development of arrangements with other PACE organizations, PACE centers, or other providers to receive participants in the event of limitations or cessation of operations to maintain the continuity of services to PACE participants.
( 9 ) The role of the PACE organization under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.
( 10 ) ( i ) Emergency equipment, including easily portable oxygen, airways, suction, and emergency drugs.
( ii ) Staff who know how to use the equipment must be on the premises of every center at all times and be immediately available.
( iii ) A documented plan to obtain emergency medical assistance from outside sources when needed.
( c ) *Communication plan.* The PACE organization must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following: ( 1 ) Names and contact information for staff; entities providing services under arrangement; participants' physicians; other PACE organizations; and volunteers.
( 2 ) Contact information for the following: ( i ) Federal, State, tribal, regional, and local emergency preparedness staff.
( ii ) Other sources of assistance.
( 3 ) Primary and alternate means for communicating with the following: ( i ) PACE organization's staff.
( ii ) Federal, State, tribal, regional, and local emergency management agencies.
( 4 ) A method for sharing information and medical documentation for participants under the organization's care, as necessary, with other health care providers to maintain the continuity of care.
( 5 ) A means, in the event of an evacuation, to release participant information as permitted under 45 CFR 164.510(b)(1)(ii).
( 6 ) A means of providing information about the general condition and location of participants under the facility's care as permitted under 45 CFR 164.510(b)(4).
( 7 ) A means of providing information about the PACE organization's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
( d ) *Training and testing.* The PACE organization must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. ( 1 ) *Training program.* The PACE organization must do all of the following: ( i ) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles.
( ii ) Provide emergency preparedness training at least every 2 years.
( iii ) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency.
( iv ) Maintain documentation of all training.
( v ) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.
( 2 ) *Testing.* The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: ( i ) Participate in a full-scale exercise that is community-based or; ( A ) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or
( B ) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
( ii ) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: ( A ) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
( B ) A mock disaster drill; or
( C ) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
( iii ) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
( e ) *Integrated healthcare systems.* If a PACE 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 PACE may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must— ( 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, participant 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.
[81 FR 64026, Sept. 16, 2016, as amended at 84 FR 51816, Sept. 30, 2019]