This regulation requires hospital transplant programs to be included in the hospital's emergency preparedness planning and program under § 482.15, though transplant programs are not individually responsible for meeting those requirements on their own. Transplant programs must have emergency preparedness policies and procedures integrated into the hospital's overall plan, and must develop mutually agreed-upon protocols with the hospital and the designated Organ Procurement Organization (OPO) covering duties during an emergency. At least one representative from each transplant program must participate in developing and maintaining the hospital's emergency preparedness process, and written documentation of this coordination must be available for surveyors.
View official sourceE-0012 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) § 482.78 Condition of participation: Emergency preparedness for transplant programs. A transplant program must be included in the emergency preparedness planning and the emergency preparedness program as set forth in § 482.15 for the hospital in which it is located. However, a transplant program is not individually responsible for the emergency preparedness requirements set forth in § 482.15. (a) Standard: Policies and procedures. A transplant program must have policies and procedures that address emergency preparedness. These policies and procedures must be included in the hospital’s emergency preparedness program. (b) Standard: Protocols with hospital and OPO. A transplant program must develop and maintain 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 designated by the Secretary, unless the hospital has an approved waiver to work with another OPO, during an emergency. Interpretive Guidelines applies to: §482.78(a), and §482.78(b). 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 program 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 programs in its emergency preparedness plan policies and procedures, communication plans, as well is the training and testing programs. Both the hospital and the transplant programs are required to demonstrate during a survey that they have coordinated in planning and the development of the emergency program. Both are required to have written documentation of the emergency preparedness plans. However, the transplant programs is not individually responsible for the emergency preparedness requirements under §482.15. Survey Procedures • Verify the hospital has written documentation to demonstrate that a representative of each transplant programs 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 programs and the associated OPOs.