This regulation requires transplant programs to develop and maintain mutually agreed-upon emergency protocols with the hospital in which they operate and the designated Organ Procurement Organization (OPO). The protocols must address the duties and responsibilities of each party during emergencies, though the transplant program itself is not individually responsible for the broader hospital emergency preparedness requirements under §482.15. Surveyors will verify that such protocols exist and are documented.
View official sourceE-0014 (Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20) §482.78(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 for §482.78(b). Transplant programs must be involved in the development of mutually agreed upon protocols that address the duties and responsibilities of the hospital, transplant program and the designated OPO during emergencies. All transplant programs are located within Medicare participating hospitals. Any hospital that furnishes organ transplants and other medical and surgical specialty services for the care of transplant patients is defined as a transplant hospital (42 CFR 482.70). Therefore, transplant programs must meet all hospital CoPs at §§482.1 through 482.57 (as set forth at §482.68(b)), and the hospitals in which they are located must meet the provisions of § 482.15, however, a transplant program is not individually responsible for the emergency preparedness requirements in §482.15. The hospital in which a transplant program is located (i.e., a transplant hospital) would be responsible for ensuring that the transplant program is involved in the development of an emergency preparedness program. This requirement does not oblige a transplant program that agrees to care for another transplant program’s patients during an emergency to put those patients on its waiting lists. We anticipate that most emergencies would be of short duration and that the transplant program that is affected by an emergency will resume its normal operations within a short period of time. However, if a transplant program does arrange for its patients to be transferred to another transplant program during an emergency, both transplant program would need to determine what care would be provided to the transferring patients, including whether and under what circumstances the patients from the transferring transplant program would be added to the receiving transplant program’s waiting lists. Survey Procedures • Verify the transplant program has developed 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 designated OPO. • Ask to see documentation of the protocols.