CMS SOM App. Z, Tag E-0014

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.