US · guidance
CMS SOM App. Z, Tag E-0012
§ 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.
History
Rev. 200, Issued: 02-21-20; Effective: 02-21-20, Implementation: 02-21-20
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
73e3c00d31b536fd0d99f955f2cc1f84ced8bacedcadf2e0da01ed6c0df61c38
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