§ 482.74Condition of participation: Notification to CMS.
(a) A transplant center must notify CMS immediately of any significant changes related to the center's transplant program or changes that could affect its compliance with the conditions of participation. Instances in which CMS should receive information for follow up, as appropriate, include, but are not limited to:
(1) Change in key staff members of the transplant team, such as a change in the individual the transplant center designated to the OPTN as the center's “primary transplant surgeon” or “primary transplant physician;'
(2) A decrease in the center's number of transplants or survival rates that could result in the center being out of compliance with § 482.82;
(3) Termination of an agreement between the hospital in which the transplant center is located and an OPO for the recovery and receipt of organs as required by section 482.100; and
(4) Inactivation of the transplant center.
(b) Upon receiving notification of significant changes, CMS will follow up with the transplant center as appropriate, including (but not limited to):
(1) Requesting additional information;
(2) Analyzing the information; or
(3) Conducting an on-site review.
Title 42 published on 2014-10-01.
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