(a) A transplant program must notify CMS immediately of any significant changes related to the hospital'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 program designated to the OPTN as the program's “primary transplant surgeon” or “primary transplant physician;'

(2) Termination of an agreement between the hospital in which the transplant program is located and an OPO for the recovery and receipt of organs as required by section 482.100; and

(3) Inactivation of the transplant program.

(b) Upon receiving notification of significant changes, CMS will follow up with the transplant program as appropriate, including (but not limited to):

(1) Requesting additional information;

(2) Analyzing the information; or

(3) Conducting an on-site review.

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 84 FR 51822, Sept. 30, 2019]