CMS SOM App. X, Tag X-150

Transplant programs must implement written transplant patient informed consent policies

that inform each patient of:

Guideline §482.102(a)

As a standard of practice for any type of surgical procedure, a hospital has the obligation to

provide a transplant candidate with sufficient information to make an informed decision.

Informed consent is a process that requires a health care provider to disclose all available

information to a transplant candidate who makes the voluntary choice to accept or refuse

treatment. The transplant physician must ensure each candidate that is considered for organ

transplantation has full knowledge and understanding of the purpose, possible risks, benefits and

other options available to them.

For each of the required components of the informed consent policies identified in standards

§482.102(a)(1) through (8), the transplant program’s policies and procedures should delineate:

1. who is responsible for discussing the informed consent process with the transplant

candidate;

2. where the discussions concerning the informed consent process are documented in the

medical record;

3. the methods used by the program to ensure and document the transplant candidate’s

understanding of the information being delivered; and

4. when the discussion(s) will take place, if the information is provided at different points of

the transplant process.

Any transplant candidate who receives the education and information necessary in preparation to

undergo an evaluation for placement on a transplant program’s waiting list, and eventual

transplantation, must have documented evidence of this informed consent.

The signed hospital surgical consent form alone is not considered evidence that the informed

consent process for transplant patients was completed to include the requirements of

§482.102(a)(1)-(8).