CMS SOM App. X, Tag X-159

Transplant programs must implement written living donor informed consent policies that

inform the prospective living donor of all aspects of, and potential outcomes from, living

donation. Transplant programs must ensure that the prospective living donor is fully

informed about the following:

Guideline §482.102(b)

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

provide patients with sufficient information to make an informed decision. Informed consent is a

process that requires a health care provider to disclose appropriate information to a patient which

allows them to make the voluntary choice to accept or refuse treatment. The physician must

ensure each patient that is considered for organ donation has full knowledge and understanding

of the purpose, possible risks, benefits and other options available to the recipient.

Transplant programs must develop and implement informed consent policies for living donors

that delineate the information to be shared and the responsibilities of any transplant staff member

that will consult with the patient.

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

§482.102(b)(1) through (9), the transplant program’s polices and procedures should delineate:

1. who is responsible for discussing the informed consent process with the potential donor;

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 potential donor’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 donation process.

Any potential donor who receives the education and information necessary in preparation to

undergo an evaluation for donation, must have documented evidence of this informed consent.

The signed informed consent form and/or hospital surgical informed consent form alone is not

considered evidence that the informed consent process for the prospective living donor is

complete. Transplant programs must provide documentation that ensures the living donor

candidate was informed of subparagraphs (1) through (9) of this standard.