§ 482.102 Condition of participation: Patient and living donor rights.

In addition to meeting the condition of participation “Patients rights” requirements at § 482.13, the transplant program must protect and promote each transplant patient's and living donor's rights.

(a) Standard: Informed consent for transplant patients. Transplant programs must implement written transplant patient informed consent policies that inform each patient of:

(1) The evaluation process;

(2) The surgical procedure;

(3) Alternative treatments;

(4) Potential medical or psychosocial risks;

(5) National and transplant program-specific outcomes, from the most recent SRTR program-specific report, including (but not limited to) the transplant program's observed and expected 1-year patient and graft survival, and national 1-year patient and graft survival;

(6) Organ donor risk factors that could affect the success of the graft or the health of the patient, including, but not limited to, the donor's history, condition or age of the organs used, or the patient's potential risk of contracting the human immunodeficiency virus and other infectious diseases if the disease cannot be detected in an infected donor;