The transplant program must use written patient selection criteria in determining a patient's suitability for placement on the waiting list or a patient's suitability for transplantation. If a program performs living donor transplants, the program also must use written donor selection criteria in determining the suitability of candidates for donation.
(a) Standard: Patient selection. Patient selection criteria must ensure fair and non-discriminatory distribution of organs.
- (1) Prior to placement on the program's waiting list, a prospective transplant candidate must receive a psychosocial evaluation, if possible.
- (2) Before a transplant program places a transplant candidate on its waiting list, the candidate's medical record must contain documentation that the candidate's blood type has been determined.
- (3) When a patient is placed on a program's waiting list or is selected to receive a transplant, the center must document in the patient's medical record the patient selection criteria used.
- (4) A transplant program must provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or a dialysis facility.
(b) Standard: Living donor selection. The living donor selection criteria must be consistent with the general principles of medical ethics. Transplant programs must:
- (1) Ensure that a prospective living donor receives a medical and psychosocial evaluation prior to donation,
- (2) Document in the living donor's medical records the living donor's suitability for donation, and
- (3) Document that the living donor has given informed consent, as required under § 482.102.
[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, Sept. 30, 2019]