CMS SOM App. X, Tag X-051

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.

Guideline §482.90

In order to be eligible for transplantation or donation, candidates must meet the transplant

program’s selection criteria to determine suitability based on their medical and/or psychosocial

health status. A transplant program’s selection criteria contains indications and

contraindications, which permit or exclude a candidate from donation or transplantation.

Contraindications may be absolute or relative – meaning further evaluation on a case-by-case

basis would be warranted.

Transplant programs are required to develop hospital-approved selection criteria to determine

suitability for organ transplantation and living donation. Each approved transplant program must

use developed, written selection criteria for its respective organ type. There must be evidence

that the written selection criteria are followed for the selection of transplant candidates to be

placed on the transplant waiting list and, if applicable, potential living donors. Transplant

candidates who are placed on the waiting list using criteria that are outside the written patient

selection criteria would not be the sole basis for a deficiency citation. However, any deviations

from the written selection criteria must be documented in the medical record.

Any changes to the hospital-approved, written selection criteria are approved according to the

hospital policy approval process.

The selection criteria (medical, psychosocial, financial, etc.) must clearly define all the factors

that are considered in determining suitability for transplantation or living donation. These criteria

may not exclude groups or individuals without documentation supporting the exclusionary

foundation(s).