Organ Transplants:

Increased Effort Needed to Boost Supply and Ensure Equitable Distribution of Organs

HRD-93-56: Published: Apr 22, 1993. Publicly Released: Apr 22, 1993.

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Pursuant to a legislative requirement, GAO provided information on the effectiveness of the organ procurement and allocation system, focusing on whether: (1) organs are equitably distributed; (2) organ procurement organizations (OPO) obtain an adequate number of donors; and (3) the Department of Health and Human Services (HHS) effectively monitors organ procurement and allocation efforts.

GAO found that: (1) potential organ transplant recipients cannot be assured that organ allocation decisions are equitable or based on medical criteria because OPO lack standardized organ allocation and procurement procedures; (2) HHS cannot adequately oversee or assess the equity of the organ allocation process because of the lack of information on OPO patient selection processes, insufficient patient selection documentation, the lack of federal regulations on procurement and allocation policies, and differences in OPO center donor acceptance criteria, choice of staff, organ procurement techniques, and minority targeting; (3) although OPO collect data on their own organ procurement and allocation programs, the Health Resources and Service Administration has not provided adequate assessment criteria guidance, requested OPO to disclose data, or required the Organ Procurement and Transplantation Network contractor to collect and submit the information; and (4) HHS and the Network contractor cannot effectively target ineffective OPO with technical assistance because of a lack of procurement performance information.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: A task force has been established including officials from UNOS, the Association of organ procurement organizations, and physicians. The task force is establishing a measure for program effectiveness and is planning to monitor compliance of its use.

    Recommendation: To increase the effectiveness of OPO in procuring organs for transplants, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to establish criteria for assessing OPO organ procurement effectiveness.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: As stated in the report, in August 1992, UNOS requested all OPO and transplant centers to submit an evaluation of their variances for review by UNOS's Organ Procurement and Distribution Committee. As of October 15, 1992, nine OPOs had submitted those evaluations. In addition, in November 1992, UNOS adopted procedures for evaluating and approving future variances to the UNOS criteria. Under those procedures, an OPO's proposal to modify the UNOS criteria must contain a detailed written explanation and justification specifying how the variance will enhance the equity of organ allocations. Subsequent to UNOS approval, an OPO and its area transplant centers must provide UNOS a periodic assessment of the variance's impact and note any allocation problems that may have arisen as a result of the changes. Additionally, UNOS must develop a plan to evaluate the impact of variances on organ allocation, patient waiting time, and patient and graft survival.

    Recommendation: To better ensure that organs are allocated equitably to recipients under a national system as envisioned by Congress, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to require an evaluation of variances to the United Network for Organ Sharing's (UNOS) allocation criteria to determine if they: (1) are achieving intended goals; and (2) should be incorporated into the UNOS criteria.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: UNOS has established compliance audit procedures for monitoring OPO and transplant center compliance. UNOS audit teams will use these when performing compliance audits. HRSA has stated that UNOS continues its monitoring of documentation and documentation has improved.

    Recommendation: To better ensure that organs are allocated equitably to recipients under a national system as envisioned by Congress, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to require OPO and transplant centers to document the reasons for not selecting potential recipients ranked higher on a waiting list than the patient to whom the organ was allocated.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: As stated on page 27 of the report, in November 1992 UNOS adopted a policy for OPO to use a single OPO-wide waiting list. The policy also states that any deviation from this practice must be approved by UNOS. UNOS has assessed OPO practices and approved 6 OPO to deviate from using a single OPO-wide waiting list. The GAO report noted that 20 OPO were not using a single OPO-wide waiting list.

    Recommendation: To better ensure that organs are allocated equitably to recipients under a national system as envisioned by Congress, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to require OPO and transplant centers to use a single, OPO-wide waiting list for allocating organs unless OPO can demonstrate compelling medical reasons for doing otherwise.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: HRSA has requested the United Network for Organ Sharing (UNOS) for a listing and description of all variances currently approved. Also, UNOS has to develop a plan under which Organ Procurement Organizations (OPO) can apply for a variance. The report on variances will be available in September 1994.

    Recommendation: To better ensure that organs are allocated equitably to recipients under a national system as envisioned by Congress, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to require OPO and transplant centers to use established Network criteria for ranking patients unless a variance to these criteria has been approved.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: HRSA has implemented a policy to provide technical assistance to OPO that request it. HRSA convenes a team of organ procurement officials from other OPO to assist the requesting organization. The UNOS OPO Committee is requesting that technical assistance not be voluntary; but for those organizations that are not effectively procuring organs, technical assistance be mandatory.

    Recommendation: To increase the effectiveness of OPO in procuring organs for transplants, the Secretary of Health and Human Services should direct the Assistant Secretary for Health to target technical assistance to those OPO identified as least effective in procuring organs.

    Agency Affected: Department of Health and Human Services

 

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