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U.S. Department of Health and Human Services Recommendations 56 and 57

The Advisory Committee on Organ Transplantation (ACOT) met on September 4, 2013, on a conference call, and unanimously agreed on the following recommendations:

Recommendation 56: Recommendation for consideration to standardize brain death testing for children and adults.
The ACOT recognizes the importance of this recommendation since no national law exists for determination of brain death. ACOT encourages adoption of national guidelines for determination and documentation of brain death in infants, children, and adults.
ACOT recommends the following:

  • Medical community use currently accepted guidelines that have been endorsed and supported by multiple national medical organizations for the determination of brain death in infants, children, and adults. These brain death guidelines should be used by clinicians tasked with determining brain death. National societal guidelines may be updated periodically to reflect currently accepted standards to determine brain death.
  • The potential donor patient must have a documented clinical examination (including a valid apnea test) as determined by currently accepted adult and pediatric brain death guidelines to make the determination of death. 1,2 In situations where a complete clinical examination and apnea test cannot be performed, the patient must have an approved ancillary test that is consistent with brain death. Documentation must support the determination of death as outlined in currently accepted adult and pediatric brain death guideline.
  • All hospitals should have brain death policies in places that reflect currently accepted adult and pediatric brain death guidelines. 1,2 Hospital policies should be reviewed and revised accordingly. It is recommended that OPOs review hospital brain death policies on a periodic basis and provide the hospital with resource information on currently accepted guidelines for the determination of death in adults and children. These policies will assist by allowing definitive documentation of the specific steps and timeline to determine and declare brain death for clinical and medical legal purposes. The OPO should remain responsible for confirming that the brain death examination and documentation is consistent with applicable hospital policy for all potential organ donors to maximize the potential for donation opportunities and provide quality end-of-life care, determination of death should be performed in a timely manner in any patient where brain death is suspected. This includes timely referral to the OPO in an effort to preserve donation options for the family or legal guardian. In situations where an observation period occurs between examinations, patients should be medically supported until declared dead by neurologic criteria, or until medical support is withdrawn.

Recommendation 57: Kidney paired donation (KPD) plays an emerging role in the United States, now comprising more than 10% of live donor kidney transplants. The current decentralized organization of KPD programs is not optimal in terms of equity of access, broad participation by centers and patients, donor safety, and transparency. Providing a nationally accessible KPD system with incentives to participation in this system rather than in smaller, decentralized programs would improve equity of access and facilitate participation by centers and patients. Implementation of a standardized reimbursement model (such as a standard acquisition charge) would improve donor safety by ensuring medical care for donors, in addition to providing an equitable framework for reimbursement of KPD transplants. Evaluation of all KPD programs by a centralized group would improve transparency.

To address these issues, we recommend that the Secretary identify a national KPD contractor responsible for implementing a nationally accessible KPD system, identifying optimal matching strategies, and encouraging participation by all transplant centers. The contractor would also be responsible for (1) administering a standardized reimbursement model for KPD costs, donor workups, and post-donation medical care that would be available to centers fully participating in the system; (2) evaluation of KPD programs and transplant centers that choose to perform KPD outside of the national registry; (3) balancing the needs of current and future patients; (4) striving towards equity in patient access to kidneys; (5) ensuring quality through frequent and critical assessment of equity and efficacy; and (6) recommending process and/or policy changes as appropriate.

Date Last Reviewed: