Donation After Cardiac or Brain Death: Regulatory and Ethical Principles

Brain Death

In 1968, soon after the first human heart transplant was performed, the Uniform Anatomical Gift Act (UAGA) was written. It was universally enacted throughout the country and provided legal means for human organs to be gifted for the purpose of transplantation. Deliberations surrounding its passage also provided one of the cornerstone concepts of transplant ethics, the dead donor rule. Although it seems a straightforward concept not to take organs for transplant from a donor unless the donor is dead, what it means to be “dead” has been a source of controversy and ethical dilemma over the past half century.

One of the most significant medical advances affecting the early growth of organ transplantation was the establishment of “brain death.” The advent of effective life support technologies in the 1950s led to an ethical and diagnostic dilemma for physicians; patients now existed with irreversible coma and no hope of recovery but without the cardiopulmonary collapse that traditionally defined death. In 1968 a commissioned ad hoc committee at Harvard Medical School published a landmark paper describing the need for the determination of death by neurological criteria in addition to the already accepted irreversible cessation of a beating heart. This was the first attempt to define the concept of brain death with neurological criteria. The committee proposed that the criteria for brain death include irreversible coma with absence of movement, breathing, and reflexes and an isoelectric electroencephalogram (EEG), all observed for at least 24 consecutive hours.

With the recognition of brain death, a new source of donor organs emerged. The DBD donor provided a much more stable, controlled situation for organ procurement and soon became the source of the majority of transplanted organs. The traditional non–heart-beating donor, or DCD donor, remained a source of organs. However, because of additional ischemic injury during procurement, these organs proved less ideal. This remains the case but has recently been balanced by a resurgence in interest spurred on by a growing disparity between transplantable organs and people with end-stage liver disease (ESLD) on the transplant waiting list.

Over the past 4 decades the definition of brain death has evolved and been redefined. For example, the EEG is no longer necessary for the diagnosis of brain death. The Uniform Determination of Death Act (UDDA) was drafted in 1981 by the National Conference of Commissioners on Uniform State Laws with the purpose of providing a comprehensive and medically sound basis for the determination of death in all situations. Unfortunately, the determination that coma is irreversible or that all clinical criteria of brain death are present is not always straightforward. Clinical advancements have made these determinations easier. Nuclear brain scans and cerebral flow studies now enhance the physician’s ability to assess brain death. These new technologies have affected the field of organ transplantation and interpretation of compliance with the dead donor rule. A 2003 review of the brain death criteria provides current diagnostic criteria used by most hospitals today. Paramount among those criteria are the need to ensure that no complicating conditions such as metabolic intoxication, hypothermia, or shock are contributing to the coma, that there are no brainstem reflexes, and that there is no spontaneous ventilation on apnea challenge. In addition, these tests must be repeated after a variable amount of time that is dependent on the donor’s age and other test results. Finally, in congruence with earlier versions, recommendations still emphasize the importance of the diagnosing physician having no conflict of interest in the transplant process.

Organ Procurement Organization

The early period of organ transplantation was characterized by a growing disparity between those needing transplants and organs with which to transplant them. As more medical centers started performing transplants, it became clear that a centralized network was needed to oversee organ donation, procurement, and allocation. In 1984 NOTA was signed into law. The law, among other important things, provided for the establishment of the OPTN to establish the rules for, and regulation of, the procurement and matching of donor organs with appropriately listed recipients. Two years later, in 1986, UNOS was contracted to administer the OPTN and has been the only organization to do so since. The federal agency responsible for oversight of the OPTN and the contract holder for the government is the Health Resources and Services Administration (HRSA), a division of the Department of Health and Human Services (DHHS). NOTA also required that data be kept on all donors and recipients through the Scientific Registry of Transplant Recipients (SRTR).

The only organization that can procure deceased human organs for transplantation by federal law is an organ procurement organization (OPO). The OPO manages donors within a donor service area (DSA), from the identification and consenting process to the clinical care of the donor and facilitation of the operative recovery of organs. Each OPO is responsible for the care of donors identified within its DSA and placing the donor organs with transplant centers based on match runs generated by UNOS through computerized algorithms. In addition to clinical services, OPOs participate in educating the public about organ donation, facilitate donor family services, and work with hospitals to develop policies to enhance organ donation. When new regulations are enacted (for example, that all hospitals must have a DCD policy to participate in Medicare), it is often the OPO that helps formulate this policy to keep its partner hospital compliant. It is important to point out that after consent for donation is obtained, all costs incurred for the care of the donor and the procurement procedure are billed directly to the OPO for distribution among its various organ cost centers as prescribed by law and never to the donor.

The Impact of the Final Rule

In 2000 the DHHS implemented the Final Rule, establishing a new set of regulatory standards for OPTN operations. Among the many refinements included in the Final Rule, those pertinent to regulation of organ allocation sought to create a level playing field regarding organ allocation and to reduce inequities resulting from socioeconomic status. The policies mandated in the Final Rule are developed through the UNOS committees, are binding upon OPTN members, voted on by the UNOS board of directors, and subject to approval by the secretary of the DHHS. Hospitals that receive organs for transplant and OPOs that manage organ procurement must be members of the OPTN and abide by these rules. This is the genesis of the MELD allocation system in 2002.

The Final Rule called for greater objectivity to be achieved through the use of an easily measured, reproducible, continuous medical severity score so that liver allocation could be more equitable. The MELD score was developed from data collected on ESLD patients undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. The score uses easily measured, objective laboratory data that reliably predict in most cases the survival of ESLD patients waiting for transplant. The overall objectivity of the MELD score and the ease with which it can be tracked have made the job of monitoring compliance with the regulations more straightforward for UNOS and the OPTN.