Analysis of State Actions Regarding Donor Registries. BACKGROUND

01/04/2000

The purpose of this report is to provide an introductory analysis of state legislative actions related to organ and tissue donor registries. This analysis focuses on describing the current state legislation on donor registries, comparing legislation among the various states, and how such policies may enhance or hinder efforts to develop, modify, and link statewide donor registries.

Access to organ transplantation remains limited by the shortage of donated organs. In 1998, 16,945 individuals received cadaveric organ transplants. In that same year, only 5,791 deaths, out of an estimated potential of 8,000-15,000 donors, resulted in donation. Another 4,122 individuals were living donors, mainly of kidneys. Despite these contributions, 4,855 patients on waiting lists died while awaiting transplantation in 1998.

Major barriers to donation have included low rates of family consent to donation and missed opportunities to identify and refer all potential donors to procurement organizations so that families may be approached. Although the latest national Gallup survey indicated that 85 percent of Americans support organ donation for transplants, studies indicate that only about 50 percent of families consent to donating a loved one’s organs when presented with the opportunity. Most polls also indicate that knowledge of the decedent’s wishes to donate would positively influence the family’s decision to consent to donation. Moreover, a 1996 study of potential organ donors in hospitals found that in nearly a third of all cases, potential donors were not identified or no request was made to the family (Gortmaker et al. 1996). The number of potential eye and tissue donors far outnumbers potential organ donors, and many more families consent to donating eyes and tissues. Some state laws allow recovery of corneas with the consent of a medical examiner or coroner, without family consent.

Efforts to increase organ donation have included public and professional education and training of donation requestors, as well as various federal and state legislative measures (e.g., routine referral, the use of donor cards to indicate a preference for donation, and development of donor registries). In 1968, the National Conference on Commissioners on Uniform State Laws drafted the Uniform Anatomical Gift Act (UAGA), which established standards for organ donor cards, prohibited sale of organs, and designated attending physicians as custodians of donated tissues and organs. Every state had adopted the act by 1972.

Many state UAGAs provide that a wallet-sized donor card, signed by an individual of at least 18 years of age in the presence of two adult witnesses, is a legal instrument in permitting authorized medical personnel to remove organs and tissues after death. In many states, documentation of intent to become a donor (or conversely, to be a non-donor) is entered into a donor registry database. Under the appropriate circumstances, hospital and/or other procurement personnel are then able to access this database to determine a decedent’s donation wishes and, in principle, act upon those wishes as an advance directive.

Unfortunately, organ donor cards (or, similarly, the affirmative designation found on drivers’ licenses in many states) have not had a substantial effect on increasing the supply of organs and tissues available for transplantation. Although a donor card or a donor designation on a driver’s license meets the legal requirement of an advance directive, many health provider personnel are reluctant to rely solely on the donor card for authorization to remove organs for transplantation purposes. Instead, in response to public concern after the passage of many state UAGAs, many requestors have set a de facto precedent of seeking consent from families before donation takes place. Reasons commonly given for ignoring a valid donor document and seeking consent from the family include: respect for the family in their time of grief, the need for a donor medical and social history, fear of bad publicity, unease about litigation, and concern about whether the decision to sign a donor card is based on informed consent (Wright, 1998). As the organ and tissue donation process has evolved, the public has come to expect that a family’s consent will be sought as an essential step in the donation process. The result is that in current practice, signed donor documentation often does not ensure that an individual’s wishes will be carried out as an advance directive.

The United Network for Organ Sharing (UNOS) commissioned the "Advance Directives and Donor Card Effectiveness Survey Report" in June 1997 to "examine the feasibility and legal ramifications of enforcing the wishes of deceased individuals who possess validly signed and witnessed organ donor cards or other forms of advance directives" (Wright, 1998). Among other findings, the survey determined that hospital and organ procurement organization (OPO) staff attitudes toward the use of advance directives potentially undermine legislation enacted in this area. Results indicated that donation is rarely performed without consent of the next of kin, reflecting a hesitancy on the part of the medical community to use donor cards as advance directives. Wary attitudes on the part of the donation community or hospital staff could diminish the effectiveness of even the most rigorous donor registry efforts. Moreover, the study found that 60% of responding OPOs did not know whether a potential donor had directives, and 47% to 60% were found to rarely check for advance directives (i.e., any evidence of a deceased person’s donation wishes). In contrast to these results, substantial support among OPOs was demonstrated for the use of donor registries. Twenty-six percent of OPOs use a donor database, and another 26% would utilize one if it were created. Of those OPOs responding, 49% stated that a state or national registry would be a useful tool.

A broader issue related to donor registries is that in order for an intention to donate (evidenced by inclusion in a registry database) to be used as an advance directive, the decision to consent must be adequately informed. Guarantees must therefore exist ensuring that the individual signing a donor card or checking the affirmative box on a driver’s license application is doing so after having been provided all relevant information. Provision of accurate and comprehensive information to the individual at the time of donor document signing would, at least from a legal standpoint, diminish or eliminate the need for obtaining consent from the next of kin at a later time. Under these conditions, the family would be informed of the decedent’s wishes rather than being asked to consent.