Analysis of State Actions Regarding Donor Registries

The Lewin Group, Inc. for
the Office of the Assistant Secretary for Planning and Evaluation
January 4, 2000

Table of Contents

BACKGROUND

METHODS

KEY FINDINGS

Public Awareness and Education

Registries as Advance Directives

Informed Consent

Access to Registry Information

Role of Medical Examiners

Additional Donor Cards

Maintenance and Technical Aspects of Registries

Evaluation

DISCUSSION

Potential Barriers and Solutions to the Development, Modification, and Linkage of State Registries

Public Awareness and Education

Registries as Advance Directives

Informed Consent

Access to Registry Information

Maintenance and Technical Aspects of Registries

Role of Medical Examiners

Additional Donor Cards

Evaluation

Potential Solutions not Apparent in State Actions

REFERENCES

APPENDIX A: Legislative SEARCH STRATEGY

Legislative Information Search Methods

APPENDIX B: STATE ACTIONS AFFECTING DONOR REGISTRIES

APPENDIX C: Summary of Conference: "Are Donor Registries Advance Directives?: Developing, Modifying, and Linking Statewide Donor Registries." New Orleans, Louisiana, July 27-28, 1999

Design and use of the Donor Registry

Public Awareness and Education

The Registry as an Advanced Directive

Informed Consent

Driver’s Licenses

Maintenance and Support/Technical Aspects

Access to Registry Information

Evaluation

Appendix D: Directory of Resources

State Legislation

OPO Directors and Contacts*

BACKGROUND

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.

METHODS

The Lewin Group conducted a thorough search for information about donor registries, advance directives, and informed consent (see Appendix A). Our search involved using the legislative search engine of the Health Policy Tracking Service of the National Conference of State Legislatures, search engines (if available) of individual states, and other sources via the World Wide Web. We also searched the DIALOG database (legislative and legal citations) for relevant articles in gray literature. Other sources included the Louisiana Organ Procurement Agency 1997 Report of State Legislation, covering state actions from the early 1990s to 1997, as well as documentation provided by registry representatives from the states in attendance of the conference, "Are Donor Registries Advance Directives?: Developing, Linking, Modifying Statewide Donor Registries," held in New Orleans, Louisiana, July 27-28, 1999 (see Appendix B). Lastly, the members of the Association of Organ Procurement Organizations were polled and solicited to submit copies of legislation each was utilizing to support development of local donor registries.

KEY FINDINGS

A number of key state actions have affected the development and modification of statewide donor registries in recent years, with most recent legislative efforts being directed primarily at increasing donation rates and addressing allocation issues. This section focuses on those state actions that most directly affect donor registries, which involve the following topic areas:

• Public awareness and education
• Registries as advance directives
• Informed consent
• Access to registry information
• Maintenance and technical aspects of registries
• Role of medical examiners
• Additional donor cards
• Evaluation of Registries

Appendix B provides a comprehensive listing of state efforts, arranged according to each of these topic areas.

Public Awareness and Education

Donor registries are often used as tools to increase public awareness and general knowledge regarding organ and tissue donation and transplantation. Four issues are related to the use of registries as public awareness tools: the method by which the message is conveyed, the choice of audiences to be targeted, evaluation of the success of awareness and education campaigns, and the development of public trust as a primary goal. Many states have taken actions to facilitate general awareness of organ and tissue donation, and to publicize the existence of the donor registry. Such actions include the following.

• States that provide the option of making a voluntary gift to fund donor awareness and educational programs at the time of driver’s license renewal include: Alabama, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Michigan, Missouri, Montana, Nebraska, Nevada, Ohio, Pennsylvania, South Carolina, Tennessee, and Texas.

• Arkansas, Louisiana, and Missouri have created multimedia donor awareness campaigns that use posters, television commercials, and radio advertisements.

• Florida and Missouri have created youth education programs in the secondary school system.

• Iowa allows county treasurers to collect funds for awareness grants.

• Louisiana and Michigan have educational sessions and registration information at many public events such as art and health fair booths, church programs, and driver’s education training.

• Ohio is considering implementation of an educational program that would automatically send donor information to individuals as a birthday card.

• Oregon sells special license plates to raise funds for donor awareness and education programs.

• Pennsylvania allows individuals to contribute to a donor awareness fund on income tax return forms.

• Louisiana has a statement of need in the state driver’s license manual.

Registries as Advance Directives

For some states, one goal of donor registries is to provide medical and/or procurement personnel easy access to the donation wishes of brain-dead patients, thereby allowing such personnel to act on those wishes as an advance directive. The primary method by which individuals make their wishes known is by indicating a preference on a driver’s license or signing a donor card. In those states having a donor registry, this also enters that individual into the registry database. However, designation on a driver’s license or other donor documentation, or documented donation wishes in a state registry (if applicable), are rarely implemented as legally binding. This remains an important issue in a number of states, and many have taken legislative actions to affirm the legal strength of such documentation as advance directives. In most states, however, this issue remains unresolved.

• States with legislation that reaffirms a signed license as an advance directive or more specifically protects OPOs, hospitals, and tissue and eye banks in carrying out individuals’ advance directives without further consent include: Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Maryland, Missouri, Pennsylvania, and Tennessee.

• In 1996, California implemented legislation allowing hospitals to use a decedent’s organs, tissues, or corneas for transplantation without next of kin consent after a "reasonable," yet unsuccessful, search for the next of kin. In 1998, the state revised the law by requiring consent for corneal donation, but not for organs or tissues.

• Arkansas expanded the method of donation consent to include a documented telephone message witnessed by at least two people.

• States with legislation that officially created donor registries through the divisions of motor vehicles include: Arkansas, Connecticut, Delaware, Florida, Illinois, Louisiana, Missouri, New Jersey, Pennsylvania, and Tennessee.

• California created a donor registry through its Department of Health and Human Services.

• Colorado, Delaware, the District of Columbia, Illinois, Maryland, Pennsylvania, and South Carolina indicate willingness, but not a refusal, to donate on their licenses.

• Texas recently passed legislation to eliminate donor status from licenses.

• States with laws specifying a prioritized list of next of kin that may authorize an anatomical gift in the absence of a documented advance directive include: Arizona, Florida, Georgia, Maryland, South Carolina, Vermont, Virginia, Washington State, and Wisconsin.

• Utah requires that the next of kin sign a form indicating that they were asked to give consent to donation.

• Nebraska may eliminate the requirement for a witness when an individual is making an advance directive.

• South Dakota enacted a measure which requires law enforcement personnel having access to the decedent’s driver’s license to inform any person having lawful custody of the body of the decedent’s wishes regarding organ and tissue donation. This enactment expands South Dakota’s previous measures, which required law enforcement personnel to inform only the next of kin, the attending nurse, or the attending physician.

• Connecticut and Minnesota specify that an individual legally authorized to make health care decisions for the decedent prior to death (i.e., a health care agent) may give consent to donation.

• Tennessee requires law enforcement personnel to make a reasonable search for a decedent’s license at the scene of an incident.

• Texas law requires that all hospitals obtain consent from the next-of-kin even when there is a clear and valid advance directive to donate.

• In Utah, where the donee is defined as an "organ procurement entity," a law specifies that "the rights of the donee are superior to the interests of others." For example, if an anatomical gift is designated to a specific OPO, no other OPO can supersede the rights to that gift.

• South Carolina and Wisconsin have very similar legislation to that of Utah, but include OPOs, individuals, hospitals, and surgeons in the definition of the donee.

• Louisiana uses a common state consent form, requiring appropriate documentation and next-of-kin signature, which ensures that the next-of-kin was provided the option of donation; a copy of this document is provided to the next-of-kin.

Informed Consent

For both legal and ethical reasons, it is necessary that the public be properly informed regarding organ and tissue donation before individuals decide to become organ and/or tissue donors. Assurances that an informed consent process is in place strengthen the ability to use donor documentation as an advance directive. No state has yet established clear legal or ethical standards for the minimum amount of information necessary to consider the decision to donate an informed one. Instead, state actions have focused on the method by which the public is informed about the donation process, standards surrounding signing donor documentation (i.e., in the presence of a notary public), and assurances of supplying adequate information to those making a decision.

• California, Colorado, the District of Columbia, Illinois, Maryland, Michigan, Missouri, Tennessee, and Virginia provide pamphlets, display posters, and/or show looped videos about organ donation at the time of driver’s license renewal, when individuals are asked to be donors.

• The District of Columbia, Massachusetts, and Rhode Island have laws requiring that donor information be included with the driver’s license renewal notice sent to license holders.

• Rhode Island requires notary public approval on organ donation cards.

• Most states require an individual to be at least 18 years of age for an advance directive to be legitimate without a parent’s consent. However, New Mexico and Washington State have laws that allow an individual 16 years of age or older to make an anatomical gift without parent’s consent.

• Georgia reduces driver’s license fees for those who become donors.

• The Illinois and Maryland divisions of motor vehicles send out "thank-you" letters to individuals who agree to be donors, in part to confirm their donation decision.

• Louisiana provides both extensive training and a standardized consent form detailing the specifics of donation to division of motor vehicles personnel in the position to speak with the public about donation. Additionally, Louisiana verifies donor consent via a follow-up mailing reiterating information initially provided at the division of motor vehicles.

Access to Registry Information

Because access to registry information is closely tied to public concern over protecting privacy, access must be limited only to those with the proper authority to view the information. Further, a mechanism must be in place to confirm that those individuals accessing the registry database are authorized to do so. Universal agreement does not exist for who should have access to a state donor registry data, or the most efficient method for accessing information from the database. States concur that OPOs should have access, but the extent to which hospital staff, tissue and eye bank personnel, and law enforcement personnel should have access remains unresolved. Several types of state actions have been implemented addressing these issues.

• Arkansas, Florida, Georgia, Hawaii, Illinois, Louisiana, Pennsylvania, and Tennessee have passed provisions that ensure 24-hour access to the divisions of motor vehicles’ donor registries via a toll-free 800-number number or through the World Wide Web.

• In Indiana, registry information is accessible only to law enforcement personnel.

• In the District of Columbia and Maryland, OPOs are able to call the state police to check donor status 24 hours a day.

• In Missouri, OPOs and eye banks have only limited access to registry information.

Role of Medical Examiners

The responsibility of the medical examiner is to determine the cause of death by performing an autopsy on the decedent’s body. Medical examiners typically have a great deal of authority over the disposition of a body, and therefore have the potential to take a key role in the donation process. Only two recent state legislative actions have significantly addressed the role of medical examiners in the donation process. First, in New Jersey and in Texas, medical examiners are required to justify their decision to deny the use of certain organs for donation. This situation is particularly relevant in cases of infant death, in which the cause of death may be less clear, and necessitate further investigation of the body (e.g., Sudden Infant Death Syndrome or child abuse). A second legislative action involves the state of Iowa, where medical examiners are able to authorize donation without next of kin consent.

Additional Donor Cards

Two broadly categorized hard-copy methods of donor documentation currently exist to record an individual’s donation wishes. The first is a donor card, specifically designed to outline an individual’s donation wishes, and signed by the individual. The second method is designation on a state-issued driver’s license, usually noted on the front of the license in a conspicuous location. Thirty states currently use donor cards in addition to a driver’s license designation, while three states (California, New Jersey, and North Carolina) use donor cards in lieu of driver’s license designation. However, no recent legislation exists that significantly affects the use of donor cards.

Maintenance and Technical Aspects of Registries

A great degree of disparity currently exists regarding the developmental stages of state donor registries. While a small number of states have a well-developed registry, most states are in only a rudimentary stage of development of a computer-based registry database. The first step in developing a state donor registry is determining where the database is to be housed. Registries may be housed in the OPO, a division of motor vehicles, a state department of health, the state police, or a managed care organization. Compatibility between the various entities that will utilize the registry must be established as the second step to developing a registry – compatibility both in terms of how the information is stored in the database and the interfacing of hardware and software used to maintain the database. Finally, mechanisms must exist for keeping the database up-to-date, including purging those individuals that pass away or opt out, and entering new individuals that have joined.

Recent state legislative efforts that have addressed various parts of this process are outlined below. One innovative effort made by a small number of states is to include images of donor documentation in the registry database, which provides a visual representation of the potential donor’s handwriting, a potentially effective tool in helping next of kin to appreciate their loved one’s wishes. Other efforts include the following.

• The Arkansas State Revenue Department computer system downloads driver’s license information on a monthly basis to the state donor registry.

• In California, the registry enrollment form is posted on the state’s health and human services Web site.

• Florida law allows funds from a procurement trust fund to be allocated towards helping to maintain the state registry. The state’s registry contains images of donor wills and signatures.

• Georgia has an advanced technological registry that allows data to be entered via a computer keyboard, magnetic tape, or document scanners.

• A field is provided in the Illinois driver’s license database which links to the state registry database.

• The Louisiana registry database allows individuals to selectively designate specific organs and tissues to be donated and search for information about blood and marrow donation.

• The Michigan registry includes a captured image of signed donor cards.

• The Missouri Department of Health maintains the state’s registry.

• The Texas Living Bank National Registry has contracted with a private firm to develop and maintain its computerized registry database.

Evaluation

Evaluation is necessary to ensure that efforts to develop registries or improve other aspects of the donation process are effective and useful. Nine states are currently evaluating various aspects of the donation process. The common goal of these evaluations is to understand how well public education initiatives and donor registry programs are being implemented (i.e., process evaluation), and to determine if these efforts are effective at increasing public awareness, and ultimately, donation rates (i.e., outcome evaluation).

• Arkansas conducts ongoing analyses of donor registrant demographics and audience-specific effectiveness of the state’s television advertisement campaign.

• Hawaii enacted a law that, among other provisions, established an advisory committee on anatomical gifts within its department of health and requires hospitals to allow death record reviews.

• Louisiana recently passed two resolutions, one geared toward studying the feasibility of paying the bereaved family’s funeral expenses, and a second designed to study the impact of coroner activities on donation. In addition, the Louisiana OPO is funded by the National Institutes of Health (NIH) to conduct an analysis of division of motor vehicles data from the Louisiana State registry, to study a new consent model, and to track the effects of its multimedia advertisement campaign. Housing of the registry within the OPO facilitates tracking the impact of registering donors and use of the registry in actual donations.

• Missouri conducted the "Arc Survey," which probed public awareness regarding the donation process.

• North Carolina passed a law that directed the state’s department of health and human services to study the development of statewide donor registries. The state also is evaluating the effect of "postcard" reminders for driver’s license renewal that contain organ donation information.

• Ohio intends to measure the relationship between a general willingness to donate and public education.

• Rhode Island recently accepted a measure to extend a Special State House Commission that is in the process of studying organ donation.

• Texas passed a law creating a public task force that will report in December 2000 on issues relating to organ allocation.

• Virginia passed two resolutions, one stipulating the development of plans to increase public awareness of organ donation, and another requiring a Joint Commission on Health Care to look at other organ donation issues.

DISCUSSION

This section outlines implications of the recent applicable state legislative actions. In some cases, state legislative efforts may represent obstacles to the evolution of registries, although the majority of state actions are expected to enhance the development, modification, and possible linkage of state donor registries. This discussion also includes identification of issues related to the donation process that might be clarified with further state legislation (e.g., more clearly defining the functions of the registry, or developing minimum levels of information necessary to establish informed consent).

Potential Barriers and Solutions to the Development, Modification, and Linkage of State Registries

Public Awareness and Education

State legislation affects the development of registries through public education in three general ways: increasing opportunities to make a financial gift to donor awareness trust funds, expanding organ and tissue donation educational programs to schools and public events, and creating multimedia campaigns. Increased funds and wider educational efforts should increase the number of individuals aware of organ and tissue donation and augment the number of people who indicate a willingness to become a donor. Increased public awareness of donation and donor registries could potentially lead to greater state support and a more effective donor registry system. The success of these varying educational and public awareness programs should be evaluated to ensure an effective methodology and efficient use of resources.

Registries as Advance Directives

Many states only recently took the initiative to create donor registries intended to function as official documentation of advance directives. Most often housed in the state divisions of motor vehicles, registries are intended to officially represent the posthumous donation wishes of individuals, and therefore to be acted upon without further consent from next of kin. However, if the actual implementation of these more recently developed registries remains dependent upon seeking next of kin consent as it does in practice in other states, such donor registries will not serve effectively as advance directives.

Some states with existing registries have taken actions to strengthen their ability to use the registry as an indication of an advance directive. Though states have taken different approaches to this issue, a clear and definitive statement regarding the specific purposes of the registry (e.g., education, procurement, demographic tracking) is a necessary first step in providing direction for change. Legislation explicitly diminishing or eliminating liability of hospital and procurement personnel who carry out the advance directive may be more effective than legislation eliminating the necessity of next of kin consent. In this latter case, hospital and procurement personnel often will remain wary of litigation, even in cases of a clear and valid advance directive.

Two additional legislative categories exist that have proven to be important in strengthening registries as advance directives. First, a small number of states require law enforcement personnel to make a reasonable search for the decedent’s driver’s license (or other donor documentation) at the scene of an incident. These actions increase the likelihood that an individual’s wishes would be determined and acted upon (either as a donor or a non-donor), and reduce time wasted in trying to determine donation wishes at the hospital, when crucial personal documentation may already have been lost. While this legislation is more applicable to the donation process as a whole, it clearly demonstrates support for ensuring knowledge of a decedent’s donation wishes, indirectly bolstering prominence of a registry in the donation process. Second, three states stipulate that donee rights are superior to the interests of all others. This legislation reinforces the right of OPOs, hospitals, surgeons, and individuals to carry out the decedent’s designation of an anatomical gift. Ultimately, this legislative support of advance directives may provide a further incentive to develop state registries as an effective tool in demonstrating the wishes of the potential donor.

While many state actions help registries function as advance directives, three areas of legislation create potential barriers to this function. A number of state actions creating or expanding a prioritized next of kin list further reduce the effectiveness of donor registries by increasing the number of people who must be found and consulted by hospital or procurement personnel. This can reduce the strength of the stated advance directive in the registry, and may waste valuable time in the donation process. Because current practice often is to ignore valid donor documents and seek consent from the family, an expanded prioritized list would further hinder procurement personnel (i.e., OPO, eye and tissue bank, and hospital staff) from carrying out an individual’s wishes.

Two state actions in Texas present potential barriers to use of registries as advance directives. One law requires that all hospitals obtain consent from the next of kin even in cases in which the individual’s wishes to donate are valid and clear. This directly undermines the function of advance directives. A second measure eliminates the printing of donor status on drivers’ licenses. This action renders the donation process less transparent and efficient by making individuals’ wishes less accessible.

Informed Consent

State legislation has not clearly established legal or ethical standards for the minimum amount of information an individual needs prior to making the decision to become a donor or to remain a non-donor. Nonetheless, some states have taken action to increase the amount of background information that individuals must receive before they decide to become registered donors. Some state actions provide that looped videos, pamphlets, and posters be present at divisions of motor vehicles, designed to enhance the awareness of the lay public as a "captive audience" in the waiting rooms of licensing offices. In some states, division of motor vehicles personnel provide explanations regarding donation. However, these measures, which are not always properly or consistently implemented, may not provide adequate information to meet informally recognized legal or ethical standards of informed consent. Further efforts should be made to decrease the disparity of information given to grieving families in the consent process and that given to individuals considering becoming donors. This could increase expansion of state donor registries and enhance the strength of the advance directive.

A second broad issue also involves utilizing the driver’s license as a means to entering individuals into a donor registry. Driver’s license renewal cycles vary from every two years to the absence of a renewal requirement, although a common cycle is every four years. An optimal cycle to encourage consent to organ donation has not been determined, and it has not been demonstrated whether cycle length affects a new driver’s decision. However, a decreased renewal frequency has the effect of both decreasing the number of times that drivers will be asked to think about becoming donors, and opportunities for donation and donor registry information to provided to the public via division of motor vehicles offices, or through fact sheets included with renewal notice packets.

An additional concern is that most states offer an individual an opportunity to donate when they first get their driver’s license, typically at 16 years of age. Generally, the age at which individuals may legally donate is 18 years of age. Individuals are consequently forced to make decisions about donation before the issue is relevant to them and may not have the opportunity to change their decision until the renewal of their license, given a typical renewal period of 4 years. The discordance among obtaining a driver’s license, becoming a legal organ donor, and the driver’s license renewal period may pose a barrier to consent.

A number of states have taken actions that may provide some assurances that the registry process is based on informed consent. Extensive donation training programs for division of motor vehicles personnel improves the quality of information they provide to the public, increases their comfort level in discussing the topic of organ and tissue donation, and may even have the effect of making them active proponents of donation. Ultimately, training increases public education and results in a more informed registered donor pool. Finally, as a way of validating a donor’s wishes as accurate and informed, two states send thank-you letters to registered donors soon after they are entered into the registry to confirm their commitment to become a donor.

Access to Registry Information

The effectiveness of donor registries as advance directives depends in large part on the ease with which OPO, hospital, and law enforcement personnel are able to access the databases. State legislation stipulating 24-hour access, toll-free 800-numbers, and/or World Wide Web access eases access to registries, and furthers registry development. Many states currently do not have a 24-hour accessible registry, which could substantially diminishing registry utilization. General consensus exists in the procurement community that registry information must be readily accessible at all times if it is to be useful in the actual implementation of advanced directives.

Because protection of privacy remains a key public concern, this must be taken into account when developing legislation in the area of registry access. Potential measures to alleviate these concerns include clearly establishing the entities or individuals having access to the registry, ensuring transparency of the policies regarding access and who has access, and developing mechanisms to confirm that those accessing the registry information have a right to do so.

Maintenance and Technical Aspects of Registries

Further legislation is needed in those states with lesser-developed donor registries to diminish the disparity that currently exists in the degree of registry development. The majority of state registries operate at only a very basic level, while a small number have more developed databases. Many states do not have a registry at all.

Registry maintenance and technical support involves determining where the database is to be housed, ensuring compatibility between the various entities that will utilize the registry, and developing mechanisms for keeping the database up-to-date. Several recent pieces of state legislation in this area have focused on addressing various parts of this process, although innovative efforts such as including visual representations of donor documentation also have been made in a small number of states.

Finally, the cost of maintaining and supporting a donor registry could be substantial, and funding mechanisms need to be established for this process to advance. Costs include those for purchasing and upgrading hardware and software, and personnel to operate and maintain the database.

Role of Medical Examiners

Medical examiners have a substantial responsibility in investigating and reporting deaths, and therefore have the potential to take a key role in the organ and tissue donation process. Nevertheless, only a relatively limited amount of state legislation has been enacted recently to address this issue. Recent measures in New Jersey and Texas requiring medical examiners to justify any refusals of organ donation should significantly decrease this barrier to the use of registries. By requiring greater accountability on the part of medical examiners for these actions, this measure makes the process more transparent to procurement personnel.

Additionally, allowing a medical examiner to authorize donation (in lieu of next of kin consent) facilitates the donation process by decreasing the number of individuals that must be consulted to begin donation procedures and, further, represents a step toward implementation of advance directives. Legislation more specifically clarifying the role of medical examiners, such as that described here, can help to ensure that the responsibilities of examiners during the donation process are clearly defined.

Additional Donor Cards

Depending on the method by which additional donor cards are used in a state, this could represent either a barrier to increasing registered donors or a facilitative measure. If a state requires donor cards in addition to a driver’s license designation to adequately demonstrate decedents’ donation wishes, it becomes unclear if both are necessary to legally represent an advanced directive. A problem also arises if one piece of donor documentation (i.e., the donor card or the driver’s license) is changed at some point while the other remains unchanged. This could lead to ambiguity as to which document takes precedence in the event of brain death, or which designation is listed in the donor registry (i.e., which document information is recorded). The dual donor card-driver’s license designation represents a potentially significant barrier to the donor registry and the advanced directive by adding unnecessary and potentially ambiguous documentation.

Alternatively, additional donor documentation beyond designation on a driver’s license could facilitate entering more individuals into the donor registry. Many individuals may not carry a driver’s license, and would therefore be precluded from entering into the registry without an alternative means of donation designation. The donor card then offers an additional mechanism for entering into the state donor registry.

Evaluation

The common goal of evaluation of the donation process is to understand how well public education initiatives and donor registry programs are being implemented (i.e., process evaluation), and to determine if these efforts are effective at increasing awareness and, consequently, donation rates (i.e., outcome evaluation). Each of these types of evaluation should be consistently and repeatedly applied to the donation process and the donor registry. Evaluative mechanisms should be built directly into the system itself, by coding and tracking educational and awareness materials, and comparing rates of success.

Potential Solutions not Apparent in State Actions

While a substantial number of state legislative measures have been enacted in recent years covering most aspects of the donation process, donor registries, and advanced directives, some areas are in need of further legislation. These areas broadly include defining the functions of registries, analyzing and standardizing registries, applying statistical analysis to registry data, addressing ethical issues surrounding the donation process, addressing liability resulting from failure to act on advanced directives, establishing coordination guidelines between those involved in the process, and detailing technical issues related to donor registries. These topics are outlined in greater detail below.

• Each state needs to clearly define the major functions of its registry. These functions include, but are not limited to, public awareness and education, increasing the number of donors, collection of funds, easing the consent process, and the use of registry information as an advance directive.

• An analysis should be conducted of the key aspects of model state registry programs. Pennsylvania, for example, often has been cited for its innovative and effective program (Nathan, 1999). Further, if a standard model is provided to states that are still developing their registries, future linkage would be facilitated with increased uniformity across states.

• The collection and statistical analysis of each state’s registry data could provide insights into the effectiveness of public awareness and educational campaigns, and aid in determining which specific areas are in need of additional public awareness efforts.

• A more comprehensive consideration of the legal and ethical aspects of using a unilateral or bilateral advance directive should be conducted. For example, it may be determined that if a positive designation on valid donor constitutes a binding advanced directive, then the negative designation should be clearly and consistently interpreted as well.

• Further study and appropriate legislation should be devoted to clarifying whether failure to act on an advance directive leaves hospital and procurement personnel open to liability from potential recipients who do not receive organs.

• Additional efforts should be made to establish programs designed to promote coordination among primary care physicians, lawyers, hospitals, OPOs, and other entities and individuals relevant to the donation process.

• Further efforts should be made to develop computer registries for inter-state linkage and 24-hour access.

• Actions to standardize (on a statewide or nationwide basis) and legally verify consent documentation would lessen the liability of hospital and procurement personnel carrying out advance directives.

• Development, modification, and standardization of donor registries have potentially substantial cost burdens. Legislation should address funding mechanisms for these efforts.

• Consensus does not exist in the procurement community regarding the contents of donor registry databases. Further clarification of what should be included in the database may be appropriately addressed by state legislation.

REFERENCES

Gortmaker SL, Beasley CL, Brigham LE, Franz HG, Garrison RN, Lucas BA, Patterson RH, Sobol AM, Grenvik NA, Evanisko MJ. Organ donor potential and performance: size and nature of the organ donor shortfall. Crit Care Med 1996; 24(3):432-9.

Nathan HM. Pennsylvania looks for answers to the organ donor shortage. June 10, 1999. PR Newswire.

National Attorneys' Committee for Transplant Awareness. Organ and Tissue Donation and Transplantation: A Legal Perspective. TransWeb. 1995. Accessed July, 1999.

Rothouse M, Kaiser E. Organ and Tissue Donation Issue Brief. June 24, 1999 update. National Conference of State Legislatures.

Wright DH. Survey Report: Advance Directives and Donor Card Effectiveness. UNOS. 1998.

APPENDIX A: Legislative SEARCH STRATEGY

Collection of the most recent state legislative information was conducted by using the legislative search engine of the Health Policy Tracking Service of the National Conference of State Legislatures, search engines (if available) of individual states, and other sources via the World Wide Web. We also searched the DIALOG database (legislative and legal citations) for relevant articles in gray literature. Other sources included the Louisiana Organ Procurement Agency 1997 Report of State Legislation, covering state actions from the early 1990s to 1997, as well as documentation provided by registry representatives from the states in attendance of the conference, "Are Donor Registries Advance Directives?: Developing, Linking, Modifying Statewide Donor Registries," held in New Orleans, Louisiana, July 27-28, 1999 (see Appendix B). Lastly, the members of the Association of Organ Procurement Organizations were polled and solicited to submit copies of legislation each was utilizing to support development of local donor registries.

To identify pertinent articles in the DIALOG database, we applied key search terms as described in the table below.

Legislative Information Search Methods

APPENDIX B: STATE ACTIONS AFFECTING DONOR REGISTRIES

Appendix C: Summary of Conference: "Are Donor Registries Advance Directives?: Developing, Modifying, and Linking Statewide Donor Registries." New Orleans, Louisiana, July 27-28, 1999

This summary provides an overview of the issues, key points, and findings of the July 27-28, 1999, conference on addressing the question of whether inclusion in a donor registry represents an advanced directive. As an accompanying theme throughout the two days, conference attendees were asked to deliberate on developing, linking, and modifying statewide donor registries. The substantive foundation of the conference was current or pending state legislation pertaining to donor registries.

While the question of whether a donor registry constitutes an advanced directive was posed as a major consideration for the conference, several other pertinent issues arose during the course of discussion. These issues included, but were not limited to:

• Design and use of a donor registry

• Ethical and legal considerations regarding informed consent

• Evaluation of registry development efforts

The first day of the conference consisted primarily of recovery agency personnel detailing for the group their efforts in the area of developing and modifying their respective donor registries. Some discussion regarding the issues of advanced directives, informed consent, potential uses of donor registries, and legislation evolved from these presentations, although lengthy discussions on these topics were reserved for the second day.

During the course of the conference, participants called into question the feasibility of linking donor registries in a way that involved electronic connections between the various databases. Trying to link registries in this fashion was thought to be impractical due to both the substantial cost of such an effort and the differing developmental stages of each of the state registries. Instead, the group deliberated on a less integrated approach involving a system of increased accessibility between states. The group agreed that, if a system of increased accessibility among state registries is implemented, three factors must be considered:

• Establishing specific purposes (e.g., education, procurement, and/or demographic tracking) each state has for the donor registry;

• Establishing consensus on a set of guidelines for accessing the database; and

• Assuring proper authorization for those accessing the information.

A more detailed description of major areas of conference discussion is provided below. This does not include summaries of state-by-state programs.

Design and use of the Donor Registry

Although design and use of donor registries varied considerably among different states, participants identified a common set of "typical" uses for a registry. These included:

• Education and public awareness (especially to facilitate informed consent)

• Increasing the number of donors in the registry

• Collection of funds

• Easing the consent process (by allowing recovery personnel access to registry information for use during the donation request)

• Use of registry information as an advanced directive

Different states emphasize each of these uses to varying degrees, including states that emphasize only one aspect, e.g., education. A major distinction was made between states using the registry to aid in both education and procurement, and others that use the registry exclusively for educational purposes. Participants emphasized that not all registries were developed with all of these functions in mind, and states should not be forced to alter the goals of their registry. This variation has implications for any attempts at linking registries. The group also addressed the ethical issue of using the registry database as a means to solicit funds for its support. No clear consensus evolved from this discussion, however.

Public Awareness and Education

Approach to Public Awareness and Education. Public awareness and education consists of several broad issues. First among these is the type of message that should be conveyed to the public, or more precisely, the "level" of information. A p