I. BACKGROUND
The purpose of this report is to provide an analysis of national and state level activity related to organ and tissue donor registries. This report describes national- and state-level initiatives related to organ donor registries and examines the relative roles of federal and state governments in such registries. The effect of these activities and policies on efforts to strengthen donor registries is assessed. This report is sponsored by the U.S. Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Office of Special Programs (OSP), Division of Transplantation (DoT) to better inform attendees of its conference Guidelines for Donor Registry Development on November 29-30, 2001. The conference is part of the HHS Gift of Life Donation Initiative. The report updates a 2000 Lewin report Analysis of State Actions Regarding Donor Registries.[1]
Despite a 2.7 percent increase in the number of cadaveric donors in 2000, there exists a considerable disparity between the supply of and demand for donor organs. As of November, 2001, there were nearly 79,000 people on the national transplant waiting list for a kidney, liver, heart, lung, pancreas, or intestine.[2] Another person is added to the waiting list every 13 minutes. In 2000, 5,984 deaths resulted in organ donation, and approximately 5,500 wait-listed patients died waiting. This translates to 15 deaths per day among individuals waiting for donations, or one death every 96 minutes. Although technological advances and human compassion have increased the number of living donations, cadaveric donation remains the primary source of organs.
A low rate of family consent to donation is one of the major barriers to donation. Although the latest national Gallup survey indicated that 85 percent of Americans support organ donation for transplants, only about 50 percent of families consent to donating a loved ones organs when offered the opportunity.[3],[4],[5],[6] Most polls indicate that knowledge of the decedents wishes to donate would positively influence the familys decision to consent to donation when their loved one dies.[7]
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 of 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 designate that a properly executed donor card is a legal instrument permitting authorized medical personnel to remove organs and tissues after death. In some states, documentation of intent to become a donor (or in some instances to be a non-donor) is entered into a donor registry database. Procurement professionals are able to access this database to determine a decedents donation wishes and, in principle, act upon those wishes as an advance directive.
Although a donor card or a donor designation on a drivers license may meet the legal requirement of an advance directive, many health care providers are reluctant to rely solely on the donor card for authorization to remove organs and tissues for transplantation purposes. Instead, many procurement organizations have set a de facto precedent of seeking consent from families before donation takes place based on their desire to avoid adding to the burden of grieving families. Reasons commonly given for seeking next-of-kin validation of a donor document 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.[8] The result is that, in current practice, signed donor documentation often does not ensure that an individuals wishes will be carried out as an advance directive.
In contrast to deferring to the wishes of the next-of-kin, organ procurement organizations (OPOs) in several states, including Pennsylvania and Virginia, have moved toward treating the decedents wishes as paramount. According to the legislation in these states, the decedents wishes are honored when adequately documented. In such cases, next-of-kin consent is not needed, and family members wishes do not override the decedents wishes. However, families are provided with education, information, and support during and after the donation process.
A 1998 report issued by the United Network for Organ Sharing (UNOS), Advance Directives and Donor Card Effectiveness Survey Report, examine[d] 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 the 65 percent of OPOs participating in the survey, it was found that hospital and OPO staff attitudes toward the use of advance directives appear to run contrary to relevant legislation. Results indicated that donation is rarely performed without consent of the next-of-kin, reflecting a hesitancy on the part of the transplant community to use donor cards as advance directives. This wariness on the part of the donation community or hospital staff can diminish the effectiveness of even the most rigorous donor registry efforts. The study found that in general, 70 percent of responding OPO staff did not know whether a potential donor had directives, and 47 percent to 60 percent were found to rarely check for advance directives (i.e., any evidence of a deceased persons donation wishes). In contrast to these findings, there was substantial support among OPOs for donor registries. Of the responding OPOs, 26 percent use a donor database, and another 26 percent reported that they would utilize one if it were created. Further, 49 percent stated that a state or national registry would be a useful resource.
The federal government is committed to increasing donation rates. Organ and tissue donor registries act as vehicles for electronically documenting a decedents wishes so they may be made readily available to the family and to procurement and hospital staff. Sharing an individuals wishes regarding donation may help to ease the burden of decision-making felt by the grieving family. Access to such information by families and procurement staff may promote decisions consistent with an individuals wishes, ultimately increasing the donation rate.
In 2000, under contract with HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE), The Lewin Group completed an analysis of state actions regarding donor registries. The 2000 report cited certain types of key state actions in the 1990s that affected the development and modification of statewide donor registries, with more recent legislative efforts being directed primarily at increasing donation rates and addressing allocation issues. State and local issues that most directly affect donor activities were the following:
· Public awareness and education
· Registries as advance directives
· Informed consent
·
Access to
registry information
· Maintenance and technical aspects of registries
· Role of medical examiners
· Donor cards, including drivers license designation and separate donor cards
·
Evaluation
of registries.
II. METHODS
The term donor registry refers to a wide range of data collection, storage, and retrieval activities. This report defines a donor registry as a means of collecting and making available (e.g., to OPOs) documentation of decedents intent to donate. The present report builds upon and updates the 2000 analysis of state actions regarding donor registries. The Lewin Group conducted searches for information about donor registries at both the state and national levels, and inquired in particular about activities in 23 states identified by the Health Resources and Services Administration (HRSA) and experts in the field as having active or rapidly evolving registries (listed in Appendix B). This effort used 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. The DIALOG database (legislative and legal citations) was also searched for relevant articles and other documentation.
Additional information was gathered from individuals in the field to explore differences among registries, such as where registries are housed, how they are maintained, and registries roles in the donation process. States also provided information on the technical innovations and maintenance procedures, and described various obstacles they encountered in the use of their registries. Additionally, members of the Association of Organ Procurement Organizations (AOPO) provided relevant information regarding their respective states donor registries.
III. overview of KEY findings
Actions regarding organ and tissue donor registries can be divided into public actions that have taken place at the national level, public actions that have taken place at the state level, and private actions. To date, the development and maintenance of donor registries have been predominantly state activities. This may be due in part to the following factors: state laws regarding the registration and donation processes vary; and responsibility for donor designation and registration has traditionally been tied to motor vehicle departments, which reside at the state level. Currently, most operational registries exist at the state level, although not all states have registries.
In recent years, the federal role in the field of organ donor registries has become more prominent. The executive branch of the federal government has been active in donation efforts through grant-making and research conducted by HHS. In addition, both houses of Congress have been involved in drafting legislation pertaining to organ donation.
Private initiatives towards developing a national donor registry have been surfacing as well, as the Internet has provided an avenue for private citizens to establish online national registries.
National and state activities occurring in the public and private sectors are described below. A discussion of these activities and the implications of interactions between the national and state levels follows.
IV. Key Findings: National Activities
A. Legislative Activities
As of November, 2001, no national laws exist that provide for the creation or maintenance of donor registries. However, four bills recently introduced in Congress promote donation and donor registries. These bills, described below, are:
· The Motor Donor Act (S. 788 and H.R. 2645)
· The Donate Act (S. 1062)
· The Organ Donation Improvement Act of 2001 (H.R. 624)
·
The Organ
Donor Enhancement Act (H.R. 955).
Appendix B provides categorical descriptions of the national legislative efforts.
1. The Motor Donor Act (S. 788 and H.R. 2645)
The Motor Donor Act (S. 788 and H.R. 2645) is co-sponsored by Sen. Charles E. Schumer (D-NY) and Rep. Leonard Boswell (D-IA). The bill was introduced in the Senate in April, 2001 and in the House in July, 2001. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions and the House Ways and Means Committee. It would amend the Public Health Service Act to establish a national organ and tissue donor registry through the department of motor vehicle license application process. The bill would create a national database administered and maintained through HHS and would combine donor information from state registries with information from donors who sign up through the website. While the data in the registry would be available nationwide, the registry would serve as a registry of intent, and would not override state laws, such as those establishing donor intent as legally binding consent for organ donation.
The Motor Donor Act:
· Assembles an advisory task force of representatives from organ donation, transplantation, and procurement fields;
· Establishes clear procedures for registering intent to donate;
· Provides grants to states (not to exceed $300,000 per state) to plan and implement registries of donor status designated through the states motor vehicle drivers license application and renewal processes;
· Establishes and maintains a national registry database that would combine information from state registries, including information on intent, name, address, date of birth, sex, height, eye color, and a registry identification number, as well as include information from those who register via the registrys website;
· Ensures that information in the national registry be made directly available to OPO staff on a 24-hour basis;
·
Provides
grants to states (not to exceed $300,000 per state) to fund public awareness
and education campaigns promoting donation;
·
Enables
federal and state governments to enhance outreach activities through the
creation of a public-private partnership;
· Creates a website no later than three years after passage of the bill as a source of information and portal for registration to the public.
2. The Donate Act (S. 1062)
The Donate Act (S. 1062) is sponsored by Senator Richard Durbin (D-IL) and was introduced in June, 2001. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions. The bill would amend the Public Health Service Act to facilitate best practices and interstate linkage among all state donor registries. The Donate Act would allow the Secretary of HHS, via HRSA, to establish a National Organ and Tissue Donor Registry Resource Center that would provide states with mechanisms for linking state registries as well as guidelines for operating state registries. Existing state practices for obtaining consent would not be preempted by any provisions in the legislation.
The Resource Center would:
·
Assemble an
advisory task force of representatives with experience in transplant medicine,
organ procurement, donor outreach, state registries, and national level
information systems, and representation of donor families;
· Provide grants and technical assistance to states to advance the development and expansion of state donor registries;
· Maintain a clearinghouse (with information available via the Internet) to facilitate 24-hour direct access to donor data among states. The clearinghouse also would collect, synthesize, and disseminate best practice information about donor registries. Best practices would be established through a review of organ donation policies by the Institute of Medicine (IOM). This IOM evaluation would develop consensus guidelines for a standard registry model. Consensus guidelines would address:
- Core functions of registries and uniformity of content;
- Clear and ethical standards for minimum levels necessary to establish informed consent;
-
Standardized
legally verifiable consent documentation;
- Privacy safeguards;
-
Guidelines
for accessing the registry;
-
Establishment
of cross-state data exchange protocols and standards;
- Methods for legally enforcing the wishes of the donor.
In addition, the Donate Act would:
· Honor donors and their families with Congressional medals;
· Make grants to donor families for costs incurred in the donation process;
· Establish a program of grants for hospital organ donation coordinator activities;
· Allow the Secretary to establish public awareness initiatives and fund educational efforts by non-profit organizations and states and other public entities.
3.
The Organ Donation Improvement Act of 2001 (H.R. 624)
The Organ Donation Improvement Act of 2001 (H.R. 624) is sponsored by Rep. Michael Bilirakis (R-FL) and was introduced in the House of Representatives in February, 2001. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions. The bill would amend the Public Health Service Act to promote organ donation in two ways.
First, the bill would allow the Secretary to make awards of grants or contracts to states, transplant centers, qualified OPOs, or other public or private entities for the purpose of providing payment of travel and subsistence expenses incurred by individuals toward making living donations of their organs. In addition, the Secretary could make awards for the payment of incidental non-medical expenses that are incurred due to the living donation. Awards would be subject to eligibility criteria and limitations on payment.
Second, the Organ Donation Improvement Act attempts to improve public awareness surrounding organ donation. The bill states that the Secretary shall (directly or through grants or contracts) carry out a program to educate the public with respect to organ donation, including the need to provide for an adequate rate of organ donation. To this end, the Secretary will fund public or private entities to conduct studies and demonstration projects of public awareness efforts. The bill also would allow the Secretary to provide grants to states for assistance in carrying out organ donor awareness and public education and outreach activities, and in developing, enhancing, or expanding their donor registries. Grantees would either be required to have an existing registry, or be in the process of developing a registry, and they would have to make registry information available to OPOs, hospitals, and other states upon search request. Grantees would be subject to eligibility requirements and report annually to Congress.
4. The Organ Donor Enhancement Act (H.R. 955)
The Organ Donor Enhancement Act (H.R. 955) is sponsored by Rep. Jay Inslee (D-WA) and was introduced to the House of Representatives in March, 2001. The bill was referred to the House Subcommittee on Health that month. The bill would amend the Public Health Service Act to provide for a national living organ donor registry, to be maintained under responsibility of the Secretary and a board of directors.
The Organ Donor Enhancement Act creates a centralized living donor registry to establish a system for identifying living organ donors nationwide. The Act does not specify the sources of data or who may access the database. The status of the living donors would be updated annually. A system of patient and donor advocates would exist as part of the registry. The bill also provides for a program of educational activities to recruit living organ donors. The registry would be funded through authorized annual appropriations for the years 2002 through 2006.
B. HHS Activities
The federal government is committed to increasing organ and tissue donation. To that end, HHS Secretary Tommy G. Thompson launched The Gift of Life Donation Initiative, a national donation effort promising long-term commitments and partnerships to encourage Americans to become donors. The Secretarys Initiative includes the Workplace Partnership for Life campaign aimed toward employers, union, and other organizations to help promote organ, tissue, marrow, and blood donation. The Initiative also created a model organ and tissue donor card that includes provisions for designating the organs and tissues that may be donated and lines for signatures by two witnesses. A proposal in the Initiative is the creation of a national medal to honor the families of organ donors and a model driver education curriculum for states and counties. Another component of the Initiative is the November 2001 conference, Guidelines for Donor Registry Development, exploring the current status of organ donor registries. Conference participants will include representatives from procurement entities and the National Conference of State Legislatures, among others. The proceedings of the conference will assist HHS in reviewing the potential and effectiveness of donor registries in all states.
HHS is currently providing approximately $33 million in research grants to over 30 organizations to explore strategies to increase organ and tissue donation. Research projects are addressing factors relevant to donor registries, such as ways to motivate individuals to declare their intent to donate and to share that decision with family members. HHSs granting portfolio includes approximately $10 million in funding that was recently allocated to 12 grantees as part of the 2001 Federal Gift of Life Donation Initiative.[9] Some of these new grantees will focus on topics such as the utilization of statewide comprehensive organ and tissue donor registry systems and involving attorneys in discussing donation with clients.[10]
C. Private Sector Activities
In addition to the federal efforts regarding donor registries, there are several private initiatives to develop a national donor registry. The Internet has provided an avenue for private citizens to establish online national registries but the legal status of private initiatives has not yet been clearly defined. These initiatives have the potential to increase public awareness regarding donation, although they may also confuse the public until their legal status relative to public registries is more clearly defined. The most notable private registry is the Living Bank, based in Texas. The Living Bank accepts registrants from all states through its website and procurement staff in other states may search the Living Bank to determine decedents donation intentions. Other private donor registry activities include on-line registries created by individuals.
V. Key findings: State Activities
In 2000, The Lewin Group performed an in-depth analysis of legislative actions of all 50 states and the District of Columbia related to organ and tissue donor registries.[11] The current report updates that analysis and provides a focused examination of states with highly active and/or rapidly evolving registries.
Presently, there are 20 states with operational registries and two states that are engaged in developing registries. States with operational registries are: Alabama, Arkansas, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Michigan, Missouri, Nevada, New Jersey, New York, Pennsylvania, Tennessee, Utah, Virginia, and West Virginia. States with plans to develop registries include California and Iowa.[12] All states provide residents with the option to designate donor status on a drivers license, but if this information is not tracked and made available to procurement staff, this does not constitute an operational registry for the purposes of this report.
Considerable variation exists among state registries in terms of their levels of implementation. There is also some variation in registry structure and processes for maintenance. State and local issues that most directly affect donor registries involve the following:
· Funding
·
Gatekeeper
· Registration and documentation
· Access to registry
· Registry maintenance
·
Public
awareness and education
· Informed consent
· Donor intent and advance directives
· Evaluation.
Appendix C provides a detailed matrix of state efforts, arranged according to these functions.
A. Funding
Funding for registries is required for start-up costs and ongoing operation and maintenance. The start-up cost of implementing a registry may pose a barrier in many states. Existing registries have been funded with both public and private dollars. Public dollars may be allocated to registries from state general funds, as a part of department of motor vehicle (DMV) operating costs, or through state health department budgets. OPOs have a significant role in providing private funding. Types of funding mechanisms are as follows:
· State general funds are used for implementation and maintenance in Maryland, Michigan, Virginia, and West Virginia.
· The New York State Health Departments operational budget provides funding for implementation and maintenance of that states registry.
· Utah is aided by the HRSA grant program. Ultimately, the Utah registry will be maintained with OPO and DMV monies.
·
OPOs in
Alabama, Arkansas, and Colorado have allocated funds towards registries or have
absorbed registry costs in their general operations.
·
Georgia
received a grant from a private organization, the Mason Trust Fund, to help
establish its registry.
· Voluntary contributions fund registries in Missouri and Pennsylvania.
B. Gatekeeper
The registry gatekeeper is the entity responsible for the operations, maintenance, and security of the registry. Gatekeepers vary by state. A registry may be housed in and maintained by the state DMV, the state health department, a state organ procurement council, one or more OPOs within the state, or another private organization, as follows:
·
State
departments of health or departments of state house the registries in
California, Florida, Illinois, New York, and Missouri. However, Florida is considering privatizing
the registry by granting full control to the OPO.
·
DMVs house
the registries in Alabama, Arkansas, Delaware, Hawaii, Maryland, Montana, and
Pennsylvania.
·
OPOs house
and maintain registries in Colorado, Georgia, Iowa, Louisiana, Michigan,
New Jersey, and Virginia.
· Nevada recently entered into a partnership with a private national registry, the Living Bank, which will serve as Nevadas gatekeeper.
C. Designation
of Donor Status/Entrance into the Registry
The following are examples of registry entry portals:
· In Michigan, drivers are sent donor cards to be signed and sent to the Office of the Secretary of State.
·
Internet-based
registration capabilities are available in Alabama, Arkansas, Colorado,
Florida, Louisiana, Michigan, and New York.
In addition to offering on-line registration, Alabamas pilot website
allows registrants to update their information and change their donor status.
· Phone-in registration via toll-free numbers is available in New Jersey and Colorado.
Donor registry activities also have been tied to state public awareness and education efforts regarding organ and tissue donation (see Section G. Public Awareness and Education).
D. Documentation of Donor Status
There are two broadly categorized hard-copy methods of donor documentation to record an individuals donation wishes. The first method is designation on a state-issued drivers license, usually noted on the front of the license in a conspicuous location. The second is a donor card designed to document an individuals donor status and signed by the individual and sometimes one or more witnesses. The use of donor cards varies among states. Among states with registries, some use donor cards in addition to drivers license designation while two others (California and New Jersey) use donor cards in lieu of drivers license designation. Additional states have donor designation coupled with drivers licenses, but do not have operational registries. While these states provide individuals the option to indicate donor status, this information is not stored and made available to procurement staff, as is the case with an operational registry. In states where both a drivers license designation and a donor card are used, there may be a lack of clarity regarding whether both are necessary to constitute a valid advance directive.
The following are examples of different documentation scenarios:
·
Donor
status may be designated on drivers licenses through a printed insignia or
affixed sticker.
·
In
Michigan, individuals who designate donor status on their drivers licenses are
not automatically included in the state registry. Individuals must send a signed donor card to the state Office of
the Secretary of State to be included in the registry, although they may sign
the back of the drivers license as designation of donor status. Likewise, Nevada and Utah residents with
drivers license donor designation will not be automatically included in the
registries used by those states.
· In Colorado, Louisiana, and New York, residents who have not designated donor status on their drivers licenses may be included in the state registry if they have registered online or through other venues.
E. Access to Registry Information
For a registry to be operational, access must be granted to relevant parties, such as organ and tissue procurement staff. Access to the registry entails matters of who may obtain information from the registry, and when and how information may be obtained. Because the registry includes private and sensitive information, access to the registry is limited, for example, to OPO and tissue or eye procurement officials and the governmental agency providing oversight. Medical examiners also may have access to the registry.
Timely access to registry information is important given the time-sensitive nature of the donation process. OPO, tissue, and eye procurement staff have 24-hour access to registry information in most states with registries. Some OPOs do not have direct access and must go through the state police or health department to get information. However, in some states, a secure computerized database allows instant access through use of the password.
·
Legislatures
have passed provisions that ensure 24-hour access (whether direct or indirect)
to registries in Arkansas, Colorado, Florida, Georgia, Hawaii, Illinois,
Louisiana, Pennsylvania, and Tennessee.
·
OPO staff
have direct access to the registry in states where the OPOs are the registry
gatekeepers, such as Louisiana, Michigan and West Virginia.
·
OPO staff
must obtain access to the registries through the state police or health or
state departments (via a toll-free phone number or through submission of a
written request) to gain access to information in Delaware, Maryland, New York,
and Pennsylvania.
F. Registry Maintenance
Registries vary widely in their stages of development and levels of technical sophistication. Designation of the site where the registry is housed has implications for its development and maintenance. A variety of mechanisms are used for maintaining currency of the registry database, e.g., entering new registrants and purging information for individuals who die or change their donor status.
Maintenance efforts include the following:
· Information is sent from the DMVs to the registries on a periodic basis in Arkansas, Missouri, Florida, and New York.
· Illinois provides a donor status field in the Illinois drivers license database that links to the state registry database.
· The Michigan Office of the Secretary of State stores the names of new donors in a temporary database that is erased weekly once the information is sent to the registry.
·
Georgia is
able to enter data into the registry in a variety of ways, including via
computer keyboard, magnetic tape, or document scanners.
·
One
innovative approach of some registries is to include images of donor
documentation in the registry database, such as a visual representation of the
potential donors signatures. Sharing
these data with the next-of-kin may help them appreciate their loved ones
wishes. Florida includes images of donors wills and signatures in
the registry. Similarly, Michigan
captures images of signed donor cards.
G. Public Awareness and Education
Donor registration is related to public awareness and education regarding organ and tissue donation and transplantation. Many states are engaging in funding campaigns or activities to increase public awareness, to educate the public and to promote organ and tissue donation and registration. In addition to their role in documenting an individuals donor status, states use registries as tools for public awareness. Examples of state funding campaigns and activities include the following.
1. Public Awareness and Education Funding
· At the time of drivers license renewal, some states are providing the option of making a voluntary gift to fund donor awareness and educational programs. These States include: Alabama, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Maryland, Michigan, Missouri, Montana, Nebraska, Nevada, Ohio, Pennsylvania, South Carolina, and Tennessee.[13]
· Iowa allows county treasurers to collect funds for awareness grants.
· Oregon sells special license plates to raise funds for donor awareness and education programs.
· Pennsylvania collects voluntary contributions to a donor awareness fund through income tax return forms.
2. Public Awareness and Education Activities
·
Arkansas,
Louisiana, and Missouri invest in multimedia donor awareness campaigns that use
posters, television commercials, and radio advertisements to promote organ and
tissue donation.
· Some states are educating new drivers. For example, Maryland provides organ donor information to youths enrolled in driving school. Florida and Missouri have youth education programs in the secondary school system.
·
Louisiana
and Michigan have educational sessions and registration information at many
public events such as art and health fair booths, church programs, and drivers
education training.
·
Utah will
use DMV information for educational efforts.
Those individuals with donor status designated in the DMV database, but
not included in an operational registry, will be given information and
encouraged to register with the gatekeeper.
H. Consent Issues
Both for legal and ethical reasons, individuals must be adequately informed regarding the donation process prior to registering as donors. Some registries may be used as registries of consent, where inclusion in a registry serves as legally binding consent to donate. It is thus imperative that individuals have provided informed consent. The assurance that a decision to donate was an informed one strengthens the validity of the intent designation.
States have not consistently established legal standards for the minimum amount of information necessary to qualify a decision to donate as informed. States actions have focused on supplying information about the donation process. To further ensure an informed decision- making process, states have established legally recognized standards of documentation (e.g., in the presence of a notary public, in the presence of two witnesses). The following are examples of state actions pertaining to informed consent:
·
California,
Colorado, the District of Columbia, Illinois, Maryland, Michigan, Missouri,
Tennessee, and Virginia provide pamphlets, display posters, and/or show looped
videos about organ and tissue donation at the time of drivers 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 drivers license renewal notice sent to license holders.
· Rhode Island requires notary public approval on donor cards.
· Arkansas expanded the method of consent to include a documented telephone message witnessed by at least two people.
· Nebraska may eliminate the requirement of a witness when an individual is making an advance directive.
·
Most states
require an individual to be at least 18 years of age for an advance directive
to be legitimate without parental 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 parental
consent.
· The Illinois and Maryland DMVs send 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 DMV 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 DMV.
I. Registries as Advance Directives
By documenting donor status and providing medical and/or procurement personnel access to this information in order to honor the wishes of the donor, registry data can serve as an advance directive. However, designation of donor status in a donor registry does not always comprise an advance directive. For example, because some state registries do not verify that intent to donate is based on an informed decision (according to legal standards of informed consent), the information is not used as an advance directive. In addition, perceptions of the needs of grieving families also may shape practices regarding the use of registries as advance directives. In most states, the next-of-kin are still approached for consent even when donor status is documented. This practice grants the next-of-kin, and not the decedent, the ultimate decision-making power regarding donation.
Ten states (listed below) have taken or are in the process of taking legislative action to make donor intent as documented in a registry paramount (i.e., cannot be overridden by the wishes of the family). A registry used in this way is referred to as a registry of consent, because the documentation of donor status is affirmed as legally valid consent. The passage of donor intent legislation allows hospital and procurement staff to adhere to the wishes of the donor; families are informed of their loved ones decisions rather than sought for consent. Donor intent legislation protects hospitals and OPOs from liability for damages in any civil action and from prosecution in any criminal proceeding when acting in good faith and in line with statutes. However, variation exists even within a state, as de facto family consent practices continue.
· California, Colorado, Indiana, Louisiana, Ohio, Pennsylvania, Virginia, and West Virginia have enacted and/or strengthened the language of donor intent legislation to make the decedents documented wishes paramount.
· Arkansas and Florida are in the process of revising or developing donor intent legislation.
·
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.
J. Evaluation
Evaluation ensures that efforts to develop and operationalize registries or improve other aspects of the donation process are effective and useful. The common goal of evaluation 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 states television advertisement campaign.
· Louisiana passed two resolutions, one to study the feasibility of paying the bereaved familys funeral expenses, and a second 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 DMV data, to study a new consent model, and to track the effects of its multimedia advertisement campaign. The number of registrants has increased from 200,000 to 700,000 in the past four years, coinciding with intensive public outreach and media campaigns. The location of the registry within the OPO facilitates research into the use of the registry in actual donations.
· The Missouri Department of Health conducted a study to explore the potential effectiveness of the state registry. According to one study finding, when hospitals approached the families of all potential donors without knowing the donor status of the patient, a high percentage (approximately 40 percent) of the decedents families decline to donate.
· North Carolina passed a law directing the state Department of Health and Human Services to study the development of statewide donor registries. The state evaluated the effect of postcard reminders for drivers license renewal that contain organ donation information.
· The Rhode Island House accepted a measure to extend a special commission studying organ donation.
VI. DISCUSSION
The most significant factor limiting the size of the donor pool is the low rate of consent by the families of potential donors. Available research indicates clearly that families who know that their loved ones wished to be organ donors are more likely to provide consent. Moreover, sharing an individuals wishes regarding donation may help to ease the burden of decision-making felt by the grieving family. However, ascertaining donor designation noted on a drivers license, donor card, or in an advance directive in order to validate intent may be time-consuming or impossible when this information is not available in a registry, presenting an obstacle to the highly time-sensitive donation process.
Organ and tissue donor registries are vehicles for electronically documenting a decedents wishes so they may be made readily available to the family and to procurement staff. Registries help to overcome barriers in the donation process by reducing the time necessary to ascertain donor designation and alleviating the need to obtain family consent when qualifying as, and used as, advance directives. Accessing an electronic database to establish and verify donor status can require less time and result in a higher standardization of practice when compared to the alternative of conducting a physical search for a drivers license or donor card, or establishing the existence of a legally valid advance directive.
In order for registries to be effective, multiple steps must occur. An individual must be aware of the option of donation and designate and document donor status; information must be collected, collated, and maintained by the gate-keeping entity; and information must be accessible to and used by appropriate hospital and procurement personnel. The sequence of these actions is summarized in Exhibit 1.
Exhibit 1: Key Actions in the Registry Process
The following section of the report discusses the inputs to these actions associated with the development and operation of registries. Because registries are operated predominantly at the state level, the discussion below of key registry elements is framed largely within state actions. However, the implications of interactions between state and national level activities are also addressed.
A. Key Registry Elements
1. Registry Definition and Variance
While there does not appear to be a common definition of a donor registry, it is reported here that a donor registry provides the means to collect and make available (e.g., to OPOs) a decedents intent to donate. This definition is inclusive of many activities.
State registries vary along multiple parameters, including each of the topics discussed below (funding, gatekeeper, etc). Registries may be private, with no state mandate, operating at the discretion of the private entity. Alternatively, registries may be established, maintained, and regulated by the state. Even among state-sanctioned public registries, there is variation in the data that are collected. Among the data collection attributes that affect the utility of a registry is whether or not a registry includes negative or equivocal indication of donor status, i.e., where registrants indicate that they not donors or are not sure of their wishes. For example, it is unclear whether nonparticipation in an affirmative-only registry could be taken as intent to not donate. State registries also vary in technological capacity. Some registries are highly evolved, electronic, web-based, linked databases, while others have limited capacity.
Reportedly, a small number of individuals die outside of their states of residence. In these cases, cross-state registry linkages could facilitate access to information regarding the wishes of individuals while reducing the need for a single federal registry. The variation and the lack of standardization and uniformity across state registries must be considered in a plan to link registries.
2. Funding
Little is known about the cost-effectiveness of registries. However, funding levels influence a registrys capacity and effectiveness. Funding sources and levels vary, and may present considerable barriers for states in the development and maintenance of registries. In addition, variation in funding levels may compound the lack of standardization in the content and processes of registries. Some states are able to secure funding for initial development from their state governments. The cost of developing a registry often falls to OPOs and tissue or eye banks, which either absorb the costs through their operating or reserve funds or seek outside public or private assistance. OPO resources devoted to registry efforts may be allocated away from other donation activities such as hospital development.
3. Registry Housing and Portals
The primary portal into a registry remains the DMV, although registration may be available through the gatekeepers or OPOs website or via donor promotional venues. When registration occurs through a non-gatekeeper entity, data must be channeled to the gatekeeper in a timely and accurate manner. Insufficient data flow could result in satellite databases, fragmenting the pool of potential donors and undermining the role of the registry as a central source of information. Thus, an effective registry must account for and coordinate various portals of entry and exit if applicable.
The significance of the DMV role underscores the need to create incentives for participation in operating a registry. DMVs are generally not bound by law to be involved with registries. Although they require DMV resources, donor registries create additional work for DMV staff. Further, because donation registration is not a primary function of the DMV, its staff may lack organ and tissue donation expertise and commitment. However, the DMV is the most common portal of entry for potential registrants. For DMVs to be effective portals, it is necessary to ensure that they have adequate resources and clear statements of their responsibilities, and that DMV staff have sufficient training to provide information to the public.
The frequency of DMV registration opportunities should also be recognized as a factor affecting entry into and exit from the registry. Drivers license renewal cycles vary from every two years to no periodic renewal requirement. A decreased renewal frequency has the effect of decreasing the number of opportunities for drivers to be asked to consider becoming donors and for donation and donor registry information to be provided to the public. Further, such decreased frequency increases the potential for a drivers current wishes regarding donation to be inconsistent with the intent recorded earlier on his or her license.
4. Documentation of Donor Status
Depending on the methods by which drivers license designation and donor cards are used in a state, documentation of donor status could represent either a barrier to or facilitator of donation. A state may require a donor card in addition to drivers license designation to verify a decedents donation wishes. The dual donor card-drivers license designation represents a potentially significant barrier to the donor registry and the advance directive by adding unnecessary and potentially ambiguous documentation. There may be confusion regarding whether both are necessary to meet the legal threshold to act as an advance directive. The size of the potential donor pool also may be reduced if fewer individuals possess both pieces of documentation. Moreover, a problem arises if one piece of donor documentation 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 death, or which designation is recorded in the donor registry.
Alternatively, a form of donor documentation separate from designation on a drivers license could facilitate entering more individuals into the donor registry. Many individuals may not carry a drivers 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 avenue for entering a state donor registry.
5. Access to Registry Information
The effectiveness of donor registries depends in large part on the ease with which procurement, hospital, and law enforcement personnel are able to access the databases. State legislation stipulating 24-hour access, toll-free numbers, and/or Internet access promotes registry effectiveness. The lack of 24-hour access to the registry could substantially diminish registry utilization. General consensus exists in the procurement community that for registry information to be useful it must be readily accessible at all times.
Because privacy remains a key public concern, safeguarding the potential donors private information must be taken into account. The public must be assured that information will not be compromised and that only authorized officials will have access to data. Potential measures to alleviate privacy 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.
6. Registry Maintenance
Registry maintenance and technical support address the compatibility of information systems among the various entities utilizing the registry. In addition, updating the database with new information and removing obsolete information are key aspects of maintenance. Registry maintenance and technical capacity are closely tied to the site of the registry database itself (e.g., DMV, OPO) and funding levels. Costs include purchasing and upgrading hardware and software, and training personnel to operate and maintain the database. Technological capabilities, such as password protection to ensure security, can help facilitate database linkage. Some state activities have incorporated technologically innovative efforts such as including visual representations (e.g., signatures) of donor documentation.
Compatibility between the various entities utilizing the registry must be established in developing a registry. Compatibility is needed in the form of the information stored and the interface of hardware and software. The ability to link or interface with a wide variety of operating systems would also affect cross-state linkage registries if they were deemed to be necessary.
7. Public Awareness and Education
Public awareness and education campaigns related to organ and tissue donation are often tied to efforts to publicize a registry. State legislation affects the development of registries through public education in at least 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 targeted at various populations. The allocation of funds leading to 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 registries relies on public awareness programs, and as such they should be evaluated and funded to ensure an effective methodology and efficient use of resources. In addition, and under appropriate conditions regarding data security and applications, states can analyze data from registries to inform policy decisions regarding populations to target with educational outreach efforts.
8. Consent Issues
State legislation has not consistently established legal standards for the minimum threshold needed to establish informed consent. A number of states have taken actions to assure that the registry process is based on informed consent. Extensive donation training programs for DMV personnel to improve 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. Finally, to confirm donors wishes, two states send thank-you letters to registered donors soon after they are entered into the registry.
Some states have taken actions to increase the amount of background information that individuals receive before they decide to become registered donors. For example, some states present looped videos, pamphlets, and posters at DMV waiting rooms and licensing offices in order to enhance the awareness among a captive audience. DMV personnel may provide explanations regarding donation. However, these measures may not provide adequate or standardized information to meet legal or ethical standards of informed consent. Greater consistency in the information given to individuals in the donor registration process would enhance the strength of the advance directive. Standards for consistently informed consent would be important in interactions among states.
Most states offer the opportunity to donate when applying for a first drivers license, typically at 16 years of age. However, in most states the age at which individuals may legally consent to donation is 18 years. Individuals consequently make decisions about donation before the issue may be perceived as being relevant to them, and they may not have the opportunity to change their decision until the renewal of their license. The discordance among obtaining a drivers license, becoming a legal organ donor, and the drivers license renewal period may pose a barrier to consent.
9. Registries as Advance Directives
Some states have recently moved towards utilizing donor registries as legal documentation of donor intent, i.e., advance directives for donation. Ten have enacted or are in the process of enacting donor intent legislation. This legislation is written to eliminate the liability of hospital and procurement personnel who carry out the donors intent as documented in the registry, even when the next-of-kin deny consent. Donor intent legislation has the potential benefits of increasing the pool of potential donors (assuming that intent will be documented for some donors whose families would otherwise deny consent) and easing sometimes burdensome decision-making on the part of grieving families. Despite the increase in donor intent legislation, most procurement organizations continue to defer to family consent.
10. Evaluation
The common goal of evaluation of the registration 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, for example, by coding and tracking educational and awareness materials.
B. Relative Roles of State and Federal Governments
Registries operate predominantly at the state level. However, the federal government has played a role in donor registries through funding and other actions by HHS. With the Secretarys Gift of Life Donation Initiative and federal legislation pending in Congress, greater attention is being paid to possible federal options in the development and improvement of registries. National registry options cannot be considered outside of the context of existing state registries and state laws related to donation. The relative roles of state and federal governments can vary greatly. Exhibit 2 shows how the four pieces of federal legislation fit on a spectrum of state and federal involvement.
Exhibit 2: Spectrum of Federal/State Roles in Pending Federal Legislation
At one end of the spectrum, registries can exist under the purview of the states, with little federal involvement. Registry design and maintenance would be at the discretion of states, based on their needs and resources. Cooperation between or among states would be initiated of their own accord. The potential advantages of this model include the maintenance of state autonomy and the avoidance of duplicating state efforts in building a new national system. States with successful registries would not have to deal with any privacy issues related to releasing their data or give up control of their registries. Potential disadvantages of this model include a decreased opportunity to standardize nationally the data collection processes and procedures for informed consent, and less consistency in technical aspects of the registries. In addition, this may not encourage registry development among the approximately half of states that do not currently have donor registries unless federal funding were to be provided.
At the other end of the spectrum, the federal government would oversee a single centralized national registry. All legal and other processes would be established at the national level. The federal government or its contractor would collect, house, and maintain the registry information. State agencies would channel all donor information to a single centralized database. The single registry would preempt the need for state collaboration, because all states would, in effect, be using the same registry. Potential advantages of this model include greater uniformity in data collected and procedures for informed consent and greater accountability at a single site. Potential disadvantages include the dismantling of successful state efforts, considerable and ongoing resources that would need to be allocated by the federal government, and public concerns about privacy and uses of this information for purposes not directly related to organ and tissue donation.
The absence of cost-effectiveness studies on registry development and implementation at either the state or national levels hampers the ability to determine the relative desirability of each model. The two pending pieces of federal legislation that are directly relevant to donor registries, the Motor Donor Act (S. 788 and H.R. 2645) and the Donate Act (S. 1062), propose models that involve a national registry consisting of a formalized linkage of existing state registries. Both bills would make funds available for states to plan and implement registries. The Motor Donor Act establishes a national database combining state information, with a national on-line entry portal. This is a more centralized model when compared to the Donate Acts National Resource Center which would act as a clearinghouse linking state data. The Motor Donor Act, unlike the Donate Act, requires grant recipients registries to be coupled with the motor vehicle drivers license application and renewal process.
The Organ Donor Enhancement Act (H.R. 955) applies to a living donor registry. As such, many of the key registry elements discussed in this report (such as issues surrounding advance directives) do not apply in the same way given that registry information is utilized while the registrant is living and could presumably verify information.
National level registry actions would need to be cognizant of the challenges present when establishing a structure where smaller scale systems already exist. In particular, national efforts could interfere with state efforts and the investment of resources by OPOs and states to develop registries and build trust within communities. National efforts face practical challenges in the need to coordinate data from a variety of state jurisdictions along multiple parameters (e.g., technical capacity and types of data collected). In addition, national efforts would need to successfully assure the public that confidentiality of sensitive information would be maintained in a national database.
C. Next Steps
Several issues should be addressed when considering both state and national registries. Among them are: 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 advance directives, and detailing technical issues related to donor registries. These topics are outlined in greater detail below.
· Each registry needs to clearly define its major functions. Possible functions to consider could include, but are not limited to, providing information for the consent process, the use of registry information as an advance directive, increasing the number of donors implementing and evaluating the need for and effects of public awareness and education, and the collection and statistical analysis of registry data.
· There may be a need for a more comprehensive consideration of the legal and ethical aspects of using a unilateral advance directive (consent to donate) or bilateral advance directive (consent or decline to donate). For example, if it is determined that a positive designation for a valid donor constitutes a binding advance directive, then should the negative designation be clearly and consistently interpreted as well? This may be a particularly important issue in view of recent donor intent legislation.
· Further study and legislation, as appropriate, may need to 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. The states that have passed donor intent legislation could be studied to determine the degree to which registry documentation is actually used as an advance directive.
· Additional efforts might be made to establish programs designed to promote coordination among primary care physicians, lawyers, hospitals, OPOs, and other entities and individuals relevant to facilitating the effective use of donor registries.
· Actions to standardize (on a statewide or nationwide basis) and legally verify consent documentation might lessen the liability of hospital and procurement personnel carrying out advance directives.
· Development, modification, and standardization of donor registries have potentially substantial cost burdens. However, this issue has yet to be carefully studied.
·
Consensus
does not exist in the procurement community regarding the contents of donor
registry databases. Further
clarification of what should be included in these databases may be needed.
· Further examination is needed on issues such as the information submitted to the registry at enrollment; entry portals for registry enrollment; education for motor vehicle administration employees and the public; access to registry information; funding and legislative support for registries; and methods of evaluating the effectiveness of registries.
VII. REFERENCES
Beasley, CL, Capossela CL, Brigham LE, Gunderson S, Weber P, Gortmaker
SL. The impact of a comprehensive, hospital-focused intervention to increase
organ donation. J Transplant Coord. 1997;7:6-13.
The Gallup Organization. The American publics attitudes toward organ
donation and transplantation. Boston, MA:
The Partnership for Organ Donation Inc; 1993.
Gortmaker SL, Beasley CL, Sheehy E, et al. Improving the request
process to increase family consent for organ donation. J Transplant Coord.
1998;8:210-217.
The Lewin Group. Analysis of
State Actions Regarding Donor Registries. January 4, 2000. Contract
HHS-100-97-0012. Available at:
http://aspe.hhs.gov/health/orgdonor/state%20organ%20donor%20registries.htm.
National Attorneys'
Committee for Transplant Awareness.
Organ and Tissue Donation and Transplantation: A Legal Perspective. TransWeb.
1995. Available at:
http://www.transweb.org/reference/articles/donation/nacta.html.
Rothouse M, Kaiser E. Organ and Tissue Donation Issue Brief. June 24, 1999 update. National Conference of State Legislatures.
Siminoff LA, Arnold RM,
Caplan AL, Virgnig VA, Seltzer DL. Public policy governing organ and tissue
procurement in the United States. Ann
Intern Med. 1995;123:10-17.
Siminoff LA, Gordon N,
Hewlett J, Arnold RM. Factors influencing families consent for donation of solid
organs for transplantation. JAMA. 2001;286(1):71-77.
U.S. Department of Health
and Human Services. HHS Grants Will Expand Study of Strategies to Increase
Organ and Tissue Donation. News Release. October 3, 2001.
U.S. Department of Health
and Human Services. Total Organ Donations Rise More Than 5 Percent in
2000;Cadaveric Donation Increases 2.7 Percent Newsroom releases. April 16,
2001.
Wright DH. Survey Report: Advance Directives and Donor Card Effectiveness. UNOS.
1998. Available at: http://www.unos.org/Newsroom/archive_other_survey_coadonorcard.htm.