Guidelines for
Donor Registry Development Conference Final Report
August, 2002 (Second Revision)
Table of Contents
Introduction
Organ, tissue, and eye donation has emerged over the last decade
as a public health imperative in the United States. In 2001, more
than 6,000 patients who were wait-listed for organ transplantation
died waiting. From 1995 to 2000, the number of patients waiting
for organ transplantation increased by 80 percent, while the number
of cadaveric donors grew by less than 12 percent. In 2001, cadaveric
donors totaled 6,081, an increase of 1.7 percent from 2000, and
resulted in the recovery of 21,920 organs. So severe is the shortage
that, today, more than 79,000 people remain on the national transplant
waiting list for a kidney, liver, heart, lung, pancreas, or intestine.
Recognizing that cadaveric donation is still the most promising
source of donation, the Department of Health and Human Services
(HHS) has been engaged in efforts to educate the public and raise
awareness on donation in order to address the shortage of donor
organs, tissue, and eyes.
One means of narrowing the gap between the demand and supply of
organs, tissue, and eyes is through the use of donor registries.
With 20 states already having operational donor registries, and
with several organ registry bills pending in Congress, there is
considerable interest on the part of both HHS and Congress to examine
the potential effectiveness and practical aspects of establishing
and operating donor registries. On November 29th and
30th, 2001, as part of the Secretary's Gift of Life Donation
Initiative, the Health Resources and Services Administration (HRSA),
Office of Special Program (OSP), Division of Transplantation (DoT)
convened a national forum on donor registries, providing a timely
opportunity to gather and assess information regarding donor registries
from various representatives from the transplant and donation communities
and from state and federal government agencies.
The conference spanned two days. On Day 1, Secretary Tommy Thompson
provided opening remarks, reinforcing the conference goals, which
were to develop guidelines for successful donor registries; recommend
options for a federal role in facilitating effective donor registries;
identify strategies to promote commitment and involvement among
government entities, organ procurement agencies, and tissue and
eye banks; and inform ongoing policy making regarding donation.
The Secretary offered registries as a potential tool to increase
donation, highlighting potentially beneficial and tangible outcomes
such as ensuring that donor's wishes are carried out and providing
an electronic database that is readily accessible within and across
states. The rest of Day 1 focused on developing guidelines and identifying
other key aspects pertaining to successful donor registries. Day
2 focused on the anticipated effectiveness and implications of pending
federal donor registry legislation.
Day 1 Findings
Prior to six facilitated working groups to discuss various issues
related to donor registries, key issues and challenges of donor
registries were highlighted by Tracy Schmidt, Chairperson of the
Association of Organ Procurement Organizations (AOPO) Donor Registry
Task Force, Lori Darr of the Missouri Department of Health and Missouri
Organ Donor Program, and Russ Hereford, Project Leader of the HHS
Office of Inspector General (OIG) Office of Evaluations and Inspections.
The three presenters concurred that donor registries need to be
uniform, accurate, readily accessible, and cost-effective. Mr. Schmidt
and Ms. Darr were in support of registry development, citing recent
technological advances, the current political interest in registries,
and their role in facilitating the consent process as contributing
factors.
Russ Hereford made comments based on the OIG study on donor registries.
Mr. Hereford noted that there is little evidence to date for the
impact of registries to yield organ donors. Further, information
exchange among OPOs and bilateral agreements among states with registries
might diminish the apparent need for a national registry. Mr. Hereford
noted the need for more public education and stressed that registries
are one of many tools that may increase donation. The topics for
each of the six working groups and their main recommendations are
as follows.
Working Group 1: Information at Registry Enrollment
This group examined the types of information that should be collected
for each participant in a registry. Points to consider in examining
this topic included that effectiveness of a registry is largely
dependent on the information collected, and registry data can enhance
the registry's potential use for outreach and evaluation activities.
The group's recommendations are as follows.
- Three main identified uses of registry data include: 1) verification
of decedent's identity, 2) data collection for evaluation, awareness,
and education outreach, and 3) registry maintenance.
- The minimum core data elements are: first and last name, date
of birth, and Social Security or driver's license number. Time
and resources permitting, additional information would include
demographic and physical characteristics, contact information,
and specification of what the registrant intended to donate and
for what purposes.
- Due to variation in legislation, regulation, and interpretation
of legally binding consent, the group did not reach consensus
on what data would best ensure informed consent.
- Only posthumous donors should be included in a state donor registry.
Though important, living donation and anatomical and medical research
donation should be considered separately.
- Registries must allow for voluntary disenrollment of registrants
and removal of those who are deceased or moved out of state.
Working Group 2: Portals of Entry
This group focused on portals of entry for registry enrollees.
Points to consider were the role of state department of motor vehicles
(DMV) as the primary portal of entry and need for coordination for
multiple portals. The group's main findings and recommendations
are as follows.
- Characteristics of an effective portal include: easy public
access, validation of data at time of enrollment and follow-up,
and ease of ongoing maintenance for the registry gatekeeper, which
is the entity responsible for the operation, maintenance, and
security of the registry
- Decoupling the portal role from that of the gatekeeper role
might help to alleviate the numerous responsibilities that come
with being responsible for both.
- Once a portal has been established, public awareness and education
are essential for the registry's success.
- Due to variation among portals, linkages across states vary
and hinder more formal linkage.
Working Group 3: Training DMV Employees and
the Public
Group 3 discussed the role of the DMV in the donor registry process.
Understanding that donor registration is not the primary role of
the DMV or the area of expertise of DMV staff, participants acknowledged
the DMV as the primary portal and provided the following recommendations
to ensure that sufficient training and adequate resources are provided
to better reconcile the needs of the donation community within the
DMV environment.
Expectations of DMV staff must be considered given the importance
of their role in the donation process vis-a-vis their primary duties,
responsibilities, and existing human resource and procedural constraints.
Develop effective strategies for preparing DMV staff and increasing
their appreciation and understanding of donation issues.
Working Group 4: Registry Access
This group focused on multiple issues related to registry access.
Recommendations included the following.
Access to registry information should only be provided in order
to facilitate the donation process as well as for outreach and educational
activities.
Besides the gatekeeper and the necessary procurement personnel,
access to the donor registry should be restricted in order to ensure
privacy and the public's trust.
Data elements that are necessary to verify the identity of the
donor should be accessible at all times, across states.
Working Group 5: Funding and Legislative Support
for Registries
Group 5 discussed registry issues related to funding and legislative
support and made the following points.
More research needs to be conducted to adequately address the costs
involved with registry development, and more information needs to
be shared among states on the start-up and operating costs of registries.
Regardless of registry costs, the group stressed that more federal
and state funding is needed to supplement funding already secured
through innovative mechanisms.
For any donor registry legislation to be successful, it must promote
and facilitate communication among states, OPOs, and tissue banks
as well as other stakeholders. Continued involvement is needed of
HHS, states, and the donation community in promoting and educating
organ donation.
Working Group 6: Evaluating Registries
This group focused on evaluating the effectiveness and impact of
donor registries and the effect of evaluation on strengthening existing
registries and increasing support for donor registries in states
where they do not exist. The group made the following recommendations.
- Evaluation needs to be tailored to registry type given the variability
that exists among registries.
- Structural, process, and outcome measures are required to evaluate
registry effectiveness in the short-term, intermediate term, and
long-term basis.
- Evaluation findings for registries can be used to support education,
outreach, and marketing efforts.
- To ensure that registries' evaluation data are current and useful,
various state agencies should cross reference or share data with
each other as well as have access to any outcome data.
Day 2 Findings
Day 2 focused on the main attributes and implications of four pending
bills in Congress, including: The Motor Donor Act (S. 788 and H.R.
2645), The Donate Act (S. 1062), The Organ Donor Enhancement Act
(H.R. 955), and The Organ Donation Improvement Act of 2001 (H.R.
624). (A fifth bill, The Organ Donation and Recovery Improvement
Act [S. 1949], was introduced following the conference.) Prior to
three facilitated breakout sessions, favorable and unfavorable attributes
of the four bills were discussed by three panelists representing
the perspectives of private registries, OPOs, and states: John Eiche
of the of the Living Bank, Louise Jacobbi of Saturn Management Systems,
and Antigone Klima of the Transplantation Society of Michigan. The
group concurred that merits of all the bills included their focus
on registry development and enhancement, promotion of linkage, inclusion
and recognition of public education and awareness, and provisions
ensuring immediate access, security, and confidentiality of registries.
Components of the bills identified as needing further development
or refinement included: the need to involve states without registries,
more details on how registries would be linked, better definition
of the HHS role, additional details on funding to implement various
provisions, and lack of first-person consent (i.e., where donor
designation is accepted as legally binding consent).
Though conference participants lauded both The Organ Donor Enhancement
Act and The Organ Donation Improvement Act of 2001 for addressing
and promoting organ and tissue donation, discussion regarding the
attributes and implications of legislation primarily centered on
the more detailed bills, The Donate Act and The Motor Donor Act.
The Donate Act was considered by conference participants to be
the most comprehensive bill of the four presented. Key favorable
attributes contributing to its near unanimous support by conference
participants were the bill's emphasis on the state's role in developing
registries with federal support in selected functions and on an
evaluation component for registries. Additional favorable aspects
include its provision for uniform consensus guidelines on consent,
privacy, and data exchange protocols.
Key favorable attributes noted by conference participants for The
Motor Donor Act were its provisions for a federal framework for
registry development, allowance for people who reside in states
without registries to sign up via a website (allowing for voluntary
exit and notification regarding registry participation), designation
of a minimum data set, and building upon existing infrastructure
through the use of DMV as the primary portal. However, the latter
point was also viewed as an unfavorable attribute, as it ignores
other portals that may serve to widen access.
In discussing various issues related to donor registries, including
pending legislation, four issues arose repeatedly. The first issue
concerns the importance of distinguishing between registries of
consent and intent to donate as this affects the purpose and role
of the registry. The second issue relates to the importance of registry-related
education and public awareness activities so that the registry is
not only an information resource, but also a functional, cost-effective
tool for education and outreach. The third issue pertains to the
need for greater coordination in the organ and tissue donation community
so as to facilitate intra-community communication for exchange of
information and experiences regarding donor registries. The last
issue addresses the need for more research and evaluation.
The conference concluded with a plenary session devoted to developing
eight themes and strategies for implementing successful donor registries.
They are as follows:
- Make organ donation a public health imperative.
Given the unacceptable gap between the availability of and the
need for organs, organ donation must be elevated to the level
of a public health imperative. This does not mean that all U.S.
residents should be obliged to become organ donors. It does mean
that every reasonable effort should be made to provide well-informed,
readily accessible opportunities for people who choose to be donors
to register as such, for families who choose to provide consent
to do so when their consent is required to proceed with donation,
and for the donation community to fulfill these designations.
- Clarify consent versus intent. The
concept of consent vs. intent to donate must be clarified, not
only for the public, but so that hospitals, OPOs, families, and
others involved in the donation process can comply with the designation
made by the donor. The absence of such clarification may limit
significant improvement in public confidence in the organ donation
process and in donation rates.
- Retain and respect state autonomy.
Continued development and successful operation of donor registries
will depend upon maintaining and promoting state-level donor registries.
States will continue to build practical and diverse experience
with registries, contributing to the knowledge base of what works
in donor registries and enhancing information exchange and other
productive linkages across states.
- Do not establish a national registry at this time.
A national registry, particularly one that supersedes or interferes
with state registry efforts, is not necessary at this time. However,
this does not preclude national efforts or selective federal involvement
in facilitating state registries, their interaction, and other
aspects of registry enhancements.
- Define the federal role. There exists
a need to define the national role in terms of such key aspects
as public awareness and education, readily accessible portals
of entry, linkages among states, research and demonstrations,
and evaluation of registries.
- Minimize public confusion. More education
and coordinated efforts are needed to clarify consent vs. intent
to donate, explain the donation process and registry participation,
and dispel myths about donation. These and other aspects of public
confusion pose significant barriers to donation.
- Provide opportunities for the public to register.
The public must have readily accessible, informed opportunities
to register as donors. The diverse means of registering among
states should provide a basis for identifying effective means
of access. Registration opportunities may be expanded via creation
of linkages between states with and without registries, and by
a national portal for accessing existing registries, as appropriate.
- Ongoing evaluation and accountability of registries.
Ongoing evaluation is necessary for understanding what works and
what does not for improving the effectiveness of registries. Further,
evaluation is needed to ensure that registries are accountable
to their purposes and to their stakeholders, including registrants,
families, procurement organizations, health care providers, and
the public.
Roles and Responsibilities
Policy makers and other stakeholders can assume certain roles and
responsibilities toward successful implementation of these strategies.
These include, but are not limited to, the following.
The Secretary of HHS can:
- Continue to promote donation as a public health issue;
- Help to clarify or explain existing federal laws and regulations
pertaining to organ procurement (including donation) and transplantation,
and the intent or implications of relevant proposed laws and regulations;
- Request an Institute of Medicine (IOM) study to explore the
ethical, legal, and practical issues surrounding registries of
consent and intent;
- Emphasize the need to respect and build upon, rather than supersede,
the principal role of states;
- Clarify that the role of registries in strengthening donation
does not require a national registry;
- With the advice of the Advisory Committee on Organ Transplantation
(ACOT) and other expert sources, determine the most effective
federal role in donor registries;
- Call for readily accessible, informed opportunities for registering
as a donor; and
- Insist that donation-enhancing efforts, including registries,
be subject to ongoing, objective evaluation and accountability.
The Congress can:
- Enact legislation and provide adequate funding to develop and
support the donation initiative;
- Recognize the principal role of states in the context of future
legislation and related funding regarding donation;
- Provide incentives for states to establish new registries and
enhance access to existing ones;
- Enact legislation and provide adequate funding for selective
federal involvement, but not a national registry; and
- Tie support for organ donation efforts, including registries,
to requirements for evaluation and accountability.
State governments, including governors, legislatures, and legislative
organizations, can:
- Promote donation in their state and linkages with other states;
- Promote their own state registries and facilitate relationships
with states that have yet to develop registries;
- Periodically evaluate and upgrade accessibility to their registries;
and
- Contribute to an appropriate federal role by providing input,
communicating with relevant stakeholders, and committing to partnerships
across agencies and with the federal government.
Donation and recovery organizations, including organ, tissue, and
eye agencies, registries, AOPO, American Association of Tissue Banks
(AATB), Eye Bank Association of America (EBAA), and others can:
- Educate the public on the importance of donation and these organizations'
respective roles in donation;
- Increase public awareness of the importance of consent vs. intent
to donate;
- Provide input to the IOM for a study of the issue of consent
vs. intent to donate; and
- Help to delineate aspects of donation most suited to federal
involvement.
Other stakeholders:
The National Governors Association, transplant centers, and others
can promote the message to retain and respect the principal role
of states.
State agencies (including DMVs and departments of health and education),
voluntary health agencies, consumer organizations, and professional
associations can support public awareness about how to register
as a donor.
U.S. Department of Health and Human Services
Health Resources and Services Administration
Office of Special Programs, Division of Transplantation
Contract HHS-GS-23F-9840H
Delivery Order No. 3
Prepared By: The Lewin Group, Inc. August, 2002 (Second Revision)
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