Transplant Statistics: Annual Report

APPENDIX B

History of the Organ Procurement and Transplantation Network (OPTN)
and the Scientific Registry of Transplant Recipients (SRTR)

LEGISLATIVE HISTORY OF THE OPTN AND THE SRTR

By the early 1980s, organ transplantation had brought renewed hope to thousands of people suffering from diseases of the heart, liver, kidneys, lungs, and other organs. Nevertheless, many patients were having difficulties obtaining transplants, leading some to seek assistance through media coverage. During 1983 and 1984, issues related to human organ transplantation were widely publicized. As the issues drew congressional attention, it soon became clear that a more comprehensive solution to transplantation-related problems was necessary. In October 1984, Congress passed PL 98-507, known as The National Organ Transplant Act (NOTA), which among other things, provided for the establishment of a Task Force on Organ Procurement and Transplantation, an Organ Procurement and Transplantation Network, and a scientific registry of the recipients of organ transplants.

As required by law, the Secretary of Health and Human Services assembled a 25-member Task Force to conduct comprehensive studies of the medical, legal, ethical, economic, and social issues relevant to human organ transplantation. To study these issues, experts in medicine, immunology, law, theology, ethics, allied health, the health insurance industry, and public advocacy were joined by representatives of the Office of the Surgeon General of the Public Health Service, the National Institutes of Health, the Food and Drug Administration, the former Health Care Financing Administration (now the Centers for Medicare and Medicaid Services), and staff from the Health Resources and Services Administration (HRSA).

Upon completion of the Task Force report, HRSA issued, in the fall of 1986, a request for proposals to establish a National Organ Procurement and Transplantation Network (OPTN) under NOTA. Also in 1986, the same year that NOTA was established, new legislation (Omnibus Budget Reconciliation Act, PL 99-509) mandated that, as a condition of participation in the Federal Medicare/Medicaid programs, Organ Procurement Organizations (OPOs) and transplant hospitals must be members of the OPTN.

On September 30, 1986, the United Network for Organ Sharing (UNOS) was awarded the OPTN contract. The SRTR contract was awarded to UNOS a year later on September 30, 1987. Provisions of NOTA were amended in 1988 and 1990, including expansion of OPTN responsibilities to increase the donor organ supply and assist OPOs in nationwide placement of organs not placed locally. Both the OPTN and SRTR contracts were competitively renewed with UNOS without interruption through December 1996 (contract terms ending September 30, 2000). In September 2000 UNOS was again awarded the OPTN contract; the SRTR contract was awarded to University Renal Research and Education Association (URREA), in collaboration with the University of Michigan.

CURRENT ROLE OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Division of Transplantation (DoT), a division of HRSA within the United States Department of Health and Human Services (HHS), administers the OPTN and SRTR contracts. Under the terms of each contract, UNOS and URREA conduct numerous tasks and projects to meet the Federally established goals of the OPTN and the SRTR, respectively. These projects include the annual data report, an Internet-based report of center-specific graft and patient survival rates, and the data request system. Written reports on the progress and completion of these tasks are provided regularly to the HRSA Project Officer and the Director of the DoT. Representatives of the DoT serve as ex-officio, non-voting members of the OPTN/UNOS Board of Directors and committees, and the SRTR Scientific Advisory Committee (SAC) and SAC subcommittees.

On April 2, 1998, HHS published in the Federal Register a final rule for operation of the OPTN, with opportunity for public comment. This rule, as amended on July 1, 1998; October 20, 1999; and December 21, 1999; became effective on March 16, 2000. It establishes requirements and procedures for operation of the OPTN, including membership in the OPTN, listing transplant candidates on a nationwide computer network, allocating organs, and maintaining records and reporting by member OPOs and transplant hospitals.

PURPOSE OF THE OPTN

From the inception of the OPTN, its purpose has been to improve the effectiveness of the nation's organ procurement, distribution, and transplantation system by increasing the availability of, and access to, donor organs for patients with end-stage organ failure. More specifically, the OPTN is responsible for functions such as establishing and maintaining a data collection system to facilitate the operation of the organ matching and allocation process by:

• Conducting research on solid organ transplantation issues to improve the state-of-the art;
• Evaluating organ transplant program effectiveness in prolonging and improving the quality of life for transplant patients; and
• Disseminating this information for use by patients and their families, physicians, payers, researchers, and other interested stakeholders.

In order to operate the OPTN, UNOS has adopted corporate by-laws and policies governing membership standards, organ procurement, organ allocation, and data management. The Secretary of HHS has reviewed these policies and by-laws. The OPTN final rule establishes the framework for additional review and oversight of OPTN policies and by-laws by the Secretary, leading to OPTN requirements that will be enforceable under the Social Security Act.

PURPOSE OF THE SRTR

The purpose of the SRTR is to support an ongoing evaluation of the scientific and clinical status of solid organ transplantation in the U.S. The SRTR is responsible for conducting inferential statistical analyses of transplantation data in support of the OPTN, HHS, the Secretary's Advisory Committee on Organ Transplantation, and other interested parties. The results of this research will:

• Support the OPTN in developing organ allocation and other policies;
• Support the analysis of transplant program, OPO, and other OPTN member performance;
• Provide information useful in transplantation decision-making by medical professionals, transplant candidates, recipients, donors, their families, and the general public;
• Support investigative efforts by payers of transplant services, researchers, and other interested parties; and
• Support the development of computer simulation (modeling) of alternative organ allocation systems.

PURPOSE OF THE OPTN DATABASE

As of October 1, 2000, all data collection is performed under the OPTN contract. The specific goals articulated in the Task Force on Organ Transplantation recommendations, the NOTA, and the HRSA contract are as follows:

• To collect, in a computer system, data on all transplant recipients and all transplant programs in the U.S.
• To provide a database that enables regular periodic analysis and reporting on the efficacy of transplantation nationwide.
• To provide a national database for basic and clinical research on organ transplantation.

The OPTN database consists of data about donors, waiting list patients, and information pertinent to organ allocation, as well as posttransplant recipient data, from the time of transplant until graft failure or recipient death, whichever comes first. Using OPTN organ-specific data collection forms (see Appendix G), transplant recipient data are collected, processed, and validated. Validated data are entered into the OPTN database. Data collected include comprehensive medical and histocompatibility information about donors, registrants, and recipients, as well as graft and patient survival information.

Subject to disclosure restrictions under various statutory and regulatory policies, data collected and generated by the OPTN are available to members of the OPTN, the Board of Directors and committees serving the OPTN, UNOS and URREA staff, the medical community, government officials, private organizations, and the general public. The data have been used in a variety of ways, perhaps the most important of which is to serve as the basis for the development of transplantation policies. With the aid of accurate and timely information about previous transplants and their outcomes, the transplant community can identify specific factors that balance the number of transplants, graft survival, and other measures of both medical utility and justice in organ allocation. Examples of specific issues that can be addressed with the aid of OPTN data are:

• The impact of HLA matching on transplant outcomes.
• The impact of various organ preservation methods on outcomes.
• The impact of various donor characteristics (e.g., age, cause of death, medical history) on outcomes.
• Differential waiting times, transplant rates, and outcomes among racial, ethnic, gender, and age groups.
• Differential risk-adjusted patient/graft survival rates among transplant programs.
• The risk-adjusted probabilities of receiving a transplant or dying while waiting for a transplant.

TASKS REQUIRED IN THE 2000 OPTN AND SRTR CONTRACTS

Under the terms of the most recent (2000) OPTN and SRTR contracts administered by HRSA, UNOS and URREA conduct a number of tasks to meet Federally established goals of the OPTN and the SRTR.

Tasks required by the OPTN contract include:

• Electing a Board of Directors composed of representatives from the transplant community; transplant candidates, transplant recipients, organ donors, and family members; voluntary health organizations; and public members.
• Establishing and maintaining a committee system with diverse representation to develop OPTN policy.
• Operating and maintaining a national computer list of patients waiting for kidney, pancreas, kidney-pancreas, liver, intestine, heart, lung, and heart-lung organ transplants.
• Developing and maintaining a computer-based organ allocation system and an Organ Center, which allows 24-hour transplant program access to the donor/recipient matching system.
• Collecting data as required and necessary to operate the computer-based matching system.
• Maintaining a data system that can be used as a resource by the Government and other interested parties. The data pertain to patients waiting for transplants, donors and recipients of donated organs, donor/recipient matching and organ allocation, and donor/recipient histocompatibility. The system contains medical and demographic information about every transplant recipient transplanted since October 1, 1987, from the time of transplant until the time of graft failure or patient death, whichever comes first.

Tasks required by the SRTR contract include:

• Producing an internet-based report of transplant institution-specific outcomes data.
• Preparing a biennial report to Congress on the scientific and clinical status of organ transplantation in the United States.
• Establishing and maintaining the Scientific Advisory Committee and the Post-Transplant Tumor Registry Transplant Advisory Committee.
• Responding to requests for data from committees serving the OPTN, HRSA, and the general public.
• Performing special studies as requested by HRSA.

Required under both contracts are:

• Preparing the Annual Data Report, and
• Developing and managing the Data Working Group, which makes recommendations on data collection processes and new data to be collected by the OPTN.