Realizing the Promise of Equity in the Organ Transplantation System (2022) / Chapter Skim
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2 The U.S. Organ Transplantation System and Opportunities for Improvement
2 The U.S. Organ Transplantation System and Opportunities for Improvement
Pages 35-60
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From page 35... ...
. With dialysis serving as a lifeboat for those awaiting transplantation and the advent of immune suppression agents to prevent organ rejection, kidney transplant operations became more commonplace by the 1960s, but donor organ procurement was primarily hospital based.
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From page 36... ...
In 1983, the growing demand for organ transplantation, controversies regarding the allocation of organs, and concerns about payment for organs prompted members of Congress to propose the creation of a formal, privately administered network to more effectively procure and equitably allocate deceased donor organs. This proposal became the National Organ Transplant Act (NOTA)
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From page 37... ...
, samples of blood sera from individuals who are included on the list and whose immune system makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such individuals with organ donors; 7. Coordinate, as appropriate, the transportation of organs from organ procurement organiza tions to transplant centers; 8.
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From page 38... ...
, issued a Notice of Proposed Rulemaking for a regulation governing the operation of the OPTN. Although the public comment period was supposed to end in December 1994, the department continued to accept comments on the OPTN's operations and its policies for allocating organs.6 Two years later, in November 1996, the department officially extended the period for public comment on the proposed rule, due to controversy over revisions in the liver allocation policies being proposed by the OPTN's board.7 Even after HRSA published the OPTN Final Rule on April 2, 1998,8 Congress twice delayed its going into effect.9 HRSA finally implemented the Final Rule on March 6, 2000.10 The OPTN board is composed of transplant physicians, recipients, candidates, family members, deceased donor families, recipient families, living donors, transplant hospitals, OPO representatives, and members of the public who are organized into various committees that are delegated with policy-making authority.
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From page 39... ...
The OPTN's oversight responsibilities include solid organ donation and transplantation from deceased donors, but also include ancillary activities on living organ donation. UNOS, a nonprofit, private voluntary organization, holds the subcontract for the OPTN and has been the sole administrator of the OPTN since the initial contract was awarded by HRSA in 1986.13 Oversight for the OPTN contract is provided by the Division of Transplantation (DoT)
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From page 40... ...
has advised the HHS secretary on (1) enhancing organ donation, (2)
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From page 41... ...
. In April 2003, then HHS Secretary Tommy Thompson joined with national leaders from the Institute for Healthcare Improvement, the American Society for Minority Health and Transplant Professionals, the Association of Organ Procurement Organizations, and others to formally commit to achieving an ambitious target of a 75 percent organ donation rate in the nation's 500 largest hospitals through a Contract for Results.
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From page 42... ...
HHS continued various forms of recognition for increased organ donation and transplantation yield through at least 2009. As part of this same quality improvement effort, in January 2004 HHS set an additional national goal, increasing the proportion of deceased donors whose deaths have been determined based on loss of circulatory function to 10 percent of the total.
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From page 43... ...
Conclusion 2-3: Since deceased donor organs are a national resource, the fairest way to allocate them to patients on the waiting list is on a national, continuous basis, in accordance with the OPTN Final Rule 2000 as most recently revised by HHS. The committee recognizes that some members of the transplant community feel strongly that deceased donor organs procured in a particular geographic area should be retained for allocation to wait-listed patients in that area.
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From page 44... ...
In particular, increase DCDD donors to at least 45 percent of all deceased donors, with no reductions in the numbers of organs procured from donors from neuro logical determination of death. ° Improve offer acceptance levels for each organ type to those achieved by the 5 to 10 percent highest-performing transplant centers for that organ type nationally.
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From page 45... ...
The sponsoring committee reviews the public comments, revises the proposal if needed (which may be subject to another round of public comments) , and then votes on whether to send the policy proposal to the Board.16 The Board considers the committees' recommended policy proposals, and receives input from Board policy groups, which are subgroups of the Board that provide initial review as part of the Board review process, consisting of stakeholders representing transplant programs, OPOs, living donors, donor families, and members with specific policyrelevant competencies.
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From page 46... ...
Recently, this already lengthy process has been further exacerbated by litigation.17 The steps in the OPTN policy-making process are also complex and variable in the time allotted for public comment periods, as well as the overall time taken from committee project approval to OPTN board approval. For example, a federal study of the similarities and differences in the processes the OPTN used to change the liver and lung allocation policies revealed variations in public comment periods for informing the policy development process.
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From page 47... ...
SOURCE: "OPTN Contract Requirement 3.3.2.: Policy Development Process Metrics – Metric 9: Average Time from Committee Project Approval to Board Approval." OPTN Policy Oversight Committee Chair Report to the OPTN Board of Directors. 6 December 2021.
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From page 48... ...
DECEASED DONOR ORGAN USE AND ECONOMICS TODAY19 This section briefly summarizes data and trends pertaining to deceased donor organ use that are relevant to the committee's charge, including statistics on wait-listing (see Table 2-1) , deceased organ donation, transplantation, and resource use metrics such as initial hospital length of stay and hospital readmission rates.
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From page 49... ...
Total waiting list candidates are 106,557; organ totals are less than the sum because of patients in multiple categories. Living donor and deceased donor organ transplants are totals for 2021.
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Most VCA organs are donated by deceased donors; however, uterus donors may also be living donors. The field of VCA is growing.
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From page 51... ...
HCV-positive donor organs have continued to increase since 2008, representing 9.7 percent of deceased donor livers in 2019. Both the number of new waiting list registrations and the number of transplants performed have been on the rise, while both the median waiting time for candidates with a Model for End-Stage Liver Disease (MELD)
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From page 52... ...
Around 3,600 heart transplants were performed in 2019 -- a slight increase over the previous year -- but the number of candidates on the waiting list continued to increase.23 The number of donor hearts increased by almost 64 percent between 2008 and 2019, when the number reached an all-time peak. The nonuse rate for deceased donor hearts was less than 1 percent, the lowest of all organs, although this rate has fluctuated over the past decade.
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From page 53... ...
or deceased donor kidney transplantation (DDKT) experience significantly longer expected survival than ESKD patients who receive dialysis therapy in terms of derived QALYs: 10 years with dialysis therapy, 4.03 QALYs; LDKT (human leukocyte antigen [HLA]
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From page 54... ...
. Being on a waiting list with possible deceased donor liver transplant (DDLT)
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From page 55... ...
With that in mind, the goal is to create a fairer, more equitable, cost-effective, and transparent system of donor organ procurement, allocation, and distribution. One successful model for health care systems operationalizing and upscaling innovations is the Veterans Health Administration's Innovation Ecosystem (VHA IE)
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From page 56... ...
Of course, the complexities of the United States organ procurement and transplant enterprise are not the only challenges to innovative practice implementation and change. External pressures from a variety of professional, political, health care, insurance, and patient advocacy groups will likely present opposition to some suggested changes; these entities may also have their own agendas and recommendations.
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From page 57... ...
. Quality improvement lessons from health care and applications to the United States organ donation and transplantation system.
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From page 58... ...
2022. All-time records again set in 2021 for organ transplants, organ donation from deceased donors.
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From page 59... ...
2006. Organ donation breakthrough collaborative: Increasing organ donation through system redesign.
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