Realizing the Promise of Equity in the Organ Transplantation System (2022) / Chapter Skim
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6 Improving Procurement, Acceptance, and Use of Deceased Donor Organs
6 Improving Procurement, Acceptance, and Use of Deceased Donor Organs
Pages 153-198
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From page 153... ...
After analyzing the performance of the organ transplantation and donation system -- and OPOs and transplant centers in particular -- and reviewing the scientific literature and publicly available data, the committee found that the current organ transplantation system, similar to other systems, is perfectly designed to achieve the results it gets (Berwick, 1996; IOM, 2006)
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From page 154... ...
donors,1 and (2) transplant centers accepting and using more of the deceased donor organs offered to individuals on the waiting list.
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From page 155... ...
Therefore, organ donation is most closely linked to OPO performance, but the use of organs by transplant centers creates an interconnectedness between OPO and transplant center behaviors. For instance, the willingness of transplant centers to accept different types of organs has often driven OPO practices of pursuing medically complex, older, or DCDD donors.
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From page 156... ...
One area of particular relevance to this report is the reliance on death certificate data for the donation rate measure. In theory, death certificate data could be considered independent of bias, as it is not self-reported by OPOs, and able to provide a larger picture of the number of potential deceased donors.
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From page 157... ...
Death that is consistent with organ donation means all deaths from the state death certificates with the primary cause of death listed as the ICD–10–CM codes I20–I25 (ischemic heart disease) and I60–I69 (cerebrovascular disease)
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From page 158... ...
The committee believes that the organ transplantation system's consideration of these issues should be informed by the experience of organizations such as the National Quality Forum that have demonstrated specific expertise in evaluating performance metrics across complex systems. Box 6-2 provides the committee's rationale for an integrated and holistic approach to the measurement and assessment of OPO performance.
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From page 159... ...
Historical Perspective Early transplant programs obtained organs either from healthy, living, related donors or from deceased donors who were declared dead by cardiopulmonary criteria. A determination of death by neurological criteria, although a legal option in the sense that state laws allowed clinicians to make determinations of death according to their own practice and custom, was not generally accepted historically as clinicians were reluctant to pronounce death in a patient who had continued heart function.
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From page 160... ...
The committee did not conduct an in-depth analysis of these issues, but notes that under current regulatory and ethical regimes, there exists an opportunity to continue and support the upward trend of DCDD organ procurement and transplantation. Current State of DCDD Donation and Transplantation Since DCDD donation has been tracked by the OPTN, the consistent pursuit of DCDD donors and use by transplant centers began to systematically increase in 2004, precipitated by the Organ Donation and Transplantation Breakthrough Collaborative (Figure 6-1)
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From page 161... ...
. Figure 6-3 shows the considerable variation in the proportion of DCDD donors procured at each of the 57 OPOs in 2021,5 from a low of 11 percent to a high of 53 percent of all deceased donors within the OPO.
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From page 162... ...
. Special Considerations of DCDD Organs Outcomes following transplantation with organs from DCDD donors are much improved when compared to remaining on the transplant waiting list without access to an organ.
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From page 163... ...
. Not only are transplant costs of care higher, there can also be higher costs for both OPOs and transplant centers in pursuit of DCDD donors.
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From page 164... ...
At the April 16, 2021 public webinar International Examples of Organ Procurement, Allocation, & Distribution,7 Axel Rahmel, of Deutsche Stiftung Organ Transplantation, presented Lessons from Eurotransplant and described a successful "old for old" program where donors above 65 are preferentially allocated to recipients above 65; additionally, Beatriz Domínguez-Gil, of Organización Nacional de Trasplantes, presented data on the average age of deceased donors in Spain, with more than 50 percent over age 60, more than 30 percent over age 70, and more than 9 percent over age 80 (see section on international lessons learned for more information)
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From page 165... ...
Lessons from International Deceased Donor Organ Transplantation Systems There are potential lessons to be gleaned from international deceased donor organ transplantation systems with a successful emphasis on equity. For example, Spain has implemented a comprehensive strategy to increase organ availability that may be instructive for improving organ availability in the United States (Matesanz et al., 2011)
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From page 166... ...
The committee concludes that an increase in the number of DCDD organs procured by OPOs, coupled with improved organ offer acceptance and use practices of transplant centers, would yield a signifi cant number of organs for waiting candidates. With the innovation of ex vivo organ perfusion for liver, heart, and lungs, there is an increased opportunity to expand the donor pool with DCDD donation and increase the organs available that were not previously considered for transplant.
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From page 167... ...
CMS and the OPTN MPSC use the SRTR performance assessment methodology for 1-year organ survival to review transplant program performance (Kasiske et al., 2016) .10 Incentives in Transplant Center Performance It is the committee's belief and experience that transplant providers intend to act in the best interests of their patients to review organ offers, accept the best organ for that patient, and perform a successful transplant.
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From page 168... ...
Transplantation of more medically urgent patients who have decreased waiting list survival, yet still have excellent posttransplant survival, could save more lives. There is also concern that the current transplant center performance metrics will lead to increases, or at least not decreases, in the already high organ nonuse rate, and continued lack of equity for minority populations who, for example, have twice the accrued dialysis time upon entry to the waiting list.
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From page 169... ...
While this process is well defined by policy, the actual acceptance and transplantation of an available organ to a recipient is much more complicated.12 The successful treatment of end-stage organ failure through transplantation continues to fuel demand for deceased donor organs, with the waiting list outpacing the number of transplants performed. However, in practice, many recovered organs are not used (SRTR, 2021)
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From page 170... ...
Prior ity on each organ waiting list is based on formal, publicly announced policies, and organs are allocated by match-run algorithms; on the other hand, a patient's access to an organ offered depends on how the transplant professionals in the program caring for the patient exercise the discretion that the system gives them regarding when to accept or reject an organ for transplantation. This divergence -- which is not transparent either to the general public or to all patients on the waiting list -- has implications for equitable treatment of all patients, for adherence to the ethical principles of autonomy and beneficence, and for trust in the system.
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From page 171... ...
(2019) assessed 182 transplant centers' use practices with kidneys perceived as having a high risk from 2010 to 2016, and found that there was significant variation by OPTN region, revealing geographic trends in kidney use and nonuse.
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From page 172... ...
Future research on assessing the variabilities of nonuse rates across transplant centers, as well as potential interventions, is needed. While the problem of demand exceeding the supply is a global issue, the deceased donor kidney nonuse rate in the United States is high relative to other similarly developed countries (Mohan et al., 2018; Stewart et al., 2017)
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From page 173... ...
. Program structure and staffing, particularly during weekends and in smaller programs, FIGURE 6-6 Rate and odds of discard of deceased donor kidneys over the course of the week, 2000–2013.
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From page 174... ...
. Operations Management Contributing to the "weekend effect" are hospital surgical scheduling and flow challenges where an entire science of operations management would help alleviate this universal issue.
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From page 175... ...
(2018) found that in the years 2008 through 2015, between 14 and 20 percent of deceased donor kidneys that were eventually transplanted were first offered to one or more deceased candidates, contributing to less efficiency in the process of organ offers, and perhaps contributing to organ nonuse.
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From page 176... ...
KEY AREA FOR IMPROVEMENT FOR TRANSPLANT CENTERS: ORGAN OFFER ACCEPTANCE The U.S. organ transplantation system was built and designed primarily to maximize the ability of transplant centers and surgeons to exercise choice in accepting and transplanting organs.
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From page 177... ...
heart transplant centers accepted a first-rank offer for a candidate on their waiting list varied significantly from 12.3 to 61.5 percent, with lower organ offer acceptance rates being associated with an increased risk of waiting list mortality. Additionally, another study observed marked variability in center practices regarding accepting livers allocated to the highest-priority patients, and that patients' odds of dying on the waiting list without a transplant were significantly increased by centerlevel decisions to decline organs (Goldberg et al., 2016)
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From page 178... ...
Waiting patients at transplant centers with low offer acceptance rates have only a 4 percent chance of getting a transplant within 3 years. Conversely, patients waiting at transplant centers with high offer acceptance rates have a 65 percent chance of getting a transplant within 3 years (King et al., 2020)
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From page 179... ...
Programs applying filters may have higher organ offer acceptance rates than programs not utilizing filters because the "filtered"
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From page 180... ...
As more organ offer filter options are developed, the interplay between filters, organ offer acceptance rates, and patient outcomes should be further evaluated. Understanding Organ Offer Tools Refusal Codes Selectivity can be a reason for organ nonuse rates, and better information will inform understanding of the low rates of organ offer acceptance.
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From page 181... ...
The ability for a transplant center to bypass organ offers also raises the question about the variability in access to transplant for patients on the waiting list. Expedited Placement of Organs Expedited placement can reduce delays in allocation by routing less-than-ideal organs to transplant centers with a proven willingness to use these organs (Mohan and Schold, 2021)
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From page 182... ...
BOX 6-4 CHALLENGES IN INCREASING OFFER ACCEPTANCES Several challenges must be overcome to increase organ offer acceptances. These include • The transplantation system's deference to the flexibility of transplant centers and teams to exercise choice in accepting and transplanting organs.
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From page 183... ...
While not all of the currently unused organs could be used, the persistence of this rate over time diminishes the fairness, equity, and transparency of the organ transplantation system. The wide variation in nonuse and organ offer acceptance rates is the result of a combination of many factors that are within the control of the transplant center, as well as resulting from operational practices and behaviors that are not supported by evidence of geography, organ supply, or patient complexity.
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From page 184... ...
. There are opportunities to increase patient shared decision making in order to improve the fairness, equity, cost-effectiveness, and transparency of the nation's organ transplantation system.
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From page 185... ...
For this example, the hypothetical patient is 55 years old, does not have diabetes, has been on dialysis for 3.5 years, and has waited 809 days on the waiting list. In this case, accepting a 60 percent KDPI kidney now would increase survival by 57.5 days on 20 See Chapter 3 for more information on increased transparency related to public trust and patient decision making, and see Chapter 5 on optimizing data for patient review in organ offers.
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From page 186... ...
The OPTN should enhance organ allocation and distribution policies and processes to reduce nonuse of deceased donor organs and make it easier for transplant centers to say "yes" to organ offers. To improve the organ offer process, the OPTN should do the following: • Require the use of more refined filters for transplant centers to indicate their prefer ences for which kidneys will be accepted, if offered.
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From page 187... ...
HHS should update the OPTN contract to require transplant center accountability for patient engagement and partnership between transplant center professionals and patients in deciding whether to accept or reject an offered organ. The updated OPTN contract should require • Close monitoring of any new transplant center performance metrics to ensure the desired outcomes are achieved and unintended consequences are avoided; • Nudges in the form of reports showing a transplant center's decisions regarding offered organs, as well as comparisons to other transplant centers, to be proac tively developed from SRTR data and shared with individual transplant centers on a monthly basis; and • Transplant programs to document shared decision making that includes a discus sion of survival benefit, relative to staying on the waiting list or dialysis, before deciding to accept or reject an offered deceased donor organ.
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From page 188... ...
Description and Use of Donor Care Units In general, a DCU is a facility built and managed by an OPO, under the guidance of the OPO's medical director, for the purposes of medically managing organ function and recovering organs for transplantation from deceased organ donors.23 Because of legal requirements under state statute for hospital licensure, only donors declared dead by neurological criteria can be transferred to a DCU and not DCDD donors. After death is declared by neurological criteria in acute care or critical access hospitals, authorization for donation by the donor or surrogate decision maker has been obtained, the donor is hemodynamically stable, and approval for transfer has been given, the donor is moved by ground or air transport to the DCU.
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From page 189... ...
The staffing model for this type of DCU is similar to the donation process in donor hospitals -- hospital staff provide bedside care and the OPO staff medically manage the donor. Partnerships with Transplant Centers The advent of transplant hospitals building in-house capabilities came about initially as a result of the interpretation of the transplant center cost report, and subsequently, as a way to increase Medicare reimbursement for the transplant center.
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From page 190... ...
The decision to build a DCU is one that requires careful collaboration between the OPO, donor hospitals, and transplant centers. The committee heard testimony of how OPOs garner support from stakeholders in their DSA in order for the DCU to be successful, and monitor satisfaction of hospital critical care staff, administration, physicians, and donor families to ensure that needs and expectations are met.
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From page 191... ...
The committee concluded that CMS should review payment incentives for transplant centers such that the transplant center is neither financially punished nor excessively rewarded for performing deceased donor organ management and surgical recovery. Conclusion 6-10: Donor care units are an innovation in organ procurement and provide an opportunity to bring consistency and high-quality care to donor organ procurement and the donor family care experience.
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From page 192... ...
Because multiple models of DCUs are in practice today, the com mittee recommends that HHS require the following attributes for each donor care unit: ° Dedicated beds for deceased donors in a dedicated space; ° Dedicated operating room with trained staff, reserved specifically for organ procurement surgery; ° Dedicated space for donor families; ° ICU-level care; ° Oversight by a critical care physician; ° Ability to conduct some in-house imaging and diagnostics of donors; ° Ability to conduct organ rehabilitation and therapy; ° Ability to conduct donor intervention research; and ° Reasonable distance to an airport. • CMS should adjust current reimbursement structures that create disincentives that dampen the willingness of some transplant centers to transfer donors to an OPO DCU.
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From page 193... ...
2020. Transplant center variability in organ offer acceptance and mortality among U.S.
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From page 194... ...
2022. Deceased donor kidneys allo cated out of sequence by organ procurement organizations.
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From page 195... ...
2021. Deceased donor kidneys utilization and discard rates during COVID-19 pandemic in the United States.
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From page 196... ...
2020. Variability in donor organ offer acceptance and lung transplantation survival.
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From page 197... ...
: An open-label study of combined glecaprevir and pibrentasvir to treat recipients of transplanted kidneys from deceased donors with hepatitis C virus infection. Journal of the American Society of Nephrology 31(11)
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From page 198... ...
2020. Kidney nonprocurement in solid organ donors in the United States.
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