What is visible is fixable: Visual dashboards for multi-domain assessment of organ procurement organization performance.

With stakeholder focus on the United States organ procurement system, there is a need for tools that permit comparative assessment of organ procurement providers. We developed a public-facing dashboard for organ procurement organizations (OPOs), using data from multiple sources, to create an online, readily accessible visualization of OPO practice conditions and performance for the period 2010-2020. With this tool, OPOs can be compared on the CMS metric of donors procured per 100 donation-consistent deaths, as well as donation after circulatory death procurement, procurement of older and minority patient populations, procurement in smaller hospitals, and procurement of patients without a significant drug history. Patterns of higher performance were identified, and 74% of differences in overall donor procurement rates could be explained using model variables. Procurement differences were affected to a greater and more reproducible degree by OPO performance among Black and non-White patient populations, as well as in smaller hospitals, than by donation service area characteristics. Dashboards such as ours support OPOs and stakeholders in quality improvement actions, through leveraging benchmarked performance data among organ procurement clinical providers.

Increasing the Donor Pool: Organ Transplantation from Donors with HIV to Recipients with HIV.

Implementation of the HIV Organ Policy Equity (HOPE) Act marks a new era in transplantation, allowing organ transplantation from HIV+ donors to HIV+ recipients (HIV D+/R+ transplantation). In this review, we discuss major milestones in HIV and transplantation which paved the way for this landmark policy change, including excellent outcomes in HIV D-/R+ recipient transplantation and success in the South African experience of HIV D+/R+ deceased donor kidney transplantation. Under the HOPE Act, from March 2016 to December 2018, there were 56 deceased donors, and 102 organs were transplanted (71 kidneys and 31 livers). In 2019, the first HIV D+/R+ living donor kidney transplants occurred. Reaching the full estimated potential of HIV+ donors will require overcoming challenges at the community, organ procurement organization, and transplant center levels. Multiple clinical trials are ongoing, which will provide clinical and scientific data to further extend the frontiers of knowledge in this field.

National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States.

BACKGROUND: Organ transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV (HIV D+/R+) presents risks of donor-derived infections. Understanding clinical, immunologic, and virologic characteristics of HIV-positive donors is critical for safety. METHODS: We performed a prospective study of donors with HIV-positive and HIV false-positive (FP) test results within the HIV Organ Policy Equity (HOPE) Act in Action studies of HIV D+/R+ transplantation (ClinicalTrials.gov NCT02602262, NCT03500315, and NCT03734393). We compared clinical characteristics in HIV-positive versus FP donors. We measured CD4 T cells, HIV viral load (VL), drug resistance mutations (DRMs), coreceptor tropism, and serum antiretroviral therapy (ART) detection, using mass spectrometry in HIV-positive donors. RESULTS: Between March 2016 and March 2020, 92 donors (58 HIV positive, 34 FP), representing 98.9% of all US HOPE donors during this period, donated 177 organs (131 kidneys and 46 livers). Each year the number of donors increased. The prevalence of hepatitis B (16% vs 0%), syphilis (16% vs 0%), and cytomegalovirus (CMV; 91% vs 58%) was higher in HIV-positive versus FP donors; the prevalences of hepatitis C viremia were similar (2% vs 6%). Most HIV-positive donors (71%) had a known HIV diagnosis, of whom 90% were prescribed ART and 68% had a VL <400 copies/mL. The median CD4 T-cell count (interquartile range) was 194/µL (77-331/µL), and the median CD4 T-cell percentage was 27.0% (16.8%-36.1%). Major HIV DRMs were detected in 42%, including nonnucleoside reverse-transcriptase inhibitors (33%), integrase strand transfer inhibitors (4%), and multiclass (13%). Serum ART was detected in 46% and matched ART by history. CONCLUSION: The use of HIV-positive donor organs is increasing. HIV DRMs are common, yet resistance that would compromise integrase strand transfer inhibitor-based regimens is rare, which is reassuring regarding safety.

Examining utilization of kidneys as a function of procurement performance.

Questions have arisen around new metrics for organ procurement organizations (OPO) due to the perception that low-performing OPOs may be limited by local centers' acceptance of marginal organs. We reviewed 2013-2019 Organ Procurement and Transplantation Network (OTPN) and National Centers for Health Statistics (NCHS) data to explore the relationship between objectively measured OPO performance and utilization of deceased donor kidneys. We found that although donor recovery declined with rising age and kidney donor profile index (KDPI), OPO performance differences were evident within each age/KDPI group. By contrast, the number of discards per donor did not vary with OPO performance. Centers in donor service areas (DSAs) with lower-performing OPOs had higher local utilization and greater import of high-KDPI kidneys than did those with higher-performing OPOs. Lower rates of donor availability relative to waitlist additions may contribute to observed center acceptance behavior. Differences in center-level performance were highly visible in Scientific Registry of Transplant Recipients (SRTR) organ acceptance metrics, while SRTR OPO metrics did not detect large or persistent variation in procurement performance. Cumulatively, our findings suggest that objective measures of procurement performance can inform discussions of organ utilization, allowing for alignment of metrics in all elements of the procurement-transplantation system.

Procurement characteristics of high- and low-performing OPOs as seen in OPTN/SRTR data.

To meet new Centers for Medicare and Medicaid Services (CMS) metrics, organ procurement organizations (OPOs) will benefit from understanding performance across decedent and hospital types. We sought to determine the utility of existing data-reporting structures for this purpose by reviewing Scientific Registry of Transplant Recipient (SRTR) OPO-Specific Reports (OSRs) from 2013 to 2019. OSRs contain both the Standardized donation rate ratio (SDRR) metric and OPO-reported numbers of "eligible deaths" and donors by hospital. Donor hospitals were characterized using information from Homeland Infrastructure Foundation-Level Data, Dartmouth Atlas Hospital Service Area data, and the US Census Bureau. Hospital data reported by OPOs showed 51% higher eligible death donors and 140% higher noneligible death donors per 100 inpatient beds in CMS ranked top versus bottom-quartile OPOs. Top-quartile OPOs by the CMS metric recovered 78% more donors than those in the bottom quartile, but were indistinguishable by SDRR rankings. These differences persisted across hospital sizes, trauma case mix, and area demographics. OPOs with divergent performance were indistinguishable over time by SDRR, but showed changes to hospital-level recovery patterns in SRTR data. Contemporaneous recognition of underperformance across hospitals may provide important and actionable data for regulators and OPOs for focused quality improvement projects.

HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV.

Liver transplantation (LT) from donors-with-HIV to recipients-with-HIV (HIV D+/R+) is permitted under the HOPE Act. There are only three international single-case reports of HIV D+/R+ LT, each with limited follow-up. We performed a prospective multicenter pilot study comparing HIV D+/R+ to donors-without-HIV to recipients-with-HIV (HIV D-/R+) LT. We quantified patient survival, graft survival, rejection, serious adverse events (SAEs), human immunodeficiency virus (HIV) breakthrough, infections, and malignancies, using Cox and negative binomial regression with inverse probability of treatment weighting. Between March 2016-July 2019, there were 45 LTs (8 simultaneous liver-kidney) at 9 centers: 24 HIV D+/R+, 21 HIV D-/R+ (10 D- were false-positive). The median follow-up time was 23 months. Median recipient CD4 was 287 cells/µL with 100% on antiretroviral therapy; 56% were hepatitis C virus (HCV)-seropositive, 13% HCV-viremic. Weighted 1-year survival was 83.3% versus 100.0% in D+ versus D- groups (p = .04). There were no differences in one-year graft survival (96.0% vs. 100.0%), rejection (10.8% vs. 18.2%), HIV breakthrough (8% vs. 10%), or SAEs (all p > .05). HIV D+/R+ had more opportunistic infections, infectious hospitalizations, and cancer. In this multicenter pilot study of HIV D+/R+ LT, patient and graft survival were better than historical cohorts, however, a potential increase in infections and cancer merits further investigation.

Barriers experienced by organ procurement organizations in implementing the HOPE act and HIV-positive organ donation.

In the seven years since the HIV Organ Policy Equity (HOPE) Act made HIV-positive organ donation to HIV-positive recipients legally permissible in the United States, there have been fewer HIV-positive organ donations than expected. Organ procurement organizations (OPOs) play a key role in the transplant system and barriers at OPOs may be partly responsible for the relatively low number of HIV-positive donors. To understand potential OPO barriers, we conducted semi-structured interviews with 20 OPO staff members. Interviews were recorded, transcribed, and analyzed using a conventional content analytic approach with two coders. OPO staff had high levels of knowledge about HOPE. Many had evaluated referrals of HIV-positive donors and approached families for authorization. Barriers to HIV-positive organ recovery identified included obtaining authorization for donation, potentially disclosing HIV status to next-of-kin, and fear of HIV infection among those engaged in organ recovery. Strategies to overcome these barriers include providing continuing education about the specific tasks required to procure organs from HIV-positive donors, implementing targeted interventions to reduce fear of infection, and developing partnerships with HIV advocacy and care organizations. Given the central role OPOs play, HIV-positive donations are unlikely to occur in significant numbers unless these barriers can be overcome.

Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance.

The Centers for Medicare and Medicaid Services announced changes to the Final Rule for organ procurement organizations (OPOs) in November 2020, after a 23-month period of public debate. One concern among transplant stakeholders was that public focus on OPO underperformance would harm deceased donation. Using CDC-WONDER data, we studied whether donation performance dropped during the era of public debate about OPO reform (December 2018-February 2020). Overall OPO performance as measured relative to cause, age, and location-consistent deaths rose by 12.3% in 2019, compared to a median annual change of 2.5% 2009-2019. Organ recoveries exceeded seasonally adjusted forecasts by 4.2% in the first half of 2019, by 8.1% following the Executive Order issuing a mandate for OPO metric reform, and by 14.1% between the Notice of Public Rule Making and the onset of COVID-19-related systemic disruptions. We describe changes in donor phenotype in the period of increased performance; improvement was greatest for older and donation after cardiac death (DCD) donors, and among decedents who did not have a drug-related mechanism of death. In summary, performance during an era of intense public debate and proposed regulatory changes yielded 692 additional donors over expectations, and no detriment to organ donation was observed.

Results of a data-driven performance improvement initiative in organ donation.

New metrics for organ procurement organization (OPO) performance utilize National Center for Health Statistics data to measure cause, age, and location consistent (CALC) deaths. We used this denominator to identify opportunities for improved donor conversion at one OPO, Indiana Donor Network (INOP). We sought to determine whether such analyses are immediately actionable for quality improvement (QI) initiatives directed at increased donor conversion. CALC-based assessment of INOP's performance revealed an opportunity to improve conversion of older donors. Following the QI initiative, INOP donor yield rose by 44%, while organs transplanted rose by 29%. These changes tolerated temporary disruption around the COVID-19 pandemic. Improved donor yield was primarily seen in older groups identified by CALC-based methods. Process changes in resource allocation and monitoring were associated with a 57% increase in the number of potential donors approached in the QI period and a subsequent rise in the number of potential donor referrals, suggesting positive feedback at area hospitals. Post-intervention, INOP's projected donation performance rose from 51st to 18th among all OPOs. OPOs can use CALC death data to accurately assess donor conversion by categories including age and race/ethnicity. These data can be used in real time to inform OPO-level processes to maximize donor recovery.

Opportunity to increase deceased donation for United States veterans.

Recent changes to organ procurement organization (OPO) performance metrics have highlighted the need to identify opportunities to increase organ donation in the United States. Using data from the Organ Procurement and Transplantation Network (OPTN), Scientific Registry of Transplant Recipients (SRTR), and Veteran Health Administration Informatics and Computing Infrastructure Clinical Data Warehouse (VINCI CDW), we sought to describe historical donation performance at Veteran Administration Medical Centers (VAMCs). We found that over the period 2010-2019, there were only 33 donors recovered from the 115 VAMCs with donor potential nationwide. VA donors had similar age-matched organ transplant yields to non-VA donors. Review of VAMC records showed a total of 8474 decedents with causes of death compatible with donation, of whom 5281 had no infectious or neoplastic comorbidities preclusive to donation. Relative to a single state comparison of adult non-VA inpatient deaths, VAMC deaths were 20 times less likely to be characterized as an eligible death by SRTR. The rate of conversion of inpatient donation-consistent deaths without preclusive comorbidities to actual donors at VAMCs was 5.9% that of adult inpatients at non-VA hospitals. Overall, these findings suggest significant opportunities for growth in donation at VAMCs.

A prospective multicenter pilot study of HIV-positive deceased donor to HIV-positive recipient kidney transplantation: HOPE in action.

HIV-positive donor to HIV-positive recipient (HIV D+/R+) transplantation is permitted in the United States under the HIV Organ Policy Equity Act. To explore safety and the risk attributable to an HIV+ donor, we performed a prospective multicenter pilot study comparing HIV D+/R+ vs HIV-negative donor to HIV+ recipient (HIV D-/R+) kidney transplantation (KT). From 3/2016 to 7/2019 at 14 centers, there were 75 HIV+ KTs: 25 D+ and 50 D- (22 recipients from D- with false positive HIV tests). Median follow-up was 1.7 years. There were no deaths nor differences in 1-year graft survival (91% D+ vs 92% D-, P = .9), 1-year mean estimated glomerular filtration rate (63 mL/min D+ vs 57 mL/min D-, P = .31), HIV breakthrough (4% D+ vs 6% D-, P > .99), infectious hospitalizations (28% vs 26%, P = .85), or opportunistic infections (16% vs 12%, P = .72). One-year rejection was higher for D+ recipients (50% vs 29%, HR: 1.83, 95% CI 0.84-3.95, P = .13) but did not reach statistical significance; rejection was lower with lymphocyte-depleting induction (21% vs 44%, HR: 0.33, 95% CI 0.21-0.87, P = .03). In this multicenter pilot study directly comparing HIV D+/R+ with HIV D-/R+ KT, overall transplant and HIV outcomes were excellent; a trend toward higher rejection with D+ raises concerns that merit further investigation.

Potential donor characteristics and decisions made by organ procurement organization staff: Results of a discrete choice experiment.

Organ procurement organizations (OPOs) evaluate referrals for deceased organ donation in the United States. Efforts to expand the donor pool, such as the HIV organ policy equity (HOPE) Act that permits transplants from HIV-positive donors to HIV-positive recipients, can only succeed if OPOs pursue referrals. However, relatively little is known about how OPO staff evaluate referrals. To better understand this process, OPO staff completed a discrete choice experiment to quantify the relative importance of seven donor characteristics on the decision to pursue a theoretical donor. Relative importance was defined by Partworth utility using a hierarchical Bayesian conditional logit model. There were 51 respondents from 36 of 58 OPOs in the United States. Of the seven attributes, organ and tissue potential were the most influential, followed by age, type of death, HIV status, donor registration, and Hepatitis C status. To be preferred to an HIV-negative donor, an HIV-positive donor needed to have the potential to donate two additional organs. These data provide insight into the preferences of OPO referral staff and may help explain the lower than expected number of HIV-positive transplants performed since the passage of the HOPE Act.

Rejecting bias: The case against race adjustment for OPO performance in communities of color.

In December of 2019, the Centers for Medicare and Medicaid Services (CMS) put out a notice of proposed rule-making for 42 CFR Part 486, specifically the section that covers the organ procurement organization (OPO) Conditions for Coverage. Most crucially, the proposed rule included two new OPO performance metrics using objective, standardized data from the Centers for Disease Control and Prevention (CDC). These new metrics would employ a denominator that included inpatient deaths from certain causes that could lead to organ donation, rather than the current unverifiable eligible death metric. Although there has been near-uniform support for replacing the eligible death denominator with CDC data, a source of contention is CMS's proposal not to adjust risk for race in their OPO outcome. Nonetheless, there have been calls for race and ethnicity to be included as risk-adjusted variables in the CMS donation metric. Herein, we lay out an argument as to why inclusion of race and ethnicity as risk adjustment variables in an OPO performance metric is not only statistically suspect but also will hide the inequities that are detrimental to optimal system performance and assurance that all patients have timely access to donation.

Utilization of deceased donors during a pandemic: argument against using SARS-CoV-2-positive donors.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become an unprecedented pandemic that has impacted society, disrupted hospital functions, strained health care resources, and impacted the lives of transplant professionals. Despite this, organ failure and the need for transplant continues throughout the United States. Considering the perpetual scarcity of deceased donor organs, Kates et al present a viewpoint that advocates for the utilization of coronavirus disease 2019 (COVID-19)-positive donors in selected cases. We present a review of the current literature that details the potential negative consequences of COVID-19-positive donors. The factors we consider include (1) the risk of blood transmission of SARS-CoV-2, (2) involvement of donor organs, (3) lack of effective therapies, (4) exposure of health care and recovery teams, (5) disease transmission and propagation, and (6) hospital resource utilization. While we acknowledge that transplant fulfills the mission of saving lives, it is imperative to consider the consequences not only to our recipients but also to the community and to health care workers, particularly in the absence of effective preventative or curative therapies. For these reasons, we believe the evidence and risks show that COVID-19 infection should continue to remain a contraindication for donation, as has been the initial response of donation and transplant societies.

Public education materials about Vascular Composite Allotransplantation and donation in the United States: Current scope and limitations.

As the field of Vascular Composite Allotransplantation (VCA) grows, demand for VCA donations will increase. The public should be made aware of this treatment option to support patients' informed decision-making and authorization for deceased donation. We assessed the availability and quality of existing VCA public education materials from organ procurement organizations (OPOs), transplant centers, the Organ Procurement and Transplant Network, Veterans Affairs, and the Department of Defense. A content analysis was performed to identify topics covered and important gaps. In total, 1314 public education materials were analyzed, including OPO Facebook posts (61.6%), OPO Twitter posts (29.9%), websites (6.4%), and written documents (eg, fact sheets, research reports) (2.1%). Upper extremity (34.7%) and face (34.5%) transplants were more commonly covered than reproductive (6.4%) or other VCA types (2.8%). Most materials (76.6%) referenced a specific VCA story. However, few materials described which patient population could benefit from VCA (eg, Veterans, amputees, burn victims, 16.4%), the authorization requirements for VCA donation (6.6%), or the appearance of transplanted VCA organs (1.2%). Current VCA public education materials do not adequately educate the public. More comprehensive education materials are needed to prepare the public to authorize VCA donation, become potential donors, or learn about transplant options.

Organs from deceased donors with false-positive HIV screening tests: An unexpected benefit of the HOPE act.

Organs from deceased donors with suspected false-positive HIV screening tests were generally discarded due to the chance that the test was truly positive. However, the HIV Organ Policy Equity (HOPE) Act now facilitates use of such organs for transplantation to HIV-infected (HIV+) individuals. In the HOPE in Action trial, donors without a known HIV infection who unexpectedly tested positive for anti-HIV antibody (Ab) or HIV nucleic acid test (NAT) were classified as suspected false-positive donors. Between March 2016 and March 2018, 10 suspected false-positive donors had organs recovered for transplant for 21 HIV + recipients (14 single-kidney, 1 double-kidney, 5 liver, 1 simultaneous liver-kidney). Median donor age was 24 years; cause of death was trauma (n = 5), stroke (n = 4), and anoxia (n = 1); three donors were labeled Public Health Service increased infectious risk. Median kidney donor profile index was 30.5 (IQR 22-58). Eight donors were HIV Ab+/NAT-; two were HIV Ab-/NAT+. All 10 suspected false-positive donors were confirmed to be HIV-noninfected. Given the false-positive rates of approved assays used to screen > 20 000 deceased donors annually, we estimate 50-100 HIV false-positive donors per year. Organ transplantation from suspected HIV false-positive donors is an unexpected benefit of the HOPE Act that provides another novel organ source.

HIV+ deceased donor referrals: A national survey of organ procurement organizations.

BACKGROUND: HIV-infected (HIV+) donor organs can be transplanted into HIV+ recipients under the HIV Organ Policy Equity (HOPE) Act. Quantifying HIV+ donor referrals received by organ procurement organizations (OPOs) is critical for HOPE Act implementation. METHODS: We surveyed the 58 USA OPOs regarding HIV+ referral records and newly discovered HIV+ donors. Using data from OPOs that provided exact records and CDC HIV prevalence data, we projected a national estimate of HIV+ referrals. RESULTS: Fifty-five (95%) OPOs reported HIV+ referrals ranging from 0 to 276 and newly discovered HIV+ cases ranging from 0 to 10 annually. Six OPOs in areas of high HIV prevalence reported more than 100 HIV+ donor referrals. Twenty-seven (47%) OPOs provided exact HIV+ referral records and 28 (51%) OPOs provided exact records of discovered HIV+ cases, totaling 1450 HIV+ referrals and 39 discovered HIV+ donors in the prior year. These OPOs represented 67% and 59% of prevalent HIV cases in the USA; thus, we estimated 2164 HIV+ referrals and 66 discovered HIV+ cases nationally per year. CONCLUSIONS: OPOs reported a high volume of HIV+ referrals annually, of which a subset will be medically eligible for donation. Particularly in areas of high HIV prevalence, OPOs require ongoing support to implement the HOPE Act.

Moving from the HIV Organ Policy Equity Act to HIV Organ Policy Equity in action: changing practice and challenging stigma.

PURPOSE OF REVIEW: The HIV Organ Policy Equity (HOPE) Act, signed in 2013, reversed the federal ban on HIV-to-HIV transplantation. In this review, we examine the progress in HOPE implementation, the current status of HIV-to-HIV transplantation, and remaining challenges. RECENT FINDINGS: Pursuant to the HOPE Act, the Department of Health and Human Services revised federal regulations to allow HIV-to-HIV transplants under research protocols adherent to criteria published by the National Institutes of Health. The first HIV-to-HIV kidney and liver transplants were performed at Johns Hopkins in March of 2016. Legal and practical challenges remain. Further efforts are needed to educate potential HIV+ donors and to support Organ Procurement Organizations. As of November 2017, there are 22 transplant centers approved to perform HIV-to-HIV transplants in 10 United Network for Organ Sharing regions. To date, 16 Organ Procurement Organizations in 22 states have evaluated HIV+ donors. The National Institutes of Health-funded HOPE in Action: A Multicenter Clinical Trial of HIV-to-HIV Deceased Donor (HIVDD) Kidney Transplantation Kidney Trial will launch at 19 transplant centers in December of 2017. A HOPE in Action Multicenter HIVDD Liver Trial is in development. SUMMARY: Significant progress toward full HOPE implementation has been made though barriers remain. Some challenges are unique to HIV-HIV transplantation, whereas others are amplifications of issues across the current transplant system. In addition to a public health benefit for all transplant candidates in the United States, partnership on the HOPE Act has the potential to address systemic challenges to national donation and transplantation.