Abstract

Out-of-sequence (OOS) allocation, the process by which organ procurement organizations (OPOs) can deviate from standard rank lists of potential recipients to expeditiously allocate deceased-donor kidneys, is rising in the U.S. We aimed to determine whether current OPO reporting practices obscure the extent of OOS allocation. Using match-run data for all U.S. deceased-donor kidney transplants from 2021-2023, we defined “miscoded” OOS (mOOS) allocation transplants as those with use of the 799 or 898 OPO- initiated refusal codes (“other, specify”) with free text responses clearly indicating OOS allocation, and compared these to “explicit” OOS (eOOS) allocation, wherein OOS transplants are appropriately coded using refusal codes 861-863. We found that the prevalence of mOOS allocation increased from 2021 (122 transplants) to 2023 (430 transplants) and accounted for 12% of all OOS transplants by 2023. Organs allocated via mOOS had a lower median KDPI than those allocated via eOOS (51% vs 55%, p <0.01). While an increasing number of OPOs used mOOS throughout the study period, the practice remained concentrated overall, with 5 “outlier” OPOs performing 66% of mOOS allocations in 2023. These findings highlight the need for stricter oversight of organ allocation and underscore the responsibility of the OPTN to ensure proper data reporting.

Competing Interest Statement

Dr. Mohan reported receiving personal fees from Sanofi, Specialist Direct and the Health Services Advisory Group; receiving grants from the National Institutes of Health; serving as past chair for the United Network for Organ Sharing data advisory committee and being the deputy editor of Kidney International Reports. Dr. Schold reports receiving consulting fees from Sanofi, eGenesis, and Novartis, as well as grants from the NIH/NIDDK, NIH/NHLBI, Kidney Transplant Collaborative, Department of Defense, and One Legacy Foundation. Dr. Schold also reports serving as the Chair of the Data Advisory Committee at UNOS and a member of the Scientific Research Committee for the SRTR. The rest of the authors do not report any disclosures.

Funding Statement

SAH is supported by NIDDK grant K23DK133729. SM is supported by DK116066, EB032910, DK126739, DK130058 and the Kidney Transplant Collaborative. DC is supported by the NIAID grant R25 AI 147393.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB of Columbia University Irving Medical Center gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability Statement

The data used for this analysis are available upon request to the SRTR.

AbbreviationsOPOOrgan procurement organizationOPTNOrgan Procurement and Transplantation NetworkSRTRScientific Registry of Transplant RecipientsMPSCMembership and Professional Standards CommitteeOOSOut-of-sequencemOOSMiscoded out-of-sequenceeOOSExplicit out-of-sequenceKDPIKidney donor profile index