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HRSA says allocation out-of-sequence practices are improving but remediation remains urgent
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Summary
HRSA reported findings that allocation out-of-sequence was occurring—about one in five matches did not follow the OPTN match run—and described a remediation plan, early April data showing more patients received organs in match-run order, and directives to strengthen procurement and NRP oversight.
Unidentified Speaker (S1), an HRSA presenter, told stakeholders that allocation out of sequence (AOS) -- where the established OPTN match run or algorithm is not followed -- had been identified during HRSA reviews and had prompted critical comments and corrective directives.
S1 said HRSA's review found instances in which patients matched to organs did not receive them and in some cases transplant centers were not notified. "When we notice that 1 in 5 cases ... the algorithm based matching run ... is not followed, we have a policy compliance problem or maybe an algorithm problem or perhaps both," S1 said.
HRSA described a remediation plan that focuses on developing shared definitions, transparent compliance assessment and monitoring, enforcement where appropriate, and potential policy or algorithm updates driven by improved definitions and compliance analysis. HRSA said it will create a dedicated web page to publish remediation materials, dashboards and policy deliberations so the broader community can track progress.
On early outcomes, HRSA said initial indicators are positive: it reported a decrease in policy noncompliance and a decrease in organ nonuse, noting that "in April alone, more than 200 patients received an organ in the order that the OPTN match run had prescribed," meaning those patients were offered organs consistent with their place on the wait list.
HRSA also highlighted procurement-safety gaps that relate to organ procurement pathways and clinical practices. The agency said it issued a data directive to collect procurement-process data, will monitor donation-after-circulatory-death (DCD) pathways, and has issued a directive to the OPTN related to normothermic regional perfusion (NRP) to assess best practices and collect more data to ensure safe application.
Why it matters: Allocation that deviates from established match runs can affect fairness and public trust. HRSA framed the remediation work as necessary to ensure patients on the wait list receive the priority determined by established policy and to preserve transparency and safety across procurement and transplant practices.
Next steps: HRSA will implement the remediation plan, publish related materials and dashboards, continue complaint reviews and monitoring, and collaborate with the OPTN and stakeholders on potential policy or algorithm adjustments.
