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HRSA directs OPTN to strengthen procurement data collection and assess NRP safety
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Summary
HRSA announced a data directive to capture procurement-process information, will monitor DCD-pathway practices, and has issued a directive to the OPTN to assess normothermic regional perfusion (NRP) best practices and data collection to ensure safe use across the system.
Unidentified Speaker (S1), an HRSA presenter, told participants that HRSA reviews had uncovered gaps in organ procurement policies and standards and that improving procurement safeguards is central to the modernization effort.
S1 said HRSA issued a data directive to collect procurement-process data so the agency can better understand the processes that support successful procurement and transplantation. The agency emphasized that procurement and transplant processes must both be safe and effective and highlighted concerns in donation-after-circulatory-death (DCD) pathways as an area for strengthened guidance and monitoring.
On normothermic regional perfusion (NRP), S1 said HRSA received a critical comment and directed the OPTN to "assess best practice, collect more data, and monitor this practice moving forward so we can ensure that it is being applied in a safe and effective manner," adding that NRP can increase access to transplant when done safely.
Why it matters: Procurement processes and clinical advancements such as NRP affect both donor and recipient safety and access to transplant. HRSA framed data collection and a directive-based approach as tools to monitor practice, surface risks, and accelerate system-wide learning.
Next steps: HRSA said procurement-process data collection will proceed through required clearances, the agency will publish related guidance and web materials, and it will continue to collaborate with OPTN contractors and the transplant community to strengthen safeguards.
