October 2025 Update
HRSA and the Organ Procurement and Transplantation Network (OPTN) remain steadfast in their mission to protect patients and ensure that life-saving organ donation, procurement and transplantation activities continue without interruption throughout the current lapse in federal appropriations. While non-critical OPTN activities have been paused, essential functions that support organ donation, transplantation, waitlist management, risk monitoring, testing and patient safety continue. The current lapse in funding does not affect our ability to oversee and maintain these OPTN services for patients, families, and providers.
Patient safety remains the guiding principle for the national organ transplantation system. HRSA and OPTN are sustaining strong oversight and coordination to ensure that every organ match is handled safely, fairly, and efficiently, with continuous monitoring of patient outcomes. They are also working together with organ procurement organizations (OPOs) and transplant centers to provide the resources and guidance needed to maintain uninterrupted, high-quality patient care. Because patient safety is central to the mission of the OPTN, its critical work continues despite the current lapse in federal appropriations.
Advancing Oversight and Transparency around Allocation Out of OPTN Sequence
HRSA continues to advance oversight and transparency around Allocation Out of OPTN Sequence (AOOS) to strengthen patient safety and fairness in the organ transplant system. Earlier this year, the OPTN developed standardized definitions and reporting requirements for AOOS, established the AOOS Workgroup, and launched a public AOOS dashboard to provide real-time visibility into allocation practices nationwide. This data-driven approach allows for closer monitoring, identifies opportunities to improve compliance, and protects patients waiting for transplants.
The AOOS Workgroup, and its three sub-teams, continue to meet regularly and actively identify policy improvements to address identified issues. With feedback and collaboration from the OPTN, HRSA is developing a standardized OPO Allocation Compliance Report, which will further support transparency and accountability. Work related to AOOS remains active and ongoing so that the OPTN can continue to refine policy recommendations that will strengthen accountability and promote fair organ allocation across the system.
Establishing Foundational Policy for Donation After Circulatory Death
Donation after circulatory death (DCD) refers to the recovery of organs for transplantation after a patient’s heart has permanently stopped beating and circulation has ceased. Unlike donation after brain death, DCD allows individuals who do not meet brain death criteria, but whose families have chosen to withdraw life-sustaining treatment, to become organ donors, helping increase the number of organs available for patients in need.
The OPTN, as directed by HRSA and with HRSA’s oversight and support, established a DCD workgroup, which recently completed an accelerated policy sprint – one of the fastest in OPTN history. The result is the first-ever proposed policy definition and requirements for adequate family education about organ donation after circulatory death, ensuring that donors’ families are fully informed and supported during the decision-making process. This policy will be made available for public comment in the coming months.
This rapid yet thoughtful approach demonstrates HRSA’s commitment to agile, data-driven policy making that prioritizes patient safety and accountability. The OPTN’s work reflects a new, innovative approach to creating timely, practical policies that can be put into action quickly. These efforts improve accountability and help ensure that every organ donated through a patient in the DCD pathway follows the strongest ethical and patient safety standards.
Strengthening Testing and Policies Around Transmissible Diseases
Significant steps have also been taken to strengthen policies that protect transplant recipients from transmissible diseases, including rare but serious infections such as rabies, Chagas disease, West Nile virus, and Human Herpesvirus 8 (HHV-8, also known as Kaposi’s sarcoma-associated herpesvirus). These efforts focus on improving donor screening, enhancing reporting requirements, and ensuring timely communication between organ procurement organizations and transplant centers when potential risks are identified.
HRSA has collaborated closely with federal partners, including the Centers for Disease Control and Prevention (CDC), to align guidance, share data, and amplify new safety protocols and educational materials for the transplant community. Together, these coordinated actions strengthen the nation’s ability to detect and respond to emerging infectious risks, reinforcing HRSA’s ongoing commitment to patient safety and the highest standards of public health oversight in organ transplantation.
Actively Monitoring Practices Pertaining to Continuous Distribution
In March 2023, the OPTN implemented a new continuous distribution (CD) system for lung allocation, replacing fixed geographic zones with a more flexible approach that considers each candidate’s medical urgency and distance from the donor hospital. This modernization was designed to make lung allocation fairer across the country. HRSA’s review of the first three years of lung CD has raised concerns that widespread AOOS/policy non-compliance has undermined the OPTN’s ability to appropriately evaluate the impact of the CD policy. The agency is working closely with the OPTN to address these issues, strengthen compliance with allocation policies, and ensure that every lung transplant opportunity is distributed safely, fairly, and transparently for all patients.
Ensuring Continuity and Modernizing the Organ Procurement and Transplant System
HRSA, in close coordination with the OPTN, continues to oversee and support the nation’s vital organ donation, procurement, and transplantation work during the lapse in appropriations because critical patient safety needs cannot be put on hold. From improving AOOS transparency to advancing DCD policy development to strengthening protections against transmissible diseases, HRSA’s efforts remain focused squarely on saving lives, protecting patients, and ensuring that every organ is allocated and transplanted with the highest standards of safety, fairness, and integrity.
Recent public statements have caused some confusion about the future of the nation’s organ donation and transplantation system at the end of this year. HRSA affirms that organ donation, procurement, and transplantation activities will continue without interruption beyond that date. The upcoming transitions reflect HRSA’s strong and ongoing commitment to strengthen the OPTN through a modernized, competitive, multi-vendor structure that enhances accountability, transparency, and performance across the system. HRSA will carefully manage this process to ensure seamless continuity of operations and patient care. The agency remains fully dedicated to protecting patients and ensuring the uninterrupted delivery of life-saving transplant services across the country.