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Organ Procurement and Transplantation Network (OPTN) Modernization Initiative

Recognizing Donate Life Month: Expressing gratitude for those who give, and honoring the resilience of those who wait

April 2025 Update

April is Donate Life Month, a time to honor the lives saved and enhanced through organ, eye, and tissue donation. Since the last Donate Life Month, 16,988 deceased organ donors and 6,927 living organ donors have helped 52,523 waitlist patients through a generous gift of life. We recognize the incredible impact of donors and their families, as well as the strength and resilience of those waiting for a transplant. 

Every organ donor gives more than the gift of life—they also inspire others across the country to become donors themselves. More than 170 million Americans have registered as organ donors, putting their trust in the national system that ensures donated organs help critically ill patients on the transplant waitlist. We hope that this Donate Life Month, more Americans will make the choice to register, as the need for organ donors remains high.  

A national system that serves 170 million registered organ donors, and more than 100,000 patients in need of a transplant, must be safe, fair, and effective. Without a strong record of safety, people may not want to register as donors in the future. Without transparency and fairness, patients risk their chance at a life-saving organ match. Without an efficient system, patients may face critically long waits for the organs they need. As part of our commitment to educating the public about the critical importance of organ donation, HRSA is taking proactive steps to ensure the safety, fairness, and effectiveness of the organ donation, procurement, and transplant system for patients and families. 

Strengthening Safety and Effectiveness Through Clearer Paths for Reporting Concerns

Improved Process for Reporting Allegations of Misconduct 

HRSA serves as the federal agency responsible for oversight of the national transplant system. Oversight of the OPTN is multifaceted, and includes: 

  • Preventing and deterring fraud, waste, and abuse; 
  • Addressing mistakes or errors that impact donor patients, waitlist patients, and recipient patients; 
  • Monitoring patient safety and public health; and 
  • Ensuring that OPTN activities achieve the intended results. 

The national procurement and transplant system is comprised of thousands of providers, frontline and support staff, and the patients and families they serve. Everyone involved in giving, receiving, or coordinating care with OPTN members should feel comfortable when sharing concerns, flagging anything that may be unsafe, or reporting potential fraud, waste, or abuse.

To strengthen patient safety and OPTN oversight, HRSA recently instituted a new process to report allegations of misconduct related to organ donation, organ procurement, or organ transplantation. Under the new process, HRSA will initially receive reports for review and triaging, changing the intake process from the previous route through an OPTN contractor, UNOS. As reports are received, HRSA can take direct oversight action, triage the complaint to the appropriate investigative body, multiple bodies, or as appropriate, to the OPTN Executive Director or OPTN President. Through this new process, HRSA aims to foster an environment where providers, patients, and families feel safe to report concerns, ensure timely and thorough investigations, and implement corrective actions as warranted. 

Please visit the updated Reporting Allegations of Misconduct page to learn more about the reporting processes and protections in place.

Increased Transparency and Accountability through the Critical Comment Process

HRSA's oversight tools include the critical comment process, as described by the OPTN Final Rule(link is external) where any individual or entity may submit written critical comments to HRSA related to the way the OPTN is carrying out its duties and/or OPTN policies. Upon review, HRSA, on behalf of the Secretary of HHS, will consider the critical comments. 

In the last year, HRSA received patient safety and transplant system fairness-related critical comments. The critical comments raised concerns about organ allocation out of sequence (AOOS), which refers to situations in which a patient who has been matched to an organ may not get access to that organ, or other non-compliant actions by an OPTN member outside of the process the OPTN has designed. Following this, another critical comment raised concerns about the practice of normothermic regional perfusion (NRP), an increasingly common clinical procedure that perfuses organs in a patient’s body during surgical organ procurement.

These critical comments, as well as the OPTN responses and HRSA directives, are published online: 

HRSA supports the OPTN in improving processes and increasing safety through oversight, including requesting information and asking questions of the OPTN. HRSA’s oversight is present to ensure the OPTN fulfills their obligation to create effective policies and processes for the operation of the national procurement and transplant system.

Engaging the Community through OPTN Regional Meetings

HRSA continues to regularly engage with stakeholders, including patients, to ensure our activities align with the bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act and advance the needs of patients and families. 

Most recently, HRSA’s Division of Transplantation represented by Dr. Raymond Lynch, Chief of the Organ Transplant Branch attended multiple OPTN Regional Meetings and facilitated feedback sessions on OPTN Modernization. The feedback sessions covered many topics related to patient experiences, including a common perception that the patient voice is often absent or insufficiently represented in the early stages of the policy making process. Participants expressed the need for greater attention to be given to the welfare and concerns of organ recipients, as well as individuals with organ failure- on and off the waitlist. 

OPTN Regional Meetings are an opportunity for OPTN members to influence policy proposals, prepare for upcoming changes, and hear perspectives from the transplant community about improvements to organ allocation. The OPTN Regional Winter Meetings were held between February 13 and March 14, 2025.  

Supporting Independent, Modernized OPTN Governance 

OPTN Board of Directors Special Election

In less than two months, the OPTN community will elect a new Board of Directors following a Special Election that adheres to the composition requirements in the bylaws, including at least 25% of the Board being transplant candidates, recipients, donors, and their family members. OPTN members will vote on the final slate of candidates in two phases: an election for the 11 Regional Councilors, and a national election for the remaining Board seats. A separate ballot question for Associate Regional Councilors will be included in the regional section of the national ballot. 

The application period, which recently closed, attracted 300 applicants, including: 

  • 182 (61%) organ transplant professionals (e.g., transplant surgeons; transplant physicians; and representatives of organ procurement organizations, transplant hospitals, voluntary health organizations, transplant coordinators, and non-physician transplant professionals);
  • 46 (15%) individuals with lived transplant experience (i.e., transplant candidates, transplant recipients, organ donors, family members of transplant recipient, family members of deceased donor);
  • 27 (9%) non-transplant professionals (e.g., professionals from law, theology, ethics, health care, public health, social and behavioral sciences, and labor and management unrelated to health care).
  • 20 (7%) organ transplant professionals with lived organ transplant experience;
  • 15 (5%) non-transplant professionals with lived experience; and 
  • 10 (3%) individuals who are organ transplant and non-transplant professionals.

OPTN Executive Director Search

Additionally, HRSA and the OPTN are seeking an accomplished Executive Director to spearhead efforts in enhancing operations, modernizing systems, and fostering collaboration among key stakeholders in organ transplantation. The OPTN Executive Director will play a critical role in promoting collaboration, guiding board activities, and advocating for the needs of patients and their families within the OPTN framework.

Ongoing Commitment to Patients and Families

HRSA remains steadfast in our commitment to improving the organ procurement and transplantation network to better serve patients, donors and families ensuring transparency throughout these reforms. The voice of transplant patients, their family members, and donor families have been instrumental in OPTN modernization and will continue to be centered and elevated as we modernize the system. 
 

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