March 27, 2024: HRSA issued a letter to the OPTN Board of Directors regarding our plan for continuity of operations and initial steps towards an independent OPTN Board of Directors. Read more about the plan (PDF - 184 KB).
HRSA Takes Historic New Steps to Transform the Organ Transplant System to Better Serve Patients and Families
February 2024 Updates
HRSA is taking historic steps as part of its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative to improve transparency, performance, governance, and efficiency of the US transplant system. Across the nearly 40-year history of the OPTN, all functions of the OPTN were managed by a single vendor rather than multiple contracts based on technical expertise in areas like IT or operations. Today HRSA is issuing requests for proposals (RFPs) to support multiple different contract awards. This action will increase competition ensuring patients and their families benefit from best-in-class vendors.
In March 2023, HRSA launched its OPTN Modernization Initiative to strengthen accountability and the performance of the nation’s organ transplant system by focusing on improving the OPTN’s governance, technology, and operations. In 2023, new legislation reformed the decades-old statute, enabling HRSA to fundamentally transform the system and make multiple different contract awards to access best-in-class vendors. The legislation also gives HRSA the authority to implement its goal of creating an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight. In addition, the new law eliminated the arbitrary appropriation cap to fund this work.
HRSA is also taking transformational steps to modernize the critical organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices. This important work on “pre-waitlist” practices will help address inequities in the transplant waitlist process by reducing racial and ethnic variation both in patient referrals and in organ procurement.
HRSA’s latest actions include:
- Releasing a contract solicitation to create an independent OPTN Board of Directors, including supporting a special election to seat a new Board of Directors within six months of contract award. To improve OPTN fairness, provide independent governance, and ensure strong conflict of interest requirements for the Board, HRSA is separating the Board of Directors, implementing robust new requirements to ensure the independence of the new Board, and issuing a solicitation for a non-profit entity with expertise in governance and process improvement to support the independent OPTN Board. This will include:
- Establishing a transitional nominating committee and seeking public input to develop a slate of candidates for a Board of Directors special election.
- Conducting a special election to establish a new, independent OPTN Board of Directors.
- Reviewing and providing recommendations for modernizing OPTN by-laws and conflict of interest policy and supporting Board implementation.
- Reviewing Board composition and structure, making recommendations and supporting implementation of approved reforms to improve functionality and system outcomes.
- Supporting the new Board of Directors in executing its oversight and management responsibilities.
- Issuing a multi-vendor contract solicitation to support broad competition and best-in-class vendors for critical OPTN functions, which will better serve the needs of patients, families, and their care teams. This will include:
- Reviewing and mapping legacy OPTN operations approaches and identifying actionable reforms to improve patient outcomes, system functionality, and system accountability through open competition and heightened HRSA oversight.
- Developing and implementing processes and metrics for monitoring and measuring patient safety, OPTN member performance, and compliance across all OPTN membership types and phases of the organ donation, procurement, waitlist, matching, transportation, and transplantation processes - with a focus on improving patient, donor, and donor family experience.
- Supporting HRSA Modernization Initiative contractors in the development phase of new modular IT functionalities and the transition to a modernized OPTN IT system that leverages industry-leading standards.
- Updating and improving IT infrastructure now as a new modernized OPTN IT platform is built and deployed.
- Providing strategic and administrative services – including improving transparency and increasing public input – to support key OPTN operations functions.
- Analyzing and implementing approved recommendations to improve transplant program waitlist processes and acceptance criteria.
- Launching the discovery and development phase of the transition to a modernized OPTN IT matching system that leverages industry-leading IT standards and practices. The discovery process will help build the foundation for the comprehensive organ matching IT system redesign in the Next Gen IT contract solicitation, which will be released this summer.
- Taking action to address “pre-waitlist” inequities in the organ waitlist process and reduce variations in referrals to transplant and in organ procurement practices. HRSA is directing the current OPTN vendor to standardize and update data reporting on referral to transplant center, time-to-patient assessment, time-to-organ procurement, and other data to allow for greater accountability in organ procurement and transplant practices across geography and populations and facilitate improved system performance.
View the full contract solicitations, information on upcoming informational sessions, and important contract timelines at https://sam.gov.
Previous updates
- December 2023: HRSA's approach to securing best-in-class expertise and an independent Board of Directors
- October 2023: OPTN Transition Contract Updates, Enhanced HRSA and CMS Collaboration, and HRSA Stakeholder Engagement
- September 2023: Enhanced HRSA and CMS Collaboration, HRSA Stakeholder Engagement, and Industry Day
- July 2023: Statement from HRSA Administrator on Passage of the Securing the U.S. Organ Procurement and Transplantation Network Act
- May 2023: The Path Forward
- March 2023: HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative
Provide feedback on the OPTN Modernization Initiative
Frequently asked questions
The modernization initiative will encompass all functions of the OPTN, inclusive of IT and non-IT related activities. As part of the initial phase of the OPTN Modernization Initiative, HRSA is announcing the following actions:
- Build Capacity for Modernization – HRSA is building its capacity to support a modernized OPTN and will be engaging a Program Management Support contractor to assist in the modernization in addition to more than doubling resources available to support the initiative in its FY 2024 President’s Budget request.
- Make Data Available for Critical Decision Making – To assist patients, clinicians, and researchers, HRSA is publishing organ donation and transplantation data to improve data transparency and decision-making. View the OPTN Data Dashboard.
- Engage Stakeholders – HRSA will engage a diverse group of stakeholders early and often to identify and prioritize pressing areas of need for patients and clinicians.
- Improve OPTN functionality – In the next Request for Proposal (RFP), move towards separating OPTN support functions, which may include Board governance, OPTN operations, and IT systems. This approach will diversify the field of potential contractors, encouraging improved functionality through greater competition and innovation.
HRSA endeavors to keep stakeholders and the public apprised of updates in a transparent fashion. HRSA will publish the latest updates on OPTN Modernization Initiative progress on this page.
In addition, to assist patients, clinicians, and researchers, HRSA is publishing organ donation and transplantation data to improve data transparency and decision-making. View the OPTN Data Dashboard.
For all media inquiries, please contact press@hrsa.gov.
Resources
Spanish
- Lea este en español: Actualización de agosto: Mayor colaboración entre la HRSA y los CMS, participación de las partes interesadas de la HRSA y Día de la industria
- Comunicado de prensa en español del 22 de marzo de 2023
- Marzo de 2023: La HRSA anuncia la iniciativa de modernización de la Red de Procuración y Trasplante de Órganos
- Mayo de 2023: El camino a seguir