Thursday, May 25, 2023

HRSA's Organ Procurement and Transplantation Network Modernization Initiative

 The Health Resources and Services Administration (HRSA) has announced a timeline for moving forward on the proposal to reorganize the system for obtaining and distribution deceased donor organs for transplant, aiming for a request for proposals in the Fall.

Organ Procurement and Transplantation Network Modernization Initiative   May 2023 Updates

"On March 22, 2023, the Health Resources and Services Administration (HRSA) announced a Modernization Initiative to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN). The initiative is focused on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation. As part of our commitment to transparency around the Modernization Initiative, HRSA is providing an update on our upcoming action steps.

The OPTN Modernization Initiative is centered on putting patients first, prioritizing information flow to clinicians, promoting innovation through continuous competition, and enhancing transparency and accountability. HRSA's planned approach and timelines for the first year of the multi-year modernization process focuses on design, implementation, and oversight, including contract solicitations that will be released Fall 2023 and Spring 2024. In addition, HRSA continues to pursue the legislative changes and increased funding included in the President's Fiscal Year 2024 budget to implement and advance the Modernization Initiative.

Summer 2023

Phase 1: OPTN Modernization Design & Strategy Development  

External Engagement and Design Planning Contract  – HRSA is currently conducting market research to inform the development of the upcoming Fall contract solicitations and will host an Industry Day for interested parties and vendors this Summer. Building on our outreach efforts over the past year, HRSA also will continue to ensure that patient, family, and clinician voices are engaged in this work, including through focus groups and other approaches. HRSA recently awarded a program management contract to support this stakeholder engagement as well as strategic and operational planning and change management.

Fall 2023

Phase 2A: OPTN Transition Management

HRSA recognizes the vital need to maintain uninterrupted access to the critical systems and functionality that support organ matching and transplantation during the modernization process. Working with the best technologists in the U.S. Government, HRSA expects to conduct this work on a dual track so that there are appropriate safeguards to ensure no disruptions in service as part of modernization implementation. Therefore, HRSA will support two significant multi-vendor solicitations between now and Spring 2024 – with the first solicitation to be issued this Fall 2023. This action will be followed by a Spring 2024 solicitation to further the next generation OPTN, as noted below. 

Competitive OPTN Transition Contracts – This Fall, HRSA plans to release a solicitation to establish new contracts that will support and enhance OPTN operations while the modernization process is underway. These contracts will ensure the continuation of critical OPTN support functions and enable appropriate upgrades on a parallel track with modernization. The Fall 2023 solicitation will seek multiple vendors for distinct functions – including supporting a separate OPTN Board of Directors – to ensure service continuity and increase oversight and accountability.

To ensure that the OPTN Transition contracts are developed in a way that meets the needs of all stakeholders, HRSA is committed to soliciting feedback from interested parties during the development and implementation of this work. By involving stakeholders in the process, HRSA can ensure that the Transition contracts advance the goals of the OPTN Modernization Initiative, provide optimal support to protect patient safety, and ensure the efficient functioning of the OPTN.

Spring 2024

Phase 2B: OPTN Modernization Implementation

In Spring 2024, HRSA intends to release a solicitation for multiple vendors to support the next generation of the OPTN, which will include enhancements in technology, governance, data transparency and operations. The separate Board of Directors contract and the deliverables from this next generation solicitation will form the foundation of a new, modernized OPTN. 

OPTN Next Generation Contracts – The proposed OPTN Next Generation contracts will represent a significant step forward in modernizing the OPTN’s foundational IT systems. In Spring 2024, HRSA expects to release a solicitation seeking multiple vendors for the OPTN Next Generation contracts to provide a comprehensive approach to modernizing the OPTN. The goal of this solicitation is to find contractors who will use innovative, best in class approaches to carrying out specific functions, including initial prototyping, testing, scaling, integration, deployment, and adoption support.  

HRSA is committed to transparency in the OPTN Modernization process and will continue to provide updates on our iterative approach toward achieving enhanced accountability, equity, and performance in the organ transplantation system, as appropriate, as this work moves forward."

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Here's a NYT story covering the announcement, with some background:

U.S. Organ Transplant System, Troubled by Long Wait Times, Faces an Overhaul The Biden administration announced a plan to modernize how patients are matched to organs, seeking to shorten wait times, address racial inequities and reduce deaths.  By Sheryl Gay Stolberg

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