December 2025 Board Actions Press Release

02/25/2026

OPTN Board approves removal of OPTN guidance on shortages of pediatric mechanical circulatory support devices and extends the HIV Open Variance

On December 12, 2025, the OPTN Board of Directors convened virtually for its monthly meeting. During this meeting, the Board voted on several OPTN policy updates, including actions to address timely patient safety issues, approval of new policy project proposals, and recommendations related to OPTN membership status changes. The Board also received updates from the Allocation Out of Sequence (AOOS) and Normothermic Regional Perfusion (NRP) workgroups, as well as progress updates on OPTN modernization efforts.

Removal of OPTN guidance on shortages of Pediatric Mechanical Circulatory Support Devices

The Board approved the removal of OPTN guidance related to shortages of pediatric mechanical circulatory support (MCS) devices, as the supply has stabilized.

At its June 9, 2025, meeting, the previous Board approved changes to the Pediatric Heart Exception Requests to address a patient safety concern from shortages of MCS devices and supporting equipment. At the time, the Board also directed the OPTN Heart Transplantation Committee to re-evaluate availability of these devices and recommend whether the guidance should remain in effect.

Ahead of the December Board meeting, the Heart Transplantation Committee recommended removing the guidance. The current Board approved this recommendation during the December 12, 2025, meeting.

Extension of open variance for recovery and transplantation of non-kidney and non-liver organs from donors with HIV

The Board approved a five-year extension of the variance allowing non-kidney, non-liver transplants from HIV-positive donors to HIV-positive recipients to ensure continuity of care for patients served by these programs. The extension will remain in effect through January 15, 2031.

The Board also discussed whether the HIV variance should eventually transition from periodic renewals to permanent policy. HRSA noted that ongoing research requirements currently preclude codification of the variance into OPTN policy.

Other actions

The Board took additional action as follows:

  • Approved summaries from the Board meetings held on July 17, August 1, August 21, September 18, November 7, and November 20, 2025.
  • Approved sending proposed refinements to the Donation After Circulatory Death (DCD) policy aimed at improving safety and standardization, particularly in defining and reporting unplanned pauses during the DCD process.
  • Approved the final seasonal West Nile Virus (WNV) Nucleic Acid Testing (NAT) proposal developed to reduce donor-derived transmission by aligning testing with peak viral prevalence.
  • Approved recommended Membership & Professional Standards Committee (MPSC) Membership Status Changes (See Exhibit A), as follows:
    • Fully approved
      • 1 new transplant hospital
      • 1 new laboratory
      • 7 new transplant programs/components
      • 5 reactivations for transplant programs/components
      • 2 conditional to full approval statuses for programs/components
      • 2 conditional extension requests for programs/components
      • 19 new non-institutional members
      • 15 renewals for non-institutional members.
    • Conditionally approved
      • 2 programs/components for 12 months
      • 2 programs/components for 24 months

Discussion items

The Board heard and discussed status updates on AOOS and NRP workgroup activities and ongoing OPTN modernization initiatives, including:

  • Updates from the AOOS workgroup:
    • The AOOS Offer team is finalizing a standardized definition of an offer and reviewing alignment with national data.
    • The AOOS Expedited Placement Policy (EPP) team developed draft criteria defining when kidneys qualify for expedited placement and will survey organ procurement organizations (OPOs) to validate assumptions.
    • The AOOS Compliance team is evaluating OPO operational practices, systems issues in UNet/DonorNet, and oversight needs to reduce AOOS events.
  • Updates from the NRP workgroup:
    • Following HRSA’s directive, the workgroup is developing new guidelines and standards focused on ethical practices and family experience. The NRP workgroup’s review expanded into specialized subgroups focusing on ethics and consent, surgical practices, and neuromonitoring requirements.
  • Updates on OPTN modernization from HRSA:
    • HRSA provided a comprehensive OPTN modernization update, including the planned migration of the OPTN website to a secure government-managed server, development of new data capabilities, and a transition toward a multi-vendor contracting model under the OPTN Modernization Act to introduce redundancy, resiliency, and improved oversight compared to historical single-vendor models.

Exhibit A. board approved OPTN member status changes

Application TypeRegionOrganization/Member NameProgram
Business – New01TransMedics, Inc.N/A
Program – Conditional Extension01Brigham and Women’s HospitalHR
Business – New02Lonza Walkersville, Inc.N/A
Medical/Scientific Organization – Renewal02International Transplant Nurses SocietyN/A
Medical/Scientific Organization – Renewal02American Society of Transplant SurgeonsN/A
Component – Conditional03Children’s of AlabamaPed LI
Business – New03Asyston Professional LLCN/A
Business – New03Arrowsmith RNsN/A
Business – New03Bluerock Health SystemsN/A
Business – New03DonorLinkN/A
Business – New03Valiant AI, LLCN/A
Component – Conditional03Wellstar MCG Health, affiliated with Medical College of GeorgiaPed KI
Individual – Renewal04GPM Riki GravesN/A
Business – Renewal05Blue Skies Aviation and Logistics LLCN/A
Business – New05Coppel Consulting, LLCN/A
Business – New05Dedicated Donor CallN/A
Business – New05Gravitas Surgical Solutions, LLCN/A
Business – New05Life Giving Resources, Inc.N/A
Business – New05Living Legacy Solutions LLCN/A
Business – Renewal05Specialist DirectN/A
Business – Renewal05Transplant Solutions, LLCN/A
Business – New05Thoracic Transplant Consultants IncN/A
Individual – Renewal06GPM Jill BrownN/A
Individual – Renewal06GPM Kathleen AndersonN/A
New Program07Mayo Clinic Hospital MinnesotaVCA – Other Genitourinary Organ
Component – Conditional to Full07Children’s Hospital of WisconsinPed KI
Program – Reactivation07Aurora St. Luke’s Medical CenterLI
Business – New08Surge Ingenuity, Inc.N/A
Business – Renewal08XVIVO Services Inc.N/A
Individual – Renewal08GPM Eric PahlN/A
Program – Reactivation08Children’s Mercy HospitalKI
Program – Reactivation08Children’s Mercy HospitalLI
Component – Reactivation08Children’s Mercy HospitalPed KI
Component – Reactivation08Children’s Mercy HospitalPed LI
Business – Renewal09Buckeye Transplant ServicesN/A
Component – Conditional to Full09Montefiore Medical CenterPed KI
New Lab09Mount Sinai Laboratory – Histocompatibility and ImmunologyN/A
Program – Conditional Extension09State University of New York Upstate Medical UniversityPA
Component – Conditional09Westchester Medical CenterLDL
Public Organization – Renewal09New York Center for Kidney Transplantation, IncN/A
Public Organization – Renewal09National Kidney FoundationN/A
Business – New10Network for LifeN/A
New Program10Mercy Health – St. Vincent Medical CenterKI
New Component10Mercy Health – St. Vincent Medical CenterLDK
New Transplant Hospital10Mercy Health – St. Vincent Medical CenterN/A
New Program10University Hospitals of ClevelandPI
Business – Renewal11Donor Call Solutions, LLCN/A
Business – Renewal11OmniLife, Inc.N/A
Business – New11OrganLink PlusN/A
Business – New11Transplant Advocates, LLCN/A
Business – New11United Network for Organ SharingN/A
New Program11MUSC Children’s HospitalLI
New Component11MUSC Children’s HospitalPed LI
New Program11Prisma Health Greenville Memorial HospitalLI
Program – Conditional11Sentara Norfolk General HospitalPA
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