Fifty-Sixth ACBTSA Meeting: November 17, 2022

November 17, 2022

Meeting Summary

Federal Register Notice

Written Public Comments

Agenda

TIMEAGENDA ITEMSPEAKER
10:00am – 11:05amWelcomeClaudia Cohn, MD, PhD
Committee Chair
10:05am – 10:08amRoll CallJames Berger, MS, MT(ASCP) SBB
Designated Federal Officer
10:08am – 10:10amCall to OrderJames Berger, MS, MT(ASCP) SBB
10:10am – 10:15amPurpose of the MeetingClaudia Cohn, MD, PhD
Presentations and Committee Business
10:15am – 10:50am   Background and History of HOPE ActDorry Segev, MD, PhD
Director,
Center for Surgical and Transplant Applied Research
NYU Langone Health
10:50am – 11:20pmKidney and Liver HOPE Transplant DataChristine Durand, MD
Associate Professor
Johns Hopkins University School of Medicine
11:20pm – 11:40pmHeart HOPE Transplant DataMarcus Pereira, MD
Assistant Professor of Medicine Medical Director
Transplant Infectious Disease Program Columbia University Irving Medical Center
11:40pm – 12:00pmLung HOPE Transplant DataGhady Haidar, MD
Assistant Professor of Medicine Division of Infectious Diseases
Transplant ID Program University of Pittsburgh and UPMC
12:00pm – 12:30pmLunch
12:30pm – 1:00pmDiscussion on HOPE Act Recommendation & VoteFull Committee
1:00pm – 1:20pmTissue Biovigilance Systems PresentationTimothy L. Pruett, MD
Professor of Surgery and Internal Medicine
University of Minnesota
1:20pm – 1:35pmDiscussion on Formation of Tissue Tracking Work GroupFull Committee
1:35pm – 2:00pmAlloantibody Exchange PresentationGeorge Hauser, MD
Associate Professor of Laboratory Medicine
Yale University
2:00pm – 2:20pmAlloantibody Exchange PresentationMeghan Walsh, PhD
Rose Li and Associates
2:20pm – 2:35pmAlloantibody Exchange Next Steps and VoteFull Committee
2:35pm – 2:45pmSummary of MeetingClaudia Cohn, MD, PhD
James Berger, MS, MT(ASCP) SBB
2:45pm – 3:00pmWrap-up and AdjournmentClaudia Cohn, MD, PhD
James Berger, MS, MT(ASCP) SBB

View the Meeting Recording

Recommendations Considered

The recommendation pertaining to HIV positive to HIV positive organ transplantation adopted by the ACBTSA is as follows:

For the transplantation of organs from HIV-positive donors into HIV-positive recipients

Kidneys and Livers – remove statutory “NIH Research Criteria and IRB” requirement (with no special restrictions other than the applicable OPTN kidney and liver policies).

All other organs including thoracic organs – remove statutory “NIH Research Criteria” requirement BUT recommend the Secretary direct the OPTN to develop and implement the following new special policies:

  1. OPTN organ-specific variance for each organ other than kidneys and livers
  2. Additional organ-specific candidate criteria and transplant program requirements analogous (but not “identical”) to the NIH Research Criteria developed specifically for the unique patient safety and outcomes monitoring characteristics of transplants other than kidneys and livers in HIV patients
  3. Additional organ-specific OPTN outcomes monitoring for candidates of organs other than kidneys and livers on the Waiting List and recipients following transplantation
  4. Each center/institution must have an IRB-approved protocol that will include measures of outcomes and safety
  5. When multiple organs are transplanted simultaneously, the default approach will be to use the guidelines of the organ with more conservative policies

The OPTN should develop and implement the above-listed new special policies within 15 months of receiving this request from the Secretary of Health and Human Services

These criteria will be reviewed and re-evaluated 2 years after implementation.

The recommendation pertaining to the creation of a Working Group to explore a Red Blood cell antibody exchange-repository adopted by the ACBTSA is as follows:

Whereas the Committee finds that:

  • Red cell alloantibodies can cause significant morbidity and mortality when incompatible blood is transfused.
  • Red cell alloantibodies can be missed in patients when antibody levels drop below the level of detection or during emergencies when blood must be issued prior to testing.
  • Patients with SCD have a higher prevalence of alloantibodies against RBCs when compared to the general population.
    • Patients in the US (including those with SCD) have fragmented care, with incomplete medical records at different hospitals.
    • The higher prevalence of alloantibodies and the fragmented care increase the risk of DHTR in patients with SCD.
  • Patients with SCD are an underserved minority population who are disproportionately affected by DHTR. These reactions, which occur in 3-5% of transfusions in patients with SCD, are fatal 11% of the time.
  • The establishment of a US-wide RBC Antibody Registry would mitigate the risk of DHTR for all patients.
    • A 50% reduction in DHTRs was achieved in The Netherlands after their national registry was introduced.
  • A registry with patients’ blood types can further improve the transfusion safety by reducing the chance of blood misadministration and ABO-associated acute hemolytic transfusion reactions due to sample collection errors.

The committee therefore recommends that:

  1. A workgroup of blood transfusion experts convened by the ACBTSA continue to support the establishment of a US-wide RBC antibody registry,

    1.1 This registry may include alloantibody, antigen, and phenotype/genotype data as the capability to include these data is developed,

  2. The US-wide RBC antibody registry be overseen by an appropriate party,
  3. The working group shall explore options for standardizing recording of RBC alloantibodies (e.g., using established ISBT-128 codes) in the electronic medical record,
  4. The OASH provide a letter of support for the development of the US-wide RBC antibody registry, and
  5. The Office of Minority Health provide a letter of support for the development of the US-wide RBC antibody Registry.
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