November 17, 2022 Meeting Summary Federal Register Notice Written Public Comments Agenda TIME AGENDA ITEM SPEAKER 10:00am – 11:05am Welcome Claudia Cohn, MD, PhDCommittee Chair 10:05am – 10:08am Roll Call James Berger, MS, MT(ASCP) SBBDesignated Federal Officer 10:08am – 10:10am Call to Order James Berger, MS, MT(ASCP) SBB 10:10am – 10:15am Purpose of the Meeting Claudia Cohn, MD, PhD Presentations and Committee Business 10:15am – 10:50am Background and History of HOPE Act Dorry Segev, MD, PhDDirector,Center for Surgical and Transplant Applied ResearchNYU Langone Health 10:50am – 11:20pm Kidney and Liver HOPE Transplant Data Christine Durand, MDAssociate ProfessorJohns Hopkins University School of Medicine 11:20pm – 11:40pm Heart HOPE Transplant Data Marcus Pereira, MDAssistant Professor of Medicine Medical DirectorTransplant Infectious Disease Program Columbia University Irving Medical Center 11:40pm – 12:00pm Lung HOPE Transplant Data Ghady Haidar, MDAssistant Professor of Medicine Division of Infectious DiseasesTransplant ID Program University of Pittsburgh and UPMC 12:00pm – 12:30pm Lunch 12:30pm – 1:00pm Discussion on HOPE Act Recommendation & Vote Full Committee 1:00pm – 1:20pm Tissue Biovigilance Systems Presentation Timothy L. Pruett, MDProfessor of Surgery and Internal MedicineUniversity of Minnesota 1:20pm – 1:35pm Discussion on Formation of Tissue Tracking Work Group Full Committee 1:35pm – 2:00pm Alloantibody Exchange Presentation George Hauser, MDAssociate Professor of Laboratory MedicineYale University 2:00pm – 2:20pm Alloantibody Exchange Presentation Meghan Walsh, PhDRose Li and Associates 2:20pm – 2:35pm Alloantibody Exchange Next Steps and Vote Full Committee 2:35pm – 2:45pm Summary of Meeting Claudia Cohn, MD, PhDJames Berger, MS, MT(ASCP) SBB 2:45pm – 3:00pm Wrap-up and Adjournment Claudia Cohn, MD, PhDJames Berger, MS, MT(ASCP) SBB View the Meeting Recording View a recording of the meeting - Part 1 View a recording of the meeting - Part 2 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: OPTN organ-specific variance for each organ other than kidneys and livers 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 Additional organ-specific OPTN outcomes monitoring for candidates of organs other than kidneys and livers on the Waiting List and recipients following transplantation Each center/institution must have an IRB-approved protocol that will include measures of outcomes and safety 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: 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, The US-wide RBC antibody registry be overseen by an appropriate party, The working group shall explore options for standardizing recording of RBC alloantibodies (e.g., using established ISBT-128 codes) in the electronic medical record, The OASH provide a letter of support for the development of the US-wide RBC antibody registry, and The Office of Minority Health provide a letter of support for the development of the US-wide RBC antibody Registry.