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Histocompatibility Committee

Histocompatibility Committee. Fall 2013 Update. Recent Public Comment Proposals. Proposed Changes to the HLA Equivalency Tables Approved November 11, 2013 Effective with programming and notice to membership. Recent Public Comment Proposals. Changes to the OPTN Bylaws governing histo labs

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Histocompatibility Committee

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  1. Histocompatibility Committee Fall 2013 Update

  2. Recent Public Comment Proposals Proposed Changes to the HLA Equivalency Tables • Approved November 11, 2013 • Effective with programming and notice to membership

  3. Recent Public Comment Proposals Changes to the OPTN Bylaws governing histo labs • Effective February 1, 2014 • Amended definition of OPTN histo lab • New deadlines and documentation for reporting changes in key personnel • Compliance with 2012 ASHI standards and CAP checklists

  4. Recent Public Comment Proposals Changes to the OPTN Bylaws governing histo labs • Removed provision adding General Supervisor to list of key personnel • Removed provision requiring 90% grade on HLA typing portion of proficiency testing

  5. Final Rule/OPTN Bylaws Article I.F Final Rule: “No OPTN member is required to become a member of any organization that is a parent, sponsor, contractor, or affiliated organization of the OPTN, comply with the bylaws of such organization, or to assume any corporate duties or obligations of any such organization.”

  6. Compromise Language Each histocompatibility laboratory must comply with the requirements, as they apply to solid organ and islet transplantation, of the American Society for Histocompatibility and Immunogenetics (ASHI) 2012 Revised Standards for Accredited Laboratories, or the College of American Pathologists (CAP) Histocompatibility Checklist, Laboratory General Checklist, Flow Cytometry Checklist, and Team Leader Assessment of Director and Quality Checklist as of September 25, 2012. This requirement does not mandate membership in either ASHI or CAP.

  7. New Committee Initiatives • New Kidney Allocation System-CPRA scores for patients undergoing desensitization • Research impact of DR and DQB mismatching • Assessing feasibility of allele level typing in UNet

  8. Recent Board Proposal Adding optional fields for DQA/DPB into DonorNet and Waitlist Not Approved Next steps • Revise estimate for fields in DonorNet only • Gather additional evidence • Educate OPOs/labs option to use .pdf upload • Collaborate with organ specific committees

  9. *For deceased heart and lung donors, if a transplant hospital requires donor HLA typing prior to submitting a final organ acceptance, it must communicate this request to the OPO and the transplant hospital must provide the HLA information required in the table above and document this request. The transplant hospital may request HLA-DPB typing, but the OPO need only provide it if its affiliated laboratory performs related testing.

  10. Questions? • Lee Ann Baxter-Lowe, Committee Chairleeann.baxterlowe@ucsfmedctr.org • Region # Representativename@email • Gena Boyle, Committee Liaisongena.boyle@unos.org

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