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OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies

OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies. Kidney Transplantation Committee Spring 2014. Background. Kidney Committee distributed KPD policies for public comment in March 2012 A number of commenters had concern with histo section due to missing requirements

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OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies

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  1. OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies Kidney Transplantation Committee Spring 2014

  2. Background • Kidney Committee distributed KPD policies for public comment in March 2012 • A number of commenters had concern with histo section due to missing requirements • Professional societies brought together a KPD consensus conference around same time • This proposal incorporates • spring 2012 OPTN public comment feedback • findings from KPD consensus conference • recommendations from OPTN Histo Committee

  3. The Problem • Low match success rate in KPD program • Antibody related issues and positive crossmatches continue to account for a number of match failures • Insufficient histocompatibility testing requirements to prevent match failure

  4. Goal of the Proposal • Increase match success rate in KPD program by preventing unexpected positive crossmatches that can break chains and prevent candidates and donors from accessing subsequent match runs and transplant opportunities • Promote transplant safety through more effective screening of kidney offers

  5. Proposed: HLA Typing • Molecular HLA typing required for donors and candidates • Loci required for donors: HLA-A, B, Bw4, Bw6, C, DR, DR51, DR52, DR53, DPB, DQA, DQB • Loci required for candidates: HLA-A, B, Bw4, Bw6, DR • If candidate has unacceptable antigens, additional loci required: C, DR51, DR52, DR53, DPB, DQA, DQB • Candidate’s hospital must retype donor to confirm HLA type

  6. Proposed: Antibody Screenings • Candidate’s transplant hospital must screen for antibodies at all of the following times: • every 90 days • when potentially sensitizing event occurs • if candidate reactivated after more than 90 inactive days • if unacceptable positive crossmatch occurs that prevents transplant with matched donor • Labs must use method at least as sensitive as crossmatch method • Physician/surgeon (or designee) and lab director (or designee) must review and confirm UA’s listed for candidate

  7. Proposed: Crossmatching • Candidate’s transplant hospital must perform physical crossmatch before donor’s nephrectomy is scheduled • Must report crossmatch results to donor’s transplant hospital and UNOS • If unacceptable positive crossmatch occurs between candidate and matched donor, candidate’s hospital must inactivate candidate before next match run, review the unacceptable antigens (UA), and report reason to UNOS w/in 7 days • Candidate can be reactivated once review and update (if applicable) of UAs is complete

  8. Supporting Evidence • Crossmatch-related refusals (postive crossmatch or unacceptable antigens) account for ~30% of failed matches • 61 programs had accepted at least one match offer for which the entire exchange fell through • Some programs may have had a disproportionately high number of crossmatch-related refusals • 39 programs refused at least one match offer due to a crossmatch-related reason

  9. Specific Feedback Request • If unacceptable positive crossmatch occurs between candidate and matched donor, candidate’s hospital must inactivate candidate in the KPD program before next match run • If this change is approved, is it less burdensome for transplant programs if the inactivation is automatic (completed by UNOS)?

  10. Specific Feedback Request • Is it burdensome to require antibody screenings every 90 days for ALL candidates (even if not sensitized?) • Should longer timeframe between screenings apply for non-sensitized candidates? • 180 days?

  11. What Members will Need to Do • Donor’s transplant hospital responsible for reporting donor HLA info, arranging shipment of donor blood sample to candidate’s hospital or histo lab • Candidate’s transplant hospital responsible for reporting candidate HLA info, confirming donor HLA info, antibody screening requirements, crossmatching requirements

  12. Questions? • Richard Formica, MD Committee Chair • Name Region # Representative Email • Gena Boyle Committee Liaison gena.boyle@unos.org

  13. Backup Slides

  14. KDPI

  15. Point changes: Sensitization CPRA Sliding Scale (Allocation Points) (CPRA<98%) 20 17.30 18 New 16 14 12.17 12 10.82 10 Points 8 Current 6.71 6 4.05 4 2.46 1.58 2 1.09 0.81 0.48 0.34 0 0 0.21 0.08 0 0 0 10 20 30 40 50 60 70 80 90 100 CPRA CPRA

  16. Summary: Member responsibilities

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