OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies

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? • Mark Aeder, MD KPD Work Group Chair mark.aeder@uhhospitals.org • Name Region # representative Email • Gena Boyle Committee Liaison gena.boyle@unos.org