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OPTN Kidney Paired Donation (KPD) Histocompatibility Testing
Policies
Kidney Transplantation CommitteeSpring 2014
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
Background
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
The Problem
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
Goal of the Proposal
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
Proposed: HLA Typing
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
Proposed: Antibody Screenings
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
Proposed: Crossmatching
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
Supporting Evidence
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)?
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?
Specific Feedback Request
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
What Members will Need to Do
Mark Aeder, MD KPD Work Group Chair
Name Region # representative Email
Gena Boyle Committee Liaison
Questions?