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

Richard Formica, MD Committee Chair

Name Region # Representative Email

Gena Boyle Committee Liaison gena.boyle@unos.org

Questions?

Backup Slides

KDPI

Point changes: Sensitization

CPRA

0 0 0 0.08 0.21 0.34 0.48 0.81 1.091.58 2.46

4.05

6.71

10.82

12.17

17.30

02468

101214161820

0 10 20 30 40 50 60 70 80 90 100

Po

ints

CPRA Sliding Scale (Allocation Points)(CPRA<98%)

Current

New

CPRA

Summary: Member responsibilities

Communicate importance of early referral

Establish protocols for A2 and A2B donors to B candidates

Report/update data to calculate EPTS and waiting time

Review candidates to identify prior living organ donors

Establish KDPI acceptance criteria and update consents for KDPI>85%

Review waiting list for unacceptable antigens

Review “other” donor screening criteria

Educate candidates and potential candidates on changes