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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

OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Policies

Kidney Transplantation Committee

Spring 2014

background
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
the problem
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
goal of the proposal
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
proposed hla typing
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
proposed antibody screenings
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
proposed crossmatching
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
supporting evidence
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
specific feedback request
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)?
specific feedback request1
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?
what members will need to do
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
questions
Questions?
  • Richard Formica, MD Committee Chair
  • Name Region # Representative Email
  • Gena Boyle Committee Liaison gena.boyle@unos.org
point changes sensitization
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