Expanding HLA Typing Requirements

(Resolution 10)

Histocompatibility CommitteeDolly Tyan, PhD Chair

Strategic Plan

New KAS takes effect in December

Candidates with CPRA greater than 98% will receive regional and national priority before all other kidney candidates

Literature shows a significant number of sensitized candidates have antibodies to HLA-DQA/DPB

There are currently no fields in DonorNet® to report these HLA types on donors or in Waitlist℠ as unacceptable antigens for candidates

Without this information, there is a high risk for discards and increased CIT in KAS

The Problem

Sequence AKDPI <=20%

Sequence BKDPI >20% but

<35%

Sequence CKDPI >=35% but

<=85%

Sequence DKDPI>85%

Highly Sensitized0-ABDRmm (top 20% EPTS)Prior living donorLocal pediatricsLocal top 20% EPTS0-ABDRmm (all)Local (all)Regional pediatricsRegional (top 20%)Regional (all)National pediatricsNational (top 20%)National (all)

Highly Sensitized0-ABDRmmPrior living donorLocal pediatricsLocal adultsRegional pediatricsRegional adultsNational pediatricsNational adults

Highly Sensitized0-ABDRmmPrior living donorLocal RegionalNational

Highly Sensitized0-ABDRmmLocal + Regional National

CPRA greater than 98%

Other Problems

HLA DQA and –DPB reported when typing is performed on DD. Program DQA and DPB fields in DonorNet® and Waitlist® as unacceptable antigens

Require consistent and complete list of loci reported on DD

Require molecular methods when performing HLA typing on DD

Align policy requirements for deceased islet donors and candidates with those of pancreas donors and candidates

Proposed Changes

Overall Project Impact

All deceased donors, candidates, and recipients. Special emphasis for highly sensitized candidates and all kidney candidates.

Frequency of DQA/DPB UAs

% of KPD Candidates with HLA-DPB and DQA UAs

N=462

CPRA ValueNote that for kidney waiting list: 84% have CPRA 0-79%, 4% - 80-94%, 5% - 95-99 and 6% - 100%

Two Programming Options

Pro: •Allows deceased donor HLA info to be reported for these types•Slight reduction in IT programming estimate

(still in large category)Con: •Patient safety concerns •Burdensome for transplant programs•Inconsistent with programming for all other HLA reporting and the KPD program•Committees expressed patient safety concerns

Pro: •Eliminates patient safety concerns •Less burdensome to transplant programs•Consistent with KPD programming•Supported by community (based on feedback from regions, Kidney Committee, OPO Committee, Pancreas Committee, Operations and Safety Committee, and ASHI)Con: •Higher IT programming cost (very large category)

Cost-Benefit Analysis

Public Comment/Professional Society Feedback

The Board is asked to approved additions and changes to Policies 2.11.A (Required information for Deceased Kidney Donors); 2.11.B (Required information for Deceased Liver Donors); 2.11.C (Required Information for Deceased Heart Donors); 2.11.D (Required Information for Deceased Lung Donors); 2.11.E (Required Information for Deceased Pancreas Donors); 3.4.D (Candidate Human Leukocyte Antigen (HLA Information); and 4.2 (Requirements for Performing and Reporting HLA Typing) to provide greater consistency in HLA typing requirements across organ types.

*Page 74 of Board book

RESOLUTION 20

Extra Slides

Background

HLA Typing Requirements for Deceased Donors

Organ A B Bw4 Bw6 C DR DR51 DR52 DR53 DPB DQA DQB

Kidney • • • • • • • • •   •

Pancreas • • • • • • • • •   •

Kidney-Pancreas • • • • • • • • •   •

Heart* • • • • • •       • •

Lung* • • • • • •       • •

Liver                      

Pancreas Islet                      *For deceased heart and lung donors, if a transplant hospital requires donor HLA typing prior to submitting a final organ acceptance, it must communicate this request to the OPO and the OPO must provide the HLA information required in the table above and document this request. The transplant hospital may request HLA-DPB typing, but the OPO need only provide it if its affiliated laboratory performs related testing.

Supporting Evidence DPB Typed Deceased Donors