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OPTN/UNOS Histocompatibility Committee
Fall 2012 Public Comment Cycle
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Recently Approved Proposals
Proposed Updates to CPRA Update frequencies to calculate CPRA for kidney/kidney- pancreas/pancreas registrations Add HLA-C to CPRA calculation Add mandatory field to Waitlist to better interpret CPRA value of 0% Status No changes post public comment Board approved - June 2012 Implementation after programming The board of directors approved two histocompatibility committee proposals in June, both of which went through public comment last spring. The first proposal deals with three actions to update CPRA. These include updating the outdated frequencies used to calculate CPRA, adding HLA-C to the CPRA calculation and adding a mandatory field to waitlist to better interpret a CPRA value of 0%. Labs that enter a 0% CPRA will have to answer the question, “Was this candidate tested for HLA antibodies?” by choosing one of the following options: Yes, antibodies detected Yes, no antibodies detected No, not tested. These changes will be implemented after programming is complete.
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Recently Approved Proposals
Technical Changes to Bylaws Governing Histo Labs Two proposed changes removed after public comment Credentialing for key personnel Chimerism testing Status Board approved - June 2012 Effective September 1, 2012 The board also approved several technical changes to the OPTN bylaws governing histocompatibility. These changes were part of the larger effort to consolidate and re-organize the OPTN bylaws. There were two controversial changes dealing with credentials for laboratory directors and chimerism testing that the committee removed as a result of the public comments received. The board approved the technical changes in June. Since they do not require computer programming, they will be effective on September 1st.
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Ongoing Committee Initiatives
Comprehensive rewrite of histo bylaws and policies Monitor implementation of CPRA Monitor discrepant HLA typing reports The committee has three major ongoing projects: a comprehensive rewrite of OPTN/UNOS bylaws and policies that govern histo labs, monitoring the use of CPRA in the transplant community and monitoring discrepant HLA typing reports in UNet. As you know, OPTN policy requires labs to resolve discrepant HLA typing reports. The committee will look very closely at unresolved reports this year and determine whether future policy proposals are needed to ensure accuracy of HLA typing.
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Bylaws/Policy Rewrite
Major issues in bylaws/policy rewrite Amend standards to reflect current clinical practice Accuracy of HLA Typing Requirements for Key Laboratory Personnel Requirements for Changes in Key Laboratory Personnel Finally, I want to concentrate for a minute on some of the major issues that the committee will look at this year in the comprehensive policy and bylaws rewrite. The committee will identify areas where language is outdated and doesn’t reflect current clinical practice. The committee will also address the accuracy of HLA typing in the rewrite. We discussed possible solutions to the discrepancies we are seeing in UNet, including requiring donor retyping prior to transplant in certain instances (for example when antibodies are reported, when CPRA is above 80% or when a virtual crossmatch is used). We will also look at membership requirements for laboratories and how we might make them more consistent with transplant hospitals. Examples include requirements for coverage plans for key personnel and more defined timelines for reporting changes in key personnel. We welcome your feedback while we conduct this comprehensive rewrite. If there are issues not discussed here that you think the rewrite subcommittees should consider, please contact me to let me know.
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New Committee Initiatives
Optional Waitlist and DonorNet fields for DQA and DPB antibodies Public Comment - Spring 2013 Updates to equivalency tables The committee will also draft two public comment proposals for Spring One will add an optional field in Waitlist and DonorNet to record the presence of DQA and DPB antibodies. The second will be an update to the equivalency tables used to calculate CPRA.
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Histocompatibility Committee Contacts
Chair: Lee Ann Baxter-Lowe, PhD Vice Chair: Dolly Tyan, PhD Committee Liaison: Gena Boyle, MPA Here are contacts for the histo committee leadership and UNOS staff liaison. Are there any questions?
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