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OPTN/UNOS HISTOCOMPATIBILITY COMMITTEE REPORT TO THE BOARD OF DIRECTORS JUNE 25-26, 2012 RICHMOND, VA Nancy L. Reinsmoen, PhD., Chair
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1. Update HLA frequencies used to calculate CPRA for kidney, kidney/pancreas and pancreas registrations 2. Add HLA-C to CPRA calculation 3. Add mandatory field to Waitlist sm to better interpret 0% CPRA value 14-Support, 0-Opposed, 0-Abstain Updates to CPRA
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Problem: CPRA calculation is based on outdated data. CPRA currently calculated using HLA frequencies gathered from deceased kidney donors from Jan 1, 2003-Dec 31, 2004 Updated data are available (gathered from January 1, 2007- December 31, 2008) Data show updated frequencies will improve accuracy and substantially increase CPRA values (above 80%) for some kidney registrations (=500) Updating HLA Frequencies
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Problem: The current CPRA calculation disadvantages candidates sensitized to HLA-C Candidates with HLA-C are screened from match runs but do not receive points toward higher CPRA value More than 10,000 kidney registrations have at least one unacceptable HLA-C antigen reported Addition of HLA-C to CPRA Calculation
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Problem: The current field displaying CPRA score does not provide needed information on candidates with 0% CPRA who have unacceptable antibodies or have not been tested Current field does not describe reason for 0% CPRA or indicate if testing occurred /patient is sensitized Mandatory field in Waitlist℠ will provide info on testing and presence of antibodies Question: Was this candidate tested for antibodies? Yes, antibodies detected Yes, no antibodies detected No, not tested Mandatory Waitlist℠ Field for 0% CPRA
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Number of Positive Crossmatches Reported as a Reason for Organ Refusal for Adult Kidney Alone Registrations Note: The data are based on deceased donor kidney match runs for donors with at least one kidney accepted for transplant. Offers that could not be accepted for a registration were excluded from the total offer count except for those refused due to the positive crossmatch. Multiple offers for the same donor were counted only once per registration. 10,545
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Update to CPRA: Public Comment Type of Response Response Total In Favor In Favor as Amended Opposed No Vote/ No Comment / Did not Consider Individual31 24 (92.3%) 0 2 (7.7%) 5 Regional11 10 (90%) 1 (10%) 00 Committee19 7 (100%) 0012
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RESOLVED, that the CPRA calculation and related fields in Waitlist℠ shall be modified as set forth in Resolution 17, effective pending programming and notice to the membership: Update the HLA frequencies used to calculate CPRA; Add HLA antigen C to the CPRA algorithm; and Add mandatory field to Waitlist℠ for all kidney, kidney/pancreas, and pancreas candidates to determine if a candidate has been tested for antibodies and having this field display in reports and on match runs. Resolution
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Problem: The UNOS/OPTN bylaws governing histocompatibility laboratories are antiquated. Part of larger effort to consolidate, re-organize and simplify OPTN/UNOS bylaws Some amendments made and language withdrawn post-public comment period; Committee will revisit later this year Final committee vote was in support with amendment to retain word “exempt” in subcontracting language Committee vote: 3-Support, 9-Support with Amendment, 1-Opposed; 0-Abstain Revisions to Appendix C
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Revisions to Appendix C Public Comment Type of Response Response Total In Favor In Favor as Amended Opposed No Vote/ No Comment / Did not Consider Individual 89 27 (32.1%) 0 57 (67.9%) 5 Regional 11 10 (100%) 1 (10%) 01 Committee 19 1 (50%) 0 1 (50%) 17
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RESOLVED, that the following modifications to Appendix C (Membership Requirements for Histocompatibility Laboratories) are hereby approved as set forth in Resolution 2, effective September 1, 2012: Resolution
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RAIS was recently revised Original assessment assumed need for match run testing but only change is a display field in candidate information section in DonorNet Clarification resulted in more than a 50% decrease in the number of hours associated with the proposal. Cost of proposal is under $100K CPRA Update: Cost Assessment
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