OPTN/UNOS HISTOCOMPATIBILITY COMMITTEE REPORT TO THE BOARD OF DIRECTORS JUNE 25-26, 2012 RICHMOND, VA Nancy L. Reinsmoen, PhD., Chair
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
Problem: CPRA calculation is based on outdated data.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, 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
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
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
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
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
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
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
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 (32.1%) 0 57 (67.9%) 5 Regional (100%) 1 (10%) 01 Committee 19 1 (50%) 0 1 (50%) 17
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
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