Histocompatibility Committee Fall 2014

Recent Public Comment Proposals Expanding HLA Typing Requirements Across Organ Types Committee will recommend to the Board programming DQA and DPB fields in DonorNet® (for donor HLA) and Waitlist℠ (for unacceptable antigens) Board review - November 2014 The Committee will recommend that the Board approve the programming option which includes the addition of DQA and DPB fields in DonorNet and add DQA and DPB fields in Waitlist as unacceptable antigens. We decided that UNet should be programmed to automatically avoid donors when unacceptable antigens are listed rather than trying to make a decision in the middle of the night when the organ is initially offered. As a result, the DQA and DPB fields will be mandatory. The required methods and list of HLA loci to be reported will apply both when OPTN policy requires HLA typing be performed and reported on deceased donor prior to allocation (i.e. for kidney, kidney-pancreas, and pancreas allocation) and in instances where HLA typing is required only if requested by the candidate’s transplant program (i.e. for heart, heart-lung, and lung allocation). This proposal newly requires HLA typing to be performed and reported for deceased liver donors if requested by a transplant program and makes HLA typing requirements for deceased pancreas islet donors and candidates consistent with those for deceased pancreas donors and candidates.

New Policies In Effect Histocompatibility Policy Rewrite (effective Sept. 1, 2014) Labs must: Use solid phase test when determining unacceptable antigens Preserve enough specimen from deceased donors to perform subsequent testing for at least five years Perform physical or virtual crossmatch for kidney transplants and multi-organ transplants involving kidney Pending programming (TBD), labs must: Resolve HLA typing discrepancies within 30 days of notification in Tiedi℠ There are several changes to the policies governing histocompatibility testing that took effect on September 1, 2014. Labs are now required to use a solid phase test when determining unacceptable antigens. Labs must preserve enough specimen from deceased donors to perform subsequent testing for at least five years. Labs must perform a physical or virtual crossmatch for kidney transplants and multi-organ transplants involving a kidney. It is worth mentioning that the federal CLIA regulations currently require a physical crossmatch, but the Board agreed with our recommendation that this should be a decision left to the physician in consultation with the laboratory. However, labs are still required to perform a physical crossmatch under federal regulation. We wrote this standard to be broad in the event that the interpretive guidelines for the federal regulation change. One piece of the rewrite requires programming before it becomes effective. After programming is complete, all labs involved in an HLA typing discrepancy must resolve the discrepancy by reporting a reason to UNOS within 30 days of receiving notification in TIEDI®.

Ongoing Committee Initiatives KAS-Desensitization Project Allow highly sensitized kidney candidates who undergo desensitization to keep prioritization points associated with CPRA for a period of time Committee will survey kidney transplant programs The KAS-Desensitization project is a joint project with the Kidney and Minority Affairs Committees. We know that there won’t be any changes to the new kidney allocation system until the policy has been in place for about a year, but we’ve been working to investigate options for equalizing access for very highly sensitized candidates who are undergoing desensitization and allowing them to keep the points associated with their CPRA score for a period of time even while unacceptable antigens are removed. In order to try to understand how many candidates might be in this category, we are planning to distribute a survey to kidney programs early next year to determine if they currently use desensitization and, if they would use it more frequently if this policy were in place. We know that some programs don’t use it because, in some way it actually disadvantages patients to remove unacceptable antigens (if their CPRA score is going to drop below 80%). Since the new system allows for additional priority for highly sensitized candidates, we’d like to increase the likelihood of finding a match by allowing them to have the additional priority and remove some unacceptable antigens for a short window of time. The survey will also help us determine what the community thinks is a reasonable timeframe to keep this prioritization.

Questions? Dolly Tyan, PhD Committee Chair Dtyan@Stanford.edu Regional Rep name (RA will complete) Region X Representative email address Andrew Miller, Esq. Committee Liaison Andrew.Miller@unos.org