Histocompatibility Committee Spring 2014

Recently Implemented Updates to Calculated Panel Reactive Antibody (CPRA) More recent cohort used to calculate HLA and ethnic frequencies Addition of HLA-C Addition of required question on Waitlist℠ for KI, K/P, PA candidates-Effective March 20, 2014 Was this candidate tested for anti-HLA antibodies? -Yes, antibodies detected -Yes, no antibodies detected -No, not tested To start, I’ll give you a quick update on several new policies and programming that UNOS recently implemented. First, effective December 5, 2013, the CPRA calculation now includes HLA and ethnic frequencies from a more recent cohort of deceased donors. And, frequencies for HLA-C are now included in the calculation. Starting on March 20, the waiting list for kidney, kidney-pancreas, and pancreas candidates will require users to answer a question about whether the candidate was tested for HLA antibodies. The question will be required for new registrations and when edits are made for existing kidney, kidney-pancreas, and pancreas candidates. The question and answer will be displayed on match runs and is intended to help the transplant team better interpret a CPRA score when making organ acceptance decisions, especially in instances where the CPRA score does not reflect whether a candidate has HLA antibodies. For instance, before HLA-C was added into the CPRA calculation, a candidate with antibodies to HLA-C could have had unacceptable antigens listed for HLA-C, but the CPRA calculation did not include those. Right now, the UNOS system does not capture DQA, DPA, or DPB, so these are not included in the current CPRA either. (The first step in getting those included into the calculation is to add these fields so we can capture data on the frequency that these are reported in the current donor pool.)

Recently Implemented Changes to Histo Bylaws—Effective Feb. 1, 2014 Notify UNOS within 7 days of change in key personnel, ubmit a personnel change application and lab coverage plan within 30 days Includes key personnel who accept additional responsibilities for more than 30 days at another histo lab Must have qualified director, tech supervisor, and clinical consultant at all times (including periods of key personnel transition) Must have written agreements with every affiliated OPO or transplant hospital Agreements must contain certain elements There are also a number of new changes to the bylaws governing histo labs in effect as of February 1. Let’s go over those and what you need to do. First, if your lab has a change in key personnel (lab director, tech supervisor, or clinical consultant), you must notify UNOS within 7 days of learning of the change. If you do not know how to notify UNOS directly, contact your regional administrator for help. After notifying UNOS, you must submit a completed personnel change application (UNOS will provide this for you) and laboratory coverage information to UNOS within 30 days. A change in key personnel now includes when the primary histo lab director accepts additional responsibilities for more than 30 days at another histo lab. And, your lab must have qualified key personnel coverage throughout any transition periods. This is all to ensure that there are qualified key personnel available to provide consultation to the OPO or transplant team. Finally, your lab must have written agreements with every transplant program or OPO that you serve. And, those agreements must address certain elements outlined in the bylaws. Please take a look at the bylaws to be sure your written agreements are in compliance. UNOS will ask for this information with any change in key personnel and new laboratory application.

Laboratory Coverage Plan Availability of key personnel List of key personnel responsibilities delegated to other staff Documentation that qualified staff are available to perform testing (24-hour coverage if DD testing for KI, K-P, or PA) If key personnel serve multiple labs, how continuous coverage is provided at each lab served Here’s a list of things that labs must provide in the laboratory coverage plan. We are looking for documentation about the availability of key personnel for facilitating organ acceptance decisions, a list of responsibilities designated to any key personnel who are being performed by someone other than the individual in that position, and documentation of key personnel coverage at all times. For labs with key personnel who serve more than one laboratory, the coverage plan must include how continuous coverage is being provided at each lab served.

Questions? Lee Ann Baxter-Lowe Committee Chair lbaxterlowe@chla.usc.edu Name Region # Representative Email Gena Boyle Committee Liaison gena.boyle@unos.org