Proposed Changes to the OPTN Bylaws Governing Histocompatibility Laboratories

1. Proposed Changes to the OPTN Bylaws Governing Histocompatibility Laboratories

2. OPTN Histo Committee Bylaws Rewrite

3. OPTN Histo Bylaws Rewrite Timeline

4. Problem #1 Problem • Bylaws do not reflect current clinical practice or lab role in organ allocation Changes • Expanded definition of OPTN Histocompatibility Laboratory • Required elements for written agreements with affiliated transplant program or OPO

5. Goals Goals • Labs have adequate facilities, testing and storage equipment, and resources • Eliminate duplicative requirements between OPTN/ASHI/CAP and CLIA Change • Required compliance with the 2012 ASHI standards or 2012 CAP Checklists • Align standards with CLIA requirements and those of transplant hospital members and OPOs (where applicable).

6. Problem #2 Problem • Relatively high number of HLA typing discrepancies still reported in UNet Changes • Separate, enhanced performance standard (90% successful grade) on every antigen reported for HLA typing on graded proficiency testing within a calendar year

7. Problem #3 Problem • Labs fail to notify OPTN of key personnel changes/provide evidence of key personnel coverage Changes • Addition of General Supervisor as a member of key personnel • New deadlines and documentation required for changes in key personnel and applications for new labs

8. What Members Will Need to Do • Written agreements between labs and every transplant program or OPO they serve • Required elements for agreements outlined in the bylaws • Change in key personnel notification within 7 days • Lab Coverage Plan and Personnel Change Application within 30 days of a change in key personnel • A Laboratory Coverage Plan for labs seeking membership • Labs to submit documentation of a 90% successful performance on every antigen reported for HLA typing on proficiency test results each calendar year

9. Proposed Update to the HLA Equivalency Tables in Appendix 3A

10. The Problem • Matching donor antigen equivalences still list broad antigen equivalences for donors • Some unacceptable antigen equivalences unnecessarily disadvantage candidates • Changes approved in 2010 (but not implemented) will substantially lower CPRA scores for some sensitized patients • Current format of tables not user friendly

11. Goal of the Proposal • Eliminate certain equivalences to better define a zero-HLA mismatch and an HLA-DR mismatch level for kidney, kidney-pancreas, and pancreas candidates • Eliminate disadvantages for sensitized patients in the screening process • Improve accuracy in the assignment of CPRA scores

12. How the Proposal will Achieve its Goal • Eliminate 8 broad antigens listed as equivalences in the ‘Matching Antigen Equivalences’ listed for A, B, and DR • Add 4 and delete 62 equivalences in the tables referencing ‘Unacceptable Antigen Equivalences’ • Reverse 2010 policy change • Delete C*13 antigen

13. Additional Background • Unintended consequence of the proposal • Candidates with certain HLA that were typed by serology will not have access to a zero-HLA mismatch offer • Education campaign for transplant centers with patients in this category

14. Supporting Evidence • Reversal of 2010 CPRA Change • DR53 as unacceptable antigen=4,697 kidney registrations and 72 kidney-pancreas and pancreas registrations • Without this proposal: • For 146 registrations patient’s CPRA value will be 3% • For comparison, 49% of deceased donors recovered between June 1, 2011-August 31, 2012 reported as DR53 positive during organ allocation.

15. What Members will Need to Do • Transplant programs may wish to request repeat HLA typing using molecular means for candidates with certain HLA who were previously typed using serology.

16. Questions? • Lee Ann Baxter-Lowe, PhD Committee Chairleeann.baxterlowe@ucsfmedctr.org • Name UNOS Region # Representativename@unos.org • Gena Boyle, MPAUNOS Committee Liaisongena.boyle@unos.org

17. HLA frequencies for deceased donors and kidney, kidney-pancreas and pancreas registrations on the waiting list