Histocompatibility Laboratory Bylaws and Policies Guidance Document Histocompatibility Committee

What problem will the proposal solve? Some policy and bylaw sections are better suited as guidance Some current histocompatibility bylaws and policies are vague As part of the histocompatibility comprehensive policy and bylaw rewrite in 2014, the Committee started this guidance document to provide clarity and suggested best practices for members on OPTN policies and bylaws. During the rewrite, the Committee identified 28 sections of policy that would be better suited for guidance because they were Difficult to monitor by UNOS Already standards required by ASHI or CAP Recommendations or suggestions for practice, not actual policies (i.e. not “must”s) The guidance document will help provide clarity for problems related to misinterpretation of the current OPTN/UNOS policies and bylaws.

What are the proposed solutions? Create guidance document as a tool for laboratories to provide clarity on OPTN policy and bylaws requirements Provide a template for best practices The guidance document contains what remains of the 28 original sections removed from policy and designated for the guidance document information for better compliance with histocompatibility policies and bylaws that were identified as potentially vague The Committee formed a Guidance Document Subcommittee (the Subcommittee). They reviewed the 28 sections individually and, along with the earlier considerations (difficult to monitor by UNOS, already standards required by ASHI or CAP, policies were really recommendations or suggestions and not “must”s) discussed whether certain sections were out of date and consequently no longer relevant or redundant to other existing policies.   After reviewing and paring down the original 28 sections, the Subcommittee drafted a guidance document with the remaining sections. The Subcommittee also created guidance for sections of the histocompatibility policies and bylaws identified by the Committee to be vague and that could benefit from clarification. Through several comprehensive edits, the Committee and Subcommittee continued to refine the document, ensuring that it was current and provided thoroughly considered suggestions for best practice.

Content included in guidance C.2 Facilities and Resources C.2.C: Written Agreements C.2.C #8: A process to obtain sensitization history for each patient C.2.C #9: The frequency of periodic sample collection C.2.C #11: The criteria for crossmatching C.2.C #12: The assay format that will be used for antibody screening and for crossmatching 4.4 Resolving Discrepant Donor and Recipient HLA Typing Results 4.6 Crossmatching 4.6.A Crossmatching for Kidney Transplants Physical Crossmatching Virtual Crossmatching 4.7 Blood Type Determination 4.8 Preservation of Excess Specimens These are the sections of current OPTN bylaws and policies that the Committee included guidance for in the document.

How will members implement this proposal? Member obligations won’t change (guidance not a policy change) Guidance document posted on OPTN website Guidance documents are meant to be informational and not requirements. As such, members will not need to do anything to implement this proposal. They can choose to follow the guidance provided if they see fit. The guidance document will be posted on the OPTN website and will be available to the histocompatibility laboratories and the public. This guidance document will address three of the OPTN goals: Improve waitlisted patient, living donor, and transplant recipient outcomes by a better understanding of histocompatibility testing practices to improve outcomes Promote living donor and transplant recipient safety by helping labs engage in high quality HLA testing and lab practices Promote the efficient management of the OPTN by assisting the community with necessary information to make informed decisions related to histocompatibility.

How will the OPTN implement this proposal? Anticipated Board approval: June 2017 Will post guidance document on OPTN website No programming required No instructional effort currently needed If approved by the Board, the guidance document will be posted on the OPTN website and will be available for both members and the general public to see. There will be no IT programming required for this project.

Questions? Robert A. Bray, Ph.D., D(ABHI), HCLD/CC(ABB) Committee Chair rbray@emory.edu Alison Wilhelm Committee Liaison alison.wilhelm@unos.org