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Histocompatibility Bylaws Rewrite: Phase 2

This proposal aims to promote transplant safety, provide accountability for labs in case of HLA typing errors, promote efficient management of the OPTN, clarify outdated Bylaws, and address key problems related to supervisor roles, lab director requirements, foreign education recognition, and oversight of HLA typing errors.

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Histocompatibility Bylaws Rewrite: Phase 2

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  1. Histocompatibility Bylaws Rewrite: Phase 2 Histocompatibility Committee Fall 2014

  2. Goal of the Proposal • Promote transplant safety • provide accountability for labs when an HLA typing error is made on a donor • Promote efficient management of the OPTN • clarify Bylaws governing histocompatibility and eliminate outdated Bylaws

  3. Problem # 1 • General Supervisor plays key role in onsite monitoring of testing • OPTN does not currently recognize General Supervisor as laboratory key personnel Proposed solution: • Add General Supervisor as laboratory key personnel • Require labs to report General Supervisor changes to UNOS

  4. Problem # 2 • Current OPTN lab director requirements mirror federal CLIA regulation • CLIA lab director doesn’t require histocompatibility experience • OPTN only recognizes one histocompatibility lab director Proposed Solution: recognize a “Histocompatibility Laboratory Director”

  5. Problem # 3 • Laboratory Director- No pathway for M.D./D.O. if they don’t have a license to practice in the state where the lab is located Proposed Solution: Amend Ph.D. pathway to include a doctoral degree in medical science

  6. Problem # 4 • Bylaws don’t recognize foreign equivalent education and experience for key laboratory personnel Proposed Solution: • Recognize foreign equivalent education and experience for laboratory key personnel • Create determination process similar to transplant program personnel • MPSC will consult with histocompatibility accrediting agencies and make final determination through peer review process

  7. Problem #5 Vague standards for MPSC review and oversight of HLA typing errors Proposed Solution: review a lab if: One or more HLA typing errors or reporting errors on a donor results in: • An incompatible transplant • Reallocation of an organ to an individual other than the intended recipient

  8. HLA Typing Errors

  9. Proposed Process for Reviewing Laboratory with Donor HLA Error

  10. What Members will Need to Do • Labs must report General Supervisor changes to UNOS • The OPTN will survey all histocompatibility labs • verify which individuals in their laboratory meet the new definition of general supervisor • The OPTN will monitor HLA typing discrepancies • Board Review – June 2015 If approved, implementation Date: Sept. 1, 2015 • Adding a general supervisor will require IT programming

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

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