Histocompatibility Bylaws Rewrite: Phase 2 Histocompatibility Committee Fall 2014

 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made on a donor  Promote efficient management of the OPTN  clarify Bylaws governing histocompatibility and eliminate outdated Bylaws Goal of the Proposal

 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 Problem # 1

 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” Problem # 2

 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 Problem # 3

 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 Problem # 4

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 Problem #5

HLA typing error identified Histo Committee quarterly review Reports through the Improving Patient Safety Portal HLA Typing Errors

Identify HLA error Determine if it resulted in incompatible tx/re-allocation or near miss MPSC reviews case, may request performance review of lab UNOS works with histo-accrediting agencies to conduct performance review MPSC considers results of review and takes action Proposed Process for Reviewing Laboratory with Donor HLA Error

 Labs must report General Supervisor changes to UNOS  The OPTN will survey all histocompatibility labs  verify which individual 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 What Members will Need to Do

 Dolly Tyan, PhD Committee Chair  Regional representative name (RA will complete) Region X Representative address  Andrew Miller, Esq. Committee Liaison Questions?

 Name and CV  ASHI or CAP designated as review agency  Describe histocompatibility laboratory coverage plan  Does the individual meet the qualifications defined by CLIA? (Y/N)  Describe duties  Describe how qualifications meet Bylaws for three years experience General Supervisor Application