Histocompatibility Bylaws Rewrite: Phase 2Histocompatibility 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eliminate outdated Bylaws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 Errors

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 Dtyan@stanford.edu

Regional representative name (RA will complete) Region X Representative email address

Andrew Miller, Esq. Committee Liaison Andrew.Miller@unos.org

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