Histocompatibility Bylaws Rewrite: Phase 2 Histocompatibility Committee Fall 2014.
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Transcript of 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eliminate outdated Bylaws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
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 [email protected]
Regional representative name (RA will complete) Region X Representative email address
Andrew Miller, Esq. Committee Liaison [email protected]
Questions?