Current Members

The Committee consists of 20 members, including the Chair. In addition, the Committee includes three voting ex officio members (or designees), including the Director, CDC; the Administrator, CMS; and the Commissioner, FDA. A nonvoting representative from AdvaMed serves as the industry liaison. The Designated Federal Officer (DFO) or their designee and the Executive Secretary are present at all meetings to ensure meetings are within applicable statutory, regulatory and HHS General Administration manual directives.

Reynolds M. Salerno, Ph.D
Designated Federal Officer

Reynolds M. Salerno, PhD
Acting Associate Director for Laboratory Science and Safety
Acting Director, Office of Laboratory Science and Safety
Acting Director, Center for Laboratory Systems and Response
Centers for Disease Control and Prevention

Jordan Laser
Chair

Jordan Laser, MD
Founder
Laser Laboratory Consulting, LLC

Members


Esther Babady, PhD, D(ABMM), FIDSA, FAAM

Esther Babady, PhD, D(ABMM), FIDSA, FAAM
Chief, Clinical Microbiology Service
Director, Clinical Microbiology Fellowship Program
Memorial Sloan Kettering Cancer Center

Michael Black, MBA, MT(ASCP), DLM

Michael Black, MBA, MLS/DLM (ASCP)
Vice President, Hospital Operations, Laboratory Service Line
Ochsner Health

Chester W. Brown, MD, PhD

Chester W. Brown, MD, PhD
Professor, Pediatrics and Genetics, Genomics, and Informatics
The University of Tennessee Health Science Center

Kimberle C. Chapin, MD, ABMM, FCAP

Kimberle C. Chapin, MD, ABMM, FCAP
Chief Medical Officer
Deepull

James M. Crawford, MD, PhD

James M. Crawford, MD, PhD
Senior Vice President of Laboratory Services
Northwell Health

Heather Duncan, MPH, MT

Heather Duncan, MPH, MLS
Director of Laboratory Operations
ECU Health Medical Center

Mary E. Edgerton, MD, PhD

Mary E. Edgerton, MD, PhD
Professor
Department of Pathology and Microbiology
The University of Nebraska Medical Center

R. Tanner Hagelstrom, PhD

R. Tanner Hagelstrom, PhD
Senior Laboratory Director
Natera

Yael K. Heher MDCM, FRCSC, MPH

Yael K. Heher MDCM, FRCSC, MPH
Associate Chief of Pathology, Quality and Safety
Massachusetts General Hospital
Director, Quality & Safety
Mass General Brigham Enterprise Laboratory Service

David Donald Koch, PhD

David Donald Koch, PhD
Director, Clinical Chemistry, Special Chemistry, Toxicology, and Point-of-Care Testing
Grady Memorial Hospital

Nirali M. Patel, MD

Nirali M. Patel, MD
Senior Pathologist, Tempus

Michael A. Pentella, PhD, MS, SM(ASCP), CIC, D(ABMM)

Michael A. Pentella, PhD, MS, SM(ASCP), CIC, D(ABMM)
Director, Iowa State Hygienic Laboratory
Clinical Professor, University of Iowa

Hung S. Luu, PharmD, MD

Hung S. Luu, PharmD, MD
Associate Professor
Department of Pathology
The University of Texas Southwestern Medical Center

J. Mark Tuthill, MD

J. Mark Tuthill, MD
Division Head, Pathology Informatics, Department of Pathology
Henry Ford Hospital

R. W. (Chip) Watkins, MD, MPH, FAAFP

R. W. (Chip) Watkins, MD, MPH, FAAFP
Chief Medical Officer, Sanesco International Inc.

Ex Officio Members


Gregg S. Brandush, RN, JD

Gregg S. Brandush, RN, JD
Director, Division of Clinical Laboratory Improvement and Quality
Quality and Safety Oversight Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services

Collette Fitzgerald Leaumont, Ph.D

Collette Fitzgerald Leaumont, PhD
Deputy Director for Science
Division of Laboratory Systems
Center for Laboratory Systems and Response
Office of Laboratory Science and Safety
Centers for Disease Control and Prevention

Timothy T. Stenzel, MD, PhD

Timothy T. Stenzel, MD, PhD
Director, Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Office of Product Evaluation and Quality
Food and Drug Administration

Executive Secretary
Heather L. Stang, MS, MT(AMT)

Heather L. Stang, MS, MLS(AMT)
Senior Advisor for Clinical Laboratories
Division of Laboratory Systems
Center for Laboratory Systems and Response
Office of Laboratory Science and Safety Centers for Disease Control and Prevention

Liaison Representative
April Veoukas, JD

April Veoukas, JD
Director, Regulatory Affairs
Abbott Quality & Regulatory
Abbott Laboratories