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, PhD
Director
Division of Laboratory Systems
Center for Laboratory Systems and Response
Office of Laboratory Science and Safety
Centers for Disease Control and Prevention
Jordan Laser, MD
Founder
Laser Laboratory Consulting, LLC
Members
Esther Babady, PhD, D(ABMM), FIDSA, FAAM
Chief, Clinical Microbiology Service
Director, Clinical Microbiology Fellowship Program
Memorial Sloan Kettering Cancer Center
Michael Black, MBA, MLS/DLM (ASCP)
Vice President, Hospital Operations, Laboratory Service Line
Ochsner Health
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
Chief Medical Officer
Deepull
James M. Crawford, MD, PhD
Senior Vice President of Laboratory Services
Northwell Health
Heather Duncan, MPH, MLS
Director of Laboratory Operations
ECU Health Medical Center
Mary E. Edgerton, MD, PhD
Professor
Department of Pathology and Microbiology
The University of Nebraska Medical Center
R. Tanner Hagelstrom, PhD
Senior Laboratory Director
Natera
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
Director, Clinical Chemistry, Special Chemistry, Toxicology, and Point-of-Care Testing
Grady Memorial Hospital
Nirali M. Patel, MD
Senior Pathologist, Tempus
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
Associate Professor
Department of Pathology
The University of Texas Southwestern Medical Center
J. Mark Tuthill, MD
Division Head, Pathology Informatics, Department of Pathology
Henry Ford Hospital
R. W. (Chip) Watkins, MD, MPH, FAAFP
Chief Medical Officer, Sanesco International Inc.
Ex Officio Members
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, 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
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
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
April Veoukas, JD
Director, Regulatory Affairs
Abbott Quality & Regulatory
Abbott Laboratories