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 external iconserves as the industry liaison. The Designated Federal Official (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 Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention
Valerie L Ng, MD, PhD
Chair, Department of Laboratory Medicine and Pathology
Alameda Health System/Highland Hospital
Members
Birthale Archie, DNP, MSN, BS, RN
Assistant Professor, Department of Nursing
Bowie State University
Marc Roger Couturier,
PhD, D(ABMM)
Medical Director of Parasitology/Fecal Testing, Infectious Disease, Antigen Testing and Microbial Immunology, ARUP Laboratories
Associate Professor of Pathology, University of Utah
Mary E. Edgerton, MD, PhD
Associate Professor, Department of Pathology
The University of Texas MD Anderson Cancer Center
Susan J. Gross, MD, FRCSC, FACOG, FACMG
Clinical Professor, Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai
Chief Medical Officer, Cradel Genomics, San Diego, CA
Lee H. Hilborne, MD
Medical Director, Care Coordinator, UCLA Health System, Ronald Reagan-UCLA Medical Center
Steven H Hinrichs, M.D.
Chair, Department of Pathology and Microbiology
University of Nebraska Medical Center
Jordan Laser, M.D.
Medical Director, Department of Pathology
Long Island Jewish Medical Center
Thomas S Lorey, MD
Medical Director, Regional Reference Laboratory
The Permanente Medical Group, Inc.
Kaiser Permanente Northern California
Lavinia P. Middleton, MD
Professor, Department of Pathology/Laboratory Medicine, The University of Texas MD Anderson Cancer Center
Carole Moss
Founder/Patients’ Rights Advocate, Strategic Alliances and Health Policy Officer, Nile’s Project
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
Katherine K Perez,
PharmD, BCPS-AQ ID
Clinical Specialist-Infectious Diseases, Department of Pharmacy, Department of Pathology and Genomic Medicine, Houston Methodist Hospital
Jennifer Rhamy, MBA, MA, MT(ASCP)SBB
Director, Blood Donor Center, SCL Health – St. Mary’s Medical Center
Gregory N. Sossaman, MD
System Chairman, Ochsner Health System, Department of Pathology and Laboratory Medicine, Oshsner Medical Center
R. W. (Chip) Watkins, MD, MPH, FAAFP
Chief Medical Officer, Sanesco International Inc.
Thomas L Williams, MD
Chief Medical Officer, retired
Director, Division of Public Health
Nebraska Department of Health and Human Services
Donna M. Wolk, PhD, D(ABMM)
System Director, Clinical and Molecular Microbiology, Geisinger Health System, Department of Laboratory Medicine
Ex Officio Members
Collete Fitzgerald Leaumont, PhD
Deputy Director for Science
Division of Laboratory Systems
Center for Surveillance, Epidemiology, and Laboratory Services
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
Regina S. Van Brakle, MT(ASCP)
Acting Director, Division of Clinical Laboratory Improvement & Quality
Center for Medicaid and State Operations
Centers for Medicare & Medicaid Services
Nancy Anderson, M.M.Sc., MT(ASCP)
Senior Advisor for Clinical Laboratories
Center for Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention
Andy Quintenz
Scientific & Professional Affairs Manager
Quality Systems Division I
Bio-Rad Laboratories