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 Externalserves 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
Ramy A Arnaout, MD, DPhil
Associate Director
Clinical Microbiology and Clinical Informatics Fellowship Training Program
Beth Israel Deaconess Medical Center
Sheldon M Campbell, MD, PhD
Clinical Pathologist Pathology and Laboratory Medicine Service,
VA Connecticut Healthcare System
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
Keith E Davis, MD
Medical Director and Family Physician, Shoshone Family Medical Center
Susan J. Gross, MD, FRCSC, FACOG, FACMG
Clinical Professor, Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai
Medical Director of the Reproductive Genetic Laboratory Division at Sema4, Mount Sinai Health System
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
Brad S Karon, Ph.D.
Consultant, Division of Clinical Core Laboratory Services, Department of Laboratory Medicine and Pathology
Mayo Clinic
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
Sharon P Massingale, PhD
Alabama Department of Public Health
Bureau of Clinical Laboratories
Lavinia P. Middleton, MD
Professor, Department of Pathology/Laboratory Medicine, The University of Texas MD Anderson Cancer Center
Helen Mills, RN, MSN
Clinical Educator for Ancillary Services
Martin Health System
Valerie L Ng, MD, PhD
Chair, Department of Laboratory Medicine and Pathology
Alameda Health System/Highland Hospital
Katherine K Perez,
PharmD, BCPS-AQ ID
Clinical Specialist-Infectious Diseases, Department of Pharmacy, Department of Pathology and Genomic Medicine, Houston Methodist Hospital
Bonnie D Rubin, CLS(ASCP), MBA, MHA
Program Consultant, Kirkwood Community College
Adjunct Professor, University of Iowa College of Public Health
Gregory N. Sossaman, MD
System Chairman, Ochsner Health System, Department of Pathology and Laboratory Medicine, Oshsner Medical Center
Cynthia E. Wilkerson, MT(ASCP)D
Director, Center for Laboratory Medicine, Memorial Sloan Kettering Cancer Center
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
Karen Dyer, MT (ASCP) DLM
Director, Division of Clinical Laboratory Improvement & Quality
Center for Medicaid and State Operations
Centers for Medicare and Medicaid Services
Collete Fitzgerald Leaumont, PhD
Associate Director for Science
Division of Laboratory Systems
Center for Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention
Peter Tobin, PhD
Chemist, Division of Program Operations and Management
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
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