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.

Designated Federal Official
Reynolds R. Salerno, Ph.D

Reynolds M. Salerno, PhD
Director, Division of Laboratory Systems
Center for Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention

Chair
Ramy A Arnaout, MD, DPhil

Ramy A Arnaout, MD, DPhil
Associate Director
Clinical Microbiology and Clinical Informatics Fellowship Training Program
Beth Israel Deaconess Medical Center

Members
Sheldon M Campbell, MD, PhD

Sheldon M Campbell, MD, PhD
Clinical Pathologist Pathology and Laboratory Medicine Service,
VA Connecticut Healthcare System

Marc Roger Couturier, Ph.D., D(ABMM)

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, M.D.

Keith E Davis, MD
Medical Director and Family Physician, Shoshone Family Medical Center

Susan J. Gross, MD, FRCSC, FACOG, FACMG

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

Lee H. Hilborne, MD
Medical Director, Care Coordinator, UCLA Health System, Ronald Reagan-UCLA Medical Center

Steven H Hinrichs, M.D.

Steven H Hinrichs, M.D.
Chair, Department of Pathology and Microbiology
University of Nebraska Medical Center

Brad S Karon, Ph.D.

Brad S Karon, Ph.D.
Consultant, Division of Clinical Core Laboratory Services, Department of Laboratory Medicine and Pathology
Mayo Clinic

Jordan Laser, M.D.

Jordan Laser, M.D.
Medical Director, Department of Pathology
Long Island Jewish Medical Center

Thomas S Lorey, M.D.

Thomas S Lorey, MD
Medical Director, Regional Reference Laboratory
The Permanente Medical Group, Inc.
Kaiser Permanente Northern California

Sharon P Massingale, Ph.D.

Sharon P Massingale, PhD
Alabama Department of Public Health
Bureau of Clinical Laboratories

Lavinia P. Middleton, MD

Lavinia P. Middleton, MD
Professor, Department of Pathology/Laboratory Medicine, The University of Texas MD Anderson Cancer Center

Helen Mills, RN, MSN

Helen Mills, RN, MSN
Clinical Educator for Ancillary Services
Martin Health System

Valerie L Ng, M.D., Ph.D.

Valerie L Ng, MD, PhD
Chair, Department of Laboratory Medicine and Pathology
Alameda Health System/Highland Hospital

Katherine K Perez, PharmD, BCPS-AQ ID

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

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

Gregory N. Sossaman, MD
System Chairman, Ochsner Health System, Department of Pathology and Laboratory Medicine, Oshsner Medical Center

Cynthia E. Wilkerson, MT(ASCP)D

Cynthia E. Wilkerson, MT(ASCP)D
Director, Center for Laboratory Medicine, Memorial Sloan Kettering Cancer Center

Thomas L Williams, M.D.

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)

Donna M. Wolk, PhD, D(ABMM)
System Director, Clinical and Molecular Microbiology, Geisinger Health System, Department of Laboratory Medicine

Ex Officio Members
Karen Dyer, MT (ASCP) DLM

Karen Dyer, MT (ASCP) DLM
Director, Division of Clinical Laboratory Improvement & Quality
Center for Medicaid and State Operations
Centers for Medicare and Medicaid Services

Collette Fitzgerald Leaumont, Ph.D

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, Ph.D

Peter Tobin, PhD
Chemist, Division of Program Operations and Management
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health

Executive Secretary
Nancy Anderson, M.M.Sc., MT(ASCP)

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

Liaison Representative
Andy Quintenz

Andy Quintenz
Scientific & Professional Affairs Manager
Quality Systems Division I
Bio-Rad Laboratories

Page last reviewed: September 25, 2018