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.

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

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

Members


Birthale Archie, DNP, MSN, BS, RN

Birthale Archie, DNP, MSN, BS, RN
Assistant Professor, Department of Nursing
Bowie State University

Michael Black, MBA, MT(ASCP), DLM

Michael Black, MBA, MT(ASCP), DLM
Assistant Vice President, Clinical Laboratory System
Avera McKennan Hospital
Sioux Falls, SD

Kimberle C. Chapin, MD, ABMM, FCAP

Kimberle C. Chapin, MD, ABMM, FCAP
Medical and Scientific Affairs
Cepheid
Sunnyvale, CA

James M. Crawford, MD, PhD

James M. Crawford, MD, PhD
Senior Vice President of Laboratory Services
Northwell Health
New Hyde Park, NY

Heather Duncan, MPH, MT

Heather Duncan, MPH, MT
Microbiology Manager, Vidant Medical Center, Greenville, NC

Mary E. Edgerton, MD, PhD

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

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

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

Ewa King, PhD

Ewa King, PhD
Associate Director of Health, State Health Laboratories
Rhode Island Department of Health
Providence, RI

David Donald Koch, PhD

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

Lavinia P. Middleton, MD

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

Carol Moss

Carole Moss
Founder/Patients’ Rights Advocate, Strategic Alliances and Health Policy Officer, Nile’s Project

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

Jennifer Rhamy, MBA, MA, MT(ASCP)SBB

Jennifer Rhamy, MBA, MA, MT(ASCP)SBB
Director, Blood Donor Center, retired
SCL Health – St. Mary’s Medical Center

Gregory N. Sossaman, MD

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

J. Mark Tuthill, MD

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

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

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

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


Collette Fitzgerald Leaumont, Ph.D

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

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

Monique Spruill

Monique Spruill
Director, Division of Clinical Laboratory Improvement and Quality
Quality and Safety Oversight Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services

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: July 26, 2021