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 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

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

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

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

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

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

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

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

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

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

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

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

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

Heather L. Stang, MS, MT(AMT)
Deputy Chief, Quality and Safety Systems Branch
Division of Laboratory Systems
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