CLIA Regulations Assessment Workgroup
The CLIA Regulations Assessment Workgroup provides input to CLIAC for deliberation on how the CLIA might specifically be updated, considering the April 2019 reports by the Personnel Regulations, Non-Traditional Workflow Models, and NGS workgroups. The workgroup is charged with providing advice to CLIAC for consideration in making recommendations to HHS on revising the CLIA regulations.
Co-Chairs
Kimberle C. Chapin, MD
Medical and Scientific Affairs
Cepheid
Gregory N. Sossaman, MD
System Chairman, Ochsner Health System
Department of Pathology and Laboratory Medicine
Ochsner Medical Center
Reports
- April 14, 2022 Interim Report to CLIAC
- November 9, 2022 Interim Report to CLIAC
- April 2023 Interim Report to CLIAC
- November 2023 Final Report to CLIAC
Workgroup Designated Federal Officer and Ex Officio Members
Designated Federal Officer
Heather L. Stang, MS, MLS
Senior Advisor for Clinical Laboratories
Clinical Laboratory Improvement Advisory Committee Executive Secretary
Division of Laboratory Systems
Office of Laboratory Science and Safety
Centers for Disease Control and Prevention
Ex Officio Members
Sarah Bennett, MT(ASCP)
Technical Director
Division of Clinical Laboratory Improvement and Quality
Quality, Safety and Oversight Group
Centers for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Víctor R. De Jesús, PhD
Chief, Quality and Safety Systems Branch
Division of Laboratory Systems
Office of Laboratory Science and Safety
Centers for Disease Control and Prevention
Tamara Pinkney, MT(ASCP)
CLIA Program Lead/Policy Analyst
Division of Program Operations and Management
Office of In Vitro Diagnostics
Center for Devices and Radiological Health
Food and Drug Administration