CLIA & POCT Webinar
July 14, 2011

If you missed this timely and informative topic

please download the audio and slides or just slides by

clicking the appropriate link below.



Summary - "CLIA and Point-of-Care Testing:

  • Included current CLIA laboratory enrollment data with a focus on the applicable CLIA requirements for point-of-care testing.

  • Identify the CLIA requirements for POCT and differentiate between the CLIA requirements for the waived and moderate complexity testing. 

  • Demonstrated how the growth of waived facilities has exploded over time, why and what types of issues CMS is finding when conducting its educational visits to these laboratories.

  • Covered the CMS’ plans for the future with regard to oversight of entities that do not have any regulatory standards or surveys currently.

  • Provided plenty of opportunity for dialogue and questions.

Objectives - After viewing this webinar, you will be able to:

  • Have an overview of the Clinical Laboratories Improvement Amendments (CLIA) program.  This overview includes CLIA test complexity, the types of CLIA certificates, and the options for laboratory oversight. Following the webinar, the participant will know the relationship between the CLIA test complexity and the types of CLIA certificates.

  • Differentiate between the CLIA personnel requirements for waived versus moderate complexity testing. 

  • Understand CMS’ position on POCT, the problems identified in waived laboratories through the CMS Certificate of Waiver Project, and CMS’ plans to address the exponential growth in laboratories with no routine oversight.

Vendor Sponsors:  Alere; Eurotrol; Medical Automation Systems

Karen Dyer, MT(ASCP) DLM is a registered Medical Technologist with certification in Laboratory Management. She received an AA degree from Essex Community College in Medical Laboratory Technology and a BA degree from the University of Maryland Baltimore County in Health Science and Policy. She is an analyst with the CLIA program at CMS, working primarily with interpretation of regulations, evaluations of survey consistency between Accrediting Organizations and CLIA, policy development, electronic health records and data collection and analysis. Prior to joining the CLIA program at CMS, she was employed by the Johns Hopkins Hospital Medical Laboratories, as an Affiliate Laboratory Supervisor and, most recently, Point of Care Testing Coordinator.

Daralyn Hassan, MS, MT(ASCP) received a B.S. in medical Technology from Michigan State University, and a M.S. in Health Science from Towson State University.  Daralyn has been with the CLIA program since 2000, where she helps to provide oversight to clinical laboratories, and surveyor training.  Prior to coming to the federal service, she was a laboratory surveyor for the State of Maryland, and was promoted to a Health Facilities Survey coordinator. She has 16 years of clinical laboratory experience.