This presentation will inform the audience about federal CLIA regulations that apply to point-of-care testing environments regarding test complexity categorization. This presentation will also provide an overview of the CLIA program and the most recent CLIA updates.

Learning Objectives:

  • Provide a brief overview of the CLIA program, including history, responsibilities, test complexity, certificate types, and statistics.
  • Indicate which federal CLIA regulations apply to point-of-care testing in regards to test complexity categorization.
  • Discuss the most recent CLIA updates.

​​​​This basic-level, complimentary webinar is produced by Whitehat Communications. Whitehat Communications is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

About the Speaker

Kathleen David
Serafina Brea, MBEE, MLS(ASCP)CM

Serafina Brea is a medical laboratory scientist with 15 years of experience in the clinical laboratory setting. She received her Associate of Applied Science degree in Medical Laboratory Technology from Villa Julie College in Pikesville, Maryland, then received her Bachelor of Science in Medical Technology from The University of Maryland, Baltimore.

Brea has worked extensively in all areas of the laboratory, but has most recently filled the position of Quality Assurance Technologist for Point-of-Care Testing at the Johns Hopkins Bayview Medical Center in Baltimore, Maryland.

While working in her QA position, Brea completed the Master of Biotechnology Enterprise and Entrepreneurship program, with a concentration in Legal and Regulatory Affairs, from Johns Hopkins University.

She currently works for the Centers for Medicare & Medicaid Services, where she interprets, develops, and implements regulatory policy; conducts training for the regional offices and state agencies; grants deeming authority to accreditation organizations and states with licensure programs; and monitors adherence to the CLIA program requirements with the regions and states.

We thank the Northwest Point-of-Care Network for their commitment to supporting continuing education.

Orchard Software is a proud sponsor of this P.A.C.E®-accredited opportunity on behalf of ​Whitehat Communications