Background Analysis: US CDC Advisory Committee to Hear Workgroup Updates and Discuss Topics Related to Clinical Laboratories – APR 10-11, 2018 (CLIAC)

Announcement

The US Centers for Disease Control and Prevention (CDC) has announced that there will be a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC) on Tuesday to Wednesday, April 10-11, 2018 to hear updates from the CDC, the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). In addition, there will be presentations and discussion on other topics of interest to clinical laboratories.

Background

About CLIAC

The CLIAC is charged with providing scientific and technical advice and guidance to the Secretary of Health and Human Services (HHS); the Assistant Secretary for Health at HHS; the Director of the CDC; the Commissioner of the FDA; and the Administrator of CMS. The Committee’s guidance focuses on improvement in clinical laboratory quality and laboratory medicine practice and specific issues on any revision of the Clinical Laboratory Improvement Amendments (CLIA) standards, including impact on medical and laboratory practice; and modification of standards and non-regulatory guidelines to accommodate technological advances, such as new test methods or electronic transmission of laboratory information.

The Committee includes diverse membership across laboratory specialties, professional roles, (laboratory management, technical, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative. The laboratory specialties represented include microbiology, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing, and informatics. The Committee also includes three ex officio members from the federal agencies that oversee the CLIA program: the CDC, CMS, and the FDA. In addition, a nonvoting liaison representing the laboratory industry participates on the Committee.

Agenda

Presentations will include updates from the CDC, CMS, and FDA, followed by Committee discussion with each presenter.

Other presentations and discussions will focus on:

·      the clinical laboratory workforce;

·      implementation of next generation sequencing in clinical laboratories;

·      laboratory interoperability and

·      using clinical laboratory data to improve quality and laboratory medicine practices.

What’s Next?

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.