Background Analysis: US CDC Advisory Committee to Hear Workgroup Updates and Discuss Topics Related to Clinical Laboratories – April 10-11, 2019 (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 Wednesday to Thursday, April 10-11, 2019 to hear updates from the CDC, the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). Presentations and discussions will focus on an update from the CDC’s Office of Infectious Diseases (OID) Board of Scientific Counselors meeting and reports from three CLIAC workgroups: the Clinical Laboratory Improvement Amendments (CLIA) Personnel Regulations Workgroup, the Nontraditional Testing Workflow Model Workgroup, and the Next Generation Sequencing (NGS) Workgroup. Agenda items are subject to change as priorities dictate.

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 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.

The CLIAC has posted a table of their recommendations at the following website: https://www.cdc.gov/cliac/docs/CLIAC_Recommendations_Web_10012018.pdf.

Agenda

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

Other presentations and discussions include:

·       An update on the CDC OID Board of Scientific Counselors meeting;

·      The CLIA Personnel Regulations Workgroup Report;

·      The Nontraditional Testing Workflow Model Workgroup Report; and

·      The NGS Workgroup Report.

Agenda items are subject to change as priorities dictate. The CLIAC advises the public to check their website on the day of the meeting for the current meeting agenda and other meeting materials: www.cdc.gov/cliac .

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.

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