Clinical Laboratory Improvement Advisory Committee (CLIAC)
At the November 6-7, 2019 meeting, CLIAC is specifically soliciting public comments to address the questions below. Information provided via public comments will not be considered advice directly addressed to HHS. Rather, it will be used by CLIAC to inform their deliberations and recommendations to HHS and to help focus a CLIAC workgroup that will be convened in response to an April 2019 CLIAC recommendation that such a workgroup be charged with providing input to CLIAC in advising how CLIA might be updated.
- Are bioinformaticists needed in clinical and public health laboratories? If so, what are the current roles, responsibilities, and competencies of bioinformaticists in these settings?
- What areas exist in CLIA where specific requirements or guidance might be needed to ensure the accuracy and reliability of new and emerging laboratory technologies and nontraditional testing workflow models, including next generation sequencing, biomarker testing, metagenomics, and others?
- What data are available that could assist in answering how CLIA may need to be revised or where guidance may be needed to ensure the accuracy and reliability of emerging technologies?
In general, each individual or group requesting to make oral comments will be limited to a total time of ten minutes (unless otherwise indicated). Written comments can also be provided up to the first day of the meeting. Send comments to CLIAC@cdc.gov.
The Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the Centers for Disease Control and Prevention (CDC), provides scientific and technical advice and guidance to the Department of Health and Human Services (HHS). 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 clinical and anatomic pathology 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 Clinical Laboratory Improvement Amendments (CLIA) program, specifically the CDC, the Centers for Medicare & Medicaid Services (CMS), and the Food and Drug Administration (FDA). Last, a nonvoting liaison representing the laboratory industry participates on the Committee.
The advice and guidance CLIAC provides to HHS pertains to general issues related to improvement in clinical laboratory quality and laboratory medicine practice. In addition, the Committee provides advice and guidance on specific questions related to possible revision of the
For more information, please see the Federal Advisory Committee Database CLIACexternal icon page.
Next Meeting: November 6-7, 2019
Venue: Centers for Disease Control and Prevention
1600 Clifton Road NE
Tom Harkin Global Communications Center
Building 19, Auditorium B
Atlanta, Georgia 30329-4018