CLIAC was established under Section 222 of the Public Health Service Act [42 USC 217a], as amended. The Committee is governed by the provisions of the Federal Advisory Committee Act, as amended, 5 USC App., which sets forth standards for the formation and use of advisory committees.
By providing scientific and technical advice and guidance to CDC, CMS, and FDA, the Committee supports the Secretary, HHS’ authority under the Clinical Laboratory Improvement Amendments (CLIA) to establish quality standards to assure consistent performance of accurate and reliable testing in sites that perform testing for the diagnosis, prevention, or treatment of disease or the assessment of human health.
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 CLIA standards. Please see the CLIAC Recommendations Table for a full listing of all CLIAC Recommendations and their status.