State Operations Manual (Pub. 100-07), Ch. 6 § 6024
Consultative CLIA Activities
6024 - Consultative CLIA Activities
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
The Centers for Disease Control and Prevention (CDC) - provides scientific
and technical assistance to CMS in the promulgation of CLIA regulations and
CLIA related efforts.
Clinical Laboratory Improvement Advisory Committee (CLIAC) - CLIAC is a
committee that consists of experts knowledgeable in all scientific areas of the laboratory
disciplines, the field of medicine, public health, manufacturers, clinical practice and
consumers. The authority for this committee is 42 U.S.C. 217a, § 222 of the PHSA, as
amended. This committee provides scientific and technical advice and guidance to HHS
regarding the need for, and the nature of:
• Revisions to the standards under which clinical laboratories are regulated;
• The impact on medical and laboratory practice of proposed
revisions to the standards; and
• The modification of the standards to accommodate technological advances.
CDC oversees the CLIAC and provides CMS with any other required scientific
and technical expertise.