CLIAC: The Clinical Laboratory Improvement Advisory Committee
CLIAC, the Clinical Laboratory Improvement Advisory Committee, is managed by CDC. It gives scientific and technical advice to HHS on clinical laboratory quality, laboratory medicine practice, and revisions to CLIA standards. Under 42 CFR 493.2001, it meets at least once a year. It is an advisory body and does not write or enforce CLIA rules.
Sound Lab Consultants (SLC) follows CLIA developments for labs nationwide. This page summarizes official CDC and eCFR information about CLIAC.
What CLIAC is
Per CDC's CLIAC page, CDC manages CLIAC, and the committee gives scientific and technical advice to the Department of Health and Human Services (HHS). Its advice covers general issues in improving clinical laboratory quality and laboratory medicine practice, as well as revisions to CLIA standards. CDC's CLIA overview also lists managing CLIAC as one of CDC's CLIA program responsibilities.
CLIAC is written into the CLIA regulations themselves, at 42 CFR 493.2001 (Subpart T, Consultations).
What 42 CFR 493.2001 says CLIAC does
Under § 493.2001:
HHS establishes CLIAC to advise and make recommendations on the technical and scientific aspects of Part 493.
Members come from people who provide laboratory services, use laboratory services, or develop tests and methods, plus others HHS approves.
HHS may designate specialized subcommittees.
The committee meets as needed, and at least once each year.
At HHS's request, CLIAC reviews and makes recommendations on:
criteria for categorizing nonwaived testing,
determining which tests are waived,
personnel standards,
facility administration and quality systems standards,
proficiency testing standards,
how the standards apply to new technology, and
other Part 493 issues HHS raises.
HHS provides the committee with the data and information it needs.
Who serves on CLIAC
According to CDC, CLIAC includes a consumer representative and members drawn from:
several laboratory specialties: microbiology, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing, and informatics,
a range of professional roles, including laboratory management, technical staff, physicians, and nurses, and
academic, clinical, and public health settings.
It also has three ex officio members from the agencies that oversee CLIA: CDC, CMS, and FDA. A nonvoting liaison represents the laboratory industry. CDC lists CLIAC@cdc.gov for agenda topic suggestions and nominations.
How CLIAC fits with CMS, FDA, and CDC
CMS: Certifies labs, inspects them, enforces CLIA, and publishes CLIA rules (FDA's summary of agency roles).
FDA: Categorizes test complexity and reviews CLIA waiver applications.
CDC: Provides technical standards, research, PT monitoring, and education, and manages CLIAC.
CLIAC: Advises HHS. It has no rulemaking or enforcement authority of its own.
A CLIAC recommendation does not change the rules by itself. CLIA requirements change only when CMS publishes rules in the Federal Register, such as the personnel changes that took effect December 28, 2024. See CLIA personnel rule changes and CLIA proposed rule 2026.
Why CLIAC matters to your lab
The topics CLIAC reviews, such as test categorization, waiver, personnel, quality systems, PT, and new technology, are the same areas where future CLIA changes come from. Following CLIAC discussions, together with Federal Register notices in CDC's CLIA documents database, helps a lab director prepare before a rule is proposed.
Checklist: tracking CLIA changes
☐ Check the CDC CLIAC page for meeting information and committee updates.
☐ Watch the Federal Register (through CDC's CLIA documents database) for CMS proposed and final rules.
☐ Map each proposed change to your affected procedures, such as personnel, QC, or PT.
☐ Comment on proposed rules during the comment period if they affect your lab.
☐ Update policies, training, and personnel files when final rules take effect.
FAQs
What does CLIAC stand for?
Clinical Laboratory Improvement Advisory Committee.
Who runs CLIAC?
CDC manages the committee, and it advises HHS.
Does CLIAC make CLIA rules?
No. It makes recommendations. CMS publishes CLIA regulations, and CMS and its agents enforce them.
How often does CLIAC meet?
As needed, and at least once a year under 42 CFR 493.2001(d).
What topics does CLIAC review?
At HHS's request: nonwaived categorization criteria, waived test determinations, personnel, facility administration and quality systems, PT, new technology, and other Part 493 issues.
Are CMS, FDA, and CDC on CLIAC?
Yes. Each has an ex officio member.
Get help keeping up with CLIA
SLC helps clinical labs nationwide turn CLIA changes into updated procedures and training. Start with What is CLIA? or talk with a CLIA consultant.
Sound Lab Consultants Mailing address: PO Box 2135, Chandler, AZ 85244