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Common questions

Is CLIA and CMS the same?

Is CLIA and CMS the same?

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

How do I find my CLIA number?

You may verify your CLIA certification level and effective dates at: https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.

Does CLIA enforce CMS regulations?

The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS.

Is CLIA only for Medicare?

CLIA Research CLIA applies to all entities providing clinical lab services and requires these labs meet applicable federal requirements and have a current CLIA certificate, including those that don’t file Medicare test claims. CLIA requirements also apply to labs in physician offices.

What does CLIA stand for?

Clinical Laboratory Improvement Amendments of 1988
“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.

What is the CLIA number?

Will I receive an identifying CLIA number? You will receive a ten-character alpha-numeric code on the CLIA certificate. This number will be utilized to identify and track your laboratory throughout its entire history. You should use this number when making inquiries to the State Agency and CMS about your laboratory.

What is considered waived testing?

Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as “waived.” Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result.

What are the four levels of CLIA complexity?

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.

What are CLIA tests?

“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.