View source for CLIA Number

In United States, prior to operating a laboratory of medium or high complexity the laboratory most apply for a receive a CLIA number from Centers for Medicare and Medicaid Services (CMS).

Any change or addition of new methodologies used must be reported to CLIA/CMS.

The Laboratory Directory is responsible for the overall quality and function of the laboratory.  The Laboratory Directory is required to take an initial 20 hours of medical education to become a laboratory directory.

The laboratory is inspected every 2 years by a CMS/CLIA designee.  This is usually the Division of Facility Services for the state or by COLA which contracts with CMS to provide this service.

CLIA is an acronym for the law US "Clinical Laboratory Improvement Act" passed in 1988.  It has been subsequently amended.


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