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This question is about laboratory director certifications.
What is a CLIA certification?
A CLIA certification is a Clinical Laboratory Improvement Amendments accreditation. There are several different types of CLIA certifications, including:
Certificate of Waiver: issued to a lab that performs only waived tests
Certificate of Provider-performed Microscopy procedures: issued to labs that perform specific microscopy procedures during a patient visit
Certificate of Registration: issued to labs that conduct non-waived testing
Certificate of Compliance: issued to a lab once the state agency or CMS surveyors conduct an inspection and determine the lab is compliant
Certificate of Accreditation: issued to labs based on their accreditation by a CMS-approved organization
CLIA certification is required for all facilities that perform applicable tests on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment, or the assessment of the health of human beings.
If a facility performs tests for these purposes, it is considered a laboratory under CLIA and generally must apply for certification from the CLIA program. CLIA certification may not be required if your laboratory is located in the states of New York or Washington, as they have their own laboratory regulatory programs.
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