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CLIA generally requires all facilities that perform even one applicable test, including waived tests, on \u201cmaterials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings\u201d to meet ...
\u201cCLIA-exempt\u201d formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program ...
CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.
The CLIA certificate should be displayed in a prominent area and will need to be readily available upon request by CMS.
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