Step 3

Know the type of application for the tests you are performing

Waived Laboratories - These laboratories perform "waived tests" only. Waived tests are tests that the federal Centers for Medicare and Medicaid Services (CMS) have determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder. A valid CLIA Certificate of Waiver is required.

Non-Waived Laboratories - These laboratires perform tests that are not "waived" by CMS. This laboratory license also includes Provider Performed Microscopy (PPM) laboratories.

If you are unsure if the test you wish to perform is waived, the Food and Drug Administration provides a website to check the complexity of the test you are performing. If the test is moderately complex or higher, then it is non-waived.

FDA

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