"materials 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" to meet certain Federal requirements. If your laboratory is outside of the United States, or is not one of the territories of the United States and is seeking CLIA certification, before completing a CMS-116, you should contact requires all entities that perform even one test, including waived test on.
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NOTE FOR INTERNATIONAL LABORATORIES: The CLIA certification process for international laboratories is outlined in the download below (i.e., International Laboratory CLIA Certification Process). Tests commonly performed and their corresponding laboratory specialties/subspecialties.Guidelines for counting tests for CLIA and.Instructions for completing the CMS-116.
The CMS-116 form and its instructions are found as a download in the Related Link Inside CMS section below and contain the following information: Refer to the State Agency & Regional Office CLIA Contacts page located on the left navigation bar to obtain the appropriate state agency address. This form should be completed and mailed to the address of the local State Agency (PDF) for the state in which your laboratory resides. The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116. APPLICATION FOR A CLIA CERTIFICATE: FORM CMS-116
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