Cms 116 pdf 2025

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The document is the Clinical Laboratory Improvement Amendments (CLIA) application form (CMS-116) used for certification of clinical laboratories. It outlines the necessary information required for initial applications, changes in certification type, and details about the laboratory's operations, including types of tests performed and their volumes. The form also specifies requirements for laboratory directors and provides guidelines for compliance with federal regulations.

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What is the purpose of completing a CMS Form 116?

The CLIA application (Form CMS-116) collects information about your laboratorys operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facilitys laboratory operation.

How do you get a copy of your CLIA Waiver?

0:49 1:59 Office. You can locate information about your state office at cms.gov. Next pay the clearMoreOffice. You can locate information about your state office at cms.gov. Next pay the clear certificate of waiver fee which will be effective for two. Years.

What is the purpose of a certificate of Waiver?

You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available online at .cms.hhs.gov/clia or from your local State Agency. Forward your completed application to the address of the local State Agency for the State in which your laboratory is located.

What is the purpose of the Clinical Laboratory Improvement Amendment?

Waived tests include test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria. While CLIA requires waived tests to be simple and low-risk, they are not completely error-proof.

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