Cms 116 pdf 2026

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

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Click ‘Get Form’ to open the cms 116 PDF in the editor.
Begin by filling out the General Information section. Enter your CLIA Identification Number if applicable, or leave it blank for initial applications. Provide your facility name, Federal Tax Identification Number, email address, and telephone number.
Complete the Facility Address section with the physical location of your laboratory. Ensure accuracy as this is where your fee coupon will be mailed.
In the Type of Certificate Requested section, check only one box that corresponds to your application type (e.g., Certificate of Waiver).
Proceed to indicate the Type of Laboratory by checking the most descriptive option that fits your facility's operations.
Fill in the Hours of Laboratory Testing section using HH:MM format for each day of the week.
If applicable, complete the Multiple Sites section by indicating whether you are applying for a multiple site exception and providing necessary details.
Continue through sections on waived testing, PPM testing, and non-waived testing by specifying tests performed and estimated annual test volumes.
Finally, review all entries for accuracy before signing and dating at the end of the form.

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