Form CMS-116, CLIA APPLICATION FOR CERTIFICATION Form CMS-116, CLIA APPLICATION FOR CERTIFICATION 2026

1. Click ‘Get Form’ to open it in the editor.
2. Begin by filling out Section I: GENERAL INFORMATION. Provide your facility name, CLIA identification number (leave blank if initial), and contact details including email and phone number.
3. In Section II, select the TYPE OF CERTIFICATE REQUESTED based on the tests your laboratory will perform. Ensure you check only one option.
4. Proceed to Section III and choose the TYPE OF LABORATORY that best describes your facility. This helps categorize your application correctly.
5. Complete Section IV by indicating the HOURS OF LABORATORY TESTING. Use HH:MM format for accuracy.
6. If applicable, fill out Section V regarding MULTIPLE SITES, ensuring you meet regulatory exceptions for multiple testing locations.
7. Continue with Sections VI to VIII to detail WAIVED TESTING, PPM TESTING, and NON-WAIVED TESTING. Be specific about test types and estimated annual volumes.
8. Finally, review all sections for completeness before submitting your application to the appropriate State Agency as indicated in the instructions.

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