Get Cms-116 2021-2025

The CMS-116 form is essential for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This guide provides step-by-step instructions to ensure users can easily and accurately complete the form online.

Follow the steps to successfully complete the CMS-116 form.

1. Press the ‘Get Form’ button to access the CMS-116 form and open it in your preferred online editor.
2. Begin with Section I: General Information. Fill out your laboratory's name, CLIA identification number (leave blank if you're a first-time applicant), and contact details, including email and phone number.
3. Select the appropriate certificate type in Section II. Choose from Certificate of Waiver, Certificate for Provider Performed Microscopy (PPM), Certificate of Compliance, or Certificate of Accreditation.
4. In Section III, choose the type of laboratory that best describes your facility from the provided options.
5. Fill in Section IV with the hours during which testing is performed, using HH:MM format. If testing is available 24/7, check the applicable box.
6. If applicable, complete Section V regarding multiple sites. Indicate whether you are applying for a single site CLIA certificate to cover multiple testing locations.
7. Complete Section VI for waived testing if applying for a Certificate of Waiver. List the waived tests along with their estimated annual test volume.
8. If applying for a Certificate for PPM, fill in Section VII with the PPM tests performed and their estimated volumes.
9. Complete Section VIII for non-waived testing if applying for a Certificate of Compliance or Accreditation. Provide detailed information about tests performed and estimated test volume.
10. In Section IX, describe the type of ownership of your laboratory.
11. If the laboratory director oversees other certified laboratories, list them in Section X.
12. After completing all applicable sections, review the information for accuracy. Save your changes, and if necessary, download or print the completed form.

Complete your CMS-116 application online today and ensure your laboratory meets all necessary certification requirements.