Get Cms-116 2010

Completing the CMS-116 form online is essential for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This guide provides step-by-step instructions to help users accurately fill out the form with ease and confidence.

Follow the steps to successfully complete your CMS-116 application.

1. Click ‘Get Form’ button to access the CMS-116 application and open it in your preferred online environment.
2. Fill in the general information section, indicating whether this is an initial application, survey, or other type of change. Ensure you leave the CLIA identification number blank if this is your first application.
3. Provide the facility name and federal tax identification number. Be specific to ensure accurate identification.
4. Enter your email address and telephone number with area code.
5. Complete the facility address, ensuring you include any applicable building, floor, or suite details. Include a mailing or billing address if it differs from the physical address.
6. Input the name of the director, followed by their contact information. This should include the last name, first name, and middle initial.
7. Select the type of certificate requested by checking the appropriate box. Complete the required sections based on your selection.
8. In the type of laboratory section, check the option that best describes your facility. Provide additional details if your laboratory is shared.
9. Indicate the hours of laboratory testing in HH:MM format for each day of the week.
10. If applicable, answer the questions about multiple site exceptions, and describe the regulatory exceptions if you are applying for such provision.
11. Identify the waived testing performed and estimate the total annual test volume for these tests.
12. Detail any PPM testing performed and provide the estimated annual test volume for these tests.
13. Outline any non-waived testing performed in the facility and include the estimated annual test volumes.
14. Select the type of control for your facility and provide the relevant details.
15. If the laboratory director oversees additional laboratories, list those laboratories and their respective CLIA numbers.
16. Review the entire form for completeness and accuracy. Save your changes once you are satisfied.
17. Download, print, or share the form as needed for submission to the appropriate State agency.

Complete your CMS-116 application online to ensure your laboratory meets CLIA certification requirements.