Get Cms Form 116

The Cms Form 116 is an essential document for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This guide provides clear, step-by-step instructions for completing the form online, ensuring users can easily navigate each section.

Follow the steps to successfully complete the Cms Form 116 online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Provide general information about your laboratory. This includes selecting the type of application (initial, survey, or change), entering the facility name, federal tax identification number, email address, and telephone number.
3. Detail the facility address, ensuring to include the physical location where testing will be performed. If different, provide the mailing or billing address.
4. Indicate the name of the laboratory director by entering their last name, first name, and middle initial.
5. Select the type of certificate requested. Choose only one option between certificate of waiver, certificate for provider performed microscopy procedures, certificate of compliance, or certificate of accreditation.
6. Specify the type of laboratory by checking the appropriate box that describes your facility type.
7. Input the hours of laboratory testing by listing the times during which testing is performed for each day of the week using HH:MM format.
8. If applicable, indicate whether you are applying for the multiple site provisions and provide the necessary details.
9. List the waived testing performed, indicating the estimated total annual test volume for all waived tests.
10. Identify any provider performed microscopy (PPM) testing conducted and the estimated annual test volume for all PPM tests.
11. Complete the non-waived testing section with the estimated annual test volume, including specialty or subspecialty information.
12. Select the type of control that describes your laboratory's operational model.
13. List any additional laboratories for which the director is responsible under different certifications.
14. Review the form for completeness, ensure all required fields are filled, and print it for signature.
15. After signing the application, save changes, download, print, or share the completed form as needed.

For efficient processing, complete the Cms Form 116 online today.