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CLIA CMS-116 Form

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What is CMS-116?

CMS-116 is the form that has to be filed by every laboratory that provides tests on humans. It should be accompanied by other documents that match CLIA standards. The first time this form is filed, the laboratory received a Certificate of Registration. After that, there will be an inspection of this facility, and the laboratory will need another certificate. There will be more documents to send to inspectors, and the laboratory will have to contact the State Agency.

CLIA CMS-116 Form Screenshot

What I need the CMS-116 for?

This form is required from every institution that makes laboratory testing on humans;
Every facility that wants to be a clinical laboratory has to complete the form;
Facilities with CMS-116 form can work on preventing diseases, providing health condition assessments, making diagnoses;
The form is needed from every laboratory, even if they provide their tests for free.

This is the first form that must be filed by the facility. But it may take over 2 months to complete and gather all documents. Yet, the laboratory can start its work after they passed through the registration and paid the fee. In 2 weeks they will receive a Certificate.

Filling out CMS-116

Before you start filling out the CMS-116 form, you have to get all the documents you will need. The whole procedure for completing the form is not hard. Check all the information twice:

General information on the laboratory, including name, address, director’s name, type of application;
Laboratory type;
Name of certificate you want to receive and whether it is appropriate for tests you are planning to provide;
Hours you will spend on testing;
Control type;
Multiple or single sites;
Affiliation of director with another laboratory, if there is such;

CLIA CMS-116 Form Screenshot 2

Exact date and signature of the facility owner or director. It is recommended to put the date after everything in the form is filled out.

Organizations that work with CMS-116

State Agency;
The USA officials.

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