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Form CMS-116
CLIA Application
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Form reference
Before you begin.
Use these notes as a starting point. Check the issuing agency’s current form and instructions for your client’s situation.
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Gather Essential Information
Before you start filling out Form CMS-116, ensure you have all necessary details at hand. This includes your laboratory's name and address, types of tests to be performed, the name and qualifications of the laboratory director, and descriptions of your quality control program, record keeping system, equipment, and the laboratory director's signature. Having this information ready will streamline the application process.
Details worth checking
Missing CLIA Identification Number
A unique CLIA Identification Number is essential for processing the initial CLIA application. Not including this number can lead to significant delays or rejection. Ensure you have this number before starting your application to avoid unnecessary setbacks.
Unspecified Certificate Type
Selecting the correct type of certificate—such as a Certificate of Waiver or a Certificate of Compliance—is critical. Omitting this information can result in application processing delays or rejection.
Incorrect Laboratory Type Selection
Choosing the wrong laboratory type, such as hospital or independent laboratory, can cause delays or rejection of your application. It's vital to accurately represent your laboratory's classification.
Omitted Testing Hours
The application requires detailed testing hours for each day of the week. Missing this information can hinder the processing of your application.
Unreported Waived Testing and Test Volume
Information about waived testing and the estimated total annual test volume is mandatory. Failing to report this can cause delays or rejection.
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