0938 0581 2010 form-2025

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The document is the Clinical Laboratory Improvement Amendments (CLIA) application form (CMS-116) used for certification of clinical laboratories. It outlines the necessary information required for initial applications, changes in certification type, and details about the laboratory's operations, including types of tests performed and their volumes. The form also specifies requirements for laboratory directors and provides instructions for completing the application to ensure compliance with federal regulations.

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How long is a CLIA certificate good for?

CLIA Compliance Checklist I. General Administrative Personnel. Has a CLIA certificate been obtained? II. Facility and Safety. III. Patient Test Management. IV. Proficiency Testing. V. Instrument maintenance. VI. Procedure manual. VII. Quality Control. VIII. Quality Assurance.

How long does it take to get a CLIA?

The average time to receive your CLIA Certificate is four to six weeks. NOTE: If your application is for a CLIA certificate of compliance or accreditation, you will receive a certificate of registration.

How to submit a CLIA waiver application?

You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available online at .cms.hhs.gov/clia or from your local State Agency. Forward your completed application to the address of the local State Agency for the State in which your laboratory is located.

How do I renew my CLIA certificate in Florida?

The certificate renewal process is automatic for any existing CLIA certificate. CMS will mail out the renewal invoice approximately 6 months prior to the expiration date of the current certificate. There will be a total of 3 invoices mailed out, every two months prior to the expiration date of the current certificate.

How to check CLIA application status?

Methods to Check the Status of Your CLIA Application Contact the CLIA Program. The most direct way to check the status of your CLIA application is to contact the CLIA program directly. Check the CLIA Database. Contact the State Survey Agency. Reach Out to Your Accrediting Organization.

How do I get my CLIA certificate?

How do I apply for a CLIA certificate? The CLIA application (Form CMS-116) is available online. Send your completed application to the address of the local State Agency for the State in which your laboratory is located. Additionally, check with your State Agency for any other state- specific requirements.

0938 0581 2010 form-2025

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