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The document is the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), which outlines the requirements and procedures for laboratories seeking certification to perform testing on human specimens. It includes sections for general information, types of certificates requested, laboratory type, hours of operation, waived and non-waived testing details, and ownership type. The form collects essential data to assess compliance with federal regulations and determine applicable fees. Instructions for completing the form and guidelines for counting tests are also provided.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

How long does a CLIA inspection take?

During the inspection, the surveyor will review various aspects of your laboratory, including your facilities, equipment, personnel qualifications, Quality Control measures, and testing procedures. The inspection may take several hours to complete, depending on the size and complexity of your laboratory.

How long does it take to get a CLIA card?

How long does it take to receive a CLIA card? Most groups require you to earn a minimum of $5,000 in commissions before travel agents receive CLIA cards. However, at TPI, we waive this! Once you apply with CLIA, the average turnaround time to receive your card is four to six weeks.

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.

How much does it cost to get a CLIA?

California $5,500. Maryland $3,000. New York Starts at $5,500.

How do I apply for a CLIA certificate?

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.

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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.

What is an example of a CLIA format?

This is an example of a valid CLIA number format: 19DX. The first three characters are the two-digit state code followed by the letter D. The remaining seven digits are the unique CLIA system number assigned to the provider. Do not add the letters CLIA to the 10-character CLIA number.

What is a CMS 116 form?

Form # CMS 116. Form Title. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION.

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