Clia waiver application texas 2025

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The document is a comprehensive guide from the Texas Department of State Health Services regarding the application process for a Clinical Laboratory Improvement Amendments (CLIA) Certificate. It outlines the necessary information and forms required for laboratories to apply, including details about tests performed, qualifications of laboratory personnel, ownership disclosures, and specific instructions for completing the CLIA application form (CMS-116). The document emphasizes compliance with federal regulations and provides resources for further assistance.

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How do I get a CLIA Waiver in Texas?

The Texas Health and Human Services Commission (HHSC), on behalf of the CMS CLIA program, uses Form 3225 to process CLIA certificate applications. Applicants must forward a completed Form 3225 to their appropriate CLIA State Agency regional office for HHSC to accept and process their CLIA application.

How long does a CLIA Waiver take?

Once you fill out the initial form with your information and sign the 90-day free contract, we will have all the information we need to submit the CLIA application. After applying, it typically takes 4-6 weeks to receive the CLIA certificate.

What are the three types of CLIA waived?

As defined by CLIA, waived tests are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. Examples of waived tests include: dipstick urinalysis, fecal occult blood, pregnancy tests, and blood glucose monitoring.

How do you obtain a CLIA Waiver?

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.

What is the first step for Clia waived tests?

Explanation: The first step for CLIA waived tests is to obtain a CLIA Certificate. CLIA, or the Clinical Laboratory Improvement Amendments, regulates laboratory testing and requires facilities to have a certificate in order to perform certain types of tests.

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What is the difference between a CLIA license and a Waiver?

A CLIA waiver is for facilities performing waived tests, which are simple and low-risk. A CLIA certification is required for facilities conducting more advanced testing, such as: Moderate-complexity tests (e.g., automated CBCs or certain blood analyzers). High-complexity tests (e.g., PCR tests or genetic testing).

Which agency provides the application for a certificate of Waiver?

Professional Licensing: If you are looking for a certificate of waiver in a professional context (e.g., licensing for healthcare or legal professions), the relevant state licensing board or regulatory agency would provide the application. Each profession has its governing body that oversees compliance and regulations.