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  1. The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory …

  2. How to Apply for CLIA Certification – Filling out CMS-116

    Feb 14, 2025 · What are the next steps in the process to apply for a CLIA license? Here's an overview of how to apply for a CLIA certificate by filling out the CMS-116 form.

  3. Clinical Laboratory Improvement Amendments (CLIA)

    Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found …

  4. Clinical Laboratory Improvement Amendments | Clinical Laboratory ...

    Sep 11, 2024 · The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations apply to all U.S. facilities or sites that test human specimens for health or disease assessment.

  5. How to apply for a CLIA Certificate and other information

    This page provides information on how to apply for a CLIA certificate and additional information on what to expect after submittal.

  6. Through the Clinical Laboratory Improvement Amendments (CLIA) Program, CMS regulates all lab testing (with some specific exceptions and state exemptions) done on humans in the U.S. to ensure …

  7. Application and Information - Illinois Department of Public Health

    Laboratory Certificate Application Process How to obtain a CLIA Certificate (CMS*) How to obtain a CLIA Certificate of Waiver (CMS) CLIA License Application CMS-116 and instructions (CMS) Making …

  8. How to Apply for a CLIA Certificate, Including International ...

    Jun 7, 2024 · Applying for a CLIA Certificate What form do I use to apply? Where do I send my completed CLIA form? What credentials do I need to apply? What credentials are needed to be a …

  9. Getting CLIA-Certified: The Application and Inspection Process

    Feb 13, 2025 · Get CLIA-certified with confidence. Learn how to navigate applications, inspections & more to ensure your labmeets federal standards for diagnostic testing.

  10. Clinical Laboratory Improvement Amendment (CLIA) Frequently Asked ...

    Sep 10, 2025 · For changes in ownership, fill out the Centers for Medicaid and Medicare Services (CMS) 116 form with a cover letter indicating your CLIA number and the effective date.