What is CLIA Certification?

CLIA (Clinical Laboratory Improvement Amendments) certification is a federal certification program that ensures the quality and accuracy of laboratory testing performed on human specimens. It sets standards for laboratories that perform testing on human specimens for the purpose of diagnosis, prevention, and treatment of disease.

Is CLIA Certification important?

CLIA certification is important because it ensures that laboratories are meeting standards for accuracy, precision, and reliability in their testing. This is important for patient care, as accurate laboratory test results are essential for making correct diagnoses and decisions about treatment. Inaccurate or unreliable laboratory test results can have serious consequences for patients, including misdiagnosis or delay in treatment.

How to be CLIA-certified lab?

To be CLIA-certified, a laboratory must go through a certification process that includes an on-site survey to assess the laboratory's compliance with CLIA regulations. The laboratory must also submit a CLIA application, pay a fee, and meet other requirements. Once the laboratory has been certified, it is required to maintain its certification by continuing to meet the CLIA standards.

CLIA certification is granted by the Centers for Medicare and Medicaid Services (CMS) and is based on rigorous standards for quality control, personnel qualifications, and laboratory facilities. Without CLIA certification, a laboratory may not be able to bill Medicare or Medicaid for its services in the US.


3billion now became a CLIA-certified lab. We hope to help more rare disease patients in the US to receive correct diagnoses and end their diagnostic odyssey.

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