Get Clia Form

CLIA certification is the requirement under the Clinical Laboratory Improvement Amendments of 1988 that all entities that perform even one test, including waived tests, on materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or ...

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. ... Each agency has a unique role in assuring quality laboratory testing.

In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.

CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.

CLIA generally requires all facilities that perform even one applicable test, including waived tests, on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings to meet ...

The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116. This form should be completed and mailed to the address of the local State Agency (PDF) for the state in which your laboratory resides.

You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located.