Question: What Does CLIA Stand For?

What is CLIA and what is its purpose?

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..

What tests are CLIA waived?

Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.

What is the difference between CAP and CLIA?

In general, CAP has more specialty-specific quality standards than other accreditation organizations. While the requirements across all organizations with accreditation authority differ slightly, they all represent adherence to a higher standard of quality than with CLIA compliance alone.

What does CLIA mean?

Clinical Laboratory Improvement AmendmentsThe 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.

Who needs a CLIA?

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 …

How do you get CLIA certified?

To receive a CLIA certification, a laboratory must apply using the CLIA application (Form CMS- 116). This form collects information about your laboratory operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA.

How much does CLIA certification cost?

Upon processing the application, your facility will be billed a certification fee of $150.00, renewable every two years. Some states may require additional forms, have additional fees, or have other specific requirements regarding CLIA certification.

Why is CLIA important?

Why Is CLIA Important? CLIA established quality standards for laboratories to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test is performed. CMS data indicates that CLIA has helped to improve the quality of testing in the United States.

What are the three levels of CLIA testing?

CLIA was passed by Congress in 1988 to improve the quality of testing in all laboratories nationwide. These health assessment tests examine diagnoses, prevention and treatment of the human body. The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.

What is a CLIA inspection?

The Clinical Laboratory Improvement Amendments (CLIA) program regulates laboratories that test human specimens and ensures they give accurate, reliable, and timely patient test results regardless of where the test is performed.

What are the different types of CLIA certificates?

Types of CLIA CertificatesCertificate of Waiver. A Certificate of Waiver allows a facility to perform only tests that are classified as waived. … Certificate for Provider Performed Microscopy Procedures (PPM) … Certificate of Registration. … Certificate of Compliance. … Certificate of Accreditation.

How do I get a CLIA waiver?

How to Apply for a CLIA Certificate of Waiver. Obtaining a Certificate of Waiver is generally a straightforward process. An application (form CMS-116) can be obtained at the CMS Web site or from your state health department.

What is CLIA exempt?

“CLIA-exempt” formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program …

What is CLIA in medical billing?

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). … The objective of the CLIA program is to ensure quality laboratory testing.