What is CLIA and what is its purpose?

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.

What is meant by CLIA?

Abbreviation for Clinical Laboratory Improvement Amendments. Federal legislation and the personnel and procedures established by it under the aegis of the Health Care Financing Administration (HCFA) for the surveillance and regulation of all clinical laboratory procedures in the United States.

Who does the CLIA protect?

CLIA ’88 applies to anyone who performs testing of human specimens for the diagnosis, prevention or treatment of disease or health problems. This includes everyone from physicians performing the most basic tests (e.g., dipstick urinalysis) to the technicians working in POLs.

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 is CLIA and CAP?

In simple terms, being CLIA certified and CAP accredited ensures your test results are meeting and exceeding industry standards for clinical laboratory testing. The College of American Pathologists (CAP) is such an agency. The CAP releases its own requirements building upon CLIA ’88 regulations.

Is CLIA federal or state?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

Is CLIA state or federal?

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.

What CLIA 1988?

Who funds CLIA?

The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.

What happens if CLIA is violated?

Violations that could cause false point-of-care results—primarily due to improper quality proceduresor those that could cause patient harm can result in significantly higher fines, exclusion from federal programs, suspension or revocation of your CLIA-waived certificate, or in extreme cases, prison time.

How do you start a CLIA lab?

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.