Asked by: Marey Kiralyasked in category: General Last Updated: 10th April, 2020
Why is CLIA important?
In this manner, 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.
Additionally, who needs a CLIA number? 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.
Additionally, why was CLIA needed?
Congress passed CLIA in 1988 to establish quality standards, strengthen Federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test results. CLIA applies to all entities providing clinical laboratory services including those that do not file Medicare test claims.
Who does CLIA affect?
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.