What does being CLIA certified mean?
Having a CLIA certificate demonstrates that OralDNA® Labs meets the federal regulations for clinical diagnostic testing, ensuring quality and safety in the laboratory and laboratory results. Further, a laboratory can pursue a higher level of quality by becoming accredited by a recognized accreditation agency.
What does the CLIA stand for?
Clinical Laboratory Improvement Amendments of 1988
“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.
What is a CLIA compliance certificate?
This certificate is issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations. Certificate of Compliance.
Why was CLIA needed?
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.
How many types of CLIA are there?
five different types
The regulatory requirements of CLIA vary based on the types of tests a laboratory performs. CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived. There are five different types of CLIA certifications, and each is generally effective for two years.
How to obtain a CLIA certificate?
complete the CMS-116 Application to get a CLIA certification. Completed forms should be sent to the state agency for the employer’s state. An employer can apply for a single CLIA certificate for multiple locations. Multiple locations can be listed as separate temporary testing sites under one CLIA certificate. The person listed as
How to look up a CLIA certificate?
– CMS home page for CLIA external icon – The FDA home page for CLIA external icon – CDC-INFO, CDC’s national contact center and publications
How to apply for a CLIA certificate?
1546 28th St.,Boulder.
How do I apply for CLIA certification?
HOW DO I APPLY FOR A CLIA CERTIFICATE? The CLIAapplication (Form CMS-116) is available online at the CMS CLIA website located at the end of this brochure. Forward your completed application to the address of the local State Agency for the State in which your laboratory is located. This information is available
