What is a CLIA application?
The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility’s laboratory operation.
What is CLIA certified?
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.
How do I get CLIA certified in California?
A successful submission will consist of the online application and completed forms CMS 116, LAB 182, and LAB 183. The forms must be completed and uploaded to the application portal. The federal CLIA program will bill applicants separately for the federal CLIA certification fee.
What are the three levels of CLIA testing?
Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.
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 does it mean CLIA waived?
A device that is CLIA Waived does not require highly trained laboratory personnel to administer the test and does not require costly laboratory quality control testing.
What is a CLIA waived laboratory test?
As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver.