How many CLIA labs are there in the US?
260,000 laboratory entities
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). In total, CLIA covers approximately 260,000 laboratory entities.
What are the different CLIA certificate types?
Certificate of Waiver.
What are the different CLIA levels?
CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived.
How many CLIA waived labs in the US?
Over 1,400 test systems have been waived as they meet the following requirements: Simple, non-technical methodology.
What is a moderately complex lab?
A test defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as one requiring basic lab knowledge and training for personnel performing the test.
What is the difference between moderate and high complexity testing?
Low scores indicate low complexity, with tests obtaining a total score of ≤12 being categorized as moderate complexity. Tests with final scores >12 are categorized as high complexity.
What lab tests are considered high complexity?
Tests with final scores >12 are categorized as high complexity.
What are the 3 levels of CLIA testing?
Certificate of Waiver.
What tests require CLIA certification?
Regulatory Requirements for Point-Of-Care and Rapid Testing
What is a CLIA waived lab test?
– Waived tests – Tests of moderate complexity – Tests of high complexity
What is a CLIA certified laboratory?
The expansion of Salimetrics’ CLIA certification enables the Salimetrics Laboratory to receive samples from every state in the USA for high complexity testing, except for New York. However, Salimetrics also maintains partnerships with testing labs in New York that can further enable saliva-based CLIA-certified testing when needed.