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The three categories of testing for CLIA purposes are waived, moderate complexity (including the provider-performed microscopy procedures [PPMP] subcategory), and high complexity.
By law, CLIA regulations are based on a complexity model, with more complicated testing subject to more stringent requirements (6). The three categories of testing for CLIA purposes are waived, moderate complexity (including the provider-performed microscopy procedures [PPMP] subcategory), and high complexity.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include: Certain tests listed in the CLIA regulations. ... Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met.
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.
A score of 1 indicates the lowest level of complexity, and the score of 3 indicates the highest level. The 7 scores are added together and the tests with a score of 12 or less are categorized as moderate complexity, and those with a score above 12 are categorized as high complexity.
Special notes regarding Gram stains: Gram stains are considered moderate complexity ONLY if. The specimen is an endocervical or urethral sample; and. The slide is made directly from the clinical specimen . All other specimen sites are high complexity .
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Nonwaived testing is the term used to refer collectively to moderate and high complexity testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M.
Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.
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