Diagnostic test systems are categorized under CLIA based on what criteria?

Diagnostic test systems under the Clinical Laboratory Improvement Amendments (CLIA) are categorized primarily based on the potential risk to public health. This classification reflects the understanding that different types of tests present varying levels of risk associated with false results or misdiagnosis, which can significantly impact patient care and public health outcomes.

For instance, tests that could lead to immediate harm or public health risks are classified as high complexity, requiring stricter regulations and oversight. Conversely, tests that pose minimal risk are classified as waived tests, which have fewer regulatory requirements. This tiered approach ensures that more complex and potentially hazardous diagnostic testing is held to higher standards of accuracy and reliability, protecting patients and the broader community.

The other criteria mentioned—cost of tests, type of specimen, and technology used—do play roles in laboratory operations and test selection, but they do not influence the CLIA categorization system focused on public health risk, which is the key factor guiding how tests are regulated under CLIA.