In what context is "high complexity" referenced concerning CLIA?

The reference to "high complexity" within the context of the Clinical Laboratory Improvement Amendments (CLIA) pertains to a category of diagnostic tests that pose significant risks due to their complexity and the consequences of erroneous results. High-complexity tests typically require more advanced technological capabilities, specialized training for laboratory personnel, and stringent quality control measures. They are often associated with intricate procedures and require a deeper understanding of the underlying molecular mechanisms and biological principles.

In this context, the certification and regulation of laboratories performing these tests are essential to ensure accuracy and reliability in diagnostic results, which can significantly impact patient management and outcomes. Consequently, the categorization of tests as high complexity reflects the structured oversight necessary for their safe and effective implementation in clinical practice.