What are the established categories of tests under CLIA based on test complexity?

The established categories of tests under the Clinical Laboratory Improvement Amendments (CLIA) framework classify laboratory tests based on their complexity and required level of oversight. The correct choice refers to three specific categories: waived tests, moderate complexity tests (which include microscopy), and high complexity tests.

Waived tests are those that carry a low risk of an incorrect result and are straightforward in nature. These tests typically require minimal training to perform and are low-risk enough that they can be conducted outside of traditional laboratory settings.

Moderate complexity tests are more intricate than waived tests and typically require more sophisticated equipment and trained personnel to interpret results accurately. The moderate complexity category encompasses various types of testing processes, including those that involve microscopy, which further increases the reliance on skilled technicians for interpretation.

High complexity tests are the most intricate and require a significant level of expertise for both performance and interpretation. These tests often involve advanced procedures and technological intervention, necessitating a higher level of quality control and assurance processes to maintain accuracy and reliability.

Understanding these categories is essential for compliance officers and laboratory personnel to ensure that testing practices align with regulatory requirements and to maintain the quality of laboratory services. The incorrect options suggest alternative and non-standard classifications that do not align with the established CLIA categories, which emphasizes