What type of tests fall under the category of high complexity according to CLIA?

In the context of the Clinical Laboratory Improvement Amendments (CLIA), tests classified as high complexity are those that necessitate specialized knowledge and skills. This classification is based on the need for expert understanding of the procedures and the ability to interpret complex data accurately. High complexity tests often involve sophisticated techniques, intricate instrumentation, and the application of advanced methodologies that require substantial training and experience to ensure quality results.

The requirement for specialized knowledge implies that personnel performing these tests must not only understand the technical aspects but also have a comprehensive grasp of the underlying biological processes and potential implications of the results. This ensures that testing is conducted accurately and that results can be reliably used in patient care.

Although there are various testing methods that may be automated, high complexity is not solely reliant upon the use of automated machinery. Additionally, routine tests often fall under lower complexity categories because they involve simpler processes that can be performed with minimal training and less specialized knowledge. Consequently, the core defining feature of high complexity tests lies in the specialized skills and in-depth understanding required to perform them correctly.