The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate laboratory testing. They require clinical laboratories to obtain state and Center for Medicare and Medicaid Services (CMS) certification before they can perform diagnostic tests on human samples. 

CLIA also assigns levels of test complexity based on seven criteria stated in the CLIA regulations. The U.S. Food and Drug Administration (FDA) determines whether diagnostic tests are waived, moderate, or high following approval of the tests using a criteria scorecard.

Diagnostic tests are categorized as waived if they are simple to use and there is a low risk of producing inaccurate information or causing harm if the test is performed incorrectly. Tests cleared by the FDA for home or over-the-counter use are automatically assigned a waived categorization.

Before testing, clinical laboratories need to know whether a test system is waived, moderate, or high because different CLIA requirements apply at each level. The more complicated tests have more rigorous CLIA requirements, mostly relating to required personnel skill level.  

Moderate complexity tests achieve a score of 12 or less. Criteria include:

• Scientific and technical knowledge
• Training and experience
• Reagent and material preparation
• Control or automation of operational steps
• Calibration, quality control, and proficiency testing materials
• Troubleshooting and equipment maintenance
• Result interpretation and judgment

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