A CLIA waived test requires that operators

• A. Must follow manufacturer's instructions.
• B. Must have annual competence assessment.
• C. Must perform proficiency testing.
• D. Must perform QC daily.

Answer: (A)

Fueled by the idea that these tests are simple and low risk, the essential requirement for a CLIA waived test is that the operator perform it exactly as the manufacturer instructs. Following the labeled steps—how to collect the specimen, mix reagents, timing, interpretation of results, and any precautions—ensures the test works as intended and keeps the test within its waived category. This is why adherence to the manufacturer’s instructions is the key point.

Annual competence assessments, proficiency testing, and daily quality control are not mandated for CLIA waived tests. Proficiency testing and ongoing competency assessments are typically required for higher-complexity testing, and routine QC is generally not a CLIA requirement for waived tests, though a facility may have its own QA practices. The safety and accuracy of the result in a waived test hinge on following the product’s instructions precisely.