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Even though a test is CLIA-waived, the laboratory retains responsibility for ensuring accurate performance. ASCP-aligned practice includes lot-to-lot verification: before using a new lot, perform quality checks per manufacturer instructions and facility policy—this typically includes running positive and negative controls, verifying expected reactivity, checking storage conditions, confirming expiration dates, and documenting results. If controls fail, quarantine the new lot and troubleshoot (e.g., storage temperature excursions, shipment conditions, faulty controls) before releasing it for patient testing. Staff must be trained and competency-assessed on the specific device and test kit, and procedural documents should reflect current instructions for use. Relying on “looks about right” comparisons or postponing verification undermines quality and can lead to false negatives/positives, particularly during respiratory seasons where clinical decisions may hinge on rapid antigen results. Proper QC, operator technique, and documentation create a defensible record that the test system was functioning as intended when patient results were produced, protecting patients and the laboratory’s regulatory standing.