CLIA Waived Testing Daily Quality Control Log

This template covers one QC session for a CLIA-waived point-of-care test, including session identification, reagent and control verification, positive and negative control results, and final acceptance or corrective action. It is designed to document the exact test, operator, lot numbers, and whether controls were acceptable before patient testing. If your site runs multiple waived assays, you can duplicate the log for each analyte or instrument. It is not a patient result record.

Use it each day you perform waived testing, and also any time your policy or the manufacturer requires a new QC check, such as after a new lot, new shipment, or instrument restart. Many sites also complete it when controls are borderline, invalid, or when storage conditions may have been compromised. The right cadence is driven by the test manufacturer, your lab policy, and applicable CLIA-waived testing procedures. If a run fails, document the repeat QC after corrective action on the same log.

The operator who performs the QC run should complete the log and initial the session, since they are the person verifying the control materials and recording the results. A supervisor, lab director, or designated reviewer should be notified if QC fails or if the run cannot be corrected. In small clinics, the same person may perform and review the entry if that is allowed by site policy. The key is that the record clearly shows who ran the QC and who was informed of any failure.

This log supports CLIA waived testing documentation by showing that controls were run, materials were in date, and corrective action was taken when needed. It also aligns with manufacturer instructions for use, which are the primary source for acceptable control ranges and storage requirements. If your organization follows broader quality systems, the log also fits well with ISO 9001-style traceability and internal audit expectations. It does not replace required competency, training, or maintenance records.

Common problems include recording a control result without the lot number, forgetting to check open-vial expiration, and failing to note whether reagents were stored per manufacturer instructions. Another frequent issue is documenting a failed control without recording the corrective action and repeat run. Borderline or invalid results are also often missed when no photo is attached. This template forces those checks into the workflow so the session is easier to defend during review.

Yes. The template is meant to be cloned for each waived assay, such as glucose, urine pregnancy, influenza, strep, or rapid antigen testing, and you can rename fields to match the manufacturer’s terminology. You can also add device-specific prompts for internal quality checks, temperature logs, or cartridge handling if your procedure requires them. Keep the core fields for lot number, expiration, control result, and corrective action so the record stays audit-ready.

No. The log documents that you followed the instructions, but it does not replace them. You still need to use the manufacturer’s acceptable ranges, storage requirements, and run frequency for each test system. If the package insert requires a different control scheme, the log should be adjusted to match it. The safest approach is to mirror the manufacturer workflow inside the template.

Start by assigning one owner for each waived test area, then standardize the fields and acceptable response options before launch. Train operators to complete the log at the time of testing, not after the shift, so lot numbers and control results are captured accurately. Review the first few logs for missing signatures, missing photos on borderline results, and incomplete corrective actions. After that, fold the log into your daily opening checklist or QC routine.