Inspections rarely fail on the big things. They fail on the small, everyday gaps — the binder nobody updated, the competency form nobody signed. After years of walking labs through CLIA, CAP, and COLA inspections, here are the five areas inspectors probe first, and what 'ready' looks like in each.

1. Document control. Every SOP current, signed, and actually followed? Inspectors will pull a procedure at random and watch your staff perform it. If the bench doesn't match the binder, that's a finding.

2. Personnel records. Training, competency assessments, and qualifications complete for every testing role — including the lab director's delegation records. Missing or expired competency files are among the most common deficiencies.

3. QC records. Not just that QC was run, but that outliers were investigated, documented, and resolved. An unexplained QC failure with no corrective action is a red flag.

4. Corrective action log. Inspectors want to see that when something went wrong, you found the root cause, fixed it, and verified the fix worked. 'We retrained the tech' without a root-cause analysis won't satisfy them.

5. Management review. Evidence that leadership actually reviews quality metrics and acts on them — meeting minutes, trend data, follow-through.

The pattern: inspectors aren't looking for perfection. They're looking for a system that catches problems and fixes them. If you can show that, you're in good shape.

Want a second pair of eyes before your next inspection? We do mock inspections that find the gaps while there's still time to fix them — book a consultation at zilgene.com.

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