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CLIA survey readiness check
A ten-minute self-check built from the requirements surveyors cite most often. Answer from your records, not from memory. At the end you get a list of gaps, the regulation behind each one and what to fix first.
Runs in your browser. Your answers are not sent anywhere or saved.
Your result
Gaps to close
A "Not yet" is useful. Log it on your corrective action log, fix it and date the fix. This check covers federal CLIA requirements only and does not predict a survey result.
How the check was put together
The questions for nonwaived laboratories follow CMS's 2024 list of most-cited deficiencies and the structure of 42 CFR Part 493: proficiency testing, personnel, analytic systems, reports and records, and quality assessment. The waived set follows the Certificate of Waiver requirements and the manufacturer's instructions, which waived sites must follow. See the most-cited deficiencies for the numbers.
Is this a mock inspection?
No. It is a short self-check built from the requirements CMS surveyors cite most. A full self-audit covers more ground, and neither one predicts what a surveyor will find.
Where do my answers go?
Nowhere. The check runs in your browser. Nothing is sent to us and nothing is saved when you close the page. Use Copy summary or Print to keep a record.
How often should we run it?
Quarterly works for most laboratories, and again whenever the test menu, an instrument or the staff changes.
Want the full audit?
The Inspection Readiness Kit has a longer self-audit by subpart, a survey binder index, a personnel file checklist, a plan of correction template and a survey day sheet. For the analytic systems questions, the Procedure Manual and Method Verification Kit has the procedure template, verification plan and worksheet, and the maintenance, calibration and storage records.
Sources
Summaries on this page are ours and are written for convenience. The regulation and the agency documents control.