Healthcare Facility Compliance 12 items
Clinical Laboratory CLIA / CAP Inspection Readiness
Inspection-readiness checklist for clinical laboratories covering CLIA personnel, quality control, proficiency testing, and specimen management.
CLIA 42 CFR 493CAP Laboratory AccreditationCMS
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Certification & Personnel
- Does the laboratory hold a current CLIA certificate appropriate to the complexity of testing performed? *
- Are the laboratory director, technical supervisor, and testing personnel qualified for their roles? *
- Is competency of testing personnel assessed at least semiannually the first year and annually thereafter? *
Quality Control
- Are quality control materials run at the frequency required for each test system? *
- Are QC results reviewed and corrective action documented when QC is out of range? *
- Are calibration and calibration verification performed at least every six months or per manufacturer? *
Proficiency Testing
- Is the laboratory enrolled in an approved proficiency testing (PT) program for each regulated analyte? *
- Are PT samples tested in the same manner as patient samples, without referral or interlaboratory communication? *
- Is corrective action documented for any unsuccessful PT performance? *
Pre-Analytic & Post-Analytic
- Are specimen collection, labeling, transport, and rejection criteria defined and followed? *
- Is a test validation/verification performed before reporting patient results for new methods? *
- Do reports include reference intervals, critical values with read-back, and required identifiers? *
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