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Clinical Laboratory CLIA / CAP Inspection Readiness

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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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