CLIA surveys under 42 CFR Part 493 are organized into subparts. The AILS CLIA Self-Audit Agent runs through each of these areas against your live data and flags gaps before a surveyor does.
CLIA requires documented initial training and ongoing competency assessment for every testing personnel category. Six evaluation elements are required annually for non-waived testing — direct observation, monitoring, test performance records, QC records review, PT review, and problem-solving assessment.
AILS checks
Training records module flags any staff member whose competency assessment is overdue. The agent checks whether all 6 elements are documented per analyst and surfaces gaps by name and test method.
The lab director must meet qualification requirements and be actively involved. Organizational chart, director responsibilities, and personnel records must be current and accessible during survey.
AILS checks
Roles and credentials are documented in the personnel module. The agent verifies lab director designation is current and that required qualification documentation is on file and accessible.
The most surveyed subpart. Covers pre-analytic, analytic, and post-analytic systems — sample management, test procedures, QC, result reporting, corrective actions, and complaint handling.
AILS checks
The agent sweeps open deviations, unresolved QC failures, COAs with flagged results lacking documented corrective action, and complaint records without closure dates — and returns a scored findings list.
Labs must enroll in an approved PT program for each analyte and testing specialty. Unsuccessful PT events must trigger investigation and corrective action. PT results cannot be referred to another lab for resolution.
AILS checks
PT enrollment, event results, and investigation records are tracked in the Proficiency Testing module. The agent flags any unsatisfactory event without a linked CAPA and checks PT coverage against your active test menu.
Labs must make all records, personnel, and operations available during CMS or accrediting organization surveys. This subpart governs the survey process itself and what labs must produce on demand.
AILS checks
The agent generates a pre-survey document readiness report — listing which records are current, which are overdue, and which need attention before you'd hand them to a surveyor.
Covers CMS enforcement actions — condition-level vs. standard-level deficiencies, plans of correction, and civil money penalties. Understanding this subpart helps labs prioritize which gaps carry the most risk.
AILS checks
The agent classifies findings by severity — condition-level vs. standard-level — so you know where to allocate corrective action resources before a survey. High-risk gaps are surfaced first.
Specific QC frequency requirements vary by test complexity. Surveyors check whether QC is run at required intervals, reviewed by qualified personnel, and that out-of-control events are documented and resolved before patient testing continues.
AILS checks
QC run frequency is tracked per instrument and method. The agent identifies any period where QC cadence fell below requirement and checks whether out-of-control events have resolution records before the next patient result was issued.
Sample integrity documentation — collection procedures, sample acceptance/rejection criteria, transport and storage conditions, and labeling requirements must all be documented and followed consistently.
AILS checks
Chain of Custody records are reviewed for sample rejection documentation, collection condition flags, and labeling completeness. Patterns of missing pre-analytic data are surfaced across the COC log.