Why QC and Validation Are Central to CLIA
CLIA mandates that laboratories ensure the accuracy and reliability of test results. This starts with proper validation of methods and continues with ongoing QC to monitor performance.
Core QC Requirements
- Follow manufacturer instructions for control materials and frequency.
- Run and document appropriate controls for each test system.
- Define acceptance criteria and statistical rules for control evaluation.
- Investigate and document all QC failures and corrective actions.
Validation and Verification Expectations
Before reporting patient results, labs must validate or verify:
- Accuracy and precision.
- Reportable range and linearity.
- Reference intervals (where applicable).
- Sensitivity, specificity, and interference (for certain methods).
Documentation Needed for QC & Validation
- Written QC and validation policies.
- Protocols for each study performed.
- Raw data, calculations, and summary reports.
- Approval signatures from the laboratory director or designee.
Standardizing QC & Validation with mylabcompliance.io
mylabcompliance.io helps labs meet CLIA QC and validation requirements by:
- Providing configurable templates for validation studies.
- Capturing QC results in structured digital logs.
- Flagging missing QC runs or overdue validations.
- Maintaining complete, searchable records for inspections.