Why You Need a CLIA Compliance Checklist
CLIA regulations cover every aspect of your laboratory—from personnel and procedures to quality control and proficiency testing. A structured, annual checklist ensures your lab remains inspection-ready and avoids costly surprises during surveys.
2025 CLIA Compliance Checklist
Use the sections below as a practical checklist. Many laboratories track these items directly inside mylabcompliance.io to maintain a real-time view of their compliance status.
1. CLIA Certificate and Licenses
- Active CLIA certificate that matches testing complexity.
- State licenses (if required) are current and uploaded.
- Certificates and license numbers recorded in a centralized system.
2. Personnel Qualifications
- Lab director meets CLIA educational and experience requirements.
- Technical consultants, general supervisors, and testing personnel documented.
- Job descriptions aligned with CLIA-defined responsibilities.
3. Personnel Competency & Training
- Initial training documented for each test system.
- Six-month and annual competency assessments completed and signed.
- Continuing education activities logged.
4. Test Menu Documentation
- Up-to-date list of all tests performed, including complexity and method.
- Verification/validation records for each non-waived test.
- Reference ranges, reportable ranges, and critical value policies documented.
5. Quality Control (QC)
- QC policies for each test system.
- Documented QC results with clear pass/fail criteria.
- Corrective actions recorded for out-of-control events.
6. Proficiency Testing (PT)
- Enrollment in appropriate PT programs.
- Timely submission of PT results and review of scores.
- Corrective action plans for unsatisfactory performance.
7. Quality Assessment (QA)
- Regular review of pre-analytic, analytic, and post-analytic quality indicators.
- Documentation of QA meetings and improvement projects.
- Tracking of complaint investigations and incident reports.
8. Instrument and Maintenance Logs
- Preventive maintenance, service calls, and calibration activities recorded.
- Lot numbers and expiration dates tracked for reagents and controls.
- Backups and downtime procedures documented.
9. Policies, Procedures, and Manuals
- Current procedure manuals accessible to testing personnel.
- Change control and approval process for procedure updates.
- Safety policies, specimen handling, and waste disposal documented.
10. Inspection Readiness
- Previous inspection deficiencies addressed and documented.
- Mock inspection or self-audit performed within the last year.
- Central repository of documents and records ready for surveyors.
Digitizing Your CLIA Checklist with mylabcompliance.io
Instead of tracking this checklist on paper, labs use mylabcompliance.io to:
- Assign tasks and owners to each requirement.
- Set due dates and reminders for recurring activities.
- Store evidence (documents, images, certificates) in one place.
- Generate real-time dashboards that show which items are complete, in progress, or overdue.