CLIA Compliance Assessment

Does your laboratory possess a valid CLIA certificate?*

All clinical labs must have CLIA certification to perform patient testing

Is your CLIA certificate appropriate for the complexity of tests performed?*

Waived, moderate complexity, or high complexity certificate types

Are all test systems listed on your CLIA certificate?*

Does your laboratory director meet CLIA qualification requirements?*

Education, training, and experience requirements vary by test complexity

Are personnel qualifications documented and verified for all testing staff?*

Do you conduct competency assessments for all testing personnel annually?*

Annual competency required for all non-waived testing

Are continuing education requirements tracked and met for lab personnel?*

Do you perform daily quality control for all moderate and high complexity tests?*

Two levels of QC daily or as specified by manufacturer

Are QC results documented, reviewed, and out-of-range values investigated?*

Do you maintain equipment maintenance logs and calibration records?*

Are test systems validated before patient testing begins?*

Accuracy, precision, reportable range, and reference intervals

Do you participate in proficiency testing for all applicable analytes?*

Required three times per year for regulated analytes

Are PT samples treated as patient samples (no special handling)?*

Referral or special treatment of PT samples is prohibited

Do you achieve acceptable PT performance (80% or better)?*

Failing 2 consecutive or 2 of 3 events triggers sanctions

Do you have written procedures for patient preparation, specimen collection, and handling?*

Are test requisitions reviewed for completeness before testing?*

Patient name, test ordered, ordering provider required

Are patient test results reported with reference ranges and critical value flags?*

Do you have a procedure for reporting critical values to providers promptly?*

Critical values require immediate notification

Are test records retained for at least 2 years?*

CLIA requires 2-year retention; some states require longer