CLIA: Laboratory Requirements
The Clinical Laboratory Improvement Amendments (CLIA) regulations establish quality standards for all laboratory testing performed on human specimens to ensure accuracy, reliability, and timeliness. Any facility performing laboratory testing on human specimens for health assessment, diagnosis, prevention, or treatment must have a CLIA certificate.
Key Points
All labs testing human specimens must be CLIA-certified, including physician office labs and point-of-care testing sites
Four certificate types: waived, provider-performed microscopy, moderate complexity, and high complexity
Waived tests (e.g., rapid strep, urine dipstick, glucose monitoring) have minimal regulatory requirements
Moderate and high complexity labs must meet personnel, QC, proficiency testing, and quality assessment standards
Labs must enroll in an approved proficiency testing program for each regulated analyte
Key Areas
Certification
Certificate types, application, inspection
Personnel
Director qualifications, testing personnel requirements
Quality Systems
QC, proficiency testing, quality assessment
Key Provisions
Certificate Types
Determines which certificate a lab needs based on test complexity. This drives all subsequent regulatory requirements.
Quality Control (QC)
Requirements for control procedures, including calibration, control testing frequency, and corrective actions for out-of-range results.