CLIA Compliance Guide for Clinical Laboratories
The foundation of laboratory quality in the United States. Here's what CLIA requires and how to build compliance into daily operations.
CLIA Certificate Types
Certificate of Waiver
~73% of labsScope: Simple tests with low error risk
Requirements: Follow manufacturer instructions, PT where applicable
Certificate of PPM
~5% of labsScope: Provider-performed microscopy
Requirements: Moderate complexity requirements, practitioner present
Certificate of Compliance/Accreditation
~22% of labsScope: Moderate/high complexity
Requirements: Full CLIA requirements or accreditation (CAP, COLA)
Core CLIA Requirements
Personnel Qualifications
Director, supervisor, consultant, and testing personnel must meet education/experience requirements
Quality Control
Two levels of controls daily, established ranges, documented results, corrective action
Proficiency Testing
CMS-approved PT for regulated analytes, treated like patient specimens
Quality Assessment
Ongoing monitoring of pre-analytical, analytical, and post-analytical factors
Patient Test Management
Positive specimen ID, verification before reporting, critical value notification
Records & Reporting
Requisitions, testing records, QC data, PT results—2+ year retention
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