What is CLIA?
Clinical Laboratory Improvement Amendments
Trusted by leading diagnostic labs and life sciences companies
- CLIA
- CLIA (Clinical Laboratory Improvement Amendments) is a U.S. federal regulatory program that establishes quality standards for all laboratory testing performed on human specimens. CLIA certification is required for any lab that tests human samples for health assessment or disease diagnosis.
CLIA was enacted in 1988 and is administered by the Centers for Medicare & Medicaid Services (CMS). The regulations cover approximately 320,000 laboratory entities and are designed to ensure accuracy, reliability, and timeliness of test results regardless of where the test is performed.
CLIA Certificate Types
Certificate of Waiver (CoW)
For labs performing only waived tests (simple, low-risk tests like dipstick urinalysis, rapid strep, glucose monitoring)
Examples: POC glucose, rapid flu, pregnancy tests
Certificate of Provider-Performed Microscopy (PPM)
For physicians performing microscopy during patient encounters
Examples: Wet mounts, KOH preps, urine sediment
Certificate of Compliance
For labs performing moderate or high complexity testing, inspected by CMS
Examples: Most clinical chemistry, hematology, microbiology
Certificate of Accreditation
For labs inspected by CMS-approved accrediting organizations (CAP, COLA, etc.)
Examples: Same scope as Compliance, different inspection pathway
Key CLIA Requirements
How LIMS Supports CLIA Compliance
Audit Trails
Automatic tracking of all system changes and user actions
Personnel Tracking
Manage competency assessments and training records
QC Management
Westgard rules, Levey-Jennings charts, QC review workflows
PT Tracking
Proficiency testing enrollment and result management
Procedure Control
Version-controlled SOPs with acknowledgment tracking
Reporting
Compliance dashboards and inspection-ready reports