Almost half of all tests listed in the FDA CLIA database are classified as moderately complex.2
What is CLIA?
CLIA stands for Clinical Laboratory Improvement Amendments of 1988. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans, whether for health assessment or to diagnose, treat, or prevent disease, through CLIA.1
CLIA regulations include quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed.
Test Categorization:
Tests are categorized in two general categories depending on test complexity:
- Waived
- Nonwaived
- Moderate complexity
- High complexity - Specialized scientific knowledge and training are required.
CLIA Moderate Complexity Testing Reference Guide
This guide provides summary information and helpful links to assist you in navigating the CLIA requirements for performing moderate complexity tests. For example, you’ll find information on the following:
- CLIA certification
- CLIA moderately complex testing
- CLIA certification and CMS-approved accreditation
- CLIA quality standards
- Personnel requirements and competency
- Quality control (QC) procedures
- Proficiency testing (PT)
- Verification of performance specifications
- Calibration and calibration verification
- Applying for CLIA certification for moderate complexity testing
- CLIA: helpful resources
- Siemens Healthineers customer resources
