CLIA Moderate Complexity Testing

A Reference Guide

CLIA Moderate Complexity Testing cover

Almost half of all tests listed in the FDA CLIA database are classified as moderately complex.2

Sites performing Point-of-care testing (POCT) must obtain Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification prior to testing. 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
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