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CLIA (Clinical Laboratory Improvement Amendments) Requirements

CLIA requires that a laboratory have quality systems in place to focus on comprehensive and coordinated efforts to achieve accurate, reliable, and timely testing services. The quality system approach includes all laboratory policies, processes, procedures, and resources needed to achieve consistent, high quality testing services. Integral to the quality system approach is quality assessment, which includes the following activities:

  • ongoing monitoring of each testing process used to identify errors or potential problems that could result in errors
  • taking corrective action
  • evaluation of corrective actions to make sure they were effective and prevent reoccurance