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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Compliance

As part of the QMS, regulating and accreditation agencies require that laboratories maintain methods for detecting and evaluating errors, incidents, and non-conformities in their products/services that may impact patient care. These methods, reviewed by laboratory management, are intended to:
  • Document the identification of a problem
  • Investigate and analyze the cause of the problem
  • Derive a corrective action to prevent the recurrence of the problem
  • Implement and verify that the action is effective
  • Communicate the corrective action to responsible parties