The Laboratory Quality Management System and Non-Conforming Events (NCEs)

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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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The Laboratory Quality Management System and Non-Conforming Events (NCEs)

The laboratory's quality management system (QMS) is the framework for a systematic approach to meeting an organization’s quality objectives. The QMS looks at the whole laboratory and addresses all processes to ensure the accuracy and timely reporting of laboratory results.

One fundamental element of a QMS includes the management of non-conforming events (NCEs). Its general purpose is to cultivate an environment in which problems or occurrences can be used in a positive way to improve the quality of laboratory services.
A non-conformity is defined as a non-fulfillment of a requirement. An NCE occurs when there is a deviation from established policies and procedures or when a product or service does not meet the customer’s expectations. In the laboratory, examples of NCEs may include:
  • Unlabeled/mislabeled specimens
  • Missing specimens
  • Specimen preparation errors
  • Delay in turnaround times
  • Incorrect delivery of reports
  • Corrected reports
The consequences of NCEs can be significant (eg, adverse effects on patient safety), ranging from minor to critical, or low risk to high risk. By managing NCEs we can learn about laboratory errors and improve quality.