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 assure the accuracy and timely reporting of laboratory results.
One fundamental element of a QMS is the management of non-conforming events (NCEs). The general purpose of NCE management is to cultivate an environment in which problems or occurrences can be used 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.