Error identification in a high-volume clinical chemistry laboratory: Five-year experience

Scand J Clin Lab Invest. 2015 Jul;75(4):296-300. doi: 10.3109/00365513.2015.1010175. Epub 2015 Feb 27.

Abstract

Introduction: Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale.

Materials and methods: Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled.

Results: In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes.

Conclusions: Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.

Keywords: Laboratory proficiency testing; errors; healthcare; quality control; quality indicators.

MeSH terms

  • Chemistry, Clinical / standards*
  • Clinical Laboratory Techniques / standards*
  • Diagnostic Errors*
  • Humans
  • Laboratories*
  • Phlebotomy / standards*
  • Quality Control