A new internal quality control chart based on biological variation

Coskun A. , Serteser M. , Fraterman A., Unsal I.

ACCREDITATION AND QUALITY ASSURANCE, vol.13, no.2, pp.69-75, 2008 (Journal Indexed in SCI) identifier identifier

  • Publication Type: Article / Article
  • Volume: 13 Issue: 2
  • Publication Date: 2008
  • Doi Number: 10.1007/s00769-007-0345-7
  • Page Numbers: pp.69-75
  • Keywords: biological variation, decision interval, levey-jennings chart, quality control, quality management, six sigma, westgard multirules, PERFORMANCE, SPECIFICATIONS


The instruments and analytical methods currently used in clinical laboratories today have better precision and stability than those used in the past. With the development of chemical and immunological methods and instrumentation technology, test precision has increased. However, the application of the Westgard multirule procedure to control sera in the Levey-Jennings chart may not be useful or cost-effective. We devised a new test-specific decision limit for accepting or rejecting runs based on the data of within-subject biological variation and prepared a control chart. We then applied these new limits and control chart to a group of tests performed in our laboratory. With the exception of the tests for albumin, total protein, and calcium, for which desirable performance standards could not be attained with the current technology and methodology, the application of these control limits was cost-effective and convenient. It is estimated that the value of healthy within-subject biological variations is constant, irrespective of the methodology, the area in which the study has been performed, and the number of subjects included in the study. We believe that control limits based on biological variation are reliable and cost-effective, and may be useful in modern and accredited laboratories.