Quality control limits: Are we setting them too wide?

Clinica Chimica Acta; International Journal of Clinical Chemistry
Robert L SchmidtLauren N Pearson

Abstract

Quality control charts (Levey Jennings Charts) are based on estimates of variation. There are two general approaches for estimating variation: those based on short-term variation and those based on long-term variation. We have observed that clinical laboratory science (CLS) tends to estimate variation using long-term variation but that most other fields use short-term variation. The objective of this study is to compare these two methods of estimating process variation, compare the accuracy of control limits generated by each method, and explore whether it would be useful for clinical laboratories to adopt methods used in other fields. We conducted a literature review to compare recommendations for methods for estimation of variation in CLS with other fields. We searched textbooks for suggested methods and also searched the primary literature for references to methods associated with short-term and long-term variation. We provide theoretical results from statistics to show that, in theory, short-term estimates can differ from long-term estimates of variation. We used simulation studies to show that one can construct examples where short-term and long-term estimates of variation lead to significant differences in control limits....Continue Reading

Citations

Jun 30, 2019·Laboratory Medicine·Brandon S WalkerRobert L Schmidt
Oct 1, 2021·Clinica Chimica Acta; International Journal of Clinical Chemistry·Sten A WestgardJames O Westgard

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