page_title: Laboratory quality control
section_title: Levey–Jennings chart
hierarchical_section_title: Laboratory quality control / Levey–Jennings chart
caption_attribution_description: English: Made myself, using Microsoft Excel 2003 with random data.
context_page_description: Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and whenever patient results seem inappropriate. Quality control material should approximate the same matrix as patient specimens, taking into account properties such as viscosity, turbidity, composition, and color. It should be simple to use, with minimal vial-to-vial variability, because variability could be misinterpreted as systematic error in the method or instrument. It should be stable for long periods of time, and available in large enough quantities for a single batch to last at least one year.
context_section_description: A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations. It is named after Stanley Levey and E. R. Jennings, pathologists who suggested in 1950 that Shewhart's individuals control chart could be used in the clinical laboratory. The date and time, or more often the number of the control run, is plotted on the x-axis. A mark is made indicating how far the actual result was from the mean, which is the expected value for the control. Lines run across the graph at the mean, as well as one, two and three standard deviations to either side of the mean. This makes it easy to see how far off the result was.
  Rules such as the Westgard rules can be applied to see whether the results from the samples when the control was done can be released, or if they need to be rerun. The formulation of Westgard rules were based on statistical methods. Westgard rules are commonly used to analyse data in Shewhart control charts. Westgard rules are used to define specific performance limits for a particular assay (test) and can be used to detect both random and systematic errors. Westgard rules are programmed into automated analyzers to determine when an analytical run should be rejected. These rules need to be applied carefully so that true errors are detected while false rejections (of valid results that are outside of range) are minimized. The rules applied to high-volume chemistry and hematology instruments should produce low false rejection rates.
  The Levey–Jennings chart differs from the Shewhart individuals control chart because the standard deviation (σ, "sigma") is estimated. The Levey–Jennings chart uses the long-term (i.e., population) estimate of sigma whereas the Shewhart chart uses the short-term (i.e., within the rational subgroup) estimate.
caption: An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation
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