Westgard rules

The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control, in "runs" consisting of measurements of multiple samples. They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control.[1] The rules are:[2]

RuleCriteriaSuspectedExample
12s One measurement exceeds 2 standard deviations either above or below the mean of the reference range. Inaccuracy and/or imprecision
13s One measurement exceeds 3 standard deviations either above or below the mean of the reference range. Inaccuracy and/or imprecision
22s 2 consecutive measurements exceed 2 standard deviations of the reference range, and on the same side of the mean. Inaccuracy.
R4s Two measurements in the same run have a 4 standard deviation difference (such as one exceeding 2 standard deviations above the mean, and another exceeding 2 standard deviations below the mean). Imprecision.
41s 4 consecutive measurements exceed 1 standard deviation on the same side of the mean. Inaccuracy.
10x 10 consecutive measurements are on the same side of the mean. Inaccuracy.

The recommended consequences when any of the above patterns occur is to reject the run, except for the rule of 12s (top in table), which serves as a warning and a recommendation of careful inspection of the data.[2]

See also

References
  1. Ofer Harel; Enrique F. Schisterman; Albert Vexler & Marcus D. Ruopp (July 2008). "Monitoring Quality Control: Can We Get Better Data?". Epidemiology. 19 (4): 621. doi:10.1097/ede.0b013e318176bfb2. PMC 2625303. PMID 18496467.
  2. Heidi Hanes. "Westgard Rules - Guidelines". SMILE, Johns Hopkins University. Review date: 1 April 2020
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