![]() The result may be a patient result or it may be a quality control (QC) result. When a diagnostic test is performed in the medical laboratory, the outcome of the test is a result. The run is rejected.Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. The rule could also apply if 4 consecutive controls fall on the same side of the mean with both controls. 8 x rule: This rule applies when 8 consecutive controls fall on the same side of the mean, either above or below.The controls could be normal, abnormal, or a combination of the two. 4 1s rule: This rule applies when four consecutive control samples all exceed the +1 or the -1 limit.This rule detects random errors and applies within one control level (ie, day 3 the control result falls above +2 SD and day 4 the control result falls below -2 SD) or across two control levels within one run such (ie, day 6 the high control is above +2 SD and the normal control is below -2 SD). R 4s rule: This rule applies when the difference between the highest and lowest result of a run exceeds 4 standard deviations.A violation of this rule usually indicates a systematic error. The controls could be normal or abnormal (across runs), or one of each (within a run and both outside the same 2SD). 2 2s rule: This rule applies when two consecutive results exceed the +2 or the -2 standard deviation limit.Usually, this indicates that a random error has occurred. 1 3s: This rule applies when a control result falls outside of the 3s limit, either above or below the mean.If no other rules are broken, results can be accepted. Warning Rule 1 2s: If one point is outside ± 2 standard deviations, this warning rule should trigger careful inspection of the data by the rejection rules listed below.If two controls are used, the Westgard Rules that may be considered for rejecting an analytical run are: The Westgard multi-rule approach can help to determine whether there is a problem and whether that problem is due to random or systematic error. Quality control charts are examined to see if there are problems in the measuring system. ![]()
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