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Pro50-10 Guide Westgard Rules
Pro50-10 Guide Westgard Rules
Westgard Rules are multirule QC rules to help analyze whether or not an analytical run is in-control or out-
of-control. It uses a combination of decision criteria, usually 5 different control rules to judge the
acceptability of an analytical run.
Westgard Rules are generally used with 2 or 4 control measurements per run, which means they are
appropriate when two different control materials are measured 1 or 2 times per material, which is the case
in many chemistries application.
For hematology, coagulations, and immunoassays applications some alternate control rules are more
suitable when three control materials are analyzed.
12s
One control measurement exceeding 2 standard deviations of control limits either above or below the mean.
This rule is used a warning rule to trigger careful inspection of the control data.
13s
This rule is commonly used with a Levey-Jennings chart when the control limits are set as the mean +3
standard deviations of control limits. A run is rejected when a single control measurement exceeds the
mean +3 control limits.
22s
The control run is rejected with 2 consecutive control measurements 2 standard deviations of control limits
on the same side of mean with this rule.
R4s
This rule rejects a run if two control measurements in a group exceed the mean with a 4 standard deviation
difference between the 2 controls
41s
This rule rejects a run with the 4th consecutive control measurement exceeding 1 standard deviation on the
same side of the mean.
10x
This rule rejects a control run when there are 10 consecutive controls on the same side of the mean.
The 12s rule is used as a warning to trigger application of the other rules. Any time a single measurement
exceeds a 2 standard deviation control limit, you respond by inspecting the control data using the other
rules. This doesn’t mean stop, it just means to look carefully at the data before proceeding.
By using the following diagram you should be able to decide what if any action is required.
Control Data
In-control
12s Report Results
Yes no
no no no no
2of32s
For this rule reject a control if 2 out of 3 control measurements exceed the same mean +2 or -2 control
limits.
31s
For this rule reject when 3 consecutive control measurements exceed the same mean +1 or -1 control limits.
6x
For this rule reject when 6 consecutive control measurements of one control fall on one side of the mean.
Reference
Westgard JO, Barry PL, Quam EF, Shrmeyer SS, Plaut D, Statland BE. Chapter 6 in Basic QC Practices,
Training in Statistical Quality Control for Healthcare Laboratories, 2 nd Edition, Westgard QC, Inc,
Madison, WI, 2002, pp77-88.