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Pro50-10-G
12/18/06
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SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your labs
specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering
their use in other applications. If you have any questions contact SMILE.
319649900.doc
Ver 1.0
5/30/2016
SMILE
Johns Hopkins University
Baltimore, MD USA
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 doesnt 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
Report Results
12s
No
no
Yes
no
13s
no
22s
yes
no
R4s
yes
no
41s
yes
10x
yes
yes
319649900.doc
Ver 1.0
5/30/2016
SMILE
Johns Hopkins University
Baltimore, MD USA
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.
319649900.doc
Ver 1.0
5/30/2016