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Abbott Diagnostics Aeroset - WESTGARD QC RULES

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MODULE 7: QUALITY CONTROL
7-40 AEROSET
®
Customer Training Guide
94858-103 — July 2003
WESTGARD QC RULES
The AEROSET System can be configured to evaluate the QC results
with the Westgard QC Rules.
The following rules are available:
The Operator can select which rules will be used for evaluation on a
System-wide basis. Each assay can be configured to use the selected
rules or to not use any rules. Different rules cannot be configured for
each assay.
NOTE: For each data point, only the highest priority rule will be
displayed. The priority is shown in the above table.
If the Westgard Rules will be used for evaluation, the expected mean and
SD must be defined for each assay to be evaluated.
NOTE: Refer to Section 2, Installation Procedures and Special
Requirements of the AEROSET System Operations Manual
for details on Configuring QC Rules.
NOTE: For other QC rules to be checked when a value is within
2 SD, the first QC rule (1-2 SD) must be modified by adding a
zero in the Num field box of this rule. This would allow QC
results to be evaluated against the other rules.
If the System determines that a control value violates a Westgard Rule,
an Error Log Message is generated. The violated rule is also displayed on
the ASSAY STATUS screen in the QC Rule column.
Rule Description
1
2S
One control value exceeds ± 2 standard deviations.
1
3S
One control value exceeds ± 3 standard deviations.
2
2S
Two consecutive control values for one level exceed ± 2
standard deviations.
R
4S
The difference between two consecutive control values
exceeds 4 standard deviations.
4
1S
Four consecutive control values for one level exceed ± 1
standard deviation.
10
x
Ten consecutive control values for one level lie on one side
of the mean.
Total of 10 rules; we use 6.
The ones that use QC for one level
are employed here.
The remaining cover multiple
levels.
•1
2S
rule is the threshold. When
configured, this rule must be
violated before any other rules will
be looked at.

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