Users Manual Part 2

9 - 12 Operator’s Manual
9 Using the QC Program
9.3.2 Analyzing the Causes
Retest the samples with outliers. If the retest result still contains outliers and the trend is the same as
that of the previous result with outliers, see “Figure 9-5 Analyze the cause of QC outliers” to find
out the cause of outliers.
Figure 9-5 Analyze the cause of QC outliers
9.3.3 Taking Corrective Measures
Analyze the possible causes of QC outliers and make corrections in time, see “Figure 9-5 Analyze
the cause of QC outliers”.
9.3.4 Verifying Effectiveness of Corrective Measures
After taking corrective measures, retest the QC samples and verify whether the QC results are
within the range.
If the cause of outliers is still not determined after all factors are analyzed, replace the controls with
new one for verification, or directly contact Customer Service Department.
Possible Causes
Control-related
Operation-
related
Analyzer-
related
Reagent-related
Others
Used unmatched controls
Color of the control abnormal,
showing dark or black
Control type/ lot/ level not
corrected
The control expired or out of the
open-vial validity period
Control volume insufficient
Failed to rewarm the control
fully
Failed to mix the control fully
Failed to run the QC test as
instructed
Failed to maintain the analyzer
with probe cleanser
Selected wrong mode
Used unmatched reagents
Reagent expired or out of the
open-vial validity period
Reagents not correctly connected
Enter unmatched target value,
limit and/or QC rules