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PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Assays/Reagents
Not for Customer Distribution
78
AEROSET
®
System Troubleshooting Guide
94816-107—November 2004
d. After calibration, if any control is not within its
control limits, check control, calibrator, and reagent
handling, then rerun the control. If the control is
within its control limits after retesting, test patient
samples.
8. Use the temporary limits until permanent control limits
are established. Record and plot all routine control results
on Levey-Jennings charts. These control results are used to
determine the permanent control limits.
Permanent Control Limits
1. Start on the first testing day after temporary control limits
were established; assay one aliquot each of two or more
controls in a single run.
2. Use the following rules to determine if the run can be
accepted.
a. If controls are within the temporary control limits,
test patient samples.
b. If the control is still not within its control limits,
reject the run and recalibrate. Run controls again.
After recalibration, if the controls are within their
control limits, accept the run.
c. If the control is still not within its control limits,
reject the run then recalibrate. Run controls again.
After recalibration, if the controls are within their
control limits, accept the run.
d. If after recalibration the control is not within its
control limits, check the control, calibrator, and
reagent handling, then rerun the control. If the
control is within its control limits after retesting, test
patient samples.
3. Evaluate control results for 30 calendar days (a minimum
of 20 values for control level) to determine the permanent
control limits. Recalibrate whenever a control fails or
every 14 calendar days. Record control results. Do not
discard any result unless it was generated by operator error
or instrument malfunction, or results can be rejected as a
statistical outlier.