6-4
CELL-DYN
®
3200 System Operator’s Manual
9140181H—October 2001
Calibration Procedures
General Information
Section 6
When to Calibrate
Scheduled calibration of the CELL-DYN 3200 should conform to the guidelines
established by regulatory agencies.
Calibration should be confirmed on a regular basis according to the requirements
governing quality control in your laboratory. In keeping with good laboratory
practices, this should include daily confirmation on each shift and following a
reagent lot number change.
Unscheduled calibration is indicated following service adjustments performed by
Abbott Field Service Representatives, such as major component changes.
Unscheduled calibration is also necessary when indicated by the results of the
Quality Control program. Quality Control includes (1) statistical computations and
Westgard
®
Rules for commercial or patient controls, and (2) monitoring of patient
samples for WBC parameters with moving averages and RBC parameters using
Bull’s Moving Average Program (X-B).
The laboratory should make the decision to recalibrate based on the results of the
instrument’s performance, as indicated by these quality control programs.
However, calibration should be considered as the very last step in a troubleshooting
sequence. Performing unnecessary calibrations may mask an underlying problem
with the instrument’s performance.
Calibration is also recommended following the replacement of any major
instrument component, such as the Shear Valve, that could affect the accuracy of
the instrument. Calibration should also be confirmed by running the same samples
used to calibrate the instrument to test the accuracy of the reported results. The
procedures for confirming calibration are described in subsections
Auto-Cal
Method
and
Enter Factor Method
.