CELL-DYN
®
3200 System Operator’s Manual
11-17
9140181K—July 2002
Section 11
Quality Control
Running Controls
Abbott recommends using CELL-DYN Control materials for performing Quality
Control checks on the CELL-DYN 3200 System. Run a minimum of two levels of
control at the beginning of each eight hours of operation prior to running patient
samples. In addition, run controls after the following events:
• After calibration (confirmatory step).
• After Daily Start-Up procedures are completed.
• After a reagent lot number change.
• After maintenance, a service call, or component replacement.
• After detection of an unusual trend or shift in patient results.
• In accordance with the laboratory's Quality Control protocol.
• According to regulatory requirements.
Controls should be run in both operating modes, (Open or Closed). Always do the
following:
• If the System has been idle for 15 minutes or more, run a background
immediately prior to running a control specimen.
• Follow the proper warming and mixing procedures previously described,
including those located on the control package insert.
• Run control samples for each measured parameter in the same manner as
patient samples.
• Verify that control results are within the laboratory's acceptable limits.
• If the control results fall within acceptable limits, review the data for shifts or
trends, record the results, and begin to process patient samples.
• If one or more result falls outside the laboratory's acceptable limits, review
Troubleshooting and Diagnostics
;
. Perform suggested maintenance steps for the
parameter that is out-of-range, then try using another vial from the same lot.
If the problem persists, contact the Abbott Hematology Customer Support
Center.
