PN 177196BB
4-2
QUALITY ASSURANCE
SETTING UP OR MODIFYING CELL CONTROL FILES
3. Help the trainee find Heading A.6 SETTING UP A CONTROL FILE, in the Online Help System or
the Instructions for Use manual, and set up their control files.
a. If the instrument has the optional Barcode Scanner and the control vials have a
bar-code label, demonstrate how to use the Barcode Scanner correctly.
The instructions for using the Barcode Scanner are under
Heading 5.6, WORKING WITH
BAR-CODE LABELS
, in the Online Help System or the Instructions for Use manual.
b. Emphasize the importance of selecting the
Reserved option, reserving the control lot
number as the Sample ID for that control.
1) Reserved is the default setting.
2) If the control lot number is reserved as the Sample ID, the system recognizes
the Sample ID as being a control and places the control results in the correct
control file.
3) If the control lot number is not reserved as the Sample ID, the system does not
recognize the Sample ID as being a control and places the results in with the
patient sample results.
4) The screen that happens to be displayed when running a control has no affect
on the placement of the control results.
c. If your laboratory establishes its own running means and expected ranges for the
control results, you can modify this setup accordingly.
4. If you modify the control file setup after data is in the file, that event is logged in the
Quality Control Log.
a. From the Main Menu screen, click tt to access the Quality Control Log.
1) The most recent entry is displayed on the top of the log screen.
2) The log entry includes the date and time of the event, the name of the Operator
logged in, and the lot number and expiration date of the control and the event.
3) The Quality Control Log saves entries for up to one year.
4) Prior entries to the log are deleted on a “first in, first out” basis as the capacity
is exceeded.
b. To add comments to an entry (up to 50 alphanumeric characters), click on the entry
and then on the
Add Comments button.
5. Give the trainee a copy of the
CONTROL FILE SETUP AND MODIFICATION SUMMARY from this
Training Guide. This summary has two procedures; review the procedure for setting up a
control file and then go over the procedure for modifying a control file.
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