d. Slowly pour the contents of the diluent water vial into the control vial. Make sure
no water drips out.
e. Re-insert the stopper into the control vial.
f. Hold the stopper in place, vigorously shake the control vial until fully
reconstituted, and then let it stand for 5 minutes at room temperature.
g. Shake the control vial vigorously again and let stand 5 more minutes.
4. From the Home screen on the TEG analyzer, touch new qc.
5. Insert the cartridge into the slot, as indicated on the screen, with the bar code on the
left side.
6. After the cartridge pretest has completed and you have verified that the assay is
what you intended to run, touch next. If the cartridge is not the desired assay, touch
stop and start over.
7. On the Test Information screen, enter information for the test (if desired), and then
touch next.
8. Pipette the prepared QC sample into the cartridge sample port, filling up to or above
the line marked on the cartridge.
9. Touch next.
The TEG analyzer starts the test, and the results are displayed as they become
available.
10. When the analyzer displays the "Remove cartridge" prompt, remove the used
cartridge from the slot and immediately dispose of it.
Results
No calculations are necessary to obtain test results; these are displayed on the TEG
analyzer display, and may be printed if a printer is attached.
Limitations of the Procedure
Use of Results
• Results outside of the normal ranges listed below may indicate a problem with
analyzer performance, or it may be caused by improperly prepared control material
or product deterioration. It is recommended that any failed QC control test should be
repeated. Repeated failures should be reported to the supervisor.
• Do not report any patient results until the control parameters are within their
appropriate ranges.
Expected Values
Expected values for test results are within the reference ranges that were established
based on testing, following Clinical and Laboratory Standards Institute (CLSI)
publication C28-A3c, Defining, Establishing and Verifying Reference Intervals. Each
laboratory may establish its own level of performance to monitor quality assurance.
Follow your institution's policy to establish mean target values and ranges for the quality
controls.
3 / EN