28
Section 7 Quality Control
To ensure the accuracy of test results, the
Mission
®
PT/INR Monitoring
System can run an internal Level 1 or Level 2 electro-optical calibration
check when a strip is inserted and
EC Tst
is selected. The internal Electronic
Calibrator independently simulates the optical signal produced by a
specimen applied to a test strip and produces an INR reading, which is the
same as applying a blood specimen. The inserted test strip is not affected or
consumed and can then be run in the normal sequence with a normal blood
specimen if used within 10 minutes from when the test strip was first
removed from the pouch.
Control solutions (Level 1 and Level 2) are provided as a second method to
confirm the test strips and meter are working together properly and to
ensure the test is being performed correctly. The labels on the control
solution bottles are printed with the acceptable range for the control INR
results.
To ensure continued accuracy of results, control solutions should be run
when any of the following events occur:
INR values are unusually high or low
A meter malfunction is suspected
A new box or lot of test strips is opened
Each new day of testing (professional use)
A new operator uses the meter (professional use)
After performing maintenance or service on the meter
If QC tests do not provide expected results, perform the following checks:
Ensure the test strips are not expired.
Ensure the controls are not expired.
Repeat the test to ensure no errors were made during the testing.
Electronic Calibrator
To initiate the Electronic Calibrator subsystem, insert a test strip to turn the
meter on. After the checkerboard test, hour glass, patient ID entry and
close optics cover screens are shown, the following screen will be shown.
