Quality Controls - Accumetrics VerifyNow User Manual

Quality Controls

5
Accumetrics has designed the VerifyNow System with a comprehensive set of quality
control measures that provide control of the complete analytical process as defined
in the CLIA regulation. This includes control of the following factors:
• Test system performance (both instrument and reagents)
• Environmental conditions
• Variations in operator performance
The extensive quality control features of the VerifyNow system are outlined in the
Appendix. Accumetrics' recommendations for frequency of external control
(Electronic Quality Control, Wet Quality Control levels 1 and 2) testing are stated in
the individual assays' package inserts and are summarized in Table 5-1.
Electronic Quality Control (EQC) is a procedure during which the software will verify
instrument optics performance, reagent mixing, and instrument pneumatics. Assay
Wet Quality Control (WQC) follows the same procedure as an actual patient test,
except that optically absorbent solution is used in lieu of blood. It verifies continued
performance by checking that actual results are within a standard range.
Table 5-1 Quality Control (QC) Tests
Quality
Control
Electronic Recommended to run once a day to
(EQC) confirm the integrity of the instrument.
Run after resetting the date and time.
Level 1 Run during troubleshooting to resolve
WQC unexpected events.
Use as part of your institution's quality
control program.
VerifyNow System User Manual
When do I use it
Page 25
QUALITY CONTROLS - 5
What it does
Verifies that instrument components
are functioning properly – including
optics, reagent mixing, and
pneumatics. It also confirms correct
calibration parameters and simulates
assay testing at two levels of results
to check correct data acquisition and
calculations.
Verifies instrument performance by
checking that actual results are within
a lower range of values.
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