ITC VerifyNow System Platelet Reactivity Test - Manual (Page 21)

Page 17 14439.C 03/2013
Quality Controls - 5
VerifyNow System User Manual | USA
5 Quality Controls
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 tests’ 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. 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
When do I use it What it does
Electronic
(EQC)
Recommended to run once a day to confirm the integrity
of the instrument.
Run after resetting the date and time.
Verifies that instrument components are
functioning properly – including optics, reagent
mixing, and pneumatics. It also confirms correct
calibration parameters and simulates testing
at two levels of results to check correct data
acquisition and calculations.
Level 1
WQC
Run during troubleshooting to resolve unexpected events.
Use as part of your institution’s quality control program.
Verifies instrument performance by checking that
actual results are within a lower range of values.
Level 2
WQC
Run before the first use of each new lot (or shipment) of
test device kits.
Run during troubleshooting to resolve unexpected events.
Refer to Chapter 10, Troubleshooting.
Run when the test device kit temperature indicator (if
present) shows exposure to elevated temperatures. Refer
to Chapter 4, Reagent Storage and Handling.
Run every 30 days (for PRUTest and IIb/IIIa Test).
Use as part of your institution’s quality control program
Verifies instrument performance by checking that
actual results are within a higher range of values.
The following sections provide a detailed description of the procedures.
5.1 Electronic Quality Control
Electronic Quality Control (EQC) is the primary quality control mechanism for the VerifyNow Instrument.
It consists of a re-usable device that is inserted by the operator into the test port and is used to perform
a comprehensive testing routine that confirms performance of key instrument components.
This procedure involves a reusable EQC device and takes up to two minutes. If a fault is detected in any
of its systems, the instrument cannot perform patient testing until the fault is corrected.