Manual

Appendix - 11
Page 92 14439.C 03/2013VerifyNow System User Manual | USA
procedures or changing instrument parameters).
• As an additional security feature, various instrument display screens may be set to time out after
a default time period set by Accumetrics (2 to 5 minutes), or a time period set by the user (from 0
to 255 minutes). If the instrument is idle for a longer period, it will automatically return to the Main
Menu and require re-entry of User ID if applicable.
• The laboratory may decide to assign a Patient ID to each patient sample, to allow traceability of test
results.Ifthisoptionisselected,thelaboratorydenestheformat(numberofcharacters)forthe
Patient ID number and the VerifyNow Instrument will not accept a patient sample without entry of a
Patient ID in the designated format.
• Electronic Quality Control: The Electronic Quality Control (EQC) is the primary quality control
mechanism for the VerifyNow Instrument. It is a re-usable device that is inserted by the operator
intothetestportandisusedtoperformacomprehensivetestingroutinethatconrmsperformance
of the following key VerifyNow Instrument subsystems.
• Veriesproperperformanceofinstrumentoptics.
• Conrmsproperfunctioningofthepneumaticssystemthatdrawsthesampleintothetestdevice
and moves it into the test device for reaction and measurement.
• Monitors reagent mixing parameters and sample data acquisition.
• Conrmscorrectcalibrationparameters.
• Simulates testing at two levels of results, to check correct data acquisition and calculations.
Specically,theEQC measures two levels of turbidimetric signal that verify the dynamic range of
the instrument. One of these signals is at the level that would be observed in a patient with
a minimal amount of platelet aggregation (Negative or Low Level Control), and the other
represents a patient who demonstrates a signicant amount of aggregation (Positive or High
Level Control).
• The required EQC testing frequency is input into the VerifyNow Instrument by the user. Accumetrics
recommends that the EQC be run at least on a daily basis, although the institution may select their
preferred EQC testing frequency. When the established interval has elapsed, the user is locked out
from running a patient test until the EQC test has been successfully completed.
• When run according to Accumetrics’ recommendations, the EQC meets CLIA requirements
for daily QC of the instrument system.
• System Controls for Each Sample Tested: Each time a test device is run on the VerifyNow System,
theinstrumentveriesthedeviceexpirationdate,samplelling,opticsperformance,correctuid
transfer, and proper mixing. The system controls prevent the operator from running an expired test
device. The system also detects certain other operator errors, such as placing the test device or the
sample in the instrument at the wrong time, or removing the test device before the test is complete.
These controls prevent reporting of an inaccurate test result. These controls exceed the CLIA
requirement for daily QC because they are performed for each test device.
11.9.1.2 VerifyNow Test Device
• Test Device Internal Controls: Each test device incorporates two levels of quality control to identify
invalid test runs caused by random errors, reagent degradation or inappropriate blood samples.
Beforeplateletactivationandbrinogen binding begin, the Negative (Aspirin) or Low-Level (P2Y12
and IIb/IIIa)InternalControlperformsatestfornon-specicaggregation.Duringtheactivephase
of the test, the Positive (Aspirin) or High-Level Internal Control channel monitors the reaction and
calculatesClinicalControlUnits,whichmustfallwithinspeciedlimits.Afailureofeitherinternal
control results in an error message by the VerifyNow Instrument, which prevents the reporting of an
inaccurate result.