Accumetrics VerifyNow User Manual page 124

voltages; and 4) system intra-communication validation. These self-tests
serve as one component of the quality control check of the instrument system.
• System Security and Access Controls: The VerifyNow Instrument has been
designed with features that restrict instrument access and improve patient
result traceability:
•
The laboratory has the option of assigning a User ID to each user, so that
instrument access may be restricted to only trained operators who have
demonstrated competency. If this feature is selected, a User ID and a
password must be entered before an operator can use the instrument.
This can facilitate CLIA compliance and prevent errors due to operator
variability.
•
If the User ID feature is enabled, it is also possible to assign different
authority levels to each user, depending upon the instrument functions
delegated to each user (e.g. running patient samples, QC 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
defines 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 assay port and is used to
perform a comprehensive testing routine that confirms performance of the
following key VerifyNow Instrument subsystems.
•
Verifies proper performance of instrument optics.
•
Confirms proper functioning of the pneumatics system that draws the
sample into the assay device and moves it into the assay device for
reaction and measurement.
•
Monitors reagent mixing parameters and sample data acquisition.
•
Confirms correct calibration parameters.
•
Simulates assay testing at two levels of results, to check correct data
acquisition and calculations. Specifically, 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
VerifyNow System User Manual Page 124
APPENDIX - 11
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