ITC VerifyNow System Platelet Reactivity Test - Manual (Page 95)

Page 91 14439.C 03/2013
Appendix - 11
VerifyNow System User Manual | USA
11.9 Compliance with CLIA Control Requirements
The CLIA Regulation, section 493.1256 - Control Procedures, states that the laboratory must perform
control procedures as specified by the test manufacturer. It goes on to state that at least once each
day of patient testing, a positive and negative control must be run for qualitative tests and two controls
materials at different levels must be run for quantitative tests.
These requirements have traditionally been met for batch tests by running external controls. For
unitized test systems, such as the VerifyNow system, where each patient sample is its own test run,
quality control should be run for each sample. External quality controls, such as the VerifyNow WQC,
are an important element of the entire QC system, but they are not the most important QC element for
unit-test systems.
The VerifyNow System provides “equivalent” quality control procedures including daily (or more
frequent) system checks with the Electronic Quality Control (EQC) and two levels of quality control
included in each test device. In addition to these equivalent QC procedures, the Wet Quality Controls
(WQC) are run according to Accumetrics’ recommendations. This system provides more comprehensive
quality control than can be provided by external quality control testing alone.
The quality control features of the VerifyNow System are described in detail on the following pages.
11.9.1 Description of the VerifyNow System Control Measures
The VerifyNow System includes a comprehensive system of quality control measures that are designed
and manufactured into the VerifyNow System to provide control for the complete analytical process, as
defined in the CLIA Regulation. Various QC mechanisms detect errors caused by various factors that
can influence test results and potentially lead to erroneous results:
• Instrument system failure
• Reagent system failure
• Adverse environmental conditions
• Variations in operator performance
The VerifyNow quality control measures are described in detail below.
11.9.1.1 VerifyNow Instrument
• Startup Checks: The VerifyNow Instrument performs a self-testing procedure each time the
instrument is turned on. These startup self–tests include: 1) a system program and data memory
check to ensure memory integrity; 2) a system temperature check to ensure the test warming plate
reaches and maintains the proper temperature; 3) system check of proper operating 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