Compliance With Clia Control Requirements; Description Of The Verifynow System Control Measures - Accumetrics VerifyNow User Manual

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 assays by running external
controls. For unitized test systems, such as the VerifyNow system, where each
patient sample is its own assay 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 assay 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 assay 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 assay warming plate reaches and
maintains the proper temperature; 3) system check of proper operating
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