Manual

Page 93 14439.C 03/2013
Appendix - 11
VerifyNow System User Manual | USA
The test device internal controls can detect failures of the reagent system due to improper storage
orhandlingconditions.Theinternalcontrolswillalsoaganimproperlycollectedormishandled
blood sample, or a blood sample with certain types of interfering substances. The Test Device
Internal Controls detect errors from the reagent system, adverse environmental conditions,
and additional types of operator errors. The Test Device Internal Controls exceed the CLIA
requirement of daily controls because two levels of control are run with each test.
• Test Device Kit Temperature Indicator: Each VerifyNow Aspirin and IIb/IIIa Test kit has a
temperature indicator on the outside of the packaging. The user is instructed to inspect the indicator
upon receipt of the kit. If the indicator has changed color, the kit has been exposed to elevated
temperatures, and a Wet Quality Control (WQC) Level 2 must be run to ensure that the reagents
are performing properly. The Temperature Indicator detects errors due to adverse environmental
conditions.
11.9.1.3 VerifyNow Assay WQC
• Wet Quality Controls Levels 1 and 2 are available from Accumetrics for verifying the integrity of the
VerifyNowSystemandforevaluatingoperatorprociency.WQC Level 1 and Level 2 are formulated
at clinically relevant levels. In the VerifyNow Tests, Level 1 is representative of a sample with
platelet inhibition, and Level 2 is representative of a sample with no platelet inhibition.
Laboratories may elect to run these controls on a regular basis for QC of the VerifyNow
Tests, although Accumetrics believes that the comprehensive QC components built into every
VerifyNow test make this unnecessary. Accumetrics recommends that Level 2 WQC be run
under the following conditions:
• Whenever a new shipment or lot number of VerifyNow Test Devices is received.
• When a temperature indicator changes color, indicating that a VerifyNow Aspirin or IIb/IIIa Test kit
has been exposed to elevated temperatures.
• In the case of repeated failures of the Test Device Internal Control, to rule out degradation of test
device reagents as the cause of the failure.
• VerifyNow Assay WQC kit (part number 85047) may be used as a tool for other types of activities
required by the CLIA Regulation, other than the daily quality control requirements. These activities
include the following:
• Prociencytesting
• Laboratory personnel competency evaluation
• Establishmentandvericationofsystemperformancespecications(493.1253)
• Analytical system quality assessment (493.1289)
Accumetrics Technical Support can advise on the use of WQC as tools in meeting these CLIA
requirements.
NOTE: The recommendation for the VerifyNow IIb/IIIa Test only is to run Level 2
WQC with each lot or shipment, or every 30 days.
11.9.1.4 Accumetrics Quality Control Procedures
To assure that VerifyNow System components are of the highest quality, Accumetrics subjects its
products to rigorous quality control procedures before they are shipped to customers.
• Each VerifyNow Instrument is tested mechanically, optically and electrically throughout the
manufacturing process. The instrument’s performance is validated by comparing it to Accumetrics’
internal reference standards. The validation process consists of the following: