Abbott i-STAT 1, System Manual

Page: 135 / 658

Abbott Point of Care Inc.
• Abbott Park, IL 60064 • USA
Art: 730078-00A Rev. Date: 26-Oct-11
TECHNICAL BULLETIN
i-STAT
®
LIQUID QUALITY CONTROL PASS/FAIL
CUSTOMIZATION ON THE i-STAT 1 HANDHELD
OVERVIEW
As part of the on-going READi initiative ( Responds, Enhances, And Delivers Innovations), Abbott Point of
Care (APOC) has released a new Liquid Quality Control Automatic Pass/Fail (QC Auto P/F) customization
feature for the i-STAT 1 handheld. This feature can automatically determine if the results of a liquid QC
test run on an i-STAT cartridge are within APOC’s published quality control ranges. Since control ranges
vary with the handheld’s CLEW software version and with i-STAT cartridge and control lot numbers,
manually applying the correct control limits can be cumbersome; with QC Auto P/F, the potential
for this human error is avoided. Used in conjunction with the new Liquid QC Schedule and Lockout
customization features, QC Auto P/F helps a system administrator (e.g. Point of Care Coordinator or
Laboratory Administrator) assure compliance with QC requirements. By default, the feature is turned off.
For more information on the Liquid QC Schedule and Lockout customization features, please see
the Technical Bulletin: “Liquid Quality Control Schedule and Lockout Customization on the i-STAT 1
Handheld”.
Functionality
Previously, i-STAT 1 users performing liquid quality control tests on i-STAT cartridges had to manually
determine the acceptability of the results by accessing Value Assignment Sheets (VAS) posted on the
APOC website and comparing each test result value to the corresponding listed control range.
With the new QC Auto P/F feature, the system administrator can go to the APOC website and download
an electronic value assignment sheet (eVAS) file: an electronic file containing the complete set of the data
from the current i-STAT QC Value Assignment Sheets. By saving the eVAS file to a specified directory, the
eVAS is available to the i-STAT Central Data Station (CDS) or i-STAT/DE software applications. Once the
file is downloaded and the eVAS feature is enabled in the Customization Workspace, the file is transferred
to individual i-STAT 1 handhelds the next time they download data to the CDS or i-STAT/DE applications.
Each i-STAT 1 handheld will then have a complete database of all current i-STAT control ranges stored in
its memory.
When testing liquid QC samples with i-STAT cartridges on an i-STAT 1 handheld customized for the new
QC Auto P/F feature, the user scans barcodes from both the control fluid vial and the cartridge pouch.
Using this information, the handheld automatically evaluates each measured test result for acceptability
against the control ranges defined in the eVAS. A “Pass” or “Fail” status is determined for each result,
and an overall determination of “Pass” is made if every measured analyte in the test panel passes. The
status of individual failed results will be displayed on the handheld as either an up-arrow (
#
) for out-of-
range high results, or a down-arrow ( i ) for out-of-range low results. The overall determination for the QC
test panel is indicated by a PASS or FAIL message being displayed above the results.