Abbott i-STAT 1, Системное руководство

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Abbott Point of Care Inc.
• Abbott Park, IL 60064 • USA
Art: 730077-00B Rev. Date: 14-Mar-12
TECHNICAL BULLETIN
i-STAT
®
LIQUID QUALITY CONTROL SCHEDULE AND LOCKOUT
CUSTOMIZATION ON THE i-STAT 1 HANDHELD
OVERVIEW
As part of the on-going READi initiative (
Responds, Enhances, And Delivers Innovation), Abbott Point
of Care (APOC) has released a new Liquid Quality Schedule and Lockout feature for the i-STAT 1
handheld. This new feature allows a system administrator (e.g. Point of Care Coordinator or Laboratory
Administrator) to define a liquid quality control plan for their i-STAT 1 handhelds and enables them to
enforce quality control (QC) compliance by invoking automatic lockout of patient and proficiency testing
pathways if QC requirements in the plan are not fulfilled. By default, the feature is turned off.
This feature can be used in conjunction with the new Liquid QC Pass/Fail customization to automate and
manage liquid quality control testing on the i-STAT 1 handheld. Please see the Technical Bulletin “Liquid
Quality Control Pass/Fail Customization on the i-STAT 1 Handheld” for more information.
Functionality
Previously, system administrators had to “manually” manage and enforce QC requirements for the i-STAT
1 System, since no automated liquid QC lockouts were provided. With this new customization feature,
the system administrator can define a customized QC plan that includes:
• which cartridge types and liquid QC fluids must be run,
• which cartridge types are enabled by running the liquid QC, and
• under what schedule the liquid QC is to be performed.
A. QC Profile
Using the Customization Workspace in the i-STAT CDS application or i-STAT/DE, the system
administrator defines a number of QC
cartridge sets , consisting of:
• a QC cartridge type (i.e. the cartridge type to be tested with specified liquid QC fluids during the
QC procedure), as well as
• any number of dependent cartridge types (i.e. associated cartridge types that will be enabled
by the analyzer if the QC requirements for a given cartridge set are met on that analyzer. A QC
cartridge set is allowed to have zero dependent cartridges).
Note: A QC cartridge in one QC cartridge set cannot be a dependent cartridge in another QC cartridge
set within the same schedule, but it can be a dependent cartridge in a QC cartridge set belonging to a
different schedule.
The system administrator also creates a QC test profile by associating the defined cartridge set with up
to six (6) specific QC fluids (i.e. specified types and levels of liquid control fluid). All APOC control fluids
as well as three generic (user-defined) fluids are available for selection in the QC test profile.