Abbott i-STAT 1 System Manual page 118

B. QC Scheduling
The system administrator associates each QC test profile with at least one of three definable liquid QC
schedules. Each schedule can accommodate up to eight (8) QC test profiles. The liquid QC schedule
has an administrator-definable "Due Time" and "Grace Period". The Due Time sets the time when QC
Cycles (a test run in the Control pathway consisting of a QC cartridge and a corresponding QC fluid)
will begin to count toward completing QC test profiles, i.e. when QC will become "due to start". The
Grace Period is the period of time, starting from the Due Time, during which the QC test profile must be
completed before the corresponding cartridge set is locked out.
There are a number of options to allow flexibility in the liquid QC schedules. QC Due Times can be
set to daily (every day), weekly (on a specified day of the week, e.g. every Tuesday) or monthly (on a
specified day of the month e.g. every first Saturday) on selected months and at a defined time of the
day. The Grace Period is set in hours, up to 23 hours for daily schedules, up to 167 hours for weekly
schedules and up to 255 hours for monthly schedules. The minimum Grace Period is one hour for any
schedule type.
C. QC Lockout
By defining a QC test profile with a specified schedule, the system administrator enables the lockout of
the corresponding cartridge sets when the QC profile has not been satisfied within the Grace Period.
"Lockout" means that the i-STAT 1 Patient and Proficiency pathways are disabled until the QC test
profile is satisfied. A QC test profile is satisfied when at least one of each required QC cycle is run and is
determined to have "passed". Once a given cartridge set is locked out, its corresponding QC test cycles
can still be run on the QC pathway, i.e. the QC pathway is never locked out.
The following important lockout rules apply:
1. Even if multiple Due Times have passed, the QC test profile will only need to be satisfied once to
unlock testing (i.e. there is no "build up" of overdue QC cycles).
2. If liquid QC is due for a given schedule, and some of the required QC test profiles are
successfully completed but others are not, then when the profile becomes due again, all of the
QC test profiles within the schedule need to be re-run.
3. If a handheld is configured for information-first with cartridge lot enabled, when the cartridge lot
number is scanned in the patient or proficiency pathways, if the cartridge type is locked out, the
test cycle will not proceed.
4. A failed QC cycle in itself will not cause a cartridge set to be locked out. Lockout occurs
only when a QC test profile is past the set grace period and has not been satisfied.
GENERAL NOTES AND CONSIDERATIONS
1. The Liquid QC Schedule and Lockout feature is only available on the i-STAT 1 handheld, and not
the i-STAT Portable Clinical Analyzer (i-STAT 200 series model).
2. In order to create Liquid QC Schedules, users must have the i-STAT 1 handheld and either the
Central Data Station Version 5 or i-STAT/DE data management applications. This feature is not
customizable through the i-STAT 1 handheld keypad.
2
Art: 730077-01C Rev. Date: 21-Mar-14