Qc lockout – ITC IRMA TruPoint Blood Analysis System User Manual

Page 50

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2.20

QC LOCKOUT

The QC Lockout feature allows the QA User to define the number of
successful QC tests (EQC and/or liquid) required to support patient testing.
When activated, either 1, 2, or 3 successful quality control tests must be run
during a shift or the analyzer will deny access to the patient test screen, or in
the case of a partial lockout condition, limit access to the tests available. Shifts
can be specified as 8-, 12-, or 24- hours in length.

SATISFYING QC LOCKOUT - GENERAL RULES

• QC Lockout can be configured separately for EQC, and for each product

type (liquid).

• When EQC Lockout is on, an EQC test failure at any time (i.e., even if

EQC passed earlier on a shift) will lockout patient testing. Following an
EQC test failure, a passed EQC test is required to resume patient testing.

• When liquid QC limits have been established, results must fall within the

established QC limits to be considered a successful test and satisfy QC
lockout requirements.

• When no liquid QC limits have been established, running the designated

number of controls will satisfy QC lockout requirements for all non-
suppressed results.

• Result Suppression during an liquid QC test: If an individual sensor on a

cartridge errors during the analysis phase of an liquid QC test, the result
for that sensor and any other sensors that are dependent on that sensor will
be suppressed. Suppressed results will be dashed-out on both the screen
and printout, and will not satisfy QC lockout requirements for the
associated analyte group (with or without QC limits established).

• If a patient test is initiated and QC Lockout is “on” and Lockout

requirements have not been met, a QC lockout screen displays.

QC LOCKOUT SCREENS

If a patient test is initiated and QC Lockout is on and Lockout requirements
have not been met, one of the following lockout information screen displays:

All Analyte Groups and Product Types are

locked out (none of the QC lockout
requirements for the current shift have been
satisfied).

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