ITC IRMA TruPoint Blood Analysis System - Manual (Page 53)

3.1
Section 3
Quality Control Testing
OVERVIEW
Quality Assurance (QA) can be defined as the required systems and actions to
provide adequate confidence that a service, such as a point of care diagnostics
program, satisfies the medical needs of the patient.
1 Quality Control (QC) is a
major component of a QA program, and can be defined as the systematic
process of assessing and documenting the analytical performance of an
analysis system.
By design, a point of care (POC) system is intended to be used by non-
laboratory clinical staff who typically do not have a background in the quality
control, analyzer maintenance, and calibration procedures that are inherent
components of traditional laboratory analyzer QA programs. Traditional
laboratory analyzer QC programs are designed to detect system problems
primarily through the use of liquid controls. System problems are typically
related to calibration or maintenance problems that result from the exposure
of the system and sensors to multiple samples. The IRMA TruPoint system
was designed to eliminate problems related to calibration and maintenance.
Single-Use Cartridges
The IRMA TruPoint system utilizes single-use cartridges, also referred to as
unit-use or disposable cartridges. Each cartridge houses miniaturized
electrochemical sensors and a pre-packaged calibrant. A single-use cartridge
is used to perform analysis on one sample, then is discarded.
Cartridge Calibration
Prior to sample introduction, the sensors on each IRMA TruPoint cartridge
are automatically calibrated using a pre-packaged calibrant. The calibrant is
manufactured and tested with NIST traceable gases and standards. Calibration
of the cartridge is completed when information determined at the factory for
each lot of cartridges (the Cal Code) is combined with measurements taken
during the calibration process. The factory derived Cal Code information is
stored in the analyzer memory following initial entry of a new cartridge lot, or
can be entered via the bar code reader.