2002 OPEN FORUM Abstracts
EVALUATION OF INTELLIGENT QUALITY MANAGEMENT (iQM) IN THE IL GEM® Premier 3000 CRITICAL CARE® ANALYZER:
John J. Ancy,
MA, R.R.T.1, Kevin Fallon, PhD.2, Sohrab Mansouri, PhD.2
1. St. Elizabeth?s Hospital,
2. Instrumentation Laboratory, Lexington, MA
Background: Traditional blood gas Quality Control (QC) involves the periodic analysis of ampouled controls with subsequent statistical evaluation. Resultant values that are within acceptable ranges according to the laboratory?s statistical rules intermittently confirm that the instrument is ?in control? and available for analysis of patient samples. The cartridge based GEM Premier 3000 with Intelligent Quality Management (iQM) employs Failure Pattern Recognition (FPR) software, which automatically and continuously monitors sensors, fluidics and electronics. FPR also provides corrective action without the need of operator intervention. FPR continuously assures that the instrument is ?in control?. After each cartridge is validated at start-up with external Calibration Validation Product (CVP) iQM conducts automatic analysis of internal reference solutions to confirm acceptable performance. This analysis occurs with every sample and periodically during periods on non-use. This study tested the effectiveness of the iQM process to produce results comparable to a GEM Premier 3000 (reference system). Normal external controls confirmed the reference system.
Method: Whole blood samples were analyzed on the GEM Premier 3000 with iQM and on the standard IL GEM Premier 3000, the IL 1745 analyzer, and, for glucose and lactate, the YSI 2300 Stat Analyzer. Analytes included pH, PCO2, PO2, sodium (Na+), potassium (K+), ionized calcium (Ca++), glucose, lactate, and hematocrit. Table I displays the average difference between the systems for each analyte. In addition to the correlation study, we confirmed that FPR decreases the influence of some interfering substances by analyzing blood specimens spiked with Thiopental or Benzylkonium Chloride. Finally, we confirmed that FPR could recognize the presence of a clot, perform a special clot removal procedure automatically, and return the system to full operation. The system recognized when the clot could not be removed and prevented the analysis of patient samples.
Results: Table I demonstrates that the data confirms that the GEM Premier 3000 with iQM provides high quality data comparable to the reference systems. The PO2 differences have been demonstrated in other studies to be caused by sample handling procedures.
The average of the differences between the IL GEM Premier 3000 and the reference systems All values are in common units (mmHg, mmol/L, etc.)
Conclusion: This study demonstrates the effectiveness of the GEM Premier 3000 with iQM in assuring quality results without operator intervention. There are no statistical differences between the test and reference instruments.