2002 OPEN FORUM Abstracts
STATISTICAL COMPARISON OF EXTERNAL QC PROCEDURES AND THE AUTOMATIC PROCESS CONTROL PROGRAM OF THE IL GEM PREMIER® 3000 WITH iQM.
Kevin Fallon, PhD. and Sohrab Mansouri, PhD., Instrumentation Laboratory, Lexington MA.
Introduction. Instrumentation Laboratory recently introduced Intelligent Quality Management (iQM) as an option on the GEM Premier 3000. This system analyzes whole blood for blood gases, electrolytes, glucose, lactate, and hematocrit. Critical Care testing sites require the highest possible test accuracy without overburdening the already overworked staff. A high level of accuracy is not always demonstrable with the popular single use testing devices. The IL GEM Premier 3000 is a disposable, multi-use cartridge-based system. Up to now, traditional QC methods have been used during the cartridge?s three week use-life. IQM eliminates the need for external controls and the other labor-intensive QC activities. This paper documents the comparability of iQM quality management with traditional QC using statistical comparison of the two methods on a series of cartridges. iQM additionally incorporates Failure Pattern Recognition (FPR) that enhances quality control by recognizing the pattern associated with drift and other failure conditions and then providing automatic corrective actions with confirmation of effectiveness of the corrections.
Methods. During the evaluation period instruments were used in normal clinical applications. Quality control ampoules were analyzed according to normal laboratory practices and statistical rules applied to the data. Simultaneously the IL GEM 3000 was performing ?constant? checks for any drift in the calibration and correcting this drift. All data is stored for statistical analysis of the calibration drifts. Internal quality management, which provides both analysis and correction of drift, occurs after each sample and periodically during periods of instrument non-use. While external quality control is usually done after a calibration, the iQM process control checks are set up to monitor the instrument at the point of maximum drift. Process Control Solutions are analyzed like a patient sample and the values recorded. After analysis any required corrective actions are taken and documented.
Results. Table I presents data that supports the fact that the IL GEM Premier 3000 does provide tight control of the system and that statistical analysis show that the two methods are comparable for maintaining the system for clinical use.
The average of the standard deviations for the internal automatic Process Control Solutions and the traditional ampoule controls. Analytes are presented in common units (mmHg, mmol/L, etc.)
Conclusion. iQM on the IL GEM Premier controls the system in a manner analogous to standard traditional quality control programs.