The Science Journal of the American Association for Respiratory Care

1996 OPEN FORUM Abstracts

EVALUATION OF THE ^{GAS}TRAX E_{x}TEND pH/BLOOD GAS HIGH AND LOW QUALITY CONTROL PRODUCTS

RA Brown, BS, RRT, RPFT; R Kozlowski-Templin, BA, CPFT. Pulmonary Diagnostic Services, University of Wisconsin Hospitals and Clinics, Madison, WI and Central Blood Gas Laboratory, Northwestern Memorial Hospital, Chicago, IL.

Introduction: Our study was designed to evaluate the stability and reproducibility of commercial products having extreme pH and blood gas values which are then intended for use as materials to validate reportable ranges as required by regulatory agencies. Two laboratory settings having dissimilar instruments (Ciba- Corning and Radiometer versus Instrumentation Laboratory [IL]) were employed in the study. Methods: Each laboratory measured a minimum of 25 runs/level (of the same lot number) on consecutive days, using calibrated pH/blood gas analyzers. Meticulous attention was paid to adhering to manufacturer recommendations regarding instrument calibration for normal operation, standardizing analyte preparation, as well as assuring continuous solid samples were introduced into each instrument. All runs were performed after instrument performance was deemed acceptable by internal QC. Recovered values were transcribed exactly as displayed by each instrument (data were not rounded up or down). Results:

Mean Recovered Values from Single Analyzer Runs

LOW HIGH

Analyzer pH PCO2 PO2 pH PCO2 PO2

Radiometer 500 #6 6.793 96.3 29.2 7.797 13.5 553.5

. CV % 0.1 2.8 9.4 0.1 2.5 2.0

Radiometer 500 #7 6.786 101.0 26.0 7.799 13.9 553.1

. CV % 0.0 2.0 12.6 0.0 1.1 1.1

Radiometer 500 #8 6.783 98.9 23.7 7.800 13.2 558.8

. CV % 0.0 0.6 7.1 0.0 1.2 0.9

Ciba-Corning 288 6.799 102.0 18.2 7.808 13.0 570.0

. CV % 0.1 1.2 14.4 0.1 1.4 2.9

IL 1306 6.796 95.6 19.2 7.787 15.5 575

. CV % 0.1 1.5 15.7 0.0 1.8 2.1

All recovered values (standard units) were within the product manufacturer's instrument and model specific ranges. Coefficient of Variation (CV% = [SD/Mean] X 100) reflects relative variability among analyzers. Conclusion: These products are acceptable materials to validate the reportable ranges of these analyzers. Each laboratory is responsible for establishing performance acceptability criteria.

Reference: OF-96-049

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