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KMID : 0981820060260060400
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Korean Journal of Laboratory Medicine
2006 Volume.26 No. 6 p.400 ~ p.407
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Evaluation of Fixed Quality Control Range of Bayer Rapidpoint 400 Blood Gas and Electrolyte Analyzer with Six Sigma Metrics
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Kim Yun-hee
Min Won-Ki
Park Hyo-Soon
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Abstract
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Background: Bayer Rapidpoint 400 analyzer for point of care testing (POCT) uses fixed quality control (QC) range even when the lot number of a cartridge for quality control changes. To evaluate the fixed QC range recommended by the manufacturer, we analyzed internal QC data of 9 analyzers with Six Sigma metrics.
Methods: We investigated QC data of 9 analyzers over 5 months from May to September, 2004 for 8 parameters (pH, pCO2, pO2, Na+, K+, iCa++, Cl-, and glucose). One hundred eighty six groups of QC data were analyzed with capability index (Cp=total allowable error (TEa)/3 standard deviation (SD)) and capability index considering bias (Cpk,=(TEa-bias)/3 SD). Acceptability was evaluated with criteria of 1.33 Cpk, 4 sigma level or quality criteria of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88).
Results: In 80.7% (150 of 186 groups), both Cp and Cpk were at or above 1.33, which indicated that the use of fixed QC range was adequate. In 19.3% (36 of 186 groups), Cpk was below 1.33, which indicated the inadequacy of fixed QC range. Among them 14.5% (27 of 186 groups) showed Cp below 1.33, indicating that the errors had a random factor and 4.8% (9 of 186 groups) had Cp at or above 1.33, indicating that the errors had a systematic factor.
Conclusion: The quality criteria mandated by CLIA ’88 was satisfied in about 80% of study groups using fixed QC ranges, but in about 20%, more strict instrument maintenance and specimen handling by operators, and quality improvement of QC materials by manufacturer was required. (Korean J Lab Med 2006;26:400-7)
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KEYWORD
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Blood gas and electrolyte analyzer, Capability index, Capability index considering bias, Point of care testing, Quality control, Six Sigma
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