Introduction: The Six Sigma methodology is an opportunity for a better understanding of the performance of analytical methods and for a better adaptation of the quality control management policy of the medical biology...Introduction: The Six Sigma methodology is an opportunity for a better understanding of the performance of analytical methods and for a better adaptation of the quality control management policy of the medical biology laboratory. Using the sigma metric, this study assessed the performance of the Biochemistry analytical system of a medical biology laboratory in Côte d'Ivoire. Methods: Six Sigma methodology was applied to 3 analytes (alanine aminotransferase, glucose and creatinine). Performance indicators such as measurement imprecision and bias were determined based on the results of internal and external quality controls. The sigma number was calculated using the total allowable error values proposed by Ricos et al. Results: For both control levels, ALT had a sigma number greater than 6 (7.6 for normal control and 7.9 for pathological control). However, low sigma numbers, less than or equal to 2 for creatinine (1.4 for normal control and 2 for pathological control) and less than 1 for glucose were found. Conclusion: This study revealed good analytical performance of ALT from the point of view of 6 sigma analysis. However, modifications to the overall quality control procedure for glucose and creatinine are needed to improve their analytical performance. The study should be extended to the entire laboratory’s analytes in order to modify the strategies of quality control procedures based on metric analysis for an overall improvement in analytical performance.展开更多
文摘Introduction: The Six Sigma methodology is an opportunity for a better understanding of the performance of analytical methods and for a better adaptation of the quality control management policy of the medical biology laboratory. Using the sigma metric, this study assessed the performance of the Biochemistry analytical system of a medical biology laboratory in Côte d'Ivoire. Methods: Six Sigma methodology was applied to 3 analytes (alanine aminotransferase, glucose and creatinine). Performance indicators such as measurement imprecision and bias were determined based on the results of internal and external quality controls. The sigma number was calculated using the total allowable error values proposed by Ricos et al. Results: For both control levels, ALT had a sigma number greater than 6 (7.6 for normal control and 7.9 for pathological control). However, low sigma numbers, less than or equal to 2 for creatinine (1.4 for normal control and 2 for pathological control) and less than 1 for glucose were found. Conclusion: This study revealed good analytical performance of ALT from the point of view of 6 sigma analysis. However, modifications to the overall quality control procedure for glucose and creatinine are needed to improve their analytical performance. The study should be extended to the entire laboratory’s analytes in order to modify the strategies of quality control procedures based on metric analysis for an overall improvement in analytical performance.
