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APPLICATION OF QUALITY GOAL INDEX RATIO FOR EVALUATION THE QUALITY SYSTEM OF HbA1C ON TOSOH HPLC-723G11 ANALYZER
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Abstract
Background: Hemoglobin A1c (HbA1c) it plays a major role in diagnosing and managing diabetes. Reliable results are the primary goals of medical laboratories. Sigma metrics is an important tool to evaluate the errors in quality control of laboratory systemby combining bias, precision, and total allowable error (TEa). Quality goal index (QGI) is a newer parameter to represent the relative extent to which both bias and precision meet their respective quality goals. Objects: The aim of our study was to apply the QGI to evaluate the analytical performance of HbA1c on TOSOH HPLC-723G11 analyzer based on intenal quality control (IQC) data. Methods: this is a retrospective study, two levels of controls of HbA1c were run on a TOSOH HPLC-723G11 analyzer. Data were extracted over a period of 11 months, between July 2020 and June 2021. For Bias CV%, and SD, values that the firm provided from IQC results. 6% were basis for the allowed total error values (NGSP). Monthly process sigma level and QGI were calculated subsequently. Results: The sigma metrics for internal quality control level 1 meet acceptable performance with sigma metrics between 3 and 6, of which 7 months had metrics between 3 and 4 . For level 2, all of months achieved six sigma with metrics 6, which showed excellent world class performance. The QGI indicated that seven months of level 1 had sigma scale between 3 and 6, the main problem was imprecision (QGI<0.8) except in July-2020, November-2020, June-2021 showed both imprecision and inaccuracy (0.8≤ QGI ≤ 1.2). Conclusions: In our study it was observed that HbA1c test is in conformity with the process sigma levels according to IQC and it was also evaluated as favorable considering our laboratory performance. On the basis of sigma metrics and QGI, it may be concluded HbA1c on TOSOH HPLC-723G11 was able to achieve good performance and required modification in quality control procedure as their QGI.
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Keywords
Sigma, Quality goal index, Bias, Coefficient of variation, TOSOH HPLC-723G11
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