Abstract
SummaryBackgroundThe Six-Sigma Methodology is a quality measurement method in order to evaluate the performance of the laboratory. In the present study, it is aimed to evaluate the analytical performance of our laboratory by using the internal quality control data of immunoassay tests and by calculating process sigma values.MethodsBiological variation database (BVD) are used for Total Allowable Error (TEa). Sigma values were determined from coefficient of variation (CV) and bias resulting from Internal Quality Control (IQC) results for 3 subsequent months. If the sigma values are ≥6, between 3 and 6, and <3, they are classified as »world-class«, »good« or »un - acceptable«, respectively.ResultsA sigma value >6 was found for TPSA and TSH for the both levels of IQC for 3 months. When the sigma values were analyzed by calculating the mean of 3 months, folate, LH, PRL, TPSA, TSH and vitamin B12 were found >6. The mean sigma values of CA125, CA15-3, CA19-9, CEA, cortisol, ferritin, FSH, FT3, PTH and testosteron were >3 for 3-months. However, AFP, CA125 and FT4 produced sigma values <3 for varied months.ConclusionWhen the analytical performance was evaluated according to Six-Sigma levels, it was generally found as good. It is possible to determine the test with high error probability by evaluating the fine sigma levels and the tests that must be quarded by a stringent quality control regime. In clinical chemistry laboratories, an appropriate quality control scheduling should be done for each test by using Six-Sigma Methodology.
Highlights
In clinical laboratories, medical laboratory processes can be devided in three basic stages; preanalytical, analytical and post-analytical
It is aimed to evaluate the analytical performance of our laboratory by using the internal quality control data of immunoassay tests and by calculating process sigma values
Sigma values were determined from coefficient of variation (CV) and bias resulting from Internal Quality Control (IQC) results for 3 subsequent months
Summary
Medical laboratory processes can be devided in three basic stages; preanalytical, analytical and post-analytical. When the laboratory errors are evaluated according to these stages, it is found that errors mostly occur at the pre-analytical phase, secondly at post-analytical phase and the lowest rate is found at the analytical phase [3]. Inaccuracy and imprecision, which are the typical features of analytical performance, are basic parameters for systematic and random errors [4]. These parameters are expressed as bias and coefficient of variation (CV), and can be used to calculate the total error (TE) [5]. The total error of a test is calculated by: TE = Bias + 1.65CV
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