Evaluation of Analytical Quality of Cardiac Biomarkers in the Emergency Laboratory by Sigma Metric

Abstract

Objectives: The Six-Sigma Methodology is a quality measurement method in order to evaluate the performance of the laboratory. In the present study, we aimed to evaluate the analytical performance of our emergency laboratory by using the internal quality control data of cardiac biomarkers and by calculating process sigma values. Materials and Methods: Biological 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 4 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 . Results: When the sigma values were analyzed by calculating the mean of 4 months, Troponin I (cTnI), CKMB mass, Myoglobin (Mb) were found <3. Conclusions: The “poor quality” levels of cTnT, CKMB mass, Myoglobin sigma values, decision is taken for the improvement of cardiac markers in our laboratory. 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.

Keywords: Six Sigma, total allowable error, bias, Cardiac Biomarkers

DOI: 10.7176/JSTR/5-9-05