Abstract Background Effective quality control processes within clinical laboratories are crucial for monitoring and assessing the analytical performance in terms of precision and accuracy. The regular measurement of these parameters plays a pivotal role in ensuring patient safety and is often a prerequisite for accreditation by various organizations. Six Sigma metrics have emerged as one of the most efficient tools for evaluating the analytical performance of clinical laboratory systems. This approach integrates Total Allowable Error (TEa), encompassing both random and systematic errors into a single comprehensive index. This study details the establishment of Six Sigma in our laboratory for Thyroid Stimulating Hormone (TSH) for eight different modules of Siemens Atellica IM. Methods A one-year dataset was compiled from the assessment of internal quality control for evaluating the imprecision (expressed as coefficient of variation - CV%) and Bio Rad’s Unity Interlaboratory Program for inaccuracy (quantified as bias%) in TSH test processed across eight modules of Atellica IM (Siemens). The data was categorized into two groups based on QC levels. The TEa utilized in this study was set at 20% according to CLIA standards. Six Sigma metrics were subsequently calculated for each QC level and equipment based on TEa, CV%, and bias%, utilizing the formula Sigma=(TEa - bias%)/CV%. Results Six Sigma values calculated for the QC level 1 ranged from 4.92 to 6.20 across all equipment, while for the QC level 2 Six Sigma varied from 4.87 to 7.59. All values found were classified as Good, Excellent and World Class according to the normalized method decision chart. These results showed that analytical performance of all eight modules of Atellica IM were similar in terms of random and systematic error. Conclusions Six Sigma serves as potent tool for monitoring the analytical performance of the TSH test. It is crucial to independently track different levels of QC in TSH testing for enhanced control over the analytical system. The performance of Siemens TSH test in our laboratory has proven to be very satisfactory.
Read full abstract