Evaluation of Quality Control in Clinical Hematology laboratory by using Six- Sigma

Abstract

Background

Clinical laboratories' unreliable and false results have serious implications for patients. Sigma metrics is a standardized tool for assessing the quality of test results in a laboratory. The goal of quality control in the hematology laboratory is to ensure that reliable test findings are produced with the required precision and accuracy. The quality control system’s aims to keep record and track the analytic processes, we discover the analytic errors during the process of analysis, and prevent inaccurate patient values are being reported. Six σ is a well-known quality management approach that employs statistical tool or methods to identify to remove flaws and variations of observations .In this proximity of the research gap, the present study was undertaken to evaluate the quality of the analytical performance of clinical hematology well on laboratories by calculating sigma metrics.

Material and Method

The study was conducted at Clinical Pathology Laboratory, National Institute of Unani Medicine Hospital, Bangalore. Internal quality control (IQC) datasets of 5 analytes were analyzed retrospectively in 2 months from January 2021 to February 2021 by using Councell V3 plus Auto HematologyAnalyzer. The analytics were assessed for red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), platelet (PLT) and white blood cell (WBC) etc.

Results

 Thehighest co efficient of variation (CV %) percentage value was 8.7% for platelet and the lowest was 1.06% in HB. The highest Bias percentage value is 6.5% in HB and the lowest <1 % for WBC.  In case of  IQC, HB, WBC, RBC, HCT, PLT the criteria sigma value for world class performance was seen in HB &HCT, good to excellent performance on RBC &WBC ,poor performance for PLT.

Conclusion

The Councell V₃ plus Auto hematology assay would be excellent, with a expressive range of 5 to > 6 sigma values. The accuracy performance is more suitable for routine examination of research intervention, because its accuracy and reproducibility, the imprecision is acceptable level. However, the low sigma expression is an indication for Vigorous monitoring and CAPA will be implemented by advice.