IMPROVING QUALITY AND EFFICIENCY PERFORMANCE OF ANALYTICAL TESTING PROCESS USING SIGMA METRICS IN EMERGENCY LABORATORY OF KING FAHD ARMED FORCES HOSPITAL, JEDDAH, SAUDI ARABIA

Background: Six Sigma is a popular quality management system tool used for process improvement. Using that, the clinical technologist can directly intervene to improve the quality of test reporting during the analytical phase of the total testing process in the medical laboratory. The present study aimed to assess and continuously improve the performance of individual biochemical and hematological parameters on a Sigma Scale by calculating the Sigma metrics for individual parameters redesigning and customizing the internal quality control (IQC). A sigma metric is a simple measurement of assay quality that compares an assays precision and bias performance to a total allowable error (TEa) goal. This analysis uses the Alinity-ci system, Alinityhq, and Stag for 47 assays from the Emergency Department of King Fahd Armed Forces Hospital.

Methods:The present study is retrospective-prospective conducted in a clinical Emergency laboratory of King Fahd Armed Forces Hospital (KFAFH) Medical Pathology, Jeddah, Saudi Arabia, from May 2021 to September 2022. A retrospective secondary data analysis of eight months duration was carried out in an ED laboratory with a follow-up prospective study for more than six months. During this period, 47 analyses were tabulated to analyze the Internal Quality Control (IQC) coefficient of variation percentage and external Quality Control (CAP). Bias %) and total error allowable for the same analytic were obtained monthly, and the sigma metrics were calculated for each analytic. Standardized QC sigma charts were established with these parameters.Root cause analysis (RCA) was used to discover potential problems for the analytes.For analytes with a sigma value <4, appropriate measures were taken to improve the quality of laboratory investigations.

Results: At critical decision levels, all data analyzed those parameters and identified the assays that were four Sigma or better. Those assays which meet these criteria are now considered to be verified. The method decision chart showed that out of 47 analyses, 57 % demonstrated a world-class performance of 6 sigma level, whereas 2 % showed an Excellence of 5 σ performance, and 12.0 % showed a good performance of 4 sigma level. In contrast, 30 % showed poor performance of less than four sigma at the QC levels. From root cause analysis, the source of error was detected and corrected. However, for all analyses of less than four sigma levels, indicating the area requiring improvement. In contrast, the SQC control rules have been redesigned for the improvement.

Conclusions:For the analyses listed in this report, under the circumstances detailed in the report, Westgard QC, Inc. is proud to re‐verify that the Sigma performance of KFAFH, ED laboratory is achieving the appropriate goals of analytical quality performance. For QC procedure, sigma metric analysis is helpful to evaluate the performance and optimize the protocol for improvement and cost-effectiveness.