Maximizing Returns: Optimizing Biochemistry Lab Performance through Six Sigma application, a Yearlong Cost-Benefit Study in an Indian Laboratory.

Introduction: One of the most essential components of a clinical laboratory's overall quality management system is quality control (QC) validation. We typically tend to use more reagents and resources than necessary in an attempt to preserve quality. Achieving higher results while using fewer resources is time imperative. We have attempted to address this issue by providing cost-benefit analysis by implementing effective QC procedures using six sigma methodology and their financial benefits. Material and methods: Six sigma calculation of 23 routine chemistry parameters was performed over a period of one-year using bias% and cv%. New Westgard sigma rules were applied using Biorad Unity 2.0 software. A comparison was made before and after new sigma rules application including false rejection rate, probability of error detection rate, cost of all reruns, repeats, etc. Relative and absolute annual savings were computed and compared. Results: Compared to the current rule, there was absolute savings of Indian Rupees (INR) 750105.27 when both internal failure and external failure costs were combined after the candidate rule was employed. The reduction in expenses varied with the quantity of samples examined and the quantity of QC operations carried out each day leading to an internal failure costs cut down by 50% (INR 501808.08) and external failure costs by 47% (INR 187102.8). Conclusion: The study highlighted how quality control techniques in clinical laboratories need to be carefully planned in order to achieve significant cost reductions by lowering internal or external failure costs and effective prevention and appraisal cost planning activities prior.