Lean Six Sigma Applications in a Multicenter Pathology Laboratory: an Industrial Pathology Model

Total quality management (TQM) is an approach that focuses on involving all members of an organization in continuous improvement efforts. Six Sigma is a specific methodology within TQM that aims to minimize process variation and defects by applying statistical analysis. It focuses on achieving near-perfect quality levels by reducing the occurrence of defects to a rate of no more than 3.4 per million opportunities. Lean management is a practical improvement approach, especially in competitive markets, for reducing waste and cost, shortening diagnosis and treatment time. Considering that there may be irrevocable errors in the health sector, the standardization of methods for minimizing human error in the system (reducing them to a near zero level through Six Sigma) is critical. Thus, the use of lean principles combined with the Six Sigma approach ensures improvement of the process. TQM and ISO 9000 provide a broad framework that encompasses various quality improvement approaches and also provide error reduction, while Lean Six Sigma offers a more specialized methodology with a strong focus on statistical analysis and data-driven decision-making and measurable results can further encourage a culture of continuous improvement. In our study, we aimed to share the application of Lean Six Sigma practices in the operation of a multicenter pathology laboratory with international JCI accreditation that averages 126,500 samples per year from 16 hospitals and 9 medical centers affiliated with our institute. For this purpose, we created a project team and prepared a project charter with project details, schedule, and an SIPOC map. The project aimed to decrease macroscopy and laboratory process time to 12 h or less. The critical to quality (CTQ) elements in the processes were identified. We used the Define, Measure, Analyze, Improve, and Control (DMAIC) tool of the Lean Six Sigma (LSS) methodology. Visual process control was integrated into the pathology laboratory software program, and standard operating procedures were designed. The macroscopy and laboratory process time was reduced by 57%. The use of less formalin provided a more effective use of warehouse space. The use of LSS shortened the sampling time and laboratory process time of the pathology specimens, and the establishment of standards in the pathology laboratory saved considerable working time.