Simulation of Clinical Laboratory Process Improvement based on ISO 15189 Standard

Abstract

The clinical analysis laboratory plays a crucial role in the diagnosis and prevention of diseases, consequently, the results of the examinations must be issued under optimal conditions of quality and precision that allow safe medical decisions to be supported. Accreditations such as ISO 15189 are instruments that allow laboratories to ensure, through their criteria and characteristics, results that meet quality standards, ensure traceability, and have high reliability, furthermore, the analysis and application of this Standard contribute to the continuous improvement and optimization of resources in clinical laboratories, which generates greater productivity in the processes. In the present investigation, a simulation model of the laboratory service process in a medical center was designed to which proposed improvements were applied considering the evaluated criteria of the ISO 15189 Standard. The simulation model was developed in the Arena software and executed the initial system model and the one proposed for comparison, where the processing time of patient care capacity in the laboratory was increased by 33%, achieving an increase from 12 to 16 clinical analyses performed per day. Likewise, the improvement in laboratory efficiency is directly related to the 32.3% increase in the medical center's monthly income from the tests performed in its laboratory. This demonstrates that implementing the ISO 15189 Standard can generate positive impacts that only translate into the quality of the service but also the profitability of the laboratories.