A Case Study on the Method of the Development of Ishikawa Diagram for the Quality and Competence in Clinical Laboratory

Abstract

Contemporary clinical laboratories are mandated to yield measurement outcomes characterized by elevated precision and consistency. To fulfill this imperative, numerous laboratories have recently instituted quality management systems conforming to ISO 15189, primarily to meet the exigencies of both patients and the clinicians overseeing their healthcare. The utilization of the Fishbone (Ishikawa) Diagram is instrumental in delineating the architecture of potential variables influencing measurement results throughout the entire analytical procedure. This research endeavors to establish foundational elements for inclusion in the Ishikawa Diagram and to conceptualize a framework for the diagram, thereby facilitating the construction of bespoke Ishikawa Diagrams tailored to specific measurement parameters across diverse operational contexts. Consequently, a methodological approach is recommended following an analysis of the pertinent issues encountered at Hospital A, culminating in the identification of 81 universal factors.