An integrated assessment system for the accreditation of medical laboratories.

Medical laboratory accreditation becomes a trend to be trustable for diagnosis of diseases. It is always performed at regular intervals to assure competence of quality management systems (QMS) based on pre-defined standards. However, few attempts were carried out to assess the quality level of medical laboratory services. Moreover, there is no realistic study that classifies and makes analyses of laboratory performance based on a computational model. The purpose of this study was to develop an integrated system for medical laboratory accreditation that assesses QMS against ISO 15189. In addition, a deep analysis of factors that sustain accreditation was presented. The system started with establishing a core matrix that maps QMS elements with ISO 15189 clauses. Through this map, a questionnaire was developed to measure the performance. Therefore, score indices were calculated for the QMS. A fuzzy logic model was designed based on the calculated scores to classify medical laboratories according to their tendency for accreditation. Further, in case of failure of accreditation, cause-and-effect root analysis was done to realize the causes. Finally, cloud computing principles were employed to launch a web application in order to facilitate user interface with the proposed system. In verification, the system has been tested using a dataset of 12 medical laboratories in Egypt. Results have proved system robustness and consistency. Thus, the system is considered as a self-assessment tool that demonstrates points of weakness and strength.