The Implementation and its effect of ISO 15189:2007 Recommendations on Clinical Chemistry Laboratory of The Hospital for Tropical Diseases

Abstract

Objectives: To improve the quality of Clinical Chemistry Laboratory by implementing ISO 15189: 2007 and to compare the results of key performance indicators before and after the implementation.

Methods: The study collected data from routine laboratory and other medical personnel in the Clinical Chemistry Laboratory. The steps used in quality improvement included: 1) Prioritizing the area of development, 2) Selection and establishment of key performance indicators (KPIs), 3) Implementation of ISO 15189 quality system, and 4) Collection and analysis of KPIs’ data.

Results: The results of improvement were reflected by five quantitative KPIs, which were calibration rate of laboratory equipment, rate of critical value reporting, rate of average customer satisfaction, passing rate of external quality assessment (EQA), and passing rate of staff competency assessment, were all increased, while rate of specimen rejection was
decreased. All of 243 qualitative KPIs requirements were complied.

Conclusion: After implementation of ISO 15189, all KPIs change indicated clear improvement. Laboratory staff gained significant knowledge and insight into quality management system. The key success factors were strong determination of the researcher, good team working and financial support from top management.