Abstract:

Objective To establish an informationization-based risk control model for clinical laboratories according to ISO 15189 quality system. Methods Based on ISO 15189 quality system,the whole process closed-loop management of risk setting,information collection,identification,warning,disposal,regular assessment and risk plan adjustment was established by means of informationization according to the 42 automatic identification indicators and 147 risk points. The difference was compared between before and after using the risk control system. Results Since the operation of the risk control system,the system had identified a total of 497 risk events. The risk events were mainly distributed in personnel,environment,reagents,information system,specimens,analytical equipment,quality control,testing process and reports and clinical laboratory management. After 5 risk assessments,the overall risk assessment value decreased by 27.7% compared with that before using the risk control management system. Conclusions The clinical laboratory can select suitable risk points and risk indicators for management,monitoring and regular assessment according to the specific situation of the clinical laboratory,so as to identify the risk factors that are easy to cause harm to patients,and effectively reduce the occurrence of medical errors. Finally,the sharing of information resources of each business module of clinical laboratory is realized,and the effect of clinical laboratory improvement is evaluated and tracked from the perspective of risk management.

Key words: Information system, Risk control, Quality system, Clinical laboratory