Study And Design Of Quality Information Management System For Clinical Laboratory Based On 15189 Quality Criteria

With the improvement of detection technology and detection means in the clinical laboratoty, the extension of detection area continually, the extension of the clinical laboratoty scale,the changes of the system requirements, the criterion of law environment,the increase of medical competition, it will become an important problem how to manage clinical Iaboratoty,so that to get the good social and economic benefits. Quality management is one part of clinical laboratoty managements and because of the important function in the laboratory work , it becomes the kernel problem of laboratoty management study .ISO 15189 document is a laboratoty quality criteria issued by ISO (International Organization for Standardization) in February of 2003, drafted out by ISO/TC212. From the point of medical specialty view, it describes the quality management requirements of the clinical laboratoty ,it becomes the most advanced and applicable quality criteria in the clinical laboratory.I n 2004 ,we introduced the ISO15189 quality criteria to the clinical laboratoty quality management, through more than two years, we first established the quality management system based on ISO15189 quality criteria in china and got the accreditation of the CNACL.In the process of establishing the quality management system, we hope that we can introduce the information technology to the quality management and realize the auxiliary laboratoty quality management by computer. And now quality information management system is not normative, so we first tentatively introduce the ISO15189 quality criteria to the quality information management system in order to make it more standard scientific normative ,and it will also advance the computer application in the quality management and improve the quality management level.The article dissertated the ISO15189 quality criteria ,and also study the applicability and necessity of the auxiliary laboratoty quality management by computer. According as the requirements of ISO 15189 quality criteria, we study and design quality information management system under C / S mode,using Power B uilder as the design tool. It strictly conforms to the requirements of the ISO15189 quality criteria,and has the function of quality and technology management. It has thirteen function modules, including nine quality management modules and four technology management modules.Nine quality management modules are document control management module, contract Contract censoring management module, out_providing control management module , medical consultation control management module, no_ accord item management module,out_communion management module, quality register management module, management censoring control module. Four technology management modules are person management module, instrument management module,clinical laboratoty log management module,quality assurance management module. System can collect and note quality data, it can also statistics and analyse the quality information. It provides the whole quality interface for the consumers, provides the grounds for the clinical laboratoty management and decision-making, improve the quality management level of the clinical laboratoty,ensure the durative normal running of the quality management system based on ISO15189 criteria.