Study On The Status Quo Of The Quality Management Of Clinical Laboratory And Supervision Strategy In Medical Institutions Of Jiading District, Shanghai Municipal

BackgroundDevelopment of modern medicine shows that a thorough understanding of the nature and process of the disease relies heavily on the exact information of the body, and Clinical laboratory’s role is to translate and process the information, to convert it to a higher level of medical language, what can be understood by doctors quickly, efficiently and directly. With the use of laboratory techniques, Clinical laboratory undertake the task to help to confirm or establish the diagnosis of disease, monitor the development of the disease, and observe patients’ response to treatment. With the rapid development of laboratory medicine, Clinical medicine is more and more dependent on the clinical laboratory. According to relevant statistics, the treatment which is unnecessary or delayed because of the incorrect test results or not timely test results in the loss of hundreds of million dollars to society. Therefore, it’s important to further strengthen the management of the laboratory, improve the quality of examination, and reduce errors.ObjectivesTo understand the status quo of the quality management of clinical laboratory in Jiading District, to explore the problems of the quality management of clinical laboratory and accordingly to put forward the relevant suggestions which provide policy recommendations to improve the quality of clinical examination.MethodsThe research data were derived from field survey, questionnaire survey, quality monitoring, and focus group interview.32 medical institutions which have clinical laboratory were selected for the survey. The quantitative data were put into database through Epidata Software, and analyzed through SPSS 17.0. The qualitative interview data was recorded into word document on spot, was classified and summarized to further analysis of the problems which had be found.Results1, the status of clinical laboratory’s quality managementCurrently, Medical institutions at all levels in Jiading District have initially constructed management system of quality management of laboratory, and some work has be done such as training of inspectors, laboratory equipment management, and quality control work. Overall, the laboratory’s quality management of the second level medical institutions is best; the laboratory’s quality management of the first level medical institutions is relatively poor; the laboratory’s quality management of private medical institutions is worst.2, lab workers’awareness of quality management knowledgeThe quality management knowledge of lab workers in medical institutions in Jiading District is not comprehensive. It has a relationship with several aspects such as the nature of the hospital, lab workers age, education, positional titles, staff training, and the establishment of rules and regulations. Lab workers of the second level medical institutions get the highest score, while lab workers of the private medical institutions get the lowest score; the middle age group get higher score than the others; the higher the level of education and professional titles, higher knowledge scores; lab workers who participate in training scored higher than those who did not participate in training; the hospitals which have complete rules and regulations got higher score.3, monitoring and evaluation of the qualityRoutine blood testing had pass rate of 96.43%; blood smear testing had pass rate of 64.29%; bacterial vaginosis testing had pass rate of 85.71%; biochemical detection testing had pass rate of 76.19%. The public medical institutions have higher lab quality than the private medical institutions; the medical institutions those did good work in lab workers’training, laboratory equipment management, and quality control, have higher lab quality.Conclusions and Policy RecommendationThrough this study found that, at present, there are several problems in the lab quality management of medical institutions in Jiading District. In the own management of medical institutions, there are problems such as inadequate attention to lab quality management, incomplete rules and regulations, some laboratory staff is lack of knowledge, laboratory equipment management is not in place, no strict quality control. In the external supervision aspect, the regulatory legal system needs to be further improved; regulatory troop strength is not strong; industry management failed to play its due role, and so on. Therefore, we suggest the administrative department of public health beginning from amending and improving the legal content, improving the professional quality of law enforcement officers, strengthening the cooperation between departments, encouraging and promoting the development of independent medical laboratories, to strengthen regulatory means, improve regulatory efficiency. At the same time, we need medical institutions to strengthen self-discipline, to enhance self-management, and further improve the quality inspection.