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目的分析湖北省血防专业机构实验室管理体系建立与运行现状,为规范血吸虫病实验室检测与管理提供依据。方法依据湖北省各级血吸虫病实验室标准,从2013至2015年对全省60个血防专业机构开展规范化建设达标验收,逐个跟踪核查管理体系的建立和运行情况。结果各机构管理体系已全覆盖并正式运行,发现不符合项588项,不符合率为19.60%。在6个方面的标准中,质量管理体系文件管理与实施、仪器设备要求的不符合率较高,分别占38.10%(224例)、23.81%(140例)。结论实验室管理体系为湖北省血吸虫病实验室的管理起到重要的质量保障作用。
Objective To analyze the establishment and operation status of laboratory management system for blood-borne disease prevention agencies in Hubei Province and provide evidence for the standardization of laboratory testing and management of schistosomiasis. Methods According to the laboratory standards of schistosomiasis at all levels in Hubei Province, from 2013 to 2015, 60 blood-block prevention and professional institutions in the province were standardized to meet the acceptance standards and one by one to verify the establishment and operation of the management system. As a result, the management system of each institution was fully covered and formally operated. It found that 588 items were not eligible, and the non-compliance rate was 19.60%. Among the six standards, the non-compliance rate of the management and implementation of quality management system documents and equipment requirements were high, accounting for 38.10% (224 cases) and 23.81% (140 cases) respectively. Conclusion Laboratory management system for the management of schistosomiasis laboratory plays an important role in quality assurance.