Objective: To analyze the construction and operation status of management system of laboratories of schistosomiasis control institutions in Hubei Province, so as to provide the reference for the standardized detection and management of schistosomiasis laboratories.
Methods: According to the laboratory standard of schistosomiasis at provincial, municipal and county levels, the management system construction and operation status of 60 schistosomiasis control institutions was assessed by the acceptance examination method from 2013 to 2015.
Results: The management system was already occupied over all the laboratories of schistosomiasis control institutions and was officially running. There were 588 non-conformities and the inconsistency rate was 19.60%. The non-conformity rate of the management system of laboratory quality control was 38.10% (224 cases) and the non-conformity rate of requirements of instrument and equipment was 23.81% (140 cases).
Conclusions: The management system has played an important role in the standardized management of schistosomiasis laboratories.
[摘要]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。.
Keywords: Hubei Province; Laboratory; Management system; Schistosomiasis.