临床实验室标准化电子文档管理系统的研发与应用  

Development and application of standardized electronic document management system in clinical laboratory

作　　者：韩心远 阚丽娟 陈大洋 熊丹 张丽军 欧铜 张秀明 HAN Xinyuan;KAN Lijuan;CHEN Dayang;XIONG Dan;ZHANG Lijun;OU Tong;ZHANG Xiuming(School of Medicine, Anhui University of Science and Technology, Huainan 232001, Anhui;Medical Laboratory of Shenzhen, Luohu Hospital Group, Shenzhen 518001, Guangdong, China)

机构地区：[1]安徽理工大学医学院,安徽淮南232001 [2]深圳市罗湖医院集团医学检验实验室,深圳518001

出　　处：《临床检验杂志》2022年第2期150-154,共5页Chinese Journal of Clinical Laboratory Science

基　　金：深圳市卫生计生委学科建设能力提升项目(SZXJ207018);深圳市医疗卫生三名工程项目(SZSM201601062)。

摘　　要：目的开发满足ISO15189质量管理体系要求的临床实验室电子文档管理系统。方法基于ISO15189相关要求,借助互联网,采用浏览器/服务器(Browser/Server,B/S)模式,利用Java和MySQL数据库等信息技术构建电子化文件管理系统(以下简称系统);通过向实验室184名员工发放调查问卷评价该系统的应用效果。结果该系统现存400余篇外部文件和7000余篇内部文件,可作为检验知识库供工作人员查阅学习。采用多流程控制模式授权专人根据文件类型和属性进行修订、审核、批准与发布,旧文件自动进入作废文件夹。所有内部文件均具有统一的格式和唯一的识别码。系统可即时提醒各级相关负责人完成需要执行的任务,操作完成后自动形成完整详细的电子记录,充分保证了文件的唯一性、可溯性、规范性。用户可通过电脑或手机端在线通过文件列表或查找功能查阅多种类型文件,并形成学习日志。调查问卷结果显示,超过95%的员工反馈文件查阅、修订、审批的时间大幅度缩短,98.91%的员工反馈该系统操作简便,36.4%的员工反馈搜索功能有待改进,7.6%的员工反馈文件更新速度需要提升。结论该系统全面满足ISO15189关于文件管理的要求,实现对实验室所有文件的信息化管理,方便员工及时了解国内外检验医学的最新标准和指南,及时学习和充分利用实验室的质量体系文件开展检验工作。Objective To develop a management system for electronic documents in clinical laboratory in line with the requirements of ISO15189 quality management system.Methods Based on the ISO15189 relevant requirements with the aid of Internet,Browser/Server(B/S)model,Java,MySQL database and other information technologies were used to build an electronic document management system(hereinafter referred to as the system).A questionnaire was distributed to 184 employees in laboratories to evaluate the application effects of the system.Results The system has more than 400 external documents and 7000 internal documents,which can be used as a knowledge bank of laboratory medicine for staff to consult and learn.Multi-process control mode was adopted to authorize special personnels to revise,review,approve and release documents according to the types and attributes of the documents.The documents out of date were automatically put into the obsolete folder.All the internal files had uniform format and unique identification codes.The system immediately remind the relevant responsible staff in charge at all levels to complete their tasks that need to be performed,and automatically form complete and detailed electronic records after the operation was completed,which fully ensures the uniqueness,traceability and standardization of the files.The users could check various types of file through the file list or search function online through computer or mobile phone and form a learning log.The questionnaire results showed that over 95%of employees reported that the spent times for document review,revision and approval were dramatically shortened,98.91%of employees gave feedback that the system was easy to operate,while 36.4%of employees believed that the search function needed to be improved and 7.6%of employees reported that the speed of document update needed to be perfected.Conclusion The system fully meets the requirements of ISO15189 on document management,realizes the information management of all documents in laboratories.It is conv

关 键 词：ISO15189 信息化 文件控制 实验室管理 

分 类 号：R446[医药卫生—诊断学]