基于 ＩＳＯ１５１８９ 开发临床实验室试剂管理系统

目的 开发满足ISO15189认可要求的临床实验室试剂管理系统，为试剂的精细化管理提供对策。方法 本系统采用B/S系统架构，软件功能由JAVA语言实现，MySQL 5.7为应用数据库，Redis 3.2.100为缓存数据库。软件后台底层架构使用SpringMVC+SpringJDBC架构技术，通过SnakerFlow进行流程控制管理。结果 建立了临床实验室标准化试剂管理系统，实现了供应商管理、物资管理、采购管理、库存管理、预警提醒、温湿度实时监控、库存盘点等功能。结论 该系统不仅满足试剂使用的各种需求，而且紧扣ISO15189认可条款，为试剂的标准化管理提供高效的解决方案。     

临床实验室信息化管理平台的设计与应用

目的 依据ISO 15189质量管理体系,结合计算机技术建立临床实验室信息化管理平台。方法 系统采用B/S架构,基于JAVA+R语言开发,采用Spring+Shiro+Snakerflow技术框架,以Redis为缓存数据库,MySQL5.7为业务数据库,建立临床实验室信息化管理平台。结果 临床实验室信息化管理平台包括10个功能模块：文档管理、电子记录、人事管理、ISO 15189认可迎检、内审核查、试剂管理、设备管理、业务管理、质量指标和性能评价,各模块之间既可互联互通,也可单独安装使用,且全面满足ISO 15189医学实验室认可要求。结论 该平台与实验室管理工作高度契合,以业务智慧化、记录电子化、系统标准化和审核便捷化为主线,显著提高了实验室管理能力。     

实验室信息管理系统在血站实验室管理工作中的应用

随着贯彻执行<血站实验室质量管理规范>的不断深入,如何构建实验室信息管理系统(laboratory information management system,LIS或LIMS)越来越引起重视.LIMS基于计算机局域网,专门针对一个实验室设计,是一个包括信号采集设备、数据通讯软件、数据库管理软件、实验室的内部管理软件在内的高效集成的管理系统软件[1].我中心血液检测实验室于2007年年底引进了一套新实验室信息管理系统(LISWELL软件),采用数据库管理技术对实验室的人员、标本、仪器、试剂、方法 、环境等信息实行全面管理,极大地规范了实验室的信息化管理.现将其实验室管理功能分述如下.     

利用Access数据库开发临床实验室试剂出入库管理系统

目的利用Access数据库开发临床实验室的试剂出入库管理系统，生成相应的统计图表和统计报表，提高试剂管理效率与管理质量水平。方法应用Access数据库创建相应的表、查询、窗体、报表和宏，生成应用程序。结果在试剂出入库管理系统中输入试剂出入库的信息，包括记录试剂出入库的时间、数量、批号、有效期、组别和操作者，按照年月查询试剂使用量、统计试剂成本、试剂库存和查询试剂有效期，以图和表显示，打印数据报表。结论，系统操作界面友好、操作快速、简便、省力省时、维护方便、安全性能好，能满足临床实验室对试剂出入库管理的要求。     

基于B/S架构多通道中央监护系统的设计

设计了一个基于B/S架构的多通道中央监护系统.整个系统由监护中心的中央监护服务器端软件、运行在客户端浏览器的ActiceX控件和多参数采集器构成.服务器端软件能够接受多个客户端的数据传输请求,实现基于Internet的多患者生理参数远程实时监护.客户端采用B/S架构,客户端只需安装一个ActiveX控件,使用浏览器就可以实时查看和发送生理参数和波形.将监护仪从床边延伸到了家庭,有利于患者的长期跟踪观察,节省住院费用,也为医疗仪器普及化和网络化提供了新的解决方案.     

临床实验室试剂智能化管理的开发及应用

目的通过直接采集仪器主控系统中试剂使用过程的数据和信息,优化原有试剂管理流程,实现试剂的智能化管理。方法利用计算机编程技术、数据库技术进行仪器对接、开发智能化试剂管理系统。结果直接从检测仪器获取试剂的使用数据和信息,包括试剂的批号、使用时间、失效时间、使用数量、对应检测的样本信息等。将使用的试剂信息与检测的样本信息对应。将试剂批号更换或定标后的质控或样本比对数据传输至系统。可直接计算试剂的实际测试数和使用效率。实时查询和统计显示检测仪器的试剂余量,生成需补充的试剂清单。结论该系统不仅实现试剂采购、出入库、使用、查询、统计等信息化管理,而且样本与试剂的溯源同试剂使用的全过程实现无缝连接,达到省时、高效、精准的试剂智能化管理。     

临床输血智能管理与评估系统的优化与应用

目的构建医院全面信息化和智能化的输血管理系统。方法以医院"军卫一号"信息管理系统中的医院信息子系统、检验信息子系统、手术麻醉子系统及输血管理分系统为主要数据源,采用B/S架构、关系型数据库My SQL以及JAVA语言开发,创建临床输血智能管理与评估系统。结果临床输血智能管理与评估系统涵盖了输血统计、输血合理性评估与有效性评价、输血数据挖掘与科学研究、试剂耗材设备管理、科室事务管理等功能模块,实现了临床输血全面信息化和智能化管理,并可为学科发展提供重要的数据储备。结论该系统能够充分利用医院各种数据资源提升临床科学合理输血水平,促进输血相关科学研究,推动学科可持续发展。     

OLYMPUS AU400由试剂位设置引起的系统死机原因及处理方法

AU4 0 0全自动生化分析仪是由日本 OLYMPUS光学株式会社制造 ,该仪器每小时能进行 4 0 0项测试 ,共有三个试剂 Round,每个 Round有 76个试剂位 (通道 ) ,如所有检验项目用单试剂 ,当项目超过 76个时 ,则用到第二、第三个试剂 Round,但大部分医院只用一个试剂 Round已能满足临床检验的工作需要。由于 AU4 0 0系统软件存在着缺陷 ,试剂位设置有两种情况可引起系统死机 ,导致仪器不能工作 ,下面是详细报道 :1　导致系统死机的两种情况1 .1　当 Round中的试剂位用到 75个 ,只剩下一个试剂位 ,仪器执行“检查所有试剂位试剂量”菜单时 ( S…     

血液检测实验室LIS应实现试剂信息管理化

随着血站信息化技术的发展,LIS和BMIS等系统的使用,进一步简化了各种工作流程,降低了工作量,也提供了相应准确信息,为领导决策提供科学依据.LIS本质上是一种基于数据库的实验室全面计算机管理系统,是BMIS的一部分,或者说是通过高级的计算机技术来提高质量管理的一种手段[1].血液检测实验室是血站保证血液检测质量的核心部门,而试剂作为血液检测要素中的重要组成部分,它的科学管理对于保证血液安全,节约成本和实现成本核算等具有重要意义,正是基于以上几点,笔者认为检验科LIS系统必须实现试剂的信息化管理.     

ISO15189认可中自建系统与原装系统项目测定结果的比对及偏倚评估

目的 通过对更换试剂厂家的项目与原装系统进行方法比对及偏倚评估,来验证更换新试剂后的自建系统与原装系统是否具有可比性.方法 按照美国临床标准化委员会EP9-A2的要求,在雅培C8000全自动生化分析仪上以雅培原装系统为参比系统,德赛试剂组成的自建系统为实验系统.每个项目共40份患者新鲜标本,分别对血糖(GLU)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、尿酸(UA)、总胆红素(TB)、直接胆红素(DB)、碱性磷酸酶(ALP)进行检测,通过计算两个系统之间的相关性及偏倚来评价是否有可比性.结果 通过对德赛试剂的GLU、ALT、AST、UA、TB、DB、ALP和雅培原装试剂的检测,两种实验的相关系数均大于0.975,且相对偏移均小于科室要求,即小于1/2美国临床实验室修正法规(CLIA'88)的要求临床可以接受.结论 在ISO15189认可中,当实验室改变试剂厂家时,应按EP9-A2进行方法学比对及偏倚评估,通过对两种试剂厂家的检测,两厂家的试剂差异无统计学意义,德赛试剂可替代雅培原装试剂进行临床检验与研究.     

IVD industry role for quality and accreditation in medical laboratories.

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.     

Effect of accreditation schemes on the setting of quality specifications by laboratories

In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory clinic interface are the most difficult to assess and evaluate in an adequate quality management system.     

临床微生物实验室与ISO15189 医学实验室认可标准常见不符合条款分析及持续改进措施

目的　回顾总结临床微生物实验室2011~2019 年在ISO15189 医学实验室认可实施过程中发现的不符合条款, 促进质量体系的持续改进。方法　参照《CNAS-CL02:2012 医学实验室质量和能力认可准则》和《CNAS-CL02-A005 医 学实验室质量和能力认可准则在临床微生物学检验领域的应用说明》,总结微生物实验室近十年发现的不符合条款及 采取的纠正、预防措施。结果　在不符合条款构成比中,第一位是CNAS-CL02:2012 条款5.3 设备、试剂和耗材,占 47.37%;第二位是CNAS-CL02-A005 条款5.6 检验结果质量保证,占15.79%;第三位是CNAS-CL02-A005 条款5.5 检 验过程。结论　不断地总结分析不符合条款,持续改进,有利于提高实验室检验质量,保证ISO15189 质量体系的良好 运转,更好地服务于临床。     

上海地区医疗机构实验室质量管理现状分析

目的根据2019年上海地区不同类别医疗机构实验室现场督查结果分析上海地区实验室质量管理现状。方法依据《上海市医疗机构临床实验室质量管理规范》(简称管理规范),采用现场督查方式对289家实验室的质量管理情况进行评价,并分析督查不符合结果。结果289家医疗机构实验室得分中位数为89分,其中通过ISO 15189认可的37家实验室得分中位数为98分。三级医院、二级医院、一级医院、医学检验实验室和社会办医院实验室的优秀率分别为70.0%(35/50)、23.4%(18/77)、0(0/80)、47.8%(22/46)和16.7%(6/36),不合格率分别为0(0/50)、7.8%(6/77)、17.5%(14/80)、2.2%(1/46)和19.4%(7/36)。不同类别医疗机构实验室不符合发生率居前3位的条款均包括"5.6检验结果质量保证";其余条款不完全相同,包括"4.2质量管理体系""4.5受委托实验室的检验""4.14评估和审核""5.1人员""5.3实验室设备、试剂和耗材"。结论通过ISO 15189认可实验室质量管理优于非认可实验室,三级医院实验室质量管理总体情况优于其他医疗机构实验室。不同类别医疗机构实验室不符合条款发生频率不尽相同。     

ISO 15189:2012与临床实验室人员管理

临床实验室人员管理涉及到 实验室检验前、检验中到检验后的整个工作流程,所以实验室人员是组织中最有价值的资源。ISO 15189:2012也对实验室人员作出了相应的要求。根据ISO 15189:2012中的相关要求并综合相关文献,该文主 要对实验室人员管理的四个连续过程进行阐述,包括雇用前管理、人员任用和员工表现评估、员工发展管理 和雇用终止管理,以期为实验室管理人员的整个雇用过程提供相关建议。     

多层架构实验室信息系统的开发与应用

目的探索开发数字化、自动化的、符合ISO15189相关要求的实验室信息系统。方法以科学合理的实验室工作流程为基础,结合条形码、仪器通讯,卫生信息交换标准(HL7)等技术要求,采用多层架构设计,编写多层架构实验室信息系统。结果运行后实验室实现了标本条码化、双向通信、无纸化报告、质控管理、办公管理等信息自动化;全面提升了实验室的工作效率,保证了检验质量,有效促进了检验与临床、检验与患者的沟通和服务。结论采用多层架构、HL7标准等设计的多层架构检验信息系统符合ISO15189对实验室信息系统要求,并满足现代化实验室发展的要求,有更多的可扩展性。     

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory II

ObjectivesOur laboratory was accredited for 531 tests according to ISO 15189 standard (ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories) in 2007. An ambitious and young group of laboratory personnel has spent efforts with commitment and dedication to complete the heavy work of preparation and passed through assessment with success. We herewith share our experience of the accreditation, the stages we have been through; our solutions to obstacles which we came across during the process.Design and methodsOur approaches to topics of environmental conditions, document management system (CentroDMS), use of the laboratory information system (CentroLIS), corrective/preventive actions and measurement uncertainty are summarized in this article.ResultsExperience of our laboratory in different areas of ISO 15189 accreditation is presented in summary.ConclusionAccreditation of medical laboratories increases the quality of the results, motivates the laboratory personnel and is beneficial for all interested bodies. Continous improvement and dedicated people are the key elements for continuation of the quality assurance in an accredited medical laboratory.     

ISO and CEN documents on quality in medical laboratories.

The forthcoming international standard ISO 15189 "Quality management in the medical laboratory" is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form (ISO/DIS 15190), deals with safety management for medical laboratories. ISO 15189 (and probably 15190 also) are expected be adopted by CEN as a European Standard (EN).     

ISO 15189 Accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory I

AimMedical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence.MethodsInternational Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation.ResultsAccreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet.ConclusionPreparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has to concentrate on patient safety issues related to laboratory testing and should perform quality improvement projects.     

Clinical laboratory accreditation in India

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.