上海地区社会办医疗机构临床检验质量问题分析

目的了解上海地区社会办医疗机构临床检验质量现状,分析存在的问题。方法对2019年上海地区40所医学检验实验室和36家核定床位100张及以上民办医院检验科现场质量督查不符合项进行统计分析。结果共发现654个不符合项,主要涉及实验室设备、试剂和耗材(16.21%),检验结果质量保证(14.98%),评估与审核(7.49%),质量管理体系(7.03%),人员(6.57%),受委托实验室的检验(6.57%),管理评审(5.50%),组织和管理责任(5.20%)等主条款。对应的比较集中或严重的次条款分别涉及设备校准(54.72%)、实验室间比对(43.88%)、室内质量控制(40.82%)、内部审核(42.86%)、程序和文件(82.61%)、人员资质(37.21%)、培训(34.88%)与能力评估(18.60%)、受委托实验室的选择与评估(72.09%)、管理评审报告(58.33%)与程序(38.89%)、实验室主任(47.06%)、组织总则(14.71%)。结论上海地区社会办医疗机构临床检验质量仍存在许多缺陷和不足,亟待加强培训和综合监管,以促进社会办医疗机构医学实验室持续、健康、规范发展。     

上海市18家医学实验室认可现场评审中不符合项汇总分析

目的通过对上海市18家医院实验室在ISO15189实验室认可现场评审中不符合项的汇总分析,提出不符合项规范纠正方法和路径,为其他医学实验室提供参考和借鉴。方法收集18家医学实验室ISO15189现场评审不符合项,按分布条款进行筛选、整理和分析,并按照不符合描述、原因分析、纠正措施、纠正实施、纠正验证5个方面重新编写,提出对共性问题的纠正方法。结果共收集18家医学实验室297个不符合项,其中管理部分76项,占25.6%,技术部分221项,占74.4%;检验程序的质量保证共61项,占20.5%(61/297),有6类47种表现形式。结论通过对不符合项的汇总分析和重新整理,理清了各种不符合项的原因,对医学实验室质量改进和实验室认可起到了很好的借鉴参考作用。     

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。     

国际标准的信息网络化建设在病理科实验室质量控制中的应用

根据国际标准化组织(ISO)15189对实验室信息系统的基本要求,制定相应的规章制度和操作规程,可以提高实验室信息系统(LIS)的服务质量和能力,推动和指导实验室信息化建设,加强实验室的控制和管理。随着LIS的发展,实验室逐渐成为完整的、彻底的、集成的数字化实验室,在检验前、中、后全面地采用信息技术,提供智能化的决策支持资料。同时,实验室要通过ISO15189《医学实验室质量和能力认可准则》的认可,就必需使LIS的各个部分符合ISO15189的要求。     

通过ISO 15189认可医学实验室检验前质量指标结果分析

目的通过分析我国获得ISO 15189认可医学实验室检验前质量指标结果,了解国内临床实验室检验前过程的质量水平。方法国家卫生健康委临床检验中心联合31个省级临床检验中心同步开展质量指标室间质量评价计划,并通过已开发的Clinet-EQA系统下发调查表,收集2016—2019年获得ISO 15189认可医学实验室的基本信息和检验前质量指标数据,并按照专业类别、信息化建设水平等进行统计分析。结果 2016—2019年,除了血培养污染率和标本溶血率外,所有通过ISO 15189认可医学实验室的所有检验前质量指标都达到3σ的最低可接受标准。其标本类型错误率、标本采集量错误率、标本容器错误率、标本溶血率、抗凝标本凝集率以及血培养污染率在4σ以上水平的实验室分别为99.67%、99.51%、100%、97.11%、96.75%和38.74%,急诊标本和住院标本检验前周转时间中位数的分布分别为50 min内和10～100 min。结论我国通过ISO 15189认可实验室检验前质量表现较好,但实验室仍需关注血培养污染率、抗凝标本凝集率和标本溶血率。     

ISO15189认可对检验诊断学实习教学质量的促进作用

通过对比经实验室医学实验室ISO15189认可前后检验诊断学实习生在检验操作技能、质量管理体系知识、质量活动及质量意识各方面变化。参与ISO15189认可活动的学生,在质量意识及操作规范性显著提升,特别熟悉质量管理的流程及方法,培养及建立了良好的质量及规范性意识。     

上海市临床检验中心近期举办“POCT管理和质量控制学习班”

正2016年9月7日至9月9日,上海市临床检验中心(以下简称中心)举办了"2016年POCT管理和质量控制学习班",这已是中心第2次面向医院POCT相关医务人员(护士、医师)举办的POCT质量管理学习班。此次学习班参照国际国内最新的管理文件和标准,如《医疗机构临床实验室管理办法》、ISO15189"医学实验室质量和能力认可准则"、ISO22870"即时检验质量和能力的要求"等临床实验室管理文件,向学员全     

实验室ISO 15189认可对学科建设的几点启示

通过ISO15189认可，可提高医学实验室质量管理水平，提高医疗质量，保证实验的精确性、准确性、可溯源性。笔者所在实验室在全国首家通过ISO15189认可。笔者认为：（1）ISO15189的核心是建立全面质量管理体系；（2）分析前质量管理是认可准备的难点；（3）ISO15189定义实验室的功能拓宽了检验科工作的范围；（4）要从ISO15189中认真学习先进的管理理念；（5）要将ISO15189标准灵活应用于医学实验室；（6）注重参与、注重过程是“认可”收实效的关键。     

萍乡地区部分医院检验科生化结果互认研究

为保证实施医学检验结果互认的科学性和可靠性．依据卫生部《医疗机构临床实验室管理办法》、《江西省“医院管理年”活动“创建满意医院”建设活动考评细则》和《医疗实验室质量和能力的专用要求》（ISO15189：2003）中对临床实验室基本要求的原则，萍乡市有五家市直医院（A、B、C、D、E分别表示五家医院）自发参加了萍乡市实施检验结果互认研究工作，通过研究，该工作对于减轻老百姓负担，提高检验质量都有很重要价值。     

萍乡地区部分医院检验科生化结果互认研究

为保证实施医学检验结果互认的科学性和可靠性．依据卫生部《医疗机构临床实验室管理办法》、《江西省“医院管理年”活动“创建满意医院”建设活动考评细则》和《医疗实验室质量和能力的专用要求》（ISO15189：2003）中对临床实验室基本要求的原则，萍乡市有五家市直医院（A、B、C、D、E分别表示五家医院）自发参加了萍乡市实施检验结果互认研究工作，通过研究，该工作对于减轻老百姓负担，提高检验质量都有很重要价值。     

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.     

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 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 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.     

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.     

Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.     

我国医学实验室认可与相关国际标准动态

我国医学实验室ISO 15189认可工作在国内得到了各方越来越多的关注,如何确保和提高认可的科学性和有效性,将是认可机构和医学实验室共同面临的课题,从认可制度建立的基础即国际要求和国际标准的制定、实施和应用方面进行分析研究,有利于我们找到正确的解决方案和未来发展方向.本文对负责ISO 15189起草的国际标准化组织(ISO/TC212)、医学实验室认可相关国际标准文件、我国医学类实验室认可的现状及展卑等方面的动态做一个简单而概括的介绍,为医学实验室工作人员及行业专家在医学实验室管理和认可方面的技术及发展趋势研究提供一些基本的信息.     

我国医学实验室认可与相关国际标准动态

我国医学实验室ISO 15189认可工作在国内得到了各方越来越多的关注,如何确保和提高认可的科学性和有效性,将是认可机构和医学实验室共同面临的课题,从认可制度建立的基础即国际要求和国际标准的制定、实施和应用方面进行分析研究,有利于我们找到正确的解决方案和未来发展方向.本文对负责ISO 15189起草的国际标准化组织(ISO/TC212)、医学实验室认可相关国际标准文件、我国医学类实验室认可的现状及展卑等方面的动态做一个简单而概括的介绍,为医学实验室工作人员及行业专家在医学实验室管理和认可方面的技术及发展趋势研究提供一些基本的信息.     

我国医学实验室认可与相关国际标准动态

我国医学实验室ISO 15189认可工作在国内得到了各方越来越多的关注,如何确保和提高认可的科学性和有效性,将是认可机构和医学实验室共同面临的课题,从认可制度建立的基础即国际要求和国际标准的制定、实施和应用方面进行分析研究,有利于我们找到正确的解决方案和未来发展方向.本文对负责ISO 15189起草的国际标准化组织(ISO/TC212)、医学实验室认可相关国际标准文件、我国医学类实验室认可的现状及展卑等方面的动态做一个简单而概括的介绍,为医学实验室工作人员及行业专家在医学实验室管理和认可方面的技术及发展趋势研究提供一些基本的信息.     

我国医学实验室认可与相关国际标准动态

我国医学实验室ISO 15189认可工作在国内得到了各方越来越多的关注,如何确保和提高认可的科学性和有效性,将是认可机构和医学实验室共同面临的课题,从认可制度建立的基础即国际要求和国际标准的制定、实施和应用方面进行分析研究,有利于我们找到正确的解决方案和未来发展方向.本文对负责ISO 15189起草的国际标准化组织(ISO/TC212)、医学实验室认可相关国际标准文件、我国医学类实验室认可的现状及展卑等方面的动态做一个简单而概括的介绍,为医学实验室工作人员及行业专家在医学实验室管理和认可方面的技术及发展趋势研究提供一些基本的信息.