Quality improvement of medical diagnostic laboratories

Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.     

Accreditation of medical laboratories

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.     

军队综合性医院检验科人员管理

人员是CNAS-CL02:《医学实验室质量和能力认可准则》(ISO 15189:2007)中技术要求的第一要素,是科室全面质量管理的执行主体。在军队医院精简编制的形势下,医院发展,包括检验科,面临着人才短缺的问题。本文从检验科人员构成特点、人员素质培养、归属感建立、人才队伍建设等方面,对军队综合医院检验科人员管理初步探讨。     

计算机信息管理在国家实验室认可中的应用

随着经济全球化的进展 ,开展国家实验室认可工作成为卫生检测实验室与国际接轨的手段。在中山市疾病预防控制中心创建国家认可实验室工作期间 ,计算机信息管理系统在合同评审、样品管理、检测流程管理、检测报告管理等各方面都起到了积极的作用 ,为质量体系的运转建立起了符合ISO/IEC 170 2 5 :1999要求的平台 ,保证了质量体系规范运行 ,极大地提高了工作效率 ,为中心通过国家实验室认可奠定了坚实的基础。     

Quality, accreditation and certification in free-market economy. Part I. Quality and quality assurance systems according to international standards]

The problems concerning the quality and quality assurance systems were discussed on the base of the International Standards series ISO 9000. The structure, scope and the field of application of these Standards were described. The special attention has been drawn to the models of quality assurance specified in ISO 9001, ISO 9002 and ISO 9003. The role of the International Standards series ISO 9000, as a useful tool to harmonize the international trade in free-market economy was stressed. It was emphasized that the application of quality management and quality assurance systems according to ISO 9000 is compatible with the implementation of Hazard Analysis Critical Control Point (HACCP) system in the food industry.     

医院质量管理体系诊断与改进中评价标准应用研究

为实现医院质量管理体系的诊断与改进，本文对ISO9000：2000标准和Baldrige标准的结构、主要内容以及两者的特点等进行了分析比较。在此基础上，提出一个将ISO9001和Baldrige标准集成的模型，并应用于医院质量管理体系的诊断与改进过程。该模型依据Baldrige标准，分析诊断出医院质量管理体系中存在的主要问题及改进策略，进而通过两个标准之间的相关关系，将质量管理体系改进策略分解配置到相关的ISO9001条款；最后，参照ISO9001标准中相应条款的要求，制订出具体的改进计划和改进措施。     

ISO9001：2000质量管理体系与医疗纠纷管理

随着国家医疗卫生体制改革的深入,医院面临着医疗纠纷的困扰,引进ISO9001标准建立完善的医院医疗纠纷管理体系,是医院质量管理的必由之路。医疗纠纷防范关键在于运用ISO9001标准,以患者为中心抓好医疗服务全过程,发挥机关职能作用,保证医疗纠纷管理体系有效运行,持续改进医院医疗服务质量,并不断满足患者需要和提高患者满意度,树立医院品牌形象。     

贯标ISO 9001:2000构建检验质量管理平台

目的　通过ISO 9001:2000 贯标建立统一的高效的检验质量管理平台。方法　通过ISO 9001:2000 贯标建立检验特色的文件系统: 以病人为中心,程序控制,修正现有程序,预防和纠正行动,以及持续的改进。结果　建立了质量管理平台,满足了顾客的服务需要。结论　ISO 9001:2000 是检验管理的一种新事物,它使人们的检验工作方法能达到每个追踪的环节。建立这个质量管理的检验平台有利于用国际质量标准来进行管理。此法能使人避免诉讼的纠缠,正常生活不致不必要的中断。     

采用国际标准再造服务流程建立医院统一的质量管理平台

目的 为了建立有效的医院质量管理体系,通过实施ISO9001:2000标准,弥补和完善医院系统原管理体制的不足,形成医院标准化管理模式,提高医院总体管理水平和服务质量。方法 建立质量管理体系的具体程序:领导决策、全员参与、建立文件化质量体系、形成医院统一的质量管理平台。以顾客为关注焦点、采用国际标准改进质量管理,注重过程、再造流程;预防为主、持续改进。结果 建立标准化质量管理平台,形成以制度管人,以体系管事、以法治院的医院管理,提升医院内外顾客的满意度。结论 ISO9001:2000标准是医院实施质量管理有效性的指南;采用国际标准再造流程,为医院的发展提供了空间,而顾客是最大的受益者。建立标准化质量管理平台,为医院从传统的经验管理向现代化科学管理转变创造了条件。     

军队医学工程人才队伍现状及对策探讨

分析了目前军队医学工程人才素质现状，探讨了军队医学工程人才素质弱化原因，结合部队医学工程人才来源和培养的实际情况，提出了只有积极寻求新时期医学工程人才培养对策，加大人才培养力度，才能造就一支具有高科技专业知识、有严谨科学作风、懂技术会管理的人才队伍。     

Quality assurance in health sciences literature searching: applying the ISO 9000 quality standard

Medicine is a literature-based discipline. Ensuring that the literature review which precedes a significant piece of medical research has met predetermined standards is essential. A list of items reviewed carries no guarantees that all appropriate items have been included in the survey of the literature, or that appropriate sources have been efficiently searched. This would be a matter for concern in any discipline. In medicine it is a matter of life and death. Quality assurance procedures that offer guarantees of the standards built into the process, rather than quality control which measures only outputs, can provide the necessary reassurance. The ISO 9000 quality standard offers a much needed quality assurance process. A methodology for applying the ISO 9000 standard to the task of searching the medical literature is outlined in this paper. A new role for medical librarians in promoting a rigorous methodology in the literature review equal to that of the research it supports is defined.     

ISO9001标准在医院后勤贡量管理体系中运用前景分析

ISO9001质量管理体系标;隹在国内开始认证工作已有20多年,作者根据质量管理体系的基本原则和主控要素,分析了医院质量管理与ISO9001标准的相容性,并根据现阶段医院质量管理与ISO9001标准目前结合的现状,论证分析了医院质量管理运用ISO9001标准前景。     

ISO9000质量管理标准在精神卫生医疗机构的实践及体会

探讨了ISO9000质量管理体系标准在精神卫生医疗机构中的实施情况,介绍了实施该标准的意义和导入标准过程中的关键环节,阐述了精神卫生医疗机构质量管理体系标准应把握的要点和应该注意的问题。     

Accreditation of analytical laboratories and proficiency testing: experiences from Thailand on the issues of pesticide analysis.

Thailand, the economic growth of which largely depends on agriculture-based industry, recognizes the importance of international standards for harmonization of international food trade and for protection of human health from chemicals used as food additives or those present as contaminants. Pesticides which are widely used in Thailand are the anticholinesterase pesticides, pyrethroids, coumarin derivatives, bipyridinium salts, and to some extent organochlorine compounds such as DDT in malaria control. Proficiency testing and accreditation of laboratories are recognized as effective means to ensure quality and validity of data and to enable adequate risk assessment of pesticide residues in food, work environment and environment in general. The paper is a synthesis of relevant local reviews and in-depth interviews with experts in the area of pesticide laboratory accreditation and proficiency testing. The paper refers to other schemes for quality assurance such as ISO guide 25, ISO 9000, and ISO 14000, and addresses future prospects of ongoing activities such as accreditation of inspection bodies in the area of industrial chemicals and occupational safety and health.     

用国际标准化质量管理体系规范和监控医院医用耗材的管理

医用耗材已是医院医疗诊治活动中不可缺少的物质基础，而医用耗材的生产厂家和供应商繁多。供应渠道复杂．用国际标准化质量管理体系规范和监控医院医用耗材的管理，是确保医用耗材的质量、预防不良事件的发生、保护患者权益的有效措施。     

医疗设备供应商标准化评价体系建立与实践

供应商评价是医院进行供应商管理、监督和改善等一系列活动的基础和标准,在医院的发展中起至关重要的作用。本文介绍在ISO9001标准的基础上引入风险分析对供应商进行评价,以此建立一个规范可靠的选择医疗设备供应商的评价体系,以降低以往凭经验选择供应商导致的产品质量、售后服务等方面的风险。     

ISO9001质量管理体系在医疗设备全程管理中的应用——质量管理原则

应用ISO9001质量管理体系对医疗设备全程管理,论述了质量管理八项原则,以利于质量管理体系持续改进。     

构建门诊医疗质量管理体系

通过借鉴ISO 9001标准、PDCA循环和Donabedian质量测量模型等理论和方法，根据大型综合医院门诊的属性定位、服务内容及管理特点等，从质量目标、质量策划、质量保证、质量控制以及持续改进等5个维度构建了门诊医疗质量管理体系。该体系的构建促进了多院区门诊一体化管理。截至2018年，医院日均门急诊量较2016年上升11%；急危重症抢救成功率达99.79%；患者预约后平均等待时间较2016年缩短了近20分钟；每万人次投诉率下降至2.2%。门诊医疗质量管理体系有助于提升门诊管理质量，增强患者获得感，值得推广     

信息技术在军队人员医疗费用审核中的应用

目的:加强军队人员医疗费用的经济核算,控制医疗费用的不合理增长,实现低消耗高保障的目标。方法:构建军队人员医疗费用审核系统,由军区和医院两级审核管理,控制军队人员医疗费用的结构和额度。结果:为军区机关、后方医院和体系部队提供了安全可靠、资源丰富及全程透明的军队人员医疗保障监督管理信息平台。结论:运用信息技术规范医务人员的医疗行为,促进医疗保障水平的提高,实现军队人员医疗费用统一审核、统一考评和统一管理的新模式。     

用国际标准化质量管理体系规范医院医用耗材的管理

医用耗材已是医院医疗诊治活动中不可缺少的物质基础,而医用耗材的生产厂家和供应商繁多,供应渠道复杂,用国际标准化质量管理体系规范和监控医院医用耗材的管理,是确保医用耗材的质量,预防不良事件的发生,保护患者权益的有效措施。