上海市临床实验室质量管理体系规划和初步建设

目的　初步建立上海市临床实验室质量管理体系。方法　在检验试剂、仪器、项目、人员、室内质量控制和室间质量评价等 6个方面加强监督、管理和服务。结果　 (1)参与了上海市食品药品监督管理局组织的临床检验类仪器、试剂注册过程中的企业标准审核、型式试验和临床试验 ;(2 )对上海市物价局核准收费的 6 0 0余项临床检验项目组织专家评审 ,提出了基本、参考和建议取消项目 ;(3)上海市各级医院检验人员参加质量培训的人次大幅度增加 ;(4 )参加上海市地区性室内质量控制和室间质量评价的医院数量逐年增多 ;(5 )上海市各级医院盲点调查及现场检查合格情况逐年好转。结论　上海市各级医院临床实验室管理水平已经有了一定程度的提高 ,但还有不少问题有待进一步解决。     

上海市临床实验室质量管理体系规划和初步建设

目的 初步建立上海市临床实验室质量管理体系。方法 在检验试剂、仪器、项目、人员、室内质量控制和室间质量评价等6个方面加强监督、管理和服务。结果 (1)参与了上海市食品药品监督管理局组织的临床检验类仪器、试剂注册过程中的企业标准审核、型式试验和临床试验；(2)对上海市物价局核准收费的600余项临床检验项目组织专家评审，提出了基本、参考和建议取消项目；(3)上海市各级医院检验人员参加质量培训的人次大幅度增加；(4)参加上海市地区性室内质量控制和室间质量评价的医院数量逐年增多；(5)上海市各级医院盲点调查及现场检查合格情况逐年好转。结论 上海市各级医院临床实验室管理水平已经有了一定程度的提高．但还有不少问题有待进一步解决。     

The changing face of clinical laboratories.

Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.     

浅谈台湾医院检验科之品质管理

通过与台湾4家医院检验科和1家能力验证组织的交流,了解台湾实验室品质管理的方法,对实验室质量管理的改进和实验室认可的推动提供指导。台湾实验室品质管理可归纳为3种模式:第一种是基于信息化的无缝式管理模式,即通过信息化功能将品质管理的要求嵌入实验室每一工作环节,可操作性极强,极大提高了管理效率;第二种是基于关键岗位责任制的管理模式,采用应聘上岗方式,变被动为主动工作,通过层层管控,传帮带教,提高品质管理的参与率;第三种是基于绩效考核的管理模式,是建立在到位的政府管控加上有序的市场化运作基础上,运用以人为本的激励机制,推动实验室的良性发展。台湾医院检验科以科学化、人性化的方法改进品质管理,使得实验室人员积极主动地参与到建立质量管理体系中,不断提升检验品质,满足临床需求。     

Recommendations for detection and management of unsuitable samples in clinical laboratories.

A large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.     

应用6σ理论评价临床实验室各阶段性能及设计质控方案

目的运用σ指标全面评价临床实验室检验前、中、后各阶段性能，以期发现问题，指导质量改进。方法根据检验项目的不准确度、不精密度及总允许误差计算σ值，评价检验中阶段性能，并以此设计质量控制方案。对分析性能低于6σ的项目，计算质量目标指数（qualitygoalindex，QGI）查找导致性能不佳的主要原因，指导质量改进。统计标本合格情况、血清钾紧急值通知情况、患者抱怨情况、标本周转时间（turnaroundtime，TAT）等，计算上述4个指标的盯值，利用标本合格情况σ值评价检验前阶段性能，血清钾紧急值通知情况σ值评价检验后阶段性能，患者抱怨情况和TATσ值评价检验全程性能。结果在27个检验项目中，8个项目分析性能大于6σ，所有项目的平均σ值（即检验中阶段性能）为4．44。在未达6σ的19个检验项目中，12个项目需优先改进精密度。标本合格情况、紧急值通知情况、患者抱怨情况、急诊及常规TAT的σ值分别是4．9、2．9、5．6、2．8、2．9。结论σ指标为临床实验室检验各阶段的性能评价提供客观的衡量标准，体现实验室目前所处的性能水平及今后的改进方向。     

我国临床实验室全自动化发展面临的挑战及对策

本文介绍了临床实验室全自动化检验流水线的主要特征、发展现状、面临的主要问题和相应的解决策略,旨在为我国临床实验室全自动化的健康发展提供参考.     

护理质量管理实施中的问题与对策

作者在实施现代护理模式中存在的问题,通过现代的护理管理方法进行适当整改,使护理质量和服务质量得到保证,病人住病综合满意度由1998年上半年的63％至1999年全年至2000年8月份均为100％。     

Key elements of the implementation of a quality system in three Finnish clinical laboratories.

The aim of the study was to discover how an implemented quality system succeeded in fulfilling the personnel and management expectations and to identify the factors that facilitate or hinder quality management implementation in clinical laboratories. The concepts assessed include leadership (commitment and change management), clear and common goals, human recourses focus, client focus, management by fact and process improvement. The quality process in the laboratories had not, even after 3-4 years, reached a level of acceptance allowing its use as a daily development tool. The factors that predict a success of the quality system include willingness to improve the laboratory services and to keep the process going and good atmosphere at work. However, the study showed that the senior managers of the laboratory should take a more visible role in leading the change, and emphasize more explicitly the long-term goals. The middle managers (physicians, biochemists and head technologists) should arrange opportunities for the staff to participate in the system and disseminate the information on, and practical applications of, the quality principles and tools. The staff should be more active in finding new information and in participating in the system.     

医学实验室质量指标模型设计

目的结合医学实验室认可准则的要求,以国际临床化学联合会(IFCC)和美国病理家协会(CAP)质量指标为基础,建立适合我国医学实验室的质量指标模型。方法以CAP的数据收集方法为依据,设计适合于手工方法和不同信息系统通用的数据采集表格;采用《临床实验室质量管理与控制指标及数据采集分析软件》,对所收集的实验室内及实验室间的质量指标数据进行汇总、分析、处理和存档,并实现自动化和标准化。结果建立的质量指标模型中共有100个指标,按用途可划分为通用指标85项、专业特异指标15项;按整个检测流程划分,又可将通用指标分为分析前质量指标25项、分析中质量指标30项、分析后质量指标26项、安全管理指标4项。质量指标模型中设置了哨兵指标13项,并制定了质量指标使用流程。结论医学实验室可根据本实验室的具体情况,从本研究设计的质量指标模型中选择适合的质量指标进行监测,从而识别易造成患者危害的风险因素,有效减少医疗差错的发生,实现临床实验室间信息资源共享,评估和追踪临床实验室改进活动的效果。     

临床护理科研存在的问题与对策

本文从客观和主观方面分析了目前开展临床护理科研普遍存在的问题。并针对存在的原因进行了探讨,认为护理作为一门专业,有其系统的知识体系,只有通过科研才能不断发展,必须在重视临床技术实践的同时,高度重视临床护理科研,要树立科学思维的头脑,强化临床护理人员的科研意识,从全面提高临床护理人员的整体素质着手,加强培养学科带头人,加强惭科带头人,加强组织管理来促进临床护理科研的发展。     

Process and risk analysis to reduce errors in clinical laboratories.

BACKGROUND: An important point in improving laboratory quality is the definition of some indicators to be monitored as measures of a laboratory trend. The continuous observation of these indicators can help to reduce errors and risk of errors, thus enhancing the laboratory outcome. In addition, the standardization of risk evaluation techniques and the definition of a set of indicators can eventually contribute to a benchmarking process in clinical laboratories. METHODS: Five Italian hospital laboratories cooperated in a project in which methodologies for process and risk analysis, usually applied in fields other than healthcare (typically aeronautical and transport industries), were adapted and applied to laboratory medicine. The collaboration of a board of experts played a key role in underlining the limits of the proposed techniques and adapting them to the laboratory situation. A detailed process analysis performed in each center was the starting point, followed by risk analysis to evaluate risks and facilitate benchmarking among the participants. RESULTS AND CONCLUSIONS: The techniques applied allowed the formulation of a list of non-conformities that represented risks of errors. The level of risk related to each was quantified and graphically represented for each laboratory to identify the risk area characteristic for each of the centers involved.     

基于生物学变异的质量规范和六西格玛管理方法在临床生化质量控制中的应用研究

目的探讨基于生物学变异的质量规范和六西格玛(6σ)管理方法在临床生化质量控制中的应用研究。方法根据Westgard生物学变异数据库提供的质量规范,对28个临床生化项目计算西格玛(σ)值;允许不精密度[百分变异系数(CV%)表示]的数据是采用本实验室2018年3-9月室内质控数据;百分偏倚(bias%)的数据是采用2018年第二次卫生部临床生化室间质评比对的偏倚数据;根据σ值和功效函数图选择合适的质控规则,以及根据质量目标指数(QGI)查找出不合格项目的主要原因,为实验室全面质量控制管理奠定坚实的基础。结果28个临床生化项目中,有2个、9个和15个项目分别选择了最低、合适和最佳的CV%生物学变异质量规范,Na和Mg未能达到最低目标要求;分别有12个和10个选择了合适和最佳的bias%生物学变异质量规范,Na、Cl、Ca、ALB、TP未能达到最低目标要求;分别有5个、11个和4个选择了最低、合适和最佳的允许总误差(TEa)生物学变异质量规范,GLU、Ca、TP、Na、Cl、Mg、ApoA1、ApoB未能达到6σ目标要求。未能达到6σ目标要求的项目,通过计算QGI值发现需要优先改进精密度的项目占87.5%。结论运用生物学变异不同水平的质量规范和6σ质量管理方法,可以有效地提高临床实验室质量水平,是临床实验室开展质量控制的一项有效的管理工具。