循证检验医学在临床基因扩增检验全程质量控制方面的应用研究

目的 按照IS015189医学实验室质量和能力的要求和卫生部下发关于临床基因扩增检验的三个文件规定,针对基因扩增检验技术具有高度特异性、灵敏性、微量而快速的特点,利用循证检验医学(evidence-based laboratory medicine,EBLM)的理论,在临床基因扩增检验中寻求一条可靠、经济实用、有效的全程质量控制措施.方法 通过查找大量相关基因扩增质量控制方面研究的文献报道,进行系统荟萃评价(SR)和随机对照试验(randomized control trial,RCT),以及结合临床实践操作的效果进行验证.结果 临床基因扩增诊断以快速的检测手段,向临床提供真实可靠的诊断报告,科学、经济、有效的全程质量控制措施是非常有效的手段.结论 这是"以患者利益为核心"的循证医学基本思想的体现.     

生化检验报告的循证研究

临床的生化检验报告是循证医学（evidence—based medicine,EBM）过程的凭据之一,报告的真实性首先要有实验室最好的研究证据为基础,其次是患者检测结果的真实性,这有利于医师依据生化循证质量控制（evidence—based of quality control,EBQC）的基本方法,分析病人自身内部因素与生化反应的随机性变化规律;从保护患者的价值方面,把握好各项生化的随机性变化的合格“产品”,得出临床正确的系统评价。     

临床生化检验的循证质量控制

临床生化检验的运行过程实际包含了各种可波动的误差因素,实施质量控制时.应该遵照循证医学(Evidence-based medicine,EBM)的基本理论,遵循质量控制的证据;按照生化检验的循证质量控制公式△SEc=CCV/CV,来表达实验室内部与外部质量管理(即室内质控IQC与室问质评EQA)、个体质量变异与总体质量变异(即CV与CCV)相互之间联系又制约的规律性,是生化检验循证质量控制(Evidence-based of Quality Control,EBQC)要获取重要证据的必然途径.     

浅谈做好临床生化检验质量控制的体会

随着检验医学的迅速发展，保证检验工作质量、检验结果准确可靠已成为检验工作的核心。在临床生化检验质量控制过程中，涉及到标本的采集及处理、标本分析和结果的报告与反馈等阶段，每个环节出现问题都可影响检验结果的准确性。现就如何做好临床生化检验质量控制的粗浅体会报道如下。     

检验医学专业学生循证能力的培养

循证检验医学是将循证医学与原则应用到检验医学中的现代检验医学学科理论,它强调应用最好的现代医学检验技术和质量控制体系对检验结果进行严格的质量控制和客观评价,以达到向临床医生提供反映受检者真实客观的机体和病理情况的证据的目的[1].目前,循证医学所采用的方法学和思维方法在世界发达国家的卫生行业已被广发采用,我国检验医学专业学生是否具备这种能力关系到他们的就业和发展.     

循证检验医学与实验室质量控制

随着EBM在全世界的传播与普及,循证检验医学悄然兴起,但实质性研究目前还不多。本文从医院临床检验实际出发,探讨用循证医学原理和方法指导实验室质量控制的可行性。     

将循证检验医学运用于临床检验工作具有现实的临床意义

目的　探讨研究“循证检验医学”(evidance basedlaboratorymedicine ,EBLM)对临床检验工作思路的可操作性。方法　从临床检验实际工作出发,运用循证检验医学的原理和方法指导临床检验报告准确、快速地服务于临床,预防医疗事故的发生。结果　更加丰富地体现了临床检验医学实质和存在价值。结论　循证检验医学对促进临床检验实验室的进步和检验医学的发展具有重要作用。     

循证检验医学与实验室质量控制

随着EBM在全世界的传播与普及，循证检验医学悄然兴起，但实质性研究目前还不多。本从医院检验实际出发，探讨用循证医学原理和方法指导实验室质量控制的可行性。     

脑血管病患者血脂和血流动力学的循证检验

循证检验医学(evidence-basedlaboratorymedicine,EBLM)对于临床具有两方面意义,一是为临床医生提供尽可能好的检验结果以协助做出诊断、预防、治疗决策。二是对不断增加的检验技术进行评估,以确定其所用的技术是否准确、可靠、安全、经济和有效。循证医学的定义也适用于循证检验医学。恰当地运用循证检验医学方法,有可能较好地解决目前医疗市场中检验项目过多所造成的一些问题,尤其是因医疗保险产生的患者愿望和外部预算限制之间的紧张关系。     

循证医学在检验医学中的应用

循证医学（evidence—based medicine，EBM）是以证据为基础的医学，循证医学在检验医学的应用即为循证检验医学（evidence—based laboratory medicine，EBLM）。EBLM就是遵循EBM的核心思想，在应用大量可靠的临床资料和经验的基础上，研究检验项目临床应用的价值，为临床诊断、疗效观察、病情转归提供最有效、最实用、最经济的检验项目及检验组合，并最终获得可靠的检验信息资料，为医疗决策提供循证。     

POCT干式生化分析仪在联合国驻黎巴嫩临时部队维和检验中的应用研究

目的 研究联合国驻黎巴嫩临时部队(UNIFIL)我军和外军维和官兵部分生化指标的差异性,初步探讨POCT(point of care testing,POCT)干式生化分析仪在维和检验中的应用价值.方法 以UNIFIL外军维和官兵作为观察组(n=115～303),中国维和工兵营作为对照组(n=167),同时对两组生化检验数据均值行t检验分析其统计学差异性.结果 与167例中国赴黎维和工兵营官兵生化检测结果 相比较,赴黎维和外军官兵生化检测结果 中ALB、TBIL、GPT、GOT、LDH、GLU、TCH显著升高(P<0.01),CRE显著降低(P<0.001),TPRO、TG差异无统计学意义(P>0.05).结论 UNIFIL外军和中国维和官兵部分生化指标存在统计学差异性,建议中国维和二级医院检验科应分别建立不同的判断标准;POCT干式生化分析仪在维和检验医学中保障作用优势明显.     

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.     

How can we make laboratory testing safer?

BACKGROUND: Diagnostic errors occur in laboratory medicine resulting from an error or delay in diagnosis, a failure to employ indicated tests, and the use of outmoded tests. Since laboratory tests provide essential information used by physicians to make medical decisions, it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. METHODS: The US Quality Institute Conference in 2003 and the Institute for Quality in Laboratory Medicine in 2005 brought together providers of, users of, and payers for laboratory services to explore how working together they could help to reduce laboratory testing errors and enhance patient safety. RESULTS AND CONCLUSIONS: Users of and payers for laboratory services must become partners in the laboratory's efforts to reduce laboratory testing errors and enhance patient safety. They must be linked to a laboratory information system that provides assistance in decisions on test ordering, patient preparation, and test interpretation. Laboratory quality assessment efforts need to be expanded to encompass the detection of non-analytical mistakes. Healthcare institutions need to adopt a culture of safety that is implemented at all levels of the organization.     

A comparative study of laboratory utilization behavior of "on-service" and "off-service" housestaff physicians

Highly specialized housestaff programs often call for training in another specialty area, especially internal medicine. Because of differences in training background and experience with internal medicine, laboratory utilization patterns might differ. Hence, laboratory test comparisons between medical ("on-service") and nonmedical ("off-service") housestaff were carried out on the general medicine service. On-service and off-service housestaff were found to have similarly ill patients and similar workloads. Off-service housestaff generally used less laboratory services than on-service housestaff, although both groups used large numbers of tests. Despite differences in experience and training, off-service housestaff appeared to deliver less costly and apparently equal quality medical care, compared with on-service housestaff.     

合肥地区基层医疗机构检验科血常规室间比对结果分析

目的了解合肥地区基层医疗机构检验科血常规的检测水平,分析影响室间比对结果的主要原因。方法随机抽取43家乡镇卫生院和社区卫生服务中心检验科,进行现场调查和血常规项目室间比对。结果室间比对合格率41.9%,平均72.37分,明显低于省临检中心合格率(94.1%)和平均分(95.97分),差异均有统计学意义(P0.05);血常规参数(白细胞、红细胞、血红蛋白、红细胞比容、血小板)平均合格率均低于安徽省临检中心,差异均有统计意义(P0.05);基层实验室人员学历偏低,非检验专业人员占18.80%;血常规分析仪以国产为主,且53.49%的仪器使用时间超过5年;实验室整体质量管理水平落后。结论合肥地区基层医疗机构实验室血常规检测水平远不及二级以上医疗机构。需做好日常实验室室内质控,逐步完善质量管理体系。     

临床实验室内不同生化分析系统间检测结果的比对

目的探讨如何确保不同生化分析系统之间检测结果的可比性。方法以贝克曼生化分析仪为对比,日立7170S生化分析仪为试验方法。按要求定期进行定标,每天用质控品(至少二个水平)进行测定,当质控结果符合要求后,方可进行标本测定,并每天随机抽取来自住院病人的新鲜静脉血清5份(浓度覆盖范围尽可能大),测定20天,共100分。分别同时于两台生化仪上测定23项生化指标,并对结果进行统计处理。结果23个项目在二台仪器上的测定结果均具有良好的相关性,差异无显著性意义(P>0.05)。结论定期对仪器进行校正,每天除了做好室内质控外,应定期对两台生化仪进行方法对比和相关性分析,确保测定结果的高度一致性和准确性。     

The truth about quality: medical usefulness and analytical reliability of laboratory tests

BACKGROUND: In this age of evidence-based medicine, nothing is more important than the quality of laboratory tests. It is commonly thought that laboratory tests provide two-thirds to three-fourths of the information used for making medical decisions. If so, test results had better tell the truth about what is happening with our patients. METHODS: The age-old "truth standard" for the quality of evidence describes three dimensions that are important-a test should tell the truth, the whole truth, and nothing but the truth. This three-dimensional model can be used to characterize the clinical and analytical reliability of laboratory tests and guide the translation of outcome criteria, or quality goals, into practical specifications for method performance. RESULTS: Clinical reliability, or medical usefulness, should assess the correctness of patient classifications based on stated test interpretation guidelines, taking into account the precision and accuracy of the laboratory method, and allowing for the known within-subject biologic variation and the QC needed to detect method instability. Analytical reliability should assess the correctness of a test result based on a stated error limit, taking into account the precision and accuracy of the method and allowing for the QC necessary to detect method instability. These assessments challenge the reliability of current tests for cholesterol, glucose, and glycated hemoglobin in the implementation of U.S. national clinical guidelines. CONCLUSIONS: Evidence-based medicine must employ scientific methodology for translating test interpretation guidelines into practical, bench-level, operating specifications for the imprecision and inaccuracy allowable for a method and the QC necessary to detect method instability.     

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.     

Charting the course of medical laboratories in a changing environment

BACKGROUND: In recent decades, dramatic changes have occurred in the organization, number and type of tests, and role of medical laboratories in healthcare. The role of laboratory professionals has undergone a radical change, which calls for greater analytical accuracy, and more stringent test selection, and interpretation of results. METHODS: The ancillary role of clinical laboratories in the past was analyzed in order to understand why the change has taken place, and to identify old and new areas in which laboratory information is largely used for improving upon decision making for treatment, and patient management. RESULTS: The availability of real-time laboratory results and more effective tests, the enhanced clinical consulting role, the involvement in therapeutic decisions, the efforts to prevent rather than cure disease, the shift from anecdotal care to evidence-based medicine, and the assessment of outcome for laboratory tests have all contributed to the changing role and duties of medical laboratories. CONCLUSIONS: Crucial elements in sustaining the changes in the role and contribution of medical laboratories to a high-quality healthcare are the ability of laboratory professionals to: guarantee the quality of laboratory tests irrespective of where they are performed; improve the quality of services; improve clinical outcomes; and perform joint clinical/laboratory research projects. A key factor in effecting the change has been the awareness of the importance of the knowledge and skills required for the new role of laboratory professionals.     

中国驻利比里亚维和二级医院集训中护理工作的组织实施

根据联合国1509号决议,我国奉命派出首批赴利比里亚维和医疗队,进行为期4个月的封闭式集训.本文介绍了集训中护理工作的组织与实施,包括对护理人员的挑选要求,护理人员的编制组成;外语、军事体能、维和知识、野外求生等培训;维和物资准备.在前期集训和后来执行维和任务过程中得出了一些经验教训：英语是护士集训的重点和难点,一专多能是完成维和任务的关键,充足的医疗护理物资是完成维和任务的前提.