体外诊断试剂的正确选择和使用

实验室质量管理的三个组成部分是：质量保证、质量控制和质量评价。对医学检验实验室，质量保证包括科学合理的实验室布局、先进的仪器设备、高素质的技术人员和优质的诊断试剂等。因此，体外诊断试剂是实验室质量保证的重要组成部分，只有科学合理选择体外诊断试剂，实验室才能正常有序地开展检验活动。     

影响医学卖验室质量的关键因素

目前，检验医学技术有了飞速发展，医学实验室使用了各种类型的自动分析仪，质量评价越来越受到医学实验室,和临床各科室的重视。但中国临床检验质量技术的应用还存在一定的缺陷，一方面是培训教育跟不上检验技术的发展；另一方面缺乏质量方面系统的教材。传统上实验室人员把质量控制等同于实验室检测结果的质量控制，但实验室的检测过程是复杂的，分析前和分析后存在的许多问题，如患者的确认、患者准备、标本收集、标本处理、试验结果的传递等。所以，实验室的质量保证有内部和外部两种因素，内部是实验室本身，外部是临床和患者，即分析前因素。笔者就影响实验室质量的因素谈谈自己的看法，报道如下。     

实验室管理与临床检验质量控制

在临床工作中，实验室指标对病症的诊断、治疗、预后及医学科学研究十分重要。临床检验的质量直接关系到病人的诊断、治疗、预后。近年来，医学检验技术迅速发展，好的检验方法不断产生，致使临床医生对检验结果的依赖越来越大，因此，加强实验室科学管理，提高检验质量，保证检验结果的准确性越显重要，所以必须提高临床检验质量控制。     

护理部加强检验标本质量管理的体会

实验室质量控制受多方面的影响，除自身质控外，护理工作在检验质量保证系统中占有非常重要的地位。近几年，我们护理部重视检验标本的采集、送检等环节的质量管理，较好地发挥了护理管理在检验标本质控中的作用。具体体会介绍如下。     

《临床实验室质量保证的要求》简介

《临床实验室质量保证的要求》WS／T250-2005等效采用了《美国临床实验室改进修正案88》（Clinical Laboratory Improvement Amendments 88, CLIA＇88）中“J亚章-中度或高度复杂检验患者检验管理”和“P亚章-中度或高度复杂检验质量保证”中的内容，于2005年12月113起实施，是改善我国临床实验室管理，提高检验水平，开展实验室认可，实现与国际接轨的技术指导性文件。标准规定了对临床实验室质量保证的要求，适用于从事医疗活动的临床实验室。标准明确规定：临床实验室必须建立并遵守质量保证（QA）的政策和程序，用所建立的QA政策和程序来监测和评价整个检验过程（分析前、分析中、分析后）的质量。实验室的QA规划必须能评价其政策和程序的有效性，识别并纠正问题，保证报告检验结果的准确和及时，保证工作人员合适和有能力。     

护理人员在医学检验质量控制中的作用

近年来，我国卫生主管部门已将医学榆验的质量控制列入了医院管理评价的重要内容。为实现全面质量管理的目标，除实验室本身的质量控制以外，临床所提供的标本也是质量控制不可忽视的一个重要环节。为此，护理人员有必要熟悉有关临床检验标本留取的一些技术问题。笔者就多年来的工作经验，结合质量控制实践，参考有关文献资料，提出临床检验标本留取过程中护理人员需要掌握的一些技术性内容及其职责；     

医学检验的质量控制

医学检验的质量控制就是提高医学检验水平，保证检验结果可靠性的重要手段。是实验室建设、管理、检验人员的培训、检测、结果的评价、误差分析及纠正等全部过程。通过控制物所得控制图来控制某成分的检测误差的过程，可以评价实验室工作水平，控制系统误差和部分偶然误差。通过一系列质控，可以防止、发现和纠正实验误差，以提高检验质     

加强临床实验室与临床的交流建立全面质量管理体系

质量管理是临床实验室管理的核心 ,是实验室生存发展的前提 ,特别是 2 0 0 2年我国出台的《关于民事诉讼证据的若干规定》中明确指出“举证倒置” ,这对提高临床实验室质量管理提出了更高的要求。实验室检查是临床诊疗工作中一个基本环节 ,其工作质量要靠临床医护人员和检验人员共同努力来保证。广大医护人员有必要了解临床实验室的工作程序 ,并与检验医师与技术人员一起 ,加强检验与临床交流与合作 ,共同建立完善的临床实验室全面质量管理体系。一、临床实验室全面质量管理体系的概念全面质量管理是指对临床检验全过程进行标准化管理。一个…     

质量管理对临床生化检验的重要性

质量管理是I临床实验室保证工作质量的重要手段。随着医学检验的发展,实验室的质量管理已越来越被重视,1999年国际标准化组织专门组织专家制定了针对医学检验实验室的认可方案,     

检验质量控制中护理工作的影响与对策

目的 探讨进入实验室前标本可能造成的护理误差对医学检验质量的影响。方法 通过药物、体位改变、使用止血带、病人行为干扰、标本采集转送方式等四个方面进行分析，提出解决护理影响的对策。结果 通过相互学习，建立合理制度，能够控制进入实验室标本的质量，从而建立全方位质控网络，促进检验医学与护理管理水平逐渐规律化、科学化。结论：标本进入实验室前，护理工作对检验医学质量有影响。     

Carnitine homeostasis in patients with rheumatoid arthritis

The radical changes made in the delivery of modern health care have serious implications for laboratory services, because reasoning in laboratory medicine should follow a clinical rather than a technological logic. Appropriate test requesting and interpretation coupled with a patient-oriented vision improve the outcomes for patients, and so ensure the best cost containment strategy. The fact that analytical operations are standardized and quality controlled, may lead to a greater recognition of the importance of pre- and post-analytical issues. Particularly critical aspects are the formulation of the clinical question and the interpretation of laboratory results. Laboratory–clinic communication is fundamental in achieving and maintaining total quality in laboratory services. Effective consultancy stands or falls with the knowledge and experience of laboratorians, as well as continuous education is required to maintain the best utilization of laboratory information in clinical decision-making. As clinical audit is an important tool for reviewing and improving the quality of the service in clinical laboratories, it should make up an important part of programs for accreditation and quality improvement. If a patient-centered vision predominates, the clinical laboratory will be linked to both physicians and patients, making it more tangible to the latter.     

Laboratory medicine in the United Kingdom: 1948-1998 and beyond

The National Health Service in the United Kingdom was created in 1948, effectively becoming the main provider of healthcare and funded by the government from taxation. By the late 1970's, and despite many achievements, it was seen to be approaching a financial crisis. Radical reforms were introduced in the early 1990's bringing in general management, a split between purchaser and provider, and competition. Whilst there has been a change of government more recently several of these initiatives have been retained, with the exception of competition (the internal market) which has been abandoned. There is now a much greater focus on the quality of care with increased clinical and financial accountability. Laboratory medicine (generally termed pathology in the United Kingdom) has evolved to meet the demands of more patients, reducing turnaround times, a greater repertoire of investigations and a continuing improvement in productivity. There is an increasing focus on improved dialogue between the laboratory and the clinician covering interpretation of results, audit of services and outcomes, research and development and continuous education in the pursuit of a high quality service. The major challenges for the future focus on alternative modes of delivery, on issues relating to staffing and on quality of service, in the face of an ever increasing demand.     

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。     

Laboratory medicine in Ontario: its downsizing and the consequences on quality

Health care in Ontario consumes 35% of provincial government annual revenues. Fiscal constraint mandates restructuring of health services to maintain a fully, publicly-funded universally-accessible health system that is patient-focussed and health-outcome driven. Acute-care hospital restructuring under the authority of the Health Services Restructuring Commission and primary health-care reform characterise present government initiatives. Laboratory medicine services at about Can $1 billion annually account for about 5% of health expenditure. A Laboratory Services Restructuring Secretariat created by the Ministry of Health in 1995 has planned regionally-based integrated laboratory services systems bringing together public and private providers, designed a province-wide laboratory information system, developed a quality management program, reviewed the human resource needs for laboratory physicians, scientists and technologists, and recommended that the legislation be rewritten so as to be enabling - not controlling. Meanwhile both hospital and private laboratories have closed, leaving 296 in 1998 compared to 394 in 1991. Laboratory physician numbers at 39 per million population falls far short of the recommended target of 52 and many are within 10 years of retirement. Renewal of laboratory physicians and scientists to meet the shortfall is not occurring. The numbers of registered laboratory technologists has fallen by 6. 8% over 2 years. Consolidation and downsizing of laboratories with the formation of core laboratories has resulted in multi-discipline and cross discipline tasking of specialist technologists. Senior and middle level management technologists have been declared redundant. As a consequence, quality control practices have been hard hit. Plans to address these deficiencies through regional integration and sharing of resources remain to be implemented.     

Physician-executives past, present, and future.

The dramatic changes in the United States' health care system during the last decade have sparked increasing interest in physician-executives. These executives, skilled in both clinical medicine and health care management, can be found in hospitals, managed care organizations, group practices, and government institutions. This paper outlines the physician-executive's roles and the development process. The remarkable growth in the number of physician-executives is expected to continue as they demonstrate their abilities to help health care providers expand ambulatory services, facilitate provider-physician relationships and physician recruitment, and lend expertise in quality improvement and risk management issues.     

The beginning of the second decade of the era of patient safety: Implications and roles for the clinical laboratory and laboratory professionals

Providing high quality, effective laboratory services is not new to the laboratory profession. The laboratory began examining its analytical quality in the 1920s when the American Society of Clinical Pathologists (ASCP) began a voluntary proficiency testing (PT) program with that was the predecessor of the College of American Pathologist's current PT program. The program focuses primarily on analytic quality, 1 of the 3 phases of what has become known as the “total testing process,” a cyclical process conceptualized by the Centers for Disease Control (CDC) that provides a framework for assessing quality of laboratory services. Laboratory testing is particularly essential in the practice of medical genetics. The translation of human genomic research into clinical practice has resulted in a rapidly expanding portfolio of DNA-based tests for heritable conditions and markers of drug metabolism. This creates an opportunity for laboratory professionals with genetic training but also brings with it a threat to the quality of care that might result from inappropriate use of unfamiliar, costly and inappropriate testing. As for conventional laboratory tests, there is the need to identify and control all phases of the “total genetic testing process.” An agenda for the second decade of the era of patient safety must be developed and here we offer a few key areas for practice improvement in laboratory medicine.     

Overview of evidence-based medicine: challenges for evidence-based laboratory medicine

Evidence-based medicine (EBM) has been driven by the need to cope with information overload, by cost-control, and by a public impatient for the best in diagnostics and treatment. Clinical guidelines, care maps, and outcome measures are quality improvement tools for the appropriateness, efficiency, and effectiveness of health services. Although they are imperfect, their value increases with the quality of the evidence they incorporate. Laboratory professionals must direct more effort to demonstrating the impact of laboratory tests on a greater variety of clinical outcomes. Laboratory and clinical practitioners must be familiar with many of the accessible electronic and paper tools for searching for evidence. Detailed statistical and epidemiologic knowledge is not essential, but critical appraisal skills and a competent understanding of the strengths and weaknesses of systematic review and metaanalysis are necessary. Overemphasis on complexity and failure to recognize time limitations are major barriers to translating EBM into everyday practice. Emphasizing and practicing the role of the laboratory professional as a skilled clinical consultant strongly grounded in evidence as well, in addition to better integration of laboratory and clinical information and improved laboratory reports will overcome most barriers. There is a poverty of good, primary studies of test evaluations. Institution of more consistent standards for the design and reporting of studies on diagnostic accuracy should improve the situation. If nothing else, systematic reviews have demonstrated the need for more good-quality primary research in laboratory medicine.     

Quality specifications: self pleasure for clinical laboratories or added value for patient management?

Analytical quality specifications play a key role in assuring and continuously improving high-quality laboratory services. However, I believe, that there are two "missing links" in the effective management of quality specifications in the delivery of laboratory services. The first is the evidence that pre-analytical variation and related problems are not taken into great consideration by laboratory professionals. The second missing link is the communication of quality specifications to clinicians and other possible stakeholders. If quality specifications represent "the level of performance required to facilitate clinical decision-making", they cannot be used only for internal quality management procedures but must be communicated to facilitate clinical reasoning, decision-making and patient management. A consensus should be achieved in the scientific community on these issues to assure better utilization of laboratory data and, ultimately, improved clinical outcomes.     

Designing an integrated extracorporeal therapy service quality system.

Reorganization in clinical operations of a national service provider organization, Fresenius Medical Care Extracorporeal Alliance (FMC-EA), provided the opportunity to overhaul and integrate quality systems. Under the new structure, the management of acute dialysis, apheresis, open-heart perfusion, and intraoperative autotransfusion services were combined into an integrated service portfolio supported by a multidisciplinary team of nurses, perfusionists, and technicians. This communication is intended to be a concise review of the literature that establishes the foundation for the new quality system as well as a discussion of the five clinical policies and clinical procedure guidelines that govern clinical behavior in mobile, point of care, acute extracorporeal therapy services. The clinical policy standards are based on recognized essentials and guidelines published by professional organizations, federal and state government agencies, and accreditation groups. The standards list the essential behaviors that clinicians should exhibit during the provision of extracorporeal therapy procedures such as acute therapeutic apheresis. Compliance with the redesigned procedure guidelines and policies will provide the clinical practice platform for continuous quality improvement (CQI) activities, benchmarking, and self-improvement. These practices can lead to improvements in the quality of care, a decrease in medical errors, and a reduction in overall health care costs.     

Appropriateness in programs for continuous quality improvement in clinical laboratories

BACKGROUND: External reviews and the accreditation of medical laboratories involve more than the mere assessment of conformance with standards for organisational processes. The new approaches to quality improvement suggest that, rather than using inspection to correct unusual errors, there should be more emphasis on improving the processes of health care to ensure that desired outcomes are produced. Appropriateness plays a key role in programs for quality improvement. METHODS: Appropriateness in laboratory medicine can be assessed, and improved, through the governance of the entire testing process. This begins with test selection, proceeds through valuable pre-, intra- and post-analytical procedures, and concludes by assuring the correct interpretation and utilization of laboratory information. RESULTS: The International Standard, specifically developed for medical laboratories (ISO 15189) recognizes the value of appropriate interpretation and advisory services, although it does not specify requirements for assessing appropriateness, requesting tests and interpreting results. The effectiveness of clinical laboratories can be assessed by using surrogate markers, which indicate physicians' satisfaction, and clinical audits. Effectiveness is also enhanced by stressing the importance of the technical and professional competence of evaluators. CONCLUSIONS: Inappropriate laboratory utilization unjustifiably increases health care costs, can harm patients and perpetuates the vision of laboratory testing as a commodity. Improvement in laboratory appropriateness can be achieved by seeking a better relationship with physicians and by stressing the role of laboratory specialists in providing clinical advice for the selection of laboratory tests, and the interpretation and utilization of their results, thus leading to more satisfactory clinical outcomes.