能力验证及其评价

The definitions, purposes and uses of proficiency testing and interlaboratory comparison were expounded in detail. Main types of proficiency testing were illustrated. Special emphases were made on the organization, practice and evaluation of the planning of proficiency testing. Related policies about proficiency testing given by the China National Accreditation Board for Laboratories （CNAL） were also briefly introduced.     

北京中实国金国际实验室能力验证研究有限公司

<正>北京中实国金国际实验室能力验证研究有限公司成立于2002年,是专业从事国际实验室能力验证、测量审核服务的研究中心。中实国金于2004年1月首次通过中国合格评定国家认可委员会的认可(No.CNAS PT0002),是国内具有能力验证提供者资格的第三方独立法人机构。     

Bootstrap方法在能力验证统计分析中的应用北大核心CSCD

由于经济全球化和高科技迅猛发展的需要,我国许多实验室已通过了中国合格评定国家认可委员会（CNAS）的认可,还有许多实验室正在准备认可。在实验室认可活动中利用实验室间比对的能力验证活动是一项非常重要的内容,它受到国际实验室认可合作组织及世界各国实验室认可组织的高度重视。能力验证是利用实验室间的比对来判定实验室和检查机构能力的活动[1-2],     

利用实验室间国际比对验证15N丰度的测定能力

参加了由FAO／IAEA组合的全氮和^15N丰度检测能力验证的实验室国际间的比对两年的比对结果表明,我们实验室对3个植株样品全氮和^15N丰度的测定值与指定值十分吻合,检测结果准确,此项计划的实施,证明了本实验室的检测能力和国际实验室间的水平。     

云南省质检中心在国际实验室能力验证中取得优异成绩

不久前,英国FAPAS组织了可口可乐饮料国际实验室间的能力验证,云南省产品质量监督检验中心（国家热带农副产品质量监督检验中心）参加了4项参数,Z值在-0．1～0．2之间（｜Z｜〈2为满意结果）,全部为满意结果,成绩优异,此次能力验证结果从一个侧面证明了本中心的检测能力和技术水平已达到国际先进水平。     

国际实验室间转基因产品检测能力验证的研究

以转基因大豆为例，介绍开展APLAC T034国际间实验室转基因检测能力验证的项目。对于样品量值(添加值)的设定进行试验，对样品的均匀性和稳定性进行检验，并对参试实验室的测试结果进行系统的评价和分析。影响转基因产品测试结果的关键因素是检测方法、基因组DNA提取的质量、PCR反应体系中模板DNA的加入量．以及是否使用标准物质作为质控对照和使用定量标准物质求出相关系数对定量检测结果进行校正。     

茶叶中甲氰菊酯测定能力验证中结果评价方式的选择

实施茶叶中甲氰菊酯测定能力验证计划,对不同的结果评价方式进行对比。制备含甲氰菊酯的茶叶样品,经均匀性和稳定性考察合格后用于能力验证。以专家实验室结果平均值作为指定值,由再现性标准差和重复性标准差求计算出能力评定标准差,评价参加者能力。用稳健算法、经验模型法确定统计评价量,与本法测定结果进行比对。结果显示,5家专家实验室提供了呈现正态分布且等精度的结果,评价结果的满意率为88.7%。与其它评定方式相比,本法给出的满意结果区间较为严格,能够反映检验机构应达到的检测水平。     

2011年宝山钢铁股份有限公司开展的能力验证项目计划

<正>宝山钢铁股份有限公司分析测试研究中心是最早获得中国合格评定国家认可委员会(简称CNAS)认可的能力验证计划提供者之一(认可代码:No.P003),获准认可的能力范围包括:钢铁/铁矿石/耐火材料化学成分分析、金属材料力学性能检测、金属及矿物微束分析等。根据认可规则,CNAS承认本     

水杨酸片溶出度测定测量审核结果分析与常见问题探讨

通过对2015—2020年开展的水杨酸片溶出度测定测量审核工作的回顾和梳理,阐述了水杨酸片溶出度测量审核工作的实施模式,分析了可能影响溶出度测定结果的因素,并就参与实验室存在的问题和相关的改进措施进行了探讨。水杨酸片溶出度测定测量审核是相关实验室提升溶出度测定检测能力的一种有效方法,在加强组织方质量管理体系的改进和建设方面也有积极的促进作用。     

Proficiency testing and external quality assurance: crossing borders and disciplines

Proficiency testing and external quality assurance of medical laboratories is now entering its sixth decade. These activities comprise a broad range of applications including: providing participants and public health authorities with estimates of measurement uncertainty and national infrastructure; providing education; provision of a practical basis for accreditation and regulatory compliance. All branches of medical laboratory science have employed external quality assurance as a basis for improvement and comparability. The opportunities and challenges reviewed here include: the proper establishment of multiple target values in comparison to a system of traceability to reference or definitive methods; the problems of matrix effects and commutability of patient and proficiency test samples; generating information on laboratory infrastructure and trends in analytical technique and performance; providing education and setting goals for laboratory improvement; problems of specimen distribution; application of Internet technology; the role of programs in legal mandates and accreditation. Received: 24 April 2002 Accepted: 11 July 2002     

EAL interlaboratory comparison Wa1 – Testing of potable water

 The accreditation of laboratories has emphasized the use of interlaboratory comparisons as a tool to monitor the comparability and accuracy of results laboratories produce. An interlaboratory comparison for water laboratories was organized among European Cooperation for Accreditation (EA) member countries; 30 laboratories, 7 of which were not accredited, from 14 European countries participated in this intercomparison. All the laboratories were chosen by the appropriate national accreditation bodies, with the instruction to select as participants those laboratories which act as national reference laboratories in this field. About 90% of the data collected was considered satisfactory after statistical treatment. Non-accredited laboratories performed as well as accredited laboratories. The laboratories were asked to take corrective action and report the corrections to the accreditation bodies. A great variation in the reported uncertainties of the results was observed. There seems to be a need to organize EA interlaboratory comparisons for national reference laboratories analysing water. It is obvious that even reference laboratories need training in how to estimate the uncertainty of results. Received: 22 July 1998 · Accepted: 21 September 1998     

Improvements in performance in medical diagnostics tests documented by interlaboratory comparison programs

There is evidence to support the notion that interlaboratory comparisons (ILCs) are an effective tool for laboratory improvement. However, despite widespread experience and anecdotal evidence of improvements there are few published studies demonstrating any benefits from ILCs– in any field of testing. Published demonstrations of benefits can help justify the growing use of ILCs. ILCs and proficiency testing have been common for many years in medical laboratories; there has been open information on the results of ILCs, and there has been standardization of results from thousands of laboratories. These studies show general improvement over time in several areas of testing in different countries. Many articles cite specific reasons for the improvements, either proven or supposed. An early version of this paper was presented at the International Laboratory Accreditation Cooperation Conference ”ILAC 2000” in Washington D.C., on 31October, 2000. Received: 10 February 2001 Accepted: 21 January 2002     

The WADA Proficiency Testing Program as an integral part of the fight against doping in sport

This article provides a brief perspective of the World Anti-Doping Agency (WADA) in the context of the fight against doping in sport and of the WADA Proficiency Testing Program as an essential element of the World Anti-Doping Program. The WADA Proficiency Testing Program exists within the framework of the WADA-accredited laboratories and is aimed at improving the effectiveness of the fight against doping by testing the ability of the laboratories to reliably identify and measure the substances and methods defined in the WADA Prohibited List. The paper provides an overview of the WADA Proficiency Testing scheme with respect to organization, test composition and evaluation of anti-doping methods and techniques. Scientific research is mentioned in the context of WADA’s involvement in generating reference materials for improvement of analytical activities of the WADA-accredited laboratories. WADA’s funding of a reference material for 19-norandrosterone in human urine is illustrated as an example.     

ISO/IEC 17043: the new International Standard for proficiency testing

The revision of ISO/IEC Guide 43 is well underway by CASCO Working Group 28, with the author as Convener. The ballot on the committee draft was successfully completed in June 2008. The Working Group met in September to resolve the CD comments and to recommend that the document should advance as an ISO/IEC DIS. The document is in harmony with ISO/IEC 17025 (2005), ILAC G13 (2007), and the IUPAC Harmonized Protocol (2006) for proficiency testing. Major changes from Guide 43 include considerations for inspection bodies, requirements for metrological traceability of assigned values for calibration schemes, limitations on subcontracting, requirements for reporting the uncertainty of assigned values, and for including method information and technical commentary in scheme reports. Minor changes include requirements for equipment used in the manufacture and testing of proficiency test items, considerations for handling laboratories’ reported uncertainties, and the issuance of certificates of participation. These changes have not generated any substantial objections from the CASCO membership and liaisons.     

Statistical treatment of proficiency testing data

 There are three stages to evaluating a laboratory's results in an interlaboratory proficiency test: establishing the correct result for the test item, determining an evaluation statistic for the particular result, and establishing an acceptable range. There are a wide variety of procedures for accomplishing these three stages and a correspondingly wide variety of statistical techniques in use. Currently in North America the largest number of laboratory proficiency test programs are in the clinical laboratory field, followed by programs for environmental laboratories that test drinking water and waste water. Proficiency testing in both of these fields is under the jurisdiction of the federal government and other regulatory and accreditation agencies. Many of the statistical procedures are specified in the regulations, to assure comparability of different programs and a fair evaluation of performance. In this article statistical procedures recommended in International Organization for Standardization Guide 43, Part 1, are discussed and compared with current practices in North America. Received: 22 April 1998 · Accepted: 12 May 1998     

Approaching target uncertainty in proficiency testing schemes: experience in the field of water measurement

Good correspondence between evaluations of the proficiency testing data for water measurements according to different scoring schemes was found as a result of implementation of the measurement quality according to the target uncertainty defined in the Drinking Water Directive. The accuracy of the evaluation is determined by the uncertainty of the assigned value, and this uncertainty should be in correspondence with the target uncertainty. Modification of the zeta-score by the thorough application of the target uncertainty is presented. It is convenient for generalised presentation of the proficiency testing data. The allowed bias is included as a linear term on the measured value scale, as it is treated in uncertainty analysis. The importance of implementation of the target measurement uncertainty in other fields of the routine measurements is indicated.     

Proficiency testing schemes: solutions for homogeneity control

The organisation of the homogeneity control of samples prepared for proficiency testing schemes (PTS) is a challenge for the PTS organisers and engenders logistical and financial problems. Samples used in PTS need to be homogeneous in order to be sure that if a laboratory has a result different from the other laboratories, its error can be attributed to its analysis method and not to its sample. The present paper describes the solutions found by the Bureau Interprofessionnel dEtudes Analytiques (Bipea) in order to answer the homogeneity control requirement. The methodologies of homogeneity control are adapted to specific characteristics of the products proposed in Bipeas PTS. The first methodology of control, the preparation approach, concerns specific PTS where the samples are formulated and where the assigned values are known and chosen. The second methodology, the target approach, concerns mainly the field of the environment and implies the choice of homogeneity targets. The third methodology, the global approach, concerns the agricultural and agro-food fields and involves comparison of near-IR spectra samples. Each methodology of control has its advantages and disadvantage and is suited to specific products prepared with specific preparation procedures. It has to be stressed that the solutions developed answer quality requirements but are not a substitute for the use of adapted and detailed preparation procedures with validated and regularly checked devices and for the a posteriori control of the results of the laboratories.