The College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves. Received: 8 August 2002 Accepted: 10 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to A. Rabinovitch     

Lessons from the first international proficiency test for the detection of spores from the honey bee pathogen Paenibacillus larvae

We report on the first proficiency test in the context of honey bee disease testing on a broad international scale. Honey samples were distributed to 12 participating laboratories for isolation and identification of spores of the etiological agent of American foulbrood, Paenibacillus larvae. Of the 11 laboratories responding to this proficiency testing event, only 6 (54%) provided data that were in full agreement with the previously determined status of the honey samples; eight (72%) laboratories fell within the threshold for qualification as defined a priori in this proficiency test (=level of agreement of at least 90%). Some lessons can now be drawn from the organizational point of view and will certainly improve new initiatives to be taken.     

External proficiency testing exercises on human leukocyte antigen typing in Italy between 1998 and 2002

External proficiency testing exercises are essential tools for measuring the quality of different kinds of performances related to health care and to ensure that they are uniform throughout a region. For many years, the Italian National Transplant Centre and the Italian National Institute of Health have been organizing external proficiency testing exercises for serological and genomic human leukocyte antigen (HLA) typing, following the rules of the European Federation of Immunogenetics. This society provides accreditation for immunogenetical tests to those European countries which want to collaborate on programmes on solid organ and bone marrow transplantation. The results of the Italian external proficiency testing exercises are very satisfactory because of the progressive improvement of the quality of HLA typing seen in Italian laboratories between 1998 and 2002. The attained outcome will certainly guarantee a more reliable service in clinical practice, and will contribute to the process of approaching the highest quality in health care.     

Evaluation of the long-term performance of water-analyzing laboratories

After 7 years of successful operation, the database of the proficiency testing (PT) scheme for water analysis organized by the Institute for Agrobiotechnology (IFA), Tulln contains nearly 4,000 data sets from over 300 interlaboratory comparison samples. About 70 analytical parameters (major ions, metals, trace ions, herbicides, volatile halogenated hydrocarbons, organochlorine pesticides and polycyclic aromatic hydrocarbons) were covered by the PT scheme. The data were evaluated using robust statistics in order to determine a set of coefficients of variation (CV) for each analytical parameter. Concentration and time dependence of the CV were checked. The CV were combined to obtain standard deviations for proficiency assessment (Z-score criteria). Furthermore, a viewer program was designed to facilitate monitoring of the analytical performance of participating laboratories.     

Accreditation for United States environmental laboratories

 There is currently no national program for recognition of United States environmental laboratories. This situation should change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency test samples, and meet specified quality assurance standards.     

French laboratory proficiency testing program for food microbiology

The proficiency testing program in food microbiology (Réseau d'Analyses et d'Echanges en Microbiologie des Aliments; RAEMA), created in 1988, currently includes 440 participating laboratories. The program establishes proficiency in detection of Salmonella and Listeria monocytogenes, as well as quantitation of aerobic microorganisms, Enterobacteriaceae, coliforms, Escherichia coli, Clostridium perfringens, coagulase-positive Staphylococcus, and Listeria monocytogenes. Twice a year, 5 test samples are sent to participants to assess their precision and trueness for enumeration and detection of microorganisms. Results show an increasing involvement of food microbiology laboratories in quality assurance programs and use of standard and validated analytical methods. However, the percentage of laboratories obtaining questionable and unsatisfactory microbiological results remains relatively constant.     

Proficiency testing schemes for therapeutics and toxicology

 This report addresses the proposition: current proficiency testing (PT) schemes for therapeutics and toxicology can easily engender complacency. The proposition was based on the premise that there are substantial between-laboratory differences and objectives in the supply of services for the measurement of drugs, as a result of which it is difficult to design PT schemes which adequately cover the requirements of all laboratories. Thus, acceptable performance in a PT scheme may lead participants to consider that they have tested their procedures more rigorously than is the case. Four areas, validity of the PT scheme, PT material, frequency of testing and acceptance criteria are examined. Received: 15 April 2000 · Accepted: 15 April 2000     

Bias analysis of proficiency testing programme results

A proficiency testing programme might involve a great number of participating laboratories coming from different countries or regions, and normally they analysed the same test materials using their own routine analytical methods. Hence, the results of a proficiency testing programme may contain valuable information which could serve purposes other than just performance evaluation. This study attempted to extract information from the results of a proficiency testing programme for the purposes of educating the participating laboratories as suggested by ISO/IEC 17043. The “bias analysis” approach introduced in this study was based on the statistical model of measurement and the nature of bias in chemical analysis. With this approach, the participating laboratories could estimate the bias associated with different settings of experimental conditions according to the statistics of subset distribution of the reported results from the participating laboratories. This would be useful for them to review the analytical procedures they used and modify their methods if needed. The approach was applied to the analysis of data obtained from a number of past proficiency testing programmes, and the findings were discussed in this paper.     

Application of a new AMIQAS computer program for integrated quality control, method evaluation and proficiency testing

Summary The computer program AMI - Quality Assessment Scheme (AMIQAS) was designed to give easy statistical management of analytical data in relation to method evaluation, internal quality control and proficiency testing. The program is designed in accordance with the recommendation of the ISO 5725 guideline and other official recommendations. The program consists of a database, test for outliers, statistics and graphs for evaluation of an analytical method for chemical, biological and environmental analysis, different control charts to be used in day-to-day internal quality control (Shewhart charts and z-charts). Finally the program has facilities to perform proficiency testing (also called external quality control) and produce the relevant evaluation reports for the documentation of method performance and quality control of results of measurements. The present paper demonstrates the applicability of the AMIQAS program for integrated method evaluation, internal quality control and proficiency testing using the determination of the concentration of lead in human whole blood as the numerical example.     

Proficiency testing programmes as a tool in food quality assurance: Overview of Italian experiences

Proficiency testing involves the performance of test procedures on routine samples by a number of laboratories. Interlaboratory proficiency testings provide multiple benefits to participants since they play a key-role in the total quality control of laboratory activities. They serve as a means of self-improving, as a mechanism of continuing education and as a source of information for accreditation agencies. This review highlights basic principles, benefits, criteria and capabilities of a proficiency testing programme for food analysis laboratories as well as their role in the implementation of rapidly developing food control legislation.     

Quality issues in proficiency testing

 Proficiency testing is a means of assessing the ability of laboratories to competently perform specific tests and/or measurements. It supplements a laboratory's own internal quality control procedure by providing an additional external audit of their testing capability and provides laboratories with a sound basis for continuous improvement. It is also a means towards achieving comparability of measurement between laboratories. Participation is one of the few ways in which a laboratory can compare its performance with that of other laboratories. Good performance in proficiency testing schemes provides independent evidence and hence reassurance to the laboratory and its clients that its procedures, test methods and other laboratory operations are under control. For test results to have any credibility, they must be traceable to a standard of measurement, preferably in terms of SI units, and must be accompanied by a statement of uncertainty. Analytical chemists are coming to realise that this is just as true in their field as it is for physical measurements, and applies equally to proficiency testing results and laboratory test reports. Recent approaches toward ensuring the quality and comparability of proficiency testing schemes and the means of evaluating proficiency test results are described. These have led to the drafting of guidelines and subsequently to the development of international requirements for the competence of scheme providers. Received: 2 January 1999 · Accepted: 7 April 1999     

纺织品中4-氨基偶氮苯的测定能力验证分析

“P00012-2011-T07纺织品中禁用偶氮染料的测定(测试项目:4-氨基偶氮苯)”能力验证严格按照能力验证计划运作要求实施,并采用稳健统计法对测试结果进行统计,测试样品指定值为54.8 mg/kg,标准化四分位距(NIQR)为6.8941 mg/kg.共有12个省市、自治区的61家实验室参加本次能力验证,采用Z比分数对各实验室结果进行评价,结果满意率为86.9％.     

The organization of proficiency testing in plant pathology (qualitative methods of analysis) according to the ISO/IEC 17043: example of the French national reference laboratory

The use of methods of analysis capable of producing reliable analytical results is a prerequisite to the effective control of quarantine plant pathogens. Proficiency testing is considered to be one of the most reliable ways to verify and coordinate analytical results. As a French national reference laboratory in plant pathology, the Anses Plant Health Laboratory organizes proficiency tests in order to ensure that officially approved laboratories (certified by government services) are capable of producing reliable analytical results for the detection of plant pathogens. Proficiency tests in plant pathology have a number of notable features including the processing of qualitative results. This paper presents the experience of the Anses Plant Health Laboratory’s Unit for Tropical Pests and Diseases (LSV-RAPT) as an organizer of proficiency tests in plant pathology. The LSV-RAPT has gained recognition for the methodology it has developed in the form of accreditation as a proficiency testing provider according to the ISO/IEC 17043. The methodology can be applied to many other disciplines that use qualitative detection methods.     

Practical uses of proficiency testing as valuable tools for validation and performance assessment in environmental analysis

Besides their role as an external quality control tool, PT results or samples could be used as an alternative to fulfil some of the quality assurance requirements such as analytical precision, uncertainty assessment, and internal quality control. This additional use of proficiency testing could help laboratories to reduce the financial impact of their quality assurance process. The purpose of this paper is to highlight some practical uses of PT results or samples in the environmental analytical field, which have been implemented at ISSeP (Institut Scientifique de Service Public), either for method validation or for internal quality control.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia     

The American (USA) perspective six years after implementation of CLIA'88 (Federal) regulations

 On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement (CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process. Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992. Received: 5 October 1998 · Accepted: 20 October 1998     

The determination of adsorbable organically bound halogens (AOX) in soil: interlaboratory comparisons and reference materials

The interlaboratory variability in the quantification of adsorbable organically bound halogens (AOX) in industrially contaminated soil is presented. Three consecutive rounds of a proficiency testing scheme, in which between 88 and 119 routine laboratories participated, yielded relative reproducibility standard deviations between 7 and 20% at AOX contents between 10.9 and 268 mg kg⁻¹. Nineteen laboratories with established proficiency were invited to participate in the certification of the AOX content in three soil reference materials meant for the internal quality control in analytical laboratories. The certified values are (1349 ± 59) mg kg⁻¹, (80 ± 7) mg kg⁻¹ and (102 ± 8) mg kg⁻¹, respectively.     

水中易释放氰化物能力验证样品的研制及应用

根据国家地表水环境质量监测网监测任务要求和环境监测的实际需要,制备了水中易释放氰化物能力验证样品。通过均匀性、稳定性检验以及量值一致性评价,研制的样品均匀性良好,在3℃~6℃冷藏避光保存条件下1年内稳定,样品配制值与多家实验室协作测定结果一致。探讨了样品在能力验证活动中的应用,共有来自全国11个省的32家实验室参加了水中易释放氰化物的能力验证计划,实验室满意率在80%以上,实验室结果出现有问题或不满意主要是由于样品前处理以及检测过程质量控制不当导致的。经检测及实验室反馈的数据验证,该能力验证样品能够应用于能力验证活动。     

玩具油漆涂层中有机锡检测能力验证样品研制及应用分析

制备了用于可迁移有机锡检测能力验证的玩具油漆涂层样品,并开展了相关测定能力验证计划,采用迭代法、四分位法和敏感分析法3种不同统计方法对23家实验室数据进行统计分析,并对不满意结果的原因进行了分析。结果表明所研制样品的均匀性和稳定性良好,能满足能力验证要求。不同统计方法对实验室能力评定结果存在差异,但指定值差异很小,而能力评定标准差差异较大,运用卡方检验能选择出更合理的统计方法。     

氧指数检测能力验证结果分析

为了解氧指数检测实验室的能力水平,中国合格评定国家认可委员会(CNAS)开展了"塑料燃烧性能试验(氧指数法)"能力验证计划。通过对氧指数能力验证计划的结果进行统计分析,评价了氧指数检测实验室的整体水平,指出了氧指数检测实验室普遍存在的几类问题并提出了相应的建议。     

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