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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.6, #4-5)

CEN – Regional agreements (pp. B195-B195).
Bridging cultural gaps in quality assurance by U. Örnemark; Nick Boley; Jean-Claude Libeer (pp. 138-139).

Proficiency testing in analytical chemistry, microbiology, and laboratory medicine – working group discussions on current status, problems, and future directions by U. Örnemark; Nick Boley; Khalid Saeed; Petronella M. van Berkel; Rainer Schmidt; Michael Noble; Irma Mäkinen; Mauri Keinänen; Adam Uldall; Heidi Steensland; Adriaan Van der Veen; Daniel W. Tholen; Manfred Golze; Jytte Molin Christensen; Paul De Bièvre; E. W. B. De Leer (pp. 140-146).
Working group (WG) discussions on proficiency testing (PT) held at the joint Eurachem/ EQALM workshop, Borås, Sweden, 24–26 September 2000 are summarized. The discussions focused on aspects of PT and accreditation (WG 1), general aspects of PT in analytical chemistry (WG 2), microbiology (WG 3), and laboratory medicine (WG 4), incorporation of measurement uncertainty into PT schemes (WG 5), international harmonization of PT schemes (WG 6), and the role of PT in the international structure of chemical measurement (WG 7). Current status, problems and future directions are identified. Each WG contained a majority of participants experienced in the subject being covered by that WG, and a few participants with different expertise. This was done to promote cross-fertilization of ideas between sectors, a key objective of the workshop. The WG issues reflected the content of the keynote lectures and some issues were covered from different perspectives by more than one group.

Keywords: Keywords Accreditation; External quality assessment; International harmonization; Proficiency testing; Uncertainty


An error model for evaluation and interpretation of proficiency testing by Göran Nilsson (pp. 147-150).
Data from proficiency testing can be used to increase our knowledge of the performance of populations of laboratories, individual laboratories and different measurement methods. To support the evaluation and interpretation of results from proficiency testing an error model containing different random and systematic components is presented. From a single round of a proficiency testing scheme the total variation in a population of laboratories can be estimated. With results from several rounds the random variation can be separated into a laboratory and time component and for individual laboratories it is then also possible to evaluate stability and bias in relation to the population mean. By comparing results from laboratories using different methods systematic differences between methods may be indicated. By using results from several rounds a systematic difference can be partitioned into two components: a common systematic difference, possibly depending on the level, and a sample-specific component. It is essential to distinguish between these two components as the former may be eliminated by a correction while the latter must be treated as a random component in the evaluation of uncertainty.

Keywords: Keywords Proficiency testing; Error models; Measurement uncertainty; Precision; Systematic errors


External quality assurance programmes in medical laboratories by Jean-Claude Libeer (pp. 151-153).
 Medical laboratories have a long tradition of external quality assessment. Starting from pure quality control of laboratory performances, most schemes have evolved to a powerful tool for improving quality of clinical outcome of results. External quality assurance in medical laboratories not only includes laboratory performance evaluation, but also evaluation of method performance, post-marked vigilance, training and help. In the future, the quality of programmes must further be improved by accreditation of schemes and by using electronic data interchange.

Keywords: Keywords Medical laboratories; External quality assurance


Microbiological proficiency testing: a personal perspective by Keith Jewell (pp. 154-159).
The author considers the fundamental differences between analyses in microbiology and those in chemistry and physics, deducing special issues for microbiological proficiency testing. He concludes that the variability and uncertainty implicit in microbiological analysis requires a broader range of proficiency scheme providers providing a broader range of services than in chemistry and physics.

Keywords: Keywords Microbiological proficiency testing; Uncertainty


Uncertainty evaluation in proficiency testing: state-of-the-art, challenges, and perspectives by Adriaan M. H. van der Veen (pp. 160-163).
The evaluation of measurement uncertainty, and that of uncertainty statements of participating laboratories will be a challenge to be met in the coming years. The publication of ISO 17025 has led to the situation that testing laboratories should, to a certain extent, meet the same requirements regarding measurement uncertainty and traceability. As a consequence, proficiency test organizers should deal with the issues measurement uncertainty and traceability as well. Two common statistical models used in proficiency testing are revisited to explore the options to include the evaluation of the measurement uncertainty of the PTRV (proficiency test reference value). Furthermore, the use of this PTRV and its uncertainty estimate for assessing the uncertainty statements of the participants for the two models will be discussed. It is concluded that in analogy to Key Comparisons it is feasible to implement proficiency tests in such a way, that the new requirements can be met.

Keywords: Keywords Proficiency testing; Measurement uncertainty; Reference value; Consensus value; Assessment of laboratories


Economy of proficiency testing: reference versus consensus values by A. Baldan; Adriaan M. H. van der Veen; Daniela Prauß; Angelika Recknagel; N. Boley; Steve Evans; Derek Woods (pp. 164-167).
Many proficiency tests are operated with a consensus value derived from the participants’ results. Apart from technical issues, one of the reasons often mentioned is that proficiency tests operated with consensus values would be cheaper than those using reference values obtained from a priori characterisation measurements. The economy of a proficiency test must of course be balanced by the need of the participants, and the quality of the comparison in general. The proficiency tests selected in this study had both a reference value and a consensus value, one of which was used for assessing the performance of the participating laboratories. In this work, both a technical and an economical assessment of how the comparisons were operated is made. From the evaluation, it follows that usually the use of consensus values does not necessarily reduce the costs of a proficiency test. However, frequently it may be observed that the quality of the assessment of the laboratories is better with a reference value.

Keywords: Keywords Proficiency testing; Economy; Assigned values; Food; Environmental analysis; Mechanical testing


Anti-HIV quality assurance programs in Australia and the southeast Asian and Western Pacific regions by A. Gust; Sandy Walker; Roderick J. Chappel; Elizabeth M. Dax (pp. 168-172).
Anti-HIV testing is the most regulated area of laboratory medicine in Australia. These regulations have placed the National Sero-logy Reference Laboratory, Australia (NRL) in a unique position to implement a comprehensive quality assurance (QA) program for HIV testing. The elements of our QA program include pre-market evaluation of assays, external quality assessment schemes (EQAS), quality control, specificity monitoring, consultations, and training workshops. The results of the NRL EQAS for Australian laboratories were compared with those of a program developed by the NRL for reference laboratories in the Southeast Asian and Western Pacific (SEAWP) regions. For laboratories authorized to use tests for HIV in Australia, participation in the entire QA program is mandatory, whereas the SEAWP EQAS program is voluntary. While the overall percentage of discrepant results for these programs are similar, the percentage of false negatives, variation in laboratory results, and choice of assay differ. These differences have decreased with time with improvements in assays and laboratory testing practices. The educational component of both EQAS, which comprises workshops, laboratory questionnaires, consultancies, and newsletters, has had a critical impact on the testing practices of laboratories.

Keywords: Keywords Australia; Asia-Pacific; Anti-HIV; Quality assurance; External quality assessment scheme


Determination of hydrocarbons in water – interlaboratory method validation before routine monitoring by P. Woitke; Reinhard Kreßner; Peter Lepom (pp. 173-177).
The clarification of hydrocarbon input into the Baltic sea via rivers is one of the priority issues of the 4th Pollution Load Compilation (PLC-4) within the framework of international Baltic Sea marine monitoring. An interlaboratory comparison was conducted to check the applicability of a new method for the determination of hydrocarbons by solvent extraction and gas chromatography. Surrogate oil solutions with known hydrocarbon content were distributed among the participants for preparation of water samples of different hydrocarbon concentration. In using these concentrations as assigned values and by setting target values for precision, the proficiency of participating laboratories could be tested as a qualifying step before involvement in PLC-4 routine monitoring. The results of the exercise indicate that hydrocarbons in water samples can be monitored as a mandatory test item within the framework of PLC-4.

Keywords: Keywords Hydrocarbons; Mineral oils; Water monitoring; Quality assurance; Interlaboratory comparison


Experience with in-house PT-schemes in the chemical industry by Rainer A. Schmidt (pp. 178-180).
There are many different means of demonstrating the quality of performance of an analytical laboratory. Proficiency testing (PT) is just one! As in other analytical fields, interlaboratory comparisons play an important role in the chemical industry. Collaborative trials or method performance studies do have a long tradition in this field. Sometimes they were designed as laboratory performance studies with the clear aim of making analytical results comparable, e.g. petrol, coal, gas, noble metals analyses – not to mention the biggest PT scheme run on a daily world-wide basis – trade itself. All this is an ongoing process, which started long before the idea of assessing and accrediting the performance of analytical laboratories was born. However, when striving for accreditation in 1996, the analytical production laboratories of the Chemicals Business Unit of the Bayer AG in Germany implemented another facet of PT schemes. In-house-PT schemes are performed regularly and turned out to be useful in evaluating, monitoring, and thus improving, the quality of routine analytical work.

Keywords: Keywords Proficiency testing; Analytical measurements; Comparability


Definition of assigned values for proficiency tests in water analysis by M. Koch; Jörg W. Metzger (pp. 181-185).
The definition of an assigned value is usually achieved by calculating mean values from the data (with different methods) or by designating reference laboratories. Neither method is completely satisfactory. In this paper a new method is presented for the definition of the assigned value for spiked samples with an unknown content of the analyte in the matrix. The method consists of two parts. The first is the estimation of the assigned values from the spiked amounts and the content in the matrix, based on the results of reference laboratories. The other is the designation of these reference laboratories by comparing their results with the assigned values. Because each of these parts requires the other, an iterative procedure is necessary. As an example, the results of a proficiency test for the analysis of copper in wastewater are used to compare the calculated values with those from other methods, e.g., the Huber estimation.

Keywords: Keywords Assigned value; Proficiency testing; Water analysis


Environmental analysis in the Czech Republic: organisation of proficiency testing and its use in laboratory assessment by Eva Klokočníková; Alena Nižnanská; I. Koruna (pp. 186-189).
The history, origin, and development of a system for monitoring and assessing water and other environmental laboratories in the Czech Republic is described. The system started in 1991 and has matured to its present complexity with similarities to the accreditation systems found in other countries. Differences from internationally recognized procedures are being corrected step by step. During the first year of its existence ASLAB, as part of its brief, organised proficiency testing (PT) programs for fifty laboratories. Today the total number of regularly participating laboratories exceeds 700 from the Czech Republic, the Slovak Republic, and Germany. This paper describes the ASLAB PT system, discusses some experiences with its use, and describes the use of PT results in assessment of the competence of laboratories.

Keywords: Keywords Accreditation; Proficiency testing scheme; Czech Republic; ASLAB


Proficiency testing as tool for ISO 17025 implementation in National Public Health Laboratory: a mean for improving efficiency by Zeev Dveyrin; Hilla Ben-David; Abraham Mates (pp. 190-194).
Public Health Laboratories (PHL) as part of Public Health Services are involved in law enforcement and ensuring food and water quality. The laboratories had to go through an organizational and monetary change imposed by the growing and changing needs of the state of Israel. The laboratories had to become more modern and to implement new and more sophisticated testing methods. Another requirement was to perform a steadily increasing number of tests and to be more flexible towards customers’ demands. Yet, the budget was not changed accordingly, as the Public Service to which the laboratories belong to do not respond to changing needs. Management realization was that the accreditation process could be used as a tool to achieve organizational and cultural change. Understanding and transformation were required throughout the organization, including management. Proficiency testing is performed for all testing methods in all areas even for non-accredited tests such as clinical tests. Proficiency testing was used as a tool for organizational culture change. It is a great index with game elements, that gives employees and managers the possibility for comparison, fixing problems and corrective action. The demands of ISO 17025 made it necessary to change peoples’ attitudes and views on both professional and communication levels. Laboratory quality consists now on the four main principles, described in the 5M&E model which is typical to small organizations and which ensures a constantly improving system: ”Policy statement”, ”Machine”, ”Material”, ”Measurement”, ”Method”, ”Manpower”, and ”Environment” targeted to achieve ”Quality upgrade”. Slowly we succeeded in providing better and more reliable services and have increased our income on what would hopefully become our way to financial independence. We hope this process would provide the Ministry of Health with a better chance to public health using the same financial sources.

Keywords: Keywords Proficiency testing; ISO 17025; Public health; Accreditation; Microbiology


Information system and qualifying criteria for proficiency testing schemes by Manfred Golze (pp. 199-202).
Since October 1998 the European Commission has financed a concerted action on Information System and Qualifying Criteria for Proficiency Testing Schemes within the 4th framework program. As a major result of this project EPTIS, the European Information System on Proficiency Testing Schemes which is available on the Internet since March 2000, is presented in this paper. Today EPTIS contains comprehensive information on approximately 640 proficiency testing schemes from 16 European countries providing information on the state of the art in proficiency testing in Europe. Finally some possible approaches for interlinkages and recognition of proficiency testing schemes are discussed.

Keywords: Keywords Proficiency testing; EPTIS; Quality characteristics; Accreditation

Accreditation of providers of proficiency testing schemes by Maree Stuart; Alan Squirrell (pp. 203-205).

Interlinkages and recognition of proficiency-testing schemes by Nick Boley; Adriaan van der Veen; Andreas Müller; Angelika Recknagel; Bernd Steffen; M. Golze (pp. 205-207).
 Because proficiency testing (PT) is increasingly used for the accreditation of testing laboratories and as a tool for backing up existing multilateral recognition arrangements between accreditation bodies, the question of performance and comparability of the proficiency-test providers arises. In this paper different approaches to assess the equivalence of European PT schemes and the competence of their providers are presented. As a first step a workshop is proposed to agree on a pilot study. The final aim is to create confidence in the existing PT schemes in Europe and to use them as common European tools.

Keywords: Keywords Proficiency testing; Accreditation; Multilateral recognition arrangement


Proficiency testing in occupational and environmental health – Current practice and international initiatives for harmonisation by J. M. Christensen; Kirsten Byrialsen (pp. 207-210).
An increasing number of proficiency testing schemes (PT schemes) related to occupational and environmental health have been organised. Most schemes emphasise the importance of the validation of analytical results. With regards to harmonisation of the schemes, there are many differences between the schemes at many levels. These include factors concerning their relationship with legislation, national status, type and quality of proficiency testing material, analytical range and priorities for future development. Since differences between PT schemes have been recognised at the European level by organisers of PT schemes and external quality assessment schemes (EQASs) it seems appropriate to reinforce collaboration between scheme organisers in order to improve the quality of analytical performance in occupational and environmental health.

Keywords: Keywords Proficiency testing; External quality assessment scheme; Occupational health; Environmental health; Harmonisation


Accreditation of proficiency-testing schemes in The Netherlands by Petronella Mathilda van Berkel (pp. 210-213).
Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.

Keywords: Keywords Proficiency testing; Accreditation; Guide lines; Quality aspects; State of the art


The sixth meeting of CCQM, April 2000 by R. I. Wielgosz (pp. 213-214).
A report is given of the sixth meeting of the Consultative Committee on Amount of Substance (CCQM). The CCQM has been active since 1993. It is the committee, established by the Comite International des Poids et Mesures, which is responsible for issues regarding metrology in chemistry. It has four established working groups in the fields of organic analysis, inorganic analysis, gas analysis and electrochemical analysis. A further twoad hoc working groups in the fields of surface analysis and metrology in biotechnology were established during the meeting. The working groups are involved in the identification, development and execution of a series of key comparisons, which will establish the technical basis for the mutual recognition of measurement capabilities among the National Measurement Institutes. 17 key comparisons are currently planned for the period 1999–2002, with 29 other international comparisons planned for the same period.

Keywords: Keywords CCQM; Metrology in chemistry; Key comparisons
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