Is accreditation useful for quality improvement?

 The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.     

Analysis of nonconforming work as a tool for status analysis and continuous improvement

Absract  The methodology for statistical processing of reports on nonconforming work and unexpected situations which occur in the laboratory of Gamma-Ray Spectrometry Group at the Jožef Stefan Institute is presented. The results of statistical analyses are discussed. Pareto analysis has shown that the majority of cases of nonconforming work originates in errors made by personnel. The sociological and psychological aspects of strategies aimed at preventing careless work are discussed. It is proposed that motivation should be used as a tool against habits that lessen awareness during routine operations. Specific recommendations regarding communication with personnel are given. Received: 20 July 2001 Accepted: 24 October 2001     

Plans for implementation of a quality system in the control laboratory of the Romanian National Medicines Agency

This paper describes the practical implementation of a quality system in the control laboratory of the National Medicines Agency, Romania, the main aim being the alignment of the requirements of the control of drugs in Romania with European Union standards. Activity in this field is relatively new in Romania, however, it is of great importance to Romania’s compliance with international standards. Received: 13 September 2000 Accepted: 19 February 2001     

Basic steps towards a self-sustainable quality system and laboratory accreditation

 Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories. Received: 5 June 1997 · Accepted: 7 December 1997     

The scope and limitations of a QA system in research

 The article analyses the scope and limitations of quality systems for research centres in the light of the problems involved, foreseen advantages, and growing need created in the context of the globalisation phenomenon. Some propositions are put forward concerning the development of possible quality assurance strategies for research activities. Received: 30 June 1999 / Accepted: 24 September 1999     

Controlling the quality of testing

 This article mainly focuses on the testing of products, materials, etc., but the general principles are applicable in a broader perspective. Quality of testing should be judged based on fitness for purpose. This judgement includes both objective and subjective elements. The possibility to make decisions and other professional judgements based on test results alone is discussed and compared with the decisions and judgements being made through the certification and inspection process. Quality, including the uncertainty of the test results, depends on many factors, and in order to make necessary improvements in the testing procedures based on the customers' needs, the right issues should be addressed. The question arises as to whether, in laboratories' quality systems and in the accreditation and certification process, attention is really paid to those factors that are crucial to obtaining reliable results.     

QASKI – the quality assurance system of the National Institute of Chemistry

 The quality assurance system (QASKI) developed and implemented in the National Institute of Chemistry is presented. It tries to eliminate the incompatibilies between the present methods of quality assurance used in research and development institutes such as good laboratory practice and accreditation. Since 1991, QASKI has been used for internal accreditation of laboratories located in the institute, regardless of the fact that some of them deal with routine analyses and others with research and development. Every laboratory that wishes to ensure the credibility of its research or routine work enters QASKI and at the same time chooses an external method of approval. All interested laboratories, study directors, principal investigators, internal auditing staff, heads of documentation, quality assurance unit staff, the Director of the institute and the Quality Management Board participate in the internal system.     

Quality assurance system for a decomposition method as demonstrated for the Wickbold combustion technique

 A five-step model for a quality assurance system is developed for an internal quality control check. It includes the quality control of the decomposition method and the detection method as steps belonging together. The Wickbold combustion technique as decomposition method in combination with atomic absorption spectrometry was chosen. The vaporization of the elements mercury, arsenic, lead, antimony and selenium is based on combustion in an oxyhydrogen flame. To check the efficiency of the analytical system, the uncertainty of results was calculated on the basis of the "Guide to the Expression of Uncertainty in Measurement". Received: 13 January 1997 · Accepted: 29 March 1997     

Keeping the spotlight on quality from a distance

 Maintaining the quality of testing in remote locations can be demanding of laboratory resources in terms of daily visits to instruments and providing support outside of normal working hours. Recently technology and software solutions have appeared to reduce this burden for laboratory scientists dramatically. The AVL Auto QC unit, in conjunction with OMNILink software, allow laboratory staff to perform many quality control and maintenance procedures on instruments in wards and medical units from a PC in the central laboratory. Assessment of this technology and software in the Special Baby Care Unit at Bradford Royal Infirmary has demonstrated many benefits including reduction in ward visits, better support out of hours, regular quality control checks, and improved analytical quality. Received: 15 April 2000 · Accepted: 15 April 2000     

Need for quality management in research and development

 There is growing interest in setting up a general concept for quality management and quality control in research and development, which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea for a quality management system in all fields of research and development and will probably initiate broad discussion on this delicate topic. Received: 28 June 1998 · Accepted: 13 July 1998     

The Russian system for accreditation of analytical laboratories (centers)

 The history and the present state of the national system for accreditation of analytical laboratories in Russia are described. Received: 1 September 1998 / Accepted: 1 September 1998     

The Italian way: Accreditation and continuous quality improvement in clinical laboratories

 The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.     

ISO compliant laboratory quality systems and incident monitoring improve the implementation of laboratory information systems

Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS) in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system; this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS. Received: 4 August 2001 Accepted: 21 March 2002     

Review of European Union requirements: quality standards for food analysis laboratories

 The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation, participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that official food control laboratories have in place the measures to ensure that consistently reliable data can be produced. Received: 29 November 1995 Accepted: 8 January 1996     

Global trends in quality specifications: a report from the Stockholm Conference

 In Stockholm a conference entitled: "Strategies to Set Global Quality Specifications in Laboratory Medicine" was held in April 1999. The primary aim in organizing the Conference was to provide a vehicle for reaching consensus on global quality specifications in laboratory medicine. This objective was achieved and a lively constructive debate, after the presentations were complete, led to agreement on the principles laid down in the Consensus Statement. The International Federation of Clinical Chemistry (IFCC), the International Union of Pure and Applied Chemistry (IUPAC) and the World Health Organization (WHO) kindly sponsored the Conference but it must be noted that the Consensus Statement reflects the views of the presenters and registrants who participated in the Conference and does not necessarily represent those of the sponsoring bodies. This paper reports on the standardization efforts so far, the Stockholm Consensus Conference, the ISO uncertainty concept and the consensus reality. A hierarchy of quality specifications in laboratory medicine was defined and agreed on. Received: 15 April 2000 · Accepted: 15 April 2000     

Information system and qualifying criteria for proficiency testing schemes

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.     

The practical advantages of hospital quality systems such as NIAZ/PACE

 The Netherlands Institute for Accreditation of Hospitals (NIAZ) was established at the end of 1998. It was founded by the PACE foundation, the Society of University Hospitals, the Netherlands Association of General Hospitals and the Society of Medical Specialists in the Netherlands. Since then in the Netherlands 19 pilot accreditations have been performed based upon 35 NIAZ-PACE standards for hospital departments and functions, and the overall standard 'quality system'. The aims and methods of the accreditation system were inspired by examples from the other side of the Atlantic, especially from Canada. The characteristics are: voluntary-based, self-evaluation, peer-review and aiming at continuous improvement of quality of care. Received: 15 April 2000 · Accepted: 15 April 2000     

A practitioner's approach to the assessment of the quality of sampling, sample preparation, and subsampling

 The methodology of evaluating the performance of sampling, sample preparation, and subsampling is reviewed. The requirements to be set for a successful experiment are revisited. The central role of the reference method is explained, and so is the choice of the parameters and the measurement methods. Based on the principles of the "Guide to the expression of uncertainty in measurement" (GUM), a statistical model is developed that demonstrates the influence of the experimental design on the outcome of the assessment experiment. This relationship is often overlooked in practice, as it is hardly mentioned in written standards dealing with this kind of quality assessments. The statistical framework thus developed covers the statistical procedures commonly appearing in written standards. Finally, the issue of testing the significance of the bias obtained from the experiment is discussed. Received: 14 June 1997 · Accepted: 2 September 1997