External quality assurance programmes in medical laboratories

 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. Received: 9 December 2000 Accepted: 14 December 2000     

Accreditation of PT providers – is it worth the money?

This topic is being presented from two perspectives, namely the views of an accreditation body and those of an accredited provider of external quality assessment schemes. The first perspective, from an accreditation body, is based on the experience of Australia's national laboratory accreditation body (NATA), which has accredited fourteen proficiency testing (PT) providers and is currently processing an application from another. The second perspective is based on the experience of EQUALIS, the national quality assurance organisation for laboratory medicine in Sweden, which was granted accreditation in 2002.Presented at 5^th Eurachem Workshop on Proficiency testing in analytical chemistry, microbiology and laboratory medicine, Portorož (Slovenia) 25–27 Sept 2005     

Setting a precedent in international accreditation

 The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed. Received: 30 May 1997 · Accepted: 16 June 1997     

Quality assurance in analytical laboratories engaged in research and development activities

 Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories. Received: 11 July 2002 Accepted: 29 November 2002 Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to M. Valcárcel     

Laboratory authorization versus accreditation in transitional economies: case study of Serbia

Many CEE governments are still using various systems of laboratory authorization together with ISO/IEC 17025 laboratory accreditation. It is difficult to understand from the EU prospective, the existence of two parallel laboratory competence verification systems. The basic relations between laboratory accreditation and authorization: independence and succession have been defined. The case study of testing laboratory accreditation versus authorization in Serbia, has been presented and discussed. Relevant requests and procedures for water quality, food and air quality testing laboratory authorization were analysed in detail. Comparative analyses of accreditation and authorization have established: (i) independent relations, (ii) relevant regulation is in collision and barely legal, (iii) authorization is (technically) on the far lower level than accreditation is, and (iv) authorization requests cause high space and personnel costs. It has been concluded that it is not adequate to perform two policies at the same time: one EU oriented—laboratory accreditation, and one non-EU oriented—laboratory authorization. The policy proposal is that all CEE countries should abandon existing laboratory authorization procedures and replace them by accreditation. Proposed goal could be reached in rather a short transition process of 2–3 years.     

Quality assurance in the view of a commercial analytical laboratory

 The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses. This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation, can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must be demanded of all laboratories. Received: 4 October 1996 Accepted: 15 January 1997     

The attitude of laboratory personnel towards accreditation

 A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload had been increased by the accreditation process but they did not think that the process had improved the quality of their results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather than in a non-accredited one. Received: 5 October 1998 · Accepted: 20 October 1998     

Accreditation: worth the trouble?

 Since the late 1980s, much attention has been paid to the usefulness of ISO-9000 certification. At present more than 45000 companies and institutions worldwide have been granted an ISO-9000 certificate. In the field of quality assurance, however, the ISO-9000 series does not completely cover the aspect of traceability. Demonstrable traceability is a particular problem in quality assurance of products by chemical analysis. In this paper realisation of demonstrable traceability is discussed, using the field of gas analysis as an example. Attention is focused on the usefulness of accreditation for laboratories performing quality assurance analyses. The basic question is asked whether and, if so, when accreditation is worth the trouble in cases where demonstrable traceability is required. Received: 15 February 1996 Accepted: 6 March 1996     

Quality assurance in the microbiology laboratory

 The pertinent issues necessary for the establishment of quality assurance in the microbiology laboratory are discussed. Quality assurance is a planned system of control measures that enables management to ensure that the analytical data produced in the laboratory are valid. To introduce quality assurance, all activities in the laboratory that affect the production of analytical data must be documented and controlled. These include sampling, method selection, laboratory environment, equipment, reagents and media, staff, reference materials and internal and external quality control. Laboratory accrediation in accordance with EN45001 and ISO Guide 25 enables laboratories demonstrate to an external agency their ability to perform analytical work and produce valid analytical data. This gives creditability to the laboratory and allows management to have confidence in the data produced. Received: 6 June 1995 Accepted: 3 July 1995     

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.     

Proficiency testing in analytical laboratories: how to make it work

 This paper covers the role of proficiency testing schemes in providing an occasional but objective means of assessing and documenting the reliability of the data produced by a laboratory, and in encouraging the production of data that are "fit-for-purpose". A number of aspects of proficiency testing are examined in order to highlight features critical for their successful implementation. Aspects that are considered are: accreditation, the economics and scope of proficiency testing schemes, methods of scoring, assigned values, the target value of standard deviation σ_p, the homogeneity of the distributed material, proficiency testing in relation to other quality assurance measures and whether proficiency testing is effective. Stress is placed on the importance of any proficiency testing scheme adhering to a protocol that is recognised, preferably internationally. It is also important that the results from the scheme are transparent to both participating laboratory and its "customer". Received: 03 November 1995 Accepted: 20 November 1995     

Conditions of nucleation in crystallizable polymers: reconnaissance of positions — a critical evaluation

 In view of the enormous difficulties in obtaining reliable experimental data for the purpose of structure simulation with the aid of computer programs (presently being so popular), every classifying endeavor must be considered of great importance. One of the goals of such an endeavor is the demarcation of characteristic temperature ranges. With the aid of thermodynamic considerations an estimate of the restricted temperature range of metastable undercooling, in which the classical theory of homogeneous nucleation, as developed for polymer solutions, is valid also for polymer melts (“thermal nucleation”) can be given. This consideration includes a discussion of the course of the relevant interface tensions along the co-existence lines of the P–T diagram. The so-called spinodal crystallization mode (see [1–3]) is found at lower temperatures and seems to be quite common in polymer crystallization. In this connection the so-called athermal nucleation can be identified with a specific process. However, the present author is not in favor of the term “spinodal mode”. This is explained by a comparison with the meaning of spinodal decomposition into two phases in the ordinary gas–liquid phase transition, which always occurs at the lower bound of the metastable undercooling. Remarkably, spinodal decomposition cannot be defined in the same way for the liquid–solid transition. Anyway, the author tries hard to induce unorthodox trains of thought in the hope to revive the discussion of a difficult matter, which has almost gone to sleep, before a satisfying settlement has been reached. Received: 3 June 1997 Accepted: 19 August 1997     

Compliance with GLP standards and management in analytical laboratories: current status

 Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility. The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method, laboratory information management, and security systems. The differences in the responsible authorities and scopes under the six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals. Received: 27 September 1996 Accepted: 11 November 1996     

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     

The Marshall Islands Radioassay Quality Assurance Program: An Overview

The Lawrence Livermore National Laboratory has developed an extensive quality assurance program to provide high quality data and assessments in support of the Marshall Islands Dose Assessment and Radioecology Program. Our quality assurance objectives begin with the premise of providing integrated and cost-effective program support (to meet wide-ranging programmatic needs, scientific peer review, and build public confidence) and continue through from design and implementation of large-scale field programs, sampling and sample preparation, radiometric and chemical analyses, documentation of quality assurance/quality control practices, exposure assessments, and dose/risk assessments until publication. The basic structure of our radioassay quality assurance/quality control program can be divided into four essential elements: (1) sample and data integrity control, (2) instrument validation and calibration, (3) method performance testing, validation, development and documentation, and (4) periodic peer review and on-site assessments. While our quality assurance objectives are tailored towards a single research program and the evaluation of major exposure pathways/critical radionuclides pertinent to the Marshall Islands, we have attempted to develop quality assurance practices that are consistent with proposed criteria designed for laboratory accreditation.     

Implementation of a ”data filter” for the UK National Marine Monitoring Programme

The implementation of a strategy for the assessment of the validity of environmental monitoring data – a ”data filter”– is described. The approach was developed through the UK National Marine AQC Scheme for application to data collected during the UK National Marine Monitoring Programme. Data reported for the year 1999, by nine laboratories, for 74 determinand-matrix combinations were assessed on the basis of the completeness of their supporting quality assurance and quality control information. The approach to the establishment of criteria of acceptability for quality information is described. Received: 28 August 2001 Accepted: 29 November 2001     

Trace analysis of microcontaminations in compliance with ISO 9001: monitoring and diagnostics in large-scale silicon manufacturing

 Severing principles are reported concerning the certification of and quality assurance in a trace-analysis laboratory that handles a large number of real samples, about 60 000 analyses/year with 50 validated methods. ISO 9001 emphasizes monitoring rather than diagnostics. For monitoring purposes the trace-analysis methods must be highly selective and of high precision, with high throughput and uptime within a justifiable economic framework in the analytical range of interest. All trace-analysis methods must be cross-checked using independent analytical tools. The analytical laboratory must be fully integrated in the total quality management of the plant. The analyst must know not only the performance of the trace-analysis tools but also the materials and processes involved in manufacturing. Received: 19 October 1995 Accepted: 15 November 1995     

Different approaches to legal requirements on validation of test methods for official control of foodstuffs and of veterinary drug residues and element contaminants in the EC

 In order to ensure food consumer protection as well as to avoid barriers to trade and unnecessary duplications of laboratory tests and to gain mutual recognition of results of analyses, the quality of laboratories and test results has to be guaranteed. For this purpose, the EC Council and the Commission have introducedprovisions – on measures for quality assurance for official laboratories concerning the analyses of foodstuffs on the one hand and animals and fresh meat on the other, – on the validation of test methods to obtain results of sufficient accuracy. This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions and requirements have to be revised and further additions have to be made.     

The contribution of the accreditation process to public administration: promotion of vital organizational changes

Accumulative evidence suggests that the implementation of international standard operating procedures, induce, by their virtues, major organizational changes. These changes are both cultural and behavioral including changes in decision-making processes, organizational norms, and values. The decision of any organization to adopt quality assurance, specifically via accreditation, should be regarded as a strategic one. As such, it prerequisites top management commitment, budgeting the process and promoting active inter-collaboration of all organizational members. The accreditation process according to ISO/IEC 17025:1999 of the Haifa Public Health Laboratory, will be used as a case study. A number of practical benefits of such organizational changes will be demonstrated and discussed, among them improved quality customer service and handling customer's complaints, establishing multichannel communication, enhanced interlaboratory collaboration and coordination. It is important to note that the accreditation process was accompaniment by extensive training of both management and employees on-site and off-site.     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998