The Virtual Central Laboratory approach for the retrieval and management of clinical laboratory data for clinical studies

In 1996, the Virtual Central Laboratory (VCL) concept was presented at the 2nd Conference on Quality [R]evolution in Clinical Laboratories: participating laboratories measure calibrators. The outcome of these measurements is used to calculate conversion factors. The obtained factors are subsequently applied to standardize the results of a number of routine chemistry parameters. This conversion method is now part of a quality system to collect clinical laboratory data in accordance with the Good Clinical Practice guidelines on patients participating in clinical trials organized by the pharmaceutical industry. This approach eliminates the need for centralized laboratory services. Presently over 300 laboratories participate in a number of pan-European clinical trials where the VCL is applied. In this paper our experiences over the last 2?years will be discussed.     

NATA: 50 years experience with accreditation

 Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA), has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the benefits of laboratory accreditation. Received: 24 June 1996 Accepted: 25 June 1996     

Flexibilization of the scope of accreditation: an important asset for food and water microbiology laboratories

Beltest, the Belgian accreditation body, has investigated flexibilization of the scope of accreditation for chemistry laboratories and food and water microbiology laboratories. This flexibilization, synonymous with test-type accreditation, allows a laboratory to add new test methods or retry previous test methods without having to undergo a new audit by Beltest. It has been used for nearly ten years by German and Swiss accreditation bodies. Flexibilization permits the validation of methods and results, given that the competence of the particular laboratory is already well established. This new concept in microbiology allows client’s needs to be adequately met, and facilitates the quick establishment of a method in several laboratories at once in case of a public health crisis. The first laboratory to participate at this investigation on the flexibilization concept, as a test of the concept, was the Belgian reference laboratory for food microbiology.     

The ILAC Arrangement – Part I

As of August 2001, 38 laboratory accreditation bodies of the International Laboratory Accreditation Cooperation (ILAC) have signed the multi-lateral, mutual recognition arrangement (the ”ILAC Arrangement”) to promote the acceptance of accredited test and calibration data. This Arrangement provides significant technical underpinning to international trade. Until now, there has been no international mutual recognition agreement in laboratory accreditation, which has been a hindrance for some types of international trade. The key to the Arrangement is the developing global network of accredited testing and calibration laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies. The signatories have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. Now that the ILAC Arrangement is in place, governments can take advantage of it to further develop or enhance trade agreements. The ultimate aim is increased use and acceptance by industry, as well as government, of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of ”a product tested once and accepted everywhere” can be realised.     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

Experience with in-house PT-schemes in the chemical industry

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. Received: 5 December 2000 Accepted: 15 January 2001     

Assessors’ attitudes toward and experiences of national quality standards: a qualitative study in Iran

To establish a national accreditation system for medical laboratories, Iran has set national standards based on the international standard ISO 15189. Central to the accreditation process are the technical assessors. Their attitude in this regard and their experiences should be identified. This study aims to explore assessors’ attitudes toward national laboratory accreditation and their experiences of assessment process in order to identify current gaps and suggest required interventions to solve them. A qualitative study using an open-ended questionnaire was employed. A total of 150 assessors working in the General Directorate of Laboratory Affairs participated in the study. While almost all Iranian laboratory accreditation assessors were generally supportive about the necessity of laboratory accreditation and cited benefits of this process, they pointed to improvement areas including developing assessor selection and appraisal criteria, continuous training, taking into consideration the heterogeneity of laboratories throughout the country, participation of professional associations and adopting measures to increase laboratories’ involvement.     

Laboratory accreditation: The operation of an established scheme

NAMAS, the National Measurement Accreditation Service, was formed in 1985 and has currently accredited some 1050 testing and calibration laboratories in the United Kingdom. NAMAS is managed by an Executive of 60 staff which is based at the National Physical Laboratory, one the UK's largest Government Research Establishments. Laboratories seeking accreditation are assessed by fully trained technical experts contracted by NAMAS, against the criteria set out in the NAMAS Accreditation Standard M10; the criteria contained in this document are fully consistent with the international standards for laboratory accreditation EN 45001 and ISO Guide 25. NAMAS has recently published a document which provides guidance on the interpretation of the NAMAS Accreditation Standard for analytical laboratories. Assessment involves a consultative preassessment visit which is followed by a thorough on-site assessment of a laboratory's quality system and testing activities by a team of expert assessors. Following the correction of any noncompliances found at the assessment, the laboratory receives a certificate of accreditation and a schedule which defines those tests and analyses for which the laboratory is accredited. NAMAS has negotiated a number of mutual recognition agreements with similar accreditation bodies in other countries and negotiations with other schemes are underway. The imminent approach of the European Single Market has highlighted the need for independent third party assurance of testing and calibration and this should ensure the continued growth of NAMAS and similar schemes elsewhere in Europe.     

Can single-operator laboratories comply with all of the requirements of ISO/IEC 17025:2005?

ISO/IEC 17025:2005 states that its requirements are “applicable to all laboratories regardless of the number of personnel” and would therefore include single-operator laboratories. However, there are reservations as to whether these laboratories can comply with all of the requirements without jeopardizing independence of judgement and impartiality. Similarly, there are some requirements of ISO/IEC 17025:2005 including staff supervision, internal communication processes and appointment of deputies that are considered unlikely to apply to a single-operator laboratory. The ISO/IEC 17025:2005 is widely used as the international standard of quality assurance by which accreditation bodies assess the competency of testing and calibration laboratories. There does, however, appear to exist, disagreement amongst accreditation experts when considering single-operator laboratories. Some accreditation bodies accredit single-operator laboratories, whilst others require additional human resources prior to granting accreditation. This discrepancy leads to unfair competition amongst laboratories as a single-operator laboratory by definition needs less resources (both human and financial) to achieve and maintain accreditation, compared with a laboratory where additional human resources need to be sought prior to and in order to maintain accreditation. The ISO/IEC 17025:2005 is in the process of being revised, and this is an opportune moment to address the issues aforementioned with the aim of removing ambiguity and enhancing clarity. In addition, the hope is to assist the accreditation bodies themselves to adopt a consensus approach when granting accreditation towards single-operator laboratories.     

Tunisian traceability system

The concept of metrology first appeared in Tunisia towards 1909. At the end of the 1990s, bodies for evaluating conformity of measurement at different levels have been instituted to meet calibration and testing needs of the national industry. These bodies were divided into three categories: Class A where we find mainly the Central Laboratory for Analysis and Testing LCAE and the National Defence Laboratory DEFNAT; these two laboratories are in charge of the technological upgrading of the other bodies of Class B which, in turn, would transfer their knowledge to the industries, the latter constituting Class C. Nowadays, the accreditation of Tunisian laboratories at the international level by recognized reference foreign bodies and participation in the European proficiency network enabled the national laboratories of Tunisia to establish the degree of equivalence between their measurement results and those of other foreign laboratories.     

实验室的认可和质量管理体系的建立与运行

简要介绍了实验室认可的发展情况，开展实验室认可的必要性，实验室的质量管理体系的建立、运行及认证认可。     

Accreditation in analytical laboratories: a critical assessment of its impact on human beings and techniques

Summary The relationships between Quality, Quality Assurance and Third Party Approval by accreditation based on formal application of EN 29002, EN 45001 and ISO Guide 25 are briefly outlined for analytical chemical laboratories working in the non-regulated area. The roles of human beings in laboratories and accreditation bodies are discussed and recommendations are made on how to minimize friction during accreditation processes. The structures of the European Accreditation Systems are reviewed and the efforts towards mutual recognition of the national accreditation bodies are described and critically assessed. The lack of competition based on free market conditions in the framework of company law is deplored. The assessment of laboratory systems, rather than assessing the activity of laboratories against technical standards, is recommended (unless it is otherwise requested). The beneficial effects of the process of accreditation on competence and quality of the activity of the laboratory are emphasized.     

An efficient implementation of a drug candidate database

The recent advances in laboratory technologies have resulted in a wealth of chemical and biological data. The rapid proliferation of a vast amount of data has led to a set of cheminformatics and bioinformatics applications that manipulate dynamic, heterogeneous, and massive data. An example of such application in the pharmaceutical industry is the computational process involved in the early discovery of lead drug candidates for a given target disease. In this paper, an efficient implementation of a drug candidate database is presented and evaluated. This study shows that high performance data access can be achieved through proper choices of data representation, database schema design, and parallel processing techniques.     

实验室认可基础、评审方法与发展趋势

从什么是实验室认可和中国实验室国家认可委员会、实验室评审认可依据和基本要求、实验室认可过程、现场评审技巧和国内外发展趋势五个方面对实验室认可作了介绍,可为我国实验室逐步实现与国际接轨的规范化管理提供借鉴。     

Implementation of a quality management system in a public research centre

In recent decades, it has become increasingly important for public research centres to attract external clients, including government, private and public bodies and companies. They do this by demonstrating their research excellence. A research centre??s ability to provide professional research services can be assessed by competent technical bodies which verify that the research centre??s laboratories operate according to certain predetermined criteria or standards. Although there is no set of generally accepted standards, some regional accreditation bodies already offer accreditation assessment for the R&D laboratories which are in their territory. This article analyses the successful application of a quality management system in a public research centre employing 57 people including researchers, technicians and administrative staff. This system is based on the scheme of regional accreditation of industrial research laboratories which was inspired by ISO 9001:2008 and ISO 17025:2005 and set up by the regional authority. The overall aim of the management system is to monitor all of the industrial research and services which the centre offers to external users, such as government, private and public bodies and companies, and to guarantee that final products, usually technical reports and prototypes, respond to their needs. The accreditation applies to all of the activity of the research centre except for basic research. In this article, the critical factors influencing the success of the implementation of the management system are outlined together with benefits and opportunities. Weak points and problems are analysed, and the actions which were undertaken in order to prevent and manage problems are described.     

Variations of moisture measurements in cheese

Data were accumulated during interlaboratory trials for cheese moisture determination from laboratories using officially recognized methods: AOAC; International Dairy Federation, and Standard Methods for the Examination of Dairy Products (SM). In one trial, ranges of means of 5 cheeses were 0.67, 0.56, and 0.19% for 5, 9, and 8 laboratories, respectively. The lower ranges for the SM method were typical of 3 other interlaboratory trials, with ranges of 0.27, 0.34, and 0.34% for 6, 7, and 5 laboratories, respectively. Within one laboratory, there were no significant differences among the 3 methods, but they all gave about 0.2% lower results than 2 other methods, one using freeze-drying, followed by drying in a vacuum, the other using cheese that was spread on sand and dried in a vacuum oven for 24 h. This finding indicated that none of the officially recognized methods removed all the moisture. Data showed that many laboratories tended to give either higher or lower results than the mean of all of them in a series of 7 interlaboratory trials. Constant results, free of biases or systematic errors, are important in application of formulas for prediction of yield of cheese for purposes of yield control, but are difficult to obtain. It is proposed that results by a laboratory in interlaboratory trials be compared with those obtained by one or more reference laboratories using a method that removes all the moisture from cheese. The difference would be applied as a constant in the predictive yield formula. That difference would likely be best as a running mean of differences in an ongoing series of trials. The reference laboratories would use frozen samples for quality control to ensure uniformity of results among trials. Mean moistures of 36.10 and 36.11% were obtained on subsamples before and after freezing for 7 months.     

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     

Can the new ISO Guide 25/EN 45001 create better confidence in laboratory operations?

 Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process. The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration laboratories is foreseen to come from closer interaction between laboratories and their customers.     

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