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     

Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

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.     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Aspects of auditing in clinical laboratories

Quality and patient safety are terms that both providers and recipients of healthcare are very familiar with. Accreditation is another term that is closely linked to quality and patient safety. Audit is a systematic, independent, and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Accreditation and audit are integral components of the same process. Three different types of audit are well recognized—internal, external, and co-operative. Reading of relevant documents, observation of laboratory practices, and asking open-ended probing questions are important auditing techniques. For auditing to be successful, experienced, qualified, and well trained auditors are essential. Furthermore, the auditor should be open-minded, not prejudiced, a team player and effective communicator, both in writing and verbally. In many instances, the emphasis for seeking laboratory accreditation has shifted from building quality systems—to produce reliable results and ensure patient safety—to just passing the inspection. Recently, the emphasis for laboratory quality improvement has been placed on pre and post-analytical processes in preference to analytical quality. The analytical quality of laboratory results is still far from ideal and it may be detrimental if less emphasis is placed on this aspect of laboratory medicine. Auditing or on-site inspection as a regulatory tool does not work or present a realistic picture of laboratory quality. A continuous quality improvement approach will help laboratories to build quality into their systems. Presented at the Conference “Excellence in Laboratory Medicine”, November 2007, Al Ain, United Arab Emirates.     

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     

Quality assurance in analytical measurement

 The peculiarities of analytical measurement require to check characteristics of the error (its components) of the obtained analysis results to assure the quality of the measurements. This article deals with the various quality assurance procedures and algorithms which are used to check the quality indices, i.e. the accuracy, reproducibility, certainty and repeatability of analytical measurements: These procedures include: laboratory rapid control; Intra-laboratory statistical control (statistical selection control by alternative attribute, statistical selection control by quantity method of periodic check of the analysis procedure for conformity to the specified requirements) and external control (inter-laboratory control checks, inter-laboratory comparison tests, and intra-laboratory control algorithms carried out by the appropriate supervisory body.) in the separately taken laboratory. The respective algorithms, control plans and control requirements, specified according to the different control aims and assurance tasks, enable the quality and certianty of analytical information obtained in laboratories in Russia to be assured. Received: 9 November 1998 / Accepted: 24 November 1998     

Reference materials and analytical standards to stimulate improved laboratory performance: Experience from the external quality assessment scheme for trace elements in biological samples

The performance of a large number of laboratories measuring trace elements in biological fluids has been monitored over many years by examination of their results in the Guildford external quality assessment scheme. Specific experiences of the UK trace elements reference laboratories have been used to stimulate improvements in performance of other participants in the scheme. The key features of these initiatives were: specially prepared reference materials, used as internal quality control specimens within a common procedure, contributed to accuracy control; proposed standards of satisfactory and unacceptable analytical performance associated with a new system for scoring; regular non-threatening open discussion of performance with interested colleagues. The impact of these features is illustrated with reference to measurements of Al and Zn in serum and Pb in whole blood.     

Revision of ISO guide 25

 ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.     

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.     

标准物质在商检分析实验室中的应用

介绍了标准物质在商检分析实验室的质量管理和实验室认可工作中的应用。     

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     

Quality in clinical laboratory measurements

 Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international, regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results from clinical laboratories.     

A survey of non-conformances raised during accreditation inspections of medical laboratories in South Africa.

Under the auspices of the South African National Accreditation System (SANAS) the South African medical laboratory accreditation programme was established in June 1999. This study reports the non-conformances identified during the assessment of 103 medical laboratories in South Africa between September 1999 and December 2001. Laboratories were assessed by SANAS, which is the single accreditation body in the Republic of South Africa. All documentation relating to the assessment of each laboratory was reviewed in detail by the authors to identify the numbers and classification of non-conformances under each of the 25 points of the check list. A total of 862 non-conformances were raised. The top five non-conformances identified were (1) quality management system, (2) test methods, (3) records and (4) quality control and laboratory safety. The deficiencies identified in South African medical laboratories should be viewed in a positive light and promote a culture of continuous quality improvement with appropriate allocation of resources. SANAS should continue to align its requirements and procedures relating to accreditation of medical laboratories with those of their international counterparts with whom mutual recognition agreements/arrangements exist.     

Twenty years of the Me.Tos. Project: an Italian national external quality assessment scheme for trace elements in biological fluids

The Me.Tos. Project, started in 1983 and still running, is an external quality assessment (EQA) scheme for laboratories performing specialized analyses in occupational and environmental laboratory medicine. Besides the organization of EQA exercises, initiatives for further education of the participants and the harmonization of EQA procedures at a European level are carried out. Participation in EQA schemes allows laboratories to comply with the international standards for the quality and competence of testing and clinical laboratories. The organization of the scheme includes the preparation of control materials, their distribution to the participants, according to strategies aimed to avoid identification of the samples, the statistical analysis of the results and the evaluation of laboratories' performance according to international guidelines and criteria set by the organizers. An overview of the scheme operation and the current performances of participants will be given.     

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     

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     

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     

Toward standardization of quality assessment in laboratory medicine by using the same matrix samples for both internal and external quality assessments

The main purpose of quality assurance procedures in clinical laboratories is to ensure that test results are appropriate to maintain excellence in the diagnosis, monitoring, and treatment of disease. However, in current practice, no standardized procedure or frequency for the evaluation of methods exists, particularly in external quality assessment. Furthermore, different quality control materials are typically used for internal and external quality assessment. To overcome these discrepancies, we used samples with the same matrix for both internal and external quality assessments of a group test performed in our laboratory. We then calculated total error using real bias (target value obtained by reference method) and the imprecision of each test and compared our results with the total error allowable, derived from biological variation data. We suggest that the strategy of using the same matrix samples for both internal and external quality assessment is cost-effective, can be readily used by staff, and will facilitate the standardization of quality control in clinical laboratories.     

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.