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     

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     

Why do food analysts need quality assurance?

 Most sophisticated products require testing for compliance with specifications and safety regulations before release into many markets, and trade in many simpler commodities and products also requires supporting technical information. Test documentation has become an essential element in this trade. Food intended for human consumption certainly falls into the "sophisticated products" category. Lack of acceptance of laboratory test data across national borders may be a significant barrier to trade. In order to avoid such barriers and unnecessary duplication of laboratory tests, mutual recognition of laboratory results should be regarded as an important means of facilitating international trade in food products. It is difficult to envisage recognition of test data across borders without internationally agreed criteria for assessing the competence of testing. These criteria should, as a minimum, require that a laboratory involved in the analysis of foods operates a suitable quality system. The laboratory must create a quality system appropriate to the type, range and volume of work performed. It is necessary for the elements of this system to be documented in a quality manual which is available for use by the laboratory personnel. The quality manual must be kept up-to-date by a person or persons having responsibility for quality assurance within the laboratory. This paper describes and discusses the elements of a quality system in a food laboratory, including suitable quality assurance measures, the use of validated analytical methods and participation in proficiency testing schemes. Received: 24 February 1996 Accepted: 13 March 1996     

Quality assurance in research laboratories

During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.     

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     

Accreditation for United States environmental laboratories

 There is currently no national program for recognition of United States environmental laboratories. This situation should change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency test samples, and meet specified quality assurance standards.     

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     

Key requirements for introducing quality assurance in measurement laboratories

 The implementation of a quality assurance system is fraught with difficulties. However, these difficulties may be overcome if the laboratory uses suitable means to facilitate the process. It is necessary to mobilise the intelligence and energy of all members of the laboratory. In order to command adherence, the project must be shared, and this necessitates a major effort by all concerned. Communication is a major factor in obtaining the support of all parties. Six important steps must be distinguished: – Defining quality policy – Creating awareness, information, training – Creating a quality structure – Establishing a deadline for obtaining accreditation – Progressive implementation – Experimentation and validation. Even if the task of obtaining and maintaining accreditation remains difficult, it clearly promotes a minimum level of organisation and stepwise progress in quality assurance. The laboratory must keep improving its quality system, using European Standard EN 45001 as an effective management model. Received: 9 April 1997 · Accepted: 11 September 1997     

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.     

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 experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

Practical uses of proficiency testing as valuable tools for validation and performance assessment in environmental analysis

Besides their role as an external quality control tool, PT results or samples could be used as an alternative to fulfil some of the quality assurance requirements such as analytical precision, uncertainty assessment, and internal quality control. This additional use of proficiency testing could help laboratories to reduce the financial impact of their quality assurance process. The purpose of this paper is to highlight some practical uses of PT results or samples in the environmental analytical field, which have been implemented at ISSeP (Institut Scientifique de Service Public), either for method validation or for internal quality control.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia     

The handbook of analytical methods for trace elements as adopted by the national reference laboratories for residues

The instrumental approaches, quality assurance schemes and management of chemical laboratories should in general be harmonized at the highest possible level. This is all the more so for the national reference laboratories (NRLs) for residues in live animals and their products which have to implement quality assurance systems inspired to the principles of good laboratory practice as well as to the general norms for the operation of testing laboratories (EN 45000 criteria). Directive 23/96/EC of 29 April 1996 prescribes that NRLs are assisted in this process by the four community reference laboratories (CRLs) for residues. To this end, the Rome CRL systematically collects in a handbook all the analytical methods in use at NRLs for the determination of As, Cd, Cu, Hg and Pb, as well as other chemical elements, in animal matrices. One major goal of this action is to foster the harmonization of analytical approaches by the NRLs and their ability to provide comparable results of similar quality. The Rome CRL is committed to revise this handbook twice a year. The role of the handbook is also to encourage the exchange of information among the NRLs as regards the possibility of improving existing methods.     

Quality issues in proficiency testing

 Proficiency testing is a means of assessing the ability of laboratories to competently perform specific tests and/or measurements. It supplements a laboratory's own internal quality control procedure by providing an additional external audit of their testing capability and provides laboratories with a sound basis for continuous improvement. It is also a means towards achieving comparability of measurement between laboratories. Participation is one of the few ways in which a laboratory can compare its performance with that of other laboratories. Good performance in proficiency testing schemes provides independent evidence and hence reassurance to the laboratory and its clients that its procedures, test methods and other laboratory operations are under control. For test results to have any credibility, they must be traceable to a standard of measurement, preferably in terms of SI units, and must be accompanied by a statement of uncertainty. Analytical chemists are coming to realise that this is just as true in their field as it is for physical measurements, and applies equally to proficiency testing results and laboratory test reports. Recent approaches toward ensuring the quality and comparability of proficiency testing schemes and the means of evaluating proficiency test results are described. These have led to the drafting of guidelines and subsequently to the development of international requirements for the competence of scheme providers. Received: 2 January 1999 · Accepted: 7 April 1999     

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.     

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     

Are there two decks on the analytical chemistry boat?

 This paper examines some problems of implementation of quality assurance (QA) principles in chemical measurement in the university academic environment. Being developed and introduced in practice by industrial and independent commercial laboratories, the 'quality lifestyle' has been largely ignored by the academic analytical community. The academic community is now faced with the fact that teaching, education and training of analytical QA and analytical quality management are no longer a matter of choice.     

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     

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     

Quality and timeliness in medical laboratory testing

In terms of testing, modern laboratory medicine can be divided into centralized testing in central laboratories and point-of-care testing (POCT). Centralized laboratory medicine offers high-quality results, as guaranteed by the use of quality management programs and the excellence of the staff. POCT is performed by clinical staff, and so such testing has moved back closer to the patient. POCT has the advantage of shortening the turnaround time, which potentially benefits the patient. However, the clinical laboratory testing expertise of clinical staff is limited. Consequently, when deciding which components of laboratory testing must be conducted in central laboratories and which components as POCT (in relation to quality and timeliness), it will be medical necessity, medical utility, technological capabilities and costs that will have to be ascertained. Provided adequate quality can be guaranteed, POCT is preferable, considering its timeliness, when testing vital parameters. It is also preferred when the central laboratory cannot guarantee the delivery of results of short turn-around-time (STAT) markers within 60 or (even better) 30 min. POCT should not replace centralized medical laboratory testing in general, but it should be used in cases where positive effects on patient care have been clearly demonstrated.