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     

Introduction for the special issue on the Antwerp Conferences

Quality management of laboratory medicine has become a hot topic at many conferences. Also, many national and international organizations have created working groups and committees with the task of working out standards, guidelines or recommendations for quality management of medical laboratories. We have observed that there is a great deal of interest not only from professional and scientific organizations directly involved in medical laboratory tests, but also from accreditation and certification bodies, from test laboratories in general, from in vitro diagnostic devices (IVD) manufacturers and their associations, and from other medical laboratory suppliers. However, we found that all these parties were discussing from their own point of view, without taking into account the position of other involved partners and that there was a need for creating a discussion forum for quality management in clinical laboratories. So in 1995, we started the Antwerp conferences on quality (r)evolution in clinical laboratories. The aim was to bring together all concerned partners and to establish a forum for brainstorming, independently of any pressure group. The leitmotif for the Antwerp conferences (Fig. 1) is a chain model showing the interfaces and relationships between all the partners involved in laboratory tests. During the conferences, this chain model has been examined from different angles and a summary of the concepts evolving from the discussions can be found in the conference abstracts and conference review reports in this journal. A Selection of ideas emerging from these conferences are presented below. Received: 5 October 1998 · Accepted: 20 October 1998     

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     

Unification of the quality assurance systems of public health laboratories conformed to ISO 17025, ISO 15189, and ISO 9000: a major organizational change

The Department of Public Health Laboratories consists of five major laboratories located across the country of Israel: four environmental laboratories performing microbiological and chemical testing of food and water products [accredited according to International Organization for Standardization (ISO) 17025 since 1999) and a fifth laboratory that is dedicated to virology testing (certified according to ISO 9000 since 2003). Historically, each laboratory operated independently and developed its own quality assurance (QA). On November 2004, an important strategic decision was made: to unify all five laboratories’ QA systems conformed to ISO 17025, ISO 15189, and ISO 9000—a transition from five laboratories operating independently in the field of QA toward establishing a multisite laboratory. This process was considered and visualized as a major organizational change and therefore raised some resistance among both QA managers and the professional laboratories’ management. Thus, it was necessary to overcome the resistance and at the same time induce thoughts of ways of reshaping and formatting the new and uniform quality manual and uniform standard operating procedures (SOPs). In September 2005, the first phase of the process was completed, and all four environmental public health laboratories successfully passed a reaccreditation audit using a uniform QA manual guide and partially uniform SOPs. We shall share our experience and discuss the major contributions of this process to overall laboratory management. Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel.     

A review of autovalidation software in laboratory medicine

Although autovalidation procedures have been around for many years, through the use of computers and the application of (medical) protocols, they are now becoming part of the production environment of medical laboratories. The introduction of high volume instruments within routine medical laboratory testing certainly speeded up their application as well. After defining autovalidation, autoverification and autoconfirmation, this paper provides a framework for the different ways and places where these tools can be applied within laboratory medicine. Technology as well as organization are essential building blocks to reach well-defined, transparent and assured quality. A laboratory automation system (LAS) brings both areas together in a logical, future-oriented way. Strengthening the information loop, reaching guaranteed quality (analytical, turnaround times and efficiency), leads towards strict management of the laboratory processes. This includes all laboratory processes and here autovalidation and autoreporting become essential. A survey of currently available software routines and their appraisal from a managerial viewpoint are given. It can be concluded that autovalidation software in laboratory medicine is maturing and is rapidly becoming a critical success factor in any medical laboratory. Quality can be automated for sure and autovalidation software will prove to be a valuable aid to do so. Received: 23 August 2002 Accepted: 26 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium     

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     

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.     

A view of uncertainty at the bench analytical level

 The problem with which analytical laboratories are confronted, after traceability of their results has been demonstrated, is correctly estimating their uncertainty– to which traceability is also to some extent subject. While the general principles for calculating the uncertainty of physical measurements are applicable to chemical metrology, some refinements are needed, especially careful selection and planning the level at which uncertainty will be estimated by each laboratory in accordance with its capacity and required demands. Depending on the particular decision to be made, the mechanism to be used to estimate the uncertainty varies markedly; also, the rigour of the estimation increases with increasing stringency of the demands. This paper describes the primary sources of uncertainty in chemical metrology and discusses different approaches to its estimation in relation to the type of analytical laboratory concerned. The view presented tries to be close to the bench analytical level, in order to be practical and flexible for laboratories, although it could sometimes be considered slightly heterodox. Received: 25 March 1997 · Accepted: 20 September 1997     

From misconception to a must: The measured merits of total quality management and accreditation in INAA

Increasingly govemmental bodies and industry require that supporting analytical laboratories have their quality assurance program implemented in a quality system by international standards such as derived from the ISO-25 guide. Neutron activation analysis (NAA) laboratories may have to deal with this trend too. In universities and research laboratories the need for it, and the implications of total quality management system are sometimes misconceived by unfamiliarity with the issue. The laboratory for INAA in Delft has been accredited for its quality system since 1993. Some of the tangible improvements since the introduction of quality management are presented. Four strategical considerations are given to consider the introduction of quality management at NAA laboratories, viz. with respect to the role of NAA for the validation of other methods, the role of NAA in the certification of reference materials, the preservation of knowledge and the acceptance of NAA as a respectable method.     

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     

The European way to go: Virtual Central Laboratory

In clinical pharmaceutical trials often one central laboratory is used for the analysis of routine parameters, the so-called safety parameters. In many countries the heads of laboratory departments question the quality of such analysis in terms of quality of samples after transport, continuity of patient related medical laboratory information before, during and after the trial; turn around time; alerting procedures and consultancy to requesting physicians. On the other hand, the pharmaceutical industry prefers to work with central laboratories since they can claim certification or accreditation. Also the use of one set of reference values is an important issue, as well as electronic data transfer to the trial organizer's database. The concept of a Virtual Central Laboratory (VCL), initiated in the Netherlands, tries to solve this conflicting situation. In the concept, local hospital laboratories receive computer-assisted aid in the identification of patients, trials, visits and requests. The laboratory data are transformed using calibrator sets to produce a homogeneous data set across laboratories, resulting in one set of reference values. The data are electronically transferred to a central computer from which they are send in any desired format to the trial organizer's database. Participating laboratories are obliged to work towards accreditation. The VCL acts as a central counterpart for both the pharmaceutical industry and local laboratories. The concept offers advantages to the pharmaceutical industry, the investigator and local laboratories.     

Establishment of an ISO 17025:2005 accredited forensic genetics laboratory in Italy

Forensic genetics is extremely useful for the resolution of criminal cases, identification of missing persons and in paternity/kinship testing. Each and every laboratory that works in the forensic genetics area has developed its own working method independently, however, generally in accordance with international guidelines. More than thirty institutional, public and private forensic laboratories that deal with the identification/paternity testing through DNA in Italy have been surveyed, but to this day, only five public laboratories (four of the police and one of a university hospital) and two private ones are accredited. There are, however, many other laboratories that perform occasional forensic genetics activities that have not been surveyed. The need to achieve the ISO 17025:2005 accreditation may represent for these laboratories an excellent opportunity to improve their activities. Although the DNA analysis for forensic investigation is used in Italy since the beginning of the technique, the quality of the results has been called into question more than once, as it appears by many court cases in which the results of genetic tests have been subject to strong criticisms. Obviously, the ISO 17025:2005 is not sufficient to guarantee the quality of the results. It is essential to show the laboratory working method to the scientific community in order to obtain reliable and robust analytical results that can be used in court to accuse/exonerate individuals accused of a crime or to assign a true biological father to a child. Here, we show a part of the workflow validation process of the internal method used in the Forensic Genetic Service (FGS) of the Diagnostic Genetics Unit (DG) of the Careggi University Hospital. This article outlines some relevant aspects of the methods adopted to ensure robustness, reliability and reproducibility of genetic profiles used for forensic identification.     

The establishment of quality systems in veterinary diagnostic testing laboratories in developing countries: experiences with the FAO/IAEA External Quality Assurance Programme

Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated, resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE) general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary diagnostic laboratories world-wide.     

Particles and microfluidics merged: perspectives of highly sensitive diagnostic detection

There is a growing need for diagnostic technologies that provide laboratories with solutions that improve quality, enhance laboratory system productivity, and provide accurate detection of a broad range of infectious diseases and cancers. Recent advances in micro- and nanoscience and engineering, in particular in the areas of particles and microfluidic technologies, have advanced the “lab-on-a-chip” concept towards the development of a new generation of point-of-care diagnostic devices that could significantly enhance test sensitivity and speed. In this review, we will discuss many of the recent advances in microfluidics and particle technologies with an eye towards merging these two technologies for application in medical diagnostics. Although the potential diagnostic applications are virtually unlimited, the most important applications are foreseen in the areas of biomarker research, cancer diagnosis, and detection of infectious microorganisms.

The current status and future of medical laboratory quality regulation and accreditation in Ghana

High-quality and reliable laboratory services are important components of effective and well-functioning health systems. Accurate, reliable and timely medical laboratory testing is crucial to patient care and disease surveillance. Unfortunately, in many sub-Saharan African countries, medical laboratory systems are adversely affected by the unavailability of medical laboratories, poor laboratory infrastructure and lack of well-trained personnel [1]. Quality in the laboratory is only achieved in a systematic way through the implementation of a quality management system. The results of the study showed that approximately 60?% of the 78 respondents were unaware of the requirements of ISO 15189:2007. A trial of proficiency testing, termed ??blind proficiency testing??, was carried out in which 19 laboratories determined the concentrations of urea and cholesterol in a proficiency testing material. Of the 19 laboratories that determined the concentration of urea, 63?% produced satisfactory results with scores between ?2 and +2. Similarly, 63?% of the participating laboratories obtained satisfactory z scores for cholesterol determination. Some of the laboratories that obtained satisfactory scores for urea determination had unsatisfactory scores for cholesterol determination and vice versa. It is recommended that the Ghanaian government pass a law and establish a standard to regulate medical laboratories in Ghana in order to improve quality in a significant way.     

浅析实验室内部审核

介绍了实验室领导、质量负责人以及内审员在实验室内部审核中的不同作用,提出了改进内部审核工作成效的措施.     

Laboratory information management and quality

Summary It is frequently stated that for the development of a quality system in the laboratory, a LIMS (Laboratory Information Management System) is needed. In this paper the relation between LIMS and quality systems is discussed. LIMS may have benefits for the quality system, but not necessarily. A constraint — which is not met in many laboratories — is that the LIMS is properly fit into the organization. The LIMS may even turn out to be an obstacle for the quality system. The laboratory quality system makes demands on the LIMS. Most suppliers are not able to meet these demands. Adherence to a quality system by the LIMS supplier is becoming necessary.     

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     

Reliability of food measurements – a South African perspective

 High quality analysis of food involves a comprehensive process, which includes proper sampling, validated methodology, experienced technical staff and the use of standard reference materials. Today there is more international emphasis not only on generating food composition data but also on data quality and the main issue is that South African data should be internationally recognized as acceptable and representative. Quality is multi-dimensional and should at least include aspects of accuracy, precision and representativeness. A major step forward is that laboratories can apply for accreditation, which involves, inter alia, documented, validated methodology, regular interlaboratory studies, the use of certified reference materials and the existence of a sound quality system. The South African National Accreditation System (SANAS) is a regulatory body in South Africa, which is internationally recognized. Assessment of laboratories against specific standards is performed regularly and laboratories have to comply with certain managerial and technical requirements. Once a laboratory is accredited, ongoing validation and verification of results as well as regular assessment ensure reliability of results and overall competency of the laboratory. With a quality assurance programme in place, the reliability of results of the Irene laboratory is beyond doubt and nutrient data could be included in food composition tables. Received: 31 January 2002 Accepted: 4 February 2002 Correspondence to Louwrens Erasmus Smit     

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.