Laboratory accreditation – where next?

 Laboratory accreditation is now well established and can justly claim to have had a beneficial impact on the quality of the services provided by accredited laboratories. However, the needs of laboratories and their customers are continually evolving. It is necessary for accreditation practices to keep abreast of these changing requirements if they are to continue to be of benefit to laboratories and their customers. This paper gives a brief review of current accreditation practice and suggests some changes that should be made to help laboratories meet the demands made on them by their customers. Received: 2 July 1998 · Accepted: 3 August 1998     

ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting

Accreditation of healthcare services is recommended to ensure operation according to the highest quality standards. Various initiatives, such as legislation or accreditation by ISO or JCI, may be active to support and improve quality. The growing trend toward JCI hospital accreditation raised the concern of redundancy between JCI requirements for the use of referral laboratories and the ISO 15189 accreditation for medical laboratories. This would result in needless administrative efforts for hospital laboratories to collect and maintain required documentation, as the JCI quality requirements would be guaranteed given that the referral laboratory is ISO 15189 accredited for those examinations. A consensus meeting was organized by the Working Group for Hospital Accreditation of the Belgian Zorgnet-Icuro network, the University Hospitals of Leuven and the Red Cross to discuss the avoidance of any redundancy between both standards and to issue best practice guidelines for referral laboratories. It was concluded that JCI measurable elements for referral laboratories are covered by the ISO 15189 accreditation scope. The article substantiates the consensus that JCI and ISO quality requirements are harmonized and that accurate knowledge and interpretation of prevailing quality standards are essential to avoid redundancy in quality measures.     

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.     

Do we need to accredit proficiency testing schemes?

 Proficiency testing (PT) is being increasingly used as an important quality assurance tool for laboratories. The subject of quality of the providers of PT schemes has been discussed increasingly in recent years. Some countries have implemented systems for the accreditation of PT schemes. This paper looks at the background to the accreditation of PT schemes, the likely mechanisms which could be employed for accreditation, and some of the practical aspects.     

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     

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     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

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.     

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     

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     

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.     

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.     

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     

Accreditation of proficiency-testing schemes in The Netherlands

Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.     

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.     

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.     

The Slovak National Accreditation System

 After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993, being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000 and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic principles, and the structure and competence of accreditation bodies are described in this article.     

EAL interlaboratory comparison Wa1 – Testing of potable water

 The accreditation of laboratories has emphasized the use of interlaboratory comparisons as a tool to monitor the comparability and accuracy of results laboratories produce. An interlaboratory comparison for water laboratories was organized among European Cooperation for Accreditation (EA) member countries; 30 laboratories, 7 of which were not accredited, from 14 European countries participated in this intercomparison. All the laboratories were chosen by the appropriate national accreditation bodies, with the instruction to select as participants those laboratories which act as national reference laboratories in this field. About 90% of the data collected was considered satisfactory after statistical treatment. Non-accredited laboratories performed as well as accredited laboratories. The laboratories were asked to take corrective action and report the corrections to the accreditation bodies. A great variation in the reported uncertainties of the results was observed. There seems to be a need to organize EA interlaboratory comparisons for national reference laboratories analysing water. It is obvious that even reference laboratories need training in how to estimate the uncertainty of results. Received: 22 July 1998 · Accepted: 21 September 1998     

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