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     

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 College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves. Received: 8 August 2002 Accepted: 10 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to A. Rabinovitch     

Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory

 The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation. This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such as handling of samples and report generation are arranged according to the individual requirements of the various standards. Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations a harmonization of the different quality systems would be desirable. Received: 1 October 1998 · Accepted: 10 January 1999     

Basic steps towards a self-sustainable quality system and laboratory accreditation

 Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories. Received: 5 June 1997 · Accepted: 7 December 1997     

Setting a precedent in international accreditation

 The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed. Received: 30 May 1997 · Accepted: 16 June 1997     

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.     

On the way to formal accreditation

The Radiochemical Laboratory participated in the Technical Co-operation (TC) Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004 organized by the International Atomic Energy Agency (IAEA) during the period June 1999 and September 2001. Motivations, major goals of participation in the project, milestones of implementation of the project, establishing the quality system, improvements fulfilling both technical and management requirements as well as major achievements for future activities of the laboratory with respect to technical and financial conditions are discussed in detail.     

The Russian system for accreditation of analytical laboratories (centers)

 The history and the present state of the national system for accreditation of analytical laboratories in Russia are described. Received: 1 September 1998 / Accepted: 1 September 1998     

Comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro

The development of an internationally recognized laboratory accreditation process, accompanied by a mutual recognition agreement (MRA), is an issue of great interest in Central and Eastern European countries. This paper presents a comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro. The basic analysis technique was preliminary laboratory accreditation assessment (PLAA). The analysis data were obtained via a questionnaire issued from January to June 2004, with the participation of accreditation bodies. Results from the study are presented in four sections: accreditation body standards, accreditation body organization, assessors and proficiency testing, and inter-laboratory comparisons. Research results for the countries were accessed using PLAA techniques and conformity/non conformity statements. The analysis verified that PLAA can provide low cost, rapid assessment of the key influencing factors in laboratory accreditation bodies.     

Experience of implementing ISO 17025 for the accreditation of a university testing laboratory

The experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory, is presented in the example of the Environmental Radiology Laboratory. Such implementation in a university institution is a difficult task, since the setting and environment are both unfavourable. The particularities are the collaboration of many independent units of the university, and the involvement of teachers and young researchers who have to coordinate all these different tasks, which makes the number of people working quite variable. Some specific aspects of the system are discussed. The conclusion is that implementation of a quality system on ISO 17025 and accreditation are completely achievable, and are helpful activities to put university members in touch with the real world and broaden their minds, which in the end has a positive impact on research studies and academic content.     

The application of data from proficiency testing to laboratory accreditation according to ISO 17025

Current methods of testing laboratories for their proficiency in reporting correct measurement results are liable to substantial errors of the second kind. This means that laboratories with deflated uncertainties are accepted as proficient, even though their reported measurement results pave the way for erroneous conclusions. Only by using E _n numbers based on an accepted reference value with the lowest possible uncertainty can the risk of recognising incorrect measurement results be kept at an acceptable level. Based on an actual set of proficiency test (PT)-data for the concentration of Pb in water, this paper compares PT results obtained by methods using E _n numbers with methods based on z-scores. Kaj Heydorn is a technical assessor at The Danish Accreditation and Metrology Fund (DANAK).     

The American Association for Laboratory Accreditation

 The American Association for Laboratory Accreditation (A2LA) marks its 20th year of existence. Its major aim as a non-profit, public service organization is to promote laboratory quality and competence. In terms of the number of current accreditations, A2LA is the largest multidiscipline laboratory accreditation body in the United States and the fourth largest in the world. An overview of current activities and status is provided.     

强化无机及分析化学实验室管理工作的实践

介绍了南京林业大学化学基础教学实验中心无机及分析化学实验室强化管理工作的若干经验。实践表明,实验室的管理逐步走向了规范化、科学化,有利于更好地服务于实验教学,顺利完成各项实验教学任务。     

ISO compliant laboratory quality systems and incident monitoring improve the implementation of laboratory information systems

Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS) in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system; this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS. Received: 4 August 2001 Accepted: 21 March 2002     

Practical experience of simultaneous accreditation and certification acquired in RIVM's official medicines control laboratories

 This article presents an overview of the practical experience acquired in two governmental medicines control laboratories in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer requirements. Received: 1 October 1998 · Accepted: 21 December 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     

Determination of Silver in Plants by Flameless Atomic Absorption Spectrometry and Neutron Activation Analysis

Abstract

Three analytical techniques suitable for determining silver concentrations in plants are presented and compared. Graphite furnace atomic absorption spectrometry performed directly on sample digests was the most sensitive and convenient. Neutron activation analysis, measuring ^110mAg gave good reproducibility, but lower sensitivity. A cyclic activation scheme to generate and detect the short-lived isotope ¹¹⁰Ag was useful as a quick reconnaissance technique, but interference from ⁷⁶As reduced its effectiveness.

Data are presented on the silver content of terrestrial plants. Background silver concentrations for lichens and bryophytes collected from Wales, U.K. were <0.07μgg^?1. Samples collected from areas contaminated by derelict metal mines contained between 0.1-1.0μAgg^?1. The aerial portions of vascular species usually contained less silver than bryophytes growing on the same substrate. Fungi are shown to bioconcentrate silver to a greater extent than cadmium, copper or lead.     

Validation of the determination of tin by <Emphasis Type="Italic">k</Emphasis><Subscript>0</Subscript>-instrumental neutron activation analysis in foodstuff

Several recent intercomparisons and certification exercises have shown that the determination of tin in e.g. food samples and plastics is not straightforward. k ₀-Instrumental Neutron Activation Analysis (k ₀-INAA) offers some intrinsic quality control opportunities for the determination of the tin content in samples since several monitoring radioisotopes are formed. In this work we will discuss the validation of the determination of tin by k ₀-INAA using different reference materials. The results show that only few of these radioisotopes are reliable in terms of accuracy and that from a survey of the tin content in a range of canned foods detection limits as low as 2 mg/kg can be achieved.