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John W. Locke 《Accreditation and quality assurance》1998,3(9):356-361
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 相似文献
3.
R. Dybkaer 《Accreditation and quality assurance》1999,4(3):90-92
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 相似文献
4.
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. 相似文献
5.
P. Davies 《Accreditation and quality assurance》1996,1(6):240-246
Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent
laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The
concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation
system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA),
has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement
and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation
system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the
benefits of laboratory accreditation.
Received: 24 June 1996 Accepted: 25 June 1996 相似文献
6.
R. Dybkaer 《Accreditation and quality assurance》2001,6(1):16-19
The medical laboratory must provide results of measurements that are comparable over space and time in order to aid medical
diagnosis and therapy. Thus, metrological traceability, preferably to the SI, is necessary. The task is formidable due to
the many disciplines involved, the high production rate, short request-to-report time, small sample volumes, microheterogeneity
of many analytes, and complex matrices. The prerequisite reference measurement systems include definition of measurand, unit
of measurement (when applicable), consecutive levels of measurement procedures and calibrators in a calibration hierarchy,
international organizations, reference measurement laboratories, dedicated manufacturers, written standards and guides for
the medical laboratory, production of reference materials, internal and external quality control schemes, and increasingly
accreditation. The present availability of reference measurement procedures and primary calibrators is shown to be insufficient
to obtain international comparability of all types of quantity in laboratory medicine.
Received: 19 April 2000 / Accepted: 3 July 2000 相似文献
7.
P. Schmidt 《Accreditation and quality assurance》1999,4(4):129-132
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 相似文献
8.
Terry Antony Gough 《Accreditation and quality assurance》1997,2(5):216-223
The contribution to the debate on the quality of forensic science in the UK by various bodies including government, professional
and accreditation organisations, is discussed. The practical steps that have been taken over many years to improve quality
and to ensure that there are well-documented systems in place are considered. These include laboratory quality systems, proficiency
testing and the training of forensic scientists.
Received: 6 November 1996 Accepted: 12 December 1996 相似文献
9.
Alain G. Verstraete 《Accreditation and quality assurance》1999,4(3):82-83
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 相似文献
10.
Keith W. Davies 《Accreditation and quality assurance》1999,4(1-2):18-26
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 相似文献
11.
Gurdeep Singh Dhatt Sumedha Sahni Hassan Abu Damir 《Accreditation and quality assurance》2008,13(9):505-509
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. 相似文献
12.
Anthony J. Russell Ulf Örnemark Lena Hård Gunnar Nordin 《Accreditation and quality assurance》2006,11(8-9):388-390
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 5th Eurachem Workshop on Proficiency testing in analytical chemistry, microbiology and laboratory medicine, Portorož (Slovenia) 25–27 Sept 2005 相似文献
13.
R. Wood 《Accreditation and quality assurance》1996,1(4):140-149
The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to
be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation,
participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar
approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that
official food control laboratories have in place the measures to ensure that consistently reliable data can be produced.
Received: 29 November 1995 Accepted: 8 January 1996 相似文献
14.
Daniel William Tholen 《Accreditation and quality assurance》1998,3(9):362-366
There are three stages to evaluating a laboratory's results in an interlaboratory proficiency test: establishing the correct
result for the test item, determining an evaluation statistic for the particular result, and establishing an acceptable range.
There are a wide variety of procedures for accomplishing these three stages and a correspondingly wide variety of statistical
techniques in use. Currently in North America the largest number of laboratory proficiency test programs are in the clinical
laboratory field, followed by programs for environmental laboratories that test drinking water and waste water. Proficiency
testing in both of these fields is under the jurisdiction of the federal government and other regulatory and accreditation
agencies. Many of the statistical procedures are specified in the regulations, to assure comparability of different programs
and a fair evaluation of performance. In this article statistical procedures recommended in International Organization for
Standardization Guide 43, Part 1, are discussed and compared with current practices in North America.
Received: 22 April 1998 · Accepted: 12 May 1998 相似文献
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A. Rabinovitch 《Accreditation and quality assurance》2002,7(11):473-476
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 相似文献
17.
N. P. Boley 《Accreditation and quality assurance》1999,4(8):347-349
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. 相似文献
18.
Robert George Visser 《Accreditation and quality assurance》1999,4(3):108-110
The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated
the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have
the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during
the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In
this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on
the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency
of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status
and quality without changing the set-up of the proficiency test. 相似文献
19.
R. Dybkaer 《Accreditation and quality assurance》2003,8(2):46-52
The establishment of a reference examination system necessary for metrological traceability of the many types of sophisticated
examination result in laboratory medicine is a daunting task, which has been made mandatory by the EU Directive on in vitro
diagnostic medical devices and the requirements for accreditation. Following a definition of examinand and allowed examination
uncertainty, a dedicated calibration hierarchy is established from stated reference through alternating reference examination
procedures and calibrators providing a traceability chain from examination result to the reference, often a definition of
a measurement unit. The various types of possible calibration hierarchy are outlined in EN ISO Standards. Recent efforts by
national and international stakeholders to establish a global reference examination system have led to the creation of a Joint
Committee on Traceability in Laboratory Medicine with the International Committee for Weights and Measures, International
Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Laboratory
Accreditation Cooperation, and World Health Organization as the principal promoters. This structure will identify reference
procedures, reference materials, and reference laboratories, and seek support for further prioritised and coordinated development
of the system.
Received: 1 August 2002 Accepted: 22 November 2002
Based on a lecture at an IUPAC Seminar, EC JRC Institute for Reference Materials and Measurements, Geel, BE, 2001–12–18
Correspondence to R. Dybkaer 相似文献
20.
Jarl Forstén 《Accreditation and quality assurance》1998,3(6):256-257
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. 相似文献