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1.
Jean-Claude Libeer 《Accreditation and quality assurance》2001,6(4-5):151-153
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 相似文献
2.
3.
Axel Colling Martyn Jeggo Helder Louvandini Mamadou Lelenta Mark Robinson 《Accreditation and quality assurance》2008,13(1):33-45
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. 相似文献
4.
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
5.
P. Hübner Edgar Studer Daniel Häfliger Markus Stadler Christian Wolf Martin Looser 《Accreditation and quality assurance》1999,4(7):292-298
The detection of genetically modified organisms (GMOs) by the polymerase chain reaction (PCR) is a complex multiparameter
problem. Therefore, a number of critical issues in respect to quality control need to be considered. For practical purposes,
the PCR process itself can be divided into three subprocesses: template isolation and reaction setup (pre-PCR), PCR reaction
and detection of amplification products, and data evaluation (post-PCR). Crucial factors for the pre-PCR process are the following:
homogeneity of the sample to be analysed, performance of template isolation and purification in terms of yield and purity,
standardized process for the estimation of concentrations of genomic DNA and all reagents used in the reaction. For the PCR
itself, crucial factors to be controlled are: setup of reactions, batch to batch variations of reagents, temperature-time
programs used for the PCR amplification, and the performance of different types of hardware (e.g. different brands of thermocyclers).
The crucial factor for the post-PCR process is the detection of the amplification products of the PCR. The tremendous sensitivity
of PCR methods requires a careful and consequent separation of the three processes in terms of hardware, laboratory space
and sample handling. The avoidance of contamination is one of the most critical factors. The goal of quality assurance measures
must be to ensure appropriate results at maximum sensitivity. The complexity of any PCR system used for the detection of GMOs
leads to the requirement of a careful validation process for any laboratory using such methods. For qualitative analyses crucial
validation parameters are: specificity, selectivity, repeatability, intermediate precision, reproducibility, limit of detection
and robustness.
Received: 5 October 1998 / Accepted: 22 February 1999 相似文献
6.
L. Mouillet 《Accreditation and quality assurance》1998,3(1):11-13
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 相似文献
7.
Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical
testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a
new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside
by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality
test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through
instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must
create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory
Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system
approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error”
matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where
all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of
care.
Received: 26 June, 2002 Accepted: 17 July 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium
Abbreviations NCCLS National Committee for Clinical Laboratory Standards (formerly) · POCT point of care testing · QC quality control ·
HACCP hazard analysis critical control points · CLIA clinical laboratory improvement amendments (of 1988)
Correspondence to S. S. Ehrmeyer 相似文献
8.
C. L. Burns 《Accreditation and quality assurance》1997,2(7):327-331
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 相似文献
9.
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
10.
Göran Lindholm 《Accreditation and quality assurance》1998,3(7):296-297
This article describes on the idea behind Nordtest, the results of its activities and how Nordtest has influenced testing
and quality assurance. By financing projects in the field of technical testing Nordtest has been able to utilise the best
available Nordic knowledge and resources to respond to Nordic needs and has gained acceptance in all Nordic countries. During
Nordtest's 25 years of operation its projects have resulted in over 500 test methods and over 350 technical reports that are
widely used both within and outside the Nordic countries. Examples of some project results are given. Important issues in
testing and quality assurance are expressed in Nordtest position papers. Nordtest's active participation in the European and
global co-operation in testing and quality assurance is also described. 相似文献
11.
12.
Healthcare is changing and clinical laboratory testing must change with it. In no discipline is this change more profound
than in hematology. The principles of total quality management (TQM) including continuous quality improvement, reengineering
and strategic planning can facilitate these changes. In the past, hematology has often been exlcuded from these processes
due to its many manual procedures and the degree of expertise and skill needed to perform the testing. As automated technology
continues to evolve, hematology testing, like other testing, will become integrated into the core, clinical laboratory. We
suggest TQM can, and should, guide the way.
Received: 15 April 2000 · Accepted: 19 April 2000 相似文献
13.
The specific standard described here constitutes the heart of the quality system set up by the Commissariat à l'Energie Atomique
– French Atomic Energy Commission – for its main "Fundamental Research" entity, the Directorate for the Sciences of Matter.
It is a coherent standard (set of shared rules and provisions laid out in a clear fashion) designed, in the first instance,
to provide those taking part in research, including the hierarchy, with the means to satisfy their requirements in the field
of quality. And, secondly, to create the conditions for recognition of this action by third parties, which all research entities
must nowadays convince of their trustworthiness (supervisory ministries, research partners, industrial companies, etc.). This
standard places particular emphasis on the preponderant roles of initiative and freedom in fundamental research, which are
a prerequisite for creativity, innovation and, last but not least, the motivation of personnel. 相似文献
14.
Rob T. P. Jansen 《Accreditation and quality assurance》2000,5(9):363-366
Most efforts in quality control have been focussed on the reduction of intralaboratory variation and the assessment of interlaboratory
variation. Over the last few years, the importance of bias in interlaboratory variation and intralaboratory shifts has become
clear. Small shifts can sometimes have a large impact on the number of treated patients, particularly in assays where cut
off values are used. For example in cholesterol, HDL-cholesterol, HbA1c and TSH assays. There is an obvious need for adequate
calibration material. However, the process of development of international primary reference materials and reference methods
takes time, and even if reference materials exist and are used by in vitro diagnostics manufacturers, there still remains
significant and clinically relevant interlaboratory variance and intralaboratory shifts, as is seen, e.g. in protein chemistry.
The harmonization of inter laboratory and intralaboratory results needs an impulse from professional organizations to convince
individual laboratories of the importance and significance of bias. This applies to all subdisciplines of laboratory medicine.
On the occasion of the 25th anniversary of the Foundation for External Quality Assessment (SKZL), a large interdisciplinary
harmonization project called Calibration 2000 was launched in The Netherlands The strategy and first results are reported
in this paper. The project aims at harmonization of laboratory data of several disciplines, using secondary calibration materials,
leading to common reference ranges throughout The Netherlands.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
15.
Anti-HIV quality assurance programs in Australia and the southeast Asian and Western Pacific regions
A. Gust Sandy Walker Roderick J. Chappel Elizabeth M. Dax 《Accreditation and quality assurance》2001,6(4-5):168-172
Anti-HIV testing is the most regulated area of laboratory medicine in Australia. These regulations have placed the National
Sero-logy Reference Laboratory, Australia (NRL) in a unique position to implement a comprehensive quality assurance (QA) program
for HIV testing. The elements of our QA program include pre-market evaluation of assays, external quality assessment schemes
(EQAS), quality control, specificity monitoring, consultations, and training workshops. The results of the NRL EQAS for Australian
laboratories were compared with those of a program developed by the NRL for reference laboratories in the Southeast Asian
and Western Pacific (SEAWP) regions. For laboratories authorized to use tests for HIV in Australia, participation in the entire
QA program is mandatory, whereas the SEAWP EQAS program is voluntary. While the overall percentage of discrepant results for
these programs are similar, the percentage of false negatives, variation in laboratory results, and choice of assay differ.
These differences have decreased with time with improvements in assays and laboratory testing practices. The educational component
of both EQAS, which comprises workshops, laboratory questionnaires, consultancies, and newsletters, has had a critical impact
on the testing practices of laboratories.
Received: 30 October 2000 Accepted: 9 December 2000 相似文献
16.
P. Vermaercke 《Accreditation and quality assurance》2000,5(1):11-15
Quality has always been one of the key issues in laboratories in general and formal quality assurance (QA) in testing laboratories has gained popularity over the last decade. However, the implementation QA in research and development (R&;D) laboratories is still the domain of a few pioneers. We can even ask whether a QA system in research makes sense at all and if such a system really provides any added value? Difficulties with respect to the implementation of such a system are mainly associated with the nature of the research process itself. However, it is obvious that QA offers clear advantages in R&;D, if some critical success factors have been taken into account. An important issue is the selection of a good QA standard for R&;D. This is certainly not an easy task, since there are no specific standards. Fortunately, some useful international guides have been published recently. 相似文献
17.
Henry Travers 《Accreditation and quality assurance》2002,7(8-9):364-366
Providing laboratory external quality assessment (EQA) programs for countries in need requires special considerations not
ordinarily part of EQA for laboratories in industrialized countries. Cultural, professional, service and economic factors
must be understood and accommodated in order to carry out successful programs. Coordination of worldwide efforts for countries
in need requires more resources and planning than have thus far been devoted to the enterprise. 相似文献
18.
There is growing interest in setting up a general concept for quality management and quality control in research and development,
which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea
for a quality management system in all fields of research and development and will probably initiate broad discussion on this
delicate topic.
Received: 28 June 1998 · Accepted: 13 July 1998 相似文献
19.
The micro element content of food is an important quality index due to the action of these elements on human health. In this
article, we discuss how to ensure the reliability of analytical data on micro elements in order to truly represent the condition
of food. Sampling, treatment of the analytical sample, selection of the analytical method, standard solution, and certified
reference material, blank test, calibration of the instrument and equipment, application of the quality control chart, assessment
of the final analytical result, and quality assurance system are briefly described.
Received: 5 July 2001 Accepted: 19 November 2001 相似文献
20.
V. Dvorkin 《Accreditation and quality assurance》1999,4(5):207-211
The history and the present condition of external quality assessment (EQA) schemes for clinical laboratories in Russia are
described briefly. The creation of EQA programmes started in Russia in the 1980s. Now almost 20 years later these schemes
have been transformed. The National External Quality Assessment Scheme ensures quality control in the clinical chemistry sector
(more than 2000 laboratories) and is the most powerful scheme in Russia. The (Sistema Vneshnego Kontrola Katchestva, *) (BKK)
system, covering about 120 Russian laboratories, and a lot of local regional programmes (mainly in Siberia), is also very
active. The purposes and design of the operating programs, reference materials used, algorithms of estimation, modes of result
representation and development prospects are considered. The basic obstacle to the development of EQA schemes in Russia is
financial restriction. 相似文献