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1.
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
2.
Rainer A. Schmidt 《Accreditation and quality assurance》2001,6(4-5):178-180
There are many different means of demonstrating the quality of performance of an analytical laboratory. Proficiency testing
(PT) is just one! As in other analytical fields, interlaboratory comparisons play an important role in the chemical industry.
Collaborative trials or method performance studies do have a long tradition in this field. Sometimes they were designed as
laboratory performance studies with the clear aim of making analytical results comparable, e.g. petrol, coal, gas, noble metals
analyses – not to mention the biggest PT scheme run on a daily world-wide basis – trade itself. All this is an ongoing process,
which started long before the idea of assessing and accrediting the performance of analytical laboratories was born. However,
when striving for accreditation in 1996, the analytical production laboratories of the Chemicals Business Unit of the Bayer
AG in Germany implemented another facet of PT schemes. In-house-PT schemes are performed regularly and turned out to be useful
in evaluating, monitoring, and thus improving, the quality of routine analytical work.
Received: 5 December 2000 Accepted: 15 January 2001 相似文献
3.
S. S. Tahir Rauf Naseem Anwar ul Haq Khalid Saeed 《Accreditation and quality assurance》2005,10(7):362-368
This inter-laboratory comparison study was arranged for 28 laboratories from different public and private sector organizations
in Pakistan having wastewater testing capabilities aimed at improving the quality and comparability of test results. This
national inter-laboratory study was started in December 2003 and completed in July 2004. Laboratories were invited to analyze
the wastewater collected from printed circuit board (PCB) industry for lead and copper contamination. The samples fulfill
the criteria for homogeneity and stability as done by the reference laboratory. The results obtained from participating laboratories
were analyzed in terms of Hampel Test for outliers, while the performance evaluation of the participating laboratories was
done on the basis of Z-score. An assigned value derived from the participant's results was compared with a reference value provided by a reference
laboratory. Overall >50% of the participating laboratories have shown good performance in this PT-program 相似文献
4.
Ian Robert Juniper 《Accreditation and quality assurance》1999,4(8):336-341
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 相似文献
5.
Stanley Rasberry 《Accreditation and quality assurance》2001,6(6):252-256
Traceability implies comparison of the results of measurements, or comparison to national or international measurement standards.
One of several approaches that have been used in chemistry to provide for such comparisons is distribution of proficiency
evaluation materials which have been measured by a reference laboratory. A newer approach is based on receipt and measurement
at a reference laboratory of materials that have been produced and analyzed by other laboratories. Traceability concepts and
approaches to realization will be described together with discussion of the relative merits of various approaches. Extension
into metrological fields other than chemistry will also be explored.
Received: 14 November 2000 Accepted: 11 December 2000 相似文献
6.
Siu-kay Wong 《Accreditation and quality assurance》2011,16(11):539-544
Proficiency testing (PT) is an essential tool for laboratories to assess their competency. Also, participation in PT has become
one of the mandatory requirements for laboratory to seek accreditation according to ISO/IEC 17025. For this reason, the effectiveness
of performance evaluation by PT scheme is of great concern for the participants and for accreditation bodies as well. In practice,
owing to unavailability of other appropriate alternatives, PT scheme providers may have to choose using consensus values to
evaluate the performance of participants. However, such consensus values approach was not recommended by relevant international
guidelines for PT schemes with limited number of participants. With the use of Monte Carlo simulation technique, this study
attempted to investigate the effectiveness of using consensus values for performance evaluation in PT schemes with limited
number of participants. The simulation process was schemed according to the statistical model provided by ISO 5725-1 for laboratory
measurement results, which covered components like method bias, laboratory bias, and measurement precision. The effectiveness
of the consensus value approach was expressed as the percentage of participants in a simulation run could get the same evaluation
result, either satisfactory or unsatisfactory, against the “true value.” The findings indicated that the number of participants,
choice of consensus values, mass fraction of analyte, method bias, laboratory bias, and measurement repeatability of participating
laboratories would all affect the effectiveness of the consensus value approach but at different extent. However, under certain
circumstances, use of consensus value could still be considered as an acceptable approach for performance evaluation even
the number of participants was limited. Some of the findings were further verified using real data from PT schemes where appropriate
certified reference materials or reliable reference values were available. 相似文献
7.
P. Bode K. Heydorn R. W. Innes R. Wood R. Zeisler 《Accreditation and quality assurance》1998,3(5):197-202
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 相似文献
8.
Marina Patriarca Ferdinando Chiodo Marco Castelli Federica Corsetti Antonio Menditto 《Microchemical Journal》2005,79(1-2):337
The Me.Tos. Project, started in 1983 and still running, is an external quality assessment (EQA) scheme for laboratories performing specialized analyses in occupational and environmental laboratory medicine. Besides the organization of EQA exercises, initiatives for further education of the participants and the harmonization of EQA procedures at a European level are carried out. Participation in EQA schemes allows laboratories to comply with the international standards for the quality and competence of testing and clinical laboratories. The organization of the scheme includes the preparation of control materials, their distribution to the participants, according to strategies aimed to avoid identification of the samples, the statistical analysis of the results and the evaluation of laboratories' performance according to international guidelines and criteria set by the organizers. An overview of the scheme operation and the current performances of participants will be given. 相似文献
9.
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
10.
N. P. Boley Paul De Bièvre Philip D. P. Taylor Adam Uldall 《Accreditation and quality assurance》2001,6(6):244-251
Many laboratories take part in proficiency testing schemes, external quality assessment programmes and other interlaboratory
comparisons. These have many similarities but also important differences in their modus operandi and evaluation of performance of participating laboratories. This paper attempts to highlight both the similarities and differences. It also puts particular emphasis on requirements
called ”target values for uncertainty” and their meaning.
Received: 24 January 2001 Accepted: 25 January 2001 相似文献
11.
David W. Holt 《Accreditation and quality assurance》2000,5(9):389-391
This report addresses the proposition: current proficiency testing (PT) schemes for therapeutics and toxicology can easily
engender complacency. The proposition was based on the premise that there are substantial between-laboratory differences and
objectives in the supply of services for the measurement of drugs, as a result of which it is difficult to design PT schemes
which adequately cover the requirements of all laboratories. Thus, acceptable performance in a PT scheme may lead participants
to consider that they have tested their procedures more rigorously than is the case. Four areas, validity of the PT scheme,
PT material, frequency of testing and acceptance criteria are examined.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
12.
Andrew Taylor Jurgen Angerer Josiane Arnaud Françoise Claeys Robert L. Jones Olav Mazarrasa Eric Mairiaux Antonio Menditto Patrick J. Parsons Marina Patriarca Alain Pineau Sinikka Valkonen Jean-Philippe Weber Cas Weykamp 《Accreditation and quality assurance》2006,11(8-9):440-445
Quality specifications (QS) are proposed for lead in blood and for aluminium, copper, selenium and zinc in serum as part of the aim to set standards of performance for laboratories so that results can be demonstrated to be fit for the purpose to which they are applied. The QS were established taking account of the analytical state-of-the-art, physiological variations in the concentrations of the analyte and the clinical purpose for which the assay is to be used. A procedure was devised that uses these QS to give equivalence of assessment among external quality assessment schemes (EQAS), thus avoiding conflicting information which has been demonstrated in the past. Advantages of this procedure are: to provide direct comparison of performance of laboratories taking part in different schemes, to provide equivalence of assessment of laboratory performance necessary to establish mutual recognition agreements, and to demonstrate the fitness for purpose of results from participants.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia 相似文献
13.
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
14.
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. 相似文献
15.
H. H. Siegrist V. Pünter-Streit A. von Graevenitz 《Accreditation and quality assurance》1998,3(5):203-207
The Swiss External Quality Assessment Scheme in Bacteriology and Mycology was created in 1980 and has been organised since
1983 by the Department of Medical Microbiology in Zurich. The number of Swiss participants has steadily risen from 66 in 1989
to 92 in 1996. Twelve bacterial and fungal strains are sent to the participants in four despatches, each containing three
specimens, per year. Scores are allocated per specimen and range between 0 and 1. Participants with mean scores of ≤0.75 are
considered poor performers. The mean scores increased from 0.85 in 1992 to 0.91 in 1996. This improvement can be attributed
to the educational effect of the external quality control scheme, since all participants receive a detailed discussion for
each specimen together with their individual results. On average, both large University and Cantonal (state) laboratories
as well as private laboratories show satisfactory performance. In particular, laboratories officially recognised by the Swiss
Federal Office of Public Health (SFOPH) rate better than non-recognised participants. Many small regional hospital laboratories,
most of them not SFOPH-recognised, are often among the poor performers. They are often managed by technical staff and lack
a trained microbiologist. The recently introduced legislation in Switzerland renders participation in external quality assessment
schemes compulsory, and all clinical microbiology laboratories are required to employ qualified microbiologists. This will
certainly help to improve the quality standards of all laboratories performing microbiological tests.
Received: 13 November 1997 · Accepted: 28 December 1997 相似文献
16.
Göran Nilsson 《Accreditation and quality assurance》2001,6(4-5):147-150
Data from proficiency testing can be used to increase our knowledge of the performance of populations of laboratories, individual
laboratories and different measurement methods. To support the evaluation and interpretation of results from proficiency testing
an error model containing different random and systematic components is presented. From a single round of a proficiency testing
scheme the total variation in a population of laboratories can be estimated. With results from several rounds the random variation
can be separated into a laboratory and time component and for individual laboratories it is then also possible to evaluate
stability and bias in relation to the population mean. By comparing results from laboratories using different methods systematic
differences between methods may be indicated. By using results from several rounds a systematic difference can be partitioned
into two components: a common systematic difference, possibly depending on the level, and a sample-specific component. It
is essential to distinguish between these two components as the former may be eliminated by a correction while the latter
must be treated as a random component in the evaluation of uncertainty.
Received: 20 November 2000 Accepted: 3 January 2001 相似文献
17.
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
18.
Petronella Mathilda van Berkel 《Accreditation and quality assurance》2001,6(4-5):210-213
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. 相似文献
19.
M. Plebani 《Accreditation and quality assurance》1999,4(3):84-86
The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories
is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like
the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these
independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance
and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not
the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement
is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related
to a high-quality laboratory service. 相似文献
20.
Data from various proficiency testing schemes, operated by LGC Standards, was collated and reviewed to determine whether regular involvement within third party, proficiency testing, either over a prolonged period of time or via multiple participation, had improved the performance of those laboratories taking part. Three statistical evaluations were applied to historical PT results, a review of improvements over time, demonstrated by the evaluation of satisfactory performance scores achieved, a review of the relative robust standard deviations obtained from multiple methods and a focused review of one analyst participating in proficiency testing over a prolonged period of time. In each case the data indicated that long term participation and evaluation via proficiency testing had resulted in consistent and sustained improvements in laboratory performance. 相似文献