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1.
Haim Hacham Nurit Tetro Salit Kochavi-Azolai Nava Stern Dana Mizrahi Anna Lisenker Emanuel Gazit 《Accreditation and quality assurance》2007,12(8):409-413
The Department of Public Health Laboratories consists of five major laboratories located across the country of Israel: four
environmental laboratories performing microbiological and chemical testing of food and water products [accredited according
to International Organization for Standardization (ISO) 17025 since 1999) and a fifth laboratory that is dedicated to virology
testing (certified according to ISO 9000 since 2003). Historically, each laboratory operated independently and developed its
own quality assurance (QA). On November 2004, an important strategic decision was made: to unify all five laboratories’ QA
systems conformed to ISO 17025, ISO 15189, and ISO 9000—a transition from five laboratories operating independently in the
field of QA toward establishing a multisite laboratory. This process was considered and visualized as a major organizational
change and therefore raised some resistance among both QA managers and the professional laboratories’ management. Thus, it
was necessary to overcome the resistance and at the same time induce thoughts of ways of reshaping and formatting the new
and uniform quality manual and uniform standard operating procedures (SOPs). In September 2005, the first phase of the process
was completed, and all four environmental public health laboratories successfully passed a reaccreditation audit using a uniform
QA manual guide and partially uniform SOPs. We shall share our experience and discuss the major contributions of this process
to overall laboratory management.
Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel. 相似文献
2.
Proficiency testing as a means of external quality assessment plays the role of independent evidence of laboratories’ performance.
To enable laboratories to fulfil the requirements stated in legislation, methodology for evaluation of laboratories’ performance
in proficiency testing schemes should incorporate principles of measurement results which are fit for intended use and incorporate
evaluation of laboratories’ performances based on independent reference value. A proficiency testing scheme was designed to
support Drinking Water Directive (98/83/EC) specifically. The methodology for performance evaluation, which takes into account
a “fitness for purpose”-based standard deviation for proficiency assessment, is proposed and discussed in terms of requirements
of the Drinking Water Directive. A ζ′-score, modified by application of target uncertainty was developed in a way that fulfils requirements defined in the legislation.
As an illustration, results are reported for nitrate concentration in water. The approach presented can also be applied to
other fields of measurements. 相似文献
3.
Victoria Ivanova Thierry Boghosian Olivier Rabin 《Accreditation and quality assurance》2007,12(9):491-493
This article provides a brief perspective of the World Anti-Doping Agency (WADA) in the context of the fight against doping
in sport and of the WADA Proficiency Testing Program as an essential element of the World Anti-Doping Program. The WADA Proficiency
Testing Program exists within the framework of the WADA-accredited laboratories and is aimed at improving the effectiveness
of the fight against doping by testing the ability of the laboratories to reliably identify and measure the substances and
methods defined in the WADA Prohibited List. The paper provides an overview of the WADA Proficiency Testing scheme with respect
to organization, test composition and evaluation of anti-doping methods and techniques. Scientific research is mentioned in
the context of WADA’s involvement in generating reference materials for improvement of analytical activities of the WADA-accredited
laboratories. WADA’s funding of a reference material for 19-norandrosterone in human urine is illustrated as an example. 相似文献
4.
Anita Schmidt 《Accreditation and quality assurance》2001,6(6):277-278
The 5th Eurolab Symposium on 4th and 5th October in Edinburgh was the highlight event of Eurolab in 2000, Eurolab’s 10th anniversary
year. Under the title: ”Confidence in Testing Services – new expectations, new rules, new challenges” it reflected recent
changes and developments in the laboratory scene and focussed on new tasks and challenges. The most essential changes for
laboratories are connected with the new standard ISO/IEC 17025 ”General requirements for the competence of testing and calibration
laboratories”. Keywords in this respect are uncertainty of measurement and traceability to SI units, requirements on personnel,
proficiency testing, customer orientation, and management systems. 相似文献
5.
Kris Vernelen Michael A. Noble Jean-Claude Libeer 《Accreditation and quality assurance》2008,13(9):501-504
Clinical Microbiology Proficiency Testing (CMPT; Canada) and the Institute of Public Health (IPH; Belgium) set up a joint
external quality assessment (EQA) project in which they sent identical simulated clinical samples to their respective participants.
Samples were sent out as throat swabs containing Streptococcus pyogenes (as pathogen) and viridans streptococci (as commensal). Results from identification by the Belgian laboratories were excellent:
99.5% detected the group A streptococci. About 10% of the Canadian laboratories reported the absence of reportable β-haemolytic
streptococci, although for most of them the issue was one of non-examination of small or pin-point streptococci. Overall,
Canadian and Belgian laboratories performed well in this EQA; the joint project clearly showed that although many similarities
exist, there are differences between laboratories in treating EQA samples and reporting results. 相似文献
6.
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
7.
Siu Kay Wong 《Accreditation and quality assurance》2005,10(8):409-414
Proficiency testing (PT) is an essential tool used by laboratory accreditation bodies to assess the competency of laboratories.
Because of limited resources of PT providers or for other reasons, the assigned reference value used in the calculation of
z-score values has usually been derived from some sort of consensus value obtained by central tendency estimators such as the
arithmetic mean or robust mean. However, if the assigned reference value deviates significantly from the ‘true value’ of the
analyte in the test material, laboratories’ performance will be evaluated incorrectly. This paper evaluates the use of consensus
values in proficiency testing programmes using the Monte Carlo simulation technique. The results indicated that the deviation
of the assigned value from the true value could be as large as 40%, depending on the parameters of the proficiency testing
programmes under investigation such as sample homogeneity, number of participant laboratories, concentration level, method
precision and laboratory bias. To study how these parameters affect the degree of discrepancy between the consensus value
and the true value, a fractional factorial design was also applied. The findings indicate that the number of participating
laboratories and the distribution of laboratory bias were the prime two factors affecting the deviation of the consensus value
from the true value. 相似文献
8.
A soil proficiency test (PT) was administered to 50 participant laboratories in which two sets of samples, consisting of 20 yearly
PT samples and 5 ‘blind’ samples in clients’ names were analyzed for pH, organic matter, total acidity, extractable calcium,
magnesium, potassium and phosphorus by the laboratories. Our objective was to determine whether laboratories take extra care
to analyze clients’ samples as they do with regular PT samples. The analytical data were evaluated essentially by the procedure
described in the international harmonized protocol for proficiency testing of analytical chemistry laboratories. Performance
of participant laboratories was assessed by z-scores and summary z-scores statistics involving sum of squared z-scores interpreted as chi-square ( cn2 ) \left( {\chi_{n}^{2} } \right) distribution for zero-centered z-scores with unit variance. From 8 750 determinations, outliers and stragglers accounted for less than 2% of the entire data.
Over 93% of the data were satisfactory, whereas between 2 and 4% were either unsatisfactory or questionable in both the PT
and ‘blind’ tests. On the basis of sum of squared z-scores interpreted from cn2 \chi_{n}^{2} distribution table, between 30 and 40% of the laboratories had more than 90% probability of having their measurement data
within the robust mean and standard deviation for each soil parameter, while another 30–42% of the laboratories had less than
50% probability of having measurement data within the robust mean and standard deviation. Overall, 21 laboratories (42%) were
ranked in Class A either in the PT or ‘blind’ tests out of which 12 of them (57%) retained this ranking in both tests. Fourteen
laboratories (28%) were ranked in Class C in either the PT or ‘blind’ tests with only 5 of them (36%) consistently ranking
in this class in both tests. 相似文献
9.
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
10.
Daniel W. Tholen 《Accreditation and quality assurance》2002,7(4):146-152
There is evidence to support the notion that interlaboratory comparisons (ILCs) are an effective tool for laboratory improvement.
However, despite widespread experience and anecdotal evidence of improvements there are few published studies demonstrating
any benefits from ILCs– in any field of testing. Published demonstrations of benefits can help justify the growing use of
ILCs. ILCs and proficiency testing have been common for many years in medical laboratories; there has been open information
on the results of ILCs, and there has been standardization of results from thousands of laboratories. These studies show general
improvement over time in several areas of testing in different countries. Many articles cite specific reasons for the improvements,
either proven or supposed. An early version of this paper was presented at the International Laboratory Accreditation Cooperation
Conference ”ILAC 2000” in Washington D.C., on 31October, 2000.
Received: 10 February 2001 Accepted: 21 January 2002 相似文献
11.
A. Chabirand G. Anthoine O. Pierson B. Hostachy 《Accreditation and quality assurance》2014,19(2):111-125
The use of methods of analysis capable of producing reliable analytical results is a prerequisite to the effective control of quarantine plant pathogens. Proficiency testing is considered to be one of the most reliable ways to verify and coordinate analytical results. As a French national reference laboratory in plant pathology, the Anses Plant Health Laboratory organizes proficiency tests in order to ensure that officially approved laboratories (certified by government services) are capable of producing reliable analytical results for the detection of plant pathogens. Proficiency tests in plant pathology have a number of notable features including the processing of qualitative results. This paper presents the experience of the Anses Plant Health Laboratory’s Unit for Tropical Pests and Diseases (LSV-RAPT) as an organizer of proficiency tests in plant pathology. The LSV-RAPT has gained recognition for the methodology it has developed in the form of accreditation as a proficiency testing provider according to the ISO/IEC 17043. The methodology can be applied to many other disciplines that use qualitative detection methods. 相似文献
12.
P. S. Unger 《Accreditation and quality assurance》2001,6(12):521-522
As of August 2001, 38 laboratory accreditation bodies of the International Laboratory Accreditation Cooperation (ILAC) have
signed the multi-lateral, mutual recognition arrangement (the ”ILAC Arrangement”) to promote the acceptance of accredited
test and calibration data. This Arrangement provides significant technical underpinning to international trade. Until now,
there has been no international mutual recognition agreement in laboratory accreditation, which has been a hindrance for some
types of international trade. The key to the Arrangement is the developing global network of accredited testing and calibration
laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies. The signatories
have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. Now that the ILAC Arrangement is in place,
governments can take advantage of it to further develop or enhance trade agreements. The ultimate aim is increased use and
acceptance by industry, as well as government, of the results from accredited laboratories, including results from laboratories
in other countries. In this way, the free-trade goal of ”a product tested once and accepted everywhere” can be realised. 相似文献
13.
In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA) (). The CLIA link test quality and adherence to a body of testing regulations intended to ensure accurate, reliable, and timely patient test results. The goal of the CLIA legislation was to ensure a minimum, fundamental level of quality. In the context of “NEXUS,” quality must “go beyond getting the ‘right’ answer on the ‘right’ patient that can be interpreted against ‘right’ reference values. CLIA regulations with specific minimum, performance requirements, or safeguards, are designed to prevent testing errors. The US Institute of Medicine found that testing processes fail as a result of human error, lack of documentation, and lack of test management. In the latest (2004) interpretations of CLIA regulations, the minimum quality control requirement continues to be analyzing at least two external, liquid quality control materials per test per day. In 1995, we proposed that the responsibility for achieving quality test results shifts from the sole purview of the laboratory director to an “alliance” of laboratory professionals, manufacturers, and regulators. The EQC (equivalent quality control) concept as proposed is a positive step in achieving this alliance. With the obvious lack of scientific and statistical robustness, EQC falls far short of ensuring quality. Achieving the “NEXUS Vision” for quality laboratory testing will not come solely from laboratory professionals. The NEXUS is about how to ensure the full-quality assessment of the testing process – pre-analytical, analytical, and post-analytical.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium. 相似文献
14.
Rodrigo Irani Medeiros Nelson Roberto Antoniosi Filho Maria Inês Gon?alves Leles 《Journal of Thermal Analysis and Calorimetry》2009,97(1):337-342
The objective of this work is the TG and DSC analysis of “Merla” samples as well as the separation and identification of organic
compounds by Ultra Fast GC method. The obtained results showed the grouping and the establishment of the degree of the sample’s similarity based in
the Euclidean Distance. The cluster was a useful tool to determine if the samples, confiscated from different users by police,
were manufactured in the same or different laboratories. Consequently one can conclude if in any city operates one or more
drug manufacturing laboratories. 相似文献
15.
For over 10 years now various expert systems have been on the market, but very few have reached the level of performance of
Validation Assistée pour les Laboratoires d’Analyses Biologiques (VALAB). Over 25,000 rules are combined through an inference
engine to reproduce human reasoning in the complex ”biological validation” process. After a review of the product concept
and its development program, we will see how this ”intelligent” tool can bring quality to clinical laboratories, from a production
as well as legislation point of view. With more than 140 laboratories using VALAB in Europe in daily routines, our designer
and vendor experience in installation, maintenance, upgrading, reliability, efficiency, and liability is excellent.
Received: 9 October 2001 Accepted: 22 July 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium
Correspondence to E. Rogari 相似文献
16.
This paper briefly summarises the current situation for proficiency testing (PT) in China, outlines the policy for PT of China’s
national accreditation committee for laboratories (CNACL), and exemplifies activities of the CNACL’s metal working group.
Received: 9 December 2000 Accepted: 14 December 2000 相似文献
17.
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
18.
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
19.
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
20.
N. Majcen 《Accreditation and quality assurance》2003,8(3-4):108-112
The fact that various definitions and terminology applied to measurements in analytical chemistry are not always consistent
and straightforward, by not only answering the question ”what”, but also ”how”, leads to their various interpretations. This
results in non-uniform implementation of very basic and essential metrological principles in chemistry. Such a diverse situation
is not conducive to the endorsement of harmonised measurements all across the world, to serve as a tool for improving the
quality of life in its broadest sense for all its citizens. The discussion in this paper is focused on problems associated
with terminology and definitions of ’reference material’ and ’validation’. The role of reference materials in measurement
processes for purposes other than calibration and validation principles in analytical chemistry are also discussed in this
paper. Where possible, potential solutions are proposed, but more often, questions of essential importance are raised in order
to initiate international discussion which will hopefully lead to equally understandable answers.
Received: 2 November 2002 Accepted: 3 February 2003
Acknowledgements
The author is grateful to Aleš Fajgelj for his comprehensive comments on the topic described in this paper. Sincere thanks
also to Philip Taylor, Ewa Bulska, Emilia Vassileva, Miloslav Suchanek and Margreet Lauwaars for their contribution during
fruitful discussions on validation.
Presented at the CERMM-3, Central European Reference Materials and Measurements Conference: The function of reference materials
in the measurement process, May 30–June 1, 2002, Rogaška Slatina, Slovenia
Correspondence to N. Majcen 相似文献