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1.
Public Health Laboratories (PHL) as part of Public Health Services are involved in law enforcement and ensuring food and water
quality. The laboratories had to go through an organizational and monetary change imposed by the growing and changing needs
of the state of Israel. The laboratories had to become more modern and to implement new and more sophisticated testing methods.
Another requirement was to perform a steadily increasing number of tests and to be more flexible towards customers’ demands.
Yet, the budget was not changed accordingly, as the Public Service to which the laboratories belong to do not respond to changing
needs. Management realization was that the accreditation process could be used as a tool to achieve organizational and cultural
change. Understanding and transformation were required throughout the organization, including management. Proficiency testing
is performed for all testing methods in all areas even for non-accredited tests such as clinical tests. Proficiency testing
was used as a tool for organizational culture change. It is a great index with game elements, that gives employees and managers
the possibility for comparison, fixing problems and corrective action. The demands of ISO 17025 made it necessary to change
peoples’ attitudes and views on both professional and communication levels. Laboratory quality consists now on the four main
principles, described in the 5M&E model which is typical to small organizations and which ensures a constantly improving system:
”Policy statement”, ”Machine”, ”Material”, ”Measurement”, ”Method”, ”Manpower”, and ”Environment” targeted to achieve ”Quality
upgrade”. Slowly we succeeded in providing better and more reliable services and have increased our income on what would hopefully
become our way to financial independence. We hope this process would provide the Ministry of Health with a better chance to
public health using the same financial sources.
Received: 25 October 2000 Accepted: 12 December 2000 相似文献
2.
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
3.
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
4.
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
5.
F. Macá?ek P. Ková? P. Rajec R. Lepej 《Journal of Radioanalytical and Nuclear Chemistry》2009,280(2):389-400
Except the nuclear fuel reprocessing and nuclear materials safeguards, at present there are two areas of an increased responsibility
of nuclear scientists for their results: radioecology and human medicaments. At both of them, quality and trustfulness of
results is of great importance for their end-users and may have serious economical and legal consequences. The trends of implementation
of good laboratory and manufacturing practices under umbrella of international quality management standards like ISO 17025:2005
and ISO 9001:2000 in radiochemical and radiopharmaceutical laboratories are discussed as expanding to “good scientific practice”.
The case studies of the Comenius University laboratory LARCHA authorized for radiochemical analysis, and the company BIONT
producing medical radionuclides and PET radiopharmaceuticals are used as the examples. 相似文献
6.
P. Tighe 《Accreditation and quality assurance》2000,5(12):488-490
The need for “quality” in near patient testing (NPT) has been acknowledged since the mid 1980s. The commonest biochemical
NPT device is the dry reagent strip or “dipstick” for urinalysis. Dipsticks may be read in three ways, against the color chart
printed along the side of the bottle, using a benchreader (the color chart printed on a flat card) or using an electronic
reader. This report uses the results of a urinalysis quality assurance (QA) program, over 1998, to evaluate the “error” rates
which occur using the three different reading methods. The QA samples are buffered aqueous solutions which are “spiked” to
give concentrations midway between two color blocks for each analyte. Results are scored as ±1 if a color block adjacent to
the target value, ±2 for results two color blocks (defined as “error”) and ±3 for results three color blocks (defined as “gross
error”) from the target value. Analysis of the results show that the error rates are similar reading visually by either method,
but greatly reduced when read electronically. Some persisting errors when using the electronic reader are explained by observation
studies. The study highlights the value of a urinalysis QA program for NPT urinalysis in understanding the error rates of
this simple but ubiquitous test.
Received: 10 July 2000 / Accepted: 10 July 2000 相似文献
7.
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
8.
David Lee Duewer 《Accreditation and quality assurance》2008,13(12):725-726
The distribution of interlaboratory results can often be successfully modeled as a mixture of distributions: a “majority”
population of results from laboratories of high and roughly equal competence and a (hopefully) minority “contaminant” population
from laboratories of lesser competence. Approximating the majority population as a normal distribution and the contaminant
as a uniform distribution can be and has been used to produce mixture populations that have realistically “heavy-tails” (i.e.,
leptokurtic).
Papers published in this section do not necessarily reflect the opinion of the Editors, the Editorial Board and the Publisher. 相似文献
9.
This paper presents the result of an investigation concerning which areas of EN 45001 are considered as especially problematic
by small laboratories (<10 employees). The investigation was performed by distributing questionnaires to European laboratories.
To be able to differentiate between areas considered as problematic only by small laboratories and areas considered as problematic
by laboratories in general, some questionnaires sent in by larger (>10 employees) laboratories were used. The determination
of measurement uncertainties within reasonable efforts and the requirements to take part in round robin and proficiency testing
were considered problematic by laboratories of all sizes. Training is an area where small laboratories have specific problems
and so are the requirements for the identification of all equipment. Other problematic areas for small laboratories are areas
were there are needs for personnel, e.g. appointing supervising personnel and expenditure for internal audits. The last area
to be considered as problematic is matters concerning documentation. Finally some advice concerning assessment of small laboratories
is given.
Received: 25 February 2000 / Accepted: 20 April 2000 相似文献
10.
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
11.
As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system. 相似文献
12.
Martina Bednarova Yetunde Aregbe Caroline Harper Philip D. P. Taylor 《Accreditation and quality assurance》2006,10(11):617-626
The aim of International Evaluation Programme (IMEP) is to present objectively the quality of chemical measurements. Participants in IMEP compare their reported measurement results with independent external certified reference values with demonstrated traceability and uncertainty, as evaluated according to international guidelines. Three major interlaboratory comparisons (ILCs), IMEP-6, IMEP-9 and IMEP-12, on trace elements in water were carried out from 1994 to 2000. Participants' results for Cd, Fe and Pb concentrations from these three different IMEP water ILCs were compared by means of suitable performance indicators. The performance evaluation criteria were set according to the requirements stated in the Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Two different performance indicators were selected for evaluation of the individual participants' results: the commonly used z-score and the not so well-known E
n
number. The group performance indicator is based on the variation of z-scores. To assess the individual measurement performance, not only the deviation of the reported measurement values from the certified reference value, but also criteria for maximum and minimum acceptable uncertainties were taken into account. The participants' performance is also reviewed by means of using a simple graphical tool, called “Naji-plots”. 相似文献
13.
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
14.
N. E. Bores M. K. Schultz J. M. Rankin A. J. Denton G. F. Payne 《Journal of Radioanalytical and Nuclear Chemistry》2009,282(3):985-990
The Intercomparison Studies Program (ISP) at the Oak Ridge National Laboratory (ORNL, Oak Ridge, TN USA) provides natural-matrix
human urine quality-assurance/quality-control (QA/QC) samples to radiobioassay analysis laboratories. Samples are provided
to these laboratories as “single-blind” or “double-blind” unknowns, spiked with radioactive-solution standards at “low” levels
(e.g., 0.7–7 Bq g−1 for 3H and 0.7–7 Bq kg−1 for 90Sr). Participants use the results as a tool for self-evaluation and a measure of performance. In this paper, sample preparation
and the results of testing during the years 2001–2005 for 3H and 90Sr are presented and discussed. 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.
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
17.
D. A. Wade C. Mao A. C. Hollenbeck S. A. Tucker 《Analytical and bioanalytical chemistry》2001,369(3-4):378-384
The ability of pyridinium chloride (PC) to selectively quench alternant as opposed to nonalternant polycyclic aromatic hydrocarbons
(PAHs) in organized media is examined. PC was previously shown to be a selective quenching agent of alternant PAHs in neat
polar solvents. Carboxylate-terminated poly(amido) amine (PAMAM-CT) dendrimers and anionic surfactants – sodium dodecanoate
(SD), sodium octanoate (SO), and sodium dodecylsulfate (SDS) – were chosen as the solubilizing media for this study. Selective
quenching of alternant PAHs is observed in the presence of the SDS and SO micelles. However, the extent of PAH quenching in
SO is significantly reduced compared to PAHs dissolved in either water or SDS micelles. In the case of the smaller generation
4.5 (G4.5) PAMAM-CT dendrimers, PC was prevented from quenching both alternant and nonalternant PAHs to any appreciable extent.
The dendrimer is able to “protect” the PAHs from the PC quencher that resides at the dendrimer surface. Both, SD and G5.5
PAMAM-CT precipitated out of solution with the addition of PC. Differences between traditional micelles and “unimolecular
micelle” dendrimers were also examined. These studies further confirm that the PAHs did not reside in the “analogous” palisade
region of the dendrimers as they do in micelles. The PAHs must reside in the outermost branches of the dendrimer, but sufficiently
far enough away from the charged surface groups, where PC associated, to prevent fluorescence quenching. This work further
illustrates the differences between “unimolecular micelle” dendrimers and traditional micelles.
Received: 27 July 2000 / Revised: 25 September 2000 / Accepted: 27 September 2000 相似文献
18.
Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000
standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top
management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness,
and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing
the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation
of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data
collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data
must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources,
etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are
taken that improve the effectiveness of the quality-management system. As output from the management review process, there
should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements;
corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the
processes involved and using the process approach in the management review ensures the continual improvement of the quality
system.
Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium. 相似文献
19.
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
20.
S. Rückold K. H. Grobecker H.-D. Isengard 《Fresenius' Journal of Analytical Chemistry》2000,368(5):522-527
According to official methods the moisture content of milk powders is determined by drying techniques and the loss of mass
defined as water content. The mass loss, detecting the volatiles evaporated under the applied conditions, is strongly dependent
on the drying parameters. An ideal method should be able to determine “free water” without including “bound water” in the
result. Two collaborative studies showed that drying methods are not capable of distinguishing between different binding forms
of water and only the total water content, measured with Karl Fischer titration, provides results which can be attributed
to a defined physical property. Results from two European collaborative studies are employed to evaluate three different drying
techniques and Karl Fischer titration. Adsorption isotherms of skimmed milk powder at different temperatures were used to
calculate the isosteric heat of sorption.
Received: 3 April 2000 / Revised: 17 May 2000 / Accepted: 24 May 2000 相似文献