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A laboratory information management system (LIMS) can make a major contribution to the quality and therefore to the efficiency
and competitiveness of a laboratory. Since it can impact all aspects of a laboratory's organization it must be the key if
not the principal player of the laboratory's quality system. It should support the laboratory in establishing, maintaining
and applying quality procedures thereby enabling the laboratory to achieve its quality goals. As a tool, LIMS permits the
laboratory to input and use its own know-how and experience to optimize the total organization (internal and external) and
workflow of generated information. However, perceived "quality" in the context of an LIMS, can be viewed as being made up
of different facets such as the security, reliability and accessibility of information as well as its turn around time and
production cost. This paper reviews the role of a LIMS in the laboratory and the contribution that both system design and
functionality can have on "building quality ".
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
3.
R. Dybkaer 《Accreditation and quality assurance》1999,4(3):90-92
Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition,
are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency
to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family),
to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation
are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization
for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through
participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines
exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are
obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving
accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel.
The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
4.
K. Janssens L. Vincze B. Vekemans C. T. Williams M. Radtke M. Haller A. Kn?chel 《Fresenius' Journal of Analytical Chemistry》1999,363(4):413-420
The sensitivity and applicability of the synchrotron radiation induced X-ray microfluorescence (μ-SRXRF) spectrometer at
the Hamburg synchrotron laboratory Hasylab for the determination of the distribution of trace concentrations of rare-earth
elements (REE) in fossilized bone are discussed and critically compared to those of other trace analytical methods such as
instrumental neutron activation analysis (INAA) and LAMP-ICPMS (laser ablation microprobe inductively-coupled plasma mass
spectrometry). Measurements were carried out on two bone samples from contrasting terrestrial depositional environments at
Olduvai Gorge (Tanzania). Results indicate that the microdistribution of the REE in these biological materials is not homogeneous
and that the relative abundance of these elements can provide information on the palaeoenvironment during the fossilization
process. The heterogeneous distribution of the REE can be determined in a quantitative and completely non-destructive manner
provided the concentrations of individual REE are above 10 μg/g.
Received: 18 January 1998 / Revised: 6 October 1998 / Accepted: 10 October 1998 相似文献
5.
Quality management of laboratory medicine has become a hot topic at many conferences. Also, many national and international
organizations have created working groups and committees with the task of working out standards, guidelines or recommendations
for quality management of medical laboratories. We have observed that there is a great deal of interest not only from professional
and scientific organizations directly involved in medical laboratory tests, but also from accreditation and certification
bodies, from test laboratories in general, from in vitro diagnostic devices (IVD) manufacturers and their associations, and
from other medical laboratory suppliers. However, we found that all these parties were discussing from their own point of
view, without taking into account the position of other involved partners and that there was a need for creating a discussion
forum for quality management in clinical laboratories. So in 1995, we started the Antwerp conferences on quality (r)evolution
in clinical laboratories. The aim was to bring together all concerned partners and to establish a forum for brainstorming,
independently of any pressure group. The leitmotif for the Antwerp conferences (Fig. 1) is a chain model showing the interfaces
and relationships between all the partners involved in laboratory tests. During the conferences, this chain model has been
examined from different angles and a summary of the concepts evolving from the discussions can be found in the conference
abstracts and conference review reports in this journal. A Selection of ideas emerging from these conferences are presented
below.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
6.
Alain G. Verstraete 《Accreditation and quality assurance》1999,4(3):82-83
A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories
had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload
had been increased by the accreditation process but they did not think that the process had improved the quality of their
results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures
followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages
were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that
more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased
the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather
than in a non-accredited one.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
7.
D. G. Holcombe 《Accreditation and quality assurance》1999,4(4):133-138
The paper describes the experiences of a medium-sized analytical laboratory in implementing and developing a quality system
compliant with several standards. The effect of the laboratory's changing role and work pattern on the quality system are
considered. The laboratory costs are explored. The laboratory's particular experiences are shown to be consistent with recent
market research in the United Kingdom. Some of the factors a laboratory needs to consider in formulating a quality strategy
are described, including the possibility of joint assessments. Also, possible courses of development of the standards themselves
are suggested. These developments could simplify the existing situation where laboratories are forced into a quality approach
based on multiple standards and assessment.
Received: 1 October 1998 · Accepted: 26 January 1999 相似文献
8.
G. M. Overvliet 《Accreditation and quality assurance》1999,4(4):139-142
This article presents an overview of the practical experience acquired in two governmental medicines control laboratories
in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and
risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous
accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard
to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that
a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises
technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer
requirements.
Received: 1 October 1998 · Accepted: 21 December 1998 相似文献
9.
The paper covers the main principles of setting up and the function of the Russian system of metrological assurance of analytical
measurements for the production of light alloys and superalloys.
Received: 20 October 1998 / Accepted: 9 November 1998 相似文献
10.
Jianping Lin 《Fresenius' Journal of Analytical Chemistry》1999,363(7):706-707
The concentration of iodate in seawater samples was determined at various pH values using differential pulse polarography
(DPP). The sensitivity for the iodate determination decreased rapidly below pH 7 and above pH 9. The decrease below pH 7 may
be caused by conversion of iodate to iodide, followed by the successive formation of I2 and I3
–. The decrease above pH 9 is probably due to the combination of iodate and hydroxide. Theoretical calculations have demonstrated
that the optimum pH for iodate determination is above pH 7.4 for Po2 = 0.101 Pa.
Received: 14 July 1998 / Revised: 2 October 1998 / Accepted: 3 October 1998 相似文献
11.
On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement
(CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by
imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human
body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum
requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow
manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently
run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process.
Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional
organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint
Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has
still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
12.
A random error and accuracy estimation approach for polychlorinated dibenzo-p-dioxins (PCDD) and dibenzofurans (PCDF) analysis
is presented based on statistical treatment of all the data set registered in a run or in a bunch of uniform runs.
Received: 18 August 1998 / Accepted: 21 October 1998 相似文献
13.
R. Kaiser M. Friedrich T. Schmitz-Hübsch F. Sellam T. U. Kampen K. Leo D. R. T. Zahn 《Fresenius' Journal of Analytical Chemistry》1999,363(2):189-192
3,4,9,10-Perylenetetracarboxylic dianhydride (PTCDA) was deposited using organic molecular beam deposition (OMBD) onto various
substrates, i.e. mica(0001), Au(111) layers on mica, and Se-passivated GaAs(100). Layer thicknesses were from 2 to 30 nm.
Reflectance and transmittance measurements were performed in order to identify PTCDA absorption features and find suitable
laser wavelengths for subsequent Raman investigations. Despite the low thicknesses the Raman spectra reveal strong scattering
by the molecular vibrational modes, in particular above 1200 cm–1. Frequency shifts of various modes in the layers from their values in PTCDA source material may indicate the influence of
the substrates. Similar shifts were also observed in infrared spectra of the same materials.
Received: 5 August 1998 / Received: 25 October 1998 / Accepted: 26 October 1998 相似文献
14.
R. Kaiser M. Friedrich T. Schmitz-Hübsch F. Sellam T. U. Kampen K. Leo D. R. T. Zahn 《Analytical and bioanalytical chemistry》1999,363(2):189-192
3,4,9,10-Perylenetetracarboxylic dianhydride (PTCDA) was deposited using organic molecular beam deposition (OMBD) onto various
substrates, i.e. mica(0001), Au(111) layers on mica, and Se-passivated GaAs(100). Layer thicknesses were from 2 to 30 nm.
Reflectance and transmittance measurements were performed in order to identify PTCDA absorption features and find suitable
laser wavelengths for subsequent Raman investigations. Despite the low thicknesses the Raman spectra reveal strong scattering
by the molecular vibrational modes, in particular above 1200 cm–1. Frequency shifts of various modes in the layers from their values in PTCDA source material may indicate the influence of
the substrates. Similar shifts were also observed in infrared spectra of the same materials.
Received: 5 August 1998 / Received: 25 October 1998 / Accepted: 26 October 1998 相似文献
15.
M. Micov L. Turi Nagy D. Tunega M. Liška P. Perichta 《Theoretical chemistry accounts》1998,99(6):378-383
A method of solvation energy computation is proposed for ions and molecules in the environment of an ionic melt, based on
the approximation of the ionic melt as an ideal conductor. The method is used to compute equilibrium constants of some equilibria
in cryolite melt. Theoretically obtained results predict that aluminium is bound in tetrafluorocomplexes AlF4
−.
Received: 16 March 1998 / Accepted: 19 June 1998 / Published online: 7 October 1998 相似文献
16.
Subduction of Q-conjugacy representations and characteristic monomials for combinatorial enumeration
Shinsaku Fujita 《Theoretical chemistry accounts》1998,99(4):224-230
A new method of combinatorial enumeration is presented. The subduction of Q-conjugacy representations gives a characteristic subduction table and a characteristic monomial table. A cycle index is defined
on the basis of such monomials and used for combinatorial enumeration of isomers.
Received: 10 October 1997 / Accepted: 13 February 1998 / Published online: 17 June 1998 相似文献
17.
Substituent effects on the structure of radicals and parent hydrocarbons formed by isolated or condensed three-membered rings
have been investigated by Hartree-Fock, post-Hartree-Fock and density functional methods. The trends of structural parameters
computed for the hydrocarbon systems are in agreement with available experimental data. Substituent effects can be rationalized
in terms of interactions between localized orbitals obtained by natural bond analysis. The effects are even larger in free
radicals and can be analyzed using the same model.
Received: 13 March 1998 / Accepted: 13 July 1998 / Published online: 9 October 1998 相似文献
18.
The current state of production, certification and use of standard samples of aluminium- and titanium-based alloys with specified
contents of gas impurities is described. A list of the certified standard samples with a specified gas impurity content which
are available in Russia is presented.
Received: 20 October 1998 / Accepted: 9 November 1998 相似文献
19.
The adsorption of hexavalent chromium onto bone charcoal was studied as a function of time, amount of charcoal, pH, concentration
of chromium and sample volume. The cross interference with other elements was also investigated. Tests were carried out with
solutions of chromium(VI) at concentrations between 5 and 25 mg · L–1. Chromium removal efficiencies higher than 90% were achieved at pH = 1 using 2 g of bone charcoal and a stirring time in
the order of 30 min. Acid and alkaline pretreatments of bone charcoal did not improve the sorption capacity of bone charcoal
against Cr(VI). The presence of other ions had practically no influence on the chromium removal. The presence of a matrix
of tannery effluents did not reduce the removal capacity of bone charcoal for Cr(VI), but it was confirmed that only 47% of
Cr(III) can be removed using these conditions.
Received: 20 July 1998 / Revised: 4 October 1998 / Accepted: 10 October 1998 相似文献
20.
H.-J. Guchelaar L. Chandi O. Schouten W. A. van den Brand 《Fresenius' Journal of Analytical Chemistry》1999,363(7):700-705
A simple and adequate HPLC method was developed for screening of human urine for the following 17 diuretic drugs: acetazolamide,
bendrofluazide, bumetanide, canrenoic acid, chlorothiazide, chlorthalidone, clopamide, epitizide, etacrynic acid, furosemide,
hydrochlorothiazide, indapamide, mefruside, piretanide, spironolactone, torasemide, and triamterene. The assay involves extraction
from two 2 mL urine samples with ethyl acetate at pH = 5, washing with a phosphate buffer at pH = 6 and analysis by HPLC
using a reversed phase C18 column and ultraviolet detection with a diode array detector for all drugs (except triamterene)
using two eluents consisting of water, triethylamine, phosphoric acid and acetonitrile at different ratios and different pH
values. Triamterene is determined by direct injection of diluted urine onto the column and is measured by fluorescence detection.
The recoveries of the diuretic drugs were determined at two different concentrations and ranged from 43–110% (median: 87%)
which is sufficient to detect abuse of these drugs. The repeatability of the assay ranged from 1–12% (median: 5.5%).
Received: 13 July 1998 / Revised: 23 October 1998 / Accepted: 29 October 1998 相似文献