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1.
Healthcare is changing and clinical laboratory testing must change with it. In no discipline is this change more profound
than in hematology. The principles of total quality management (TQM) including continuous quality improvement, reengineering
and strategic planning can facilitate these changes. In the past, hematology has often been exlcuded from these processes
due to its many manual procedures and the degree of expertise and skill needed to perform the testing. As automated technology
continues to evolve, hematology testing, like other testing, will become integrated into the core, clinical laboratory. We
suggest TQM can, and should, guide the way.
Received: 15 April 2000 · Accepted: 19 April 2000 相似文献
2.
Hans Küffer 《Accreditation and quality assurance》2000,5(9):374-376
The laboratories of six hospitals in the Canton of Wallis in Switzerland have been connected to one central laboratory, using
the same database, the same software applications for the laboratory, pathology and pharmacy, and the same office and administration
software. Some instruments in "Point of Care" sites are online for result transmission and for telemaintenance. The physicians
may order drugs, material for sampling, analyses for specified patients and may consult knowledge bases, the patient data
base, results and reports in different formats (ASCII, HTML, PDF, JPG, GIF, ...) using browsers like Netscape or MS-Explorer.
To guarantee privacy, the access is restricted and protected by user-name, password and firewall. This report describes conditions for a successful introduction and usage of quality management through laboratory telematics.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
3.
Anders Kallner 《Accreditation and quality assurance》2000,5(9):397-398
In Stockholm a conference entitled: "Strategies to Set Global Quality Specifications in Laboratory Medicine" was held in
April 1999. The primary aim in organizing the Conference was to provide a vehicle for reaching consensus on global quality
specifications in laboratory medicine. This objective was achieved and a lively constructive debate, after the presentations
were complete, led to agreement on the principles laid down in the Consensus Statement. The International Federation of Clinical
Chemistry (IFCC), the International Union of Pure and Applied Chemistry (IUPAC) and the World Health Organization (WHO) kindly
sponsored the Conference but it must be noted that the Consensus Statement reflects the views of the presenters and registrants
who participated in the Conference and does not necessarily represent those of the sponsoring bodies. This paper reports on
the standardization efforts so far, the Stockholm Consensus Conference, the ISO uncertainty concept and the consensus reality.
A hierarchy of quality specifications in laboratory medicine was defined and agreed on.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
4.
Rob T. P. Jansen 《Accreditation and quality assurance》2000,5(9):363-366
Most efforts in quality control have been focussed on the reduction of intralaboratory variation and the assessment of interlaboratory
variation. Over the last few years, the importance of bias in interlaboratory variation and intralaboratory shifts has become
clear. Small shifts can sometimes have a large impact on the number of treated patients, particularly in assays where cut
off values are used. For example in cholesterol, HDL-cholesterol, HbA1c and TSH assays. There is an obvious need for adequate
calibration material. However, the process of development of international primary reference materials and reference methods
takes time, and even if reference materials exist and are used by in vitro diagnostics manufacturers, there still remains
significant and clinically relevant interlaboratory variance and intralaboratory shifts, as is seen, e.g. in protein chemistry.
The harmonization of inter laboratory and intralaboratory results needs an impulse from professional organizations to convince
individual laboratories of the importance and significance of bias. This applies to all subdisciplines of laboratory medicine.
On the occasion of the 25th anniversary of the Foundation for External Quality Assessment (SKZL), a large interdisciplinary
harmonization project called Calibration 2000 was launched in The Netherlands The strategy and first results are reported
in this paper. The project aims at harmonization of laboratory data of several disciplines, using secondary calibration materials,
leading to common reference ranges throughout The Netherlands.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
5.
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
6.
Axel Colling Martyn Jeggo Helder Louvandini Mamadou Lelenta Mark Robinson 《Accreditation and quality assurance》2008,13(1):33-45
Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the
sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated,
resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing
quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology
transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External
Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing
country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories
using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance
rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth
disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use
of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to
enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation
of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the
EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE)
general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests
For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary
diagnostic laboratories world-wide. 相似文献
7.
H. C. Wallin 《Accreditation and quality assurance》1996,1(4):163-170
Most sophisticated products require testing for compliance with specifications and safety regulations before release into
many markets, and trade in many simpler commodities and products also requires supporting technical information. Test documentation
has become an essential element in this trade. Food intended for human consumption certainly falls into the "sophisticated
products" category. Lack of acceptance of laboratory test data across national borders may be a significant barrier to trade.
In order to avoid such barriers and unnecessary duplication of laboratory tests, mutual recognition of laboratory results
should be regarded as an important means of facilitating international trade in food products. It is difficult to envisage
recognition of test data across borders without internationally agreed criteria for assessing the competence of testing. These
criteria should, as a minimum, require that a laboratory involved in the analysis of foods operates a suitable quality system.
The laboratory must create a quality system appropriate to the type, range and volume of work performed. It is necessary for
the elements of this system to be documented in a quality manual which is available for use by the laboratory personnel. The
quality manual must be kept up-to-date by a person or persons having responsibility for quality assurance within the laboratory.
This paper describes and discusses the elements of a quality system in a food laboratory, including suitable quality assurance
measures, the use of validated analytical methods and participation in proficiency testing schemes.
Received: 24 February 1996 Accepted: 13 March 1996 相似文献
8.
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
9.
G. Mertens Maria Gielis Denise De Smet Gert Van Cleynenbreugel 《Accreditation and quality assurance》2000,5(9):381-382
The European Federation for Immunogenetics (EFI) has its own standards for histocompatibility testing. Compared with EN 45001
and ISO Standards, EFI Standards are more detailed, actually stating "what to do" in the laboratory. The decision of Eurotransplant
that all its organ transplantation programmes must be EFI-accredited by the year 2000, illustrates the importance of the these
standards. It took us 11 months to prepare the EFI questionnaire, describing the main features of our laboratory and how they
complied with EFI Standards. After approval of this file, inspection was performed by a team of two peers who routinely worked
in an EFI-accredited tissue typing laboratory. The pre-analytical, analytical and post-analytical phases were inspected during
a one day visit. Furthermore, a checklist was reviewed against the laboratory's documentation system. Within 1 month of reception
of the inspection report, we were expected to send a reply listing the corrective actions taken. Upon acknowledgement of the
latter, EFI Accreditation was granted, for 1 year. We feel that detailed standards, specifically designed for a certain type
of laboratory, offer many advantages.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
10.
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
11.
Reliable, traceable and comparable measurements provide the rational basis for evaluation of the quality of a result and
the starting point for recognized laboratory accreditation in any national area. Modern medical diagnostics and treatment
involve rapidly rising numbers and types of clinical laboratory measurements, that are reliable. Therefore, the basic principles
to be followed to assure the traceability of clinical measurements as required by the Romanian Laws of Metrology are reviewed.
Main sources affecting the quality of the unbroken chain of calibrations that relate the measurements back to appropriate
measurement standards are discussed. Examples of how to achieve traceable measurements in clinical laboratories are presented.
Details of specific uses of reference materials, measuring instruments and standard measurement methods are also discussed.
Received: 8 January 1998 · Accepted: 21 April 1998 相似文献
12.
F. Linnebank 《Accreditation and quality assurance》2000,5(9):377-380
The Netherlands Institute for Accreditation of Hospitals (NIAZ) was established at the end of 1998. It was founded by the
PACE foundation, the Society of University Hospitals, the Netherlands Association of General Hospitals and the Society of
Medical Specialists in the Netherlands. Since then in the Netherlands 19 pilot accreditations have been performed based upon
35 NIAZ-PACE standards for hospital departments and functions, and the overall standard 'quality system'. The aims and methods
of the accreditation system were inspired by examples from the other side of the Atlantic, especially from Canada. The characteristics
are: voluntary-based, self-evaluation, peer-review and aiming at continuous improvement of quality of care.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
13.
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
14.
L. Mouillet 《Accreditation and quality assurance》1998,3(1):11-13
The implementation of a quality assurance system is fraught with difficulties. However, these difficulties may be overcome
if the laboratory uses suitable means to facilitate the process. It is necessary to mobilise the intelligence and energy of
all members of the laboratory. In order to command adherence, the project must be shared, and this necessitates a major effort
by all concerned. Communication is a major factor in obtaining the support of all parties. Six important steps must be distinguished:
– Defining quality policy
– Creating awareness, information, training
– Creating a quality structure
– Establishing a deadline for obtaining accreditation
– Progressive implementation
– Experimentation and validation.
Even if the task of obtaining and maintaining accreditation remains difficult, it clearly promotes a minimum level of organisation
and stepwise progress in quality assurance. The laboratory must keep improving its quality system, using European Standard
EN 45001 as an effective management model.
Received: 9 April 1997 · Accepted: 11 September 1997 相似文献
15.
The aim of this study was to evaluate the primary experience of implementing a quality system in a clinical laboratory. The
second interrelated aim was to evaluate the quality and financial indicators needed for continuous measurement of quality,
decision making in the laboratory management and everyday process control in analytical work. The quality process itself should
be evaluated because the building up of a quality system requires a considerable amount of resources. The most effective and
practical ways of using a quality system as a management tool should be found and the need for financial appraisal when the
quality system is implemented is stressed. According to our study, when the effects of the quality system were evaluated,
the managers of the laboratory had not considered the appropriate financial indicators. The quality indicators considered
to be the best were internal quality control, external quality assessment and customer satisfaction surveys. The first benefits
of the quality system evaluated by the personnel were other than the purely financial benefits, they include a more systematic
and empowering approach to laboratory management, better working instructions, better knowledge of the methods and equipment,
and fewer errors. The financial evaluation of a quality process in a public-owned clinical laboratory is complicated due to
the fact that financial indicators are not as far developed and diverse as in industrial organisations. When starting to implement
a quality system, it is important to pay attention to all measures that motivate the staff and help them benefit from the
practical effects of the system.
Received: 10 November 1999 / Accepted: 12 January 2000 相似文献
16.
I.-L. Popescu H. Y. Aboul-Enein D. V. Napradean G. L. Radu I. G. Tanase 《Accreditation and quality assurance》2001,6(8):376-378
This paper describes the practical implementation of a quality system in the control laboratory of the National Medicines
Agency, Romania, the main aim being the alignment of the requirements of the control of drugs in Romania with European Union
standards. Activity in this field is relatively new in Romania, however, it is of great importance to Romania’s compliance
with international standards.
Received: 13 September 2000 Accepted: 19 February 2001 相似文献
17.
W. Jäger 《Accreditation and quality assurance》1997,2(4):199-202
The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment
of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The
requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must
in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative
authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended
to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical
quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories
to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses.
This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory
by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation,
can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must
be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must
be demanded of all laboratories.
Received: 4 October 1996 Accepted: 15 January 1997 相似文献
18.
James H. Nichols 《Accreditation and quality assurance》2006,11(6):273-277
Point-of-care testing (POCT) is a complex system with many opportunities for error. Delivering quality POCT requires multidisciplinary coordination and an understanding of the preanalytic, analytic, and postanalytic processes that are necessary to deliver a test result and take clinical action. Most errors in laboratory testing occur in the pre and postanalytical phases and many mistakes that are referred to as lab error are actually due to poor communication, actions by others involved in the testing process, or poorly designed processes outside the laboratory's control. POCT requires significant operator interaction with analysis and documentation of calibration and quality control, unlike other medical devices. Clinicians often interpret POCT as equivalent to core laboratory testing, only faster, and mistakenly utilize the results interchangeably despite the differences in test methodologies. Taking quality of POCT to the next level involves looking beyond the analytical phase and integration of POCT into the entire pathway of patient care to understand how POCT relates to medical decision-making at specific points during the patient's care. A systematic review of the literature by the National Academy of Clinical Biochemistry is currently being conducted to draft guidelines for best practice that link the use of POCT to improved patient outcomes.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium. 相似文献
19.
Robert Rej 《Accreditation and quality assurance》2002,7(8-9):335-340
Proficiency testing and external quality assurance of medical laboratories is now entering its sixth decade. These activities
comprise a broad range of applications including: providing participants and public health authorities with estimates of measurement
uncertainty and national infrastructure; providing education; provision of a practical basis for accreditation and regulatory
compliance. All branches of medical laboratory science have employed external quality assurance as a basis for improvement
and comparability. The opportunities and challenges reviewed here include: the proper establishment of multiple target values
in comparison to a system of traceability to reference or definitive methods; the problems of matrix effects and commutability
of patient and proficiency test samples; generating information on laboratory infrastructure and trends in analytical technique
and performance; providing education and setting goals for laboratory improvement; problems of specimen distribution; application
of Internet technology; the role of programs in legal mandates and accreditation.
Received: 24 April 2002 Accepted: 11 July 2002 相似文献
20.
Viviane Van Hoof Hugo Cluckers Vera Verhaeghe An Hennebel Marleen Truyens Edith Van Loock Pierre Rombouts Dirk Maes Jan Van Elven Katrien Lesage Mark Flothmann Lieve Nijs Filip Colpaert Werner Vercammen Dominique Bolain 《Accreditation and quality assurance》2004,10(1-2):55-59
In response to a change of the Belgian National Directives whereby hospital laboratories became responsible for all point-of-care testing (POCT) performed within hospital walls a standardized and automated POC glucose-testing system was implemented in our hospital. The system consists of 50 AccuCheck Inform instruments (Roche Diagnostics, Vilvoorde, Belgium), 50 docking stations, a DataCare Server, and connections to the medical laboratory information system (MOLIS, Sysmex, Barchon, Belgium) and to the hospital information system. Implementation involved many parties and extensive preparation and communication. Key issues were bar-coded patient and user identification, training, and responsibilities. One year after the hospital wide implementation of this system the quality of POC glucose testing has significantly increased, thereby improving patient safety. This study describes a stepwise change over involving the medical laboratory and with a focus on hands-on quality.Presented at the ninth conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium. 相似文献