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1.
M. Plebani 《Accreditation and quality assurance》1999,4(3):84-86
The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories
is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like
the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these
independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance
and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not
the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement
is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related
to a high-quality laboratory service. 相似文献
2.
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
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.
Keith W. Davies 《Accreditation and quality assurance》1999,4(1-2):18-26
Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and
accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical
and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled
equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New
management techniques have been developed to control the quality and appropriateness of results. Developments in internal
quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of
assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer
pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities
and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient
testing outside the laboratory. This will provide new challenges to the quality of the service provided.
Received: 2 July 1998 · Accepted: 1 August 1998 相似文献
5.
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
6.
R. J. Wells 《Accreditation and quality assurance》1998,3(5):189-193
Although the validation process necessary to ensure that an analytical method is fit for purpose is universal, the emphasis
placed on different aspects of that process will vary according to the end use for which the analytical procedure is designed.
It therefore becomes difficult to produce a standard method validation protocol which will be totally applicable to all analytical
methods. It is probable that far more than 30% of the methods in routine laboratory use have not been validated to an appropriate
level to suit the problem at hand. This situation needs to change and a practical assessment of the degree to which a method
requires to be validated is the first step to a reliable and cost effective analytical industry.
Received: 22 September 1997 · Accepted: 28 November 1997 相似文献
7.
M. C. Shirani Seneviratne 《Accreditation and quality assurance》2006,10(11):613-616
A quality system according to the requirements of ISO/IEC guidelines has been introduced at the Nuclear Analytical Laboratories of the Atomic Energy Authority, which has received appreciation from International Atomic Energy Agency (IAEA) inspection evaluation reports (RAS/2/010) showing a positive indication to accreditation. The quality system has achieved the “analytical quality” through technical competence by non-conformance management. The experience in the progression towards achieving a quality system is described with examples from zero level to a positive index. This nuclear analytical service laboratory shows long-term stability of performance and enhances its credibility to customers, through the quality system. 相似文献
8.
P. Arikan O. Acar R. Acar G. A. Aycik M. A. Cetiner H. Demirel N. Efe T. Golge R. Gurellier R. Kirmaz S. Tulumen H. Yucel A. Zararsiz Y. Agus 《Journal of Radioanalytical and Nuclear Chemistry》2004,259(3):391-394
Comprehensive Quality Control (QC) and Quality Assurance (QA) Program is stated on the quality policy, organization, methods
and records for nuclear analytical laboratories which are necessary for improvement of productivity, to upgrade the performance,
credibility and reputation. The proper and complete identification of quality elements for management and technical requirements
are being written in Quality Manual as well as analytical and organizational procedures and working instructions according
to ISO 17025 standard. Technical ability of gamma, X-ray and a/b laboratories in the Center has been checked by participation
in proficiency test, critical technical variables, and quality results. Performance of quality system has been controlled
by external audit inspection, progress reports and service to clients. The present study is a framework of the model project
of IAEA, coded RER/2/004, which has resulted self-sustainable accreditation from the national body, TURKAK.
This revised version was published online in August 2006 with corrections to the Cover Date. 相似文献
9.
C. L. Burns 《Accreditation and quality assurance》1997,2(7):327-331
The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory
obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem
Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the
importance of obtaining national and international accreditation are discussed.
Received: 30 May 1997 · Accepted: 16 June 1997 相似文献
10.
Fast gas chromatography–mass spectrometry (GC–MS) has the potential to be a powerful tool in routine analytical laboratories by increasing sample throughput and improving laboratory efficiency. However, this potential has rarely been met in practice because other laboratory operations and sample preparation typically limit sample throughput, not the GC–MS analysis. The intent of this article is to critically review current approaches to fast analysis using GC–MS and to discuss practical considerations in addressing their advantages and disadvantages to meet particular application needs. The practical ways to speed the analytical process in GC and MS individually and in combination are presented, and the trade-offs and compromises in terms of sensitivity and/or selectivity are discussed. Also, the five main current approaches to fast GC–MS are described, which involve the use of: (1) short, microbore capillary GC columns; (2) fast temperature programming; (3) low-pressure GC–MS; (4) supersonic molecular beam for MS at high GC carrier gas flow; and (5) pressure-tunable GC–GC. Aspects of the different fast GC–MS approaches can be combined in some cases, and different mass analyzers may be used depending on the analytical needs. Thus, the capabilities and costs of quadrupole, ion trap, time-of-flight, and magnetic sector instruments are discussed with emphasis placed on speed. Furthermore, applications of fast GC–MS that appear in the literature are compiled and reviewed. At this time, the future usefulness of fast GC–MS depends to some extent upon improvement of existing approaches and commercialization of interesting new techniques, but moreover, a greater emphasis is needed to streamline overall laboratory operations and sample preparation procedures if fast GC–MS is to become implemented in routine applications. 相似文献
11.
B. L. Collins 《Accreditation and quality assurance》1998,3(9):351-355
The efforts to form a laboratory accreditation cooperation in the United States and North America are described, including
activities of the Laboratory Accreditation Working Group and the interim board of the National Cooperation for Laboratory
Accreditation. The vision, mission, and guiding principles developed by the two groups are presented, along with the operational
documents, such as bylaws, the recognition document, guidance documents and the quality manual drafted by the interim board.
Received: 8 June 1998 · Accepted: 16 June 1998 相似文献
12.
The practical experience on the implementation of ISO/IEC 17025 compliant quality system in a nuclear analytical laboratory of the Korea Atomic Energy Research Institute (KAERI) is described. This paper summarizes the need for a quality system and accreditation, the process of a quality system implementation, the quality system structures, and the formal accreditation of our laboratory by the Korean Laboratory Accreditation Scheme (KOLAS). Also, the improvements in the management, technical and service quality which resulted from implementation of this system are briefly reported. 相似文献
13.
Louwrens Erasmus Smit 《Accreditation and quality assurance》2002,7(10):409-411
High quality analysis of food involves a comprehensive process, which includes proper sampling, validated methodology, experienced
technical staff and the use of standard reference materials. Today there is more international emphasis not only on generating
food composition data but also on data quality and the main issue is that South African data should be internationally recognized
as acceptable and representative. Quality is multi-dimensional and should at least include aspects of accuracy, precision
and representativeness. A major step forward is that laboratories can apply for accreditation, which involves, inter alia,
documented, validated methodology, regular interlaboratory studies, the use of certified reference materials and the existence
of a sound quality system. The South African National Accreditation System (SANAS) is a regulatory body in South Africa, which
is internationally recognized. Assessment of laboratories against specific standards is performed regularly and laboratories
have to comply with certain managerial and technical requirements. Once a laboratory is accredited, ongoing validation and
verification of results as well as regular assessment ensure reliability of results and overall competency of the laboratory.
With a quality assurance programme in place, the reliability of results of the Irene laboratory is beyond doubt and nutrient
data could be included in food composition tables.
Received: 31 January 2002 Accepted: 4 February 2002
Correspondence to Louwrens Erasmus Smit 相似文献
14.
After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993,
being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000
and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing
and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and
recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic
principles, and the structure and competence of accreditation bodies are described in this article. 相似文献
15.
Many CEE governments are still using various systems of laboratory authorization together with ISO/IEC 17025 laboratory accreditation. It is difficult to understand from the EU prospective, the existence of two parallel laboratory competence verification systems. The basic relations between laboratory accreditation and authorization: independence and succession have been defined. The case study of testing laboratory accreditation versus authorization in Serbia, has been presented and discussed. Relevant requests and procedures for water quality, food and air quality testing laboratory authorization were analysed in detail. Comparative analyses of accreditation and authorization have established: (i) independent relations, (ii) relevant regulation is in collision and barely legal, (iii) authorization is (technically) on the far lower level than accreditation is, and (iv) authorization requests cause high space and personnel costs. It has been concluded that it is not adequate to perform two policies at the same time: one EU oriented—laboratory accreditation, and one non-EU oriented—laboratory authorization. The policy proposal is that all CEE countries should abandon existing laboratory authorization procedures and replace them by accreditation. Proposed goal could be reached in rather a short transition process of 2–3 years. 相似文献
16.
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
17.
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
18.
19.
Peter S. Unger 《Accreditation and quality assurance》1998,3(9):373-376
The American Association for Laboratory Accreditation (A2LA) marks its 20th year of existence. Its major aim as a non-profit,
public service organization is to promote laboratory quality and competence. In terms of the number of current accreditations,
A2LA is the largest multidiscipline laboratory accreditation body in the United States and the fourth largest in the world.
An overview of current activities and status is provided. 相似文献
20.
The “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century—A Risk Based Approach” initiative announced
by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical
technology (PAT) by the pharmaceutical industry. The potential for improved operational control and compliance resulting from
continuous real-time quality assurance was highlighted as a likely benefit that would result from PAT implementation. A considerable
amount of work has been done on this topic by academic and industrial contributors in the last decade. In this paper, we will
start with a brief overview of evolution of PAT concepts and a review of their application in the wider pharmaceutical industry.
The rest of the paper focuses on PAT applications for biotech processes with emphasis on developments in the last five years.
It is our observation that while significant advances have been accomplished with regard to our ability to analyze/monitor
key process and quality attributes in the biotech industry, much more needs to be done with regard to utilizing the collected
data for subsequent control of the process, to achieve optimum yield and product quality. The latter is necessary to achieve
the benefits that will result from PAT implementation. 相似文献