Abstract:
:The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Thelen MH,Vanstapel FJ,Kroupis C,Vukasovic I,Boursier G,Barrett E,Bernabeu Andreu F,Brguljan PM,Brugnoni D,Lohmander M,Sprongl L,Vodnik T,Ghita I,Vaubourdolle M,Huisman W,Working Group Accreditation ISO\/CEN standards (WG-Adoi
10.1515/cclm-2015-0257subject
Has Abstractpub_date
2015-07-01 00:00:00pages
1173-80issue
8eissn
1434-6621issn
1437-4331pii
/j/cclm.ahead-of-print/cclm-2015-0257/cclm-2015-02journal_volume
53pub_type
杂志文章,实务指引abstract::Despite many years of study, clinical trials of new drugs to prevent thrombosis have often been disappointing. Part of the problem lies in our incomplete understanding of the regulation of plasminogen activation and/or inhibition in vivo. We have previously shown that in vitro nitration of plasminogen in plasma by per...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.039
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abstract::The aim of this study was to clarify the effects of anti-dsDNA antibodies on the titer and the nuclear staining pattern(s) in a fluorescent antinuclear antibody (FANA) assay using HEp-2 cells. Anti-dsDNA derived from 14 patients with systemic lupus erythematosus (SLE) was individually affinity-purified. The anti-dsDNA...
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pub_type: 杂志文章,meta分析
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2004.061
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doi:10.1515/CCLM.2010.322
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0991
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.224
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2012-0191
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0218
更新日期:2019-10-25 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2017-0291
更新日期:2018-02-23 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.122
更新日期:2009-01-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2002.036
更新日期:2002-03-01 00:00:00
abstract::Two reverse transcription-polymerase chain reaction methods to detect the AML1/ETO rearrangement in the M2 subtype of acute myeloid leukaemia those of Downing et al. (Blood 1993; 81: 2860-5) and Satake et al. (Br J Haematol 1995; 91: 892-8) were evaluated. Bone marrow samples, one at diagnosis and two in complete remi...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1998.026
更新日期:1998-03-01 00:00:00
abstract::Background Some clinical chemistry measurement methods are vulnerable to interference if hemolyzed serum samples are used. The aims of this study were: (1) to obtain updated information about how hemolysis affects clinical chemistry test results on different instrument platforms used in Nordic laboratories, and (2) to...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0366
更新日期:2019-10-25 00:00:00
abstract::This review evaluates the role of platelets in bleeding risk among patients with hematological disease and thrombocytopenia. Platelets are pivotal in primary hemostasis, and possess non-hemostatic properties involved in angiogenesis, tissue repair, inflammation and metastatis. Also, platelets safeguard vascular integr...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2019-0380
更新日期:2019-11-26 00:00:00
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pub_type: 杂志文章
doi:10.1515/cclm-2016-0197
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pub_type: 杂志文章,评审
doi:10.1515/CCLM.2010.364
更新日期:2010-12-01 00:00:00
abstract::Urinary cotinine was measured according to its inhibitory activity on the agglutination of cotinine-coated latex particles by anti-cotinine antibodies, the agglutination being measured by optical counting of the remaining non-agglutinated particles (particle counting, PaC). The detection limit was 0.03 microgram/ml an...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1999.112
更新日期:1999-07-01 00:00:00
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pub_type: 杂志文章
doi:10.1515/CCLM.2010.272
更新日期:2010-10-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1515/cclm-2014-0107
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND:Risk prediction algorithms for coronary heart disease (CHD) are recommended for clinical use. However, their predictive ability remains modest and the inclusion of genetic risk may improve their performance. METHODS:QRISK2 was used to assess CHD risk using conventional risk factors (CRFs). The performance o...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2016-0984
更新日期:2017-08-28 00:00:00
abstract:BACKGROUND:The aim was to investigate whether first trimester glycodelin and angiopoietin-2 can predict small-for-gestational age (SGA) at delivery, individually or in combination. METHODS:In this case-control study we measured glycodelin and angiopoietin-2 on serum from 170 singleton pregnant women delivering SGA neo...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2015-0989
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:To prospectively evaluate the role of procalcitonin (PCT) in detecting or excluding medullary thyroid carcinoma (MTC) among patients with thyroid nodules and increased calcitonin (CT) levels. METHODS:Fourteen of 1236 patients referred for thyroid nodules had increased serum CT >10 pg/mL. A stimulation test ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0610
更新日期:2013-07-01 00:00:00
abstract::The availability of so-called high-sensitivity troponin assays (hsTn) has scored a compelling goal for laboratory medicine, allowing the safe clinical application of international recommendations for the definition of acute myocardial infarction (AMI). However, the introduction of hsTn has not been welcomed by clinici...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2014-0812
更新日期:2015-04-01 00:00:00
abstract::For several decades, researchers have been investigating the relations between the consumption of Maillard reaction products (MRPs) and biological activities, whether harmful or beneficial. Interest in this area is growing because the intake of these compounds has increased in parallel with the consumption of thermall...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2012-0823
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abstract::Circulating blood platelets play a central role in the maintenance of hemostasis. They adhere to subendothelial extracellular matrix proteins that become exposed upon vessel wall damage, which is followed by platelet activation, further platelet recruitment, platelet aggregation and formation of an occlusive, or non-o...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2016-0895
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:Metabolic syndrome is closely related to several disturbances in lipid and lipoprotein metabolism. The aim of this study was to determine the association between apolipoprotein E (apoE) genotypes and the risk of metabolic syndrome and/or coronary heart disease complications. METHODS:The study included 279 s...
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pub_type: 杂志文章
doi:10.1515/CCLM.2007.258
更新日期:2007-01-01 00:00:00