scholarly journals Current practice in laboratory diagnostics of autoimmune diseases in Croatia. Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine

2016 ◽  
pp. 376-394
Author(s):  
Andrea Tešija Kuna ◽  
Lovorka Đerek ◽  
Ana Kozmar ◽  
Vedrana Drvar
Keyword(s):  
Autoimmune Diseases ◽  
Working Group ◽  
Current Practice ◽  
Laboratory Medicine ◽  
Laboratory Diagnostics

scholarly journals Standardization of autoimmune testing – is it feasible?

2018 ◽  
Vol 56 (10) ◽  
pp. 1734-1742 ◽  
Author(s):  
Evanthia Monogioudi ◽  
Gustavo Martos ◽  
Dana Petronela Hutu ◽  
Heinz Schimmel ◽  
Pier Luigi Meroni ◽  
...  
Keyword(s):  
Autoimmune Diseases ◽  
Reference Materials ◽  
Working Group ◽  
Certified Reference Materials ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
International Federation ◽  
Wrong Diagnosis

Abstract Correct measurement of autoantibodies is essential for the diagnosis of autoimmune diseases. However, due to the variability of autoantibody results and the heterogeneity of testing, wrong diagnosis is a reality. For this and more reasons, harmonization of testing is of the outmost importance. In this review we have summarized the factors contributing to this variability. The ways with which the working group on harmonization of autoantibody testing of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has been trying to tackle the issue with the production and correct use of certified reference materials (CRMs), is discussed. Finally the advantages and the limitations of the use of CRMs are presented.

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

2015 ◽  
Vol 53 (8) ◽  
Author(s):  
Marc H.M. Thelen ◽  
Florent J.L.A. Vanstapel ◽  
Christos Kroupis ◽  
Ines Vukasovic ◽  
Guilaime Boursier ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Position Paper ◽  
European Federation ◽  
Medical Field ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Scientific Disciplines

AbstractThe 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.

Proficiency testing in analytical chemistry, microbiology and laboratory medicine: discussions on current practice and future directions

2015 ◽  
Vol 20 (4) ◽  
pp. 339-344 ◽  
Author(s):  
Brian Brookman ◽  
Owen Butler ◽  
Michael Koch ◽  
Tracey Noblett ◽  
Ulf Örnemark ◽  
...  
Keyword(s):  
Analytical Chemistry ◽  
Proficiency Testing ◽  
Current Practice ◽  
Laboratory Medicine ◽  
Future Directions

scholarly journals Conflict between Guideline Methodologic Quality and Recommendation Validity: A Potential Problem for Practitioners

2006 ◽  
Vol 52 (1) ◽  
pp. 65-72 ◽  
Author(s):  
Joseph Watine ◽  
Bruno Friedberg ◽  
Eva Nagy ◽  
Rita Onody ◽  
Wytze Oosterhuis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Practice Guidelines ◽  
Laboratory Tests ◽  
Current Practice ◽  
Research Evidence ◽  
Potential Problem ◽  
Guideline Development ◽  
Laboratory Medicine ◽  
Small Cell Lung ◽  
Methodologic Quality

Abstract Background: It is not clear if good methodologic quality in current practice guidelines necessarily leads to more valid recommendations, i.e., those that are supported with consistent research evidence or, when evidence is conflicting or lacking, with sufficient consensus among the guideline development team. To help clarify this issue, we assessed whether there is a link between methodologic quality and recommendation validity in practice guidelines for the use of laboratory tests in the management of patients with non-small cell lung cancer (NSCLC). Methods: We conducted a systematic review of data on laboratory tests in NSCLC published in English or in French within the last 10 years and retrieved 11 practice guidelines for the use of these tests. The guidelines were critically appraised and scored for methodologic quality and recommendation validity based on the Appraisal of Guidelines Research and Evaluation (AGREE) criteria and on the systematic review. Results: Overall, these 11 guidelines had considerable shortcomings in methodologic quality and, to a lesser extent, in recommendation validity. Practice guidelines with the best methodologic quality were not necessarily the most valid in their recommendations, and conversely. Conclusions: Poor methodologic quality and lack of recommendation validity in laboratory medicine call for methodologic standards of guideline development and for international collaboration of guideline development agencies. We advise readers of guidelines to critically evaluate the methods used as well as the content of the recommendations before adopting them for use in practice.

scholarly journals Cost, profitability and value of laboratory diagnostics: in God we trust, all others bring data

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Giuseppe Lippi ◽  
Mario Plebani
Keyword(s):  
Laboratory Tests ◽  
Clinical Pathways ◽  
Laboratory Medicine ◽  
Scale Economy ◽  
Therapeutic Monitoring ◽  
Laboratory Diagnostics ◽  
Clinical Value ◽  
Healthcare Budget ◽  
The Impact ◽  
Diagnostic Investigations

Abstract Although laboratory tests are the most used diagnostic investigations for screening, diagnosing, prognosticating and therapeutic monitoring of most human diseases, laboratory medicine is currently seen as many other economic industries by some policymakers and administrators, and is hence subjected to scale economy and assessed accordingly, despite the incremental clinical value that laboratory tests can generate. According to a genuine economic perspective, the impact of diagnostic testing on a healthcare budget is lower than 2.5%, whilst its profitability is over 100%, a net profit margin over 7-fold larger than whatever other human industry. Even more importantly, the impact of laboratory tests on clinical outcomes is now clear and virtually incontestable, as their use will improve clinical pathways much more than any other diagnostic investigations. The many ongoing attempts to downsize the importance of laboratory medicine as costs centers, or even the concept that public laboratory services can be safely eliminated or outsourced to external private professional organizations, shall hence be challenged. Laboratory medicine not only is vital to patient care and patient flow, and will remain so for many years to come, but is also a valuable economical resource for the healthcare facilities.

Pre-analytical quality indicators in laboratory medicine: Performance of laboratories participating in the IFCC working group “Laboratory Errors and Patient Safety” project

2019 ◽  
Vol 497 ◽  
pp. 35-40 ◽  
Author(s):  
Laura Sciacovelli ◽  
Giuseppe Lippi ◽  
Zorica Sumarac ◽  
Isabel Garcia del Pino Castro ◽  
Agnes Ivanov ◽  
...  
Keyword(s):  
Patient Safety ◽  
Quality Indicators ◽  
Working Group ◽  
Laboratory Medicine ◽  
Analytical Quality ◽  
Laboratory Errors

Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine

2016 ◽  
Vol 54 (10) ◽  
Author(s):  
Anna Carobene ◽  
Marta Strollo ◽  
Niels Jonker ◽  
Gerhard Barla ◽  
William A. Bartlett ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biological Variation ◽  
European Federation ◽  
Laboratory Measurements ◽  
Controlled Conditions ◽  
Edta Plasma ◽  
Blood Specimens

AbstractBackground:Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data.Methods:The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20–60 years; 43 women, aged 20–50 years; 10 women, aged 55–69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, KResults:Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at –80 °C.Conclusions:A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

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