Accreditation of medical laboratories in the European Union

2007 ◽  
Vol 45 (2) ◽  
Author(s):  
Wim Huisman ◽  
A. Rita Horvath ◽  
David Burnett ◽  
Victor Blaton ◽  
Rózsa Czikkely ◽  
...  
Keyword(s):  
Regional Cooperation ◽  
Clinical Chemistry ◽  
Medical Laboratory ◽  
The European Union ◽  
Iso 15189 ◽  
National Accreditation ◽  
Medical Laboratories ◽  
European Cooperation ◽  
Actual Field ◽  
The Eu

Abstract: Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU.: Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.Clin Chem Lab Med 2007;45:268–75.

scholarly journals Accreditation

2005 ◽  
Vol 24 (3) ◽  
pp. 187-192 ◽  
Author(s):  
Willem Huisman
Keyword(s):  
European Union ◽  
Continuous Improvement ◽  
Accreditation Process ◽  
Assessment Process ◽  
Medical Laboratory ◽  
The European Union ◽  
Iso 15189 ◽  
National Accreditation ◽  
Medical Laboratories ◽  
Medical Laboratory Professionals

ISO 15189 is very well accepted as the principle standard for accreditation of medical laboratories in the European countries. In cooperation with the EA linked national accreditation bodies mutual lateral agreement is well accepted for this standard. It makes it possible that the accreditation is accepted in other countries. Medical laboratory professionals play a key role in the assessment process. Their choice, training and constant education are essential to ascertain that accreditation adds value in the treatment of the patients. It should contribute to the continuous improvement of all laboratories. Some preliminary results of a questionnaire concerning the present status of accreditation in the countries of the European Union are presented. It shows quite diversity in the accreditation process in relation to the interval between assessment visits and the frequency of surveillance visits. The Working Group on Accreditation of the EC4 will use the input of this questionnaire and the content of some ILAC and EA guidelines, to offer Essential Criteria on some of these aspects. .

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

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.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

2019 ◽  
Vol 57 (4) ◽  
pp. 459-464 ◽  
Author(s):  
Marc Thelen ◽  
Florent Vanstapel ◽  
Pika Meško Brguljan ◽  
Bernard Gouget ◽  
Guilaine Boursier ◽  
...  
Keyword(s):  
Metrological Traceability ◽  
Measurement Procedure ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Worst Case ◽  
Iso 15189 ◽  
Value Assignment ◽  
Traceability Chain ◽  
Medical Laboratories

Abstract ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

Neither here, not there: Bulgaria and Romania in current European politics☆

2004 ◽  
Vol 37 (4) ◽  
pp. 509-522 ◽  
Author(s):  
Victor D. Bojkov
Keyword(s):  
European Union ◽  
Regional Cooperation ◽  
Eu Enlargement ◽  
Political Transition ◽  
The Other ◽  
European Politics ◽  
The European Union ◽  
Southeast Europe ◽  
The Eu

The article analyses the process of EU enlargement with reference to the progress that Bulgaria and Romania have made within it. It is argued that leaving them out of the wave of accession finalised in May 2004 for ten of the candidate states, has placed them in a situation of double exclusion. Firstly, their geographical belonging to the region of Southeast Europe has been rendered non-essential by their advanced position within the EU enlargement process. Secondly, their achievement in economic and political transition has been removed from the progress of the ten states, which joined the EU in May 2004 by delaying the time of their accession. As a result, any efforts in regional cooperation and integration between Bulgaria and Romania on one hand, and other Southeast European states on the other, have been effectively cancelled. Moreover, in current European politics, the two countries have come to serve the unenviable role of exemplifying on the part of the European Union how progress is being awarded and hesitation punished.

Restoring the Memory

2019 ◽  
pp. 30-49
Author(s):  
Goran Ilik
Keyword(s):  
The European Union ◽  
Main Research ◽  
East European ◽  
The Balkans ◽  
European Cooperation ◽  
Balkan Region ◽  
Key Features ◽  
Balkan States ◽  
The Eu

This chapter explores the key features of the concept of postnationalism, its modes, and theoretical implications regarding the European Union. The main research intention is to explore the EU as a model and an agent for reconciliation of the Balkan region. For that purpose, the main operative elements of both the South East European Cooperation Process and “Yugosphere” are examined. At the end, it is concluded that the emulation of EU postnational model by the Balkan countries enables the process of reconciliation. Hence, the Balkan states seems to be “forced” to cooperate with each other, in order to achieve their common objective – their full integration into the EU, which strongly confirms the role of the EU as an agent for reconciliation of the Balkans.

Laboratory medicine in the European Union

2015 ◽  
Vol 53 (1) ◽  
Author(s):  
Wytze P. Oosterhuis ◽  
Simone Zerah
Keyword(s):  
European Union ◽  
Mutual Recognition ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Patient Treatment ◽  
European Federation ◽  
The European Union ◽  
Recent Developments ◽  
Important Challenge ◽  
The Eu

AbstractThe profession of laboratory medicine differs between countries within the European Union (EU) in many respects. The objective of professional organizations of the promotion of mutual recognition of specialists within the EU is closely related to the free movement of people. This policy translates to equivalence of standards and harmonization of the training curriculum. The aim of the present study is the description of the organization and practice of laboratory medicine within the countries that constitute the EU. A questionnaire covering many aspects of the profession was sent to delegates of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne de Médecins Spécialistes (UEMS) of the 28 EU countries. Results were sent to the delegates for confirmation. Many differences between countries were identified: predominantly medical or scientific professionals; a broad or limited professional field of interest; inclusion of patient treatment; formal or absent recognition; a regulated or absent formal training program; general or minor application of a quality system based on ISO Norms. The harmonization of the postgraduate training of both clinical chemists and of laboratory physicians has been a goal for many years. Differences in the organization of the laboratory professions still exist in the respective countries which all have a long historical development with their own rationality. It is an important challenge to harmonize our profession, and difficult choices will need to be made. Recent developments with respect to the directive on Recognition of Professional Qualifications call for new initiatives to harmonize laboratory medicine both across national borders, and across the borders of scientific and medical professions.

scholarly journals Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

2008 ◽  
Vol 27 (2) ◽  
pp. 144-147
Author(s):  
Ljubinka Gligić
Keyword(s):  
Accreditation Process ◽  
Laboratory Accreditation ◽  
European Countries ◽  
Medical Laboratory ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Set Up ◽  
Definition Of

Status of Development and Implementation of Medical Laboratories Accreditation in SerbiaThrough the release of the SRPS ISO 15189:2008 standard entitled >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< conditions have been created for medical laboratory accreditation in Serbia. The application of the ISO 15189:2007 standard is an accepted mechanism for improvement of the quality of medical laboratory services throughout EU today. In that way, different approaches to the quality improvement of medical laboratories have been harmonized. Functional organisation of the accreditation process of medical laboratories in most European countries is mainly carried out in cooperation with national accreditation bodies, medical experts appointed by scientist associations and health departments. This type of collaboration has proven successful in the United Kingdom, Germany, Hungary, France, Finland, Croatia, etc. The experiences of the Accreditation Board of Serbia (ABS) in medical laboratory accreditation according to the SRPS ISO/IEC 17025:2006 standard (5 laboratories have been accredited) and the positive experiences of European countries in accreditation process constitute the basis for the development of the program for medical laboratory accreditation in Serbia. The first step in this direction is the set-up of the Committee consisting of experts from different medical fields, ABS experts and representatives of the competent Ministry, as well as the definition of their tasks, such as: preparation of the necessary documentation, set-up and preparation of qualification criteria and training programs for assessors, participation in the development of the external quality assessment scheme through interlaboratory testing, liaison with the European organisations for accreditation, organisation of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance.

scholarly journals IPA CBC FUND – TOURISM DEVELOPMENT IN THE BRCKO DISTRICT

2012 ◽  
Vol 2 (1) ◽  
pp. 64-68
Author(s):  
Aleksandar Maksimović ◽  
Keyword(s):  
Local Community ◽  
Regional Cooperation ◽  
Financial Resources ◽  
Tourist Industry ◽  
The European Union ◽  
Western Balkans ◽  
Structural Funds ◽  
Cross Border ◽  
Trained Staff ◽  
The Eu

The European Union in different ways and through the structural funds, helps countries to develop in the Western Balkans. Decision of the EU, the total amount that will be available in Turkey, Croatia, Serbia, Macedonia, Albania and Bosnia and Herzegovina in the period since 2007. 2013. is 4 billion. One of the priority measures under the IPA Cros-border coopertion (CBC) programme is the development of tourism. These measures should help and contribute to the development of tourism. How and in what way to access and become a user of these programs can help or helps? Cross-border projects involve regional cooperation and require financial resources in the preparation of the project. Trained staff is needed for this job. Local communities, along with their capacities should take on the preparation of these projects, and as partners include the tourist industry (workers) and encourage and inspire other tourist capacities in their local community.

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