Accreditation process in European countries – an EFLM survey

2016 ◽  
Vol 54 (4) ◽  
Author(s):  
Guilaine Boursier ◽  
Ines Vukasovic ◽  
Pika Mesko Brguljan ◽  
Maria Lohmander ◽  
Irina Ghita ◽  
...  
Keyword(s):  
Point Of Care ◽  
Accreditation Process ◽  
European Countries ◽  
Scientific Societies ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Flexible Scope ◽  
Current State ◽  
The Status ◽  
On Line

AbstractAccreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in the European countries but data about accreditation remain scarce. The EFLM Working Group “Accreditation and ISO/CEN standards” conducted a survey that reviews the current state of the accreditation process in European countries.An on-line questionnaire was addressed to delegates of 39 EFLM scientific societies in March 2014. One answer by country was taken into account. The survey was dealing with mandatory status, number of accredited medical laboratories in each country, possibility of flexible scope and concerned medical fields. The status of point-of-care testing (POCT) in each country was also studied.Twenty-nine responses (74%) were registered. All the assessed countries (100%) have begun an accreditation process in various ways. All the national accreditation bodies (NAB) offer or are working to offer an ISO 15189 accreditation. The accreditation process most often concerns all phases of the examination and various medical fields. Medical laboratories are responsible for POCT in 20 (69%) countries. The accreditation process for POCT, according to ISO 15189 and ISO 22870, is also developing.While there are several variations in the approaches to accreditation of medical laboratories in the European countries, the ISO 15189 accreditation project has been widely accepted. The use of a unique standard and the cooperation among countries due to scientific societies, EFLM, accreditation bodies and EA enable laboratory professionals to move toward uniform implementation of the accreditation concept.

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.

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.

scholarly journals The new ISO and CEN standards for quality and accreditation of medical laboratories

2004 ◽  
Vol 23 (3) ◽  
pp. 305-310 ◽  
Author(s):  
Kenny Desmond
Keyword(s):  
Point Of Care ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
International Standard ◽  
Laboratory Service ◽  
Medical Laboratories ◽  
Medical Environment ◽  
Common Basis ◽  
The World ◽  
Almost All

The new international standard EN ISO 15189:2003 ?Medical laboratories - particular requirements for quality and competence?, after many delays, was finally published in February 2003. This standard has been developed specifically to address requirements for accreditation of medical laboratories. It takes into account the special constraints imposed by the medical environment and the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories provide not only testing of patient samples, but also advisory, interpretative and educational services. It also acknowledges the role of diagnostics manufacturers in maintaining the quality of medical laboratory services. The international standard ISO/IEC 17025 ?General requirements for the competence of testing and calibration laboratories? is already used in some countries for accreditation of medical laboratories. This is a standard which was developed mainly for use in industrial testing laboratories, and has serious deficiencies when used in the medical environment. While still in draft form, 15189 was already approved by ILAC (International Laboratory Accreditation Co-operation) as a suitable basis for accrediting medical laboratories. It is expected that this document will be used widely in Europe and throughout the world as the preferred standard for this purpose. An informal survey of FESCC member societies shows that 15189, alone or in combination with other standards, will be used in almost all European countries for accreditation of medical laboratories. A further complementary standard, ISO 15190 ?Medical laboratories - requirements for safety? has now been published. A standard for quality and competence in Point Of Care Testing (POCT) is under development, and will be published as a new Annex to EN ISO 15189. These standards will for the first time provide a common basis for the development of quality systems and requirements for competence in medical laboratories throughout the world.

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.

French and Spanish Queer Film

2016 ◽  
Author(s):  
Chris Perriam ◽  
Darren Waldron
Keyword(s):  
Focus Groups ◽  
Sense Of Community ◽  
National Identities ◽  
Audience Research ◽  
Large Sample ◽  
Current State ◽  
Trans People ◽  
Screening Questionnaires ◽  
On Line ◽  
The Uk

This book advances the current state of film audience research and of our knowledge of sexuality in transnational contexts, by analysing how French LGBTQ films are seen in Spain and Spanish ones in France, as well as how these films are seen in the UK. It studies films from various genres and examines their reception across four languages (Spanish, French, Catalan, English) and engages with participants across a range of digital and physical audience locations. A focus on LGBTQ festivals and on issues relating to LGBTQ experience in both countries allows for the consideration of issues such as ageing, sense of community and isolation, affiliation and investment, and the representation of issues affecting trans people. The book examines films that chronicle the local, national and sub-national identities while also addressing foreign audiences. It draws on a large sample of individual responses through post-screening questionnaires and focus groups as well as on the work of professional film critics and on-line commentators.

On the Development of Islamic Jurisprudence

1999 ◽  
Vol 16 (1) ◽  
Author(s):  
Murad Wilfried Hofmann
Keyword(s):  
The State ◽  
Current State ◽  
Islamic Jurisprudence ◽  
The Status ◽  
Sensitive Issues ◽  
Status Of Women ◽  
Islam And Democracy

This article examines the state of Islamic jurisprudence with regard to many sensitive issues, such as the status of women and minorities in Islam, Islam and Democracy, hudud punishments. The author explores the current state of Islamic discourse on jurisprudence and identifies three approaches-traditional, secular and reformist. The paper explores the positions of the traditional ulama and the reformist muj­tahids on the mentioned topics and finds the reformist position more sensible and closer to the position of ihe Qur'an and Sunnah. This paper while advocating neo-ijtihad, makes an impressive case for the merit???? and Islamic credibility of the reformist jurisprudence.

Academic Technology Transfer in Poland-30 Years of Growth

2020 ◽  
Vol 7 (1) ◽  
pp. 25-32
Author(s):  
Krystian Gurba
Keyword(s):  
Technology Transfer ◽  
Private Sector ◽  
Institutional Environment ◽  
Innovation System ◽  
Legal Framework ◽  
European Countries ◽  
Support Programs ◽  
Significant Delay ◽  
Academic Technology ◽  
The Status

Organizations managing technology transfer from universities to the private sector, although born in Poland with a significant delay compared to Western European countries, are currently important actors in the Polish innovation system. The article summarizes the process of shaping the role and models of the functioning of these organizations. It discusses the status and functions of technology transfer centers and the institutional environment of academic technology transfer in Poland: legal framework, support programs, and partner organizations. Furthermore, it highlights the importance of cooperation networks in technology transfer and draws attention to specific initiatives focused on technology transfer in the biotechnology and pharmacy sectors.

Assessment of laboratory errors and best laboratory practices

2016 ◽  
Vol 5 (07) ◽  
pp. 4704
Author(s):  
Syed Riaz Mehdi* ◽  
Sharique Ahmad ◽  
Noorin Zaidi
Keyword(s):  
External Quality Control ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Control Programs ◽  
Medical Laboratories ◽  
Laboratory Error ◽  
Active Communication ◽  
Total Testing Process ◽  
Five Phases

Laboratory error is defined by ISO 22367 as “Failure of planned actions to be completed as intended or use a wrong plan to achieve an aim”. Lundeberg in 1981 outlined the concept of Total Testing Process (TTP) and Plebani elaborated it further and classified the whole testing process into five phases of Pre-Pre Analytic, Pre Analytic, Analytic, Post Analytic and Post - Post Analytic. The errors have to be identified and resolved in each phase of the process. The medical laboratories have to run Internal and External Quality Control programs and abide by the guidelines of ISO 15189 in order to be accredited by bodies like JCI, CAP or NABL. Active communication and regular interaction between the clinicians and the laboratory is recommended during Pre Analytic and Post Analytic phases of TTP in order to achieve the target of Best Laboratory Practices. 

Current state-of-the-art antiplatelet and anticoagulation therapy in diabetic patients with coronary artery disease

2021 ◽  
Author(s):  
Johny Nicolas ◽  
Victor Razuk ◽  
Gennaro Giustino ◽  
Roxana Mehran
Keyword(s):  
Diabetes Mellitus ◽  
Complex Disease ◽  
Anticoagulation Therapy ◽  
Treatment Strategies ◽  
Diabetic Patients ◽  
Current State ◽  
Organ Systems ◽  
Patients With Diabetes ◽  
The Status ◽  
Artery Disease

Diabetes mellitus is a complex disease that leads to long-term damage to various organ systems. Among the numerous cardiovascular disease-related complications, thrombotic events frequently occur in patients with diabetes. Although guidelines exist for treating and preventing most diabetes-related co-morbidities, the evidence on antithrombotic therapy in primary and secondary prevention is limited due to the scarcity of randomized trials dedicated to patients with diabetes mellitus. Most of the available data are derived from studies that only included a small proportion of patients with diabetes. The present review provides an overview of the status of knowledge on antiplatelet and anticoagulation therapy in patients with diabetes, focusing on the risk–benefit balance of these therapies and future treatment strategies.

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