Accreditation

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. .

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Accreditation of medical laboratories in the European Union

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm.2007.037 ◽

2007 ◽

Vol 45 (2) ◽

Cited By ~ 16

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.

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Quality management in medical laboratories

Hämostaseologie ◽

10.1055/s-0037-1617044 ◽

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.

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Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

Journal of Medical Biochemistry ◽

10.2478/v10011-008-0007-2 ◽

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.

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Towards a Comprehensive Knowledge Management Improvement Model for Medical Laboratories

Journal of Information & Knowledge Management ◽

10.1142/s0219649219500242 ◽

2019 ◽

Vol 18 (02) ◽

pp. 1950024

Author(s):

Lamiae Bentaleb ◽

Saâd El Kabbaj ◽

Mimoun Zouhdi

Keyword(s):

Knowledge Management ◽

Continuous Improvement ◽

Medical Laboratory ◽

Decision Making Process ◽

Medical Laboratories ◽

Comprehensive Knowledge ◽

Analysis Laboratory ◽

Medical Laboratory Professionals ◽

Medical Analysis

Medical laboratories are complex facilities in which managing knowledge could impact patients’ lives. This paper presents a comprehensive and phased framework for knowledge management (KM) developed and applied within the Research and Medical Analysis Laboratory of the Gendarmerie Royale in Morocco. The model is built according to the PDCA wheel, and the four pillars of methodology are: leadership, knowledge core process, performance evaluation, and finally elements for its continuous improvement. This KM framework will help identify the knowledge needs and expectations of the medical laboratory’s relevant interested parties, support medical laboratory professionals with the decision-making process, and therefore enhance the quality of the services they provide.

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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»

Spravočnik vrača obŝej praktiki (Journal of Family Medicine) ◽

10.33920/med-10-2012-02 ◽

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.

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

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-1212 ◽

2019 ◽

Vol 57 (4) ◽

pp. 459-464 ◽

Cited By ~ 4

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.

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Synthesis of Deuterated Surrogate Standards for the Analysis of Legally Regulated Substances in Cosmetics

10.26434/chemrxiv.13366274.v1 ◽

2020 ◽

Author(s):

Fariña Beatriz ◽

Carlos González ◽

Manuel Lolo ◽

F. Javier Sardina

Keyword(s):

European Union ◽

Continuous Improvement ◽

Analytical Methods ◽

Raw Materials ◽

Synthetic Methods ◽

The European Union ◽

Cosmetic Products ◽

Musk Xylene ◽

Harmful Substances ◽

Musk Ambrette

<p>The presence of harmful substances in cosmetic products is regulated in most countries. In the European Union the Regulation (EC) No. 1223/2009 lays down the requirements for the marketing of cosmetic products. Among others, important families of compounds restricted in the Regulation are musks, allergenic fragrances and phthalates. To ensure product safety, improved analytical methods capable of reliably and reproducibly detecting the presence of traces of prohibited and/or restricted ingredients in raw materials and finished products are required. </p> <p>For the continuous improvement of the reliability of the analytical methods developed to check the compliance of cosmetic products with the Regulation, the use of appropriate surrogate standards or contaminants (substances that are added to the samples to be analyzed to establish the recovery and the reproducibility of the quantification of the analytes) are of utmost importance. One of the best kinds of surrogate standards are isotopically labeled analogs of the analytes of interest. In this work, several synthetic methods have been developed to prepare isotopically labeled analogs of atranol, chloroatranol, di-n-octylphthalate, musk xylene, and musk ambrette, which are restricted substances in cosmetic articles.</p>

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A Critical Assessment of the European Commission's Proposals for the Risk Assessment and Registration of Chemical Substances in the European Union

Alternatives to Laboratory Animals ◽

10.1177/026119290303100315 ◽

2003 ◽

Vol 31 (3) ◽

pp. 353-364 ◽

Cited By ~ 3

Author(s):

Robert Combes ◽

Jennifer Dandrea ◽

Michael Balls

Keyword(s):

Risk Assessment ◽

European Union ◽

White Paper ◽

Assessment Process ◽

Alternative Methods ◽

The European Union ◽

Registration System ◽

Safety Testing ◽

Key Stakeholders ◽

Chemicals Policy

In May, 2003, the European Commission published detailed proposals relating to its 2001 White Paper – Strategy for a Future Chemicals Policy. The White Paper described a new registration system called the REACH (Registration, Evaluation and Authorisation of Chemicals) system, for both new and existing chemicals. Subsequently, these detailed proposals were available for an eight-week consultation period for stakeholders to voice their views and concerns. In this paper, we describe our reactions to the Commission's more-detailed proposals. These include the creation of a European Chemicals Agency to implement the REACH system in conjunction with Competent Authorities (CAs) in Member States and the Commission itself. Unfortunately, many of our concerns and suggestions, previously voiced and shared with several other key stakeholders, remain unanswered, but are as relevant as when the White Paper was published. In particular, we are concerned about the lack of a clear and coherent strategy. There is no guidance for registrants on intelligent testing to maximise the use of non-animal approaches to safety testing, based on a combination of factors for estimating exposure levels, rather than mainly on production volumes. We are also concerned about the absence of a clear programme for the development, improvement and validation of new alternative methods, in conjunction with the Commission's own unit, the European Centre for the Validation of Alternative Methods, as well as other organisations with relevant expertise and experience, including FRAME. Finally, we explain why such measures should be introduced, together with clearer guidelines for the respective roles of the Agency, the CAs and the Commission in implementing and harmonising the REACH system at the European Union and Member State levels. A series of recommendations are made, to improve the situation and to improve the risk assessment process.

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