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.

An integrated assessment system for the accreditation of medical laboratories

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Neven Saleh ◽  
Ahmed Abo Agyla
Keyword(s):  
Web Application ◽  
Assessment Tool ◽  
Laboratory Accreditation ◽  
Integrated System ◽  
Assessment System ◽  
Medical Laboratory ◽  
Quality Level ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services

AbstractMedical laboratory accreditation becomes a trend to be trustable for diagnosis of diseases. It is always performed at regular intervals to assure competence of quality management systems (QMS) based on pre-defined standards. However, few attempts were carried out to assess the quality level of medical laboratory services. Moreover, there is no realistic study that classifies and makes analyses of laboratory performance based on a computational model. The purpose of this study was to develop an integrated system for medical laboratory accreditation that assesses QMS against ISO 15189. In addition, a deep analysis of factors that sustain accreditation was presented. The system started with establishing a core matrix that maps QMS elements with ISO 15189 clauses. Through this map, a questionnaire was developed to measure the performance. Therefore, score indices were calculated for the QMS. A fuzzy logic model was designed based on the calculated scores to classify medical laboratories according to their tendency for accreditation. Further, in case of failure of accreditation, cause-and-effect root analysis was done to realize the causes. Finally, cloud computing principles were employed to launch a web application in order to facilitate user interface with the proposed system. In verification, the system has been tested using a dataset of 12 medical laboratories in Egypt. Results have proved system robustness and consistency. Thus, the system is considered as a self-assessment tool that demonstrates points of weakness and strength.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2017 ◽  
pp. 40-61 ◽  
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

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.

An Integrated Fuzzy VIKOR Method for Performance Management in Healthcare

2018 ◽  
pp. 1100-1121
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu
Keyword(s):  
Performance Management ◽  
Evaluation Method ◽  
Multiple Criteria Decision Making ◽  
Poor Quality ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Standard Iso 15189

Poor quality control has become a major threat to medical laboratory services, especially in the developing countries. It has become necessary to assess and rank the quality of diagnostic services in medical laboratories using systematic approaches. The main aim of this research is to develop and apply a quantitative method in ranking medical laboratory services. This method is based on a combination of Vlsekriterijumska Optimizacija I Kompromisno Resenje (VIKOR) with fuzzy set theory. VIKOR is a multiple criteria decision making technique which focuses on ranking and selection from a set of alternatives, and determines the compromise solution for a problem with different criteria. This approach aids decision makers to achieve the most acceptable decision amidst numerous alternatives. In the present evaluation method, international standard ISO 15189 (Medical Laboratories Particular Requirements for Quality and Competence) proposed by International Organization for Standardization (ISO) is used as a fundamental source of selected attributes of a medical laboratory. The study compares three medical laboratories to each other and ranks them. This study will be a valuable and effective contribution in enhancing both qualitative and quantitative criteria in the field of medical laboratory services. Finally, some directions for further studies are proposed.

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.

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.

scholarly journals Medical Laboratory Accreditation according to ISO 15189:2003.The Mexican Experience

2007 ◽  
pp. 188-192 ◽  
Author(s):  
Rosa Isabel Sierra-Amor ◽  
Maribel Lopez-Martinez
Keyword(s):  
Laboratory Accreditation ◽  
Medical Laboratory ◽  
Iso 15189

scholarly journals Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Laura Sciacovelli ◽  
Andrea Padoan ◽  
Sandra Secchiero ◽  
Mario Plebani
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
High Standard ◽  
Medical Laboratory ◽  
Data Sets ◽  
External Quality ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Analytical Procedures ◽  
Medical Laboratory Professionals

Abstract Objectives Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. Methods All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. Results A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Conclusions Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements.

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