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.

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 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.

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.

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 How ISO-15189 laboratory accreditation assures patient safety? / Kako ISO-15189 akreditacija laboratorija osigurava bezbednost pacijenta?

2012 ◽  
Vol 31 (4) ◽  
pp. 271-280 ◽  
Author(s):  
Mustafa Serteser ◽  
Abdurrahman Coskun ◽  
Tamer C. Inal ◽  
Ibrahim Unsal
Keyword(s):  
Patient Safety ◽  
Medical Errors ◽  
Interdisciplinary Approach ◽  
Professional Associations ◽  
Shared Responsibility ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Outcomes Of Care ◽  
Laboratory Services ◽  
The Individual

Summary Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occurrence of medical errors. Patient safety is one of the most serious global health issues and defined as the absence of preventable harm to a patient during any process of medical care. The frequency of medical errors is higher than expected. It has been concluded that the majority of medical errors are not because of the individual attitudes but mainly caused by faulty systems or processes leading the staff to make mistakes or fail to prevent them. Patient safety is a shared responsibility comprised of many stakeholders such as society, patients, nurses, educators, administrators, researchers, physicians, government and legislative bodies, professional associations and accrediting agencies. Medical laboratory services are essential to patient care and need to be available to meet the needs of both patients and caregivers. ISO- 15189:2007 Medical Laboratories-Particular requirements for quality and competence, an internationally recognized standard containing requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable laboratory services. It applies quality system requirements to the clinical laboratories with a strong focus on responsiveness to the needs of patients and clinicians. Applying the performance improvement strategies focusing on different phases in total testing process will significantly reduce the errors and therefore will improve the patient safety. In this way, laboratory professionals contribute to improvement of safety and outcomes of care by working in interdisciplinary approach manner.

scholarly journals Overview of the laboratory accreditation programme of the College of American Pathologists

2021 ◽  
Vol 8 (4-5) ◽  
pp. 654-663
Author(s):  
K. K. Abu Amero
Keyword(s):  
Gold Standard ◽  
Laboratory Accreditation ◽  
Medical Laboratory ◽  
Successful Performance ◽  
Medical Laboratories ◽  
The Past ◽  
National Body ◽  
Accreditation Programme ◽  
Accredited Laboratories ◽  
Insight Into

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories [seven] remains low. Of these, five are accredited by the College of American Pathologists’ Laboratory Accreditation Program [LAP] -the ‘gold standard’ of laboratory accreditation. It requires successful performance in the College of American Pathologists’ proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists

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.

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