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

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.

2008 ◽  
Vol 27 (2) ◽  
pp. 144-147
Author(s):  
Ljubinka Gligić

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.


Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu

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.


2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Neven Saleh ◽  
Ahmed Abo Agyla

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.


2020 ◽  
Vol 64 (4) ◽  
pp. 209-213
Author(s):  
Davlatmurod A. Olimov ◽  
Gafur M. Khodzhamurodov ◽  
Rustam A. Tursunov

Introduction. Patient safety is the absence of preventable harm to the patient in the course of medical care and the reduction of the risk of unnecessary harm associated with medical care to an acceptable minimum. Over the past two decades, the problem of patient safety has become the object and target area of public health for specific efforts to improve it. The study aims to analyze modern scientific literature to consider problems related to clinical safety, the global burden of harming patients. Material and methods. In the context of studying the problem, the results of modern research were used to identify the causes of medical errors and to find ways to prevent them. Results. The desire to improve the level of safety and the quality of medical care is growing in the world. Consequently, significant measures to evaluate the safety of medical care and its quality will be of paramount importance. To date, there is no gold standard or established array of quality indices (QI) for measuring the quality and safety of medical care. However, many indices have been developed, and some have even been tested to measure specific aspects of patient quality and safety. Such studies are in demand to achieve a clinically significant reduction in the incidence of medical errors. Conclusion. Despite the growing recognition of the role of human medical error in medicine, to prevent or mitigate their consequences requires the search for adequate ways both at the individual and systemic levels.


2021 ◽  
Author(s):  
Nkereuwem S. Etukudoh ◽  
Uchejeso M. Obeta

Patients’ (clients/customer) services and satisfaction in Medical Laboratory Services and general healthcare is one of the twelve (12) quality essentials of Total Quality Management System (TQMS) emphasized by quality standards as seen in ISO 17025, ISO 15189 and ISO 9001. The patients otherwise referred to as customers or clients to Medical Laboratory and healthcare in general, is the heart-beat and kings to the healthcare system. This chapter looks into the quality aspect of medical laboratory services from the patients’ angle towards thorough satisfaction or dissatisfaction index and otherwise creates room for improvement in the services and healthcare in general. The chapter therefore, identified medical laboratory clients to include patients and patients’ relations, physicians and other healthcare workers, public health and government, communities and interested parties, and medical laboratory profession. There is a need to administer services satisfaction survey developed by Director of Medical Laboratory Services or human resources/quality officers in line with the ISO 15189, ISO 17075 and ISO 9001 to customers/clients from time to time so the outcome can be used to correct services errors and cause quality improvement. It is believed that patients’ satisfaction causes improvement in healthcare, quick recovery of patients and willingness of the patient to return to the healthcare facility in future. Patients’ and customers’ in medical laboratory feedback contributes to quality management and improvement to Medical Laboratory services and healthcare as an ingredient of TQMS.


Author(s):  
Fikriye Uras

Medical laboratory services have a critical role as an integral component of patient care. The accreditation standard of ISO 15189, a guidance document, provides validation that a laboratory is competent to deliver accurate and reliable test results. This international standard has been evolving since 2003. Following the second publication (2007), the standard was released as a revised and updated version in 2012 (Medical laboratories – Requirements for quality and competence). The text of ISO 15189:2012 has been approved as EN ISO15189:2012. European Union members and associate countries agreed to accord it the status of a national standard by May 2013. Any conflicting national standards need to be withdrawn by November 2015 at the latest. The purpose of this chapter is to mark the differences between the two versions of the standards and to highlight the changes and additions that have been incorporated into ISO 15189:2012. A practical approach will be helpful for laboratories to make a smooth transition to the updated standard when revising their quality and technical documentation to meet the new requirements.


2018 ◽  
pp. 1100-1121
Author(s):  
Ehsan Shekarian ◽  
Salwa Hanim Abdul-Rashid ◽  
Ezutah Udoncy Olugu

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.


2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres

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.


2021 ◽  
pp. 019459982110133
Author(s):  
Ellen S. Deutsch ◽  
Sonya Malekzadeh ◽  
Cecelia E. Schmalbach

Simulation training has taken a prominent role in otolaryngology–head and neck surgery (OTO-HNS) as a means to ensure patient safety and quality improvement (PS/QI). While it is often equated to resident training, this tool has value in lifelong learning and extends beyond the individual otolaryngologists to include simulation-based learning for teams and health systems processes. Part III of this PS/QI primer provides an overview of simulation in medicine and specific applications within the field of OTO-HNS. The impact of simulation on PS/QI will be presented in an evidence-based fashion to include the use of run and statistical process control charts to assess the impact of simulation-guided initiatives. Last, steps in developing a simulation program focused on PS/QI will be outlined with future opportunities for OTO-HNS simulation.


Hydrology ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. 14
Author(s):  
Štěpán Kavan ◽  
Šárka Kročová ◽  
Jiří Pokorný

This assessment of societal readiness and resilience to water-related situations in the Czech Republic focuses on an interdisciplinary approach in the Czech Republic for solving this problem. The goal of the article is to evaluate and characterize the preparedness for handling water-related crises. The analysis is carried out via a SWOT analysis, which is a universal analytical method used to understand and interpret strengths and weaknesses and to identify opportunities and threats. For the calculation of the weight factor of the SWOT analysis, an assessment was determined based on the multicriteria analysis. The pair comparison method was used to determine the relative importance of the parameters of the strengths and weaknesses, opportunities and threats. The Fuller Triangle method was chosen for the system used to make the comparisons of the individual criteria. The uniqueness of the study consists of the issue of water management, which is thus reflected from a non-traditional perspective, being a contemporary model—the paradigm of the view on the preparedness of the planning documentation as one of the characteristics of societal resilience for water-related crises. The result of the research is the fact that a positive approach prevails in the researched area from the perspective of preparedness for water-related crises. For the creation of the conditions, the factors arising from the internal environment currently prevail slightly over those arising from the external environment.


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