scholarly journals ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety

2017 ◽  
Vol 36 (3) ◽  
pp. 225-230 ◽  
Author(s):  
Mario Plebani ◽  
Laura Sciacovelli
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
European Federation ◽  
Quality Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
International Standard ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Total Testing Process

SummaryAccreditation is a valuable resource for clinical laboratories and the development of an International Standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of the International Standard, ISO 15189, has further strengthened its value not only for improving the quality system of a clinical laboratory but also for better answering the request for competence, focus on customers’ needs and ultimate value of laboratory services. Although in some countries more general standards such as ISO 9001 for quality systems or ISO 17025 for testing laboratories are still used, there is increasing recognition of the value of ISO 15189 as the most appropriate and useful standard for the accreditation of medical laboratories. In fact, only this International Standard recognizes the importance of all steps of the total testing process, namely extra-analytical phases, the need to focus on technical competence in addition to quality systems, and the focus on customers’ needs. However, the number of accredited laboratories largely varies between European countries and also major differences affect the approaches to accreditation promoted by the national bodies. In particular, some national accreditation bodies perpetuate the use of fixed scopes, while the European co-operation for accreditation (EA) and the European Federation of Laboratory Medicine (EFLM) Working Group promote the use of flexible scopes. Major issues in clinical laboratory accreditation are the verification of examination procedures for imprecision, trueness and diagnostic accuracy and for estimating measurement uncertainty. In addition, quality indicators (QIs) are a fundamental requirement of the ISO 15189 International Standard.

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.

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.

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. 

scholarly journals How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Pieter Vermeersch ◽  
Glynis Frans ◽  
Alexander von Meyer ◽  
Seán Costelloe ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Chemistry ◽  
European Federation ◽  
Consensus Recommendation ◽  
Iso 15189 ◽  
Consensus Document ◽  
Analytical Phase ◽  
Total Testing Process ◽  
Analytical Requirements ◽  
Analytical Requirement

Abstract The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

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.

ISO 151892007-Implementation in a Laboratory Information System

2010 ◽  
pp. 64-72 ◽  
Author(s):  
Stavros Archondakis ◽  
Aliki Stathopoulou ◽  
Ioannis Sitaras
Keyword(s):  
Medical Records ◽  
Standard Form ◽  
Quality Standards ◽  
Iso 9001 ◽  
Quality Systems ◽  
Iso 15189 ◽  
Storage And Retrieval ◽  
Medical Laboratories ◽  
Certification Standard ◽  
Laboratory Information Systems

ISO 15189:2007 constitutes an international certification standard, based upon ISO/IEC 17025 and ISO 9001, which can be used by medical laboratories wishing to improve their quality standards. The requirements of this standard form a group of general guidelines that will help laboratories establish and enhance their quality systems. Although direct references to the use of computer systems are made in only 7 cases, through the mandatory section of the ISO 15189:2007, many more clauses of the standard include indirect references to electronic medical records handling. The chapter analyzes the guidelines concerning the use of laboratory information systems for medical records storage and retrieval. Furthermore, the authors discuss challenging difficulties that may be detected during implementation of ISO 15189:2007 in the field of electronic laboratory medical records.

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.

scholarly journals Challenges of Laboratory Medicine: European Answers

2011 ◽  
Vol 30 (4) ◽  
pp. 273-278 ◽  
Author(s):  
Irena Korita ◽  
Victor Blaton
Keyword(s):  
Strategic Alliances ◽  
Business Models ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biomedical Sciences ◽  
Clinical Laboratories ◽  
Laboratory Services ◽  
Enhance Efficiency

Challenges of Laboratory Medicine: European Answers Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistry and Laboratory Medicine are essential for the provision of high-quality preanalytical, analytical and consultative services. Laboratory medicine has undergone major transformations during the last decade. Ongoing technological developments have considerably improved the productivity of clinical laboratories. Information on laboratory services is globally available, and clinical laboratories worldwide face international competition and there is a huge pressure to reduce costs. To be prepared for the future, clinical laboratories should enhance efficiency and reduce the cost increases by forming alliances and networks, consolidating, integrating or outsourcing, and more importantly create additional value by providing knowledge services related to in vitro diagnostics. Therefore, business models that increase efficiency such as horizontal and vertical integration are proposed, based on collaborative networks for the delivery of clinical laboratory services. Laboratories should cooperate, consolidate and form strategic alliances to enhance efficiency and reduce costs. There is a growing conflict between the science and the art of clinical practice and on the role of the biomedical sciences in medical practice. We have a dehumanizing effect on medical care. Disease is defined at the level of sick molecules and cells and curative medicine is being replaced by the preventive care of the disease. Undoubtedly all those questions will raise considerable problems and challenges for the medical educators.

Role of laboratory medicine in collaborative healthcare

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Ian D. Watson ◽  
Patricia Wilkie ◽  
Amir Hannan ◽  
Graham H. Beastall
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Healthcare Delivery ◽  
Continuing Professional Development ◽  
Laboratory Medicine ◽  
Sources Of Information ◽  
Patient Centered ◽  
Laboratory Service ◽  
Laboratory Services ◽  
Centered Care

Abstract Healthcare delivery and responsibility is changing. Patient-centered care is gaining international acceptance with the patient taking greater responsibility for his/her health and sharing decision making for the diagnosis and management of illness. Laboratory medicine must embrace this change and work in a tripartite collaboration with patients and with the clinicians who use clinical laboratory services. Improved communication is the key to participation, including the provision of educational information and support. Knowledge management should be targeted to each stakeholder group. As part of collaborative healthcare clinical laboratory service provision needs to be more flexible and available, with implications for managers who oversee the structure and governance of the service. Increased use of managed point of care testing will be essential. The curriculum content of laboratory medicine training programs will require trainees to undertake practice-based learning that facilitates interaction with patients, clinicians and managers. Continuing professional development for specialists in laboratory medicine should also embrace new sources of information and opportunities for collaborative healthcare.

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