scholarly journals Patient Safety in Laboratory Medicine

2020 ◽  
pp. 325-338
Author(s):  
Mario Plebani ◽  
Ada Aita ◽  
Laura Sciacovelli
Keyword(s):  
Patient Safety ◽  
Clinical Decision Making ◽  
Quality Management System ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Main Task ◽  
Iso 15189 ◽  
Preventive Actions ◽  
Total Testing Process ◽  
The Right

AbstractLaboratory medicine in the healthcare system has recently been recognized as a fundamental service in the clinical decision-making process. Therefore, the notion of patient safety in laboratory medicine must be recognized as the assurance that harm to patients will be avoided, safe care outcomes will be enhanced through error prevention, and the total testing process (TTP) will be continuously improved.Although the goal for patient safety is zero errors, and although laboratory professionals have made numerous efforts to reduce errors in the last few decades, current research into laboratory-related diagnostic errors highlights that: (a) errors occur at every step of the TTP, mainly affecting phases at clinical interfaces; (b) despite the improvement strategies adopted, analytical quality remains a challenge; (c) errors are linked not only to clinical chemistry tests, but also to new, increasingly complex diagnostic testing.Medical laboratories must therefore implement effective quality assurance tools to identify and prevent errors in order to guarantee the reliability of laboratory information. Accreditation in compliance with the International Standard ISO 15189 represents the first step, establishing processes with excellence requirements and greater expectations of staff competency. Another important step in preventing errors and ensuring patient safety is the development of specific educational and training programs addressed to all professionals involved in the process, in which both technical and administrative skills are integrated. A wide variety of information is provided by a robust quality management system and consensus-approved Quality Indicators (QI) that identify undesirable events, evaluate the risk to the patient, and call for corrective and preventive actions. However, the effectiveness of the system depends on the careful analysis of data collected and on staff awareness of the importance of laboratory medicine to the healthcare process. The main task of the new generation of laboratory professionals should be to gain experience in “clinical laboratory stewardship.” In order to safeguard patients, laboratory professionals must assist clinicians in selecting the right test for the right patient at the right time and facilitate the interpretation of laboratory information.

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.

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.

scholarly journals Toward harmonization of clinical molecular diagnostic reports: findings of an international survey

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Deborah A. Payne ◽  
Katarina Baluchova ◽  
Graciela Russomando ◽  
Parviz Ahmad-Nejad ◽  
Cyril Mamotte ◽  
...  
Keyword(s):  
Molecular Diagnostics ◽  
Clinical Decision Making ◽  
Clinical Chemistry ◽  
Clinical Decision ◽  
Molecular Diagnostic ◽  
Molecular Testing ◽  
End User ◽  
Iso 15189 ◽  
Reporting Practices ◽  
Reporting Phase

Abstract Background: The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices. Methods: The International Federation of Clinical Chemistry and Laboratory Medicine’s Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics. The survey addressed the following aspects: (1) laboratory demographics, (2) report format, (3) result reporting/layout, (4) comments in report and (5) interpretation and clinical decision-making information. Additionally, participants indicated categories needing standardization. Results: Sixteen responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. Several categories yielded 100% agreement between laboratories, whereas other categories had less than or equal to 50% concordance. Participants scored “nomenclature” and “description of methodologies” as the two most frequently cited aspects needing standardization. Conclusions: The postexamination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. Surveyed laboratories were most likely to follow explicit ISO 15189 recommendations vs. recommendations when the term(s) “where appropriate or where applicable” was used. Interpretation and reporting of critical values varied among participants. Although the outcome of this study may not fully represent the practices of all molecular testing laboratories in countries around the world, the survey identified and specified several recommendations that are requirements for harmonized reporting in molecular diagnostics.

scholarly journals An overview of medical diagnostic laboratories in South Africa that meet the international standard of accreditation: ISO 15189

2021 ◽  
pp. 27-35
Author(s):  
H Khadambi-Morokane ◽  
K Bhowan ◽  
S Ayuk
Keyword(s):  
South Africa ◽  
Quality Management System ◽  
Accreditation Body ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
Patient Request ◽  
Medical Technologist ◽  
Medical Diagnostic ◽  
Accredited Laboratory ◽  
The Right

Accreditation is an official recognition that a facility or laboratory is competent to perform specific tasks and has a documented manual on a Quality Management System (QMS) in place. According to the Accreditation Act 19 of 2006, South African National Accreditation Systems (SANAS) is the only internationally recognised accreditation body in South Africa. The International Organization for Standardization (ISO) standard specifically for medical laboratory accreditation is ISO 15189:2012. This review is designed to bring awareness of accredited and unaccredited medical diagnostic laboratories in SA; to look at the number of accredited, unaccredited laboratories and the rate of accreditation growth; to examine the state of accreditation in South Africa with regard to how many are accredited, suspended or withdrawn; and to highlight the advantages of being an accredited laboratory. It also examines the nonconformances commonly raised during assessment and an overview of accreditation around the world. Upon accreditation, the laboratory is given the right to use the SANAS symbol on patient request forms or results as a confirmation of competency. This has motivated more and more laboratories to be accredited. Diagnostic laboratories contribute much toward the final decisions taken by clinicians to diagnose the patients or treatment; this may be from an accredited or non-accredited laboratory. Since patient care is inextricably linked to pathology testing, every laboratory should engage a premium QMS and be evaluated by an accreditation body to ensure that patients receive a trustworthy report. Accreditation is a voluntary process in South Africa but mandatory in some Western countries. Although some laboratories might lose accreditation along the way, the ratio compared to those accredited is still very small. The fact that a majority remain accredited is a good indication of a well-implemented QMS. The challenges faced by the medical technologist-owned laboratories remain, as they are still not accredited.

scholarly journals Ethics in Laboratory Medicine: An Overview of Considerations for Ethical Issues

2021 ◽  
Author(s):  
Neerja Aggarwal ◽  
Pawan Kumar Kare ◽  
Sudip Kumar Datta
Keyword(s):  
Ethical Issues ◽  
Clinical Chemistry ◽  
Codes Of Conduct ◽  
Laboratory Medicine ◽  
Direct Access ◽  
Medical Laboratory ◽  
Ethical Challenges ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Resource Limited

Several ethical issues exist within the diagnostic medical laboratory. The major ethical challenges such as; consent, confidentiality, codes of conduct, conflict of interest, lab utilisation, proficiency, and direct access testing are some times more prevalent in resource-limited settings. Presently, decisions regarding diagnosis and patient’s treatment are commonly taken on the basis of outcomes and interpretations of laboratory test results. Therefore, ethics plays a significant role in laboratory medicine. Apart from the lab results, laboratory staff is another important aspect of the laboratory. Hence, it is highly recommended that knowledge of ethics helps to protect confidence; operational integrity, capability, impartiality, and safety of the staff. Many countries and their professional societies have developed policies and guidance material with regard to ethical issues in the area of laboratory medicine. The organizations specially; International of federation of clinical chemistry (IFCC), American Association of Clinical Chemistry (AACC) and International Organization for Standardization (ISO) have defined ethical recommendations for clinical laboratories. They are, in general, outlined the responsibilities of laboratory professionals towards their profession, the patient, and the society. However, implication of ethical standards and guidelines are vary between different cultures, geographies, and according to available resources. In this chapter, we have mentioned the ethical consideration of IFCC, AACC and ISO 15189:2012 with regard to laboratory medicine and also addressed the various ethical issues that arises day to day in laboratory medicine in the current scenario.

scholarly journals Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory

2018 ◽  
Vol 31 (3) ◽  
Author(s):  
Roberta B. Carey ◽  
Sanjib Bhattacharyya ◽  
Sue C. Kehl ◽  
Larissa M. Matukas ◽  
Michael A. Pentella ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Daily Practice ◽  
Microbiology Laboratory ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Roles And Responsibilities ◽  
Technical Requirements ◽  
Total Testing Process

SUMMARY This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages “systems thinking” by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

2018 ◽  
Vol 57 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Min Duan ◽  
Xudong Ma ◽  
Jing Fan ◽  
Yanhong Guo ◽  
Wei Wang ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Turnaround Time ◽  
Laboratory Medicine ◽  
General Information ◽  
Critical Values ◽  
Medical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

The use of preanalytical quality indicators: a Turkish preliminary survey study

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Bagnu Orhan ◽  
Derya Sonmez ◽  
Hikmet Can Cubukcu ◽  
Oguzhan Zengi ◽  
Humeyra Ozturk Emre ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Quality Standards ◽  
Survey Study ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Medical Laboratories ◽  
Information Management Systems ◽  
Survey Results ◽  
Total Testing Process

AbstractObjectivesThe utilization of reliable quality indicators (QIs) proven to be suitable for monitoring and improvement tools is one of the best choices to minimize of the risk of errors in all laboratory processes called as total testing process (TTP). In 2008, a Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) established by International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed the Model of Quality Indicators (MQI) complying with requirements of the ISO 15189:2012 standard for laboratory accreditation. They have also been dealing with harmonizing the QIs in most laboratories worldwide since then. The present study was set out to investigate the frequency of using IFCC WG-LEPS’ pre-QIs by Turkish laboratories and to assess the conformity of them, by taking into account Turkey’s conditions.MethodsA survey consisting nine questions was applied in 81 laboratories using SurveyMonkey.ResultsAccording to the survey results, most of the laboratories reported they have used pre-QIs in the quality standards of health prepared by Turkish Ministry of Health (MOH). A part of IFCC WG-LEPS’ pre-QIs were being utilized by more than 80% of the laboratories, the rest of which only used by 10% of laboratories.ConclusionsThe majority of the medical laboratories have been using the pre-QIs included in the guidelines of Quality Standards prepared by the MOH. The pre-QIs are partially compatible with IFCC WG-LEPS’ pre-QIs. The definitions of IFCC WG-LEPS’ pre-QIs may also be revised to make them more clear and understandable by IFCC WG-LEPS. The insufficiency of Health Information Management Systems (HIMS) limits the use of pre-QIs proposed by IFCC WG-LEPS. Finally, the education of relevant personnel about the use of HIMS and pre-QIs is very crucial to harmonize and to extend the use of IFCC WG-LEPS’ pre-QIs in Turkish medical biochemistry laboratories.

scholarly journals Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (4) ◽  
Author(s):  
Giuseppe Lippi ◽  
Geoffrey S. Baird ◽  
Giuseppe Banfi ◽  
Karin Bölenius ◽  
Janne Cadamuro ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Diagnostic Testing ◽  
Laboratory Medicine ◽  
Therapeutic Monitoring ◽  
European Federation ◽  
Preanalytical Phase ◽  
Total Testing Process ◽  
The Many ◽  
High Degree

Abstract It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting “Improving quality in the preanalytical phase through innovation” in Amsterdam, 24–25 March, 2017.

Transition to ISO 15189 : 2012 for Cytopathology Laboratories Part 1

2016 ◽  
Vol 5 (3) ◽  
pp. 1-21 ◽  
Author(s):  
Eleftherios Vavoulidis ◽  
Stavros Archondakis ◽  
Maria Nasioutziki ◽  
Ourania Oustambasidou ◽  
Angelos Daniilidis ◽  
...  
Keyword(s):  
Quality Management System ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Quality Level ◽  
Highly Qualified ◽  
High Quality ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Qualified Personnel ◽  
Analytical Equipment

Nowadays, due to the latest advances in Laboratory Medicine, diagnostic medical laboratories with their highly qualified personnel and state-of-the-art analytical equipment, have completely changed the way modern healthcare is offered. In order to maintain or even increase the already high quality level of the provided testing services, diagnostic laboratories including the cytopathology ones, need to design and apply a Quality Management System (QMS) in agreement with the requirements of the ISO 15189 International Standard. The authors present their experience on the implementation of such a QMS in cytopathology laboratories and highlight the most important general and management parameters that should be taken into consideration when moving from ISO 15189:2007 to the latest ISO 15189:2012. In addition, useful recommendations and suggestions that could make the transition to the latest Standard easier are included. Finally, possible issues and potential adverse events associated with the laboratory's implementation of the ISO 15189:2012 are also described.

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