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.

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 THE PROFESSIONAL STANDARD OF A SPECIALIST IN CLINICAL LABORATORY MEDICINE AND ITS EVALUATION BY MEDICAL LABORATORY STAFF

2017 ◽  
Vol 25 (3) ◽  
pp. 63-68
Author(s):  
P. N. Zolotaryov
Keyword(s):  
Higher Education ◽  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Study Data ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Professional Standard ◽  
Laboratory Staff ◽  
Wide Range

The issue of improving the personnel service in clinical laboratory diagnostics is topical, since specialists, having modern knowledge in laboratory research, can not stay aside from active participation during their appointment and interpretation. Training of specialists of this level requires revision of the regulatory framework, namely, the development of professional standards for specialists in clinical laboratory medicine. The survey involved 83 specialists with higher education working in clinical diagnostic laboratories of various forms of ownership in the Samara Region (Russia). In the course of the study, data were obtained reflecting the readiness to perform a number of generalized labor functions of the professional standard. Prior to the evaluation of the criterion of attention paid to the labor function in each group of respondents, we expected to obtain values of 9-10 units. However, in the course of the study, we found that this indicator in various groups of respondents fluctuated in a wide range. We believe that the training of professional stuff with higher education in laboratory medicine should be implemented in parallel with the introduction of the professional standard.

Medical laboratory quality systems – a management review

2015 ◽  
Vol 28 (3) ◽  
pp. 267-273 ◽  
Author(s):  
Dimitris Theodorou ◽  
Padelis Giannelos
Keyword(s):  
Quality Management ◽  
Process Approach ◽  
Medical Laboratory ◽  
Management Systems ◽  
Quality Management Systems ◽  
Content Type ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Management Review ◽  
Top Managers

Purpose – The purpose of this paper is to highlight changes in ISO 15189:2012 and ISO 15189:2007 concerning management review requirements and to present a management review checklist, which includes all the revised ISO 15189’s requirements. Design/methodology/approach – The recent revised and updated ISO 15189:2012 standard recommends a management review using a process approach and includes some additional topics. Findings – The management review is a key element in many quality management systems, including medical laboratory management systems in accordance with ISO 15189. The process approach enables laboratory top managers and personnel to achieve all the quality management system’s important inputs and outputs. Originality/value – As laboratory staff often encounter difficulties fully exploiting the management review process, this checklist helps laboratory staff carry out an effective management review covering all the quality management system’s important aspects.

scholarly journals Safe Laboratory Practices in the Light of Covid-19 Pandemic: Way Forward in a Resource Limited Setting

2020 ◽  
Author(s):  
Kevin Odega ◽  
Ehijie Iyamah ◽  
Ephraim Ibadin ◽  
Festus Idomeh ◽  
Deborah odega
Keyword(s):  
Early Response ◽  
Technical Note ◽  
Medical Laboratory ◽  
Chinese Government ◽  
The Novel ◽  
Laboratory Practice ◽  
Laboratory Staff ◽  
Global Pandemic ◽  
Resource Limited ◽  
Good Laboratory

The 2019 Coronavirus pandemic which was initially referred to as 2019-nCoV, was first identified in Wuhan, China. Early response from the Chinese government included quarantine of infected persons, isolation and total lockdown of Wuhan province to prevent further spread. With the spread of the disease across national borders and declaration of the disease as a global pandemic, there has been a robust response by the international community to contain this deadly virus and prevent its further spread worldwide. Africa is not left out of this rampaging pandemic with documented cases in over 40 countries and still rising. Although extensive studies have been carried out on the novel SARS-CoV-2 on its pathogenesis, mode of infection and virulence but much is still unknown. However, potentially infectious samples are received routinely in the medical laboratory for analysis. This technical note reviews good laboratory practice (GLP) and processes across the different specialities of Medical Laboratory practice that should minimize the risk of infection to laboratory staff especially in resource-limited settings.

scholarly journals Comparison of regression for blood ALP levels using methods of the Japan Society of Clinical Chemistry and the International Federation of Clinical Chemistry and Laboratory Medicine in bovine, canine, feline, and human testing

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253396
Author(s):  
Akihisa Hata ◽  
Noboru Fujitani ◽  
Masahiro Takeshita ◽  
Chie Tanaka ◽  
Noriko Matsuda ◽  
...  
Keyword(s):  
Veterinary Medicine ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Animal Health ◽  
Laboratory Medicine ◽  
International Federation ◽  
Medical Laboratory ◽  
Japan Society ◽  
Medical Laboratories ◽  
Laboratory Technology

Livestock and companion animal health have a direct impact on human health. Research on clinical laboratory technology for veterinary medicine is as important as that on human laboratory technology. Reagents and analysis equipment for human medical laboratory tests are often used in veterinary medicine. Medical laboratories in Japan utilize the Japan Society of Clinical Chemistry (JSCC) method for blood alkaline phosphatase (ALP) analysis. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) method is used worldwide for ALP catalytic concentration measurement. When the IFCC method is used, human blood ALP activity is approximately one-third of the JSCC method’s activity. The JSCC method for ALP measurement was switched to the IFCC method in medical laboratories in Japan in April 2020 for global standardization purpose. It is uncertain whether conventional JSCC method reagents will continue to be supplied. In veterinary medicine, the relationship between the JSCC and IFCC methods in terms of ALP measurement is almost unclear. This study investigated the regression between JSCC and IFCC methods measuring ALP in bovine, canine, feline, and human. The regression formulas for bovine, canine, feline, and human ALP values using the conventional JSCC (x) and IFCC (y) methods are y = 0.379x + 0.124, y = 0.289x + 8.291, y = 0.358x + 0.432, and y = 0.337x + 2.959, respectively. These results suggested that the IFCC method measurement could be estimated by approximately one-third of the JSCC method measurement in animal species such as bovine, canine, and feline. By applying the conversion factors proposed in this study, a very good correlation could be obtained between the two methods for each animal.

Qualitative migration research ethics: a roadmap for migration scholars

2020 ◽  
Vol 20 (3) ◽  
pp. 269-279
Author(s):  
Ricard Zapata-Barrero ◽  
Evren Yalaz
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Codes Of Conduct ◽  
Ethical Challenges ◽  
Ethical Awareness ◽  
Content Type ◽  
Migration Research ◽  
And Migration

PurposeThis article aims to set a roadmap for an ethical programme, which we call “qualitative migration research ethics” (QMRE). It is a scoping review that maps current ethical challenges that migration scholars often face and provide guidance, while acknowledging the fact that many researchers deal with ethical issues on a case-by-case basis.Design/methodology/approachBy connecting three lines of debates – ethics in social sciences, in qualitative research and in migration studies – this article addresses the following core questions: What are the particular ethical dilemmas in qualitative migration research (QMR)? How do migration researchers deal with these ethical dilemmas? What is the role of universal ethical codes of conduct and case-by-case ethical considerations in dealing with particular situations?FindingsThis review demonstrates that special aspects of migration research context, e.g. participants' mobility, potential vulnerability and migration as a politicized issue as well as the flexible and exploratory nature of qualitative research require particular ethical awareness that cannot be sufficiently addressed by standardized guidelines.Originality/valueIt proposes that efforts to raise ethical awareness must go beyond researchers' ethical confessions or blind adherence to pre-fixed guidance. Researchers must have critical “ethical radar” before, during and after their fieldwork; not only while working on extreme and vulnerable cases but also while doing all kind of research regardless of the level of vulnerability. Last but not least, this article claims the need for including critical ethical consciousness substantially in higher education programmes at the very beginning of the research career.

Accreditation of medical laboratories in the European Union

2007 ◽  
Vol 45 (2) ◽  
Author(s):  
Wim Huisman ◽  
A. Rita Horvath ◽  
David Burnett ◽  
Victor Blaton ◽  
Rózsa Czikkely ◽  
...  
Keyword(s):  
Regional Cooperation ◽  
Clinical Chemistry ◽  
Medical Laboratory ◽  
The European Union ◽  
Iso 15189 ◽  
National Accreditation ◽  
Medical Laboratories ◽  
European Cooperation ◽  
Actual Field ◽  
The Eu

Abstract: Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU.: Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.Clin Chem Lab Med 2007;45:268–75.

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.

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.

Ethical Issues in Dissemination and Implementation Research

2017 ◽  
Author(s):  
James M. DuBois ◽  
Beth Prusaczyk
Keyword(s):  
Ethical Decision ◽  
Ethical Decision Making ◽  
Ethical Issues ◽  
Dissemination And Implementation ◽  
Ethical Challenges ◽  
Specific Complex ◽  
Dissemination And Implementation Research ◽  
Research Regulations ◽  
Human Participants ◽  
Context Specific

This chapter focuses primarily on the protection of human participants in D&I studies. It begins by reviewing the Belmont principles that undergird US research regulations and considering the ethical case for D&I research. It then proceeds to examine some ethical issues that might arise during the course of a public health, D&I research agenda in middle schools. It covers the ethical case for D&I research and common ethical challenges. The chapter also discusses strategies for ethical decision-making. While these strategies may be beneficial to all researchers, the authors believe they are of particular value to dissemination and implementation researchers because the nature of their work—context specific, complex, and unfamiliar to many peers, collaborators, and reviewers—means they will deal with uncertainty and conflict on a regular basis, and solutions to the problems they face will rarely be found through simple reference principles, rules, or regulations.

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