Manual of Biobank Quality Management
Manual of Biobank Quality Management

Author: Agnieszka Matera-Witkiewicz

Publisher: Springer Nature

Published: 2023-02-14

Total Pages: 160

ISBN-13: 3031125592

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This pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way. The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices. Aimed at both biobank employees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network. On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC „Quality Standards for Polish Biobanks” Handbook (QSPB).

Laboratory Quality Management System
Laboratory Quality Management System

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

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Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Artificial Intelligence and Machine Learning for Digital Pathology
Artificial Intelligence and Machine Learning for Digital Pathology

Author: Andreas Holzinger

Publisher: Springer Nature

Published: 2020-06-24

Total Pages: 351

ISBN-13: 3030504026

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Data driven Artificial Intelligence (AI) and Machine Learning (ML) in digital pathology, radiology, and dermatology is very promising. In specific cases, for example, Deep Learning (DL), even exceeding human performance. However, in the context of medicine it is important for a human expert to verify the outcome. Consequently, there is a need for transparency and re-traceability of state-of-the-art solutions to make them usable for ethical responsible medical decision support. Moreover, big data is required for training, covering a wide spectrum of a variety of human diseases in different organ systems. These data sets must meet top-quality and regulatory criteria and must be well annotated for ML at patient-, sample-, and image-level. Here biobanks play a central and future role in providing large collections of high-quality, well-annotated samples and data. The main challenges are finding biobanks containing ‘‘fit-for-purpose’’ samples, providing quality related meta-data, gaining access to standardized medical data and annotations, and mass scanning of whole slides including efficient data management solutions.

Quality Control in Laboratory
Quality Control in Laboratory

Author: Gaffar Zaman

Publisher: BoD – Books on Demand

Published: 2018-08-22

Total Pages: 160

ISBN-13: 1789234123

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The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Biobanks as Essential Tools for Translational Research: The Belgian Landscape
Biobanks as Essential Tools for Translational Research: The Belgian Landscape

Author: Sofie J. S. Bekaert

Publisher: Frontiers Media SA

Published: 2020-09-17

Total Pages: 109

ISBN-13: 2889660168

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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics - E-Book
Tietz Textbook of Clinical Chemistry and Molecular Diagnostics - E-Book

Author: Nader Rifai

Publisher: Elsevier Health Sciences

Published: 2017-01-16

Total Pages: 4785

ISBN-13: 0323548482

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The Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th Edition provides the most current and authoritative guidance on selecting, performing, and evaluating the results of new and established laboratory tests. This classic clinical chemistry reference offers encyclopedic coverage detailing everything you need to know, including: analytical criteria for the medical usefulness of laboratory tests, variables that affect tests and results, laboratory medicine, applications of statistical methods, and most importantly clinical utility and interpretation of laboratory tests. It is THE definitive reference in clinical chemistry and molecular diagnostics, now fully searchable and with quarterly content updates, podcasts, clinical cases, animations, and extended content online through Expert Consult. - Analytical criteria focus on the medical usefulness of laboratory procedures. - Reference ranges show new approaches for establishing these ranges — and provide the latest information on this topic. - Lab management and costs gives students and chemists the practical information they need to assess costs, allowing them to do their job more efficiently and effectively. - Statistical methods coverage provides you with information critical to the practice of clinical chemistry. - Internationally recognized chapter authors are considered among the best in their field. - Two-color design highlights important features, illustrations, and content to help you find information easier and faster. - NEW! Internationally recognized chapter authors are considered among the best in their field. - NEW! Expert Consult features fully searchable text, quarterly content updates, clinical case studies, animations, podcasts, atlases, biochemical calculations, multiple-choice questions, links to Medline, an image collection, and audio interviews. You will now enjoy an online version making utility of this book even greater. - UPDATED! Expanded Molecular Diagnostics section with 12 chapters that focus on emerging issues and techniques in the rapidly evolving and important field of molecular diagnostics and genetics ensures this text is on the cutting edge and of the most value. - NEW! Comprehensive list of Reference Intervals for children and adults with graphic displays developed using contemporary instrumentation. - NEW! Standard and international units of measure make this text appropriate for any user — anywhere in the world. - NEW! 22 new chapters that focus on applications of mass spectrometry, hematology, transfusion medicine, microbiology, biobanking, biomarker utility in the pharmaceutical industry and more! - NEW! Expert senior editors, Nader Rifai, Carl Wittwer and Rita Horvath, bring fresh perspectives and help ensure the most current information is presented. - UPDATED! Thoroughly revised and peer-reviewed chapters provide you with the most current information possible.

Quality Management in ART Clinics
Quality Management in ART Clinics

Author: Fabiola Bento

Publisher: Springer Science & Business Media

Published: 2012-11-13

Total Pages: 250

ISBN-13: 1441971394

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In the last decades, major advances have been made in assisted reproductive technologies (ART) and the public demand for these procedures has increased globally. All ART clinics, from those just starting out to the well established, must employ the latest equipment and implement the best practices, while ensuring that their resources are effectively engaged to optimize patient outcomes. This is a tenet of the fiduciary role of physicians and it is increasingly recognized as a quantifiable goal regulated by formal certifications and accreditations. Quality management protocols such as those proposed by the International Organization for Standardization (ISO) are being rapidly adopted as standards of measure. Quality Management in ART Clinics: A Practical Guide provides easily adoptable ways to implement and improve formalized quality management systems. Essential to any clinic to achieve best practices and maintenance of formal regulatory certifications, this book brings together the know-how of experienced opinion leaders operating in key areas worldwide. The book offers an overview of primary regulations in the ART field, with attention to quality management demands, and links specific requirements to practical steps for implementation. Filled with process and procedure examples, flow diagrams and administrative form templates, this book is the first of its kind, gathering the necessary elements for optimizing practice, management, and quality assurance.

Biobanks in Healthcare
Biobanks in Healthcare

Author: Nicole Arrighi

Publisher: John Wiley & Sons

Published: 2024-12-12

Total Pages: 196

ISBN-13: 1786300230

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Biobanks ensuring the governance and management of biological resources have become essential entities. The development of biotechnologies, the increased prevalence of biological drugs and the identification of biomarkers associated with molecular classifications of tissue lesions make it essential to have organized access to human biological samples, which have become precious and rare. The digital era and the production of massive data that comes with it have rendered biobanks the guarantors of the reproducibility of experiments and of the overall quality of medical research. Biobanks in Healthcare explores the upheaval linked to the massive deployment of digital health and precision medicine. The future of health biology lies in the deployment of biobanks in fields that have yet to be explored, putting them at the forefront of this extraordinary 21st-century research adventure.