Quality Control in Laboratory


Book Description

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.




Good Clinical, Laboratory and Manufacturing Practices


Book Description

Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.




Laboratory Quality Management System


Book Description

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".







Clinical Laboratory Science - E-Book


Book Description

**Selected for Doody's Core Titles® 2024 in Laboratory Technology** Using a discipline-by-discipline approach, Turgeon's Clinical Laboratory Science: Concepts, Procedures, and Clinical Applications, 9th Edition, provides a fundamental overview of the concepts, procedures, and clinical applications essential for working in a clinical laboratory and performing routine clinical lab tests. Coverage includes basic laboratory techniques and key topics such as safety, phlebotomy, quality assessment, automation, and point-of-care testing, as well as discussion of clinical laboratory specialties. Clear, straightforward instructions simplify laboratory procedures and are guided by the latest practices and CLSI (Clinical and Laboratory Standards Institute) standards. Written by well-known CLS educator Mary Louise Turgeon, this edition offers essential guidance and recommendations for today's laboratory testing methods and clinical applications. - Broad scope of coverage makes this text an ideal companion for clinical laboratory science programs at various levels, including CLS/MT, CLT/MLT, medical laboratory assistant, and medical assisting, and reflects the taxonomy levels of the CLS/MT and CLT/MLT exams. - Detailed procedure guides and procedure worksheets on Evolve and in the ebook familiarize you with the exact steps performed in the lab. - Vivid, full-color illustrations depict concepts and applicable images that can be seen under the microscope. - An extensive number of certification-style, multiple-choice review questions are organized and coordinated under major topical headings at the end of each chapter to help you assess your understanding and identify areas requiring additional study. - Case studies include critical thinking group discussion questions, providing the opportunity to apply content to real-life scenarios. - The newest Entry Level Curriculum Updates for workforce entry, published by the American Society for Clinical Laboratory Science (ASCLS) and the American Society for Clinical Pathology (ASCP) Board of Certification Exam Content Outlines, serve as content reference sources. - Convenient glossary makes it easy to look up definitions without having to search through each chapter. - An Evolve companion website provides convenient access to animations, flash card sets, and additional review questions. - Experienced author, speaker, and educator Mary L. Turgeon is well known for providing insight into the rapidly changing field of clinical laboratory science.







Good Clinical, Laboratory and Manufacturing Practices


Book Description

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.




Quality Assurance and Quality Control in the Analytical Chemical Laboratory


Book Description

A Practical Tool for Learning New Methods Quality assurance and measurement uncertainty in analytical laboratories has become increasingly important. To meet increased scrutiny and keep up with new methods, practitioners very often have to rely on self-study. A practical textbook for students and a self-study tool for analytical laboratory employees, Quality Assurance and Quality Control in the Analytical Chemical Laboratory: A Practical Approach defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Unified Coverage of QA in Analytical Chemistry Clearly written and logically organized, this book delineates the concepts of practical QA/QC, taking a generic approach that can be applied to any field of analysis. Using an approach grounded in hands-on experience, the book begins with the theory behind quality control systems and then moves on to discuss examples of tools such as validation parameter measurements, the use of statistical tests, counting the margin of error, and estimating uncertainty. The authors draw on their experience in uncertainty estimation, traceability, reference materials, statistics, proficiency tests, and method validation to provide practical guidance on each step of the process. Extended Coverage of QC/QA in Analytical and Testing Laboratories Presenting guidance on all aspects of QA and measurement results, the book covers QC/QA in a more complex and extended manner than other books on this topic. This range of coverage supplies an integrated view on measures like the use of reference materials and method validation. With worked-out examples and Excel spreadsheets that users can use to try the concepts themselves, the book provides not only know-what but know-how.




Linne & Ringsrud's Clinical Laboratory Science E-Book


Book Description

Thoroughly updated and easy-to-follow, Linne & Ringsrud's Clinical Laboratory Science: Concepts, Procedures, and Clinical Applications, 8th Edition offers a fundamental overview of the laboratory skills and techniques you'll need for success in the clinical laboratory. Author Mary Louise Turgeon's simple and straightforward writing clarifies complex concepts, and her unique discipline-by-discipline approach helps you build knowledge and learn to confidently perform routine clinical laboratory tests with accurate, effective results. Topics like safety, measurement techniques, and quality assessment are woven throughout the various skills. The new eighth edition also features updated content including expanded information on viruses and automation. It's the must-have foundation for anyone wanting to pursue a profession in the clinical lab. - Broad content scope provides an ideal introduction to clinical laboratory science at a variety of levels, including CLS/MT, CLT/MLT, and Medical Assisting. - Case studies include critical thinking and multiple-choice questions to challenge readers to apply the content to real-life scenarios. - Expert insight from respected educator Mary Lou Turgeon reflects the full spectrum of clinical lab science. - Detailed procedures guides readers through the exact steps performed in the lab. - Vivid full-color illustrations familiarize readers with what they'll see under the microscope. - Review questions at the end of each chapter help readers assess your understanding and identify areas requiring additional study. - Evolve companion website provides convenient online access to all of the procedures in the text and houses animations, flashcards, and additional review questions not found in the printed text. - Procedure worksheets can be used in the lab and for assignment as homework. - Streamlined approach makes must-know concepts and practices more accessible. - Convenient glossary simplifies the process of looking up definitions without having to search through each chapter. - NEW! Updated content throughout keeps pace with constant changes in clinical lab science. - NEW! Consistent review question format ensures consistency and enables readers to study more efficiently. - NEW! More discussion of automation familiarizes readers with the latest automation technologies and processes increasingly used in the clinical lab to increase productivity and elevate experimental data quality. - NEW! Additional information on viruses keeps readers up to date on this critical area of clinical lab science.