Verification and validation of procedures in the clinical microbiology laboratory PDF Download
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Author: Richard B. Clark
Publisher: ASM Press
ISBN: 9781555815301
Category : Diagnostic microbiology
Languages : en
Pages : 0
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Book Description
Focusing on the common qualitative and semi-quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use. Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance. The Cumitech begins with a review of federal regulations on test verification and validation, including the Clinical and Laboratory Improvement Amendments (CLIA). Next, the authors set forth the criteria for selecting a laboratory method and then verifying and validating a test, explaining all the key components of the process. Examples using both FDA-approved and laboratory-developed tests are provided, helping with the design of test verification studies that fully meet regulatory requirements.
Author: Richard B. Clark
Publisher: ASM Press
ISBN: 9781555815301
Category : Diagnostic microbiology
Languages : en
Pages : 0
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Book Description
Focusing on the common qualitative and semi-quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use. Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance. The Cumitech begins with a review of federal regulations on test verification and validation, including the Clinical and Laboratory Improvement Amendments (CLIA). Next, the authors set forth the criteria for selecting a laboratory method and then verifying and validating a test, explaining all the key components of the process. Examples using both FDA-approved and laboratory-developed tests are provided, helping with the design of test verification studies that fully meet regulatory requirements.
Author:
Publisher: John Wiley & Sons
ISBN: 1555818811
Category : Medical
Languages : en
Pages : 2891
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Book Description
In response to the ever-changing needs and responsibilities of the clinical microbiology field, Clinical Microbiology Procedures Handbook, Fourth Edition has been extensively reviewed and updated to present the most prominent procedures in use today. The Clinical Microbiology Procedures Handbook provides step-by-step protocols and descriptions that allow clinical microbiologists and laboratory staff personnel to confidently and accurately perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation. If you are looking for online access to the latest from this reference or site access for your lab, please visit www.wiley.com/learn/clinmicronow.
Author: Amy L. Leber
Publisher: John Wiley & Sons
ISBN: 1683674839
Category : Medical
Languages : en
Pages : 6587
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Book Description
Gold Standard consensus-based procedures from the experts. The Clinical Microbiology Procedures Handbook, 5th edition, provides those engaged in microbial analysis of clinical specimens with procedures for the detection, identification, and characterization of microorganisms involved in human infections. This unique and valuable collection of step-by-step descriptions of the numerous testing modalities used in the clinical microbiology laboratory was written and edited by highly knowledgeable laboratorians. The 5th edition features two new sections, one on blood cultures and one on MALDI-TOF MS, and the sections on molecular diagnostics, virology, and serology were extensively revised and updated. Presented over multiple volumes, this handbook enables laboratory staff to perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation. If you are looking for online access to the latest from this reference or site access for your lab, please visit www.wiley.com/learn/clinmicronow.
Author: Richard L. Hodinka
Publisher: John Wiley & Sons
ISBN: 155581915X
Category : Medical
Languages : en
Pages : 639
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Book Description
The definitive clinical virology resource for physicians and clinical laboratory virologists The clinical virology field is rapidly evolving and, as a result, physicians and clinical laboratory virologists must have a reliable reference tool to aid in their ability to identify and diagnose viral infections to prevent future outbreaks. In this completely revised edition of the Clinical Virology Manual, Editor in Chief, Michael Loeffelholz, along with Section Editors, Richard Hodinka, Benjamin Pinsky, and Stephen Young, have complied expert perspectives of a renowned team of clinical virology experts and divided these contributions into three sections to provide the latest information on the diagnosis of viral infections, including ebola, HIV and Human papillomavirus state of the art diagnostic technologies, including next-generation sequencing and nucleic acid amplification methods taxonomy of clinically important viruses such as polyomaviruses and zoonotic viruses This comprehensive reference also includes three appendices with vital information on reference virology laboratories at the Centers for Disease Control and Prevention, state and local public health laboratories, and international reference laboratories and laboratory systems. Additionally, a new section "Diagnostic Best Practices," which summarizes recommendations for diagnostic testing, and cites evidence-based guidelines, is included in each viral pathogens chapter. Clinical Virology Manual, Fifth Edition serves as a reference source to healthcare professionals and laboratorians in providing clinical and technical information regarding viral diseases and the diagnosis of viral infections.
Author: David H. Persing
Publisher: John Wiley & Sons
ISBN: 1555819079
Category : Science
Languages : en
Pages : 852
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Book Description
Presenting the latest molecular diagnostic techniques in one comprehensive volume The molecular diagnostics landscape has changed dramatically since the last edition of Molecular Microbiology: Diagnostic Principles and Practice in 2011. With the spread of molecular testing and the development of new technologies and their opportunities, laboratory professionals and physicians more than ever need a resource to help them navigate this rapidly evolving field. Editors David Persing and Fred Tenover have brought together a team of experienced researchers and diagnosticians to update this third edition comprehensively, to present the latest developments in molecular diagnostics in the support of clinical care and of basic and clinical research, including next-generation sequencing and whole-genome analysis. These updates are provided in an easy-to-read format and supported by a broad range of practical advice, such as determining the appropriate type and quantity of a specimen, releasing and concentrating the targets, and eliminating inhibitors. Molecular Microbiology: Diagnostic Principles and Practice Presents the latest basic scientific theory underlying molecular diagnostics Offers tested and proven applications of molecular diagnostics for the diagnosis of infectious diseases, including point-of-care testing Illustrates and summarizes key concepts and techniques with detailed figures and tables Discusses emerging technologies, including the use of molecular typing methods for real-time tracking of infectious outbreaks and antibiotic resistance Advises on the latest quality control and quality assurance measures Explores the increasing opportunities and capabilities of information technology Molecular Microbiology: Diagnostic Principles and Practice is a textbook for molecular diagnostics courses that can also be used by anyone involved with diagnostic test selection and interpretation. It is also a useful reference for laboratories and as a continuing education resource for physicians. If you are looking for online access to the latest clinical microbiology content, please visit www.wiley.com/learn/clinmicronow.
Author: Steven C. Specter
Publisher: American Society for Microbiology Press
ISBN: 155581462X
Category : Medical
Languages : en
Pages : 1853
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Book Description
A comprehensive and updated volume for the clinical virologist. • Details laboratory procedures for detecting and handling viruses, from specimen requirements and quality assurance to virus detection and identification, from the fundamentals through the latest molecular methods. • Presents the most current knowledge on the wide range of specific viral pathogens. • Includes information on services provided by federal and state public health virology laboratories. • Provides essential information for clinicians and laboratory virologists.
Author: Connie R. Mahon
Publisher: Elsevier Health Sciences
ISBN: 0323292615
Category : Medical
Languages : en
Pages : 1101
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Book Description
Providing a solid introduction to the essentials of diagnostic microbiology, this accessible, full-color text helps you develop the problem-solving skills necessary for success in the clinical setting. A reader-friendly, "building block" approach to microbiology moves progressively from basic concepts to advanced understanding, guiding you through the systematic identification of etiologic agents of infectious diseases. Building block approach encourages recall of previously learned information, enhancing your critical and problem solving skills. Case in Point feature introduces case studies at the beginning of each chapter. Issues to Consider encourages you to analyze and comprehend the case in point. Key Terms provide a list of the most important and relevant terms in each chapter. Objectives give a measurable outcome to achieve by completing the material. Points to Remember summarize and help clearly identify key concepts covered in each chapter. Learning assessment questions evaluate how well you have mastered the material. New content addresses bone and joint infections, genital tract infections, and nosocomial infections. Significantly updated chapter includes current information on molecular biology and highlights content on multidrug resistant bacteria. Reorganized chapters accent the most relevant information about viruses and parasites that are also transmissible to humans. Case studies on the Evolve site let you apply the information that you learn to realistic scenarios encountered in the laboratory.
Author:
Publisher: John Wiley & Sons
ISBN: 1119021847
Category : Science
Languages : en
Pages : 1431
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Book Description
The Manual of Commercial Methods in Clinical Microbiology 2nd Edition, International Edition reviews in detail the current state of the art in each of the disciplines of clinical microbiology, and reviews the sensitivities, specificities and predictive values, and subsequently the effectiveness, of commercially available methods – both manual and automated. This text allows the user to easily summarize the available methods in any particular field, or for a specific pathogen – for example, what to use for an Influenza test, a Legionella test, or what instrument to use for identification or for an antibiotic susceptibility test. The Manual of Commercial Methods in Clinical Microbiology, 2nd Edition, International Edition presents a wealth of relevant information to clinical pathologists, directors and supervisors of clinical microbiology, infectious disease physicians, point-of-care laboratories, professionals using industrial applications of diagnostic microbiology and other healthcare providers. The content will allow professionals to analyze all commercially available methods to determine which works best in their particular laboratory, hospital, clinic, or setting. Updated to appeal to an international audience, The Manual of Commercial Methods in Clinical Microbiology, 2nd Edition, International Edition is an invaluable reference to those in the health science and medical fields.
Author: John E. Bennett, MD, MACP
Publisher: Elsevier Health Sciences
ISBN: 1455748013
Category : Medical
Languages : en
Pages : 5094
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Book Description
After thirty five years, Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, 8th Edition is still the reference of choice for comprehensive, global guidance on diagnosing and treating the most challenging infectious diseases. Drs. John E. Bennett and Raphael Dolin along with new editorial team member Dr. Martin Blaser have meticulously updated this latest edition to save you time and to ensure you have the latest clinical and scientific knowledge at your fingertips. With new chapters, expanded and updated coverage, increased worldwide perspectives, and many new contributors, Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, 8th Edition helps you identify and treat whatever infectious disease you see. Get the answers to questions you have with more in-depth coverage of epidemiology, etiology, pathology, microbiology, immunology, and treatment of infectious agents than you'll find in any other infectious disease resource. Find the latest diagnoses and treatments for currently recognized and newly emerging infectious diseases, such as those caused by avian and swine influenza viruses. Put the latest knowledge to work in your practice with new or completely revised chapters on influenza (new pandemic strains); new Middle East respiratory syndrome (MERS) virus; probiotics; antibiotics for resistant bacteria; antifungal drugs; new antivirals for hepatitis B and C; Clostridium difficile treatment; sepsis; advances in HIV prevention and treatment; viral gastroenteritis; Lyme disease; Helicobacter pylori; malaria; infections in immunocompromised hosts; immunization (new vaccines and new recommendations); and microbiome. Benefit from fresh perspectives and global insights from an expanded team of international contributors. Find and grasp the information you need easily and rapidly with newly added chapter summaries. These bulleted templates include diagnosis, therapy, and prevention and are designed as a quick summary of the chapter and to enhance relevancy in search and retrieval on Expert Consult. Stay current on Expert Consult with a thorough and regularly scheduled update program that ensures access to new developments in the field, advances in therapy, and timely information. Access the information you need easily and rapidly with new succinct chapter summaries that include diagnosis, therapy, and prevention. Experience clinical scenarios with vivid clarity through a richly illustrated, full-color format that includes 1500 photographs for enhanced visual guidance.
Author: Timothy C. Allen
Publisher: John Wiley & Sons
ISBN: 168367393X
Category : Medical
Languages : en
Pages : 821
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Book Description
Clinical Laboratory Management Apply the principles of management in a clinical setting with this vital guide Clinical Laboratory Management, Third Edition, edited by an esteemed team of professionals under the guidance of editor-in-chief Lynne S. Garcia, is a comprehensive and essential reference for managing the complexities of the modern clinical laboratory. This newly updated and reorganized edition addresses the fast-changing landscape of laboratory management, presenting both foundational insights and innovative strategies. Topics covered include: an introduction to the basics of clinical laboratory management, the regulatory landscape, and evolving practices in the modern healthcare environment the essence of managerial leadership, with insights into employee needs and motivation, effective communication, and personnel management, including the lack of qualified position applicants, burnout, and more financial management, budgeting, and strategic planning, including outreach up-to-date resources for laboratory coding, reimbursement, and compliance, reflecting current requirements, standards, and challenges benchmarking methods to define and measure success the importance of test utilization and clinical relevance future trends in pathology and laboratory science, including developments in test systems, human resources and workforce development, and future directions in laboratory instrumentation and information technology an entirely new section devoted to pandemic planning, collaboration, and response, lessons learned from COVID-19, and a look towards the future of laboratory preparedness This indispensable edition of Clinical Laboratory Management not only meets the needs of today’s clinical laboratories but anticipates the future, making it a must-have resource for laboratory professionals, managers, and students. Get your copy today, and equip yourself with the tools, strategies, and insights to excel in the complex and ever-changing world of the clinical laboratory.
