Standard Operating Procedures for Molecular Diagnostics (2nd Edition)/分子诊断标准化操作程

Name: Standard Operating Procedures for Molecular Diagnostics (2nd Edition)/分子诊断标准化操作程
Brand: China National Publications Import & Export C
SKU: 9787547865200
Price: 5253.0 INR
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by 周庭银胡继

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ISBN13: 9787547865200
Binding: Hardcover
Subject: N/A
Publisher: China National Publications Import & Export C
Publisher Imprint: China National Publications Import & Export C
Publication Date: March 1, 2024
Pages: 532
Original Price: GBP 44.99
Language: Chinese
Edition: N/A
Item Weight: 1806 grams
BISAC Subject(s): Diagnostic Imaging / General

About The Book

The "Medical Laboratory ISO 15189 Accreditation Guidance Series" is compiled based on CNAS-CL02:2023 Guidelines for Quality and Competence in Medical Laboratories and CNAS-CL02-A001:2023 Application Requirements for Quality and Competence in Medical Laboratories, with contributions from experts across various specialties in medical laboratory science nationwide. The series provides significant guidance and practical value for institutions pursuing ISO 15189 medical laboratory accreditation. This book is divided into 2 sections and 10 chapters. The first section, "Structural Management and Resource Requirements," primarily covers the structural and management requirements, resource requirements, testing process requirements, and management system requirements for molecular diagnostics laboratories, with supplementary material on resource management elements. The second section focuses on standard operating procedures (SOPs) for molecular diagnostics, including SOPs for general and specialized instruments and equipment, as well as molecular testing for infectious pathogens, tumor gene testing, LDT (laboratory-developed test) systems, genetic disease testing, and drug sensitivity-related molecular testing. The appendix includes not only commonly used record forms in the laboratory for direct reference but also analyses of typical non-conformity cases in molecular diagnostics and key corrective actions. These features offer strong guidance and reference value. Comprehensive in content, standardized in format, concise in expression, and highly instructive, this book is suitable for managers and technical personnel in laboratories that are preparing or planning to apply for medical laboratory accreditation. It can also serve as a management code and operating manual for routine medical laboratory work in primary-level hospitals, as well as a training resource for standardized management and standard operating procedures in medical laboratories across China. "医学实验室ISO15189认可指导丛书"以CNAS-CL02：2023《医学实验室质量和能力认可准则》、CNAS-CL02-A001：2023《医学实验室质量和能力认可准则的应用要求》为指导，由全国医学检验各专业领域专家共同编写，对开展ISO15189医学实验室认可有重要的指导意义和实用价值。本书共２篇１０章。第一篇为结构管理和资源要求，主要介绍了分子诊断实验室的结构和管理要求、资源要求、检验过程要求和管理体系要求，补充了资源管理的要素。第二篇着重介绍了分子诊断标准操作规程，内容涉及仪器设备（包括一般仪器设备及特殊仪器设备）及感染性病原体项目检测、肿瘤基因项目检测、ＬＤＴ系统检测、遗传性疾病检测和药物敏感相关的分子检测等。附录部分不仅收录了实验室常用的记录表格，方便读者直接引用，而且列举了分子诊断典型不符合案例分析及整改要点，有利于读者借鉴和参考，指导作用突出。本书内容全面，编排格式规范，言简意赅，指导性强，适用于正在准备或计划准备申请医学实验室认可单位的管理和技术人员学习和借鉴，也可作为基层医院医学检验常规工作的管理规范和操作手册，还可作为我国医学实验室规范化管理和标准化操作的培训用书。

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