Standard Operating Procedures for Clinical Immunology Testing (2nd Edition)/临床免疫检验标准化&#
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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 7 chapters. The first section, "Quality and Competence Requirements," primarily introduces the structure and management requirements, resource requirements, testing process management, and management system requirements for the clinical immunology specialty group. The second section focuses on standard operating procedures for clinical immunology testing, covering laboratory performance verification and personnel comparisons, laboratory instruments and equipment (including general instruments and equipment as well as immunoassay devices using different methodologies), and test items in areas such as infection immunology, autoimmunity, tumor immunology, allergy testing, cellular immunity, and humoral immunity. The appendix includes not only commonly used record forms for clinical immunology testing for direct reference, but also examples of common non-conformities and corrective action points observed in clinical immunology laboratories. These features offer strong practical guidance and reference value. This book is comprehensive in content, standardized in format, concise in expression, and highly practical. It 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7章。第一篇为质量和能力要求,主要介绍了临床免疫专业组的结构和管理要求、资源要求、检验过程管理和管理体系要求。第二篇则着重介绍了临床免疫检验的标准操作规程,内容涉及实验室性能验证和人员比对、实验室仪器设备(包括通用仪器设备、不同方法学免疫检验设备),以及感染免疫、自身免疫、肿瘤免疫、变态反应、细胞免疫、体液免疫等检验项目。附录部分不仅收录了临床免疫检验常用的记录表格,方便读者直接引用,而且列举了临床免疫实验室常见的不符合项案例及整改要点,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,实用性强,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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