Standard Operating Procedures for Clinical Hematology and Body Fluid Testing (2nd Edition)/临床血液和体液
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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 for Clinical Hematology and Body Fluid Testing," primarily covers structural and management requirements, resource requirements, testing process management, and management system requirements. The second section focuses on standard operating procedures (SOPs), including SOPs for instrument performance verification and personnel comparison; SOPs for test items (such as routine hematology tests, bone marrow examination, coagulation tests, urinalysis, fecal analysis, puncture fluid analysis, and secretion analysis); and SOPs for laboratory analyzers. The appendix includes not only commonly used record forms for clinical hematology and body fluid testing for direct reference, but also analyses and corrective action points for typical non-conformity cases, along with answers to frequently asked questions regarding ISO 15189 accreditation applications. These features offer strong 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。第一篇为临床血液和体液检验质量和能力要求,主要介绍了结构和管理要求、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标准操作规程,包括仪器性能验证和人员比对标准操作规程、检验项目(如临床血液一般检验、骨髓检验、出凝血检验、尿液检验、粪便检验、穿刺液检验和分泌物检验)标准操作规程,以及检验分析仪操作规程。附录部分不仅收录了临床血液和体液检验常用的记录表格,方便读者直接引用,而且列举了典型不符合案例分析与整改要点,以及申请ISO15189认可相关问题解答,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,适用正在准备或计划准备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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