Standard Operating Procedures for Clinical Microbiology Testing (2nd Edition)/临床微生物检验标准
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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, the Application Requirements for Quality and Competence in Medical Laboratories in the Field of Clinical Microbiology Testing, and the Guidelines for Verification of Clinical Microbiology Testing Procedures, 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 20 chapters. The first section, "Quality and Competence Requirements," primarily introduces operational procedures for the organization and management of the microbiology laboratory, resource requirements, and laboratory risk management. The second section, "Standard Operating Procedures for Microbiological Testing," covers instrument performance verification and comparisons between different instruments, various staining methods, preparation of commonly used鉴别 reagents and biochemical tests, serological tests, antibody and antigen detection for microorganisms, smear microscopy and culture of various specimens, identification of common pathogenic bacteria, antimicrobial susceptibility testing, isolation and identification of mycobacteria, anaerobic bacteriology testing, and clinical mycology testing, among others. The appendix not only includes commonly used record forms for laboratory management, instruments and equipment, and quality control, for direct reference, but also presents analyses and corrective actions for typical non-conformity cases, along with answers to frequently asked questions relating to ISO 15189 application in the microbiology laboratory. These additions provide strong guidance and reference value. This book is comprehensive in content, standardized in format, concise in expression, and highly instructive. It can serve as a reference for clinical microbiology laboratories in hospitals that are preparing for or have already attained ISO 15189 accreditation. It also functions as a management code and operating manual for routine work in microbiology laboratories of primary-level hospitals, as well as a training textbook for students and professionals specializing in clinical microbiology. "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》、《医学实验室质量和能力认可准则在临床微生物学检验领域的应用要求》及《临床微生物检验程序验证指南》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20章:第一篇为质量和能力要求,主要介绍微生物室组织和管理、资源要求和实验室风险管理等方面的操作程序。第二篇为微生物检验标准操作规程,内容涉及仪器性能验证及与不同仪器比对、各种染色方法、常用鉴别试剂配制及生化试验、血清学试验、微生物相关抗体抗原检测、各种标本的涂片镜检与培养、常见病原菌检验、抗菌药物敏感试验、分枝杆菌分离鉴定、厌氧菌检验、临床真菌检验等。附录部分不仅收录了实验室管理、仪器和设备及质量控制等方面常用的记录表格,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,以及微生物室申请15189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,指导性强,既可作为正在准备或已经通过I
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