State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation, Sample surveillance and Whole Genome Sequencing Analysis

项目摘要 国家卫生实验室(SHL)建议1)保持和加强现有的ISO/IEC 17025：2005年食品检测微生物和化学分析认证，2) 与爱荷华州检查和申诉部合作进行监督抽样和 FDA制造食品监管计划的测试，以及3)使用下一代产品 分析食源性致病菌分离株的测序技术并将数据上传到 用于数据共享的NCBI数据库。 规划环境地政局局长会采用以pdca管理方法为基础的持续改进方法。 (休哈特循环)，以维持和加强目前SHL实验室的质量管理 系统。公司将继续进行管理评审和内部审核，积极寻求 客户反馈，并利用最佳实践来提高实验室服务质量。为 ISO范围增强，SHL将使用FDA蕨类计划提供的方法 可通过国际官方分析化学家协会(AOAC)获得的方法 国际)和FDA细菌分析手册(BAM)用于确定特定的 分析物。SHL将确定并参与适当的能力测试(PT)计划 适用于所有已实施的技术。 对于监督抽样，卫生局局长将与爱荷华州检查和 呼吁(IDIA)进行全面的监督抽样，以检查具有 挑战的历史、广泛分布的产品和对 当地的食品业。抽样将遵循FDA第四章中概述的方法 《2013年调查操作手册》(IOM)，以及FDA关于 样本收集。1年后，SHL将评估使用FDA IOM的有效性，并 确定是否应该制定一项独立的国家政策。 在下一代测序项目中，选定的食源性相关分离物将是 根据FDA GenomeTrakr协议，使用现有的MiSeq仪器进行测序。 总体运行质量将使用Illumina序列分析查看器软件进行评估。如果 最终的文件符合FDA的质量要求，它们将被上传到NCBI并与 FDA的GenomeTrakr人员。

Project Summary The State Hygienic Laboratory (SHL) proposes to 1) maintain and enhance the current ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing, 2) partner with Iowa Department of Inspection and Appeals to perform surveillance sampling and testing for FDA's Manufactured Food Regulatory Program, and 3) use next generation sequencing technique to analyze foodborne related pathogen isolates and upload the data into the NCBI database for data sharing. SHL will adopt a continuous improvement approach based on the PDCA management method (Shewhart cycle) to maintain and enhance the current SHL laboratory quality management system. SHL will continue to conduct management review and internal audit, actively seek customer feedback and utilize the best practices to improve the laboratory service quality. For ISO scope enhancement, SHL will utilize methods provided by the FDA FERN program or methods available through the Association of Official Analytical Chemists International (AOAC International) and FDA Bacteriological Analytical Manual (BAM) for the determination of specific analytes. SHL will identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented. For the surveillance sampling, SHL will collaborate with Iowa Department of Inspection and Appeals (IDIA) to conduct comprehensive surveillance sampling to inspect products with a history of challenges, broadly distributed products and products that are of significance to the local food commerce. Sampling will follow the methods outlined in Chapter 4 of the FDA Investigations Operations Manual 2013 (IOM), and any supplementary FDA guidance on sample collection. After year 1, SHL will evaluate the effectiveness of using the FDA IOM and determine if a stand-alone state policy should be developed. For the next generation sequencing project, selected foodborne related isolates will be sequenced using the existing MiSeq instrument according to the FDA GenomeTrakr protocol. Overall run quality will be evaluated using the Illumina Sequencing Analysis Viewer software. If the final files meet the FDA quality requirements, they will be uploaded to NCBI and shared with FDA's GenomeTrakr personnel.