Maintenance and Enhancements of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories

项目摘要 德克萨斯州卫生服务部实验室服务科(LSS)在 与食品和药物管理局(FDA)、疾病控制中心和 预防(CDC)和州监管机构DSHS消费者保护局(CPD)，以确保 德克萨斯州的食品和食品是安全的。LSS目前与食品和药物管理局签订了合作协议 药品监督管理局(FDA)食品应急网络(FERN)，用于获取和维护 国际标准化组织(ISO)/国际电工委员会(IEC) 17025(国际标准化组织/国际电工委员会17025)认证和与食品和药物管理局的研究合作协议 GenomeTrakr网络。国际标准化组织/国际电工委员会17025认证是测试领域最重要的标准之一 实验室并证明实验室执行特定任务的能力和技术能力 任务。LSS已通过国际标准化组织/国际电工委员会17025认证，美国实验室认可协会 (A2LA)自2016年以来。LSS在2015年实施了全基因组测序(WGS)，为 国家WGS数据库，并帮助确定国家疫情聚集性及其可能 变速箱。 LSS是一家设备齐全的实验室，雇佣了超过370名员工来提供 全面的公共卫生检测服务。目前，DSHS已经制定了监测计划，以 监测磨碎的肉制品，即食肉制品，加工厂的环境条件 利用环境拭子样本，以及FDA的食品、奶厂和奶制品， 海产品，以及海湾水中存在的生物有机体和其他有毒物质。 卫生与公众服务部有能力应对与食品有关的紧急情况，包括疫情。 该项目的目标是通过以下方式推进国家食品安全系统的目标： 1.确保代表国家进行的微生物和化学食品分析 制造食品监管计划，在国际标准化组织/国际电工委员会17025的范围内执行 经认可的实验室； 2.加强实验室与国家制造食品监管机构之间的合作 节目； 3.增加每年为监测目的收集和分析的国家样本的数量； 4.建立更强大的病原体追踪国际快速监测系统，通过 GenomeTrackr网络，对所有食品和环境使用最少的元数据字段集 分离株。 这项提议包括为以下方面提供资金： 1.维护和加强国际标准化组织/国际电工委员会17025认证分析的范围，并确保所有国际标准化组织 通过雇佣合格的员工并参加认可的熟练程度测试来达到标准 程序。 2.通过以下方式继续加强与国家制造食品计划的现有关系 采购经认可的食品检测用品，以支持抽样计划； 3.确保抽样协议计划概述了每年至少有75个样本根据 竞赛A； 4.确保每年对400个样本进行排序，以满足B竞赛的要求 包括元数据，实时发送到国家生物技术信息中心(NCBI)- 国家卫生研究院(NIH)与FDA食品安全和应用中心协调 营养学(CFSAN)。 5.增加法律服务与食品和药物管理局、疾病预防控制中心、地方和 国家公共卫生部门和大学通过共享活的隔离。

PROJECT ABSTRACT The Texas Department of State Health Services (DSHS) Laboratory Services Section (LSS) works in conjunction with the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the state regulatory body, DSHS Consumer Protection Division (CPD), to ensure food and food products in Texas are safe. LSS currently has a cooperative agreement with the Food and Drug Administration (FDA) Food Emergency Response Network (FERN) for obtaining and maintaining International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) 17025 (ISO/IEC 17025) accreditation and a Research Collaboration Agreement (RCA) with FDA for the GenomeTrakr network. ISO/IEC 17025 accreditation is one of the most important standards for testing laboratories and attests to the competency and technical capability of a laboratory to perform specific tasks. LSS has been ISO/IEC 17025 accredited by the American Association for Laboratory Accreditation (A2LA) since 2016. LSS implemented Whole Genome Sequencing (WGS) in 2015, contributed to the national WGS databases, and helped to identify national outbreak clusters and their possible transmission vehicles. LSS is a well-equipped laboratory that employs over three hundred seventy staff to provide comprehensive public health testing services. Currently, DSHS has surveillance programs in place to monitor ground meat products, ready to eat meat products, environmental conditions in processing plants utilizing environmental swab samples, and FDA food commodities, milk plant and dairy farm products, seafood products, and bay water for the presence of biological organisms and other toxic substances. DSHS has the capability to respond to food related emergencies including outbreaks. The objective of this project is to advance the goal of a national food safety system by: 1. Ensuring microbiological and chemical food analyses, performed on behalf of the state manufactured food regulatory programs, are conducted within the scope of an ISO/IEC 17025 accredited laboratory; 2. Strengthening the collaboration between the laboratories and state manufactured food regulatory programs; 3. Increasing the number of state samples collected and analyzed for surveillance purposes annually; 4. Developing a stronger international rapid surveillance system for pathogen traceback, through the GenomeTrackr network, using a minimum set of metadata fields for all food and environmental isolates. This proposal includes funding for: 1. Maintaining and enhancing the scope of ISO/IEC 17025 accredited analyses and ensuring all ISO standards are met by employing qualified staff and participating in an approved proficiency test program. 2. Continuing to build on the existing relationship with the state manufactured food program by purchasing supplies for accredited food testing to support the sampling plan; 3. Ensuring a sampling agreement plan outlines a minimum of 75 samples per year to be tested under Competition A; 4. Ensuring 400 samples are sequenced per year in fulfillment of the requirements for Competition B including the metadata, in real time to National Center for Biotechnology Information (NCBI) - National Institutes of Health (NIH) in coordination with FDA Center for Food Safety and Applied Nutrition (CFSAN). 5. Increasing the number of partnerships and collaborations between LSS and FDA, CDC, local and state public health departments, and universities via the sharing of live isolates.