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

国家食品检测实验室 ISO/IEC 17025 认证和全基因组测序的维护和增强

• 批准号: 9932648
• 负责人: Lisa H Simpson
• 金额: $ 30.99万
• 依托单位: TEXAS STATE DEPT OF HEALTH SERVICES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-05 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9932648
• 关键词: Maintenance; Enhancements; ISO; IEC; 17025

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.

项目摘要 德克萨斯州卫生服务部（DSHS）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）和国家监管机构DSHS消费者保护司（CPD），以确保 德克萨斯州的食品和食品安全。LSS目前与粮食署有合作协议， 食品药品监督管理局（FDA）食品紧急反应网络（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（ISO/IEC 17025）认证和与FDA的研究合作协议（RCA）， GenomeTrakr网络。ISO/IEC 17025认证是最重要的测试标准之一 实验室，并证明实验室的能力和技术能力，以执行特定的 任务LSS已通过美国实验室认证协会的ISO/IEC 17025认证 （A2 LA）自2016年以来。LSS于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集群及其可能的 传输车辆。 LSS是一个设备齐全的实验室，拥有超过370名员工， 全面的公共卫生检测服务。目前，DSHS已经制定了监控计划， 监测绞肉产品、即食肉制品、加工厂的环境条件 利用环境拭子样本和FDA食品商品、乳品厂和奶牛场产品， 海产品和海湾水的生物有机体和其他有毒物质的存在。 DSHS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.确保代表国家进行微生物和化学食品分析 在ISO/IEC 17025的范围内进行的制造食品监管计划 认可实验室; 2.加强实验室与国家食品生产监管机构之间的合作 程序; 3.增加每年为监测目的收集和分析的州样本数量; 4.建立一个更强有力的国际快速监测系统， GenomeTrackr网络，使用所有食品和环境的最低元数据字段集 分离株 这项提议包括为以下活动供资： 1.维护和扩大ISO/IEC 17025认证分析的范围，并确保所有ISO 通过雇用合格的工作人员和参加批准的能力测试来达到标准 程序. 2.继续建立与国家制造食品计划的现有关系， 采购认可食物测试所需的物料，以支持抽样计划; 3.确保抽样协议计划概述每年至少75个样本进行测试， 竞争A; 4.确保每年对400个样本进行测序，以满足竞争B的要求 包括元数据，在真实的时间到国家生物技术信息中心（NCBI）- 美国国立卫生研究院（NIH）与FDA食品安全和应用中心协调 营养（CFSAN）。 5.增加LSS与FDA、CDC、地方和地方政府之间的伙伴关系和合作数量。 州公共卫生部门和大学通过共享活分离株。