Admin Core - Food Defense and Surveillance in Support of the FDA by the State Hygienic Laboratory at the University of Iowa

管理核心 - 爱荷华大学国家卫生实验室支持 FDA 的食品防护和监测

• 批准号: 10176081
• 负责人: MICHAEL David SCHUELLER
• 金额: $ 4.5万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10176081
• 关键词: Admin; Core; Food; Defense; Surveillance

Project Summary/Abstract - Admin Core: The State Hygienic Laboratory (SHL) at the University of Iowa currently provides the essential structure in a public health laboratory to support and execute a food safety, surveillance, investigative and regulatory program for the State of Iowa. SHL does so in partnership with the Iowa Department of Inspections and Appeals and in partnership with the U.S. Food and Drug Administration on the national scale. The intention of the SHL is to continue the partnership with IDIA and FDA and serve Iowa needs for food safety, surveillance, and regulatory requirements. SHL has in place all the programmatic and physical infrastructure to execute the requirements of the new Laboratory Flexible Funding Model Cooperative Agreement. The SHL governance structure falls under the Office of the Vice-President of Research at the University of Iowa. The laboratory is organized and operated under a Director and three Associate Directors – Associate Director, Environmental Health Division (EHD), Associate Director, Diagnostic and Clinical Division (DCD), Associate Director, Administrative and Finance Division (AFD). The SHL employs approximately 190 staff members among the three laboratory locations. Twenty-one of those staff will be directly and indirectly involved with food safety and surveillance activities at two lab locations. Staff in Organic Chemistry, Inorganic Chemistry, and Environmental Microbiology sections fulfill analytical responsibilities for all food-related testing at SHL for FDA FERN and FDA ISO 17025:2017 and sample collection for FERN surveillance programs. The SHL maintains a comprehensive quality management system. The Quality Management Plan (QMP) defines and sets the standard for the policies, procedures, and documentation from collection of samples, through reporting final results to the client/submitter, to final disposition of the sample/specimen. The SHL QMP has been prepared in accord with Environmental Protection Agency and The NELAC Institute standards consistent with ISO/IEC 17025:2017 requirements. SHL has adopted the iPassport Document Control & Compliance Management system for document control process in which all SHL’s standard operating procedures (SOPS), QASPS, documents and policies reside. Food sample collection procedures, including actions describing specimen/sample collection, transport, preservation, storage and security are clearly defined in SHL SOP CV ENV 1311 FERN Food Surveillance (May 2018, updated May 2020) and SHL Policy 1531 Controlled Substances Handling, Storage, Use and Disposal (October 2018). These documents also refer to and require the use of legal chain of custody procedures and forms which are defined in SHL Policy 931 SHL Security and Legal Chain of Custody Policy (September 2016, updated May 2019. Sample analysis outcomes data reporting will be completed in conjunction with the IDIA for food defense samples collected by IDIA and 2) via the SHL OpenELIS LIMS using the FERN portal as well as Excel uploads submitted via the ORAPP website. The long-term goal for SHL will be to achieve the system-to-system integration with the National Food Safety Data Exchange (NFSDX).

项目摘要/摘要-管理核心： 爱荷华大学的国家卫生实验室(SHL)目前在一个 公共卫生实验室支持和执行食品安全、监测、调查和监管方案 代表爱荷华州。Shl与爱荷华州检查和上诉部门合作，并在 与美国食品和药物管理局在全国范围内建立伙伴关系。房屋及规划地政局局长的目的是 继续与IDIA和FDA合作，满足爱荷华州在食品安全、监督和监管方面的需求 要求。SHL具备执行以下要求的所有编程和物理基础设施 新的实验室灵活资助模式合作协议。SHL的治理结构属于 爱荷华大学研究副校长办公室。实验室是由组织和运营的 在一名主任和三名协理主任--环境卫生司副司长的领导下， 诊断和临床司(DCD)副主任、行政和财务副主任 (渔农处)。SHL在三个实验室地点雇用了大约190名工作人员。 其中21名工作人员将直接或间接参与食品安全和监督活动， 实验室的位置。有机化学、无机化学和环境微生物学部门的工作人员完成 美国食品和药物管理局蕨类和食品和药物管理局17025：2017年所有食品相关检测的分析责任和样品 蕨类监控项目的收藏品。卫生与公众服务部拥有一套全面的质量管理体系。 质量管理计划(QMP)定义并设定了政策、程序和 从样本收集到向客户/提交人报告最终结果，再到最终结果的记录 样品/样品的处置。SHL QMP是按照环境保护的要求编制的 机构和NELAC研究所的标准符合国际标准化组织/国际电工委员会17025：2017年的要求。Shl有 年采用iPassport文件控制与合规管理系统进行文件控制流程 所有SHL的标准操作程序(SOP)、QASP、文件和政策都驻留在其中。食物样本 收集程序，包括描述标本/样本收集、运输、保存、储存的行动 和安全在SHL SOP CV ENV 1311蕨类食品监测中有明确的定义(2018年5月，5月更新 2020年)和SHL政策1531受控物质的处理、储存、使用和处置(2018年10月)。这些 文件还指并要求使用定义的法律监管链程序和表格 在SHL政策931中，SHL安全和法律监护链政策(2016年9月，2019年5月更新。 样品分析结果数据报告将与食品防疫样品研究所一起完成 由IDIA收集和2)通过SHL OpenELIS LIMS使用FERN门户以及提交的Excel上传 通过ORAPP网站。SHL的长期目标将是实现与 美国国家食品安全数据交换中心(NFSDX)。