Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food testing Laboratories (U18 Clinical Trial Not Allowed)

密歇根州农业和农村发展部 合作协议提案 研究及相关PHS 398项目摘要/摘要 标题：ISO/IEC 17025认证的维护和增强 国家食品检测实验室的全基因组测序 编号：RFA-FD-19-018-cdfa93.103 密歇根州农业和农村发展部Geagley实验室 （MDARD）承诺满足竞赛A的目标、义务和可交付成果 和协议中描述的B。 MDARD的食品和乳制品部门已加入制成品 自2009年以来，监管计划标准（MFRPS）。MDARD实验室分部 为食品和乳制品部门提供分析测试和技术援助， 符合MFRPS标准10。 与MFRPS相关的微生物检测将继续在我们的 ISO/IEC 17025：2005（2017）认证。人员配置和设备/用品费用 通过本协议，将用于维持ISO 17025：2005认证 （2017）规范和提升食品安全相关检测范围。全基因组 将对表1中规定的必要数量的分离株进行测序（WGS）。 FDA研究合作协议（RCA），以加强国家基因组 病原体分离物数据库和本合作协议的规定。数据 将用于支持FDA的执法行动、监督活动、跟踪 通过eLEXNET门户网站和NCBI数据库返回和数据收集目的。 该实验室的食物、燃料和疾病化学单位，在 实验室的质量保证人员，将保持ISO 17025：2005（2017）认证。 这将包括质量体系的维护，ISO/IEC员工培训 要求，将数据输入eLEXNET的培训，适当的 熟练度样本和任何其他可交付成果， 协议 两个测试部分将提出一个一年计划和详细的预算，以支持 认证活动、分析工作、数据收集、培训和差旅 这个资助机会的目标和成果。 MDARD，Geagley实验室致力于提高国家食品安全 安全系统我们期待着继续与FDA的长期合作， 改善食品安全。我们将继续满足我们内部和外部的分析需求。 符合MFRPS、FERN协议和WGS RCA的外部客户。 因此，通过本合作协议获得的任何能力或知识将 纳入持续工作量和战略规划。我们致力于 维持和提高我们的实验室的能力和能力， 应急活动。

Michigan Department of Agriculture and Rural Development Cooperative Agreement Proposal Research & Related PHS398 Project Summary/Abstract Title: Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories Number: RFA-FD-19-018-cdfa93.103 The Geagley Laboratory of the Michigan Department of Agriculture and Rural Development (MDARD) commits to meeting the goals, obligations and deliverables for competitions A and B described in the agreement. The Food and Dairy Division of MDARD has been enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) since 2009. The MDARD Laboratory Division has provided analytical testing and technical assistance to the Food and Dairy Division in accordance with MFRPS standard 10. MFRPS related microbiological testing will remain accredited within the scope of our ISO/IEC 17025:2005 (2017) accreditation. Staffing and equipment/supplies charged through this agreement will be utilized to maintain accreditation to the ISO17025:2005 (2017) standard and enhance the scope of food safety related testing. Whole genome sequencing (WGS) will be performed on the requisite number of isolates specified in the FDA Research Collaboration Agreement (RCA) to enhance the national genomic database of pathogen isolates and the provisions of this cooperative agreement. Data will be provided in support of FDA enforcement actions, surveillance activities, trace back and data collection purposes through the eLEXNET portal and the NCBI database. The laboratory’s Food, Fuel and Disease Chemistry Unit, with assistance from the laboratory’s quality assurance staff, will maintain ISO17025:2005 (2017) accreditation. This will include maintenance of the quality system, staff training in ISO/IEC requirements, training for entering data into eLEXNET, performance of appropriate proficiency samples and any additional deliverables as dictated through the cooperative agreement. Both testing sections will propose a one-year plan and detailed budget to support accreditation activities, analytical work, data collection, training and travel in conformance with the goals and deliverables of this funding opportunity. The MDARD, Geagley Laboratory is committed to the enhancement of the national food safety system. We look forward to continuing our long standing collaboration with FDA to improve food safety. We will continue to meet the analytical needs of our internal and external customers in conformance with MFRPS, FERN agreements and the WGS RCA. Therefore, any capabilities or knowledge acquired through this cooperative agreement will be incorporated into the ongoing workload and strategic planning. We are committed to sustaining and enhancing the capabilities and capacity of our laboratory for routine and emergency response activities.