FDA : Laboratory Flexible Funding Model (MICROBIOLOGY)

项目概要/摘要 密歇根州卫生与公众服务部实验室局（MDHHS-BOL）传染病 微生物学部疾病司与美国农业部FERN建立了牢固的工作关系， 15年MDHHS微生物学部门是CDC PulseNet项目的中西部地区实验室 全基因组测序（WGS）的能力和能力得到增强。BOL通过ISO 17025认证 美国工业卫生协会实验室认证计划（AIHA-CHINA，LLC） 食品实验室认证计划（Food Laboratory Accreditation Program）;拥有CDC注册证书 联邦选择代理程序（FSAP）和美国农业部APHIS许可证;已被指定为一级生物 实验室响应网络（LRN）内的实验室，执行与食源性疫情相关的检测 调查;并具有对付生物恐怖主义制剂的经验和设施。这里提出的目标 旨在提高检测食品中细菌病原体的能力， 因此，支持和提高实验室在食品防御任务和疫情应对方面的能力 在密歇根州。 目标1：主要目标是为BSL 3的食品分析提供浪涌容量测试 细菌选择代理商和参与FDA监督和特殊事件活动。 目的2：研究食源性疾病肠道致病菌的基因组多样性 WGS作为GenomeTrakr网络的成员。这种能力的提高将使 MDHHS获得改进的测序比较和分析，这反过来将改善疫情 调查和食品安全。 目的3：提高环孢子虫在食品中的检测能力。以下 培训和能力，这将提高实验室在爆发时检测环孢子虫的能力。 MDHHS还将能够在环孢菌检测的特殊事件中协助FDA。

Project summary/Abstract The Michigan Department of Health and Human Services, Bureau of Laboratories (MDHHS-BOL) Infectious Disease Division, Microbiology Section has built a strong working relationship with USDA FERN for more than 15 years. The MDHHS Microbiology section is the Midwest regional laboratory for the CDC PulseNet program with enhanced capacity and capabilities for Whole Genome sequencing (WGS). BOL is accredited to ISO 17025 standard by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP, LLC) in their Food Laboratory Accreditation Program (Food LAP); has a Certificate of Registration with the CDC Federal Select Agent Program (FSAP) and a USDA APHIS permit; has been designated as an Tier-1 Biological lab within the Laboratory Response Network (LRN) performing testing associated with foodborne outbreak investigations; and has experience with and facilities for the agents of bioterrorism. The objectives proposed here are intended to enhance the capacity and capabilities in the detection of bacterial pathogens in food products, thereby, supporting and improving the laboratory capacities for food defense assignments and outbreak response in State of Michigan. Objective 1: The primary goal is to provide surge capacity testing for the analysis of food products for BSL3 bacterial select agents and participate in FDA surveillance and special event activities. Objective 2: To study the genomic diversity of enteric pathogens associated with food borne illness collected from human food by WGS as a member of the GenomeTrakr network. This increased capability will allow MDHHS access to improved comparison and analysis of sequencing, which in turn, will improve outbreak investigations and food safety. Objective 3: To develop the capacity and capability for detecting Cyclospora in human food products. Following training and competency this would increase the lab’s ability to detect Cyclospora in the event of an outbreak. MDHHS would also be able to assist FDA in special events in testing for Cyclospora.