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

项目总结： Iso/IEC 17025认证是检测实验室最重要的标准之一， 证明实验室执行特定任务的能力和技术能力。这个 产生的结果是可以根据公认的标准进行辩护的。在影响食品的大型活动期间 或食品，各州和联邦当局可以使用经认证的实验室检测结果 实验室通过简化的分析审查做出快速响应，并强制执行法规遵从性 保护国家食品供应安全。实验室分部的主要目标 肯塔基州公共卫生部的服务(DLS)将保持ISO/IEC 17025 认证(2016年9月在食品化学和微生物检测以及 2018年11月重新认可新的国际标准化组织/国际电工委员会17025：2017年标准)并加强测试 能力，扩大目前认证的范围，以进行额外的检测，以包括食品 微生物学全基因组测序分析。DLS是主要的维修实验室 代表肯塔基州人工食品进行微生物和化学食品分析 公共卫生/食品安全局的监管计划(MFRPS)，该计划有一个 目前与FDA签订的食品安全检验合同，并加入了MFRPS。DLS有一种品质 符合公司管理和技术要求的管理体系 国际标准化组织/国际电工委员会17025：2017年标准。DLS是一个食品应急网络(FERN)实验室 并参与食物水平测试，并以电子方式提交化验结果 应要求建立实验室交换网络(ELEXNET)。实验室服务部的目标是 通过引入新的检测能力来加强实验室活动。DLS已经实施了整个 环境微量食品样品的基因组测序以补充渐进检测 在暴发情况下对临床样本进行检测。这将导致更快地识别 与暴发有关的食物/病原体，并与临床和环境样本匹配。提供资金 这项建议将帮助肯塔基州MFRPS实现符合标准10“实验室 并将协助DLS继续通过基因组Trakr向FDA提交数据 通过使用BioNumerics软件的最新生物信息学功能。这使DLS能够 更快地向FDA提供可靠的数据，从而使分析结果得到接受 FDA和其他监管机构在执法行动、监督和应对中使用 食源性暴发。此外，DLS还可通过以下方式深入了解受污染食物的来源 提供给GenomeTrakr网络的基因组信息将导致 一个更强大的国际病原体追溯快速监测系统。

Project Summary: 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. The results generated are defensible to a recognized standard. During large-scale events affecting foods or food products, States and Federal authorities can use laboratory test results from accredited laboratories to respond rapidly with streamlined analytical review and enforce regulatory compliance to protect the safety of the nation's food supply. The main objective of the Division of Laboratory Services (DLS) at the Kentucky Department for Public Health is to maintain ISO/IEC 17025 accreditation (initial achievement in September 2016 for food chemistry and microbiology testing and reaccreditation in November 2018 to the new ISO/IEC 17025:2017 standards) and enhance testing capabilities by expanding the scope of current accreditation for additional testing to include food microbiology whole genome sequencing analyses. DLS is the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of the KY State manufactured food regulatory program (MFRPS) in the Department for Public Health / Food Safety Branch, which has a current food safety inspection contract with FDA and is enrolled in the MFRPS. DLS has a quality management system that is in compliance with the managerial and technical requirements of the ISO/IEC 17025:2017 standard. DLS is a Food Emergency Response Network (FERN) Laboratory and participates in Food proficiency testing and submits laboratory results through electronic laboratory exchange network (eLEXNET) as requested. The Division of Laboratory Services’s goal is to enhance laboratory activities by bringing in new testing capabilities. DLS has implemented whole genome sequencing for environmental micro food samples to complement progressive testing performed on clinical samples in outbreak situations. This will result in faster identification of the food/pathogens implicated in the outbreak and match clinical and environmental samples. Funding of this proposal will assist the KY State MFRPS in achieving conformance with Standard 10 “Laboratory Support” and will assist DLS with the continuance of data submission to the FDA via Genome Trakr with the use of the latest bioinformatics capabilities with BioNumerics software. This allows DLS to provide reliable data to the FDA much faster which leads to the acceptance of analytical results by FDA and other regulatory agencies for use in enforcement actions, surveillance and response to foodborne outbreaks. In addition, DLS can provide insight into the origin of the contaminated food by the genomic information provided to the GenomeTrakr network which will lead to the development of a stronger international rapid surveillance system for pathogen trace back.