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

维护和加强国家食品检测实验室的 ISO/IEC 17025 认证和全基因组测序。

• 批准号: 9930709
• 负责人: Beth D Johnson
• 金额: $ 14.37万
• 依托单位: KY ST CABINET/HEALTH/FAMILY SERVICES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-25 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9930709
• 关键词: Maintenance; Enhancement; ISO; IEC; 17025

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.

项目概要： ISO/IEC 17025 认证是测试实验室和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 生成的结果符合公认的标准。在影响食品的大型活动期间 或食品，州和联邦当局可以使用经认可的实验室测试结果 实验室通过简化的分析审查快速做出反应并强制遵守法规 保障国家粮食供应安全。实验室部门的主要目标 肯塔基州公共卫生部服务 (DLS) 将维护 ISO/IEC 17025 认可（2016年9月初步取得食品化学和微生物学检测和 2018 年 11 月重新认证新的 ISO/IEC 17025:2017 标准）并加强测试 通过扩大当前的额外测试认证范围以包括食品来增强能力 微生物学全基因组测序分析。 DLS 是主要服务实验室 代表肯塔基州制造的食品进行微生物和化学食品分析 公共卫生/食品安全部的监管计划（MFRPS），该部门有一个 目前与 FDA 签订了食品安全检验合同，并已加入 MFRPS。 DLS拥有品质 符合管理和技术要求的管理体系 ISO/IEC 17025:2017 标准。 DLS 是食品紧急响应网络 (FERN) 实验室 参与食品能力验证并通过电子方式提交实验室结果 根据要求实验室交换网络（eLEXNET）。实验室服务部的目标是 通过引入新的测试能力来加强实验室活动。 DLS已全面实施 对环境微量食品样本进行基因组测序以补充渐进式测试 在爆发情况下对临床样本进行。这将导致更快地识别 与疫情相关的食物/病原体与临床和环境样本相匹配。资助 该提案将协助肯塔基州 MFRPS 达到标准 10“实验室 支持”并将协助 DLS 通过 Genome Trakr 继续向 FDA 提交数据 通过 BioNumerics 软件使用最新的生物信息学功能。这使得 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 和其他监管机构用于执法行动、监视和响应 食源性疾病暴发。此外，DLS 还可以通过以下方式深入了解受污染食品的来源： 提供给 GenomeTrakr 网络的基因组信息将导致开发 更强大的病原体追溯国际快速监测系统。