Vermont Department of Health Laboratory ISO/IEC 17025 Accreditation Maintenance and Enhancement

佛蒙特州卫生部实验室 ISO/IEC 17025 认证维护和增强

• 批准号: 9931948
• 负责人: Barb Cote
• 金额: $ 14.5万
• 依托单位: VERMONT STATE AGENCY OF HUMAN SERVICES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-05 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9931948
• 关键词: Vermont; Department; Health; Laboratory; ISO

Project Summary The Vermont Department of Health Laboratory (VDHL) is located at 359 South Park Drive in Colchester, VT. The mission of VDHL is to promote health and prevent disease by providing quality analytical services, leadership in laboratory science and support to public health and environmental activities. VDHL, as the sole servicing laboratory, is committed to strengthening the food safety system in Vermont by supporting the regulatory and surveillance activities of the Vermont Department of Health Food and Lodging Program (VDHFL), who holds the State Manufactured Food Regulatory Program contract with FDA. To support these activities, VDHL must maintain and enhance its ISO/IEC 17025 accreditation, obtained in September 2016, to ensure all test data generated is valid and defensible. VDHL is requesting funds in the amount of $145,000 to be used from July 2019 through June 2020 to maintain and enhance its ISO/IEC 17025 accreditation. This achievement will be accomplished by: • Retaining a currently funded microbiologist to perform microbiological testing, hiring a consultant to assist in the transition to the 17025:2017 standard version, training of personnel, and performing internal and external audits. • Addition of the FDA Listeria monocytogenes method to its scope of accreditation and verification of new high-risk food types. • Participation in FDA’s initiatives in their support of ISO/IEC accreditation of laboratories. These activities will include, but not limited to, participating in an annual face-to-face meeting, in a Food Emergency Response (FERN) proficiency test event, in FERN bimonthly/quarterly teleconferences at the regional and national level, and purchasing equipment for the food testing program to streamline the testing process. • Collaboration between VDHL and VDHFL to collect and analyze the number and type of surveillance food and environmental samples that are described in the sample collection and analysis plan. This plan is signed by both parties and states the types of food, target analytes, frequency of collection and the number of samples that will be collected annually (at least 75 samples), and sampling methodology and transportation of samples to VDHL, including the use of chain-of-custody. • Automatically transfer the test result data generated by the food laboratory program into eLEXNET (FDA’s electronic laboratory exchange network) at the time the report is released to the customer. The outcome of these activities ensures that any food analyses performed by VDHL are conducted within the scope of an ISO/IEC 17025 accreditation, strengthens the collaboration between VDHL and VDHFL, increases the number of surveillance samples collected and analyzed annually, effectively advancing the goal of building an Integrated National Food Safety System.

项目摘要 佛蒙特州卫生部实验室（VDHL）位于佛蒙特州科尔切斯特市南方公园大道359号。 VDHL的使命是通过提供高质量的分析服务来促进健康和预防疾病， 领导实验室科学和支持公共卫生和环境活动。 作为唯一的服务实验室，VDHL致力于加强佛蒙特州的食品安全体系， 支持佛蒙特州卫生食品和住宿部的监管和监督活动 计划（VDHFL），谁持有国家制造食品监管计划与FDA的合同。到 为了支持这些活动，VDHL必须保持并加强其ISO/IEC 17025认证， 2016年9月，以确保生成的所有测试数据有效且可辩护。 VDHL要求从2019年7月到2020年6月提供145，000美元的资金，以维持 并加强其ISO/IEC 17025认证。这一成就将通过以下方式实现： ·保留目前资助的微生物学家进行微生物测试，聘请顾问协助 在向17025：2017标准版本过渡的过程中，培训人员，执行内部和 外部审计。 ·将FDA单核细胞增生李斯特菌方法添加到其认证和新产品验证范围中 高风险食品种类 ·参与FDA支持ISO/IEC实验室认证的倡议。这些活动 将包括但不限于参加年度面对面会议， 响应（FERN）能力测试事件，在区域和 在国家一级，为食品检测项目购买设备，以简化检测过程。 ·VDHL和VDHFL合作收集和分析监测食品的数量和类型 以及样品采集和分析计划中所述的环境样品。这个计划是 由双方签署，并说明食物的种类，目标分析物，收集的频率和数量 每年将收集的样本数量（至少75个样本），以及采样方法和 将样本运送到VDHL，包括使用监管链。 ·自动将食品实验室程序生成的测试结果数据传输到eLEXNET（FDA的 电子实验室交换网络）。 这些活动的结果确保了VDHL进行的任何食品分析都是在 ISO/IEC 17025认证的范围，加强了VDHL和VDHFL之间的合作，增加了 每年收集和分析的监测样本数量，有效推进了建设目标， 国家食品安全综合体系。