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

Michigan State Dept Of Agriculture, Lansing MI

Investigators

Abstract

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.