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

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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.