Maintenance and Enhancement of Iso/iec 17025 Accreditation and Whole Genome Sequencing For State Food Testing Laboratories.

Project Summary:The main objective of the Division of Laboratory Services (DLS) at the Kentucky Department forPublic Health is to maintain ISO/IEC 17025 accreditation (achieved in September 2016for food chemistry and microbiology testing) and enhance testing capabilities by expanding the scopeof current accreditation for additional testing to include food microbiology whole genome sequencinganalyses. ISO/IEC 17025 accreditation is one of the most important standards for testing laboratoriesand attests to the competency and technical capability of a laboratory to perform specific tasks. Theresults generated are defensible to a recognized standard. In addition, accreditation supports thetraceability of technical results generated by a laboratory. In the event of a large-scale terrorist activityor other large-scale events affecting foods or food products, States and Federal authorities can uselaboratory test results from accredited laboratories to respond rapidly with streamlined analyticalreview and enforce regulatory compliance to protect the safety of the nation's food supply. DLS is theprimary servicing laboratory for conducting microbiological and chemical food analyses on behalf ofthe 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 inthe MFRPS. DLS has a quality management system that is in compliance with the managerial andtechnical requirements of the ISO/IEC 17025:2005 standard. DLS is a Food Emergency ResponseNetwork (FERN) Laboratory and participates in Food proficiency testing and submits laboratoryresults through electronic laboratory exchange network (eLEXNET) as requested. The Division ofLaboratory Services?s goal is to enhance laboratory activities by bringing in new testing capabilities.DLS will implement whole genome sequencing tests for environmental micro food samples tocomplement progressive testing performed on clinical samples in outbreak situations. This wouldresult in faster identification of the food/pathogens implicated in the outbreak and matching clinical toenvironmental samples.Funding of this proposal will assist the KY State MFRPS in achieving conformance with Standard 10?Laboratory Support? of the MFRPS and will contribute to production of accurate and reliable testdata, a quicker acceptance of analytical results by FDA, and other regulatory agencies forenforcement actions, surveillance purposes and response to foodborne outbreaks. In addition, DLSwill provide insight into the origin of the contaminated food by the genomic information provided by theGenomeTrackr network which will point investigators to specific food products potentially related to anoutbreak. This will lead to develop a stronger international rapid surveillance system for pathogentraceback by further enhancing the GenomeTrackr network and growing the database.