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

The West Virginia Department of Agriculture Regulatory and Environmental AffairsDivision (WVDA-READ) had 15 biological methods ISO/IEC 17025:2005 accredited in August of2016. ISO/IEC 17025 accreditation supports a strong management and technical structure inthe laboratory. Accreditation has enhanced the laboratory in being recognized as an officiallycompetent food testing laboratory. In order to maintain and enhance the scope of accreditation, and conduct surveillancetesting, the WVDA is seeking support through a FDA cooperative agreement ?Maintenance andEnhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State FoodTesting Laboratories, funding opportunity RFA-FD-17-010. The cooperative agreement willsupport the fees associated with maintaining accreditation such as equipment calibration andpreventative maintenance, assessments, personnel, and travel for training. Personnel andconsumable costs will be supported in order to conduct surveillance testing on FDA products. The quality system is being maintained by personnel who are trained in the managementand technical requirements of ISO/IEC 17025. Personnel support is necessary for updatingdocuments, training, internal audits, conducting corrective action, and maintaining additionalquality requirements in the laboratory. ISO/IEC 17025 requires more stringent calibrations andpreventative maintenances for equipment which result in higher expenses for the laboratory.Travel funds will be used to ensure personnel will have the training available to maintainISO/IEC 17025 and attend the cooperative agreement meetings. Annually, the ISO/IEC 17025assessments will be conducted by the accreditation body in order to maintain the accreditation.The FDA Biological Analytical Manual (BAM) Cultural Salmonella method will be added to thescope of accreditation in 2018, and the FDA BAM cultural Listeria monocytogenes method willbe added in 2019. Surveillance testing is planned on FDA products throughout the year. Processedproduce will be collected by the Regulatory Officers and delivered to the laboratory for analysis.Produce will be analyzed for Salmonella spp. and Staphylococcal enterotoxin (SET) in 2018. In2019, samples will be analyzed for Listeria monocytogenes and Staphylococcal enterotoxin(SET). Sample results will be entered into the laboratory information management system(LIMS) and automatically uploaded into eLEXNET. The WVDA Microbiology Laboratory has been a participating member in the FoodEmergency Response Network since 2005 and actively tests for various pathogenic bacteria infoods, environmental samples, and food contact surfaces. In 2010, the WVDA was awarded theFERN FSIS cooperative agreement to participate in FERN directed activities such assurveillance testing, method development, exercises and proficiencies. In 2016, the WVDAMicrobiology Laboratory was awarded the Level 1 cooperative agreement to conductmicrobiological and chemical analysis. With inclusion in the ISO/IEC 17025 cooperative agreement program the WVDAcommits to maintaining ISO/IEC 17025 accreditation, expanding the scope to new methods, andconducting surveillance activities with FDA products with their Regulatory partner.