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

West Virginia State Dept Of Agriculture, Charleston WV

Investigators

Abstract

The West Virginia Department of Agriculture Regulatory and Environmental Affairs Division (WVDA-READ) had 15 biological methods ISO/IEC 17025:2005 accredited in August of 2016. ISO/IEC 17025 accreditation supports a strong management and technical structure in the laboratory. Accreditation has enhanced the laboratory in being recognized as an officially competent food testing laboratory. In order to maintain and enhance the scope of accreditation, and conduct surveillance testing, the WVDA is seeking support through a FDA cooperative agreement ?Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories, funding opportunity RFA-FD-17-010. The cooperative agreement will support the fees associated with maintaining accreditation such as equipment calibration and preventative maintenance, assessments, personnel, and travel for training. Personnel and consumable 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 management and technical requirements of ISO/IEC 17025. Personnel support is necessary for updating documents, training, internal audits, conducting corrective action, and maintaining additional quality requirements in the laboratory. ISO/IEC 17025 requires more stringent calibrations and preventative 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 maintain ISO/IEC 17025 and attend the cooperative agreement meetings. Annually, the ISO/IEC 17025 assessments 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 the scope of accreditation in 2018, and the FDA BAM cultural Listeria monocytogenes method will be added in 2019. Surveillance testing is planned on FDA products throughout the year. Processed produce 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. In 2019, 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 Food Emergency Response Network since 2005 and actively tests for various pathogenic bacteria in foods, environmental samples, and food contact surfaces. In 2010, the WVDA was awarded the FERN FSIS cooperative agreement to participate in FERN directed activities such as surveillance testing, method development, exercises and proficiencies. In 2016, the WVDA Microbiology Laboratory was awarded the Level 1 cooperative agreement to conduct microbiological and chemical analysis. With inclusion in the ISO/IEC 17025 cooperative agreement program the WVDA commits to maintaining ISO/IEC 17025 accreditation, expanding the scope to new methods, and conducting surveillance activities with FDA products with their Regulatory partner.