State Hygienic Laboratory Iso/iec 17025:2005 Accreditation; Sample Surveillance and Whole Genome Sequencing Analysis

Project SummaryThe State Hygienic Laboratory (SHL) proposes to 1) maintain and enhance the current ISO/IEC17025:2005 accreditation for the microbiological and chemical analysis of food testing, 2)partner with Iowa Department of Inspection and Appeals to perform surveillance sampling andtesting for FDA's Manufactured Food Regulatory Program, and 3) use next generationsequencing technique to analyze foodborne related pathogen isolates and upload the data intothe NCBI database for data sharing.SHL will adopt a continuous improvement approach based on the PDCA management method(Shewhart cycle) to maintain and enhance the current SHL laboratory quality managementsystem. SHL will continue to conduct management review and internal audit, actively seekcustomer feedback and utilize the best practices to improve the laboratory service quality. ForISO scope enhancement, SHL will utilize methods provided by the FDA FERN program ormethods available through the Association of Official Analytical Chemists International (AOACInternational) and FDA Bacteriological Analytical Manual (BAM) for the determination of specificanalytes. SHL will identify and participate in appropriate proficiency testing (PT) programs asavailable for all techniques implemented.For the surveillance sampling, SHL will collaborate with Iowa Department of Inspection andAppeals (IDIA) to conduct comprehensive surveillance sampling to inspect products with ahistory of challenges, broadly distributed products and products that are of significance to thelocal food commerce. Sampling will follow the methods outlined in Chapter 4 of the FDAInvestigations Operations Manual 2013 (IOM), and any supplementary FDA guidance onsample collection. After year 1, SHL will evaluate the effectiveness of using the FDA IOM anddetermine if a stand-alone state policy should be developed.For the next generation sequencing project, selected foodborne related isolates will besequenced using the existing MiSeq instrument according to the FDA GenomeTrakr protocol.Overall run quality will be evaluated using the Illumina Sequencing Analysis Viewer software. Ifthe final files meet the FDA quality requirements, they will be uploaded to NCBI and shared withFDA's GenomeTrakr personnel.