State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation, Sample surveillance and Whole Genome Sequencing Analysis

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Project Summary The State Hygienic Laboratory (SHL) proposes to 1) maintain and enhance the current ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing, 2) partner with Iowa Department of Inspection and Appeals to perform surveillance sampling and testing for FDA's Manufactured Food Regulatory Program, and 3) use next generation sequencing technique to analyze foodborne related pathogen isolates and upload the data into the 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 management system. SHL will continue to conduct management review and internal audit, actively seek customer feedback and utilize the best practices to improve the laboratory service quality. For ISO scope enhancement, SHL will utilize methods provided by the FDA FERN program or methods available through the Association of Official Analytical Chemists International (AOAC International) and FDA Bacteriological Analytical Manual (BAM) for the determination of specific analytes. SHL will identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented. For the surveillance sampling, SHL will collaborate with Iowa Department of Inspection and Appeals (IDIA) to conduct comprehensive surveillance sampling to inspect products with a history of challenges, broadly distributed products and products that are of significance to the local food commerce. Sampling will follow the methods outlined in Chapter 4 of the FDA Investigations Operations Manual 2013 (IOM), and any supplementary FDA guidance on sample collection. After year 1, SHL will evaluate the effectiveness of using the FDA IOM and determine if a stand-alone state policy should be developed. For the next generation sequencing project, selected foodborne related isolates will be sequenced using the existing MiSeq instrument according to the FDA GenomeTrakr protocol. Overall run quality will be evaluated using the Illumina Sequencing Analysis Viewer software. If the final files meet the FDA quality requirements, they will be uploaded to NCBI and shared with FDA's GenomeTrakr personnel.