Admin Core - Food Defense and Surveillance in Support of the FDA by the State Hygienic Laboratory at the University of Iowa

项目摘要/摘要- Admin Core：

Project Summary/Abstract - Admin Core: The State Hygienic Laboratory (SHL) at the University of Iowa currently provides the essential structure in a public health laboratory to support and execute a food safety, surveillance, investigative and regulatory program for the State of Iowa. SHL does so in partnership with the Iowa Department of Inspections and Appeals and in partnership with the U.S. Food and Drug Administration on the national scale. The intention of the SHL is to continue the partnership with IDIA and FDA and serve Iowa needs for food safety, surveillance, and regulatory requirements. SHL has in place all the programmatic and physical infrastructure to execute the requirements of the new Laboratory Flexible Funding Model Cooperative Agreement. The SHL governance structure falls under the Office of the Vice-President of Research at the University of Iowa. The laboratory is organized and operated under a Director and three Associate Directors – Associate Director, Environmental Health Division (EHD), Associate Director, Diagnostic and Clinical Division (DCD), Associate Director, Administrative and Finance Division (AFD). The SHL employs approximately 190 staff members among the three laboratory locations. Twenty-one of those staff will be directly and indirectly involved with food safety and surveillance activities at two lab locations. Staff in Organic Chemistry, Inorganic Chemistry, and Environmental Microbiology sections fulfill analytical responsibilities for all food-related testing at SHL for FDA FERN and FDA ISO 17025:2017 and sample collection for FERN surveillance programs. The SHL maintains a comprehensive quality management system. The Quality Management Plan (QMP) defines and sets the standard for the policies, procedures, and documentation from collection of samples, through reporting final results to the client/submitter, to final disposition of the sample/specimen. The SHL QMP has been prepared in accord with Environmental Protection Agency and The NELAC Institute standards consistent with ISO/IEC 17025:2017 requirements. SHL has adopted the iPassport Document Control & Compliance Management system for document control process in which all SHL’s standard operating procedures (SOPS), QASPS, documents and policies reside. Food sample collection procedures, including actions describing specimen/sample collection, transport, preservation, storage and security are clearly defined in SHL SOP CV ENV 1311 FERN Food Surveillance (May 2018, updated May 2020) and SHL Policy 1531 Controlled Substances Handling, Storage, Use and Disposal (October 2018). These documents also refer to and require the use of legal chain of custody procedures and forms which are defined in SHL Policy 931 SHL Security and Legal Chain of Custody Policy (September 2016, updated May 2019. Sample analysis outcomes data reporting will be completed in conjunction with the IDIA for food defense samples collected by IDIA and 2) via the SHL OpenELIS LIMS using the FERN portal as well as Excel uploads submitted via the ORAPP website. The long-term goal for SHL will be to achieve the system-to-system integration with the National Food Safety Data Exchange (NFSDX).