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


PROJECT ABSTRACT The Texas Department of State Health Services (DSHS) Laboratory Services Section (LSS) works inconjunction with the Food and Drug Administration (FDA), the Centers for Disease Control andPrevention (CDC), and the state regulatory body, DSHS Consumer Protection Division (CPD), to ensurefood and food products in Texas are safe. LSS currently has a cooperative agreement with the Food andDrug Administration (FDA) Food Emergency Response Network (FERN) for obtaining and maintainingInternational Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC)17025 (ISO/IEC 17025) accreditation and a Research Collaboration Agreement (RCA) with FDA for theGenomeTrakr network. ISO/IEC 17025 accreditation is one of the most important standards for testinglaboratories and attests to the competency and technical capability of a laboratory to perform specifictasks. LSS has been ISO/IEC 17025 accredited by the American Association for Laboratory Accreditation(A2LA) since 2016. LSS implemented Whole Genome Sequencing (WGS) in 2015, contributed to thenational WGS databases, and helped to identify national outbreak clusters and their possibletransmission vehicles. LSS is a well-equipped laboratory that employs over three hundred seventy staff to providecomprehensive public health testing services. Currently, DSHS has surveillance programs in place tomonitor ground meat products, ready to eat meat products, environmental conditions in processing plantsutilizing environmental swab samples, and FDA food commodities, milk plant and dairy farm products,seafood products, and bay water for the presence of biological organisms and other toxic substances.DSHS has the capability to respond to food related emergencies including outbreaks. The objective of this project is to advance the goal of a national food safety system by: 1. Ensuring microbiological and chemical food analyses, performed on behalf of the state manufactured food regulatory programs, are conducted within the scope of an ISO/IEC 17025 accredited laboratory; 2. Strengthening the collaboration between the laboratories and state manufactured food regulatoryprograms; 3. Increasing the number of state samples collected and analyzed for surveillance purposes annually; 4. Developing a stronger international rapid surveillance system for pathogen traceback, through the GenomeTrackr network, using a minimum set of metadata fields for all food and environmentalisolates.This proposal includes funding for:1. Maintaining and enhancing the scope of ISO/IEC 17025 accredited analyses and ensuring all ISO standards are met by employing qualified staff and participating in an approved proficiency testprogram.2. Continuing to build on the existing relationship with the state manufactured food program by purchasing supplies for accredited food testing to support the sampling plan;3. Ensuring a sampling agreement plan outlines a minimum of 75 samples per year to be tested under Competition A;4. Ensuring 400 samples are sequenced per year in fulfillment of the requirements for Competition B including the metadata, in real time to National Center for Biotechnology Information (NCBI) - National Institutes of Health (NIH) in coordination with FDA Center for Food Safety and Applied Nutrition (CFSAN).5. Increasing the number of partnerships and collaborations between LSS and FDA, CDC, local and state public health departments, and universities via the sharing of live isolates.

Tanksley, Susan ; Simpson, Lisa H
Texas Department of State Health Services
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