Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18) Proposal Summary The Washington State Department of Agriculture (WSDA) Food Safety and Consumer Services (FS-CS) Laboratory (formerly known as Microbiology Laboratory) seeks funding from the U.S. Food and Drug Administration (FDA) under RFA-FD-19-018. Funding level requested is $145,000 for one year. The title of our proposal is: Maintaining & Enhancement of ISO/IEC 17025:2005 Accreditation (Competition A) The WSDA FS-CS Microbiology Laboratory goals for this one year project are: 1. Maintain and improve ISO/IEC 17025 accreditation (achieved in 2011). 2. Enhance ISO/IEC 17025 accreditation by adding test method to scope which will support the WSDA?s work to implement the Manufactured Food Regulatory Program Standards (MFRPS). 3. Continue to strengthen the collaboration between our laboratory and our State Manufactured Food Regulatory Program partners. 4. Maintain our FERN Cooperative Agreement and FERN membership which in turn shall include participation in FERN Proficiency Tests, conference calls, FERN face- to-face meetings and other activities as requested by FERN. 5. Annually, increase the number of State samples collected and analyzed for surveillance in order to meet minimum sample requirements required by FDA. 6. Enter all data generated from all testing performed by our laboratory into FDA e- LEXNET data collection system. 7. Develop a performance measurement system that will track performance and progress toward achieving the goals 1-6. The WSDA FS-CS Microbiology Laboratory meets all eligibility requirements for this funding opportunity: 1. The Laboratory is the primary regulatory food testing laboratory in Washington State and has adequate resources to achieve the project objectives 2. The Laboratory is one of the awardees of the current FDA?s ISO/IEC 17025:2005 Accreditation for Food Testing Laboratories cooperative agreement. 3. The Laboratory has obtained ISO 17025:2005 accreditation from 2011 and seeks to maintain and improve the accreditation, also successfully participates in ISO- accredited proficiency testing programs (e.g. API-LGC; AAFCO). 4. The Laboratory is a member of the FERN and is a FERN MCAP laboratory. 5. The Laboratory has send all testing results electronically to e-LEXNET. In addition, the WSDA Food Safety and Consumer Services is: ? Currently under contract with FDA to conduct food safety inspections ? Enrolled in the Manufactured Food Regulatory Program Standards FRA-FD-19-018: ISO/IEC 17025 Accreditation for State Food Testing Laboratories
Maintenance and Enhancement of ISO/IEC 17025 Accreditation RFA-FD-19-018 Project Narrative The Washington State Department of Agriculture (WSDA) Food Safety and Consumer Services (FS-CS) Laboratory (formerly known as Microbiology Laboratory) has a history of demonstrated success as a FDA-ISO MCAP awardee Laboratory since 2012. As an MCAP member, WSDA FS-CS Laboratory actively participates in all activities associated with the Cooperative Agreement: maintain and improve the ISO accreditation, add more testing methods under the ISO scope, proficiency sample testing, training seminars, ISO-MFRPS conferences, teleconferences, group testing assignments as well as additional numbers of state samples collected and analyzed for the regulatory purposes annually. As an ISO17025 accredited laboratory, we have a quality management system in place with dedicated quality assurance staff, a safety officer and procedures in place to assure good laboratory practices. We have laboratory facilities to assure the proper environment for advanced instrumentation in addition to secure sample custody and laboratory space. As a current FDA ISO grant awardee, the WSDA FS-CS Laboratory is applying for the cooperative agreement titled: Maintenance and Enhancement of ISO/IEC 17025 Accreditation for State Food Testing Laboratories (U18), announcement RFA-FD-19-018, with anticipation of funding for 2019-2020. The WSDA FS-CS Laboratory is willing and able to participate in the following project areas: 1. Maintaining and improving the ISO 17025 accreditation, and providing technical support to other States? food laboratories in their ISO accreditation efforts. ISO 17025 accreditation was granted to the WSDA FS-CS Laboratory on December 22, 2011 under Certificate #3245.01 Biological, and we have successfully maintained the accreditation since then. More analytical methods utilized by our laboratory will be added under ISO scope during past grant cycles. Laboratory data generated related to food safety has been continuously shared through eLEXNET with FDA. Ideally, an electronic data exchange will also be maintained between the laboratory information management system (LIMS) and eLEXNET. 2. Ensuring most of microbiological and biochemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an ISO/IEC 17025 accredited laboratory. The WSDA FS-CS Laboratory will participate in Washington Food Safety program/Manufactured Food Regulatory Standard Program (MFRPS) sample collection and analysis for surveillance purposes, food emergency outbreak testing and ensure large-scale food emergency event surge capacity by using various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food. 3. Strengthening the collaboration between the laboratories and State manufactured food regulatory programs and increasing the number of State samples collected and analyzed for surveillance purposes annually Our laboratory has maintained very solid and fruitful collaboration with the state Food Safety/MFRPS Program. The number of State samples (FDA regulated products) collected and analyzed will be increased over the grant one-year period. In conclusion, the WSDA FS-CS Laboratory wishes to continue as a FDA-funded ISO-MCAP Laboratory. We have met all program requirements and will strive to meet these requirements in the future. Our Laboratory and Department has gained immensely from participating in the first grant cycles of MCAP funding, and we look forward to continued participation and the associated challenges and rewards.
