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

Award Number: U18FD006237
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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Project Summary: The main objective of the Division of Laboratory Services (DLS) at the Kentucky Department for Public Health is to maintain ISO/IEC 17025 accreditation (achieved in September 2016 for food chemistry and microbiology testing) and enhance testing capabilities by expanding the scope of current accreditation for additional testing to include food microbiology whole genome sequencing analyses. ISO/IEC 17025 accreditation is one of the most important standards for testing laboratories and attests to the competency and technical capability of a laboratory to perform specific tasks. The results generated are defensible to a recognized standard. In addition, accreditation supports the traceability of technical results generated by a laboratory. In the event of a large-scale terrorist activity or other large-scale events affecting foods or food products, States and Federal authorities can use laboratory test results from accredited laboratories to respond rapidly with streamlined analytical review and enforce regulatory compliance to protect the safety of the nation's food supply. DLS is the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of the KY State manufactured food regulatory program (MFRPS) in the Department for Public Health / Food Safety Branch, which has a current food safety inspection contract with FDA and is enrolled in the MFRPS. DLS has a quality management system that is in compliance with the managerial and technical requirements of the ISO/IEC 17025:2005 standard. DLS is a Food Emergency Response Network (FERN) Laboratory and participates in Food proficiency testing and submits laboratory results through electronic laboratory exchange network (eLEXNET) as requested. The Division of Laboratory Services’s goal is to enhance laboratory activities by bringing in new testing capabilities. DLS will implement whole genome sequencing tests for environmental micro food samples to complement progressive testing performed on clinical samples in outbreak situations. This would result in faster identification of the food/pathogens implicated in the outbreak and matching clinical to environmental samples. Funding of this proposal will assist the KY State MFRPS in achieving conformance with Standard 10 “Laboratory Support” of the MFRPS and will contribute to production of accurate and reliable test data, a quicker acceptance of analytical results by FDA, and other regulatory agencies for enforcement actions, surveillance purposes and response to foodborne outbreaks. In addition, DLS will provide insight into the origin of the contaminated food by the genomic information provided by the GenomeTrackr network which will point investigators to specific food products potentially related to an outbreak. This will lead to develop a stronger international rapid surveillance system for pathogen traceback by further enhancing the GenomeTrackr network and growing the database.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	HEALTH & FAMILY SERVICES, KENTUCKY CABINET FOR	275 E MAIN ST STE B	FRANKFORT	KY	40601	FRANKLIN	USA	Food and Drug Administration Research	000	2	3/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $145,000 )
2018	2018	HEALTH & FAMILY SERVICES, KENTUCKY CABINET FOR	275 E MAIN ST STE B	FRANKFORT	KY	40601	FRANKLIN	USA	Food and Drug Administration Research	000	2	6/13/2018	NON-COMPETING CONTINUATION	$145,000
														Subtotal = $145,000

Issue Date FY: 2017 ( Subtotal = $145,000 )
2017	2017	HEALTH & FAMILY SERVICES, KENTUCKY CABINET FOR	275 EAST MAIN ST #5WA	FRANKFORT	KY	40601	FRANKLIN	USA	Food and Drug Administration Research	001	1	9/8/2017	NEW	$0
2017	2017	HEALTH & FAMILY SERVICES, KENTUCKY CABINET FOR	275 EAST MAIN ST #5WA	FRANKFORT	KY	40601	FRANKLIN	USA	Food and Drug Administration Research	000	1	8/31/2017	NEW	$145,000
														Subtotal = $145,000

Grand Total All Awards = $290,000

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

Award Number: U18FD006237

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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