Presentation is loading. Please wait.

Presentation is loading. Please wait.

System Overview FDA eLEXNET Team. Agenda Vision and Mission eLEXNET at a Glance –Data Flow –Data Exchange Labs eLEXNET Stakeholders Benefits to ISO Labs.

Published byRaymond Watts Modified over 9 years ago

Similar presentations

Presentation on theme: "System Overview FDA eLEXNET Team. Agenda Vision and Mission eLEXNET at a Glance –Data Flow –Data Exchange Labs eLEXNET Stakeholders Benefits to ISO Labs."— Presentation transcript:

1 System Overview FDA eLEXNET Team

2 Agenda Vision and Mission eLEXNET at a Glance –Data Flow –Data Exchange Labs eLEXNET Stakeholders Benefits to ISO Labs and all Stakeholders Obligations of ISO Labs 2015 Highlights Next Steps 1

3 Mission & Vision Central integration platform for collaboration –Provide seamless, integrated, & secure info to government official engaged in food safety –Allow for coordination & Collaboration on Laboratory findings –Support real-time outbreak response with powerful analytics Key enabler of the FDA’s Strategic Priorities –Partnership for Food Protection (PFP) Integrated Food Safety System (IFSS) Dedicated professionals to protect the food supply & public health –FDA Food Safety Modernization Act (FSMA) Shifting from post-outbreak reaction, to early detection and prevention of food contamination Proactive approach rather than reactive

4 Mission & Vision (Cont’d) Transform the system into a “Unified Solution” –Common User Experience –Delivery of powerful dashboards –Consolidation & centralization of functionalities –Focus on services, collaboration, interoperability, & integration with other systems –Common lexicon & rich reporting to support predictive analytics Become the “system of choice” for food testing data –Continue to involve federal, state, & local food safety partners Develop standards for food safety data elements Test methods Data sharing Electronic data submission

5 Mission & Vision 4

6 Powerful Dashboard 5

7 eLEXNET at a Glance Java web application with COTS solutions –ORACLE database & applications –Business Objects reporting –WebCenter Portal for collaboration & process management –Rules management engine Pioneer & go-to Food Safety & Surveillance platform –Place to foster collaboration & build communities –Info center with powerful analytics Rich repository of analytical findings –300+ Labs –20K+ products & 4.5K+ analytes –890+ Samples –6M+ test records 6

8 eLEXNET DATA FLOW 7 300+ Labs 13 FDA Labs Non-FDA Labs Analytical Results Method Validation Files Repository Epidemiologists Risks Assessors Compliance Officers Public Health Officials Pattern Detection Intelligence Disaster Related Incidents Data Repository Data Analysis National Surveillance

9 Breakdown of Data Exchange Labs 8 1-4 Labs 5-9 Labs 10-14 Labs 15-25 Labs

10 Status of ISO Data Submission 9

11 ISO CAP Labs (Funded in 2012) Data Submission Statistics 10

12 ISO CAP Labs (Newly Funded) - Data Submission Status 11 Lab NameStatus Alabama Dept. of HealthIn-process Colorado Dept. of Public Health2,340 samples from 2013 - 2015 Louisiana Dept. of Public HealthIn-process Nevada State Public HealthIn-process Tennessee Dept. of AgricultureIn-process Wyoming Dept. of AgricultureIn-process

13 Other Stakeholders eLEXNET Stakeholders 12 FDA CFSAN 13 ORA Labs CVM Epi & Risk Assessors Regulatory Officials RRT & CORE USDA State Labs Academia DoD State Epi Foreign Partners Mexico Canada

14 Key Benefits to Labs Centralized “One-Stop Shop” 890+ food samples and over 6 millions test results Food samples represent 100 different industries Over 24K different products Ability to collaborate during outbreak –Melamine in Pet Food (2007) –Melamine in infant formula and milk-based products (2008) –Salmonella Saintpaul in Peppers (2008) –Deep Water Horizon (Gulf Oil Spill 2010) –Surveillance for Radiological contamination in imports from Japan (2011) Central repository of FDA’s Analytical Methods Integrated platform with: –FERN Labs –Integrated Consortium of Laboratory Network (ICLN) 13

15 ISO Labs Obligations Meet ISO-CoAg agreement requirements –Analyze surveillance and emergency response samples –Enter all data generated into eLEXNET system Participation in proficiency testing programs & share lab results through eLEXNET Facilitate development of data exchange electronically Strengthen collaboration with eLEXNET team to look at current & future opportunities to capture ISO sampling data Goal –Increase food safety surveillance, detection, & response efforts of the FDA and other regulatory agencies 14

16 FY 15 Highlights On-boarded new contractor (Booz Allen Hamilton) Expanded partnership Re-instituted management processes –Revamp Steering Committee & Change Control Board processes –Cooperated with APHL National User Group Conducted several outreach activities –4 Labs –Conducted training webinars Assisted 45+ Labs with data exchange strategies Facilitated analytical data access to 300+ Labs Surveyed labs to address evolving needs 15

17 Next Steps Labs Already Reporting –Continue to submit data –Ensure all relevant analytes are reported –Work with eLEXNET team on frequency & upload strategies –Review current profile Labs in the process –Contact eLEXNET Helpdesk Tel: (703) 377-2000 Fax: (301) 838-3729 E-Mail: elexnet_help@fda.hhs.gov elexnet_help@fda.hhs.gov –Register lab personnel to facilitate: Onboarding Reporting mechanism Get data exchange template 16

18 Analysis. Answers. Action.www.aphl.org How the System Can Work for You Randy Treadwell, MPH Animal Feed / Rapid Response Team Manager Washington State Dept. of Agriculture

19 Analysis. Answers. Action.www.aphl.org FDA National User Group (NUG) Formed in 2013 under a cooperative agreement between FDA, APHL, AAFCO and AFDO Advises FDA on information management, vocabulary and messaging standards and data exchange Provides feedback on eLEXNET upgrades Gives a voice to State labs and agencies

20 Analysis. Answers. Action.www.aphl.org National User Group Members represent: State Public Health Labs State Agriculture Labs FDA ORA State Public Health Agencies State Dept of Agriculture We want more representation from feed labs!

21 Analysis. Answers. Action.www.aphl.org National User Group

22 Analysis. Answers. Action.www.aphl.org eLEXNET Fills a Niche PulseNet FoodSHIELD eLEXNET –Non-PFGE lab results in one place –Accessible to State and FDA –Dynamic analysis of data

23 Analysis. Answers. Action.www.aphl.org The Data FDA Lab Data –95% of data from FDA regional labs is uploaded nightly Other federal agencies –US Customs & Border Protection –USDA State and local labs N EARLY O NE M ILLION S AMPLES

24 Analysis. Answers. Action.www.aphl.org Washington

25 Analysis. Answers. Action.www.aphl.org Washington Rapid Response Team (RRT) A multi-disciplinary team designed to effectively and efficiently respond to food and feed emergencies.

26 Analysis. Answers. Action.www.aphl.org RRT Core Elements Collaboration –Federal, state, local –Joint trainings, meetings, exercises, national workgroups Communication –Information sharing Policies and Procedures –Best Practices, SOPs Resources –Staff, equipment, supplies, etc.

27 Analysis. Answers. Action.www.aphl.org

28 Analysis. Answers. Action.www.aphl.org Integrating the Food Safety System

29 Analysis. Answers. Action.www.aphl.org Communities

30 Analysis. Answers. Action.www.aphl.org Regulatory Official Perspective Documentation of Outbreak Investigation Review Historical Testing at particular Firm/Facility or of particular product Reference lab results for regulatory action Prioritize testing schedule based on Trending Positives

31 Analysis. Answers. Action.www.aphl.org History of Product Contamination Example: L. monocytogenes in Ice Cream Historical review of laboratory results a)Frequency of product sampling? b)Scope of sampling? c)Results from sampling? Dr. Lauren Turner, Principal Scientist Epidemiologic Support Group Virginia Division of Consolidated Laboratory Services

32 Analysis. Answers. Action.www.aphl.org Build your Query - iDAT

33 Analysis. Answers. Action.www.aphl.org Conducting Analysis - iDAT

34 Analysis. Answers. Action.www.aphl.org Reporting - iDAT

35 Analysis. Answers. Action.www.aphl.org Sample Detail Reporting - iDAT

36 Analysis. Answers. Action.www.aphl.org Relevance of information Listeria detected in SC facility Listeria detected in TX facility Results uploaded to PulseNet Cases of listeriosis identified in KS hospital Milkshake implicated

37 Analysis. Answers. Action.www.aphl.org Key Benefits for Labs Satisfy CoAg obligations Use as a reporting mechanism for State agencies Facilitate COOP / Surge Capacity Compare tests/results to other labs Access FDA data

Download ppt "System Overview FDA eLEXNET Team. Agenda Vision and Mission eLEXNET at a Glance –Data Flow –Data Exchange Labs eLEXNET Stakeholders Benefits to ISO Labs."

Similar presentations

UCSC History. UCSC: A brief history 60s University Placement Committee A lot of field trips/interaction with employers.

UCSC History. UCSC: A brief history 60s University Placement Committee A lot of field trips/interaction with employers.
Food Safety National Center for Emerging and Zoonotic Infectious Diseases Division of Foodborne, Waterborne, and Environmental Diseases.

Food Safety National Center for Emerging and Zoonotic Infectious Diseases Division of Foodborne, Waterborne, and Environmental Diseases.
NYS Department of Health Bureau of Healthcom Network Systems Management.

NYS Department of Health Bureau of Healthcom Network Systems Management.
1 Christopher Melluso Elizabeth Higgins FDA/CVM State of New Mexico Pet Event Tracking Network (PETNet)

1 Christopher Melluso Elizabeth Higgins FDA/CVM State of New Mexico Pet Event Tracking Network (PETNet)
Investigating Foodborne Disease Outbreaks: The CDC Perspective Ian Williams, PhD, MS Chief, Outbreak Response and Prevention Branch Division of Foodborne,

Investigating Foodborne Disease Outbreaks: The CDC Perspective Ian Williams, PhD, MS Chief, Outbreak Response and Prevention Branch Division of Foodborne,
MFRPS Lesson Learned North Carolina

MFRPS Lesson Learned North Carolina
DR. CHRISTINA RUNDI MINISTRY OF HEALTH, MALAYSIA.

DR. CHRISTINA RUNDI MINISTRY OF HEALTH, MALAYSIA.
Produce Safety Rule Phase 2 Workgroup 1.

Produce Safety Rule Phase 2 Workgroup 1.
1 Webinar on: Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity Sponsored by Partnership.

1 Webinar on: Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity Sponsored by Partnership.
APHCA Emergency Preparedness Program Alabama Primary Health Care Association.

APHCA Emergency Preparedness Program Alabama Primary Health Care Association.
FSIS’ Innovative Food Security Initiatives Carol Maczka, Ph.D. Assistant Administrator USDA Food Safety and Inspection Service Office of Food Security.

FSIS’ Innovative Food Security Initiatives Carol Maczka, Ph.D. Assistant Administrator USDA Food Safety and Inspection Service Office of Food Security.
Protecting and Promoting Your Health How this work supports FDA’s mission: TO PROMOTE HUMAN and ANIMAL HEALTH by collaborating with veterinary diagnostic.

Protecting and Promoting Your Health How this work supports FDA’s mission: TO PROMOTE HUMAN and ANIMAL HEALTH by collaborating with veterinary diagnostic.
1 Federal Communications Commission (FCC) Communications Security, Reliability and Interoperability Council (CSRIC) Working Group 1A - Public Safety Consolidation.

1 Federal Communications Commission (FCC) Communications Security, Reliability and Interoperability Council (CSRIC) Working Group 1A - Public Safety Consolidation.
Central Asia Regional Health Security Workshop Co-organized with the Command Surgeon, US Central Command and the George C. Marshall European Center for.

Central Asia Regional Health Security Workshop Co-organized with the Command Surgeon, US Central Command and the George C. Marshall European Center for.
Nedra Garrett Director, Division of Informatics Practice, Policy, and Coordination (DIPPC) PHIN Partner Call April 20, 2011 Public Health Information Network.

Nedra Garrett Director, Division of Informatics Practice, Policy, and Coordination (DIPPC) PHIN Partner Call April 20, 2011 Public Health Information Network.
Multnomah County Health Department ►Essential Services ►FDA Food Standards ►PACE Tools for Food Program Excellence Lila Wickham March 17, 2004 ♣

Multnomah County Health Department ►Essential Services ►FDA Food Standards ►PACE Tools for Food Program Excellence Lila Wickham March 17, 2004 ♣
Food and Agriculture Security: Are They on the Radar Screens of Our State Homeland Security Directors?

Food and Agriculture Security: Are They on the Radar Screens of Our State Homeland Security Directors?
Part of a Broader Strategy

Part of a Broader Strategy
Look,Listen and Learn Project Regional Conference 14-15 November 2005 Birchwood Hotel, Johannesburg By Fred Kalibwani SADC FOOD SECURITY POLICY PROCESSES.

Look,Listen and Learn Project Regional Conference November 2005 Birchwood Hotel, Johannesburg By Fred Kalibwani SADC FOOD SECURITY POLICY PROCESSES.
1 Ruiqing Pamboukian, Ph.D. Office of Regulatory Affairs/Office of Regulatory Science U.S. Food and Drug Administration Governmental Food and Feed Laboratories.

1 Ruiqing Pamboukian, Ph.D. Office of Regulatory Affairs/Office of Regulatory Science U.S. Food and Drug Administration Governmental Food and Feed Laboratories.

Similar presentations

Ads by Google