1. Overview & Enhancement

2. Agenda Introduction/Timeliness History of eLEXNET
System Description/Architecture
Program Areas
System Contributions
# of Labs
# of Users
System Comparison
eLEXNET FoodShield PulseNet FoodRisk
Data Quality
Strengths, weaknesses, & challenges
Upcoming Enhancements

3. Introduction
Mission
Support FDA’S Primary Mission Essential Functions (PMEF)
PMEF 3: Communications and Responses
PMEF 6: Safety & Integrity of the Food Chain
PMEF 8: Monitoring of Adverse Events & CC
Support of FDA Vital Records
Repository for food safety historical data
PMEF 3: Coordinate domestic and international communications and response activities related to emergencies that impact the safety, efficacy, integrity or availability of FDA-regulated products or that require FDA's investigational or laboratory support to other government agencies.
PMEF 6: Monitor the safety and integrity of the supply chain for FDA-regulated products and respond to potential or actual incidents.
PMEF 8: Monitoring of Adverse Events and Consumer Complaints -- Monitor and respond to adverse event incidents and consumer complaints associated with FDA-regulated products to ensure that the public's health is not jeopardized by unsafe and/or ineffective human and animal drugs, medical devices, biologics, human and animal food, radiological products and cosmetics.
eLEXNET is required for support of FDA Vital Records.

4. Timeliness System functions as key early warning system for FDA
Detect and evaluate anomalies
Help avoid potential outbreaks
System houses approximately 800,000+ samples and five million test records
20,000 products and 4,500 analytes
Scalable, Flexible & elastic to meet demands of industry

5. History 1998: FDA & USDA identified data sharing challenges
1999: Pilot project launched
2000: eLEXNET was released to 8 labs
2005: 95 state & local labs begin sharing
2011: Approx. 260 labs registered
2012: eLEXNET revamped & Method Modules
2013: iDAT, ORACLE upgrade, Drupal implementation - eCCMS, DROOLS, & DXS
2014: Implementation of 2013 enhancements

6. System Architecture eLEXNET – System of Systems
Data Entry
Sample Entry
Product & Analyte lookups
User/Lab Mgmt.
Directories
Access Control
COMPACT
Methods Module
FERN PT
PT – Data Entry
Admin Functions
BO Reporting
Canned Reports
Standard Reports
Ad-hoc Reports
Notification Services
notification
Security Services
Authentication
Authorization
Encryption
Data Exchange
DX Server & Clients
Lab Generated XML **
Excel Entry **
Common Login
Profile Sync **
eLEXNET – System of Systems
Working together as ONE

7. Program Areas eLEXNET covers the following disciplines:
Micro
Chemistry
Pesticides (PES)
MEL & RHS – Not covered
Radio-Chemistry
Some Filths
Areas in the pipeline
More Filths PAFs to come
DIOXIN (POPs) – completed Dashboard

8. Communities and Labs 300 Labs and 3800 active users
¾ labs actively send data to eLEXNET
¼ labs send data on ad-hoc or availability

9. Systems Comparisons eLEXNET PulseNet FoodShield FoodRisk Existence
1998
1996
2004
2006
Framework
Oracle 11g
Web-Based
Database
Core SHIELD
Mission
Surveillance
Data Repository System
Emergency
Reg. System
PFGE Patterns Emergency
Collaboration Tools
Response
Consolidate risk analysis, research data and methodology
Data Exchange
Excel Spreadsheet
Custom Client
Manual Entry
XML Schema
Collect
Transfer
No data transfer Members create workgroups to engage
No data exchange capabilities
Areas Covered
Micro, Chemical, Pesticides, Filths
Micro, Chemical, Pesticides
Unknown
Biological Chemical
Data Analytic & Reporting
Dissemination
Presentation
Ad-Hoc Queries
Form Clusters
Searchable only by incident
FDA-iRISK
Data Quality
Medium
Collaboration & (Governance)
Fed, State, Local, Academia, DoD
(FDA)
Federal, State, & Local
(CDC)
Food and Agriculture Sector
(NCFPD/UMN)
USDA, EPA, FDA, CFSAN
(JIFSAN/UMD)

10. Where We Are - Current State
LAB
eLEXNET
FDA
PLSQL with embedded business rules.
Lab LIMS
Database
Custom DX Client
XML Data
eLEXNET Server
Legacy Data Processing Code
Reports
FACTS DB
Error
Log
Custom client
Manual data entry
Labs cannot review or learn the eLEXNET Business Rules
Business / validation rules are embedded within PLSQL code.
Rules validations produce internal error logs which are not reported out to labs or technical team
eLEXNET offers tabular business object reports
Trend analysis is impossible or difficult
Limited data fix capability
eLEXNET team manually collects Analyte and Product data periodically from FACTS
New Products and Analyte
not reported automatically
New Products and Analyte not reported automatically
Data Exchange workflow illustration

11. Data Quality Challenges
Two-fold approach
Business Scientific content quality of data
IT Business rules to address quality of data
Disparity in data submission to eLEXNET
Large labs with sophisticated LIMS
Smaller labs lack that capability
Data quality issues can occur at any stage in the lifecycle
Collection Stage
Testing Stage
LIMS Entry Stage
Transfer Stage
Processing Stage
Reporting Stage

12. Accomplishments Published DX brochure & help materials
Provided technical support to labs
Maintained personnel touch with labs during on boarding process
Analyzed Data Quality Issues
Updated reference data – Products & Zip Code
Improved daily error logs
Provided daily
Evaluated and made recommendation for business rules engine
Implemented new set of graphical reports for analytical purposes
Enhanced the GUI to make reporting interface more user friendly
Performed analysis of data visualization tools

13. Remaining Challenges Data Analytics & Reporting Data Exchange
Collection, Testing, LIMS, Transfer
Processing
Reporting
Data Analytics
& Reporting
Data Exchange
Data Processing
Client Foundation – Custom; time consuming; one time mapping with no ability to maintain over time
Transfer of Data - No Error detection; Lack of awareness of business rules; out of date mapping
Process/Roles – No specific role/process defined within lab for data accountability
Error Detection – Detected errors not provided to lab; out of date mapping
Error Correction – No automatic correction
Business Rules – Invisible; Hard to maintain
Visual Analytics - Lack of sophisticated analytical capabilities and visual reports
Inaccurate Report - Potential Misrepresentations due to out of date mappings

14. Future State
Production
Database
Temporary
Staging
Incoming XML Data
DX Extract
Module (Java)
Rules Engine
Actions
eLEXNET
Business Rules
Receives error notifications
Looks up,
reviews, updates
business rules
eLEXNET Analyst
eLEXNET Users
Legacy PLSQL
Transform &
Load Module
Business
Rules
Auto corrects data, updates database
Integrating modern Rules Engine (DROOLS) – replacing legacy PL/SQL code

15. System Enhancements Platform Enhancements ORACLE 11g upgrade
Revamp portal, DB, publisher, & BPM (FERN & VetLRN PTs)
Data analytics and visualization
Interactive Data Analysis (iDAT)
GIS ability to dissect the data & view
Mobile Applications
eLEXNET Collaboration & Content Management System
Outreach to incorporate more data from other systems
Data Exchange Standardization

16. Data Analytics & Visualization
Custom Dashboards to enhance End-User experience

17. Data Analytics & Visualization
End User can Query and Analyze multiple data set directly within eLEXNET (iDAT)

18. Mobile Applications - Untethered Data analytics & Visualization
iDAT’s 3 Phases - Customized Dashboards, GIS Mapping, Mobile Applications

19. eLEXNET Collaboration & Content Management System (eCCMS)
Create, Collaborate, & Share content directly within eLEXNET

20. Data Exchange Standardization
Outreached efforts to the CDC Informatics
Discussed about on-going standardization efforts
Explored possibilities to receive data from PulseNet
Met with Applied Public Health Labs (APHL)
Availability of data to labs
Framework design
Webinar & presentation sessions to ISO Labs
Working with vendor to enhance:
Framework
Synchronize efforts to meet the needs of the labs

21. Strengths/Weaknesses
National Database for food safety data
Access to food safety testing results
Transfer/submit food safety data
Allows transmission of data securely across many entities
Optimizes services to change the whole user experience with iDAT
Food Emergency Response Network
Conduct proficiency Testing
Collaborate within communities
House COMPACT Method Module
Centralized Web Resource of analytical methods
Possess strong collaboration tools with new Content Management System (eCCMS)
Data Exchange (DX) Standardization
Automation
Enhance Manual Entry
Legacy PL/SQL
Need improved Data Mapping process
Product codes
Analytes
Field Mapping is complex
Lack of Data Quality oversight
Limited Outreach/Marketing/Promotion

22. Questions