Overview & Enhancement
Agenda
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Introduction/Timeliness
History of eLEXNET
System Description/Architecture
Program Areas
System Contributions
– # of Labs
– # of Users
• System Comparison
– eLEXNET
- FoodShield
- PulseNet
• Data Quality
• Strengths, weaknesses, & challenges
• Upcoming Enhancements
- FoodRisk
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
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
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
System Architecture
FERN PT
Data
Exchange
•PT – Data Entry
•Admin
Functions
•DX Server &
Clients
•Lab Generated
XML **
•Excel Entry **
Methods
Module
COMPACT
User/Lab
Mgmt.
Data Entry
•Sample Entry
•Product &
Analyte
lookups
•Directories
•Access Control
BO
Reporting
•Canned
Reports
•Standard
Reports
•Ad-hoc Reports
Notification
Services
•Email notification
Common
Login
Security
Services
•Authentication
•Authorization
•Encryption
•Authentication
•Profile Sync **
eLEXNET – System of Systems
Working together as ONE
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
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
Systems Comparisons
eLEXNET
PulseNet
FoodShield
FoodRisk
1998
1996
2004
2006
Oracle 11g
Web-Based
Database
Web-Based
Core SHIELD
Web-Based
Surveillance
Data Repository
System
Emergency
Reg. System
PFGE Patterns
Emergency
Collaboration
Tools
Emergency
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
Dissemination
Presentation
Ad-Hoc Queries
Form Clusters
Searchable only by
incident
FDA-iRISK
Medium
Medium
Unknown
Unknown
Fed, State, Local,
Academia, DoD
(FDA)
Federal, State, &
Local
(CDC)
Food and
Agriculture Sector
(NCFPD/UMN)
USDA, EPA, FDA,
CFSAN
(JIFSAN/UMD)
Existence
Framework
Mission
Data Analytic & Reporting
Data Quality
Collaboration &
(Governance)
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
New Products and Analyte not reported automatically
• 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
Data Exchange workflow illustration
• eLEXNET team
manually
collects Analyte
and Product
data periodically
from FACTS
New Products and Analyte
not reported automatically
10
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
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 email
• 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
12
Remaining Challenges
Collection, Testing, LIMS, Transfer
Data Exchange
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
Processing
Data Processing
Reporting
Data Analytics
& Reporting
Error Detection – Detected errors not
provided to lab; out of date mapping
Visual Analytics - Lack of sophisticated
analytical capabilities and visual reports
Error Correction – No automatic
correction
Inaccurate Report - Potential
Misrepresentations due to out of date
mappings
Business Rules – Invisible; Hard to
maintain
Process/Roles – No specific role/process
defined within lab for data
accountability
13
Future State
Temporary
Staging
Database
DX Extract
Module
(Java)
Incoming
XML Data
Rules Engine
Receives error
notifications
eLEXNE
T
Busines
s Rules
Production
Database
Receives error
notifications
eLEXNET
Users
Auto corrects data,
updates database
Actions
Looks up,
reviews, updates
business rules
Legacy
PLSQL
Transform &
Load
Module
eLEXNET Analyst
Integrating modern Rules Engine (DROOLS) – replacing legacy PL/SQL code
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
Data Analytics & Visualization
Custom Dashboards to enhance End-User experience
Data Analytics & Visualization
End User can Query and Analyze multiple data set directly within eLEXNET (iDAT)
Mobile Applications - Untethered
Data analytics & Visualization
iDAT’s 3 Phases - Customized Dashboards, GIS Mapping, Mobile Applications
eLEXNET Collaboration & Content
Management System (eCCMS)
Create,
Collaborate, &
Share content
directly within
eLEXNET
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
Strengths/Weaknesses
Strengths
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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
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House COMPACT Method Module
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Conduct proficiency Testing
Collaborate within communities
Centralized Web Resource of analytical
methods
Possess strong collaboration tools
with new Content Management
System (eCCMS)
Weaknesses
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Data Exchange (DX) Standardization
– Automation
– Enhance Manual Entry
– Legacy PL/SQL
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Need improved Data Mapping process
– Product codes
– Analytes
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Field Mapping is complex
Lack of Data Quality oversight
Limited Outreach/Marketing/Promotion
Questions