Overview & Enhancement

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

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.

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 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 Email 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

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 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)

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

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

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

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

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 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

Questions