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Overview & Enhancement. Agenda Introduction/Timeliness History of eLEXNET System Description/Architecture Program Areas System Contributions – # of Labs.

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Presentation on theme: "Overview & Enhancement. Agenda Introduction/Timeliness History of eLEXNET System Description/Architecture Program Areas System Contributions – # of Labs."— Presentation transcript:

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

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 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 Authentication 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 eLEXNETPulseNetFoodShieldFoodRisk Existence 1998199620042006 Framework Oracle 11g Web-Based Database Web-Based Core SHIELDWeb-Based Mission 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 UnknownBiological Chemical Data Analytic & Reporting Dissemination Presentation Ad-Hoc Queries Form Clusters Searchable only by incident FDA-iRISK Data Quality Medium Unknown 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 10 eLEXNET Server XML Data Lab LIMS Database Custom DX Client Custom client Manual data entry Labs cannot review or learn the eLEXNET Business Rules New Products and Analyte not reported automatically New Products and Analyte not reported automatically New Products and Analyte not reported automatically eLEXNET team manually collects Analyte and Product data periodically from FACTS 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 FACTS DB Reports PLSQL with embedded business rules. Legacy Data Processing Code Error Log LABeLEXNETFDA 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 StageTesting StageLIMS Entry StageTransfer StageProcessing StageReporting Stage

12 Accomplishments 12 Published DX brochure & help materials Provided technical support to labs Maintained personnel touch with labs during on boarding process 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 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

13 Remaining Challenges 13 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 Collection, Testing, LIMS, TransferProcessingReporting Data ExchangeData Processing Data Analytics & Reporting

14 Future State Production Database Production Database Temporary Staging Database Temporary Staging Database Incoming XML Data DX Extract Module (Java) Rules Engine Actions eLEXNE T Busines s Rules eLEXNE T Busines s Rules Receives error notifications Looks up, reviews, updates business rules eLEXNET Analyst eLEXNET Users Legacy PLSQL Transform & Load Module Receives error notifications 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 Strengths 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 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)

22 Questions


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