8th. FDA IT and National Food Safety Data Exchange Updates Collaborative Data Exchange Making IT Happen. April 10, 2019

Transcription

1 8th Manufactured Food Regulatory Program Alliance FDA IT and National Food Safety Data Exchange Updates Collaborative Data Exchange Making IT Happen April 10, 2019

2 PFP IT WG: SUPPORTING FOOD SAFETY GOALS NFSDX ORAPP NATIONAL FOOD SAFETY DATA EXCHANGE System to System interface to electronically exchange information between FDA and regulatory partners Stores transactional data (who sent, when it was sent, etc.) Scenarios supported: Submit Contracted Inspection Data to FDA Request Firm Information from FDA Regulatory Partner Requests Firm Information from Another Regulatory Partner Not a data or document repository Not a website Note: NFSDX and ORAPP will incrementally expand to adopt ORA and Food Safety Modernization Act (FSMA) initiatives. NFSDX and ORAPP together will eventually replace esaf. ORA PARTNERS PORTAL Bi-directional information exchange via an integrated collaborative website for FDA and regulatory partners Interconnected with NFSDX and other FDA systems User account management Catalogs, Notifications, and alerts Scenarios supported: Produce Safety File Sharing with FDA (Farm Inventory) Not replacing FoodSHIELD Not a data repository 2

3 NFSDX PHASE I Scenarios States Systems 1. Submit Contracted Inspection Data to FDA* 2. Request Firm Data from FDA Florida, Illinois, Iowa, Minnesota, Pennsylvania, and Texas Arkansas, Illinois, Iowa, Minnesota, and Pennsylvania State systems and FDA systems (NFSDX and esaf) State systems and FDA systems (NFSDX and esaf) 3. State Requests Firm Data from Another State *Attachments are excluded Arkansas, Illinois, Iowa, and Pennsylvania State systems and FDA system (NFSDX) NFSDX Operational Scenarios Illinois - August 29, ,2, & 3 Florida - September 28,

4 NFSDX PHASE II NFSDX ORAPP Scenarios Scenarios 1. State Non-Contracted Inspections (Proof of Process) 2. Additional Inspection Types (BSE Checklist and Seafood HACCP) 1. Produce Safety File Sharing Regulatory Partners Regulatory Partners Iowa, New Hampshire, and Oregon Release Timeline FL April, 2019 TBD April 10, Contracted Sample (Lab) Results Data TBD June 17, 2019 Release Timeline March 18, 2019 Systems Regulatory Partner systems and FDA systems (NFSDX and esaf) Regulatory Partner systems and FDA systems (NFSDX and esaf) Regulatory Partner systems and FDA systems (NFSDX, elexnet, and LBS) Systems FDA system (ORAPP) 2. Firm History TBD June 17, 2019 FDA systems (NFSDX, ORAPP, and Firm360) 4

5 DATA EXCHANGE: NOW AND FUTURE Enhance NFSDX to enable BSE and Seafood Hazard Analysis and Critical Control Points (HAACP) Inspections data exchange Analyze data elements including user case scenarios and complete initial release for Sample/Lab Analysis Results using NFSDX and Electronic Laboratory Exchange Network (elexnet) Enable ORAPP to allow Produce Safety document upload and download functionality (Continued) Analyze the impact and initiate implementation discussions for incorporating documents and attachments in NFSDX Complete ORAPP enhancements for OCAR Resource Library and Firm360 Continue to expand regulatory partner adoption Enable non-contracted inspections data exchange via NFSDX Note: The priorities of the above goals and objectives are periodically updated and subject to change Enhance NFSDX to receive additional Sample/Lab Analysis data including voluntary/surveillance data Expand ORAPP to support Lab Data Capture for file upload and manual data entry Improve data visualization within ORAPP Initiate discussions and conduct analysis on Inspection data capture within ORAPP Initiate transitioning elexnet capabilities into ORAPP 5

6 ORAPP - HOME PAGE 6

7 ORAPP - LOGIN PAGE 7

8 ORAPP - FIRM SEARCH INTEGRATED WITH NFSDX

9 ORAPP - PRODUCE SAFETY USERS

10 SAMPLE ANALYSIS: SCENARIO AND INITIAL SCOPE SAMPLE PLANNING SAMPLE COLLECTION INVESTIGATIVE OPERATIONS SAMPLE ANALYSIS COMPLIANCE OPERATIONS OTHER OPERATIONS & SURVEILLANCE SUPPORT Drivers Automated and streamlined data exchange provides increased analytical capacity and expertise in an event of food outbreak/largescale food emergency requiring sample analysis Sample analysis performed by regulatory partner as a result of a sample collected by FDA investigator Reduced time for regulatory action on positive samples (e.g., Avocado samples) Scope Initial Scope Food Emergency Response Network (FERN) Cooperative Agreement (CAP) i.e., support only FDA collected samples Sample Analysis outcomes sent to FDA using National Food Safety Data Exchange (NFSDX) or Electronic Lab Exchange Network (elexnet) (DX Client, Web Upload or Manual Entry) Analysis Types limited to: Elements (ELE), Pesticides (PES), Mycotoxins (MYC) and Microbiology Microbial Analysis (MIC) PFP IT AND LAB WG: SAMPLE ANALYSIS UPDATES 10

11 Secured Web Service call SAMPLE ANALYSIS DATA EXCHANGE WORKFLOW OPTIONS REGULATORY PARTNER 1 State LIMS Custom Integration Client Web Service Secured Web Service call FDA EXTRANET NFSDX Authenticate, Validate Schema, Route to LBS FDA INTRANET Laboratory Business Service (LBS) 2 DX Client Reg. Data Secure Gateway Excel/XML Converter / WS Client Surveillance Data 3 Web Upload Excel/XML Converter / WS Client notification (validation errors) Reg. or Surv. Data elexnet.gov Site Reg. data is not stored on elexnet site. Site serves as a passthrough. FACTS Data Repository

12 INTERESTED IN PARTICIPATING? PFP IT WG or NFSDX or ORAPP Lisa Creason, PFP IT WG Chair Barbara Thiel, PFP IT WG Project Manager and National Food Safety Data Exchange Program Manager Sample Data Analysis Work Group Barbara Thiel, PFP IT WG Project Manager and National Food Safety Data Exchange Program Manager Donald Burr, PFP Lab WG Co-Chair ORAPP Produce Safety File Sharing Any CAP A/B states interested in using this functionality, send a request to the Produce Safety Support team (ProduceCAPITSupport@fda.hhs.gov) 12

13 ARKANSAS JOURNEY TO NSFDX State system code is ready for deployment Data Exchange Agreements Memorandum of Understanding (MOU) Complete Interconnection Security Agreement (ISA ) In Progress Point of Contact Phillip Fruechting (Phillip.Fruechting@arkansas.gov) Louis Nevala (Louis.Nevala@arkansas.gov) 13

14 QUESTIONS OR COMMENTS? 14

15 APPENDIX REFERENCE SLIDES 15

16 PFP IT WORK GROUP (WG): AN OVERVIEW Goals: Provide a collaborative Information Technology (IT) vision and approach for a sustainable uniform electronic data exchange with Integrated Food Safety System (IFSS) partners. 30 STATES CURRENTLY PARTICIPATING IN PFP IT WG Legend: Participating in IT WG (30) Participating in IT WG & Data Exchange (7) Identify and address IT needs across all facets of the IFSS. Analyze and define the requirements for developing an electronic information exchange between FDA and food safety partners to create harmonized and compatible IT environment. IT WG Chair: Lisa Creason (FDA) IT WG PM: Barbara Thiel (FDA) 16

17 PFP IT WG: ACCOMPLISHMENTS Introduced State data exchange roadmap Established bi-weekly data schema definition sessions to capture data element name, format, length, relationship, etc. for Firm, Inspection, and Labs Identified three scenarios for data exchange Inspection Data to FDA, FDA Firm Search, State to State Firm Search Released ORA Schema 7 for initial Proof of Concept (PoC) Launched National Food Safety Data Exchange (NFSDX) project First release of ORA Partners Portal (ORAPP) ORAPP enables capabilities, including: content management (news, documents, etc.), technical specifications, and application programming interfaces (APIs), Firm Search, Reports, and Account Management Early demo and access of ORAPP to elicit initial feedback Initiated discussions on Sample Analysis and Lab data exchange; Evaluated Data Elements for Sample Analysis ORAPP supports Produce Safety Firm Inventory capabilities (March 2019) NFSDX Non-Contracted Inspections (April 2019) Established PFP IT WG Developed Data Integration and Data Elements Harmonization Principles Reviewed Pennsylvania Department of Agriculture (PDA) Bovine Spongiform Encephalopathy (BSE) inspection results transfer project lessons learned Evaluated Data Elements to develop PFP Data Dictionary (Firm & Inspections data elements) Built Standardized Data Field Document Conducted environmental scan for industry Data Exchange standards Conducted survey with States to understand their data capture and information systems Laid foundation for a Data Exchange Established NFSDX Initial Operational Capability (IOC) Implemented iterative agile driven data exchange processes for the three scenarios Established and shared concept of operations and high-level architecture for NFSDX Established Agreements, State Onboarding Manuals, State 2016 Engagement Questionnaire, State Integration Guides, State Integration Plans, etc. Onboarded initial participating States for the three scenarios - FL, IL, IA, MN, PA, AR, and TX Released ORA information model and information exchange Schema 8.1 NFSDX Releases 1.0 and

18 DATA EXCHANGE LOOKING AHEAD 18

19 NFSDX DEMO - INSPECTION RESULTS SUBMISSION 19

20 * Estimated time frames SAMPLE ANALYSIS DATA EXCHANGE HIGH-LEVEL TIMELINE The initial implementation of automated Sample Analysis lays the foundation to future Samples/Lab scenarios such as, additional Analysis types, Work Package attachments, Analysis Assignments, Disposition, Surveillance, Compliance Outcomes, etc. Iterative Feedback Cycles and Updates to PFP IT and Lab WGs Initial Sample Analysis Release and Rollout (~1-2 months)* Release Sample Analysis integrated solution Support rollout and go-live activities Validation and Testing with regulatory partners (~3-6 months)* Conduct end-to-end testing with participating regulatory partners Iteratively enhance and address validation issues Implement Sample Analysis Data Exchange Use Case(s) (~3-6 months)* Modify NFSDX and elexnet in support of integrating regulatory partner systems to implement the initial Sample Analysis use case(s) Co-ordinate with participating regulatory partners to share design models (schema, services etc.) Iteratively build and validate design and components with participating regulatory partners via PFP IT WG Data Element Analysis and Validation (~2-3 months)* Collaborate jointly with PFP Lab and IT WGs to analyze Sample Analysis data elements to develop the structures required for initial data exchange requirements for Sample Analysis Scenario Definition and Scoping Initial scoping of Sample Analysis scenarios Develop high-level workflows and/or use case(s) Identify participating regulatory partners PFP IT AND LAB WG: SAMPLE ANALYSIS UPDATES 20