district and state recall cooperative plan
DESCRIPTION
District and State Recall Cooperative Plan. Chairs: Brad Honold, MDA Innovation Grants Project Manager Wanda Lenger, FDA ORA/OEIO/DE Recalls. March 12 th , 2014 2:45-3:15 p.m. Sponsorship/Partnership. Partnership for Food Protection (PFP) Response and Recall Workgroup - PowerPoint PPT PresentationTRANSCRIPT
District and State Recall Cooperative Plan
Chairs:Brad Honold, MDA
Innovation Grants Project ManagerWanda Lenger, FDA
ORA/OEIO/DE Recalls
March 12th, 20142:45-3:15 p.m.
Sponsorship/Partnership
• Partnership for Food Protection (PFP) Response and Recall Workgroup
• PFP Work Groups develop projects to advance the implementation of an Integrated Food Safety System (IFSS) - This is an FDA FSMA mandate to create an IFSS.
• Project approved by the PFP Governing Council
District and State Recall Cooperative Plan
Objective:Establish a “Best Practices” document(s) for outbreaks and class 1 recall situations for use by FDA and State Counterparts that will enhance reciprocal communication and sharing of recall information with the intention of reducing the burden on recall staff.
State/FDA Recall Survey 2013
Goals:• Identify Recall Contacts• Identify Barriers to Communications• Identify What Currently Works
Summary of Survey Results59 Respondents w/70 Comments:
• Sharing and Timeliness - 26• Format of Information - 10• IT Recommendations - 10• Audits / Effectiveness Checks - 9• Federal Regulations - 7• Contacts and Methods - 6• RFR Comments - 2
Our Project Team – 53 Members*!
• PFP Workgroup members• FDA Subject Matter Experts• State Public Health Officials
*These are individuals who expressed an interest in enhancing recall effectiveness, implementing an integrated food safety system, and assisting in improving transparency of communication during recalls. The team will be listed in the Best Practices document upon completion.
Creating Our Best Practices Document:
• Examine the current recall process for improvements
• Examine the RFR report distribution process• Examine regulatory restrictions that slow the
sharing process• Define common terms, and acronyms
Creating Our Best Practices Document cont.
• Establish and post a directory of recall contacts• Review IT systems for avenues to enhance
automatic notifications• Examine, identify, and recommend parameters for
information sharing (Commissioning/20.88 agreements)
Areas/Ideas Being Explored
• Contact List for Recall personnel– Identify contacts– Create and maintain contact lists – Posting of contact list
Areas/Ideas Being Explored cont.
• Barriers in Sharing – Identify Regulations – Define/Explain the Regulatory Barriers– Enhance Sharing Process
Identify Potential Mechanisms for Sharing
• Reportable Food Registry (RFR)• Food Track• Social Media• RSS Feeds for Press Releases• FoodSHIELD• Explore availability of automatic notifications
Identify Potential Mechanisms for Sharing cont.
• Initial Notifications • Minimum information• Format • Identify Staff Contacts
• Periodic Meetings
Recall Effectiveness Checks
• Assignment, Tracking, and Monitoring of Effectiveness Checks• Recall Audit Check (RAC) – electronic assignments
through eSAF (electronic State Access to FACTS)• Training • Minimize overlap of investigations by FDA and State
Notifications during dual jurisdiction recall events
• Who to contact• When to contact• How to contact• Methods to minimize duplication of efforts
Outstanding Project Needs
• We could particularly use some higher level individuals with state recall expertise (non-working member – more advisory role)
• We do have some gaps in state representation, with a particular gap in our sub-workgroup assigned with the Best Practices document assembly.
If anyone is interested, please contact Brad or Wanda
Next Steps
• Continue collaborative meetings with committees
• Plan, Prepare, and execute PFP Face-to-Face meeting late April 2014
• Present Final Draft document at 50-State meeting in August 2014
Summary
In order to enhance our joint mission to protect public health, we are exploring methods to establish a uniform “Best Practices” document to enhance reciprocal communication and sharing of recall information during outbreaks and class I recalls with the intention of reducing the burden on recall staff.
Thanks for letting us present a project update!
Contact Information
Brad Honold
Innovation Grants Project Manager
Minnesota Department of Agriculture
Data Sharing Best Practices Work Group – Time permitting…
• Created out of a vision shared between MDA and GDA• Meeting since July 2013• Collaborative FDA and State endeavor• Discuss and demo process and systems development
efforts ultimately with the goal of improved Recall and Traceback investigative efforts
• Liaising with the PFP IT Workgroup (Two members are on this WG – Don Jaccard & Daniel Pennell)
Data Sharing Best Practices Work Group – Desired Outputs
• Agreement and understanding on Key Data Elements (KDEs) to share despite different IT systems
• Develop Best Practices to support IFSS• Better data sharing between regulatory entities• Improved reporting to FDA during/after investigations
Data Sharing Best Practices Work Group – State Partners/Systems• Pennsylvania (USA FoodSAFETY)• Iowa (USA FoodSAFETY - CAI)• North Carolina (In-house developed system)• Georgia (DHD – Garrison Enterprises)• Minnesota (Sharepoint to USA FoodSAFETY)• Michigan (MI-Inspector to an Accela platform)• Kansas (WinWam and a number of other systems)• New York (In-house Access database as a LIMS)
Data Sharing Best Practices Work Group – FDA Partners/Acronym Quiz!• OP• OIM• Audits• ORA/OO/IO• PFP IT Workgroup* (See last slide for recently approved
Information Technology Data Principles - with a link)• Demos or presentations included: eSAF RAC, Palantir
(CDC), new 3177 Form (keeping these fields in mind during KDE discussions)
Further Data Element Analysis Being Pursued for Critical Tracking Events• Common Field Names• Palantir Data• Distribution Data• Key Data Elements – GS1• FDA’s Form 3177• MN Investigation Event• MI/CORE Traceback Questions• Definitions
*PFP IT Workgroup
• Information Technology Data Principles (Summer 2013) – Approved by Governing Council December 2013
• Link to the document: http://www.fda.gov/ForFederalStateandLocalOfficials/FoodSafetySystem/ucm357502.htm
• If there are any questions regarding this document, please contact Don Jaccard, FDA: [email protected]