RRT Manual A Resource for Standard 5 Panel Discussion on RRT Cooperative Agreement Program States Rapid Response Team Best Practices Manual - MFRPS Training Kansas City 2012
Sample Timeline for Manufactured Regulatory Program Standards
Investigation reports and summaries PS #5 Food-related Illness and Outbreak Response Section 5.2 Requirement Summary Section 5.5 Documentation The State program establishes systems to: a. Use epidemiological information from local, State, or Federal agencies to detect incidents or outbreaks of foodborne illness or injury b. Investigate reports of illness, injury, and suspected outbreaks c. Correlate and analyze data d. Rapidly notify customers and consumers e. Share outbreak reports and surveillance summaries with other agencies f. Disseminate current guidance to industry on food defense g. Provide guidance for immediate notification of law enforcement agencies when intentional food contamination or terrorism is suspected or threatened h. Collaborate as necessary with FDA and other Federal authorities under conditions of increased threat of intentional contamination The program maintains the records listed here. Appendix 5.1 Self-assessment worksheet- Food-related Illness and Outbreak Response A written description of epidemiology support or an agreement that defines epidemiology support similar to appendix 5.2 A complaint log or database Up-to-date emergency contact list for all relevant jurisdictions Procedure and contact person for releasing information to the public Documented timeframes for responding to complaints The illness, injury, or outbreak response procedures and the data collection forms Policies and procedures for handling incidents and threats of deliberate contamination and for collaborations with FDA and other jurisdictions under conditions of increased threat or intentional contamination Written agreements that identify and describe sources of supplemental laboratory capacity and expertise including laboratory support to detect contaminants not normally found in food
Appendix 5.1 Self-Assessment Worksheet Food-related Illness and Outbreak Response
Sample Timeline for Manufactured Regulatory Program Standards
Sample Timeline for Manufactured Regulatory Program Standards
PS #9 - Program Assessment Section 9.3 - Program Elements 2007 MFRPS 2010 MFRPS a. The State program conducts an initial selfassessment of its conformity with each standard. A subsequent self-assessment is conducted every 36 months or less after completion of the initial selfassessment. b. When conducting a self-assessment, the State program uses worksheets comparable to those contained in the appendices of each standard. The State program uses the results of its self-assessments to complete the Self- Assessment and Improvement Plan Report (also known as Worksheet 9). The State program should update this worksheet each year.
Worksheet 9a Self Assessment and Improvement Plan Report PS #5 FPP identified the modifications which need to be made to the Massachusetts Virtual Epidemiologic Network (MAVEN) in order to: Measure and show improvement to foodborne illness/outbreak complaint and incident reporting improvement Demonstrate improved foodborne illness/outbreak complaint and incident data through the State food protection and epidemiology programs Provide report on integration of state, local and industry partners with respect to planning and response to foodborne illness events to FDA Assess information technology capacity for managing information essential to foodborne illness/contamination incident Carry out social marketing of BEH/FPP foodborne illness prevention activities with regional environmental and public health staff to train and promote foodborne illness reporting Promote regulatory and food safety highlights newsletter to increase foodborne illness reporting requirements and prevention strategies Increase reporting of foodborne illness/outbreak complaints Decrease foodborne illness rates based on state-produced products Submit contributing factors to CDC identified by epidemiology and food protection program representatives for all epidemiology and/or lab confirmed outbreaks
Sample Timeline for Manufactured Regulatory Program Standards
Sample Timeline for Manufactured Regulatory Program Standards
Program Assessment Validation Audit
Sample Timeline for Manufactured Regulatory Program Standards
Sample Timeline for Manufactured Regulatory Program Standards
36-Month MFRPS Review Meeting Standard 5 Food Related Illness Outbreaks/Food Defense The PAVA team concurred with FPP as having fully implemented Standard 5. FPP reported several RRT mobilizations working closely with FDA on exercises and outbreak investigations. A system to monitor on-going progress was established using four 2009 CIFOR performance indicators broken down to coordination, evaluation, communication and intervention. FPP has also begun to collect RRT response rates for retail and manufactured food emergency response investigations. FPP should consider other improvements related to food vulnerability assessments and food defense preparedness by reaching out to partners such as the Department of Agriculture, the MDPH Bureau of Emergency Preparedness, the MA State Emergency Operations Center and regional FEMA representatives to ensure that they are included in regional food emergency response exercises and protocols. FPP may want to investigate federal DHS funding for conducting food vulnerability assessments that other State Programs have obtained.
Sample Timeline for Manufactured Regulatory Program Standards
Sample Timeline for Manufactured Regulatory Program Standards
To Do List?
To Do List Sorted by Work Areas
To Do List Sorted by Program Standard
Integration and Process Development Use of the Working With Other Agencies and Traceback Chapters of the RRT Best Practices Manual to develop capacity in food/feed outbreak response
the RRT Best Practices Manual Key Components of Effective Rapid Response for Food/Feed Emergencies Developed by the 9 Pilot FDA Rapid Response Teams (RRTs) September, 2011
I. Introduction 1. Purpose of the RRT Best Practices Manual 2. Background 3. Audience of the RRT Manual 4. How to Use the RRT Manual 5. Future Plans for the RRT Manual II. RRT Best Practices Manual: Chapters Table of Contents 1. The First Chapter 1. Working with Other Agencies 2. Planning and Preparedness (Response-Wide Capabilities) 2. Food Emergency Response Plans (FERPs) 3. Communication Standard Operating Procedures (SOPs) 4. Incident Command System Best Practices 5. Rapid Response Team (RRT) Training 3. Surveillance and Detection 4. RRT Investigations 6. Tracebacks 7. Joint Inspections & Investigations 5. Mitigation and Control 6. Post-Response/Prevention
WWOA Process Description Standard practices how to get started Building relationships multiagency teams legal framework memorandum of understanding joint management teams regularly scheduled meetings joint trainings joint exercises task forces Defining roles and responsibilities in an investigation/response Communication and responsibilities of the three legs of the investigative stool Epidemiology Environmental Laboratory Maintaining relationships
WWOA - Achievement Levels 1. No formal written working with other agencies Standard Operating Procedure (SOP) 2. Formal written working with other agencies SOP which properly identifies all relevant partners 3. All parties included in the SOP know the procedure exists, know its location, and clearly understand their respective roles as they are explained in the plan 4. The SOP is utilized during incident response and/or planned exercises 5. The SOP includes a formal review and update process.
WWOA - Standard Practices Know the lead contact person and backups in all other agencies Understand roles and responsibilities of each agency Agency missions and standards of success differ Understand laws governing release of confidential information Know how to share information appropriately Develop confidentiality agreements (e.g. FDA Commissioning) Share updates prior to any meetings/conference calls Do not surprise partners with new information Ensure that all participants have the same information Keep feed issues and agency feed partners in mind
MFRPS Appendix 5.1 The State program uses epidemiological information from agencies at all government levels 1. Is the State program responsible for epidemiological investigations identified? If no, attach agreement with lead agency WWOA 12.2.3 Building Relationships MOUs 2. Is there a system to coordinate agreements between the food and epidemiology programs that clearly identifies the roles, duties and responsibilities of each program WWOA 12.2.3 Building Relationships MOUs WWOA 12.3 Defining Roles and Responsibilities in an Investigation Outbreak reports and surveillance summaries are distributed to the appropriate agencies 3. Are all investigations coordinated with the appropriate agencies WWOA 12.3 Defining Roles and Responsibilities in an Investigation
Working With Other Agencies 12.2.3 Provides a brief description of Memorandum of Understanding (MOU) and when the document should be used. Suggests an MOU be established between all agencies represented under the epidemiology, environmental, and laboratory components of the response system MOUs should capture the roles and responsibilities of the partnering organizations and how they work together in a coordinated response MOUs should describe the events that must occur for each agency to consider an incident successfully completed Attachments A & B, provided by the North Carolina RRT, show MOUs for epidemiology and laboratory partners.
Working With Other Agencies 12.3 Provides suggested roles and responsibilities that may be established during an incident Gives examples of the communications and information that should be shared among response partners Based on the three legs of the investigative stool (epidemiology, laboratory, environmental) Epidemiology to Laboratory Current investigation updates from local health departments or other agencies Information on incoming outbreak-associated samples Environmental to Epidemiology Significant inspectional findings Samples results (confidentiality agreements) Recall information including specific distribution Notable traceback progress
MFRPS Appendix 5.1 Outbreak reports and surveillance summaries are distributed to the appropriate agencies 4. Is a procedure in place to conduct tracebacks of food implicated in an illness, injury, or outbreak, including coordination with the appropriate agencies?
RRT Best Practices Manual Part 4: Rapid Response Team Investigations Chapter 6: Tracebacks Process Description Generic Traceback Process Flow Regulatory Traceback Investigation Investigational Tracebacks Typical Problems and Potential Solutions Factors to Consider When Determining the Most Appropriate Method(s) for Gathering Investigational Traceback Information
Tracebacks- Achievement Levels 1. The agency has written traceback procedures that were reviewed within the past 12 months 2. The agency has documented an assessment of their traceback procedure against a recognized national/multi-jurisdictional guidance document (e.g., RRT Traceback Guidance) to identify and prioritize future traceback capacity development efforts 3. The agency has implemented a traceback capacity development plan that is current and on track to develop and maintain either Level 4 or Level 5 capacities 4. The agency has documented the capacity, within the past 12 months, to conduct regulatory traceback investigations consistent with national guidance (i.e., completeness and timeliness standards) either in response to real world incidents or through exercises 5. The agency has documented the capacity, within the past 12 months, to conduct both regulatory and investigational traceback investigations consistent with national guidance
Overview Tracebacks Provides a step by step guide to conducting a traceback investigation Provides a blueprint for states to develop traceback SOPs Describes both investigational and regulatory tracebacks Gives helpful hints and reminders about these types of investigations Set deadlines for firms to provide documentation Verify the meaning of any handwritten comments or additions to collected forms Ensure that all copies, faxes, and photographs collected are clear and legible
Integration and Process Development Use of the Communications Chapter of the RRT Best Practices Manual to develop capacity in food/feed outbreak response 34
Planning and Preparedness Chapter Purpose Communications Quick Review describes key elements for Rapid Response Team (RRT) communications during food/feed incident guide the development of specific SOPs (to address each key component) that state and federal partners would develop jointly to improve their communication during emergencies. See also Working with Other Agencies (II.1)
Desired Outcomes Communication Achievement Levels Level Description 1 No formal written communication SOP 2 Formal written communication SOP 3 Relevant players trained on the communication SOP 4 Communication SOP is used in incidents and/or exercised 5 Has regular review process that includes AARs and is on a review schedule
Planning and Preparedness Chapter Process for Program Specific Documents Establish a workgroup Review and discuss topics Perform a gaps analysis Determine program responses Begin amending or creating SOPs See Food Emergency Response Plans II.2.2
How does this Help with Standard 5 If no, please explain why Program Elements element is not met Outbreak reports and surveillance summaries are distributed to the appropriate agencies. Does the State program maintain a current list of communication links with Section II.2.3.12.4 & II.2.3.12.5 the appropriate agencies? Is a coordinator designated to guide investigative efforts of all agencies Section II.2.3.12.7.2.b involved? Are investigations coordinated with the appropriate agencies? Section II.2.3.12.5.2 Is a procedure in place to conduct tracebacks of food implicated in an illness, injury, or outbreak, including coordination with the appropriate agencies? Are final reports of the State program s findings of foodborne illness and injury investigations maintained and shared with the appropriate agencies? II.2.3.12.7.2 & Working with Other Agencies II.1 II.2.3.12.7.2.c
How does this Help with Standard 5 Program Elements If no, please explain why element is not met The State program provides guidance for immediate notification of appropriate law enforcement agencies when intentional food contamination or terrorism is suspected or threatened. Does the State program have written procedures for reporting threats of intentional food contamination or terrorism? Has the State program identified a coordinator to lead investigations of suspected or threatened intentional food contamination and terrorism? Has the State program identified the appropriate agencies to be contacted and the name and phone number of designated contact persons in such agencies? Does the State program collaborate as necessary with FDA and other jurisdictions when conditions of increased threat of intentional contamination occur? II.2.3.12.5.3 II.2.3.12.7.2.b II.2.3.12.4 & 12.5 II.2.3.12.7.2.b.ii & Working W/Other Agencies II.1
Texas RRT Response Operating Guide Table of Contents I. Authority II. Purpose & Scope III. Acronyms and Definitions IV. Situations and Assumptions V. Concept of Operations A. Operations B. Communications C. Working with Other Agencies VI. Document Control VII. Appendices A. TRRT Distribution Lists B. Activation and Deactivation Standard Operating Procedure C. Communication Standard Operating Procedure
Texas Rapid Response Team (TRRT) Response Operating Guide PURPOSE The purpose of the TRRT Response Operating Guidelines is to outline policies for TRRT preparedness, activation, operation, and deactivation. The manual delineates policies and responsibilities, as well as identifies standard operating procedures (SOPs) for all members of the TRRT
Appendix A TRRT Distribution Lists
TRRT APPENDIX B Activation/Deactivation SOP Purpose The purpose of this document is to describe the process for activation and deactivation of the TRRT. Figure B-1 depicts the TRRT activation process.
TRRT Activation/Deactivation SOP A Box Checked
TRRT Appendix C Communications SOP Purpose The purpose of this document is to describe the different types and methods of communication utilized during an incident. This procedure is not applicable to routine communications relating to the missions of the participating Agencies. Communication is critical throughout all phases of the a food/feed incident, including communication: 1) within the TRRT structure; 2) within the respective agencies; 3) between agencies outside of the TRRT; 4) with industry; and 5) with the public (media and consumers).
TRRT Communication SOP A Box Checked
Coming Attractions
RRT Manual What s Next Volume 2 - Expected in 2012 New Elements Metrics Cooperative Programs New Chapters After Action Reviews/Reports Environmental Assessments Industry Relations Recalls Tools Other (e.g., CIFOR Crosswalk)
RRT Manual What s Next RRT Manual Making it Useful Presentations: Summaries, examples Training Tool for other Initiatives Tool for other states/localities To coordinate with others (e.g., SOPs, so others know what RRTs do) Resource for relevant initiatives (e.g., National Standards)
Conclusion The RRT Manual can help with implementation of the MFRPS, such as Standard #5. The Manual may also help other Standards: Standard 2 & Training Chapter Standard 3 & Recalls Standard 7 & Industry Relations Future directions, collaborations, etc. to come! Thank You!