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RRT Manual

A Resource for Standard 5

Rapid Response Team Best Practices Manual - MFRPS Training – Kansas City 2012

Panel Discussion on RRT

Cooperative Agreement

Program States

Sample Timeline for Manufactured

Regulatory Program Standards

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

• Investigation reports and summaries

Appendix 5.1 – Self-Assessment Worksheet

Food-related Illness and Outbreak Response

PS #9 - Program Assessment

Section 9.3 - Program Elements

2007 MFRPS 2010 MFRPS

a. The State program conducts an initial self-

assessment of its conformity with each standard. A

subsequent self-assessment is conducted every 36

months or less after completion of the initial self-

assessment.

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

Program Assessment Validation Audit

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.

36-Month MFRPS Review Meeting

“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

Table of Contents

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 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

Tracebacks • Overview

– 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

34

Integration and Process

Development

Use of the “ Communications”

Chapter of the RRT Best

Practices Manual to develop

capacity in food/feed outbreak

response

Planning and Preparedness Chapter –

Communications Quick Review • Purpose

“…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

Program Elements If no, please explain why

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

the appropriate agencies?

Section II.2.3.12.4 & II.2.3.12.5

Is a coordinator designated to guide investigative efforts of all agencies

involved?

Section II.2.3.12.7.2.b

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?

II.2.3.12.7.2 & Working with

Other Agencies – II.1

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.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?

II.2.3.12.5.3

Has the State program identified a coordinator to lead investigations of

suspected or threatened intentional food contamination and terrorism?

II.2.3.12.7.2.b

Has the State program identified the appropriate agencies to be

contacted and the name and phone number of designated contact

persons in such agencies?

II.2.3.12.4 & 12.5

Does the State program collaborate as necessary with FDA and other

jurisdictions when conditions of increased threat of intentional

contamination occur?

II.2.3.12.7.2.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!