Module 3: Initial Response Actions Supported by the United States Food and Drug Administration Food Safety Modernization Act (FSMA) Capacity Development Grant

Key Learning Objectives Identify how the lead agency can change throughout the course of an investigation. Identify key differences between lead and supporting agencies. Identify and practice principles for an effective conference call.

Determining Lead / Coordinating Agency Legal authority Expertise Resources Responsibilities Development of investigation action plan Coordination of plan implementation Serves as point of contact about the investigation Adjusting the plan with partners as needed Writing the final report The coordinating office must have sufficient resources, expertise, and legal authority to collect, organize and disseminate data from the investigation.

Supporting Agencies Retain their authorities and responsibilities Complete commitments as agreed Timely notification of the lead agency when plans must be adjusted Complete case interviews for persons within their jurisdiction Take regulatory actions needed to control sources under their jurisdiction Are still the lead in their jurisdiction.

Designating Lead Agencies: Human Health Investigation The jurisdiction/county where the exposure occurred typically leads Alternative: if majority of the ill reside outside the county where exposure occurred, another county or MDCH may lead Multiple county exposure – MDCH will lead/coordinate LHD investigations The MJO Guidance document identifies some general rules of thumb for identifying who the lead agencies are – these are consensus principles for managing outbreaks – allowing agencies need the flexibility to determine what roles and responsibilities will work best for a specific situation. When the exposure is in one county and the majority of the ill reside in another county or are scattered around the state, the Environmental Health staff in the county of exposure is responsible for the facility/exposure location investigation. The county with the majority ill may lead the epi investigation or MDCH may lead (or coordinate) due to geographic scattering or assist in surge capacity. Examples of multiple county exposure - (e.g., commercially distributed food product or traveling tour bus) the MDCH typically will lead/coordinate the investigation between the LHDs.

Designating Lead Agencies: Food Supply Investigation Agency with jurisdiction over the source of exposure takes the lead Food service establishment – LHD Retail grocery, convenience store, food processor - MDARD Incidents involving retail / food service establishments establishments in multiple counties – MDARD Intrastate food distribution – MDARD Interstate food – FDA or USDA FSIS

Surge Capacity Options Keys to success Cross utilization of staff within the agency Sharing staff from other branches of government University students Volunteers (e.g., medical Reserve Corps) Keys to success Current contact lists and protocols for contacting Developing just-in-time training as appropriate Regardless of which agency are playing the lead and supporting roles, all agencies face the reality that they are attempting to do more and increasingly complex work often with fewer staff. Public health agencies emergency preparedness activities have focused on identifying practical options for tapping into surge capacity. Some common strategies: Cross training staff from various disciplines Sharing staff – example: MDCH Regional Epidemiologists, CDC EIS Officers University students (PHAST/UM)

Lead Agencies Often Change As Outbreak Investigations Progress Through Stages Incident Detection Incident Resolution Epidemiology / Communicable Disease Outbreak investigations progress through phases of activity, and leadership of the investigation should reflect the focus of the investigation at the time. Investigation lead agencies will typically host regularly scheduled meetings/conference calls for response partners to gather & share information and to develop investigations plans and priorities. Environmental Health / Food Regulatory Laboratory – Clinical and Food

Initial Informational Sharing Face-to-face meetings are recommended if response personnel do not have pre-existing working relationships. Conference calls are often used Early calls focus on surveillance and epidemiological information Later calls focus on food supply investigations of distribution systems and sources. Face-to-face meetings can be more effective initially because they allow time to ask questions, ready body language and, avoid some of the limitations of conference calls that we will be discussing shortly. Early response efforts focus upon the human illness (epidemiologic) investigation stage and typically led by public health communicable disease agencies. Ask participants if food regulatory agencies (local, state, federal, and tribal) should be included on the early calls/ meetings? Yes – so they can contribute to the investigation with insights on potential exposures and they will also have a better understanding of the investigation methods, findings and conclusions so the implicated product(s) can be removed from the market as rapidly as possible. Later response efforts focus on the food supply or environmental investigation – providing environmental/regulatory guidance and technical support as investigators seek to identify and control the sources of contamination. Communicable Disease control and epidemiology staff should be included in these conference calls to provide updates on the ongoing epidemiologic investigations (Example: is their ongoing exposure)?

Example Video A conference call in real life http://www.youtube.com/watch?v=DYu_bGbZiiQ

Conference Call Challenges Technology glitches Individual communication styles Tendency to multi-task during calls Unable to assess non-verbal communications Challenging to work on complex issues with groups having diverse perspectives Technology glitches include: dropped calls, poor phone reception, accessing call lines, incompatibility of systems (sharing graphics), … Differences in communications – aggressive individuals can dominate the conversations, and passive or quiet personality types may not actively contribute Non-verbal communications – tendency to multi-task during calls, easy to come unprepared to participate Complex issues – some tough issues are best worked out face-to-face so participants can focus their attention for a dedicated period of time.

Guidelines for Conference Call Etiquette Conference call host checklist Provide an agenda Maintain focus Summary Attendee etiquette Come prepared to participate Identify yourself Use MUTE, not HOLD MJO Appendix 5 contains guidelines that if used can increase the effectiveness of conference calls. A copy is included in your resource packet and we will be asking you to review them during your small group activity during this module. The host is responsible for providing the structure for an effective call. Agenda – topics and timeline. Start on time and end on time. Maintain focus – this can be challenging. Need to identify what topics will be discussed on the call vs. discussed / addressed “off line” Summarize what was discussed, and the action items coming from the call. Attendee etiquette – you will be reviewing these in detail during module 3’s group activity . Here are some key points to consider.

The Incident Command System’s (ICS) Planning P As an incident escalates in size and complexity, so does the need for a formalized planning cycle Document decisions made Clearly communicate current investigation objectives Plan for the next operational period Regularly scheduled conference calls often are the primary method used to coordinate multi-jurisdictional foodborne outbreak investigations. While outbreaks don’t require activation of ICS systems Incident Management Teams, ICS principles can be used effectively in a wide range of responses. For example, the ICS Planning P outlines a systematic and formalized process for developing and implementing response plans. This steps can be helpful to staff who are developing the response plan for the next “Operational Period” of any MJO.

Scenario & Table Discussion Small group discussion (30 minutes) Read the scenario update Use the “All Hazards Task List” to assess the situation and develop your table’s investigation plan. Prepare 2 minute situational briefing for the upcoming conference call Review “Guidelines for Conference Call Etiquette” & be prepared to actively participate Report out and large group discussion (30 minutes)