DRAFT EPS CONOPs Workshop v3iiad.tamu.edu/wp-content/uploads/2015/08/Appendix... · Summary Conclusions and Recommendations In!pursuitof!the!workshop!objectives!and!in!supportof!the!strategic!goals!and!policy!needs!

Enhanced Passive Surveillance Concepts of Operations Report from a Workshop held as part of the Towards Large-‐Scale Enhanced Passive Surveillance Project August 12-‐13, 2014 Arlington, VA

Published by the Institute for Infectious Animal Diseases, Texas A&M University, College Station, Texas 77845-‐2129, 979.845.2855, iiad.tamu.edu

2 DRAFT—NOT FOR DISTRIBUTION—DRAFT

Table of Contents Executive Summary ................................................................................................................ 3

Objectives .............................................................................................................................. 3

Summary Conclusions and Recommendations ........................................................................ 3

Highlights of the EPS CONOPs Workshop ................................................................................ 5 Day 1: August 12, 2014 ..................................................................................................................... 5 Welcome, Objectives and Overview of the Workshop ....................................................................... 5 Updates on the EPS Phase II Project and Strategies for Emerging Diseases ...................................... 6 Responding to Animal Health Anomalies Detected by the EPS System ............................................. 9

Day 2: August 13, 2014 ................................................................................................................... 16 Group Discussion: Recommendations and Guidance for the EPS Pilot Phase and System Implementation ................................................................................................................................. 16 EPS Phase II Detection Window Exercise .......................................................................................... 18

Draft framework of the CONOPs for responding to animal health anomalies detected in the EPS Phase II pilot and full scale implementation ................................................................... 19

Closing Comments ................................................................................................................ 24

Acronyms ............................................................................................................................. 25

Appendix A: Workshop Participants ...................................................................................... 27

Appendix B: Agenda ............................................................................................................. 29

Appendix C: Breakout Session Handouts ............................................................................... 31


Executive Summary The Enhanced Passive Surveillance (EPS) project uses an information technology system to integrate and analyze syndromic animal health surveillance data in real-‐time from multiple data streams, including data collected in the field from practicing veterinarians through a Biosurveillance Field Entry System (BFES) mobile application, to support State and USDA disease surveillance efforts. As the project moves into Phase II, the initial Department of Homeland Security (DHS) and US Department of Agriculture (USDA) pilot projects will be expanded to all major animal industries (including beef cattle, dairy cattle, equine, goats, poultry, sheep, and swine) and wildlife. A critical need is to define concepts of operations (CONOPs) for investigating and responding to animal health anomalies detected by the EPS system. This report describes the key findings, discussion points, and outcomes that arose during the EPS CONOPs workshop hosted by the Institute for Infectious Animal Diseases (IIAD) in August 2014. Participants included 51 personnel representing the Department of Homeland Security (DHS), US Department of Agriculture-‐Animal and Plant Health Inspection Service (USDA APHIS), State Animal Health Officials (SAHOs), veterinary diagnostic laboratories, the agricultural industries, veterinary practitioners, and IIAD (full list in Appendix A).

Objectives The main objectives of this workshop were to:

• Define the CONOPs for investigating and responding to animal health anomalies detected by the EPS system during the pilot phase

• Provide recommendations to USDA for developing the CONOPs for when the EPS system is fully implemented at a national scale

• Determine specific scenarios of interest to perform a future functional exercise to test the EPS system’s disease detection and response capabilities

The objectives were addressed through a series of presentations, breakout group discussions, and large group discussions during the 1.5-‐day meeting.

Summary Conclusions and Recommendations In pursuit of the workshop objectives and in support of the strategic goals and policy needs defined by stakeholders for the EPS Phase II pilot project, workshop participants held robust discussions and identified a number of recommendations to address for the concepts of operation for animal health anomalies detected by the EPS system. As provided in detail throughout the report, the recommendations included:


o Forming stakeholder groups, or use communication networks that already exist in states, to determine actions (or no action) resulting from animal health anomalies detected by the EPS system. These communication networks should be utilized regardless of the scenario that could occur given an anomaly is detected. Regular and consistent communication with the stakeholder group on EPS activities would ensure transparency and create expectations and normalcy for how the EPS system works and protocols for EPS detection events.

o Identifying or forming these stakeholder groups during the EPS Phase II pilot to begin exercising the recommended communication and CONOPs protocols discussed during the workshop. This would help provide further feedback and recommendations on operations for when the EPS system is fully implemented.

o Enhancing the EPS system to incorporate the additional tools, features, and incentives identified by workshop participants to ensure the system can meet the requirements of the EPS CONOPs activities as well as improve long term sustainability.


Highlights of the EPS CONOPs Workshop Day 1: August 12, 2014

Welcome, Objectives and Overview of the Workshop The workshop began with Dr. Tammy Beckham, Director of IIAD, welcoming the participants and providing an overview of the purpose, objectives, and desired outcomes of the workshop. An information technology tool called AgConnect is being developed at IIAD that allows data from multiple sources to be integrated, visualized, and analyzed in real-‐time. Dr. Beckham described how initial proof-‐of-‐concept EPS pilot projects in Colorado, New Mexico, and Texas funded by DHS Science and Technology Directorate (DHS S&T) Homeland Security Advanced Research Products Agency (HSARPA) and the USDA APHIS demonstrated the use of the AgConnect technology to support industry and state/federal government surveillance purposes, with the technology having the capability to 1) collect and analyze field and diagnostic laboratory animal health data; 2) safeguard these data through user-‐permissioned access; 3) incorporate incentives and enhancements to support daily herd health management; and 4) provide useful animal health information back to end-‐users. Dr. Beckham highlighted the significant partnership effort between industry partners, veterinarians, veterinary diagnostic laboratories, and state and federal animal health officials in developing the EPS system, which has made this sophisticated tool successful. Over the next three years, the EPS system will be piloted in all the major livestock/poultry industries and wildlife in a large-‐scale effort funded by DHS S&T HSARPA. Dr. Beckham discussed how all end-‐users’ needs need to be understood in order to know how this system can be used to advance animal health in the United States. Since animal health anomalies will be identified by the system, this workshop was organized to define the concepts of operations for responding to detection events and the roles and communication between state/federal government, veterinary diagnostic laboratories, industry, veterinary practitioners, and other stakeholders. The workshop will also help determine scenarios of interest that can be used to perform a functional exercise and evaluation of the EPS system. The outcomes of the workshop will provide guidance for operations during the EPS Phase II pilot, which will enhance industry participation by providing them with a transparent response plan for handling detection events that occur as part of the pilot. In addition, the workshop will provide recommendations to USDA for development of CONOPs for when the EPS system is fully implemented. Other intended outcomes of the workshop include gathering suggestions and input for EPS system enhancements based on EPS CONOPs discussions to ensure the system can support these activities, and creating further trust and understanding of the overall EPS system and the potential response plans that accompany animal health anomalies associated with this type of reporting.


Updates on the EPS Phase II Project and Strategies for Emerging Diseases Prior to the breakout group discussions and to help frame the workshop, an overview of the EPS Phase II project was presented followed by informational presentations. In order for the participants to become familiar with the current state of stakeholder strategies for emerging diseases, representatives from USDA APHIS and the National Pork Board (NPB) were asked to present their programs, including updates on current activities relevant to the workshop topic. • Dr. Lindsey Holmstrom, Research Scientist, IIAD and Dr. Keith Biggers, Director, Computing

and Information Technology, Texas Center for Applied Technology (TCAT) and Information Analysis Systems Theme Leader, IIAD presented an overview of the EPS Phase II project and the AgConnect technology. The EPS system is designed to protect US livestock and poultry industries by providing early detection of potential disease outbreaks or changes in animal health status from endemic diseases. Dr. Holmstrom described how the system captures animal health information on both healthy and sick animals from veterinarian practitioners in real-‐time through the use of mobile technologies. The information is then organized into an easy-‐to-‐use computer display for monitoring and analysis, where it is integrated with data from veterinary diagnostic laboratories, wildlife testing, livestock markets, and environmental data sources. By integrating and aggregating the data, decision-‐makers, veterinarians, and producers can more easily access and visualize animal health data from multiple sources within a common integrated picture. During a disease outbreak, the system could provide timely surveillance information to industry, veterinarians, and state/federal animal health officials, allowing them to respond to situations as they develop. In addition, documenting the number of animals observed or examined by veterinarians for clinical signs compatible with certain endemic and high consequence animal diseases, and documenting healthy animals, can assist in identifying geographic areas that are absent of a disease event during an outbreak. Dr. Biggers provided an overview of the AgConnect technology, which the EPS system is based upon. AgConnect is IIAD’s suite of customizable data integration and analysis products designed to enhance real-‐time animal health awareness, enable permissioned data sharing, and support decision-‐making in the event of emerging, zoonotic and/or high consequence diseases. The applications in the AgConnect suite of tools support biosurveillance, business continuity, and emergency response for the agricultural sector. Development of the AgConnect technology is a collaboration between IIAD, USDA APHIS, DHS, industry and state animal health partners, and veterinarians. A suite of mobile applications are being developed for biosurveillance that are customized to serve specific industries and incorporate tools to support and enhance industry production practices. The mobile applications allow veterinarians in the field to capture vital health information about the animals under their care. The app then transmits the information to a common operating picture, called the EPS analyst workstation, where AgConnect technology integrates and aggregates the data into a real-‐time, interactive, highly visual display. Once anonymized, data may be shared among veterinarians, industry personnel, and analysts at multiple locations based on established data sharing protocols. Data are analyzed using


automated visual, geospatial, and temporal analysis tools within the workstation that aid in early disease detection or changes in animal health status. Dr. Holmstrom then presented a vision of how the EPS system can be used by all end-‐users to support their needs and requirements. She also explained the objectives and intended results of the EPS Phase II project. Through the EPS technology and working closely with industry partners, veterinary practitioners, veterinary diagnostic laboratories, and state and federal animal health officials, the US will have a sophisticated tool that will allow for real-‐time situational awareness and ultimately defend the US food supply from disease outbreaks.

• Mr. Austin Riddle, Senior Software Engineer, Computing and Information Technology, TCAT provided a demonstration of the EPS system to participants during a working lunch.

• Dr. Elizabeth Lautner, Associate Deputy Administrator of the Science, Technology, and Analysis Services (STAS) for USDA-‐APHIS Veterinary Services (VS), presented an overview of the new USDA Veterinary Services framework for responding to emerging animal diseases in the United States. To emphasize the need for such a framework, she first provided statistics on the global distribution of emerging infectious disease events and highlighted the many connections between human, domestic animal, and wildlife populations that enable infectious diseases to spread rapidly worldwide. Dr. Lautner then reviewed Veterinary Services’ role in safeguarding animal health by optimizing surveillance competencies, facilitating the development of diagnostic / biological tools, and enhancing the USDA’s ability to identify, evaluate, and respond to animal health issues. The remainder of the presentation focused on the four main goals of the Veterinary Services framework for addressing emerging disease threats, which was developed by the Executive Team led by Dr. TJ Myers and assisted by Dr. Brian McCluskey. The four main goals are to:

1. Undertake global awareness, assessment and preparedness for animal diseases or

pathogens not currently in the United States that may be of animal or public health concern or have trade implications.

1. The USDA Center for Epidemiology and Animal Health’s (CEAH) Risk Identification Unit (RIU) will be tasked with monitoring global emerging disease threats, recommending a priority status for each disease threat, and developing innovative science-‐based options for response. This work will be done in close collaboration with many domestic and international partners to ensure that stakeholders have the relevant information needed to make educated decisions.

2. Detect, identify and characterize disease events. 1. Veterinary Services will utilize a wide range of passive and active surveillance

systems to detect emerging diseases, including data streams collected through the EPS project. A major achievement has been the development of a National List of Reportable Animal Diseases (NLRAD), which includes known notifiable diseases (diseases with high priority or severe implications), monitored diseases


(disease that are routinely tracked), and signs of an emerging disease threat (unexplained or unexpected increase in disease frequency, change in the epidemiology of a known animal disease, and the presence of exotic vectors). The NLRAD will be published as a concept paper in the Federal Register for comments. Veterinary Services will also collaborate with key stakeholders to rapidly investigate and assess the impact of emerging disease threats.

3. Communicate findings and inform stakeholders. • Veterinary Services will serve as a national repository for shared information on

emerging disease threats to ensure consistent communication with stakeholders while maintaining appropriate data security.

4. Respond quickly to minimize the impact of disease events.

• Recognizing the unique nature of emerging disease threats, Veterinary Services will use an adaptive approach to response rather than predetermined actions. Such response measures may include diagnostic and vaccine development, education, implementation of certification programs, control measures, and identification of research priorities. Response actions will always done in collaboration with affected stakeholders and Veterinary Services will work with industry to identify appropriate compensation mechanisms.

Dr. Lautner concluded the presentation by emphasizing the importance of communicating and collaborating ahead of disease outbreaks to improve the speed and effectiveness of response measures.

• Dr. Lisa Becton, Director of Swine Health Information and Research for the NPB, then provided an overview of the Swine Emerging Disease Plan, which was developed by the swine industry in response to the recent outbreak of porcine epidemic diarrhea virus (PEDV) in the United States. This outbreak highlighted the need to develop a national response plan for common production diseases as well as emerging disease threats. She used the examples of Porcine Circovirus Type 2b in China and Porcine kubovirus in the United States, which were first brought to the attention of NPB through scientific publications, to illustrate deficiencies in the current systems for sharing important animal health information amongst key industry stakeholders. Dr. Becton then reviewed the Swine Futures Project, which was developed in 1998 to strengthen the partnerships between government and industry to protect the national swine herd. Although the project recommended establishing a system for rapidly detecting and appropriately responding to emerging animal health issues, there was no strong driver to draft a formal plan until the PEDV outbreak. It was determined that such a plan requires a decision-‐making body to make key decisions, a process for identifying diseases of interests, and an independent review team to oversee the entire response process. These concerns were addressed by the National Pork Producers Council (NPPC) Forum Resolution 2014, which specifically called for:


• A prioritized list of economically significant non-‐reportable diseases in the United States

• The development of a disease response plan outlining responsibilities for industry, government, and stakeholders

• Strategies to promote efficient data sharing and management • Strategies to minimize the risk of disease introductions into the Unites States

The American Association of Swine Veterinarians (AASV) is leading efforts to identify diseases of concern, evaluate the impact of diseases using a standardized matrix, and make recommendations to stakeholders. The working group met in August 2014 and is intended to meet annually to continually review concerns. The NPB is leading the efforts to address data management needs and to establish a working group that identifies strategies to prioritize disease control efforts. The NPPC is responsible for drafting the final plan and communicating findings back to key government and industry stakeholders. The plan will draw from existing foreign animal disease response protocols, however, Dr. Becton emphasized that the response can include broad measures such as no action, education, research, field investigations, certification programs, and other disease control measures within the United States and broad measures such as disease surveillance and import policies outside the United States.

Dr. Becton concluded her presentation by emphasizing the need to:

• Encourage producers to register for a national Premise Identification Number (PIN) to facilitate data sharing and aggregation

• Define the roles of government and industry in responding to emerging infectious disease threats

• Establish a protected, centralized database of animal health information that can be analyzed and shared with stakeholders to aid in decision making

Responding to Animal Health Anomalies Detected by the EPS System To help guide discussions in the breakout sessions, veterinary epidemiologists from IIAD and USDA next reviewed how data collected through the EPS system will be analyzed to detect animal health anomalies and outlined different scenarios for what animal health anomalies might represent. The objectives were to familiarize participants with the strengths and limitations of the EPS system and to highlight important considerations for determining the level of response to different types of anomaly signals.

• Dr. Carolyn Gates, Research Scientist at IIAD, first discussed the process for detecting emerging disease threats through enhanced passive surveillance data. She used the example of the rapid spread of PEDV across the United States to illustrate the importance of developing innovative surveillance systems that can detect outbreaks sooner than traditional methods based on laboratory confirmation of specific disease agents. Poor communication between veterinarians, incomplete clinical history information on


laboratory submission forms, and poor communication within and between veterinary diagnostic laboratories were highlighted as major barriers to early disease detection. It was noted that EPS system addresses these issues by providing the Biosurveillance Field Entry System (BFES) mobile application to collect data from veterinary practitioners and by developing HL7 messaging frameworks to integrate diagnostic testing results with epidemiological data from surveillance reports.

Dr. Gates then reviewed how the data collected through the BFES mobile application (report date, report location, date of onset, animal history, clinical signs, morbidity, mortality, differential diagnoses, diagnostic testing, and treatments) could be analyzed using automated spatial and temporal algorithms to detect unusual patterns in animal health reporting that may signal an emerging disease threat. Examples of the types of anomalies included:

• Reports with rare or severe clinical signs • A sharp increase in the number of reports or the number of reports continues to rise

over time • Reports that are clustered in a limited geographic region • Reports that occur at an unusual time or in an unusual place • Reports that are confined to a particular production group of animals

She emphasized that because this is syndromic surveillance data, the anomalies could represent false positive signals due to random statistical chance, true positive signals due to non-‐infectious causes, and true positive signals due to endemic and emerging disease causes. Some of the challenges in determining the cause for anomalies included the superimposition of outbreak signals over baseline syndromic reports, the lack of clear spatial and temporal signals due to the complex transmission pathways in livestock production systems, and the lack of specific information on the disease diagnosis in cases where clinical signs were ambiguous and no laboratory diagnostic testing was performed. Dr. Gates concluded the presentation by discussing ongoing plans to develop more sophisticated machine learning algorithms to leverage the expanded clinical data that will be collected in the Phase II pilots and to develop better informal communication networks between veterinarians to enhance situational awareness.

• Dr. Aida Boghossian, Liaison Officer at the National Center for Medical Intelligence in the USDA-‐APHIS-‐VS STAS then reviewed the different types of animal health anomalies that the EPS system may detect. These were broadly classified according to the nature of the disease agent (unknown causative agent awaiting laboratory confirmation, unable to determine the causative agent following diagnostic investigation, endemic disease with expected clinical signs, and endemic disease with unexpected clinical signs) and the geographic distribution of the anomaly signal (locally isolated, contiguous states related by industry operations, non-‐contiguous states related by industry operations, and national multistate outbreaks). High consequence foreign animal diseases were not considered as there are already detailed national response plans in place.


Dr. Boghossian then asked participants to consider existing communication channels between key stakeholder groups, in particular, noting who currently informs them of emerging animal health issues, who they inform when there is a suspected emerging animal health issue, and what criteria they use in determining when and how to share information. She also asked participants to consider how the communications process may change as the anomaly scales up from local and regional response to national response. Participants were also reminded to think about suggestions for additional data fields and analytical tools that could be incorporated into the EPS system to better facilitate anomaly detection and response.

Breakout Session Objectives:

The main objectives of the breakout sessions were to: • Define general scenarios that could occur given an anomaly is detected within the EPS

System • Define CONOPs for response to each type of general scenario given an anomaly has

been identified • Defining roles of, and communication between Federal and State government, industry,

diagnostic laboratories, veterinary practitioners, and other stakeholders for each type of general scenario given an anomaly has been identified

Participants were divided into two groups based on industry: 1) beef/dairy cattle, small ruminants, and equine industries and wildlife, and 2) poultry and swine industries and wildlife. They were provided with a notional scenario tree and a list of structured questions to facilitate discussions about responding to anomalies detected in the EPS pilot (see Appendix C). These included:

• When do you involve stakeholder groups? o What level of severity or impact would trigger notification? o Should stakeholders be notified before the cause of the anomaly is

confirmed? • How should stakeholder groups be involved?

o Who should be contacted to request additional information? o Who should be notified of an anomaly? o What communications protocols are already in place?

• What level and granularity of information should be shared? o Who needs to view the data? o What other data would be useful for decision-‐making? o Should the information be shared at the county, state, regional, or national

level?

(i) Beef/Dairy Cattle, Small Ruminants, Equine Industries and Wildlife, with Federal/State Government and Diagnostic Laboratory Partners


• When do you involve stakeholder groups? The participants generally felt that the decision of when to involve stakeholder groups should first depend on who identified the anomaly and whether the cause of the anomaly was already known. The first step in any response plan should be validating the data that caused the signal and then notifying relevant stakeholders before proceeding with further investigation.

o If USDA identifies an anomaly at the national level, they should first contact state animal health officials (SAHOs) in the affected state(s). The SAHOs are then responsible for contacting veterinarians who submitted reports to verify details and request additional information.

o If a SAHO identifies an anomaly at the state level, they should first contact veterinarians who submitted reports to verify details and request additional information. If there is reason to suspect an outbreak, they should notify USDA so they can monitor to see if disease is crossing state lines.

o If diagnostic laboratory identifies an anomaly in their data stream, they should first contact the SAHO(s).

Participants felt that it would be valuable to have secure communication channels that analysts could use to informally discuss anomalies without concern of triggering a response to a false positive or non-‐infectious cause. When a disease crosses state lines, participants felt that decision-‐making roles should shift to the federal level to ensure coordinated action. Once the anomaly has been classified (unknown disease agent, endemic disease with expected clinical signs, endemic disease with unexpected clinical signs), participants felt that it was import to notify stakeholders when it would lead to a change in disease prevention, diagnosis, or treatment and when it would help to increase confidence that the EPS system was achieving its objectives of using the surveillance data to identify and respond to animal health concerns. Dr. John Wenzel, an extension veterinarian in New Mexico, highlighted the success of syndromic surveillance in detecting an abortion outbreak amongst cattle herds in New Mexico and in coordinating with USDA to obtain funding for diagnostic testing to determine the cause.

• How should stakeholder groups be involved? Participants expressed some general concerns about the process of “who contacts who” after an anomaly has been detected by the system.

o In general, it was felt that the EPS system should utilize the information source that is most trusted by the target stakeholder group. For example, extension veterinarians are a widely used information resource for small-‐scale and backyard producers. Many stakeholder groups also have listservs or social media groups that can be used to disseminate accurate information.


o Participants also emphasized the need to avoid a “top heavy” approach to communication because of negative perceptions about the response measures that may be implemented by USDA or state animal health officials. It was suggested that any communication with producers for follow-‐up information or diagnostic testing to investigate the cause of anomalies should always be conducted through the veterinarian who submitted the report, unless there were specific emergency concerns.

o Participants felt that diseases with zoonotic potential or other public health concerns would most likely be diagnosed by veterinary diagnostic laboratories, which already have protocols in place for coordinating a joint response.

Participants felt that it was important to make sure that at least one person or organization maintains a “big picture” view of what stakeholders are involved, what information is being disseminated, and what response measures are being taken. This will ensure that a consistent message is being delivered at all levels of the communication chain and that questions from non-‐participating veterinarians and the general public can be directed towards a designated point of contact within each stakeholder group. Coordinating the time of information release was also seen as important so that, for example, veterinarians find about changes in disease trends before their producers and can then serve as an authoritative information resource.

• What level and granularity of information should be shared?

In general, participants felt that it was better to be proactive in getting information out to the public since misinformation can spread very quickly through social media channels. Swine influenza was highlighted as an example of a disease outbreak that was used by animal rights activists to generate negative public perception about livestock production systems by spreading misinformation about the human health risks. It was felt that having coordinated factual messaging, bulletins, and press releases could help to diffuse panic in emerging disease situations.

Participants felt that information should be shared at sufficient granularity so that it can lead to desired changes in disease diagnosis, prevention, and treatment while still protecting the business and trade interest of participating farms. Some participants had concerns about sharing data across state lines in case it negatively affected trade within their state. At a bare minimum, the EPS system should notify all practitioners who submitted reports that were identified as being part of the anomaly and other participating practitioners in the region affected by the anomaly. One suggestion to protect confidentiality was to use advice-‐based notifications rather than sharing specific data. For example, a message could be sent to practitioners advising them to use specific vaccinations or diagnostic tests in cases with compatible clinical signs.


Participants also highlighted that information about animal health anomalies is already being widely shared through informal communication channels, which are highly variable between states and highly dependent on the relationships between stakeholder groups. It was felt that SAHOs should be aware of what animal health anomalies were appearing in other states to enhance situational awareness, but have the flexibility of deciding what level of information is released in their state. It was also suggested that participants should have the flexibility to filter notifications received through the EPS system to those that are of interest and of relevance to their practice.

A practicing veterinarian from Colorado highlighted that some producers are being proactive about sharing their farm disease status to prevent disease from spreading to other herds. The example was given of a farmer with a Trichomonas outbreak that wanted to notify other local herds to test their cattle as a precautionary measure. The cattle industry is undergoing a cultural change in regards to information sharing because nobody wants to be the one who caused or missed a disease outbreak. Under these circumstances and with express permission from the farmer and veterinarian, participants felt that it was acceptable to use the EPS communication channels to release information about the disease status of individual farms.

(ii) Poultry/Swine Industries and Wildlife, with Federal/State Government and Diagnostic Laboratory Partners

• When do you involve stakeholder groups? Participants pointed to the voluntary USDA Swine Influenza Virus (SIV) Surveillance program to use as a framework for discussing the questions on the EPS scenarios. Similar to the SIV program, participants felt that a core stakeholder group in each state should be used to determine actions for animal health anomalies identified by the EPS system. This stakeholder group would at minimum include representatives from the SAHO’s office, USDA/Assistant District Director, USDA APHIS VS CEAH (i.e., a representative who has access to the EPS data), industry, wildlife, public health, and the veterinary diagnostic laboratory. The participants suggested a team leader be identified for the group. Regular and consistent communication with the stakeholder group on EPS activities would ensure transparency and create expectations and normalcy for how the EPS system works and protocols. In all cases, existing communication protocols and networks within each state/industry should be leveraged for linking animal, wildlife, and public health officials. The participants felt that the immediate first steps for anomalies identified by the EPS system, which would be coordinated by the stakeholder group, are to:


1. Validate the data from the reports, which may include communication with the submitting veterinarians to verify details and request more information

• A person who is trusted by the industry (e.g., a representative from an industry organization) would help coordinate and/or initiate contact with EPS veterinary practitioners.

• EPS veterinary practitioners could be contacted though the BFES app, industry organization(s), and/or SAHO’s office.

• Verification of details and additional information collected would be shared at an anonymous level.

2. Determine the diagnostic tests in process and what causative agents have been ruled out

The type of analyst (e.g., SAHO, CEAH, industry) who noticed the anomaly should initiate the coordination and communication processes by the stakeholder group. If the anomaly is identified by an EPS veterinary practitioner, he/she should notify the SAHO, who would then notify the stakeholder group. The participants determined that the EPS veterinarians also need the capability to send alerts to the EPS system along with their submitted reports, such as to flag reports for analysts to further assess.

• How should stakeholder groups be involved? If it is determined that the anomaly is not of “huge significance” and is locally isolated, the EPS veterinary practitioner participants are notified through the BFES app as an “FYI”. Non-‐EPS veterinary practitioners are notified through the relevant industry organizations. As such, industry organizations agreements are needed for receiving EPS notifications and sharing with non-‐EPS veterinarians. In both instances, communications are coordinated through the stakeholder group. The participants felt any next steps would be industry driven, with state/federal officials playing more of a supporting role. If the anomaly is “significant” (e.g., multiple instances) and within one state, a stakeholder conference call would be conducted to determine next steps. This would involve notifying neighboring and industry-‐related states for their awareness. Crossing state lines may necessitate communicating with the National Assembly for SAHOs for awareness. If multiple states are involved, decision-‐making and lead roles would shift towards the federal government and actions may shift to a disease response situation. In this case, the participants felt the involved stakeholders would expand and, depending on the scenario, may include additional epidemiologists, private diagnostic laboratories, USDA National Animal Health Laboratory Network (NAHLN), DHS National Biosurveillance Integration Center (NBIC), the Food and Drug Administration (FDA; e.g., if the causative agent is a toxin), law enforcement, and the research community. The participants felt that at some point, there may be a tipping point for needing to blast communication


through various, relevant organizations (e.g., American Veterinary Medical Association [AVMA], AASV, NPB, American Association of Avian Pathologists [AAAP]) and diagnostic laboratories in order to expand the coverage of reporting veterinarians and sample submissions. The communication could direct veterinarians to download the BFES app and report for a finite period of time. Laboratory credits for diagnostic workups on specified case definitions could be used as an incentive.

• What level and granularity of information should be shared?

In general, participants felt that additional data to be collected would be scenario dependent. This may include collecting more diagnostic samples or pushing out new surveillance forms or epidemiological surveys through the BFES app for additional data collection, which is a current capability of the EPS system. The participants pointed out the need to share information at appropriate levels, and in a coordinated manner, in order to advance animal health while also protecting the agriculture industries that own the data. Information should be shared at an appropriate granularity to inform and help improve veterinary/ producer animal health management practices. Reasons discussed for sharing information from the data collected and analyzed by the EPS system include:

o Providing recommendations to veterinarians/producers for increasing biosecurity or on vaccination or diagnostic testing protocols

o Providing information to researchers and other permissioned groups for further research and/or data analysis

o Encouraging discussion or collaboration between diagnostic laboratories to improve disease testing or to workup

o Providing baseline and delta data, in anonymous and aggregate format, to United States trade partners, in some instances

Day 2: August 13, 2014

Group Discussion: Recommendations and Guidance for the EPS Pilot Phase and System Implementation The workshop participants also provided valuable feedback on additional tools, features, and incentives that should be incorporated into the EPS system to improve long term sustainability.

• Developing the capability to interface with major commercial practice management and production management software programs

o Participants felt that this would reduce data entry requirements and improve the quality / completeness of data reported into the EPS system.


o Feedlot veterinarians emphasized that their producers already collect detailed animal health records, but not in a standardized format that enables easy analysis.

o Developing analytical tools to help producers and veterinarians manage these data streams was seen as incentive sharing the subset of non-‐identifying information used in emerging disease surveillance.

• Developing secure “Are you seeing what I’m seeing?” discussion forums for veterinarians, analysts, diagnostic laboratories, and industry groups

o Participants felt that it would be valuable to have a secure means of asking colleagues for input unusual case presentations before reporting through formal channels.

o This was also seen as a valuable tool for increasing situational awareness to encourage practitioners to report cases that with unusual presentations they might otherwise not have considered suspicious.

• Developing a communications center that serves as a central resource for information

and press releases about animal health issues o Examples were given of the Equine Communication Center initiative, which is

being established as an authoritative data source for the equine industry, and the USGS call center, which mines information in social media to stay ahead of rumors about animal health issues.

• Developing standardized laboratory submission forms for use in diagnostic laboratories

across the NAHLN o Developing electronic submission forms that could automatically fill using data

fields in the BFES mobile application would save time for practitioners and ensure data quality / completeness

o Participants also felt that data standardization would enable easier sharing and analysis of data between participating diagnostic laboratories

• Developing continuing education seminars and webinars for participating veterinarians o Participants felt that this would help maintain continued interest in the

program, increase communication between veterinary practitioners, and provide valuable training in how to leverage data submitted to the EPS system.

o There were also comments during the breakout sessions that practitioners may not be aware of what emerging disease threats may look like and how we need to create an environment where they are comfortable reporting concerns without fear of negative repercussion if they are right or wrong.

• Developing “easy buttons” to help users automatically generate routine reports


o Users should be able to specify report templates that automatically update as information coming into the system changes

o The system should also include e-‐mail contact information for key stakeholders and stakeholder groups to make it easier for analysts to share reports.

o Both veterinarians and analysts should have the ability to send alerts through the chain of command using functions built into the BFES mobile application or Analyst Workstation.

• Developing in-‐person training seminars for state and local veterinary meetings to encourage program participation

o Seminars should emphasize measures that are in place to protect data confidentiality such as user permissioned access for who gets to view the data, ensuring that information shared back with participants is at high enough granularity to prevent individual identification, and the use of automated anomaly detection algorithms in the Analyst Workstation that can leverage data without it being shared directly with analysts.

o Seminars should also emphasize how the data can be used by veterinary practitioners to improve animal health management such as monitoring the efficacy of vaccine and treatment protocols, identifying risk factors for disease outbreaks, and increasing situational awareness of the prevalence of diseases in their practice area.

o Participants felt that it was important to emphasize the broad range of response measures that could be utilized when an anomaly is detected by the system.

• Developing additional functions for the BFES mobile application that allow it to operate as an electronic medical record

o Participants generally felt that many large animal practitioners were not meeting the minimum record-‐keeping requirements due to challenges in recording data on the farm.

o A major incentive for participation would the capability to automatically send billing and medical record information directly back to the receptionist

o Participants also thought it would be valuable to generate routine client reminders for services like vaccination and testing that would appear on the BFES mobile application during farm visits.

EPS Phase II Detection Window Exercise Dr. Holmstrom presented a brief overview of the objectives and intended outcomes of the detection window exercise, which is a planned activity for the Phase II project. The purpose of the functional exercise is to evaluate the efficacy of the EPS system to decrease the time to detection of endemic and emerging/foreign animal disease. The benefits of performing an


exercise are that it provides 1) assessment of the EPS system tools to ensure the intended objectives of the system are met; 2) training on the new tools and methods supporting biosurveillance; and 3) discovery of unforeseen shortfalls and how the system can be integrated into national surveillance plans. Dr. Holmstrom discussed the general approach for how the exercise will be implemented, the data requirements, and evaluation metrics. The scenarios used for the exercise will be based on input received from participants at the workshop. The intended outcomes are to increase confidence in the fielded EPS system, demonstrate a decreased time to detection when utilizing this system, and increase visibility that will encourage extended participation in the EPS program beyond those directly involved.

Draft framework of the CONOPs for responding to animal health anomalies detected in the EPS Phase II pilot and full scale implementation Using input provided by participants in the breakout sessions and the large group discussion, a draft CONOPs framework was developed for responding to animal health anomalies detected by the EPS system (Figure 1).

Step One

Following detection of an animal health anomaly either through direct reports from a participating veterinarian or through automated analysis of surveillance data streams in the EPS Analyst Workstation, the first step will always be to verify and investigate the cause of the anomaly. The initial chain of communication will depend on the party responsible for identifying the anomaly.

• If the anomaly is detected by partipating veterinarians, extension agents, or industry representatives (bottom-‐up), they should always notify the appropriate SAHOs who will then determine whether the anomaly warrants further investigation. If an infectious etiology is suspected, it is the responsibility of SAHOs to notify analysts at USDA to ensure that a central agency always retains a national perspective of ongoing disease concerns.

• If the anomaly is detected by analysts at the USDA or by the SAHO office (top-‐down), or by other epidemiologists permissioned by the agricultural industries, they should always send notifications to SAHOs in the affected states. SAHOs will then be responsible for communicating with submitting veterinarians, either through or in coordination with identified industry representatives, to verify the accuracy of information in the reports and to request additional information that may aid in determining the cause of the


anomaly signal. Any communication with producers will always be through the submitting veterinarian.

At this stage, analysts and SAHOs can use informal, secure communication channels provided by the EPS system to seek additional input from other participants and stakeholder groups to determine whether there is cause for further investigation. SAHOs may also coordinate with USDA and diagnostic laboratories to obtain funding to perform additional diagnostic testing.

• If an anomaly has characteristics that are compatible with a foreign animal disease or emerging disease threat, this will trigger the USDA Policy for the Investgation of Potential Foreign Animal Disease/Emerging Disease Incidents.

• If the anomaly is found to be false positive or related to a minor animal health concern, no further action will be taken and it is at the discretion of the USDA and SAHOs whether to share aggregate details of the investigation with participants and industry stakeholder groups to highlight that data from the system is being analyzed.

• If the anomaly represents an infectious disease concern that does not meet the foreign animal disease or emerging disease criteria, the next step will be to conduct a meeting between key stakeholders to determine the appropriate course of action. No information will be released to participating veterinarians, stakeholder groups, or the general public prior to the stakeholder meeting to ensure that business interests are protected.

Step Two

The EPS project will work with each livestock industry prior to full-‐scale implmentation of the surveillance system to identify representatives from each stakeholder group that should be involved in determing the response to confirmed animal health anomalies. These stakeholder groups may include, but are not limited to:

• USDA CEAH EPS analysts • USDA ADDs • USDA Commodity SMEs • SAHOs • Extension agents and university researchers • National industry and veterinary organizations • Veterinary diagnostic laboratories • Public health officials • DHS and law enforcement officials • Tribal representatives • Other subject matter experts


The objectives of the stakeholder meeting are to:

• Assess the potential impact of the disease outbreak on the affected industry o Rate of spread and geogrpahical distribution o Severity of clinical signs (morbidity and mortality) o Food security and production effects o Public health implications o Domestic and international trade implications o Political implications

• Determine the appropriate level of response to the disease outbreak o Notifications and educational resources for participants o Funding for further research and diagnostic testing o Biosecurity protocols to precent further spread

• Decide the chain of command for who takes responsibility for coordinating response measures

• Establish data sharing protocols to communicate important information to key stakeholder groups

o Determine level of granularity for data sharing o Determine which states, regions, or groups are notified o Develop recommendations to share with stakeholder groups

Once the stakeholder representatives have determined the appropriate course of action for responding to the disease outbreak, they will work Public Information Officers to generate standardized messages for release to the general public. The stakeholder representatives will meet regularly during the outbreak response to review and modify recommended actions as more data becomes available. Every effort will be made to protect the interests of the submitting veterinarians and affected producers, while still providing valuable information that enables stakeholder groups to implement the appropriate prevention and control measures.

The EPS system will integrate many features to support all stages of the investigation, response, and communication process. These include, but are not limited to:

• The ability to push notifications of emerging disease concerns or notifications that cases meet the criteria to receive diagnostic testing support directly to the BFES mobile applications.

• Secure discussion forums that participants can use to communicate with each other about unusual cases or emerging disease concerns without having to go through formal reporting channels.


• In-‐case-‐of-‐emergency data sharing protocols within the EPS Analyst Workstation that enabling participants to release additional data fields to USDA and SAHOs to aid in epidemiological investigations.

• The ability to share aggregrate data on emerging disease concerns with participants and other stakeholder groups in a confidential and non-‐identifying format.


Figure 1: Draft CONOPs framework for responding to animal health anomalies detected through the EPS system


Closing Comments At the end of the workshop, all participants were thanked for attending and contributing to the workshop discussion and for providing input on the EPS CONOPs. The participants were made aware that the outcomes of the workshop would be used to provide transparency to all EPS Phase II project partners for responses to animal health anomalies detected by the EPS system. The knowledge gained from the workshop will be valuable as the EPS Phase II project moves forward and in support of USDA, State, and industry plans for emerging diseases.


Acronyms AASV, American Association of Swine Veterinarians

ADD, Assistant District Director

APHIS, Animal and Plant Health Inspection Service

BFES, Biosurveillance Field Entry System

CEAH, Center for Epidemiology and Animal Health

CONOPs, Concepts of Operations

DHS, Department of Homeland Security

EDI, Emerging Disease Incidents

EPS, Enhanced Passive Surveillance

FAD, Foreign Animal Disease

HSARPA, Homeland Security Advanced Research Products Agency

IIAD, Institute for Infectious Animal Diseases

NAHMS, National Animal Health Monitoring System Unit

NCBA, National Cattlemen’s Beef Association

NCMI, National Center for Medical Intelligence

NLRAD, National List of Reportable Animal Diseases

NPB, National Pork Board

NPPC, National Pork Producers Council

OUP, Office of University Programs

PEDV, Porcine Epidemic Diarrhea Virus

PIN, Premises Identification Number

RIU, Risk Identification Unit

SAHO, State Animal Health Official

S&T, Science and Technology Directorate


SME, Subject Matter Expert

STAS, Science, Technology, and Analysis Services

TCAT, Texas Center for Applied Technology

USDA, United States Department of Agriculture

VS, Veterinary Services


Appendix A: Workshop Participants

Name Organization

Aaron Scott Senior Advisor for Epidemiology and Environmental Science, USDA APHIS VS Science, Technology an d Analysis Services (STAS)

Aida Boghossian Liaison Officer, USDA APHIS VS Science, Technology and Analysis Services (STAS)

*Albert Rovira Pathologist, University of Minnesota Veterinary Diagnostic Laboratory

Andy Schwartz Assistant Executive Director for Epidemiology and Laboratories, Texas Animal Health Commission

*Ann Fitzpatrick Research Associate, University of Minnesota Veterinary Diagnostic Laboratory

Austin Riddle Senior Software Engineer, Texas Center for Applied Technology

*Barb Powers Director, Colorado State University Veterinary Diagnostic Lab

Beth Lautner Associate Deputy Administrator, APHIS VS Science, Technology and Analysis Services (STAS)

Britt Stubblefield Rocky Top Veterinary Service LLC, Colorado Cattlemen’s Association

*Bruce Akey Executive Deputy Director, Texas A&M Veterinary Medical Diagnostic Laboratory

Bryan Richards DOI Liaison, National Biosurveillance Integration Center

Carolyn Gates Research Scientist, IIAD

*David French Staff Veterinarian, Sanderson Farms

Diane Sutton National Sheep and Goat Health Commodity Coordinator, USDA APHIS VS Surveillance, Preparedness and Response Services (SPRS)

Ellen Kasari Veterinary Medical Officer, Swine Specialist, USDA APHIS

Jamie Jonker Vice President, Sustainability & Scientific Affairs, National Milk Producers Federation

Jennifer Rinderknecht Support Contractor, DHS S&T CBD Joe Annelli Director, One Health Coordination Office, USDA APHIS VS

John Korslund EPS Program Manager, DHS S&T

John Wenzel Extension Veterinarian, New Mexico State University

*Judy Akkina Epidemiologist, USDA VS CEAH

Justin Smith Deputy Animal Health Commissioner, Kansas Department of Agriculture, Division of Animal Health

Keith Biggers Director, Computing and Information Technology, Texas Center for Applied Technology and Information Analysis Systems Theme Leader, IIAD

Keith Roehr State Veterinarian, Colorado Department of Agriculture, Animal Health Division

Kendra Frasier Animal Disease Traceability Coordinator, Kansas Department of Agriculture, Division of Animal Health


Kynan Sturgess Veterinarian, Hereford Veterinary Clinic

Larkin O’Hern Program Manager, Texas Center for Applied Technology

Lianne Moore Parr Program Coordinator, DHS S&T Office of University Programs (OUP)

Lindsey Holmstrom Research Scientist, IIAD

Lisa Becton Director of Swine Health Information and Research, Science & Technology, National Pork Board

Maria Romano Veterinary Medicine Student Trainee, USDA APHIS VS OHCC

Marianne Ash Director, Division of Animal Programs, Indiana State Board of Animal Health

Mark Remick Assistant District Director, District I, USDA APHIS VS Surveillance, Preparedness and Response Services (SPRS)

Mark Teachman Director of STAS Interagency Coordination, USDA APHIS VS

Matt Coats Associate Director and Program Manager, DHS S&T Office of University Programs (OUP)

Melissa Berquist Associate Director, IIAD

Michael Carter Acting Director, Cattle Health Center, Surveillance Preparedness & Response Services, USDA APHIS VS

Michael Robertson Systems Engineering & Technical Assistance, DHS S&T

*Michelle Colby Agriculture Defense Branch Chief, Chemical and Biological Defense Division DHS S&T

Nathaniel White Professor Emeritus of Equine Surgery, Marion DuPont Scott Equine Medical Center

Perry Durham State Veterinarian, Arizona Department of Agriculture

*Praveen Vadlani Associate Professor, Kansas State University

Rachel Whisenant Program Assistant, IIAD

Ram Raghavan Assistant Professor of Diagnostic Medicine, Kansas State University Veterinary Diagnostic Laboratory

Sam Ives Associate Professor, West Texas A&M University

Steve Weber Co-‐Director, CEAH

Tammy Beckham Director, IIAD

Teresa Quitugua Deputy Director, National Biosurveillance Integration Center, DHS

Tom Hairgrove Program Coordinator, Livestock and Food Animal Systems, Texas A&M AgriLife Extension

Wendy Stensland NAHLN Program Manager, Iowa State University Veterinary Diagnostic Laboratory

Yandace Brown Biosurveillance Analyst, National Biosurveillance Integration Center, DHS

* Participated via teleconference


Appendix B: Agenda Enhanced Passive Surveillance Concepts of Operations Workshop Hyatt Arlington, 1325 Wilson Boulevard, Arlington, VA | August 12-‐13, 2014 Webinar information:

LINK: Please click on the following URL: http://iiad.adobeconnect.com/generalsession/ and select “Enter as a Guest”. Please input a display name and affiliation, then you should gain access to the webinar.

AUDIO: Dial in: 866-‐827-‐4690 Participant Code: 7451761# Agenda Tuesday, August 12, 2014 | Hyatt Arlington, Room: Senate Salon (A and B) 8:30 – 8:45 a.m. Welcome and Introductions | Dr. Tammy Beckham, Director, Institute for

Infectious Animal Diseases (IIAD)

8:45 – 9:00 a.m. Workshop Purpose, Objectives, and Desired Outcomes| Dr. Tammy Beckham, IIAD

9:00 – 10:00 a.m. EPS Phase II Project Update | Drs. Keith Biggers, Director, Computing and Information Technology and IIAD’s Information Analysis Systems Theme Leader and Lindsey Holmstrom, Research Scientist, IIAD

10:00 – 10:30 a.m. BREAK

10:30 – 11:15 a.m. USDA Veterinary Services Emerging Disease Framework | Dr. Elizabeth Lautner, Associate Deputy Administrator, Science, Technology, and Analysis Services (STAS), USDA-‐APHIS-‐VS

11:15 – 12:00 p.m. National Pork Board – Swine Emerging Disease Plan | Dr. Lisa Becton, Director, Swine Health Information and Research, National Pork Board (NPB)

12:00 – 1:15 p.m. Lunch| AgConnect Suite of Tools Demonstration

1:15 – 1:45 pm Detecting Emerging Disease Events through EPS | Dr. Carolyn Gates, Research Scientist, IIAD

1:45 – 2:10 p.m. DRAFT Scenarios Overview for Breakout Sessions | Dr. Aida Boghossian, Liaison Officer, National Center for Medical Intelligence, USDA-‐APHIS-‐VS STAS

2:15 – 4:15 p.m. Responding to EPS System Animal Health Anomalies at the Federal, State, and Industry Levels

Breakout Session Objectives:

• Defining general scenarios that could occur given an anomaly is detected within the EPS System

• Defining CONOPs for response to each type of general scenario given an anomaly has been identified

• Defining roles of, and communication between Federal and State government, industry, diagnostic laboratories, and other stakeholders for each type of general scenario given an anomaly has been identified

Breakout Session Groups:

1. Beef/Dairy Cattle, Small Ruminants, Equine Industries and Wildlife, with Federal/State Government and Diagnostic Laboratory Partners – Room: Senate Salon (A and B)


Webinar: http://iiad.adobeconnect.com/generalsession/ Audio: 866-827-4690 Participant Code: 7451761# (Note: webinar and audio are the same as the morning session)

2. Poultry/Swine Industries and Wildlife, with Federal/State Government

and Diagnostic Laboratory Partners – Room: The Gallery

Webinar: http://iiad.adobeconnect.com/breakoutroom2/ Audio: 866-919-3553 Participant Code: 2267857#

4:15 – 5:00 p.m. Wrap-‐up and Goals for Day 2

Wednesday, August 13, 2014 | Hyatt Arlington 8:30 – 9:30 a.m. Breakout Sessions Wrap-‐up

1. Beef/Dairy Cattle, Small Ruminants, Equine Industries and Wildlife, with Federal/State Government and Diagnostic Laboratory Partners – Room: Senate Salon (A and B)

*webinar/audio information same as before, see above

2. Poultry/Swine Industries and Wildlife, with Federal/State Government and Diagnostic Laboratory Partners – Room: The Gallery

*webinar/audio information same as before, see above

9:30 – 11:00 a.m. Breakout Sessions Presentations 11:00 – 11:15 a.m. BREAK 11:15 a.m. – 12:30 p.m.

Group Discussion: Recommendations and Guidance for EPS CONOPs for Pilot Phase and System Implementation

12:30 – 1:45 p.m. LUNCH 1:45 – 3:15 p.m. EPS Phase II Detection Window Exercises

Exercise Objectives and Implementation Plan Defining Specific Scenarios for Exercises Defining Exercise Evaluation Metrics

3:15 – 4:00 p.m. Summary of Discussion and Next Steps 4:00 p.m. Adjourn


Appendix C: Breakout Session Handouts Figure 2: Enhanced Passive Surveillance Notional Scenario Tree


Table 1: Discussion Questions for each Scenario

Documents

DRAFT EPS CONOPs Workshop v3iiad.tamu.edu/wp-content/uploads/2015/08/Appendix... · Summary Conclusions and Recommendations In!pursuitof!the!workshop!objectives!and!in!supportof!the!strategic!goals!and!policy!needs!