NAHLN Steering Committee Meeting Minutes Radisson Riverfront Hotel

Governor’s II Room St. Paul, Minnesota

April 08, 2005 Finalized May 6, 2005

Date: Friday, April 08, 2005 Recorder: Teresa M. Sigafoose Attending Steering Committee Members: Beverly Byrum, Gene Erickson, Bill Hoffman (acting for Bob Smith), Randall Levings, Bret Marsh, Terry McElwain, Tom McKenna, Gary Osweiler, Willie Reed, Alfonso Torres, Bill Wagner, Barbara Martin NAHLN IT Representatives: Jim Case, Jay Kammerzell Guests: Larry Granger, Dale Rendahl, Carla Thomas

# Topic Leader 1 Group Welcome Barbara Martin

Background: Welcome extended to the new member Gene Erickson and good-bye to Alfonso Torres.

# Topic Leader 2 Strategic Planning Session Dale Rendahl

Issues: Rendahl started the discussion by asking the group what the NAHLN wanted to accomplish within the next four years to include: issues facing the NAHLN, where NAHLN is headed, and the drafting of a NAHLN Strategic Plan. He defined strategic plan as a short, four page document that states what tasks are to be accomplished and a time frame to accomplish those tasks. He presented the following 20 questions: Question 1: Why do you need a NAHLN? Group Answer: Capacity and expertise that can be used for early detection or mobilized in case of an animal health emergency. Question 2: Is NAHLN a coordinating mechanism more than a doing mechanism? Group Answer: No. NAHLN is a “doing network” and a “doing organization.” Actions are done in a uniform manner where there is confidence in test results. NAHLN recognizes the need to utilize State diagnostic laboratory resources. NAHLN must maintain standardization of testing and reporting of everyday tests and not just foreign animal diseases (FADs). In addition, the NAHLN must be prepared to perceive threats to animal agriculture, whether intentional or not. NAHLN must lead the way in the development of new diagnostic tests as technology continues to rapidly develop. NAHLN also has a role to drive surveillance testing.

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Question 3: Where does NAHLN’s responsibility for animal health begin and end? Group Answer: “Sample in and results out.” Samples may be sent to NAHLN on a routine basis to evaluate and then send on to FADDL if suspicious or positive. Current vision of the NAHLN is to have an adequate number of laboratories across the US that have BSL-3 space so that we can respond in case of a outbreak. Globalization has changed the impact of a positive result. We need to clearly communicate what a positive result on a screening test means. NAHLN does not want to be responsible for everything. Therefore, NAHLN will monitor animal health well-being and respond to animal health events. Question 4: What are Animal Health Threats? Group Answer: Bioterrorism and increased chance of introduction of disease by trade that threatens the well being of livestock. Question 5: What time frame should the initial NAHLN Strategic Plan cover? Group Answer: Short time frame of 2-3 years that can be revisited with modifications, a time frame that will show people that the NAHLN will actively pursue goals and initiate new goals. The plan should cover the funding needed to achieve the goals outlined in the plan Question 6: What dollar figure? Group Answer: $85 million to finish and an annual budget of $35 million which includes maintenance costs and the entire process of sample collection through data input. Question 7: Do you want to plan to assume that the NAHLN is getting $85 million? Group Answer: A plan must be written and then a strategy must be developed. The white paper was doing this. The white paper discussed $85 million that was to be extended across the states to ensure appropriate surge capacity. Starting with a base of 12 testing laboratories, the NAHLN would strategically expand across the US as determined by the location of laboratories and where there is lack of NAHLN coverage. Currently, there are train the trainer programs going on for 13 laboratories that have not received CSREES funding. Question 8: What do you mean by the term “Network?” Group Answer: The NAHLN is a central point, a structured group that provides uniformity, and quality assurance. Question 9: Who decides who is in the network? Group Answer: The NAHLN SC would provide input to APHIS and CSREES. The Agencies would then make decisions. The NAHLN SC is designed to discuss issues and review options but it is not an advisory group. Question 10: What is the role of the Steering Committee? Group Answer: The NAHLN SC is not an advisory committee, but a committee to represent constituents and stakeholders. The SC provides input to the Federal agencies. A group discussion followed concerning changing the mission statement to read as follows:

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The NAHLN will maintain an advanced level of preparedness in order to provide the laboratory capability and capacity to detect, diagnose, and respond to health threats of all animals including zoonotic diseases.

Question 11: How are you going to measure success? Group Answer: Success can not be measured by one thing. It can not be measured by dots on a map and 12 laboratories are not enough. It is measured by how many laboratories have been trained, proficiency tested, participate in surveillance, have BSL-3 space, and IT capabilities. Question 12: Why is “including zoonotic diseases” in the NAHLN mission statement? Group Answer: There is an issue with zoonotic disease diagnosis and because most zoonotic diseases appear in animals before humans, our laboratories routinely diagnose zoonotic diseases on a daily basis. Question 13: Where does agriculture NAHLN get into non-agriculture issues? Group Answer: The role varies with the role of the partners. The overall scope involves animals. Question 14: What are some goals that the NAHLN wants to accomplish within the next five years? Group Answer: 1. Establish a laboratory capability for every state.

2. Establish a network of laboratories capable of rapidly providing and reporting a preliminary diagnosis of designated foreign animal diseases. 3. Establish consistent results through standard protocols. 4. Establish a reporting mechanism for test results. 5. Establish the laboratory capacity to conduct the testing necessary to show the US is free of a disease post outbreak (recovery mode). 6. Comprehensive QA program for network laboratories. 7. Establish a system to define and distribute data. 8. Deploy rapid diagnostic tests to each laboratory. 9. Conduct a table top exercise of the NAHLN system. 10. Develop a communication plan to enhance an awareness of NAHLN to industry, stakeholders, and board members.

Rendahl suggested that the group should develop intermediate goals and define capacity and capability. Question 15: What do you do with a state laboratory that does not want to be a NAHLN laboratory? Group Answer: It is their choice but they must have a back-up plan to ensure that their testing will be done by another state. The Agriculture Department of the state has the power to enforce this, not the NAHLN.

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Question 16: Define capacity needed for response and recovery and how do you accomplish this? Group Answer: Money and authorities to accomplish goals along with personnel necessary in the testing laboratories. Group discussion followed concerning what can be done without money. It was decided that education can be done with minimal amounts of money. Outreach can be accomplished without money through industry; the Emergency Network, the Agriculture Extension Service in each state, Animal Ag Coalition, the State Vets, and AVIC. Question 17: What is the time frame to accomplish the 10 goals set? Group Answer: 1. Must get a re-draft of goals after everyone has commented.

2. Comments must be made in a timely manner. 3. Second version of goals must be distributed quickly. 4. Agree to live with goals after they have been revised. Version of goals

and anything committee can’t agree on, leave general. Question 18: What is this group’s role in the next step of the strategic plan? What are you going to do with the strategic plan? Group Answer: Development of key strategies and personnel to get there, work through each item one at a time, spiral goals, and prioritize list items. Question 19: What are the real priorities? Group Answer: Defining surge capacity, determining testing needs, prioritizing the addition of laboratories and the agents to be tested for, and assigning individuals to be in charge of different topics. Question 20: What was the value of this discussion? Group Answer: Re-affirmed where we started, identification of goals that can be done without money, items that must be accomplished in order to move forward, an agreement that the NAHLN needs to send out a consistent message. All felt it was very important to make progress in funding issues. Action/Outcome:

Martin – send out mission statement to NAHLN Steering Committee members for comments.

Martin – send out the 10 goals to be accomplished by the NAHLN to the NAHLN Steering Committee for comments.

Steering Committee - comment on the NAHLN mission statement and goals within one week after receipt.

# Topic Leader 3 Scenarios Carla Thomas

Background/Issues: Sebastian Heath, with the Area Emergency Coordinators Program (AECP), spoke at the January 2005 Steering Committee meeting concerning scenario testing and

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APHIS involvement. He explained that the focus of the AEC programs were on functional aspects, not specific diseases. Heath is willing to design exercises per NAHLN needs. Bev Byrum is coordinating the development of a multi-state exercise that will involve NAHLN laboratories. Carla Thomas, with the Plant Pathology Department at UC Davis, also works on scenario testing and has agreed to help the NAHLN develop scenario exercises. Discussion: Carla Thomas works in the Plant Pathology Department at UC Davis and is in charge of developing scenario exercises for the National Plant Diagnosis Network through the Plant Diagnostic Information System (PDIS) to help educate state laboratories on handling selected plant pathogens. The scenario exercises help laboratories develop communication skills through the implementation of action plans and the use of protocols. The scenario is launched by the use of a photo which is treated like a diagnostic specimen. The laboratory receives the “diagnostic specimen” and the selected laboratory personnel, administrative personnel, etc., who have been chosen to participate in the project work to diagnose the specimen through the use of their protocols. The scenario is monitored through the PDIS under secure communications between individuals within the laboratory and individuals who set up the scenario. Carla is willing to work with the NAHLN Steering Committee to develop scenarios for the NAHLN laboratories. Action/Outcome:

NAHLN Steering Committee needs to discuss (conference call) what should be exercised in a scenario, i.e., triage, surge capacity, planners, and coordinators.

# Topic Leader 4 Revisions to VS Memo 580.4 Steering Committee

Background/Issues: May ’04, Levings met with associate directors of the Eastern and Western Regions to go over VS 580.4, Procedures for Investigating a Suspected Foreign Animal Disease/Emerging Disease Incident (FAD/EDI) document. In the January ’05 Steering Committee meeting, Levings was asked to work on revisions to this document. Discussion: Revisions to VS 580.4 were made and presented to group. Changes were discussed. Action/Outcome:

Martin will provide Steering Committee members with current revised VS 580.4. Levings will discuss revised 580.4 with VS management team.

# Topic Leader 5 IT Issues Jim Case and Jay Kammerzell

Background/Issues: The NAHLN IT system has completed user acceptance testing and the production system is anticipated soon.

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Discussion: Case reported that BAH has been running practice tests for the past 3 weeks on large scale transmissions. The plan is to receive 2000 – 5000 messages per hour. A message may be a single result or a group of results for a particular accession number. New hardware has been installed at CEAH and should handle 25,000 – 50,000 results per day. Issues to address:

1. Assigning an effective date to start. Start date must be the same for every laboratory. 2. Developing mechanisms to prevent duplicate data from being sent. 3. Developing a corrections mechanism. 4. Establishing a trace back history. 5. Development of a written security policy. 6. Input of previous data. How far back do we go? 7. What to do next in terms of testing system.

Group discussion followed and only validated assay test results will be used to go live. Future development of the system should allow for interpretations for non-validated tests. For AI test results, AGID and ELISA data may be sent for chickens only and not turkeys. A start date may be set, but laboratories may not send data until a security plan is in place. Once the IT network goes live, it is anticipated that $2 million will be needed for support and maintenance each fiscal year. Action/Outcome:

Martin - talk to Steve Weber about assigning a start date. Hoffman- talk to Carla Thomas concerning security issues and get a copy of the

security document she’s developed. Martin – provide security policy documents, surveillance manuals, and SOPs at

NVSL to Case and Kammerzell. Case and Kammerzell - develop a draft security contract.

# Topic Leader 6 Budget Wagner and Martin

Budget: CSREES has $650,000 reserved for expanding NAHLN and plans are in the process. Martin is working on cooperative agreements for AHMS pass-through money for the states.

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