2006 Annual Meeting Committee Reports- Minneapolis, MN AAVLD Foundation ...... 2 Accreditation Committee...... 2 Animal Emergency Management Committee, USAHA/AAVLD Joint ...... 3 Animal Health Information Systems Committee, USAHA/AAVLD Joint ...... 6 Approved Methods Committee ...... 9 Aquaculture Committee, USAHA/AAVLD Joint...... 11 Bacteriology Steering Committee ...... 15 Antimicrobial Susceptibility Subcommittee ...... 16 Bacteriology and Mycology Subcommittee...... 17 Committee Chairs and Program Committee Joint Meeting ...... 18 Constitution, Bylaws and Resolutions Committee ...... 18 Enteric Diseases Committee...... 18 Epidemiology Committee ...... 19 Food Safety Committee ...... 20 Government Relations Committee of AAVLD ...... 20 Informatics and NAHLN IT Committees ...... 21 Journal of Veterinary Diagnostic Investigations Editorial Board...... 24 Laboratory Administrative Management Personnel Committee ...... 26 Laboratory Directors Committee ...... 28 Laboratory Emergency Management Committee ...... 28 Laboratory Safety Committee ...... 30 Membership Committee of AAVLD...... 31 NAHLN Laboratory Directors ...... 31 Pathology Committee ...... 31 Publications Committee ...... 34 Quality Assurance Committee ...... 34 Strategic Planning Committee ...... 38 Serology Committee ...... 38 Veterinary Analytical Toxicology and Mycotoxins (AAVLD) and USAHA Environmental Residues Committees...... 41 Virology Committee ...... 42

1 AAVLD Foundation Chair: Paige Carmichael. 9:3-11:30pm, Friday, October 13, 2006. Board Room 2

Present were: Paige Carmichael, Lenn Harrison, Sharon Hietala, Gavin Meerdink, Donal O’Toole, Barbara Powers, and Leon Thacker

Treasurer’s report The Foundation has a checking account balance of $43,043.16 and a mutual fund balance of $79,800.37. The total as of September, 2006 is $122,843.53.

Review of AAVLD Auction The AAVLD Foundation Auction was discussed. The performance of the auctioneer, Dr. Tom Burkgen, was commended and the committee decided to give him the right of first refusal to do the Auction next year (2007).

The Foundation Auction raised approximately $5,280 although at that time all the silent auction items had not been tabulated. The committee decided that for the 50th Anniversary Auction, items of historical significance will be solicited.

The Foundation felt strongly that the money raised in the auction be used toward veterinary student and graduate student/resident recruitment and training. The three items that were decided upon were: 1) Funding of five veterinary student externships in diagnostic veterinary medicine 2) Forming a coalition of veterinary diagnosticians that were willing to got to veterinary school and the SAVMA Symposium to engage veterinary students 3) Create a MPEG movie highlighting veterinary diagnostic medicine that could play on the AAVLD website

Review of current Foundation donation form The current Foundation donation form was reviewed and it was decided that only donations of $1,000 or more could be specifically designated while those under $1,000 would enter into the general fund to support veterinary diagnostic medicine.

Update of AAVLD Foundation brochure Paige Carmichael presented the committee with the AAVLD promotional brochure that she adapted from Donal O’Toole’s poster. The brochure was reviewed and suggestions made of changes. The final version should be available by the end of the year.

Old Business Ways to better highlight our travel trainee and graduate student presentation award winners were discussed. Suggestions included featuring them on the cover of JVDI. It was suggested that student competitors submit a passport-style photograph with their abstract. This suggestion will be forwarded to the Awards and Journal committees.

New Business Increased emphasis on media relations was also discussed. It was suggested that we talk to Jackie about this after the meeting.

Accreditation Committee Chairs: Leon Thacker and Terry McElwain, 1:00-5:00pm Thursday, October 12, 2006 in Ramsey and 8:00am- Noon, Friday, October 13, 2006, Board Room 2

The Accreditation Committee met 4 hours the afternoon of Thursday, 10/12/06 with 15 committee members in attendance and 4 hours Friday morning 10/13/06 with all 17 committee members in attendance.. The Committee received update reports from Wisconsin, Oregon, New York, Missouri, Mississippi, Oklahoma and Connecticut. Preliminary site visit reports from visits to Kansas, Texas, and South Carolina were presented. Site visits to be scheduled as soon as possible include NVSL, Illinois, Nebraska, Arizona, Arkansas, Missouri and Montana. There are 8 laboratories or laboratory systems scheduled for site visits in 2007.

The Committee discussed mechanisms for verifying laboratories’ full implementation of and compliance with New Essential Requirements for AAVLD Accredited Laboratories in 2007. By January 2, 2007 each accredited 2 laboratory shall provide to the Accreditation Committee a completed check list of new essential requirements primarily addressing revised quality system development and implementation; a copy of their most recent Quality manual; and a complete set of the laboratory’s system SOP’s/Sys Docs. In addition, each accredited laboratory must send to the Committee by April 30 a schedule and example of internal audits; and records of compliance with instrument calibration, personnel training, and corrective action requirements. Failure to document compliance with these items will result in review of the laboratory’s accreditation status.

The Committee also had a rather long discussion session considering the future and structure of the AAVLD accreditation process. A subcommittee of 5 members of the Committee was appointed to draw up initial recommendations for subsequent session(s) of this discussion.

The Committee has requested nominations from each accredited laboratory for technical experts to serve as assessors on future site visits. A training session for new assessors as well as current Committee members will be scheduled in concert with the next meeting of the Committee to be held at the time of the Western States Veterinary Conference in early 2007.

Animal Emergency Management Committee, USAHA/AAVLD Joint Chairs: Keith Roehr and Pat Blanchard, 8:00am-5:00pm, Saturday, October 14, 2006, Marquette/Lasalle

Committee Members: Mr. John B. Adams, VA, Dr. Bruce L. Akey, NY, Dr. Gary Anderson, KS, Dr. Tammy Beckham, NY, Dr. Shane Brookshire, MO, Dr. Beverly Byrum, OH, Dr. David Chico, NY, Dr. Leslie Cole, OK, Dr. Mark Davidson, CO, Dr. Kevin Dennison, CO, Ms. Shelley Doak, ME, Mr. Orlo R. Ehart, DC, Dr. Dee Ellis, TX, Dr. Francois Elvinger, VA, Dr. Cyril Gay, MD, Dr. Levle Gayle, TX, Dr. Larry M. Granger, MD, Dr. Jeffrey Hamer, NJ, Dr. Robert A. Heckert, MD, Dr. Donald Hoenig, ME, Dr. Gregory Jillson, NM, Dr. Patrice Klein, MD, Dr. Elizabeth A. Lautner, IA, Dr. Randall Levings, IA, Dr. Martha Littlefield-Chabaud, LA, Ms. Amy W. Mann, DC, Ms. Barbara Martin, IA, Dr. Thomas J. McGinn, III, DC, Dr. Lee Myers, GA, Dr. Brian V. Noland, CO, Dr. Kristy Pabilonia, CO, Dr. Deidre Qual, ND, Dr. Jeanne Rankin, MT, Mr. Paul E. Rodgers, CO, Dr. Mo D. Salman, CO, Dr. Dave Scarfe, IL, Dr. Marilyn Simunich, ID, Dr. Harry Snelson, NC, Dr. Gary Sherman, DC, Mr. George Teagarden, KS, Mr. Dave Tomkins, TX, Dr. Alfonso Torres, NY, Dr. Lyle P. Vogel, IL, Dr. William Wagner, VA*, Dr. Sherrilyn Wainwright, CO, Dr. David Warner, NC Dr. Patrick Webb, IA, Dr. Dennis Wilson, CA, Dr. Ronald B. Wilson, TN, Dr. Pam Zaabel, IA. Liaisons: Dr. Joe Annelli*, MD, Dr. Jose Diez*, MD, Dr. Tim Frana*, IA, Dr. Bethany O’Brien (Grohs)*, DC, Dr. Sebastian Heath*, MD, Dr. Cindy Lovern*, VA , Dr. Dale Moore*, CA, Dr. Stephanie Ostrowski,GA*, Dr. Samia Metwally*, NY, Dr. Carol Tuszynski*, CO, Dr. Paul Williams*, GA *Agency liaison representatives (not USAHA/AAVLD members) are not voting members of the committee.

There were ~145 people in attendance including 29 members.

Pat Blanchard reviewed the committee accomplishments for the past year. The committee met 11 times by monthly conference call and once face-to-face in Louisville, Ky. Activities included: • All-hazards subcommittee was created and they produced a resolution on the handling of all species and all hazards emergencies which will be voted on later in the meeting. • Reviewed USDA contracted Lesson Learnded developed by CNACorp from past animal events and exercises and identified 12 of the 36 recommendations as the highest priorities. These were forwarded to USDA Assoc Dep Director for EMD, Jose Diez, to address USDA’s progress and plans at the meeting. • Drafted letters to USDA, DHS, EPA and ARS to accompany the committee’s October 2005 recommendation on Disinfectants. All except DHS responded. EPA has taken the lead on an interagency working group which is addressing the recommendation as part of HPAI activities. A July 2006 letter from EPA was received updating the committee on progress. • Monthly meetings and email distribution have served as a venue to share information on upcoming meetings, events and activities related to emergency management such as Government coordinating council minutes, credentialing workgroup progress, national carcass disposal concerns, types of personal protective equipment and PPE training issues, etc. • Discussed and supported the National Livestock Continuity of Business Plan demonstration project. • Identified key initiatives at NIAA April meeting including: o need for a stronger and consistent funding stream to states to fully integrate and implement emergency preparedness with industry, local, state and federal partners. o Rapidly deployable funding to agriculture during emergencies to re-establish productivity and business operation.

3 Dr. Lee Myers, Georgia State Veterinarian, gave an overview of Government coordinating council role and membership and Food and Ag Sector council. She explained the need to engage and respond to the request from DHS to review and update the Food and Ag sector specific plan which is part of NIPP. They were asked to take part in August with a December deadline. Currently they are requesting for extension so that states can provide meaningful input. Denise Spencer is a USDA contact on effort. Drs. Brigid Echols and Marilyn Simunich are working with Lee Myers on the response but would like a subcommittee of CAEM to assist.

Mr. John Monson, Director of Minnesota Farm Services Agency presented information on the criteria to qualify for assistance, mechanism, time line and process by which funding in the form of low interest loans is made available to agriculture. The process, requirements and time lines vary based on the type of request. The three types of emergency designation request and approval processes are a Presidential Emergency/Major disaster declaration; a Secretarial designation request; and the Administrator’s (FSA administrator) Physical loss Notification request.

Dr. Jose Diez, Associate Deputy Administrator for Emergency Management and Diagnostics (EM&D) presented the progress and plans related to the 12 priority recommendations identified by the committee from the CNACorp Lessons Learned report were grouped into 4 categories: a. Roles, authorities, resources and processes; b. Disposal issues; c. Movement and quarantine issues; and d. Responsibilities of States and local authorities. USDA has leveraged HPAI funding to not only meet needs of the development of that response plan to but wherever applicable use it as a model to support broader infectious disease response planning and address CNAC recommendations. . Status of USDA Roles, authorities, resources and processes issues: The NAHEMS guidelines are available via EMRS, CD or via the web after registering for access. The draft National Avian Influenza Response Plan is available to the public and on USDA website. EM&D produced and distributed a CD to states describing prescribed USDA roles and authorities. Deployment policies are in place in VS. DHS has a credentialing project to identify animal response personnel needs. VS has developed a resource typing project for Incident Command System positions in animal diseases. EMRS/ROSS combine to create personnel credentialing tracking and request system. USDA signed an agreement with CNAC to conduct ~60 AI exercises with states. National and State Reserve Corps cooperative agreement funds for FAD training with technical experts provided. USDA completed two National Veterinary Stockpile exercises (NC and GA). Feedlot exercise planned for Jan 2007 in Texas. Status of Disposal issues: NAHEMS guidelines exist on disposal. Further carcass disposal plans and information is currently being reviewed and updated. APHIS encourages states to develop plans also. APHIS created an AI disposal working group which is co-hosting the December 4-7th National Carcass Disposal Symposium 2006 in Beltsville, MD (http://www.composting.org/NCDShomepg2.htm). Draft National Avian Influenza Response Plan includes specific AI disposal information. Status of Movement and quarantine issues: NAHEMS guidelines exist which are World Organization for Animal Health (OIE) guidance compatible and to which industry provided input regarding AI and FMD examples. Roles and authorities CD distributed to states including this topic. Status of Responsibilities of States and local authorities: National Surveillance Unit web site provides detailed case definitions. APHIS provides cooperative agreements for state-based FAD surveillance activities. APHIS provided information to states on how to access DHS Office of Grants and Training (former ODP) grants and has a liaison at DHS to facilitate process (S Heath). Facility Manuals are under development. For potential zoonotic outbreaks – work with public health: Procedures have been developed as part of National Strategic Stockpile for Pandemic Influenza. VS management team held discussion with CDC leadership. EM&D has a representative at CDC. MOU with CDC and NIH including laboratory response is in process. Dr. Diez briefly discussed the roles and responsibilities of the current 19 area emergency coordinators (AEC) and encouraged state and industry people to contact the person for their state if they have not heard from them. The AEC were heavily engaged in the HPAI efforts this year. He will continue to support hiring more AEC to ensure adequate coverage for every state. He briefly discussed challenges of juggling increasing new mandates for USDA such as PETS act with status quo staffing. Finally, he explained his management style and plans to continue to be engaged outside the beltway with constituencies.

Dr. Glen Garris, Director National Veterinary Stockpile, presented the mission, progress, stock pile materials, deployment methods and authorization, and intended use of materials in the National Veterinary Stockpile.

Dr. Sebastian Heath has been detailed for one year to the Homeland Security Office of USDA and is a liaison with DHS. One of his roles is to identify agencies and groups with common goals that are working on the same product and encourage them to work together. He reviewed accomplishments in HSO of USDA which is responsible for USDA department-wide coordination of efforts related to Homeland Security. Other agency activities that were briefly discussed: FSIS – development of prescripted mission assignments with FEMA; NRCS and EPA on carcass management; DOT; and Rural Development office of business continuity awards competitive grants which might be 4 resource for funds for the National Livestock COBP demo project. The committee and others might consider seeking input on the language in the Farm Bill that defines selection criteria for these grants. He reviewed activities of Food and Ag sector and government coordinating councils; DHS Infrastructure Protection Directorate (national performance goals, NIPP and criticality. DHS set the deadline for the sector specific plans of the NIPP so they are the only one who can change the deadline so letters from various associations (USAHA, NASDA, etc) should be sent to them. Homeland Security Institute has been contracted to develop methodology by which states can assess their critical infrastructure. DHS Office of Grants and Training has completed 4 H.S. Exercise Evaluation Program manuals and are almost done with a 5th. If your exercise design and after action report is compliant with their guidelines funding is more likely to be available. H. S Grants program this year had an increase in funding to state agriculture. 35 states received some funds that included agriculture.~9M funded to 18 states for primary agriculture investments and 24 states funded for integrated investments which included agriculture for items like broad based training, interoperable communications, etc. The HS grants for 2007 guidelines will go out late November and are due back late January 2007 with funding released in April 2007. There will be more emphasis on filling target capability gaps. Credentialing is moving forward through a workgroup under the oversight of the NIM Integration Center. Items to watch: Exercises – make them doable not overwhelming, build confidence and capability in steps. DHS and DHHS have formed a grants coordinating committee to reach agreement on cooperative agreements and competitive grants language. May form a committee wit h USDA in future. FEMA reorganization.

Dr. Tom McGinn, Director Veterinary and Agricultural Security, Department of Homeland Security, Chief Medical Office, gave an update on DHS activities related to animal emergency management. He recommended members review the Congressional Research Report on Agroterrorism Threats and Preparedness, RL32521, updated August 25, 2006 (http://www.cnie.org/NLE/CRS/abstract.cfm?NLEid=1472). This provides good material to support the value of why states need more funding to effectively prepare and what has been done so far. He also discussed Plum Island and open positions under recruitment; DHS Centers for Excellence; Lawrence Livermore National Laboratories, National Biosurveillance Information System which Dr. Kimothy Smith now directs; Vulnerability assessments; developing a search engine for OGT to be able to track funding by critical infrastructure; Aftermath of Hurricanes and Food and Ag GCC and SCC new hires funded by DHS at state and industry level.

Dr. Tom Kasari, Analytical Epidemiologist, USDA/APHIS/VS/CEAH/CADIA gave a presentation on Pathways Analysis, Risk Analysis, Regionalization, and Compartmentalization: Tools to Keep Interstate Commerce Flowing

John Adams, NMPF, gave a brief overview on the reasons behind the committee resolution in support of the National Livestock Continuity of Business Plan Demo Project. The draft project with 11 goals was sent to committee members in September.

Lt Colonel Chuck Tilton, TN and Major Mike Simpson (IA) presented the Civil Support Team overview of their role, responsibility, deployment process, analytical capabilities and their interest and willingness to collaborate and assist during an agricultural emergency.

Dr. Sandra Amass, Purdue University, reviewed the functionality, access and use of their on-line community resource tracking and management tool which is county or district based with only 1-2 emergency mangers in each county with approved access. She also reviewed the Purdue Distance learning Graduate program in Veterinary Homeland Security which is applicable to anyone in animal emergency response not just veterinarians. The certificate course requires 9 credit hours (4.5 required and 4.5 elective), is provided on line or by CD and must register with Purdue Graduate Division. Currently 2 courses are offered with 4 courses to start this spring. Cost is 255.00 per credit hour (15 lectures). Format is video with audio and ppt slides, audio with ppt slides or transcript only. 47 registered currently from 21 states. For more information on any of these programs go to their website National Biosecurity Resoure Center at www.BiosecurityCenter.org. Site also includes a disinfectant resource search tool.

Dr. Leslie Cole, Asst Veterinarian Oklahoma State, presented information on the development and conduct of a USDA certified Command and General Staff course provided in Oklahoma this past year. She suggested this efforts and material should not be lost and that the course should be put on by others. Dr Dave Warner, USDA, stated USDA plans to sponsor two sessions per year. Participants viewed this as very realistic and a rigorous training course for both team and individual effort to certify people in their functional position as a type II incident management team member. The course requires more trainers, evaluators, coaches and players than actual students.

5 Jane Colacecchi, Kirkwood Community College, presented information on their DHS funded AgTerror Emergency Responder course and Master Trainer Course. Both are intended for animal foreign animal disease emergencies. One is geared more towards first responders who also become qualified at training officers and is intended to orient them to how agriculture emergencies are handled in a state. The Kirkwood trainers will come to the state and teach the course incorporating the state’s specific agriculture emergency response plans and statutes and authorities. The Master Trainer course will be held Feb 7-9 in San Antonio, there is travel funds available for two people per state from state dept of agriculture or animal health and/or emergency management agency. Website for more information is www.agterror.org. The course is endorsed by USDA, WIFFS, Center for Food Security and Public Health, ISU; National Center for Foreign and Zoonotic Disease Defense.

Elizabeth Pyke, with the Iowa Governor office Washington DC legislative group provided information on how to develop a strategy and the challenges associated with soliciting federal funds from Congress for state agricultural emergency preparedness. What is the problem that needs fixing? Why is federal assistance needed? What is benefit to all congressional districts? Form coalitions; make sure Congress is able to do it (authority, etc). Repeat it often. Challenges are Congress jurisdiction for agriculture vs homeland security within committees; agriculture is seen as local issue, low priority, not affecting many, coalitions are not formed, Congress is focused elsewhere, states are not seen as integral to animal emergency response, Congress does not understand how ag works nationally (movement, etc). Need to show national impact, link to preparedness goals, educate, include zoonotic potential and public panic which are potentially preventable outcomes. DHS has bulk of new monies but USDA has authorities in emergency. She provided an overview of a comprehensive package which the multi-state Midwest consortium are working on and will share with the CAEM when they have completed the partners review.

Business Meeting: Dr. Bob Ehart gave an update on the work of the All Hazards subcommittee and the evolution of the current resolution as well as the outreach efforts to engage other groups including non-government organizations into review and input. He particularly noted the tremendous efforts of Dr. Kevin Dennison and noteworthy consistent and invaluable review and input by Dr. Cindy Lovern, AVMA. The subcommittee will sunset after the resolution is passed. The resolution was discussed and a few revisions and additions were made.

The National Livestock COBP resolution and National Carcass and Specified Risk Material Disposal Resolutions were discussed with very minor edits.

All three resolutions passed unanimously with a quorum of the committee voting in person or by proxy. No members volunteered for the subcommittee on SSP of the NIPP. Marilyn will forward material to the full committee for input.

Future conference calls will continue to be the last Thursday of the month at 11 Eastern time.

Animal Health Information Systems Committee, USAHA/AAVLD Joint Chairs: Bruce Akey and Francois Elvinger, 12:30-5:30pm, October 15, 2006, Marquette

USAHA Committee Members: Mr. John B. Adams, VA; Dr. J. Lee Alley, AL; Dr. Stan D. Bruntz,* CO; Dr. James T. Case,* CA; Dr. Max E. Coats, Jr., TX; Mr. Michael Coe, UT; Dr. Robert J. Eckroade, PA; Dr. Mark Engle, KY; Dr. Jaime Estupinan, VA; Dr. Peter J. Fernandez, AE; Dr. Robert Fourdraine, WI; Mr. Bob Frost, CA; Dr. Jennifer Greiner, IN; Dr. David P. Hertha, AL; Dr. John P. Honstead, CO; Dr. Robert F. Kahrs, FL; Dr. Stanley H. Kleven, GA; Dr. Paul Knepley, PA; Dr. Elizabeth A. Lautner, IA; Dr. Donald H. Lein, NY; Ms. Kelli Ludlum, DC; Ms. Jodi A. Luttropp, VT; Ms. Janet Maass,* CO; Mr. Kevin D. Maher,* IA; Mr. Larry D. Mark,* VA; Dr. Michael Martin,* SC; Dr. Charles E. Massengill, MO; Dr. Deidre Qual,* ND; Dr. John R. Ragan, MD; Dr. Valerie Rice, AZ; Dr. Stanley R. Robertson,* MS; Dr. Leon H. Russell, Jr., TX; Dr. Mo D. Salman, CO; Dr. A. David Scarfe, IL; Dr. Jack L. Schlater,* IA; Dr. John A. Schmitz, NE; Dr. Robert Smith,* VA; Ms. Chris Spaulding,* WA; Dr. David Thain, NV; Dr. Mark C. Thurmond,* CA; Mr. Victor Velez, CA; Dr. Stephen E. Weber,* CO; Mr. David A. Wiklund, MN; Dr. Saul T. Wilson, Jr., AL; Dr. Nora E. Wineland, CO.

AAVLD Committee Members: Helen Acland, Beverly Byrum, Craig Carter,* James T. Case,* Patricia Casey, Robert Eckroade, Robert Eisner, Rodney Frank, Joseph Garvin, Robert Glock, Jay Kammerzell,* Heidi Kassenborg, David Kinker, Don Lein, Ron Lewis, Charles Massengill, Grant Maxie, Carol Meteyer, Claudia Munoz-Zanzi, Pam Parnell, Kevin Razzaghi, Mo Salman, Beverly Schmitt, Marilyn Simunich, Mark Thurmond,* Susan Turnquist, Mark Walter, Jay Weidner,* Randy White.

*members present at meeting 6

The Animal Health Information Systems Committee (AHISC) held its 9th annual meeting as a joint committee of USAHA and AAVLD on Sunday, October 15, 2006 from 12:30 to 5:30 p.m. in Minneapolis, MN. Attendance fluctuated between 25 and 40 people.

Dr. Akey (Cornell University) welcomed the participants and presented the meeting agenda. Oversight of design, implementation and expansion of the National Animal Health Reporting System (NAHRS) has constituted the principal activity of the committee between meetings as the AHISC co-chairs also co-chair the NAHRS steering committee. Dr. Stanley Bruntz, NAHRS Coordinator at the National Surveillance Unit (NSU) of the USDA:APHIS:VS:Centers of Epidemiology and Animal Health, presented the annual report on the status of the NAHRS. With two more States now reporting since 2005, NAHRS presently assembles animal disease data from 44 States. Only Connecticut, Georgia, Iowa, Missouri, New Mexico and Rhode Island are non-participants to date. The NAHRS Online Reporting Application which was developed and implemented in 2005 has greatly simplified and facilitated reporting, and, in conjunction with additional administrative assistance from the NSU, has lead to consistent 12 month reporting by all participating States. Dr. Bruntz also laid out some challenges for aquaculture disease reporting and representation of sufficient and diversified expertise, i.e. finfish, mollusks and crustaceans in the working group. Currently NAHRS only collects disease information on 5 of 24 ‘aquaculture’ diseases, including only finfish but not mollusk or crustacean disease. He also indicated that a VS National Aquaculture Health Plan is in development. Dr. Bruntz also reported on the Equine Working Group’s request for expanded equine health reporting, specifically for enhanced EIA reporting. Reporting should be expanded to include numbers of tests, and numbers of positive and negative horses. This reporting would simply replace the current annual EIA testing reporting being done by each state, utilizing the on-line reporting capabilities of NAHRS to simplify and streamline the process. Currently a plan is being developed for piloting the group’s request. Dr. Bruntz also reported on the NAHRS Steering Committee meeting in Fort Collins in September. A proposed action item was to change the structure of the committee to reflect the continued evolution of the system from the 7 pilot States to now 44 States. The committee had proposed to change representation by 7 pilot States on the committee to inclusion of a State representative from each of the 5 USAHA regions, plus potential inclusion of regional AVIC representation and other representatives. A motion for this change was made, seconded and approved by membership vote. After Dr. Bruntz’s presentation, and in the business section of the meeting, members and attendees discussed the identified need for a unified federal list of notifiable and reportable diseases. All States have reportable lists which in general include most of the diseases listed by the World Association of Animal Health (OIE). Committee members introduced, proposed and seconded a motion to recommend that CEAH direct its staff to compile and evaluate all current disease reporting and notification requirements in all States and suggest a federal list of reportable diseases for consideration at the 2007 Annual USAHA Meeting in Reno, NV.

Dr. Aaron Scott (USDA:APHIS:VS:CEAH:National Surveillance Unit) reviewed activities, progress and current efforts made towards the construction of the National Animal Health Surveillance System. The recently released Surveillance and Data Standards document will inform and guide all Veterinary Services national and regional surveillance planning, development, implementation, operation and evaluation. The document provides guidelines on types and formats of data to be collected, as well as for proper data entry, storage and structuring of data systems for integration with existing and future databases of VS, States and other stakeholders in their regional and local surveillance efforts. There is a clear mandate for science-based planning within political, policy and resource constraints. National Surveillance Unit staff are working out processes that include the first phase implementation of Classical Swine Fever (CSF) surveillance based on the plan developed by the NSU and using the National Animal Health Laboratory Network; completion of the Scrapie surveillance evaluation and Brucellosis surveillance evaluation; development and posting of the surveillance inventory, presented below; completion of enhanced BSE surveillance; evaluation and planning for maintenance BSE surveillance; Avian Influenza surveillance planning; Rift Valley Fever surveillance planning. Ongoing activities include the development of a Vesicular Disease surveillance plan; development of targeted surveillance methods; and investigation of sentinel and syndromic surveillance methods.

Dr. Tracey Lynn (USDA:APHIS:VS:CEAH:National Surveillance Unit) presented the recently launched US Animal Health and Productivity Surveillance Inventory which is posted at www.aphis.usda.gov/vs/nahss/inventory.htm and which is a database application that enables users to search for information about surveillance and monitoring programs, epidemiologic studies, and other activities related to animal health in the United States. Information is accessible and searchable by animal species; disease, condition or pathogen; data source or location of data collection; specimen type; information category, such as animal health surveillance program or study, food safety surveillance or trade related monitoring program; and agency responsible for the various programs or studies.

7 Dr. Mark Thurmond, University of California, Davis, presented the ‘FMD BioPortal: a real time, web-based system for secure routing of surveillance data,’ a project of the Foot and Mouth Disease (FMD) Laboratory at UC Davis School of Veterinary Medicine in collaboration with the Artificial Intelligence Laboratory of the University of Arizona, Tucson. He presented an overview of current activities in developing specific BioPortals for FMD global surveillance and animal disease monitoring. Collaborative efforts include development of FMD BioPortal for the database used by the FMD World Reference Laboratory in Pirbright, U.K. The system allows for remote and secure retrieval of specific data based on user-specified input criteria (country, serotype, species, etc). Output includes tables, graphs, spatio-temporal visualization of the case reporting, geographic display, visualization via Google Earth, and spatio- temporal cluster analyses. A new system is being developed for surveillance of FMD virus genomic variation, which presents phylogenetic analysis and display of genetic variation for FMD viruses isolated world wide. In cooperation with the Food and Agriculture Organization, the Dutch Committee on Afghanistan, and the Afghanistan government, a BioPortal prototype is being developed to monitor 12 diseases of livestock and poultry in Afghanistan. To date, data and data summaries and displays are available for one year. The presented BioPortal applications illustrate how surveillance information can be captured, analyzed, displayed, and routed securely in real time to those who need the information.

Dr. Jim Case, California Animal Health and Food Safety Laboratory System, University of California, Davis, gave a presentation entitled ‘Limitations of Surveillance System Data and Information Systems as Action Triggers.’ There is increased interest in syndromic surveillance and early detection of emerging and foreign animal diseases. A number of areas within the National Surveillance Unit’s strategic plan specifically mention the need to detect and rapidly disseminate information about animal health events. The development of national information systems to support this rapid detection and information dissemination is a key strategy in meeting these needs. However, there are a number of limitations that exist as obstacles to dependence on information systems as the primary mechanism for disseminating information about critical animal health events. 1) Procedural Limitations - Procedural notification may be linear, delaying notification outside of a jurisdiction; restrictive protocols may result in meaningful but non-program specific data to be lost; 2) Temporal Limitations - Post-discovery actions begin before data is available in an electronic information system; 3) Interoperability Limitations - inability to share across surveillance programs; need for post-processing prior to analysis; a lack of comparability resulting in missed associations; 4) Policy Limitations - data collection may be constrained in scope and sample size; release of data to a central repository may be substantially delayed or prevented from being transmitted. Information systems supporting surveillance may not play a large role in event detection, but are very valuable in detecting incidence- based animal health events or events that are geographically separated but temporally associated.

Mr. Mark Koeneker from USDA:APHIS:VS:CEAH presented an overview of Veterinary Service’s development plans for animal health information systems. One example is a system, including hardware and software, to facilitate the collection of sample information and other data by field personnel and the subsequent seamless transmission of that data to laboratory, state and federal databases. This system is intended to be a model of information system architecture for most field data collection efforts. Starting with a pilot project in California last year that focused on sample data collection on poultry farms, the system is being expanded to inspection and sample data collection in Live Bird Markets in several states. Future plans include adaptation of the system to the Classical Swine Fever surveillance project among others. In each case, both a mobile data capture platform (tablet PC, optical pen, PDA) and a web-based interface are being created to facilitate data entry under diverse conditions. A second major effort underway involves the evolution of the Generic Database (GDB), an Oracle forms-based general application customized by each state for its use, to the Animal Health Surveillance and Monitoring (AHSM) application, a web- based interface with enhanced functionality, data validation and data quality standards. Modules are under development for the Avian Influenza, Classical Swine Fever, Scrapie, Bovine Spongiform Encephalopathy and Chronic Wasting Disease surveillance programs. In addition to data collection, mapping and spatial analysis functionality is being included to add value to the user.

Dr. William Buisch, North Carolina, laid out some recent technologic advances in data capture and entry, presenting optical pens, hand-writing recognition software and forms development software. Use of these technologies has greatly improved both the efficiency and accuracy of data collection. Estimates of time saved on completing forms with these tools are up to 67%. Time savings may result in greater accuracy of entered data.

Dr. Pam Hullinger from the Lawrence Livermore National Laboratory (LLNL) gave an update on advanced diagnostics and expanded capabilities for foreign animal disease detection and surveillance and the implementation of a supporting information systems infrastructure to support “field-to-finish” diagnostics in a presentation entitled ‘Agricultural Security Domestic Demonstration and Application Program Update (AgDDAP).’ The LLNL, under support from the Department of Homeland Security (DHS) and in collaboration with the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS), has developed a candidate multiplexed 8 nucleic acid-based assay that simultaneously tests samples for foot-and-mouth disease virus and six other viruses that cause clinical signs in animals that are indistinguishable from Foot and Mouth Disease (FMD). The assay could enable early detection of FMD, which is critical for the reduction of spread and economic impact of the disease. The National Animal Health Laboratory Network (NAHLN) together with the National Veterinary Services Laboratory (NVSL) at the Plum Island Animal Disease Center (PIADC) are the front-line for FMD diagnosis and are potential end-users of this new technology. During November and December of 2005, thirteen NAHLN laboratories and the NVSL, PIADC received training, "leave-behind" instrumentation, reagents and consumables to conduct the assay. These labs then participated in a nationwide interlaboratory comparison of the multiplexed assay, during which more than 3,000 blinded samples were analyzed and greater than 52,000 individual assays conducted. The overall assay success rate was greater than 92%. As a part of this collaborative effort, two pilot demonstrations of a rapid, scaleable, high-throughput laboratory system were conducted at the California Animal Health and Food Safety Laboratory (CAHFS), University of California at Davis, CA and the Veterinary Diagnostic Laboratory, Colorado State University, Fort Collins, CO. This high-throughput system could be used to provide timely, scaleable diagnostic laboratory support during a foreign animal disease outbreak. During each demonstration, one-thousand clinical samples were processed within ten hours using only two technicians. Automation encompassed the transfer of liquid samples from collection vials to a 96-well plate, addition of an internal control, nucleic acid purification, multiplexed reverse transcriptase polymerase chain reaction (RT-PCR) amplification, liquid array hybridization, detection and data analysis. Integration of USDA APHIS's electronic sample identification, tracking, and results reporting technology with each participating laboratory's Laboratory Information Management System enabled the live demonstration of a functional end-to-end system for surge capacity. The analytical performance characteristics of the multiplex assay will be evaluated in the months to come. Once the acquisition and analysis of the analytical data is complete, diagnostic performance data will be gathered in collaboration with the NAHLN, and other US and international partners.

Approved Methods Committee Chair: Jim Pearson, 8:00-10:00am, Friday, October 13, 2006, Duluth Room, Minneapolis Hilton

Committee Members in attendance: Jim Pearson, Barb Martin, Jim Evermann, Pat Blanchard for Jim England, Jane Christopher-Hennings, Catherine Barr, Deepanker Tewari, Jim Case, and Mark Thurmond

There were 37 members and guests in attendance. James E. Pearson, Chair, conducted the meeting.

Approved Methods Committee’s role in Laboratory Accreditation: Terry McElwain discussed the Note that had recently been appended to the AAVLD Minimal Essential Requirements. This Note provides clarification on approved methods to be used by laboratories seeking AAVLD accreditation:

Note: Test methods may be classified as “validated for use” by meeting one or more of the following criteria: 1) Endorsed or published by reputable technical organization (e.g.: OIE Manual of Standards for Diagnostic Tests and Vaccines, US Food and Drug Administration’s Bacteriologic Analytic Methods, Bergey's Manual of Determinative Bacteriology, American Society of Microbiology Manual of Clinical Laboratory Immunology, American Association of Avian Pathologists Isolation and Identification of Avian Pathogens, EPA protocols, American Fisheries Society Bluebook, AOAC, NAHLN)) or 2) Published in a peer-reviewed journal with sufficient documentation to establish diagnostic performance and interpretation of results. or 3) Documentation of internal or inter-laboratory comparison to an accepted methodology or protocol (reference standard). and 4) Documentation of internal or inter-laboratory performance using known reference standard(s) for the species and/or diagnostic specimen(s) of interest.

The Approved Methods Committee discussed this clarification and agreed that it was appropriate. It appears that this clarification may have completed the charge of the Approved Methods Committee. There was discussed further later in the meeting.

Completed Matrices for approved tests: 9 The following representatives from the discipline committees discussed the progress on utilizing the matrices for approved methods, which had been developed by this committee: Pat Blancahard, Serology Committee; Catherine Barr, Veterinary Analytical Toxicology & Mycotoxin: Jim Evermann, Virology Committee: Deepanker Tewari, Bacteriology Steering Committee; The Pathology Committee chair, Matti Kiupel, could not attend. The discipline committees have been utilizing and expanding the matrices to help identify approved methods. The discipline committees agreed that they would continue to assist laboratories to identify validated methods that meet the AAVLD accreditation requirements.

National Animal Health Laboratory Network (NAHLN) Methods Technical Working Group, Barb Martin, Coordinator for the NAHLN, made a presentation on this Working Group. The Co-Chairs of the group are Terry McElwain, and Barbara Martin. The purpose of the Working Group is • Vehicle for communication among NAHLN laboratories on current methods • Serve as a liaison with the ICLN Methods Technical Working Group. • Key role in methods assessment and ongoing evaluation. • The group will provide input on various aspects of methods validation and approval of methods including: o Review of available methods and associated gaps o Identification of potential new technologies o Validation criteria o Dossier review o Assay approval process o Equivalency of modified methods or for adaptation to new platforms o Continual performance assessment of assays o Development of performance characteristic summary documents for NAHLN assays o Issues associated with transfer of existing and new technologies to laboratories

The current activities of the Working Group are: -hold working session on validation, performance characteristics, equivalency of test methods -assay development, implementation, assessment for FMD and AI - Provide an open session for laboratory feedback on: Data generated on current assays by NAHLN labs Current assay performance in NAHLN labs – questions, issues, concerns

Planned future activities of the Working Group: -Working session on future test development and implementation - Role of NAHLN labs in validation

Status of USDA validation studies: Tammy Beckham, the recently appointed Head of the Proficiency and Validation Services Section (PVSS), Foreign Animal Disease Laboratory, National Veterinary Services Laboratories, reported on validation studies that were underway in her Section. They include: o Finalization and review of dossiers for the Foot and Mouth Disease rRT-PCR and Plum Island Animal Disease Center’s Classical Swine Fever rRT-PCR assays o The manual 96 well extraction- Equivalency studies for: Classical Swine Fever (swab and tissue) Foot and Mouth Disease (swab and epithelium) o PCR platforms—96 well-equivalency studies for the different platforms o Evaluation of high throughput initiatives/automation o Proficiency panels and internal controls, use of armored RNA o African swine fever, Rinderpest, CBPP, lumpy skin disease test validation

Assay Approval Process: Development of a Framework for International Certification by World Organization for Animal Health (OIE) of Diagnostic Tests Validated as Fit for Purpose Peter Wright, Fisheries and Oceans Canada, Moncton, New Brunswick, presented the OIE’s approach to test validation and the key points are summarized here. The OIE approach is explained in detail in two chapters in the OIE Manuals of Diagnostic Tests for Terrestrial and for Aquatic Animals. One chapter addresses validation of diagnostic assays for infectious diseases and the other validation and quality control of polymerase chain reaction methods. OIE approach to test validation: Diagnostic test applications in animal health (purpose) Validation and performance characteristics (fitness) 10 Assay certification (recognition) Key points of the OIE test validation chapters: 1. Selection of an assay fit for its intended purpose 2. Initial assay development considerations 3. Optimization and standardization 4. Repeatability 5. Analytical specificity and sensitivity 6. Assay performance characteristics (diagnostic specificity and sensitivity) 7. Threshold determination 8. Performance estimates 9. Comparison and harmonization 10. Reproducibility 11. Program implementation 12. Monitoring validity of assay performance Validation of a test is defined as: Process through which a test method is confirmed to be fit for the intended purpose Examples of purposes for a test: 1. Demonstrate population ‘freedom’ from infection a) historical freedom b) free with vaccination c) re-establishment of freedom post-outbreak 2. Demonstrate individual animal freedom for trade purposes 3. Eradicate infection from defined populations 4. Confirm clinical cases 5. Estimate prevalence to facilitate risk analysis 6. Determine immune status of individuals or populations Principles of validation of diagnostic assays for infectious diseases: • Perspective of laboratory results: A validated assay consistently provides test results that identify animals as positive or negative for an analyte or process. This is referred to as analytical validity • Perspective of an assay developer: Assay validation is the development and verification of test method performance characteristics at a defined level of statistical confidence for a particular target population. This is referred to as diagnostic validity

Discussion of future activities of the Committee: A discussion was held as to the future of the Approved Methods Committee. The charge of the committee was to assist the Accreditation Committee in identifying approved methods. The Accreditation Committee has now provided specific guidelines to the laboratories that are requesting approval. It would appear that the Approved Methods Committee will no longer play a role in this selection. There was some discussion about the Approved Methods Committee continuing to provide guidance and there was a comment that this committee was a forum for the smaller laboratories that was not available elsewhere. Deep Tewari also stated that this committee was the only forum where all the committees interact at the bench level. Otherwise it was generally agreed that the committee had completed its mandate. It was also agreed that the discipline committees should continue to provide guidance on approved methods as they were technically more qualified to provide this input.

The Chair will refer the decision on the future of the Committee to the AAVLD President.

Aquaculture Committee, USAHA/AAVLD Joint Chairs: Scott LaPatra and Kevin Snekvik, 1:00-6:00pm, Saturday, October 14, 2006, Carver Restaurant

1. Scott LaPatra called the meeting to order 2. Randy MacMillan provided an update from the National Aquaculture Association (NAA). Key points included: a. Review of NAA mission b. Viral Hemorrhagic Septicemia Virus (VHSV) i. Concern regarding broad range of species infected and significant mortalities and thus impact on commercial producers ii. Considers Great Lakes strain of VHSV a foreign animal disease iii. NAA Action Request: Additional research into disease and species impacted c. Minor Use Minor Species (MUMS) i. Reviewed background 11 ii. NAA Action request: Request 30 day public comment extension d. Antibiotic resistance/ residue i. NAA at recent meeting with WHO, FAO, OIE, outcome of meeting is that aquaculture use of antibiotics has a minor effect on the development of antibiotic resistance of human pathogens e. National Animal ID Program i. NAA has continued concern regarding the effect on the aquaculture industry ii. NAA is taking a “watch and see” approach to see what the USDA is going to do. f. Animal Welfare i. There is continued lack of scientific evidence that fish feel pain/ suffering ii. NAA has provided comment to the USDA regarding OIE guidelines in order to help craft a formal US opinion to the OIE g. NAA is working to promote a positive public perception regarding the food safety, environmental sustainability of aquaculture by educating the public in a cost effective manor. Noted the NAA/ AAAS Symposium in San Francisco in 2007 h. Activity with NOAA i. Testified to promote/ increase effective offshore aquaculture production

3. Nick Saint-Erne provided an update from the AVMA – Aquatic Vet Med Committee (AVMC). A copy of the Aquatic Veterinary Medicine Committee report from the Proceedings of the 143rd Session of the AVMA House of Delegates. Honolulu, HI July 14, 2006. Key points included: a. The AVMC established a draft policy for aquatic ecosystems for the Committee on Environmental Issues (CEI). The CEI is taking the policy under review. The AVMC also helped update the AVMA’s 2003 policy on Agriculture Waste Management at the request of the CEI. b. The AVMC recommended and the executive board approved an AVMA policy on Extralabel Use of Veterinary Feed Directive Drugs for Minor Species c. The AVMC reviewed and commented on several pieces of legislation which included support for the National Offshore Aquaculture Act of 2005; the non support for the Natural Stock Conservation Act of 2005 and the request for additional information regarding the National Aquatic Invasive Species Act of 2005. d. The AVMC reviewed the proposed Aquatic Animal Health Certificate for the export of aquatic animal and their live products. The AVMC was not in favor of the document since it would undermine USDA initiatives due to non veterinary endorsement. e. AVMC approved continued funding for the National Aquaculture New Animal Drug Approval (NADA) Coordinator, currently Dr. Roz Schnick. f. The AVMA and other stakeholders identified aquatic animal antimicrobials that were identified as critical for the United States. The drugs were noted. The list of drugs were put forth to the OIE in Feb 2006. g. Dr. Donald Prater was nominated for the Joint FAO/WHO/OIE Expert Consultation on Antimicrobial Use in Aquaculture and Antimicrobial Resistance which met in June 2006. h. Ornamental Therapeutics: Information regarding unapproved drugs which are being sold over the counter at pet stores was compiled and provided to the American Pet Product Manufactures Assoc. Pet Smart has since pulled antibiotic tablets and formulations that could be easily utilized for non aquaculture species. i. Various involvements of the AVMC in animal welfare issues and updates were covered j. Online Aquatic Veterinary Resources discussed: i. Aquavet.com ii. Aqua vet med newsletter via email: for further information contact Dr. Scarfe k. Journal of AVMA wants to expand articles to include aquaculture reports l. AVMA is looking to increase continuing. education for veterinarians in aquaculture m. Establishment of the North American Aquatic Veterinary Association n. New USDA import inspection of carp for Spring Viremia of Carp virus

4. Scott LaPatra provided an update from the Fish Health Section / American Fisheries Society (AFS). a. Background regarding the organization touched upon b. Next meeting of the AFS FHS in Jackson Hole, WY, June 2007 c. Bluebook and standardized Inspection Manual available d. Significant concerns include animal welfare issues

5. Jerry Heidel provided an update on the National Animal Health Reporting System. 12 a. Background covered. Reporting procedures would include a confirmed diagnosis in a specific state but there would be no specific backtracking b. Progress has included reformulating the committee c. Liaison to AVMA: Dr. Guppy Blair d. Future goals outlined i. Establish definitions/ concerns for aquaculture industries including 1. separation of fin fish species, crustaceans and other animals 2. Concerns for various US coasts ii. Defining a producer and how to include tribal production and resource management production iii. Defining the criteria for a definitive diagnosis of a pathogen iv. Defining laboratory reporting criteria and ensuring laboratory involvement including private laboratory reporting.

6. Gary Ergie provided an update from APHIS. a. National Aquatic Animal Health Plan (NAAHP) i. Provided Jan 2006 NAAHP pamphlet ii. Chapters 1-4 are currently listed on website and are being updated iii. Chapters 5-7 are in progress with a target completion date of June 2007 b. Spring Viremia of Carp i. Surveillance program a. 23 states involved with program and 9000 fish tested b. Samples from farmed populations c. All samples are negative via virus isolation ii. Future program: test wild populations based on seroprevalence; negative to date iii. New import regulations require live fish need to have an export health certificate confirming negative status. c. Infectious Salmon Anemia virus i. Now considered endemic in Maine ii. Emergency funds end in Sept 2006; no additional funding from Congress iii. Additional, but reduced, funding by Maine Department of Marine Resources through 2008 iv. Risk analysis in progress for import / spread of ISA d. Viral Hemorrhagic Septicemia Virus (VHSV); Great Lakes strain i. Emergence of a fresh water pathogen with 13 new species reported infected ii. Infection studies show that virus strain can infect Channel catfish and Coho via RT-PCR but lack clinical disease iii. Action to date: 1) Funded $25,000 to Cornell for epidemiology study, 2) Published industry alert e. New Export Health Certificate i. Option of importing country if they want to use form ii. Used for movement of fish out of United States iii. Drafted so certificate can be used by APHIS/NOAA/USFW

7. John Fischer provided an update of the National Fish and Wildlife Health Initiative. A. Background that the national resource managers have increased dealing with disease issues. B. The 2005 working group has put together the principles endorsed by Fish and Wildlife agencies for a national plan; program not expected to mandate at the local/ state level. C. Principles include 1. Recognize that health management is a key component of fish and wildlife resource management, 2. promote science based management strategies, 3. prevention is the primary method versus control or eradication disease strategies, 4. initiative recognizes that state fish and wildlife agencies are responsible for managing disease, 5. must protect and support state agencies, 6. recognize the wildlife/ domestic disease interface, 7. recognize interstate and international coordination, 8. initiative must include public education regarding disease issues in wildlife and integrated prevention and management program. D. The first draft composed by Jan 2006, went to Federal agencies in March 2006, went to four regional Fish and Wildlife agencies in April, went to non-government organizations in August, final revising after September. E. Goals: 1. build capacity in state fish and wildlife management agencies regarding health issues via developing processes, training people, and building support via communication between agencies,

13 stakeholders, public and policy makers. 2. minimize negative impacts by preventing introduction, early detection and rapid response.

8. David Morris provided an update from the National Animal ID (NAID) Program. David provided an overview of the goals of the program and current status of the terrestrial program. Current status of the aquaculture NAID Program is that the program is voluntary with no contingencies. Premise identification would be the major component of the program. David went on to explain the swine/ sheep program which are developing “lot” programs. The difference between the tracking program and the tracing program were described and it was shown how data from the two would be expected to interface.

9. David Gollon provided background of live game fish/ bait fish production and live hauling from a producers standpoint. The extensive interstate movement of fish was highlighted. Concerns expressed included client confidentiality, interstate testing and control of the VHSV Great Lakes strain, and reliable/ stringent testing protocols.

10. Scott LaPatra conducted new business. a. A resolution from the WI Department of Agriculture was presented by Myron Kebus. The resolution read: “The United States Animal Health Association (USAHA) requests that the United States Department Agriculture (USDA), Animal Plant Health Inspection Service (APHIS), Veterinary Services (VS) develop and implement an interim emergency regulation to prevent the movement of VHS virus from positive to negative areas.” The merits of the resolution were discussed at length. The resolution was ultimately passed. b. A resolution from the National Aquaculture Association was presented by Randy MacMillan. The resolution read: “USDA-APHIS-VS should conduct a risk assessment for Oncorhynchus masou virus disease (OMVD) as quickly as possible using an OIE recognized risk assessment procedure. If the risk assessment demonstrates that OMVD is a significant risk to United States fisheries resources, the United States Animal Health Association (USAHA) requests that the United States Department Agriculture (USDA), Animal Plant Health Inspection Service (APHIS), Veterinary Services (VS) recommend to the Office Internationale Epizooties (OIE) that OMVD be urgently considered for re-listing.” The merits of the resolution were discussed at length and wording of the resolution was debated and eventually modified. The resolution was ultimately passed. c. A resolution from the American Fisheries Society-Fish Health Section was presented by Scott LaPatra. The resolution read: “The United States Animal Health Association (USAHA) requests that the USDA, APHIS, NVSL develop and make available a standardized source of reagents for the diagnosis of Office Internationale Epizooties (OIE) notifiable or National Aquatic Animal Health Plan (NAAHP) listed diseases that are not readily available from commercial sources.” The merits of the resolution were discussed. A slight modification in the wording of the resolution was requested, accepted by the committee and the resolution was modified. The resolution passed. d. A resolution was brought from the floor. The resolution read: “The USAHA Aquaculture Committee urges the USDA, APHIS, VS, the US Department of Interior and the US Department of Commerce to propose line item funding in future budgets to adequately fund the NAAHP.” The merits of the resolution were discussed. The resolution passed.

11. As there was no old business Scott LaPatra adjourned the meeting. Attendance Scott LaPatra Clear Springs Foods, Inc. [email protected] P.O. Box 712, Buhl, ID 83316 (208) 543-3456 Kevin Snekvik WA Animal Disease Diagnostic Lab [email protected] P.O. Box 647034, Pullman, WA 99113-7034 (509) 335-6331 Gary Egrie 4700 River Rd., Riverdale, MD 20737 [email protected] Peter Wright Gulf Fisheries Center, 343 Universite Ave, [email protected] Moncton, New Brunswick, Canada, E1C9B6 Deborah Brennan 141 Experiment Station Road, P.O. Box 225, [email protected] Stoneville, MS 38776 David L. Morris 2150 Centre Ave, Bldg B-M53E20 [email protected] Fort Collins, CO 80526 T.J. Myers USDA APHIS [email protected] 4700 River Rd, Riverdale, MD 20737 Suzanne Gibbons- UW-WVDL, 445 Easterday Ln, Madison, WI [email protected] 14 Burgener 53706 (608) 262-5432 Melisse Schilling USDA APHIS-CVB [email protected] 510 S. 17th St Ames, IA 50010 Sabrina Swenson USDA-APHIS-VS-NVSL [email protected] 1800 Dayton Ave Ames, IA 50010 Nick Saint-Erne 19601 N. 27th Ave [email protected] Phoenix, AZ 85027 Mark Wilson NVSL mark.a.wilson.usda.aphis.gov 1800 Dayton Ave Ames, IA 50010 Nancy Frank* Michigan Dept of Agriculture [email protected] P.O. Box 30017 Lansing, MI 48909 Roger Hanshaw WV Dept of Agriculture [email protected] 1900 Kanawha Blvd Charleston, WV 25305 Fred L. Cunningham Mississippi State University [email protected] PO Box 6100 Mississippi State, MS 39762 Lanny W. Pace Mississippi State University [email protected] P.O. Box 97813 Pearl, MS 39288 Joyce Steinbock BioMed Diagnostic [email protected] 1388 Antelope Rd White City, OR 97503 Don Hoenig 28 SHS [email protected] Augusta, ME 04333 (207) 287-3701 Peter Vanderloo WVDL [email protected] 455 Easterday Ln Madison, WI 53706 Ben Smith 22829 4-S Ln [email protected] Juliaetta, ID 83535 Randy MacMillan NAA [email protected] Charlestown, WV Stan D. Bruntz APHIS VS CEAH [email protected] National Surveillance Unit 2150 Centre Ave, Bld B Fort Collins, CO 80526-8117 Charles Palmer CDFA Animal Health [email protected] 2135 Civic Center Dr. Rm 8 530-225-2140 Redding, CA 96001 Myron Kebus WI Dept of Agriculture [email protected] 2811 Agriculture Dr. Madison, WI 53708 David Gollon Gollon Bait and Fish Farm [email protected] 5117 Hwy 191 Dodgeville, WI 53533 Jerry Heidel OR Veterinary Diagnostic Lab [email protected] P.O. Box 429 541-737-6964 Corvallis, OR 97339-0429 Michael Greenlee Austin, TX [email protected] John Fischer SCWDS, Vet Med University of GA [email protected] Athens, GA 30602 706-542-1741 *Interested in becoming new members

Bacteriology Steering Committee Chairs: Deepanker Tewari and Brenda Love, 8:30pm-9:30pm, Saturday, October 14, 2006, Board Rm 1 15

Attendees: Dr(s) Wu, Tewari, Oaks, Maddox, Rajeev, Hyatt

The subcommittee Co-chairs reviewed minutes from their meetings. The minutes of the sub-committee meetings are being submitted separately.

The highlights and points of interest for next year are, the two sub-committees will be swapping allotted times next year to accommodate a symposium that is being planned by the antimicrobial subcommittee. Dr Maddox and Dr Rajeev will be putting the check test together with help of NVSL and other volunteers for the next year. Suggestions for improvements can be submitted directly to them. Nominations for Trek excellence award for 2007 are due March 1st, 2007. Details of which can be found on AAVLD web site.

Validation of test procedures was discussed in length. The criteria for validation were distributed in the Bacteriology subcommittee meeting. These are also available from AAVLD essential requirement document (for most current info see AAVLD web site). Discussion highlighted the potential problems for compliance that relate to financial burden on each AAVLD lab to carry out inter/intra laboratory comparisons for all assays, and in deciding a gold standard when determining Sensitivity and Specificity. This is further complicated with variety in matrices/sample types and species that are tested in veterinary laboratories. The committee expressed strong desire to revamp the list of tests submitted by approved methods committee (based on OIE). It was agreed that a response will be sent to Accreditation committee for seeking guidance and communicating the problems that face us in implementing the validation criteria. Communication channels will be kept open as we go through implementation of new AAVLD requirements. The guidance from this committee at this time is to use methods where references can be cited and or to have background data on methods selected for use. Committee understands the dilemma for routine established procedures and will be working with members on this issue.

Dr Tewari finished his term. Replacement was sought but the members present at the meeting suggested that Dr Tewari carry on at this juncture when questions of validation, grandfathering and approved methods are still being finalized. The committee also recommended moving the meeting to Friday (5-6pm) or Saturday (11am-12noon) next year.

Antimicrobial Susceptibility Subcommittee Chairs: Doreene Hyatt and Ching Ching Wu, 1:00-2:30pm, Friday, October 13, 2006, Salon E Number of attendees: 38 1. Introductions and sign-up sheet 2. Old business a. Compilation of panel designs from different laboratories – not done because of information gained from check test samples b. Other old business 3. New Business a. Updates on CLSI regarding susceptibility testing i. CLSI interpretive criteria recently approved was reported ii. Members were informed of the revision of the M31 A2 (Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacterial Isolated from Animals; nd Approved Standard – 2 Edition) documents to M31 A3. The revised M31A3 is undergoing review and comment stage. The major revised text and table were highlighted in the committee meeting and comments solicited. Any additional comments please submit to CLSI VAST office or Dr. Ching Ching Wu at [email protected] within 20 days. The M31 A3 is much more user friendly and consistent with other CLSI documents. iii. Members were informed of the new CLSI publications that may be useful to the veterinary diagnostic laboratories. The list includes: M45-A, Antimicrobial Susceptibility Testing of Fastidious or Infrequently Isolated Organisms; Approved Guideline (May 2006) M42-A, Methods for Antimicrobial Disk Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guideline (June, 2006) M49-A, Methods for Dilution Antimicrobial Susceptibility Testing of Bacteria Isolated from Aquatic Animals; Approved Guideline (June, 2006) M100-S16, Performance Standards for Antimicrobial Susceptibility Testing; Sixteenth Information Supplement (January 2006) M39-A2, Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline (December 2005) 16 M2-A9, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard (January 2006) M7-A7, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard (January 2006) M24-S1, Updated Table with Quality Control MIC Limits for Mycobacterium peregrinum and Staphylococcus aureus When Testing Rapidly Growing Bacteria M27-S2, Updated Tables with Quality Control MIC Limits for Broth Microdilution and MIC Interpretive Breakpoints M44-S1, Updated Tables with Zone Diameter Interpretive Standards and Corresponding MIC Interpretive Breakpoints b. Round table on Issues/questions related to testing and reporting i. It was requested that the committee try to compile a list of disclaimers put onto AST results by various laboratories participating in the check test. c. Q and A for Bacti Check test regarding susceptibility testing i. Questions were raised about the use of antimicrobials in different animal species. Dr. McDonough (Cornell) said that he has an Excel file that was compiled by the committee that could be updated. d. Susceptibility testing system update Trek – new panel for bovine-swine testing is set to be released soon. Also, the new updates include a QC module that can keep track of QC results. There is an additional module for epidemiology that can be purchased. Biomic – the new version 3 has been released which has a better digital camera to give more accurate reading of blood agar plates and can read strip identification kit results (API, RapidId, etc.) as long as the panel can fit into the reading drawer.

Bacteriology and Mycology Subcommittee Chairs: Susan Sanchez and Sreekumari Rajeev, Friday, October 13, 2006, 8:00am- Noon, Salon E

¾ Check tests 2005: Susan Sanchez presented the correct results and statistical outcomes of the national bacteriology “check test”. Five clinical histories with one tube of frozen bacteria were sent to 55 laboratories. In total seven bacterial organisms had to be identified. There were two submissions that were mixed culture with two different bacteria. Five laboratories did not meet the deadline. The results of the participant (50) laboratories is as follows: o 44% (22/50) correctly identified the bacteria in all 5 submissions. o 30% (15/50) correctly identified the bacteria in 4 of the submissions o 16% (8/50) correctly identified the bacteria in 3 of the submissions o 10% (5/50) correctly identified the bacteria in 2 of the submissions This year results were sent before the meeting as discussed at last year’s meeting and this seems to have been a success. Five volunteers were identified to help the committee co-chair with case ideas and grading: Jing Cui OH, Pat McDonough of NY, Karen Post of NC, Karen Olsen from MN, and Debra Royal of NE.

¾ Aerobic Bacteriology News and updates. There were three excellent scheduled speakers for the meeting. -Brenda Morningstar Flugrad, Senior Microbiologist from NVSL presented “Conventional serotyping methods for Salmonella -Dr. John J Maurer from Poultry Diagnostic and Research Center, The University of Georgia on “Molecular methods to identify and serotype Salmonella species”. Mark Wilson from NVSL updated his findings of Leptospira diagnosis from NVSL. Thanks to all speakers and we had a very interactive session because of the excellent timely topics presented by all the speakers.

Additional topics that were discussed: Ellen Portis from Pfizer Animal Health presented some information on the diagnosis and antimicrobial susceptibility of Pasteurella trehalosi infections in cattle.

¾ Anaerobic Bacteriology news and updates. No updates. Dr. Songer had food poisoning. ¾ Mycology news and updates No news to report. 17

¾ Old business Dr. Deepanker Tewari, the Co chair of Bacteriology steering committee circulated information on the minimal essential requirements of the AAVLD approved committee and invited suggestions and recommendations from the committee members.

¾ New Business Dr. Sanchez suggested changing the time at which currently the Bacteriology Steering committee is held (Saturday’s at 8:30pm after the Trek dinner). Several members had express concern as this time was not conducive to good discussion and participation. The steering committee will consider the possibility of a time venue change during their next scheduled meeting.

Dr Sanchez stepped down as Bacteriology Co chair after 3 years of her contribution in Bacteriology Check test. Her contribution to bacteriology and mycology subcommittee was very much appreciated. Nomination for the next Co chair was requested. Dr. Ching Ching Wu nominated Dr. Carol Maddox. The bacteriology and mycology subcommittee approved the nomination and is happy to have Dr. Maddox on board.

Committee Chairs and Program Committee Joint Meeting Chair: Barb Powers, 1:30-4:00pm, Monday, October 16, Board Room 2 Review of 2006 program, meeting & issues for 2007 (50th anniversary) and 2010 (return to same MN hotel) No report submitted.

Constitution, Bylaws and Resolutions Committee Chairs: Dave Steffen and Gary Anderson, 5-6pm, Friday, October 13, 2006, Board Room 1

Attending: Dave Steffen, Gary Anderson and John Andrews.

Dr. Anderson agreed to be chair in 2007. The committee reviewed three proposed resolution and made editorial comments. Two minor by-laws changes were formatted and introduced for passage at the HOD meeting. A copy of the passed resolution and by-laws changes was provided to the secretary/treasurer for updating the by-laws. The wording for the increase in dues and the effective date was also modified by the committee and further amended in the HOD meeting before passage.

New Chair Gary Anderson KSU. Members John Andrews, Dave Steffen, Suggest recruiting one to two additional members not much busy work but we need about four people to assure we always have two or three at the meeting.

Enteric Diseases Committee Chair: Francisco Uzal, 3:00-5:00pm, Friday, October 13, 2006, Salon E Attendance: approximately 50 people

1-Scientific presentations

1.1- Is Clostridium difficile-associated disease a zoonosis? Glenn Songer, Department of Veterinary Science and Microbiology, The University of Arizona. This presentation was cancelled because Dr Songer was indisposed.

1.2. Current understanding of the genetic diversity of Mycobacterium paratuberculosis. Srinand Sreevatsan, Veterinary Population Medicine Department, Center for Animal Health and Food Safety, University of Minnesota

2-Update on Clostridium perfringens review articles (Songer and Uzal)

A series of monographs on Clostridium perfringens diagnostic criteria are being prepared by Glenn Songer and Francisco Uzal. The first one on diseases of pigs was already published in JVDI and the second (small ruminants) is being prepared. Other species will follow and an invitation was extended to attendants of the meeting and AAVLD members in general to collaborate on those.

3. Discussion of future goals and/or topics for the committee (Uzal) A questionnaire was distributed to people attending the meeting with the following questions regarding the future of the committee: 18

1-Do you think this committee should perform activities other than scientific presentations during the annual meeting? Please explain:

2-Do you prefer that at the annual meeting of the committee a single topic (e.g. Johnes disease) is dealt with or would you rather that we discuss several topics?

3-Please suggest topics that you would like dealt with at the annual meeting of the committee

4-Any other suggestions for the committee?

Although the answers to those questions are being analyzed now, there was general consensus that people would like to have short case presentations in future committee meetings. It was also agreed that a mixture of topics (as opposed to a single topic per year) would be more appropriate for the committee meetings.

If any body would like to make any suggestions for the future of the committee, please feel free to contact the chair (Francisco Uzal: [email protected]; Ph 909 383 4287)

Epidemiology Committee Chairs: Mark Thurmond and Francois Elvinger, 10:00am-Noon, Friday, October 13, 2006, Hennepin/Carver

There were 45 attendees who signed in on the attendance sheet, of which 11 were committee members; 16 attendees requested membership on the committee.

This year’s meeting agenda reflected all four action items outlined in the 2005 committee meeting in Hershey, PA.

The first topic was introduced by Dr. Craig Carter, University of Kentucky in his presentation ‘Epidemiology and Diagnostic Laboratories: Status and Future Directions.’ Dr. Carter presented results of an informal survey he conducted through the AAVLD listserv on penetration of epidemiology concepts and contributions in veterinary diagnostic laboratory activities, and, specifically, on the perceived value of epidemiology in diagnostic laboratories. Replies had been received from members from 16 AAVLD accredited laboratories of which 3 employed a part-time and 8 employed a full-time epidemiologist. Epidemiologists at 9 of the 11 labs were veterinarians.

On a scale of 1 (very valuable) to 5 (a complete waste of funding), respondents from 8 labs indicated that epidemiologists were very valuable, and 2 indicated they were somewhat valuable. Individual comments about the role played by epidemiologists at their labs were generally positive. Nineteen different perceived duties were noted, including statistical analysis, disease surveillance, outbreak investigation, economic studies, and necropsy service. Dr. Carter quoted recommendation #8 of the report of the National Acadamies of Science, entitled ‘Animal Health at the Crossroads’ “…state animal and public health agencies and laboratories should improve, expand, and formalize the use of predictive, risk-based tools and models to develop prevention, detection, diagnostic and biosecurity systems and strategies for indigenous, exotic, and emerging animal diseases. Discussion that followed noted that diagnostic laboratories probably do not know what services and expertise epidemiologist can bring to diagnostic laboratories. The need for training opportunities, potential for jobs needed to be considered. Recommendations for follow up were to 1) develop and administer a formal questionnaire to AAVLD diagnostic laboratories and 2) present a list to AAVLD laboratories of the areas of epidemiology that can be applied to improve and expand service provided by laboratories.

Dr. Carter also gave a brief presentation entitled ‘Prospects for Integrated State Laboratory Surveillance: A work in Progress.’ He offered various definitions that are available for ‘surveillance’, and commented on a project in Kentucky directed to equine abortion surveillance. He outlined the Kentucky integrated animal health information network and how it could be used in animal health surveillance. He also presented results of an informal survey he conducted, as above, for response to the question ‘Do you feel that surveillance [related to collection and analysis of data streams flowing through the laboratory] is potentially useful.’ Seven of 19 responded, with four indicating it would be very useful, one indicating it would be somewhat useful, one indicating they would not report the information, and one indicating it would be a complete waste of time and resources.

Dr. Claudia Muñoz-Zanzi gave an overview of the Sampling Workshop held Thursday afternoon from 2:30 to 6:30 PM. The workshop was sponsored by the Pork Board. There were 36 attendees. General discussion followed about the level of statistics needed to present sampling concepts and methods, and the various needs for sampling by diagnosticians and diagnostic laboratories. Some felt that more education and training is necessary, which could 19 be accomplished through workshops, in a plenary session talk, and/or in production of web-based sampling instruction modules. Several at the meeting requested the slides be made available in a pdf file via the AAVLD website. Available now at: http://www.aavld.org/mc/page.do?sitePageId=35764.

Dr. Jim Case, CAHFS, UC Davis, gave a presentation entitled ‘Limitations of Surveillance System Data and Information Systems as Action Triggers.’ There is increased interest in syndromic surveillance and early detection of emerging and foreign animal diseases. A number of areas within the NSU strategic plan specifically mention the need to detect and rapidly disseminate information about animal health events. The development of national information systems to support this rapid detection and information dissemination is a key strategy in meeting these needs. However, there are a number of limitations that exist as obstacles to dependence on information systems as the primary mechanism for disseminating information about critical animal health events. 1) Procedural Limitations - Procedural notification may be linear, delaying notification outside of a jurisdiction; restrictive protocols may result in meaningful but non-program specific data to be lost; 2) Temporal Limitations - Post-discovery actions begin before data is available in an electronic information system; 3) Interoperability Limitations - Inability to share across surveillance programs; Need for post-processing prior to analysis; A lack of comparability resulting in missed associations; 4) Policy Limitations - Data collection may be constrained in scope and sample size; Release of data to a central repository may be substantially delayed or prevented from being transmitted. Information systems supporting surveillance may not play a large role in event detection, but are very valuable in detecting incidence based animal health events or events that are geographically separated but temporally associated.

Dr. Peter Wright, Canada, gave a brief overview of the status of developing procedures for Diagnostic Test Validation. He indicated that since last year, progress had been made in refining the descriptions and that the general sense was that the procedures need to be more prescriptive. A key procedural element in test validation is clearly defining the fitness for purpose of the assay.

Besides continuing work on the by now ‘traditional’ topics of this committee, which include value and penetration of epidemiology in diagnostic laboratory activities, diagnostic laboratory surveillance activities including sampling strategy development and methodologies of diagnostic test validation, the committee membership is to consider repeating the sampling workshop at the next AAVLD meeting, targeting audiences at different skill levels.

Food Safety Committee Chairs: Hailu Kinde and Pat McDonough, 6:30-8:00pm, Thursday, October 12, 2006, Salon F

Six individuals attended the meeting that followed the Food Safety and Sampling Methods Symposia. The success of the Food Safety Symposia was discussed. Attendees were pleased with the speakers and the participation by various animal industry representatives.

The primary topic of discussion focused on ways of increasing committee participation. The current time slot of meeting on Thursday evenings is probably contributing to the low attendance, because many members may be arriving later and the recent upsurge in pre-meeting symposia may also create time conflicts. A survey of AAVLD members may be necessary to determine the factors contributing to the lack of committee participation (i.e. scheduling, interest, topics). One suggestion was to propose that the Executive Committee seek a collaborative relationship between the AAVLD FS committee and the American Association of Food Hygiene Veterinarians (AAFHV). The AAFHV has traditionally hosted a half day Food Safety Symposium on Sundays at the AAVLD/USAHA annual meetings. The missions of the AAVLD and USAHA Food Safety Committees may be sufficiently different to preclude a joint AAVLD/USAHA committee.

The current Food Safety committee chair, Dr. Hailu Kinde has completed his 3 year term, and Dr. Suzanne Gibbons-Burgener was recommended as the in-coming chair to the President of AAVLD.

Government Relations Committee of AAVLD Chairs: Bruce Akey and Donal O’Toole, 3:30-5:30pm, Saturday, October 14, 2006, Directors Row 3

Members: Bruce Akey, Alex Ardans, Francois Elvinger, Tam Garland, Tanya Graham, Donald Lein, Grant Maxie, Terry McElwain, Barbara Powers, Willie Reed, Leon Thacker, and David Zeman

The AAVLD Government Relations Committee met with 14 attendees (9 members and 5 guests). The initial discussion focused on developing strategies to regain momentum in the federal funding support for the National Animal Health Laboratory Network (NAHLN). It was reported that the USDA’s Centers for Epidemiology and Animal Health has been tasked with modeling and assessing the need for BSL-3 laboratory space based on 20 animal densities. The target for funding remains at an ongoing need of $35 million per year. The search for support may need to be expanded beyond USDA to include the Departments of Homeland Security (DHS) and Health and Human Services (DHHS). Another key federal player to educate on the NAHLN may be the Office of Management and Budget (OMB) which has review and oversight responsibilities for all proposed federal budgets. It was noted that the Veterinary Workforce Expansion Act does provide for funding of capital construction but only at university-associated laboratories. It was the consensus of the group that efforts this year should focus on re- energizing the push for full NAHLN funding by reconnecting with the AVMA’s Government Relations Division and the Animal Agriculture Coalition to reach key members of Congress and clarify the current 3 different funding lines within the USDA budget that refer to NAHLN funding or activities, veterinary diagnostic activities, Animal Health Monitoring and Surveillance and the Food and Agriculture Defense Initiative within the Cooperative State Research, Education and Extension Services (CSREES) agency of USDA. There will be conference call held with members prior to the spring Government Relations Committee meeting in Washington, DC to coordinate this effort.

Drs. Tam Garland (DHS) and Beth Lautner (USDA:VS:NVSL) gave an update on the development of the National Bio and Agro-Defense Facility (NBAF) which will replace the functions currently performed at Plum Island. An initial canvas by DHS for expressions of interest for hosting the new facility has been completed and DHS is now seeking input from stakeholders on what functions should be included in the NBAF as well as what the appropriate size and capacity of the new facility should be. Dr. Randall Levings is the USDA:APHIS:VS representative on the NBAF review committee. Interested parties may send comments to Dr. Garland by e-mail ([email protected]). Comments should be sent by mid-December. Drs. Barb Powers and David Zeman will be conducting a survey of AAVLD members to identify issues that AAVLD feels should be taken into consideration in the planning and development of this important new facility.

Dr. Terry McElwain has been serving as a liaison between the AAVLD and the Government Policy Committee of the American College of Veterinary Pathology (ACVP). The function of this liaison is to facilitate cooperation between the AAVLD and the ACVP in addressing issues at the federal level. Dr. Tonya Graham has agreed to replace Dr. McElwain as liaison.

Dr. Barbara Powers is representing AAVLD as a newly invited member of the Government Coordinating Committee – Food and Agriculture Sector (GCC). The GCC is a federal entity to provide high-level coordination between federal and state agencies and industry representatives to address homeland security issues. The inclusion of the AAVLD in this forum is an important step forward in recognition of the vital role played by AAVLD- member laboratories in protecting the food and agriculture sector of the US.

Dr. Beth Lautner discussed briefly the activities of the DHS National Center for Foreign Animal and Zoonotic Disease Defense (FAZD), a consortium led by Texas A&M university. Initiatives currently underway include development of pen-side tests for Foot and Mouth Disease (soon to be evaluated at Plum Island), development of a vaccine for Rift Valley Fever and of a system for delivery of Brucellosis vaccine to bison in the wild. It was the consensus of the Committee that a FAZD representative should be invited to brief the AAVLD Executive Committee and the NAHLN Steering Committee on the activities and functioning of the FAZD. It was also suggested that a possible topic for a future AAVLD Plenary Session might be an overview of the Foreign Animal Disease research and development activities of the FAZD, Plum Island/NBAF and the Lawrence Livermore Labs. One other item of interest was reported from USDA, that being that no new FAD surveillance programs will be initiated until the National Surveillance Unit (NSU) within CEAH completes formal surveillance plans for each program. This is in accordance with the policy of the USDA to create such surveillance plans that are based on the standards developed by the NSU. Those surveillance and data standards are available on the NSU website.

Informatics and NAHLN IT Committees Chairs: Jim Case and Jay Kammerzell, 1-5pm, Friday, October 13, 2006, Hennepin/Carver

1. Introductions 2. Announcements 3. NAHLN Update a. Steering Committee Update – Heidi Schleicher The different components of the NAHLN IT system: repository, lab registry, methods repository and alerts system will all be available in early November. Q: What is the status of the production repository? It is available for real data now. For laboratories that have sent valid CSF messages, the production environment is available. Contact Shane Linke ([email protected]) at USDA to get the needed routing information. 21

b. IT Committee Updates – Jay Weidner Now that labs are sending valid messages, it is important to test the business rules that have been developed. A formal process will be developed to specifically test the existing rules and to determine if additional rules need to be put into place. It was emphasized that it is important, especially for CSF, that laboratories make an effort to move towards sending messages. There is talk from CSREES that messaging may become a required component for future funding. The ability to change forms is an important part of a developing surveillance system. There are often constraints from Office of Management and Budget (OMB) as to which forms and how much they can be changed. Form development is a difficult process, managing identifiers is a difficult process to manage from the field and we need to keep this in perspective when designing system to support the surveillance programs. The system needs to be flexible enough to handle the occasional, but not uncommon violations of data quality. The development of the ideal standard for surveillance systems often does not match well with the pragmatics of the surveillance system. The IT design must be able to accommodate the goals of the system as well as the practical aspects of the system. Jay W. has asked for people to review the forms and comment back to the CSF Change control Board (CCB). It is important for IT to review these forms and the fields that are expected to be captured so that it can be determined whether their existing systems can support them.

c. Terminology Services – Mike Martin Presentation on terminology. Discussion: A number of the labs do not have the technical expertise to do the most basic part that are needed for NAHLN messaging; extracting data from the LIMS. This would be a good specification for labs to look at as they are developing requirements for their replacement LIMS. Expertise is needed to assist the labs in this area for those that have an existing LIMS. The challenge might be getting the data into the format needed to actually begin doing the terminology mapping.

4. Rhapsody available for AAVLD Labs – Steve Weber a. Rhapsody overview Jay Kammerzell gave a brief overview of the functionality of the Orion Rhapsody product. Restriction on the enterprise license is that the communication Points must be oriented to the NAHLN functions only. Printers are not included in the communication Point allocation.

b. Rhapsody contacts Shane Linke at CEAH can provide a CD from the USDA enterprise license. Terry Matson is the secondary contact at CEAH. Jay Kammerzell can answer any questions for the committee.

5. Updates on IT portion of accreditation

There is currently only a paragraph or two on informatics in the accreditation document. It is time to update these to represent the current state of informatics in diagnostic laboratories.

Base the new accreditation standards on a revised mission statement for the Informatics Committee. Jay Kammerzell developed a set of four statements related to the mission of the committee.

Informatics Committee Objectives:

1. To provide a forum for committee members to discuss the issues surrounding laboratory information systems and ancillary technology and software.

2. To adopt, promote and enhance the use of standards in laboratory information systems.

3. To promote the National Animal Health Laboratory Network as a mechanism to share laboratory generated animal health and surveillance data.

4. To investigate future data systems requirements that may be placed on laboratories as 22 new programs evolve and new technologies are developed.

5. To promote IT related best practices for Diagnostic Laboratories.

Suggestion to go to CLIA for templates to look at to develop an accreditation checklist. There is no need to reinvent the wheel in this area, but there is currently a deficiency in the AAVLD accreditation process to adequately address this issue.

Do other non-lab testing sections (administration, HR, etc.) have the same need? Discussion lead to the conclusion that by following the essential requirements and reviewing SOPs, asking questions that will evaluate how well those are followed will accomplish the same thing as developing a specific checklist for guidance to AAVLD auditors. This is for AAVLD accreditation.

Is this sufficient to meet what might be called “best practices” for IT within a laboratory? No, so the development of a best practices document might be valuable for laboratories, especially to help them interpret section 5.4.4.3.b. of the essential requirements. A small team was formed to draft an initial ‘best practice’ document. Volunteers for IT BEST PRACTICES: Jim Case, Zac March, Stanley Robertson, Rich Baca, Steve Vollmer, Keith Neil, and Alan Herman

6. New technology showcase – no items. 7. LLNL high throughput and CaPP overview – Jay Ross 8. New business a. Mark Robinson (CSREES) - addressed the committee on the importance of comparability and communication of data among the NAHLN labs. It is important for the credibility of the data generated by the NAHLN to address data quality standards that are adopted by all of the participating NAHLN labs. A message sent to the lab directors was that while they are interested in the operational aspects of the NAHLN, the data communication aspect is also very important. It is possible when the new award criteria are announced next year that the ability to send messages or being poised to do messaging may be a contingency on the awarding of funds. The potential of the network will not be accomplished until this is accomplished.

He will be working towards addressing the needs for common terminology between all of the laboratories.

b. Jay Weidner – A question on setting the reply status of the AAVLD discussion list to reply to sender as opposed to the current default of reply-to-list. An informal poll taken last year did not give a definitive opinion of the group. He proposed that we look at moving to a forum type on communication. This would be for the entire AAVLD organization. The AAVLD website is being moved to webclicks.com and may already have this type of functionality. Need to check with Allison Reitz in secretary/treasurers off to determine what functionality already exists.

Attendance Jay Ross CAFHS [email protected] Randy Berghefer Iowa State Univ. [email protected] Keith Neal LSU [email protected] Heather King Wisc VDL [email protected] Wade Northington MurraySt [email protected] Brady James TVMDL [email protected] Alan Herman DCPAH MSU [email protected] Brandon Theiss TVMDL [email protected] Kim Ramm DCPAH MSU [email protected] Jay Weidner WADDL [email protected] Steve Weber USDA CEAH VS [email protected] Mark Hinton U of Minnesota [email protected] John Enck Penn State Univ [email protected] John Duhare USDA APHIS [email protected] Bruce Akey Cornell [email protected] Craig Carter U of Kentucky [email protected] Mike Martin Clemson [email protected] Jack Schlater NVSL [email protected] 23 Herman Honeycut N. Carolina [email protected] Cathy Horancsak USDA [email protected] Barb Porter-Spalding USDA [email protected] Sherrilyn Wainwright USDA [email protected] Rich Baca USDA [email protected] Steve Vollmer ADDL – Purdue [email protected] Zac March Missouri [email protected] Paulletta King Missouri [email protected] Stanley Robertson Miss State U [email protected] Rita Calnan ITL Corp [email protected] Diedre Qual ND Dept of Ag [email protected] Leigh Humphries FL Dept of Ag [email protected] Lanny Pace Miss State U [email protected] Regg Neiger SDSU [email protected] Bill Epperson OSU [email protected] Mary Thurn Univ of Minn [email protected] Jim Case CAHFS [email protected] Jay Kammerzell CSU [email protected]

Journal of Veterinary Diagnostic Investigations Editorial Board Chair: Jerry Saliki, 4:00-6:00pm, Friday, October 13, 2006, Board Room 2, Minneapolis

In attendance were: Drs. Baszler, Evermann, Harrison, Poppenga, Sreekumari, Van Campen, Yoon, and Zeman. The agenda included: welcome and introductions; Editor’s report; matters arising from the Editor’s report; online publication highlights; how to attract review articles to the journal; journal format issues; policy on online self- archiving of JVDI published material; editorial board appointments for 2007; other matters.

Editor’s report: Highlights of the Editor’s report included the following: In 2005, ISI ranked the JVDI number 39th among 129 journals in the Veterinary Sciences category, with an impact factor of 1.0014. Last year the journal was also ranked 39th among 123 journals. This ranking places JVDI right in the middle of the pack when compared to our closest peer journals such as Vet Pathol, Am J. Vet Res, J Comp Pathol, Vet Rec, Avian Dis, J Wildlife Dis, and Can J Vet Res. As of October 10, 2006, the JVDI had received 158 articles from 23 countries, with articles from the USA accounting for 58%. The projected number of submitted articles for 2006 is about 200. Last year the journal received 199 articles from 27 countries, with articles from the USA accounting for 51%. The current acceptance rate is 58.9% vs. 60% in 2005. The projected accepted rate range for this year is 57-62%. The number of articles to be published in 2006 is 125 (vs. 118 in 2005, 110 in 2004, 104 in 2003, 105 in 2002). In regard to timeliness of reviews: Average time (days) from submission to first decision is 33 days in 2006 vs. 36 days in 2005; the average reviewer turn around time (days) remains 12 days as in 2005; the average Editor turn around time went down from 7 days in 2005 to 2 days in 2006. In conclusion, the Editor believes the journal continues to grow, as indicated by the steady growth in numbers of manuscripts submitted (138 in 2004, 199 in 2005 and a projected ~200 in 2006) and the number of articles published (103 in 2003, 110 in 2004, 118 in 2005, and 125 in 2006). Furthermore, based on limited data, the geographical spread of countries from which manuscripts are submitted also shows a positive trend. The Editor believes the journal is trending in the right direction and challenge is to maintain and improve on quality while still growing. The Editor also reported that as a result of going online, some duties previously handled by the editorial assistant (such as receiving manuscripts, soliciting reviewers, and mailing out manuscripts) have shifted to the Editor. The editorial assistant now has more time to focus on billing and collection of page charges, which has resulted in a big increase in collected journal income. Other major duties handled by the editorial assistant include: galley proofing and advertisements in the journal.

Matters arising from Editor’s report: In reaction to the Editor’s report, editorial board members expressed their satisfaction with the editorial process and the innovations (online manuscript submission last year and the pending online publication this year), but also expressed their concern that at the current pace of editorial work, the Editor could easily “burn” out. In the ensuing discussion, board members recommended that wherever possible the Editor should shift some responsibilities to the editorial assistant and associate editors. It was also agreed that if the journal workload continues to grow, two things should be done: a) the editorial assistant should be moved from the current 75% position to a 100% position; b) the editorial board should recommend to the Executive Board the

24 appointment of a remunerated general associate editor to handle some of the workload. The Editor was charged with monitoring the workload during the coming year and reporting back to the editorial board next year.

Online publication highlights: The Editor reported that everything was in place for the new online publication site to go live around November 20. During the summer he had converted the entire back content to single-article digital PDF files. Back content will be in PDF format while current content will be both in searchable HTML and PDF formats. Access control will be by password for individual subscribers and by IP address for institutional subscribers. Following the launching of the site, there will be a 2-month free trial period during which subscriptions and access controls will be setup. When access control is implemented, the general public will have free access to all abstracts and full text of back content, except for the current and last five issues. Full access to all content will be reserved to paid-up subscribers. A pay-per-article function will be implemented whereby non-subscribers can purchase individual articles online using a credit card. Finally, an e-mail alerts function will be implemented whereby all subscribers will receive an e-mailed table of contents as soon as a new issue of JVDI is published online. At this point, the Editor showed editorial board members the site in-progress on his laptop.

How to attract review articles to the journal: The editorial board discussed ways of attracting more review articles to the journal to provide useful information and also increase journal ranking since review articles are generally more cited than original papers or case reports. After noting the failure of past attempts to recruit people to write review articles, it was agreed that two strategies should be tried: a) the Editor and board members will make serious attempts to encourage some of the plenary session speakers to transform their presentations into review articles; in this regard, the Editor stated he had already contacted two of them and will contact some more before the meeting is over; b) suggest to AAVLD membership via the AAVLD listserv specific topics for reviews; in this regard, the following topics were suggested: - Avian influenza - Bluetongue/EHD/Orbiviruses - BVDV in alpacas or pestivruses in exotic species - Canine influenza - Interpretation and application of phylogenic trees in diagnostics - Neuropathogenic herpesvirus and/or EVA - New diagnostic methodology in Veterinary diagnostics - Pooling strategies for diagnostic specimens - Porcine circovirus 2 - Quality assurance - test validation, etc. - Toxicologic diagnosis and interpretation in wildlife - Uterine biopsies - usefulness in diagnosis - Vesicular stomatitis The Editor said he will formulate an e-mail inviting reviews and submit to editorial board members for input prior to posting on AAVLD listserv.

Journal format issues: Three issues were discussed. First, the Editor presented a proposal for differential color printing whereby authors can pay lower page charges to have color plates printed in black & white in the hardcopy and in color online. He stated that both the Publications Committee and the Executive Board had given their approval for exploration and implementation of this proposal provided it would not engender any extra costs to the Association. After a brief discussion, the board suggested that if this option is to be implemented, authors must submit two separate sets of figures (black & white and color) for review and the option to print color both online and in hardcopy print should remain. Second, the Editor asked the board if members were concerned that the journal publishes about twice as many brief communications as full articles. After discussion, consensus emerged that this should not be a concern as all published information, regardless of format, is useful to Association members. Third, one member had proposed a review of the “Sources and Manufacturers” section of JVDI articles to consider inserting names and addresses of sources and manufacturers in the text rather than at the end of the text. The Editor indicated that changing the format would require several typesetting and production changes. He stated that he believed the online version would have hyperlinks to the sources and manufacturers just as for references. It was agreed that, given the extra workload that a change at this point would engender, the format should be left “as is” for now.

Policy on online self-archiving of JVDI-published material: The Editor stated that in view of the increasing desire of authors to self-archive JVDI-published material in personal or institutional websites, AAVLD needs to develop a policy regarding such self-archiving. He further stated that he had proposed and both the Publications Committee and Executive Board had approved a self-archiving policy as follows: authors may publish their JVDI- published articles on their personal or institutional website as long as three conditions are met: a) self-archiving 25 shall not occur before the journal article is published; b) AAVLD ownership of copyright shall be acknowledged; c) only the final JVDI file (PDF or HTML format) may be archived.

Editorial board appointments for 2007: The Editor stated that 1/3 of the members’ terms are expiring in 2006. Most members will be reappointed for another 3-year term, but some will be replaced. Nominations were proposed for open slots in the pathology and toxicology disciplines.

Other matters: The Editor informed board members of an unsolicited offer from California-based Sage Publications. He indicated that the Executive Board had asked the chair of the Publications Committee to explore the proposal by gathering information on cost vs. potential benefits from Sage Publications as well as Allen Press. Members of the board were generally of the opinion that if AAVLD self-publishing of JVDI is satisfying the Association’s needs, there is no need for a change of publisher. It was agreed that when more information is available on the proposal at next year’s meeting, the idea will be revisited. One member relayed a complaint received from one author regarding the way a toxicology paper had been reviewed. Specifically, the paper was a clinical toxicology paper apparently reviewed by analytical toxicologists. The Editor stated he was aware of the situation and the paper is being prepared for resubmission. He further stated that to avoid such situation in future, the help of toxicologists on the board will be increasingly sought to assure that the appropriate reviewers are assigned depending on the nature of each manuscript (clinical vs. analytical).

Laboratory Administrative Management Personnel Committee Chair: Kim Ramm, 1-5pm Saturday, October 14, 2006, Ramsey and 8:00am-Noon, Sunday, October 15, 2006, Directors Row 4. There were 18 attendees.

Membership Reviewed and confirmed LAMP membership Updated e-mail contact list (included with this document)

Process Improvement Techniques Value Stream Mapping Follow-up – How have other labs applied this concept?

Application of the Balanced Scorecard (PDF Enclosed) - Presented the Balance Scorecard concept of Strategic Objective Measurement.

Laboratory Updates Members shared current status of each laboratory and challenges being faced. Most labs are either in the process of implementing or evaluating new LIMS or designing or moving into new facilities. Everyone shared lessons learned.

Additional Agenda Items Added - New building gotchas - Rendering costs and changes to disposal processes - Changes in level of transcription and who performs it - Billing issues, specifically collecting on out of state clients - Data collection process for customer complaints - Inventory management - Testing for owners (report distribution)

LAMP Committee Mission Statement Linda Hendrickson (Purdue) recalled the establishment of a LAMP mission statement. Emily Sanson (UC Davis) believes it may be in the documentation that Geraldine Jessup (UC Davis) left with her. She will look through it and send Kim Ramm (MSU DCPAH) anything pertinent. The group brainstormed some of the things that they expected from these meetings. They are: - Exchange of ideas - Share best practices - Networking - Discuss common challenges - Hear solutions - Common good of the profession - Update on emerging issues - Know that you are not alone 26 - Learning or education - Share vendors - Hear other committee reports - Lab visits

A draft mission statement was proposed. It will be evaluated next year when we have any additional documentation to compare against:

1. To provide a forum for committee members to discuss the issues surrounding laboratory operations and administration.

2. To provide a forum to discuss laboratory compliance with current and upcoming regulations.

3. To provide round table discussions of current challenges and solutions facing each laboratory as a way of sharing information and learning of other solutions.

Suggested Topics for 2007 - Inventory management - Educational concepts applicable to administrators - Lab visit - Sharing facilities photographs Attendance

LAMP Name Organization Member E-mail Kim Ramm Michigan State University (Chair) DCPAH Yes [email protected] Willie Reed Michigan State University (Drop-in) DCPAH No [email protected] Grant Maxie (Drop-in) Guelph No Michael Lenetsky Cornell AHDC Yes [email protected] Robert Reese Cornell AHDC Yes [email protected] Emily Sanson CAHFS Davis Yes [email protected] Mississippi State University Vet Research & Diagnostic Joey Kellum Lab Yes [email protected] Mississippi State University Roy Vet Research & Diagnostic Thompson Lab Yes [email protected] MaryLynn Virginia Animal Health Lab Rowland System Yes [email protected] Sarah Michigan State University Raynak DCPAH New [email protected] Jay Kammerzell Colorado State University Yes [email protected] Linda Hendrickson Purdue University Yes [email protected] Murray State Breathitt Vet Bill Lawrence Center New [email protected] Karen Armstrong University of Kentucky New [email protected] North Dakota Veterinary Mary Finseth Diagnostic Lab Yes [email protected] 27 Leigh Humphreys Florida Dept of Agriculture New [email protected] Washington Animal Jay Wiedner Diagnostic Lab Yes [email protected] Jeanine Staller Pennsylvania Vet Lab/PDA Yes [email protected]

Laboratory Directors Committee Chairs: Helen Acland and Ron Lewis, 5:30-7:30pm, Saturday, October 14, 2006, Duluth

1. Dr. John Clifford, Deputy Administrator APHIS Veterinary Services, gave an overview of USDA activities with special relevance to veterinary diagnostic laboratories. APHIS -VS Associate Deputy Administrators are Drs. Jere Dick, Dr. Larry Granger, and Dr. Jose Diez. He expressed his support of the NAHLN, and thanked laboratory directors for their contributions to building the system. He reviewed the efforts with respect to testing for specific diseases, including avian influenza, classical swine fever, and BSE. With respect to the latter, he expressed his regret that the 5 additional laboratories were not brought on line to join the initial 7. For avian influenza testing, the USDA will be putting 22 high throughput PCR systems into NAHLN laboratories. For PCR testing for AI matrix in NPIP labs, there will have to be an acceptable quality system. His talk culminated with his reporting that at the Monday House of Delegates meeting he, Dr. Beth Lautner, Ms. Barbara Martin, and Dr. Barb Powers would be signing a renewal of the 2001 memorandum of understanding (MOU) between the AAVLD and USDA/NVSL concerning the formal recognition by USDA/NVSL and serves as a guide for state/federal interactions and provides a mechanism to work together on national animal health diagnostic issues. The renewal includes revisions that address USDA acknowledging and notifying World Organization for Animal Health that the AAVLD accreditation process is consistent with the World Trade Organization Guidelines for Quality Management in Veterinary Testing Laboratories, Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and, as such, meets WOAH requirements.

2. Dr. Beth Lautner, Director of NVSL, gave the laboratory directors a detailed slide show on the new facilities at NVSL, and an overview of staffing. She expects to be able to offer tours of the BSL-3 laboratories soon. In the USDA Wildlife Services surveillance for H5 avian influenza virus, low pathogenicity H5 virus has been submitted to NVSL from Maryland, Michigan and Pennsylvania so far. NVSL has the capacity for very rapid sequencing of the virus.

3. Ms. Barbara Martin, NAHLN Coordinator, introduced her assistant Ms. Heidi Schleicher. NAHLN Core Laboratories received $300,000 funding last year, and NAHLN Member Laboratories received $50,000. Other categories of NAHLN laboratories are Adjunct Member Laboratories and Contract Laboratories. Recently, the NAHLN Technical Working Group met, and among the emerging issues, test equivalency is becoming especially important. It is possible a secure NAHLN web site could be available soon, and protocols could be posted there.

4. LTC Chuck Tilton, 45th Civil Support Team from Tennessee gave an overview of civil support teams and their capabilities. Civil support teams are prepared to be involved in animal health emergencies as well as human health emergencies. Teams take 1 hour to assemble and 3 hours to deploy. CPT Mike Simpson, from the Iowa Civil Support Team, talked about the specific laboratory tests and instruments in the mobile laboratories used by the teams. About 80% of the instruments are civilian, and 20% are available only to the military. The laboratories can test for biological and chemical agents.

5. Mr. Neville Johnson, UK Veterinary Laboratories Agency QA Unit Proficiency testing programs spoke about the external quality assessment offered in the program. The program has many participants, with wide geographic spread. At frequent intervals, such as monthly or at a maximum every 3 months, participating laboratories are issued proficiency panels of samples to test using regular staff and equipment. In Europe, all laboratories are moving towards or have completed ISO 17025 accreditation.

Laboratory Emergency Management Committee Chairs: Pat Blanchard and Alfonso Torres, 9:00-10:15am, Friday, October 13, 2006, Ramsey

There were 28 people in attendance including 5 committee members.

28 1. This committee has been separated from the joint USAHA/AAVLD Committee on Animal Emergency Management and is back to its original structure as an AAVLD only committee.

2. Discussion of Thursday NAHLN Symposium – future actions/recommendations from committee a. Barb Martin stated she would review suggested future topics on NAHNL symposium feedback forms and they would determine if another symposium is warranted. b. Items of interest to those in attendance at committee either through a future committee meeting or symposium were: i. Plans: how are other labs going to obtain funding at start of emergency for housing, transportation and additional personnel? 1. Action Item: Pat Blanchard to investigate USDA financial/admin canned exercise availability and a possible topic next year to have state/federal admin folks from Exotic Newcastle Disease task force talk at committee meeting in Reno. ii. How will more people be trained and approved for testing during an emergency? 1. T McKenna and B Martin indicated training would be via train-the-trainer approved people and use of proficiency test (PT) panels. Ideally have one trainer approved at each NAHLN lab. NVSL will expand the number of individuals (up to 10/lab) who can be trained and PT tested at each site in advance of an emergency. PT panels will be offered 2x/year once they move to amoured RNA. 3. Topics from floor: c. Sources of additional personnel: i. Other units in your parent organization (university) ii. Have to address exempt and non-exempt union employee contracts iii. Other NAHLN labs with trained personnel – resource typing would simplify requesting the type of trained individual you would like iv. Other in-state labs (National Guard, Civil support, public health) d. National Veterinary Stockpile (NVS): Push paks- What is in NVS that labs can use? What has to happen for labs to get access (such as a state or federal emergency declaration)? Through whom do you get access to it (NAHLN coordinator, AVIC, state vet)? What is size of pallets for lab supplies? What type of facility and delivery location is required and what is the proximity of state staging areas to lab site? Action item: Tom McKenna will follow up on some of these questions for committee. e. Iowa State University Lab is planning a laboratory exercise on HPAI in the spring. f. USDA is developing a shipping module that is compliant with IATA, etc certification requirements and will be distributed on CD/DVD.

4. Posting information on a secure site – lab emergency plans, templates, after action reports a. Barb Martin is investigating adding to secure NAHLN registry a place to post individual lab’s emergency response plans, template plan, after action reports or other information to be shared. Action item: She will report to committee in December.

5. Progress on 2006 goals: a. after action and lessons learned report format – Proposed template discussed and consensus on following format: i. Executive summary ii. Exercise Objectives iii. Dates iv. Participants (#) and participating organizations v. Exercise Timeline vi. Evaluation – what worked, what didn’t work vii. Lessons Learned and associated recommendations viii. Acknowledgements ix. References x. Related Documents xi. Contact Person for further questions

Rosemary Speer with C.N.A. Corp suggested we try to use DHS Homeland Security Exercise Evaluation Program (HSEEP) template as much as possible since it could allow for future federal funding of exercises. Action Item: Pat Blanchard will check their headings but we agreed we did not want to get too bogged down in meeting requirements such that no one uses the format. The 29 current DHS LLIS.gov site where exercises are posted doesn’t seem to have a consistent format. DHS HSEEP emphasizes conduct of exercise rather than real life lessons learned to better prepare. b. concept of operations matrix – No action at this time and no future plans by committee on it. c. Funding for a planner to work on laboratory related issues- ID and CA requested, neither were funded. It had to go within their total state request under a state department request.

6. Sunset committee or decide on future goals and objectives a. Consensus was to continue committee as a forum to discuss issues yearly even if specific products were not developed. b. Suggested round table seating to improve discussion in future. c. Topics in future ask what each lab’s progress is related to emergency planning; what roadblocks they encountered, how they have dealt with the challenges; what is working d. See 2.b.i.1. as possible topic for next year.

Laboratory Safety Committee Chair: Larry Thompson, 1:00 -3:30pm, Sunday, October 15, 2006, Hennepin

The AAVLD Laboratory Safety Committee meeting had 34 members and guests in attendance. As one of the first orders of business, the Lab Safety Committee adopted the following as its mission statement:

The mission of the AAVLD Laboratory Safety Committee is to foster communication amongst member and non-member laboratories concerning current and emerging safety and waste disposal issues as well as regulations affecting animal disease diagnostic laboratories. When requested by the President or Executive Council, the Committee will develop or assist in developing position statements, guidelines or other documents required or requested by the AAVLD organization or member laboratories.

Following introductions, the Chair announced the promulgation of federal rules concerning pathological incinerators, published December 16, 2005 in the Federal Register (40 CFR Part 60, beginning 74881) entitled “Standards of Performance for New Stationary Sources: Other Solid Waste Incinerators (OSWI); Final Rule. Essentially, this final rule exempts pathological waste incinerators from any federal emission standards. This determination was made by the EPA by evaluating the total national emissions from pathological incinerators, which was deemed to be not significant especially versus the adverse effects that would occur if the pathological waste incinerators were regulated under OSWI, requiring air pollution control technology, ie scrubbers. Thus, regulations on pathological incinerators will remain on a state-by-state basis.

The Committee discussed additional carcass disposal issues, including the use of alkaline hydrolysis and related technologies. Member laboratories report continuing concern for continuation of rendering services, as more companies have to reduced service areas and increase charges. Very few member laboratories are reporting landfilling as an option for carcass disposal.

The Chair distributed copies of the IATA Infectious Substances Shipping Guidelines covering changes that were effective January 1, 2006. No major changes were initiated but questions still remain on exact definitions, eg, what defines a surveillance sample. Member laboratories were reminded that the laboratory itself, made up of animal health care professionals trained in disease control, are ultimately responsible to evaluate and make an assessment of the situation for the purposes of these regulations. If the situation is not clear-cut, it is recommended they document their evaluation process. The main problems concerning shipping regulations appears to be dealing with the US Postal Service, as the USPS is just now coming up to the latest IATA and DOT regulations, thus there is much confusion especially in the rural areas with small post offices with few personnel.

The Committee formed a Subcommittee to begin addressing safety concerns of an animal disease diagnostic laboratory necropsy floor and related activities. The Necropsy Safety Subcommittee will be composed of Peter Vanderloo, Kathy Schmidt, Terry Dobrovolsky, Ross Graham, Sheila Grimes, Lenn Harrison and the Chair. By next meeting, we plan to have an outline of concerns and other information on the topic. This information will be shared with the Pathology Committee and the Executive Committee in order to formulate guidelines that can be used in the certification process.

As a final business action, the Committee elected Catherine Barr as Co-Chair.

30 Membership Committee of AAVLD Chairs: Grant Maxie and Richard Mock, Noon-1pm, Saturday, October 14, 2006, Directors Row 4

The representatives from all seven regions of the association and one guest were present.

1. Membership statistics There are 1292 total members for the 2006 fiscal year which is an increase of 21 members from 2005. There are 1037 full members, 121 graduate student/resident members, 39 retired members, 49 associate members and 46 life members. Of the 1292 members, 165 are new members for 2006.

2. New member orientation The AAVLD new member orientation meeting was held on Friday, October 13 preceding the President’s reception. There were 24 new AAVLD members present. During the meeting Drs. Donal O’Toole (President), Barbara Powers (President-Elect) and Grant Maxie (Vice-President) presented information about the organization of AAVLD, the functions of the various committees and the AAVLD relationship with the USDA and the USAHA. There were fewer new members present than in the previous two new member orientation meetings and the notification procedure will be evaluated to assure that all new members are being informed of the meeting.

3. Life Membership The committee recommends that deceased AAVLD Life Members be designated (*) (Deceased) on the Life Members list published in the Membership Directory.

4. Committee Timeline A timeline summary of committee activities throughout the year was presented to the committee members.

5. Other business Dr. Saliki informed the committee about JVDI being published by High Wire Press that will start in November 2006. Dr. Paige Carmichael previewed the AAVLD brochure that is being prepared by the Foundation Committee which contains information from the AAVLD display poster and gives the purpose of AAVLD and the benefits to members and veterinary diagnostic laboratories.

NAHLN Laboratory Directors Chair: Barbara Martin, 7:00-9:00pm, Thursday, October 12, 2006, Salon E • NAHLN budget (and lab expansion funding strategies) • NAHLN IT system • NAHLN Brochure • NAHLN Methods technical working group • CSF surveillance update • Validation activities at FADDL • High throughput activities/opportunities No report submitted

Pathology Committee Chair: Matti Kiupel, Noon-2pm, Sunday, October 15, 2006, Salon B, Minneapolis Hilton, MN

Committee members: Helen Acland, John Adaska, Claire Andreasen, Arthur Davis, Bradd Barr, Tim Baszler, Rob Bildfell, Patrick Caplazi, Paige Carmichael, Scott Fitzgerald, Dolores Gavier-Widen, Carol Lichtensteiger, Fabio Del Piero, Neil Dyer, Tanya Graham, Justin Greenlee, Sheila Grimes, Patrick Halbur, Mark Hall, Jeff Hayes, Gayle Johnson, Bill Layton, Alan Liggett, Grant Maxie, Carol Meteyer, Doris Miller, Peg Miller, Jay Mysore, Jerome Nietfeld, Brad Njaa, Timothy O'Toole, Lanny Pace, Pam Parnell, Shivaprasad, Pepe Ramos-Vara, Willie Reed, John Schmitz, David Steffen, John Thilsted, Manos Sebastian, Steven Sorden, Larry Stuart, Flint Taylor, Francisco Uzal, Tim Walsh, Floyd Wilson, Leslie Woods, Mike Yaeger, Chair: Matti Kiupel

36 members attended

AAVLD Approved Methods Committee

Dr. Jim Pearson, chair of the AAVLD Approved Methods Committee presented the current AAVLD requirements for method validation. Intense Discussion followed. It was agreed that formulation of standardized quality system (QS) 31 guidelines for pathology present a significant challenge to the pathology committee. No agreement was reached regarding the detailed guidelines for gross or microscopic pathology. The pathology committee has already formulated a QS guideline document for immunohistochemistry (“Minimal Requirements for Performing “Integrated” IHC/ICC Tests in Veterinary Diagnostic Immunohistochemistry Laboratories”), which was approved by the AAVLD accreditation committee and Executive Board in 2005. The IHC guidelines document differentiates, for diagnostic purposes, between IHC tests performed as part of a microscopic pathology evaluation (integrated test), and “stand alone” tests which are not part of the microscopic pathology evaluation. The current IHC guidelines provide recommendations for qualifications of technicians performing IHC and pathologists/residents interpreting IHC tests. Furthermore, the document on “Essential Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, Version 3.0, July 16, 2005” provides guidance for: 1. Minimum requirements for diagnostic pathologists working in AAVLD accredited laboratories 2. Minimum requirements for necropsy technicians working in AAVLD accredited laboratories 3. Minimum requirements for histotechnicians working in AAVLD accredited laboratories

The committee agreed that the following documents need to be developed within the next year in order to assist diagnostic laboratories in meeting the requirements set forth in the “Essential Requirements for an Accredited Veterinary Diagnostic Laboratory”, Version 4.0: 1. QA/QC requirements for diagnostic pathologists working in AAVLD accredited laboratories 2. Procedures for standardized proficiency tests, administered by the National Veterinary Services Laboratory (NVSL), for “stand alone” IHC tests. 3. List of recommended SOPs for histology laboratories in AAVLD accredited laboratories 4. List of recommended SOPs for necropsy laboratories in AAVLD accredited laboratories

Action items: 1. Dr. Tanya Graham will compile existing QA/QC forms for diagnostic pathologists currently used in AAVLD accredited laboratories and present a draft for a general QA/QC document that can be adopted by the AAVLD pathology committee 2. Dr. Tanya Graham will compile existing SOPs for histology and necropsy laboratories currently used in AAVLD accredited laboratories and present a draft for a general QA/QC document that can be adopted by the AAVLD pathology committee 3. Drs. Tim Baszler and Mark Hall will develop a procedure for NVSL to compose, administer, and evaluate proficiency tests for selected “stand alone” IHC tests.

Review of Saturday slide conference; selection of co-chair for 2007.

Dr. Carol Lichtensteiger reported on the 2006 slide session. There were 19 presentations. A handout was provided. Nine of the presentations were given by residents/grad students. As in previous years, the meeting ran a little long, but not as long as in previous years. More than 20 slide boxes were sold to non-presenters generating more than $1,000. This money has been donated to the AAVLD foundation for the purposes of pathology travel awards. Action items: 1. Dr. Alan Liggett will chair the 2007 session and Gayle Johnson agreed to co-chair and to become the chair for 2008. 2. It was agreed to follow this year's format and give preference to graduate students' presentations. The number of presentations should not exceed the number of slides that can be stored I one small slide box. 3. Appropriate "surplus" abstracts should be routed to the Pathology session of the main meeting. This can still be done after the official deadline (June 15) for conference abstracts has passed, and space permitting are often welcome to round out sessions at the meeting. 4. At least 60 slides should be requested per submitter to generate at least 20 slide sets for sale. The checks for each box have to clearly indicate that the money goes to the pathology committee as payment for histology slides. Overseas shipments will be charged extra for shipping costs.

Web-based chapters on Investigation of Abortion and Perinatal Loss in Livestock and Companion Animals

Dr. Brad Njaa mailed a report on the replacement text for Laboratory Diagnosis of Livestock Abortion on the web. The following sections have been at least partially written: Dr. Flint Taylor - how to approach an abortion. Dr. Michael Yaeger - porcine abortions. Dr. Mark Anderson - bovine abortions. These sections are pending: Dr. Neil Williams - equine abortions. 32 Dr. Bruce Rideout - exotic animal abortions. There is a void for canine and feline abortions since Dr. Behzad Yamini died unexpectedly in 2006.

Action items: 1. Dr. Njaa will identify an author for canine and feline abortions and continue to interact with the authors to complete the document before the 2007 meeting. 2. Drs. Njaa and Kiupel will review the submissions and help editing them for possible submission to J Vet Diagn Invest.

Budget and Funding for Travel Awards

Dr. Matti Kiupel reported on the current financial status. The current balance is $1,105. Since 2002 the Pathology committee has brought in $4,605.00 and has spent $3,500.00 to fund travel awards. There was a balance of $1,250 in the account in the summer of 2006. The Pathology committee awarded $1,000 on 2 travel awards for P. Mouser and D. Bangari in 2006. Unfortunately, D. Bangari’s presentation was only accepted as a poster. The Foundation had agreed in 2005 that it would match up to $500 raised by individual discipline-based committees. There is no ledger for the pathology committee funds and it is very difficult to analyze the actual flow of money into and out of the account. There is no indication that the $500 was matched last year by the Foundation. Sales of slides would have generated at least $1,000 in 2006 to pay for the 2006 travel awards. If checks for slides sets are not made payable to the Pathology committee, the money will remain in the Foundation. There should be at least $1,750 in the account not considering additional donations to the Pathology Committee and there should be an additional $500 in matching funds from the Foundation for 2006.

Action items: 1. Dr. O’Toole will communicate with Dr. Barbara Powers and Allison Reitz to transfer the Foundation matching funds for the last year and this year. Also there should be some discussion on a more detailed ledger. 2. Dr. Kiupel will talk to Drs. Carmichael and Barbara Powers to change the current options for donating funds and making payments to the Pathology committee in order to ensure correct distribution of funds. 3. Dr. Kiupel will talk to Dr. Grant Maxie to encourage the AAVLD Annual meeting Program Committee to prioritize travel awardees for a platform presentation.

CL Davis conference 2006 and ideas for 2007

Dr. Matti Kiupel reported on the 2006 CL Davis symposium. The symposium on “Diagnostic Avian Pathology” was well attended and the received comments were all positive. Dr. Kiupel solicited ideas for 2007. Suggestions included a session on bone pathology by Dr. Roy Pool (possibly combine with another organ system), a session on foreign animal diseases and sessions on respiratory and enteric diseases.

Action item: 1. Dr. Kiupel will investigate availability of speakers and coordinate the next symposium along these suggestions.

Collaboration between AAVLD and ACVP

Dr. Paige Carmichael presented a proposal for collaboration between the ACVP and the AAVLD pathology committee. There was general consent that such collaboration was desirable. Following discussion on logistic and financial restrictions a proposal was made by Dr. Matti Kiupel to award every year to the best graduate student/resident presentation in the veterinary pathology session a travel award for the ACVP meeting in the coming year. The presentation would be given in the ACVP Diagnostic Pathology session and would be introduced as the AAVLD award presentation with a few sentences introducing the AAVLD at the ACVP meeting. This proposal is contingent upon a similar award by the ACVP for the best Diagnostic pathology graduate student/resident presentation to be presented at the next AAVLD meeting. The proposal was seconded by Dr. Paige Carmichael and was unanimously approved by the membership.

Action item: 1. Dr. Paige Carmichael will present this proposal to the ACVP. If the proposal is accepted by the ACVP, Dr. Carmichael will request a waiver for the registration fees for the awardees at both meetings from the ACVP and the AAVLD, respectively. Dr. Carmichael will inform the Pathology committee about the progress of her

33 efforts prior to April 2007. This will leave sufficient time to announce the award to both memberships prior to the call for abstracts for the 2007 meetings.

Publications Committee Chair Dave Steffen, 8-10am, Friday, October 13 2006, Board Room 3

Present: Dave Steffen, Dwayne Hamar, Bruce Janke, Pat Blanchard and Jerry Saliki Absent: Carlos Reggiardo, John Adaska

Carlos Reggiardo was absent but after the meeting agreed to assume chair for 2007 through 2009 term. No other candidates present accepted the invitation.

JVDI: A report for the Journal was filed by Dr. Saliki and approved by the committee. The committee was complimentary regarding the online review process and the move to on-line publication in 2007. It was suggested that a minimum six issue 12 month delay before making the content public be instituted to continue benefit and incentive to subscription and AAVLD membership. The option of on-line color printing and black and white hard copies was discussed and it was agreed that if the color enhances the on-line publication and the black and whites were of high quality and worked in the paper publication it would be acceptable to reduce printing costs to authors. The committee felt it would be necessary to include both in the review process if the author was requesting the publication of different color aspects to the prints. The committee also supported a recommendation to the executive board that they approve $500 to support the setting up E-mail notification to subscribers of new journal availability on-line. The issue of self archiving or posting off manuscripts by authors was discussed. It was recommended that this be allowed but only after print publication by JVDI and that the on-line publication by author must be an exact duplicate of the official publication and that it be done in a PDF or some other unalterable format to assure integrity is maintained.

Newsletter: A report was filed by Pat Blanchard. The committee supported dropping hard copy publication in favor of a regular on-line newsletter with table of contents links e-mailed to the members. Pat was asked to work on the technical aspect of this with web hosts to assure it is functional. Concern was raised about some E-mail systems not supporting HTML links and an attached PDF was suggested to compensate for those users.

Web: A new web editor is needed. It was suggested that most of the posting be coordinated through the secretary treasurer’s office and the editor serve only as a resource for discriminating appropriateness of content. There was concerns raised that ISU also provided database functions along with web hosting. It will be necessary to explore that capability with the new web host or it may need to move to the secretary treasurer’s site. Randy will need to discuss the OID issues with the secretary’s office.

Committee structure was discussed as no monograph editor has participated in recent years as no monographs were in the works. The by-laws indicate that monograph editors shall serve on publications but it doesn’t require one be on the committee at all times. A recommendation was made to invite the current monograph editor (Brad Njaa) to join the committee to assure coordination of the publication if it is the intent of the authors to facilitate publication through AAVLD website.

The JVDI was approached by a publishing company offering publication assistance. Insufficient data was presented to judge the offer. A strong need for assistance was not voiced and the recommendation was not made to pursue the matter at this time.

Recommendation to current president. Chair -Carlos Reggiardo Continuing members to maintain some continuity: Dwayne Hamar, Bruce Janke

Other current members and terms are in the directory, Dave Steffen would like to exit the committee due to other responsibilities.

Quality Assurance Committee Chair: Dave Korcal, 1:00-400pm, Friday, October 13, 2006, Salon G

Committee Members Present: David Korcal, Helen Acland, Denise Archer, Jordan Brod, Robert Busing, Emily Cooper, Mark Davidson, Robert Everson, Darla Ewalt, Suzanne Gibbons-Burgener, Dwayne Hamar, Gregory

34 Jillson, Joseph Kellum, Paatricia Lukens, Kathryn Moser, Donald Munro, Rajesh Parmar, Mary Rowland, Alma Roy, Emily Sanson, Marilyn Simunich, Jeanine Staller, Kaye Tipton, John Williams

1. Call to Order: David Korcal called the meeting to order at 1:05 PM.

2. Summary of the Previous Year’s Activities

David Korcal presented a summary of committee activities for 2006.

• The year started with Dr. Monte Reimers, Quality Assurance Manager at Michigan State University, distributing 4 documents for the committees review. o Draft SOP on SOPs for AAVLD o Draft SOP on Committees (Current committee guidelines in SOP format) o Draft Site Visit SOP (Current site visit guidelines in SOP format) o Draft Quality Assurance Audit SOP

• David Korcal was appointed the chair of the Quality Assurance Committee in June 2006.

• Quality Assurance Committee met by phone on July 6, 2006 the agenda included: o Planning the 2006 QA Symposium o Meeting Agenda for the October 13th meeting o Discussion of the draft documents prepared by Dr. Monte Reimers

The phone conference got off to a rocky start due to technical difficulties, but was well attended and kicked off the planning of a successful 2006 QA symposium and generated many great topics for the fall meeting.

• Emily Sanson provided an excel spreadsheet containing the proficiency test information that has been gathered. The document was circulated to the committee to confirm content. In September Emily updated the spreadsheet to reflect the feedback and finalized the document.

• Thursday October 12, 2006 the QA committee held an educational QA symposium at the Hilton Minneapolis. There were 60 registered participants with 5 no shows. Information on Document Control, Non-conforming test results, corrective and preventive action and Management Review were presented and discussed. It was unanimous that the Qualopoly game devised by Pat Lukens was the highlight of the symposium.

The symposium stayed under budget and the preliminary numbers indicate that the funds remaining were ~ $70. AAVLD receives any excess money generated by the symposium.

3. Proficiency Testing Document

Emily Sanson reported on the proficiency testing document. Emily indicated that she had only received a small number of changes and the changes were completed in August. A final version of the document was sent to the QA committee chair in early September.

After discussion, the committee decided to make the proficiency testing document available on the AAVLD web site. Emily agreed to remain the owner of the document, any changes and/or additions should be sent to Emily. Following revision, Emily will forward the document appropriately to update the web and notify the committee chair. The committee chair will send an e-mail to the committee indicating an update has occurred. A motion was made to make the proficiency testing document available on the AAVLD web site; it was seconded and carried unanimously.

3. QA Mission Statement

David Korcal presented the QA Committees current mission statement. David Korcal also reported that Dr. Donal O’Toole did approve the QA committee’s mission statement in July 2006.

"The mission of the Quality Assurance Committee of the American Association of Veterinary Laboratory Diagnosticians is to be the central resource for quality assurance information, communication and support within AAVLD." 35

4. Method Validation

David Korcal introduced Dr. Beverly McEwen from the Animal Health Laboratory at the University of Guelph. Dr. McEwen presented to the committee how method validation is handled at the Animal Health Laboratory at the University of Guelph.

Following the discussion of Dr. McEwen’s presentation, David Korcal indicated that with Dr. McEwen’s approval he would distribute the slides from the presentation in a pdf format, to the QA committee members.

5. Current Site Visit Updates

John Williams from the Texas Veterinary Medical Diagnostic Lab reported on their recent site visit. John reported that the auditors did use the auditor checklist. John indicated that a member of the quality unit was able to accompany the auditors during the visit. It was indicated that there was an emphasis on laboratory safety during the visit. John indicated he had a good idea of their deficiencies, but would have liked more feedback on deficiencies during the exit session with the auditors.

Chandra Gordon from Kansas State University reported on the recent site visit at the Kansas lab. Chandra indicated that the auditors used the auditor checklist and that a quality manager was able to accompany the auditors during the visit. Safety issues were emphasized. Like John, Chandra would have liked more detail on their deficiencies at the exit session with the auditors.

Patricia Lukens did indicate that their site visit went very much the same as the Texas and Kansas visits. Pat confirmed all the points that John and Chandra made.

6. SOP format and Core QA Documents

Accreditation committee update: (David Korcal)

• A copy of page 13, Version 4.0 of the Essential Requirements Document was distributed. It was brought to the committee’s attention that the Note under section 5.4.3.1 was added following the Accreditation Committee’s meeting July 2006 in San Francisco.

• The accreditation committee appointed a sub committee and charged it to write a site visit SOP that would cover the application process, the site visit and the following report process. The sub committee is being chaired by Dr. Francis Galey and David Korcal is a member of the sub committee.

• All accredited AAVLD laboratories will be receiving a request to submit the following materials, electronically if possible, by January 2, 2007.

1. A current version of the laboratories Quality Manual. 2. Current versions of the laboratories System/Administrative SOPs. 3. A completed AAVLD Auditors checklist.

• All accredited AAVLD laboratories will be receiving a request to submit the following materials, electronically if possible by May 1, 2007.

1. 2 Examples from different laboratory sections of calibration records for both pipette calibrations and balance calibrations. 2. 2 Examples from different laboratory sections of employee training records. 3. Corrective action logs with two detailed examples from different laboratory sections. 4. An internal audit schedule with two examples.

SOP Format

David indicated that with the information from the accreditation committee, the QA committee should discuss focusing on the format of AAVLD SOPs and the SOP on SOPs for the organization. David asked for volunteers to participate on a sub committee to write an SOP on SOPs. Denise Archer, John Williams and Joey Kellum volunteered to serve on the committee. David Korcal appointed Denise Archer as the 36 Chair of the sub committee. A motion was made to have a sub committee chaired by Denise Archer write an SOP on SOPs for the AAVLD organization. The motion was seconded and carried unanimously.

David Korcal again briefly outlined the four documents circulated by Dr. Reimers in early 2006. After discussion, the committee agreed to drop the other documents circulated by Dr. Monte Reimers and focus on providing a SOP format for the forthcoming Site Visit SOP that the accreditation committee is working on.

7. Document Control Software Update

The committee discussed two software packages, Sharepoint from Microsoft and TMS. After hearing discussion about both products, it appeared that Sharepoint was less expensive, but was more intensive in terms of support and set up than was TMS.

David Korcal indicated that he would circulate a blank spreadsheet to gather information regarding both of these products. David would collect the data and a summary would be made available as a link on the AAVLD web site.

8. QA Training Resources

Marilyn Simunich from the Idaho State Department of Agriculture was introduced. Marilyn presented information to the committee on the topic of QA training resources. Following the presentation Marilyn agreed to assemble the information gathered and put it in a spreadsheet format similar to the proficiency testing document.

The committee agreed that Marilyn would remain the owner of the document and any additions and/or changes would be forwarded to her. All revisions would be appropriately forwarded to be updated on the AAVLD web site and David Korcal would send out notification to the committee that a new version was available. A motion was made to include a link to this document on the web site. The motion was seconded and carried unanimously.

9. QA Guidance Documents

David Korcal presented the topic of QA guidance documents. David indicated that he felt there was a need for guidance documents that would cover basic QA topics such as Document Control, Internal Audits and Management Review for starters. It was explained that the guidance documents would provide further information for member laboratories on a specific topic of Quality Assurance. This information could be utilized to educate, plan and implement the process covered.

Following discussion, David asked for volunteers to help draft some initial guidance documents. Denise Archer volunteered to prepare a document on Document Control. Patricia Lukens volunteered to cover Management Reviews and David Korcal volunteered to prepare a guidance document on Internal Audits. Once completed, a draft of these documents would be distributed to the committee for review.

10. Auditor Training

David Korcal presented further information from the accreditation committee. The accreditation committee is forming a pool of auditors that can be called upon to participate in future site visits. Directors of AAVLD Accredited laboratories were contacted and asked to nominate two employees from their laboratories for the auditor pool, one discipline expert and one quality assurance expert. Nominations are due October 31, 2006 to the chair of the accreditation committee.

The Accreditation Committee indicated that they are attempting to schedule auditor training for individuals that are selected for the auditor pool. Currently they are looking at scheduling the training in Las Vegas during The Western States Conference in February 2007. A confirmed training or training date was not available at the time of the meeting.

11. 2007 QA Symposium

37 David Korcal asked for volunteers to serve on a sub committee to plan a QA Symposium for 2007 in Reno. Patricia Lukens, Darla Ewalt and Mark Davidson volunteered. David Korcal appointed Patricia Lukens as chair of the sub committee. A motion was made to have a sub committee chaired by Patricia Lukens plan the 2007 QA Symposium. The motion was seconded and carried unanimously.

Action Items:

Note: (Deadlines were determined by the committee chair and were not part of the committee meeting. They are designed to keep the committee on task over the next year.)

1. David Korcal will submit the proficiency document to be added as a link on the AAVLD web site. Deadline November 1, 2006.

2. David Korcal will send out a pdf of Dr. Beverly McEwen’s presentation following approval from Dr. McEwen. Deadline November 15, 2006.

3. David Korcal will send out a blank spreadsheet to accumulate data on Document Control Software. Deadline November 15, 2006.

4. David Korcal will summarize the Document Control Software spreadsheet and have it posted to the AAVLD web site. Deadline February 28, 2006

5. Marilyn Simunich will consolidate the information on educational opportunities and submit the document to be added as a link on the AAVLD web site. Deadline January 31, 2007.

6. The sub committee assigned to write the SOP on SOPs for AAVLD will provide a draft of the SOP to the committee for review. Deadline January 31, 2007.

7. The sub committee assigned to plan a symposium for 2007 will prepare a preliminary agenda and budget. Deadline is January 31, 2007.

8. David Korcal, Denise Archer and Patricia Lukens will prepare drafts of guidance documents for internal audits, document control and management review. Deadline March 31, 2007.

Strategic Planning Committee Chair: David Zeman, 3:00-5:30pm, Sunday, October 15, 2006, Board Room 3.

The committee met with 15 members in attendance. The committee reviewed the November 30, 2005 edition of the strategic plan item by item. Several goals were updated or modified and action items were adjusted accordingly. The revised document will be shared first with committee members for a final edit. Then the revised plan will be submitted to the Executive Board for their February meeting.

Serology Committee Chair: Jim England (absent) Facilitated by Pat Blanchard, 4:00-6:00pm, Saturday, October 13, 2006, Salon A

There are approximately 60 people in attendance including 8 members of the committee.

1. NVSL Proficiency testing Diagnostic Virology Laboratory 2006: a. Dr. Beverly Schmitt discussed overview of proficiency testing (PT) serology programs: Well characterized samples are used. However, results are based on comparison between all participants using a Poisson distribution with a cutoff where 95% of the labs agree. This requires that 95% of laboratories have returned their results to calculate the cutoff values so delays in returning results delays reporting to all participants. Proficiency testing programs are developed for regulatory program diseases.

Laboratories that fail are allowed to retest with a new scrambled panel. After a second failure they are removed from the approved list and must complete retraining before retesting. Most serology PT is for a laboratory site approval not individual technician (exception is Brucella).

38 NVSL occasionally sponsors ring testing, though this is most often for inter-laboratory comparison of non- program disease testing such as IgM for West Nile Virus (WNV).

b. Dr. Sabrina Swenson: PRV: 75 labs took Pseudorabies latex, screening ELISA, g1 ELISA, or meat juice ELISA PT. 46 states and Puerto Rico were approved, 8 labs failed on initial latex panel, with one lab dropped from approved laboratory list for the latex. There were no failures for g1 or screening ELISA. There was one newly approved lab for g1 and latex. The next test panel will be sent in November 2006. They will skip 2007 and send a panel in January 2008 to move to first of year cycle.

c. Dr. Eileen Ostlund: EIA: 472 labs took the EIA PT using a 20 sera panel. 413 agreed with each other and NVSL on all 20 samples; 59 had one or more deviations, 19 labs had 3 or more and failed the initial test, and 18 of the 19 passed on a retest and one discontinued testing. There is a moratorium on adding any new EIA labs due to the large number of laboratories already approved. Bluetongue Virus: 58 labs took the test on a 20 sera panel for export test purposes. 50 agreed with each other and the NVSL result on all 20 samples. Discrepancies on up to 2 samples were considered passing. Two laboratories failed but passed on retest. Bovine Leukemia Virus (BLV): 59 labs took the PT on a 20 sera panel. 51 agreed with each other and NVSL. One miss was allowed for passing. 3 failed on the first testing, 2 retested and passed, and 1 failed. IgM Capture ELISA for WNV: 28 labs tested a 10 serum panel - sent prediluted at 1:40 for use at 1:400, 6 strong positives, 2 weak positives, and 4 negatives were included. 17 of 28 labs had same results on all samples. A variety of reagents and serology kits were being used. Most disagreements were on the weak positive, some of which were reported as negative or nonspecific. Future plans are to have larger volume of serum for panel use, possibly pooling samples, so they can send undiluted samples.

2. NVSL Leptospira serology update – Mark Wilson, NVSL a. During the period of September 1, 2005 through August 31, 2006, the National Veterinary Services Laboratories Leptospira Reference Center received a total of 2,472 sera submitted for Leptospira microscopic agglutination test (MAT). Of these, 1,970 were for diagnostic and 502 were for export purposes; total tests performed were 10,459. During this same period, clients requested and were provided 262,000 milliliters of polysorbate 80-bovine albumin medium, 159 Leptospira reference cultures, 90 vials of Leptospira reference antiserum, 67 vials of Leptospira multivalent fluorescent antibody conjugate, and 13 vials of flazo orange counterstain. b. Three Leptospira MAT training schools were held during September 2006. Seventeen trainees from 12 states attended. It is anticipated that a 2007 Leptospira training school will be held. c. Sixty-one people participated in the 2006 Leptospira proficiency test. Two participants were from laboratories located in Canada and New Zealand. Twenty sera were tested against five Leptospira antigens. Scoring was based on two parameters: identity (positive-negative, 500 points possible) and accuracy (titer, 500 points possible). For correctly identifying a sample as positive or negative, five points were awarded. Identification results show 85% of the participants scored 95% or better on the identity component of this proficiency panel. No points are awarded for incorrectly identifying a sample (e.g., a negative sample as positive or vice versa). A gradient of points was assigned for accuracy. Results that match the median score were awarded five points; for each two-fold deviation from the median titer, a 1 point deduction was scored. The consensus identity response and median titers of the participating group served as targets to compare individual laboratory results. An overall score was calculated from the parameter scores. A summary of the results is available upon request. Comparing results from consecutive years, 55.7% scored 95% or better on the overall score which is 13% lower than last year.

3. AAVLD Grandfathering Requirements for serology methods – Dr. Sharon Hietala The criteria sent to attendees via email prior to the meeting was briefly reviewed. A test that is not validated for a species, sample type or disease can be run but the laboratory should inform clients it is not valid for the specific circumstance. The current challenge is that the compiled list of ~300 serology tests performed in US labs that was sent to attendees includes about 140 that are OIE preferred or alternate, US regulatory (including NPIP), commercial kit or meet criteria of published by an established organization (AAAP). This leaves ~160 tests we need to data or references on to establish as valid.

If a valid test protocol is modified by a lab, the onus is on that laboratory to prove it is equivalent. There are not yet published guidelines on proving equivalency. Analytic sensitivity and specificity should be documented for all assays. Standard controls to show reproducibility and prove the assay is performing within expectations on a daily basis will meet the last criteria. The Executive Board approved call-in conference calls for serology to share information on criteria and sources of information to help meet the 39 criteria. As group we could accomplish getting information or data for most tests, though, individually it may take a large amount of work to complete.

4. Brucella ovis serology – progress and future plans – Steve Hennager, NVSL A problem developed with this assay due to the antigen strain becoming lab adapted so it no longer grew, lost its robustness, and was not stable. In addition, several years earlier the cut-offs had been changed to increase the specificity and decrease the sensitivity as the prevalence dropped. OIE uses international reference strain REO198. Due to a great deal of variation on a proficiency test panel, the test was reworked. Sera were obtained from culture positive and culture negative animals. 441 samples from negative animals revealed: 28 positive/413 negative on Maxisorp and 4 positive/437 negative on Polysorp. Also tested 179 sera from culture positive animals. Outcome: Maxisorp: 85.8% sensitivity and 88.2% specificity. Polysorp: 100% sensitivity and 98.5% specificity. Positive and negative predictive values were 92.2% and 78.6% for Maxisorp and 99.1 % and 100% for Polysorp. Dr Jim Evermann provided invaluable sera from culture positive animals.

The REO198 antigen was considered stable and was stored as a master seed. The Blue Phos system is consistent and reactive. Polysorp plate has nonspecific reactions with and without antigen in wells and when this is subtracted out, it cleans up the background. A new NVSL protocol is under development. A new low positive control is being developed.

5. UM&R for Brucellosis testing in non-program species (goats, horses, llamas, etc) – Steve Hennager a. There is no UM&R required or recommended test for non-program species. However, you can obtain an SOP from NVSL on the Card test that they use for non-program animals. Use of this test might require a disclaimer on the laboratory report stating it is not validated in the species being tested. NVSL believes the card test is the best test as it has the best specificity.

6. NVSL proficiency testing in bacteriology – Teresa Sigafoose: a. Brucella, Mycobacterium and Anaplasmosis sera was provided to participating laboratories for proficiency testing that included negative, positive, and weak positives. It’s become increasingly difficult to get samples from positive and weak positive animals as Brucellosis has declined in the US. b. Proficiency is approved by technician for Brucella and by laboratory for Anaplasma, and Johne’s. There is still no Bovine Tuberculosis gamma interferon proficiency test policy in place at this time. c. Brucella: passing score was >90% and 2/3 of all test takers must agree with the outcome of that sample for it to count. Panel included positive, weak positive, negatives. 2005: 1511 people in 85 labs took test – 1456 people in 85 labs passed on at least one Brucella test method on the first try. 2006: 1626 people in 85 labs took test, 1359 people in 84 labs were certified on at least one Brucella test. d. Johne’s 5 positives, 5 negatives, 15 close to the cut-off in the panel of 25 sera. Required to pass: All negative and positive samples must be correctly identified and >90% of all cut-off samples must be correctly identified to pass, 2005: 81 labs took the test, 87.8% passed using Biocor and 96.7% passed using IDEXX. 2006: 82 laboratories took the test and 93% passed using Biocor and 90% using IDEXX kit. e. Anaplasma, 20 sera in panel required >80% correct to pass. 2005: 95% of the labs taking the test passed. 2006 panel sent out October 11. f. TB gamma interferon only the ELISA portion of the test has been evaluated by proficiency testing in the past. g. Both Johne’s and Brucellosis need more mid range serum. h. Timeliness of reporting results to proficiency test participants is linked to the fact they need 95% of the labs to report results in order to determine scores. i. In the future more e-mail reporting and requests will be used. j. Cost of proficiency testing for non-program diseases, like Johne’s, must include cost of developing positive serums.

7. IDEXX product updates – Mr. Frank Winslow a. Johne’s ELISA kit changes and their validation IDEXX worked to improve it's specificity from 96.88% to 99.2% following outcome of a Collins 2005 study showing a high background on negative populations. The sensitivity has stayed the same with the changes to improve specificity. Correlation of ELISA to fecal culture R2 improved from 0.45 to 0.55. Signals are reduced when compared to the original kit, resulting in lower S/P for strong positive samples. The new kit has been on the market since mid July. The sensitivity on fecal culture positive animals is 27% and specificity for disease negative animals is 99%. 176 of disease positive animals were kit positive, 471 were kit negative, 18 of disease negative animals were kit positive and 2316 were negative. 40

BVD Virus Antigen ELISA Kit will be changing from a 2-plate to a 5-plate format. As soon as the 2-plate runs out, only 5-plate kits will be sold. The protocol is also being changed to add optional overnight sample incubation in wells and added a new x-Chek user defined protocol. Thimerosal has been removed as a preservative.

FlockChek AI testing is showing excellent specificity - 99.6 to 99.8% for broilers and 98-99% for layers and breeders. IDEXX is now developing a multi-species screen; pending approval by USDA. Poster was available in the abstract book.

Question on why time ranges were removed from BVDV ELISA protocol and replaced with single time when the latter is more difficult to use during audit of test. European marketed kits reportedly use ranges per IDEXX technical staff. IDEXX is looking for ways to make kits more similar. They will take the issue back to their technical staff.

8. Future of the committee – sunset or establish goals, active membership and co-chairs: When asked, attendees did not express a desire to sunset. When asked for potential future goals other then completing the criteria for grandfathering testing, there were no suggested goals. Future status of the committee, chairmanship, activities, and goals remains undetermined.

Veterinary Analytical Toxicology and Mycotoxins (AAVLD) and USAHA Environmental Residues Committees Chairs: Catherine Barr and Brent Hoff, 3:30-6:30pm, Saturday, October 14, 2006, Rochester

39 people in attendance. Attending: Linda Aston, Catherine Barr, Karyn Bischoff, Emmett Braselton, Mike Carlson, Bob Everson, Mike Filigenzi, Frank Galey, Ramesh Gupta, Dwayne Hamar, Bill Hare, Brent Hoff, Steve Hooser, Paula Imerman, Anant Jain, Anita Kore, Jason Kuchar, Andreas Lehner, Randall Lovell, Gavin Meerdink, Michelle Mostrom, Mike Murphy, Fred Oehme, Lynn Post, Birgit Puschner, John Reagor, Jane Robens, Wilson Rumbeiha, Norm Schneider, Nick Schrier, Tricia Talcott, Larry Thompson, Asheesh Tiwary, Elizabeth Tor, Petra Volmer; international guests Philippe Berny, Alan Seawright, Theuns Naude, and Allan Julian.

Gavin Meerdink – chair of the USAHA Committee on the Environment, encouraged participation in the committee and gave way to the need for a focus on method validation.

Incoming representatives to the Veterinary Analytical Toxicology Steering Committee were selected and approved by acclamation (Linda Aston, Brent Hoff, Lynn Post, and Christina Wilson). Paula Imerman was named to replace George Yang. Steve Hooser was elected Committee Chair for 2007.

Catherine Barr conducted a discussion of emerging mycotoxin problems for 2006. In general, it was too early in the season for most areas of North America to report. Texas has already seen high (50 – 2500 ppb) aflatoxin concentrations in the corn crop, and abnormally high fumonisin levels are also expected due to drought. The North Dakota lab has found several low to mid aflatoxin levels in feeds. New Zealand had a bad year for facial eczema (sporidesmin) and zearalenone.

Nick Schrier presented practical applications of method validation for analytical diagnostic toxicology. The method must be fit for the intended purpose. One method may be adequate for making a diagnosis; requirements for legal defensibility necessitate a different method/testing tier. The method identifier is noted on the client report. Sample rejection criteria must be specified in the method. A formal, written Validation Plan provides a re-usable framework to meet points of the AAVLD (or ISO 17025) audit checklist with respect to selectivity, specificity, repeatability, limit of detection, precision, measurement uncertainty, recovery and other applicable parameters. A less stringent Verification plan is sufficient for methods published with supporting validation data in a peer reviewed journal. A Youden 7-factor matrix allows method ruggedness testing using only 8 samples. A generic controlled document for Non-Routine Testing situations (NRT; client-driven, defined as happening not more than 2-3-times a year) provides a checklist citing the testing method to be altered, the non-routine parameter, the expected effects of the change on the test result, and the required documentation of client communication for agreement on the degree of method validation to be performed prior to testing. An NRT can be a new test, a rare test, or a critical variation of an existing test (off-label kit use, non-routine specimen, extra dilution required due to sample size). Increases in frequency of similar NRTs indicate the need for scope expansion after further method validation. A generic controlled document is also used for Spreadsheet Validation.

41 Catherine Barr distributed copies of AAVLD Minimum Essential Requirements ver 4.0 (8/27/06) § 5.4.3.1 NOTE: 1- 4 and facilitated discussion in the context of the above presentation in combination with the Single Laboratory Analytical Method Validation Symposium presented 10/13/06 (Anant Jain, AOACi).

Jason Kuchar – Thermo Corporation, presented an update on instrumentation and instrument systems, illustrating the consolidation of many top-of-the-line product families under the Thermo umbrella. This allows and entire laboratory to be furnished with all necessary equipment from one source. Special attention was given to emerging LC-MS/MS technologies.

Petra Volmer led a multi-focal discussion regarding the business side of toxicology within the diagnostic laboratories. Issues included profitability/critical availability of toxicology testing; proportions of state/fee/research/other funding for operating costs, personnel, and capital equipment; effects of contract labs on diagnostic lab toxicology submissions; bases for test charges (reagents, controls, duplicates, personnel/instrument time); proportion of time spent on research/teaching vs. diagnostic work.

Steering Committee members: Chair - Steve Hooser, 2007 Through 2007 - Dwayne Hamar, Andreas Lehner, Frank Galey, Larry Thompson Through 2008 - Steve Hooser, Paula Imerman, Michelle Mostrum, Bob Poppenga Through 2009 – Linda Aston, Brent Hoff, Lynn Post, Christina Wilson Liaison: AOAC – open FDA - Randall Lovell ABVT – Bob Poppenga AAVCT – Ramesh Gupta

Virology Committee Chairs: Jane Christopher-Hennings and Jim Evermann, 1:00-4:00pm, Friday, October 13, 2006, Salon A

Dr. Evermann opened the committee meeting at 1pm with announcements and welcoming to all 75 attendees. Key announcements were as follows:

1) the group paused for a minute in memory of John Black, President of American Biosciences in Tennessee, who passed away in July, 2006. John was an outstanding virologist and gentleman. He and his wife, Pat started their company and fulfilled a valuable place in providing quality reagents to labs nationally and internationally; 2) the assembly was reminded that beginning in August, 2006, all accredited labs would need to conform to the Essential Requirements for An Accredited Laboratory by completing the documentation showing that all virology assays have a section on ‘validation of test methods’ with assays documented by publications, recognized reference manuals, etc; 3) presentation of the 2nd annual ‘Pioneers in Virology Award’. This year’s awardee was Dr. Leroy Coggins from North Carolina. Dr. Coggins could not attend, so Dr. Evermann read his biography to the assembly. Dr. Coggins plaque and letter will be sent to his home.

The general meeting started at 1:20pm with Dr. Bev Schmitt from NVSL, Ames, Iowa. Bev gave updates in the virology activities at NVSL and an overview of the new bio-safety facility that was built. At 1:30pm, Dr. Pat Halbur from Iowa State University spoke on Pathologic features of porcine circovirus. Pat indicated the multiple disease situations that can occur with this virus, the role of concurrent viral and bacterial infections in the disease process, and the diagnostic detection methods available. At 2:30pm, Dr. Kay Faaberg from University of Minnesota spoke on the Emergence and evolution of PRRS virus in the United States. Kay gave a great overview of the molecular epidemiology of PRRS in the U.S. and Europe. At 3:15pm, Dr. David Suarez from the SE Poultry Research Lab in Georgia spoke on the Divergence of Avian Influenza Virus. David gave a wonderful summary of current interspecies spread of the AI virus and surveillance strategies that are being used throughout the U.S.

The Pioneers in Virology subcommittee (members below*) met briefly to confer on the 2007 awardee. It was agreed that Dr. Janice Miller would be the recipient of the award. Dr. Evermann will contact Dr. Miller to see if she can attend the next meeting in Nevada.

Dr. Christopher-Hennings concluded the meeting at 4:00pm and thanked all the participants and speakers. * Pioneers in Virology Subcommittee members: Dr. Ed Dubovi, Dr. Fernando Osorio, Dr. Gail Scherba, Dr. Melissa Kennedy, Dr. David Benfield, Dr. Jane Christopher-Hennings, and Dr. Jim Evermann. 42