The NAHLN Quarterly - 2010 August Edition

--A few weeks ago, we completed the first National Animal Health Laboratory Network (NAHLN) and American Association of Veterinary Laboratory Diagnosticians (AAVLD) training course on Quality Management Systems (QMS). We had 88 participants from 50 laboratories. The instructors brought with them years of expertise and a passion for laboratory quality. The training course was well received and we are excited about how we can expand it in the future for use in other networks and countries.

--Foot and Mouth Disease (FMD) table-top exercises in California, Colorado, New York, and Ohio. Sarah Tomlinson, our NAHLN Associate Coordinator, and I are committed to attending as many of the exercises as possible. We will be collecting participants' input on all topics related to laboratory communication and response including the revised NAHLN Operational Plan.

--On June 15-16, 2010, we held the inaugural meeting of the NAHLN Coordinating Council. As stated in the charter, "The Coordinating Council provides a forum for discussion of current and future needs of the NAHLN." A list of the State representatives on the Council is provided in the Coordinating Council article below.

Recently, we asked for your input on The NAHLN Quarterly. We wanted your feedback on the frequency of distribution, format of the newsletter, content and length of articles, and suggestions for improvement. Over 100 responses were received and we will use those as we look at potential areas for improvement. A summary of the input will be provided in our next issue of The NAHLN Quarterly. The number of subscribers continues to increase. We currently have 1,209 subscribers! The number of current subscribers is posted directly beneath my column. If you didn't have the opportunity to respond and have ideas for regular or feature articles or suggestions for improvements, please feel free to contact me at Barbara.M.Martin@aphis.usda.gov or the NAHLN Program Office at NAHLN@aphis.usda.gov.

Sincerely,

Barbara M. Martin
NAHLN Coordinator

National Veterinary Services Laboratories
USDA, APHIS, VS

Current Number of Subscribers:

1,209

Upcoming Events

July-September, 2010: Foot and Mouth Disease (FMD) Tabletop Exercises in 15 locations, to see full schedule go to article titled "Update on FMD Table-Top Exercises"
September 8-9, 2010: First Symposium for the International Society for Companion Animals, Toulouse, France
September 15-17, 2010: First Congress of the European Association of Veterinary Laboratory Diagnosticians (EAVLD), Lelystad, the Netherlands
September 30-October 6, 2010: American Biological Safety Association (ABSA) Conference, Denver, Colorado
November 11-17, 2010: 53rd Annual AAVLD/USAHA Meeting, Minneapolis, Minnesota

Coordinating Council Meeting

On June 15-16, 2010 the National Centers for Animal Health in Ames, Iowa hosted the first meeting of the NAHLN Coordinating Council. The Council Co-Chairs, Beth Lautner, Veterinary Services (VS); Muquarrab Qureshi, National Institute for Food and Agriculture (NIFA); and Gary Anderson, Kansas State University, welcomed the members and facilitated the meeting.

John Clifford, Deputy Administrator of VS and Merle Broussard, Deputy Administrator of Plant and Animal Systems, NIFA, thanked the members of the Coordinating Council for their participation and stated that they are looking forward to feedback from the group as we look to move the NAHLN forward. They also highlighted some of the NAHLN accomplishments over the past few years including;

Conducting surveillance for endemic and foreign animal diseases
Participating in pandemic H1N1 validation and quick work on deploying approved assays
Developing the first quality management system course to be held in August, 2010

The agenda for the meeting focused on the activities of the Coordinating Council as outlined in the Charter and included the following:

Review and comment, at least annually, on goals, strategic plan, and operational objectives of NAHLN

--Input from USAHA/AAVLD Joint Committee on the NAHLN

Review and comment, at least annually, on the specific criteria that defines a NAHLN Laboratory

--Laboratory review process and approval/continued approval

--Laboratory responsibilities - VS and NIFA

Discussion of those policies that relate to the NAHLN that do not infringe on the statutory authority of the Federal or State governments

--NAHLN checklist and policy documents

--Surveillance programs, testing activities, and determination of laboratory participation

Review and comment as necessary on any other programmatic or operational issues of relevance to the NAHLN in an effort to enhance the effectiveness of the Network

--NAHLN Working Groups updates and discussion

NAHLN Methods Technical Working Group
Exercises and Drills
IT Working Group

--Standardizing PT processes

--FMD Exercises

--NAHLN Activation

--NAHLN capacity modeling needs

--NAHLN communications

--NAHLN Coordinating Council charter review

New Areas for the NAHLN

--One Health

--Emerging Diseases

--Toxicology

The notes from the Coordinating Council meeting will be reviewed by members of the Coordinating Council and then posted on the NAHLN website at www.aphis.usda.gov/animal_health/nahln/.

State Representatives of the NAHLN Coordinating Council

Article submitted by Barbara Martin, NAHLN Coordinator, USDA/APHIS/VS/NVSL, NAHLN Program Office, Ames, IA

Quality Management System (QMS) Training Program

NAHLN Laboratories may be involved in surveillance for early detection of a foreign animal disease, surge testing during an outbreak, and testing samples during the outbreak recovery phase. As such, there must be a high degree of confidence in the quality of the laboratories and the associated test results. All NAHLN Laboratories must be fully accredited by AAVLD or by an accrediting body according to the World Organisation for Animal Health (OIE) and International Organization for Standardization (ISO) 17025 standard. If a NAHLN Laboratory is not accredited, it must have implemented a quality management system consistent with the OIE/ISO 17025 standard, be willing to participate in regular site visits, and must be approved by the USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), National Veterinary Services Laboratories (NVSL).

To assist NAHLN Laboratories in meeting this requirement and to continuously improve quality management systems throughout the Network, the NAHLN Program Office has collaborated with the AAVLD Accreditation Committee to develop and deliver a Quality Management System (QMS) Training Program. The QMS Training Program was recently held on August 3-5, 2010 at the National Centers for Animal Health in Ames, Iowa.

The training program provided an interactive class environment that included training on quality system requirements, the accreditation process, document control, internal auditing, and root cause analysis. In addition, a wet laboratory provided the opportunity for participants to conduct an audit, recognize non-conformances, analyze the root cause, and write corrective actions.

The course was opened to personnel from all NAHLN Laboratories and was offered at no cost to the participants. The NAHLN Program Office provided funds for all costs associated with the training.

A follow-up to the QMS Training Program will be provided in an upcoming issue of The NAHLN Quarterly.

Article submitted by Jill Brown, Program Analyst, USDA/APHIS/VS/NVSL, NAHLN Program Office, Ames, IA

NAHLN Surveillance Update

Wild Bird Avian Influenza (AI) Surveillance

The new biological year for conducting surveillance for highly pathogenic avian influenza in wild, migratory birds began on April 1st. Approximately 30% of the target number of 44,000 samples is collected from April through September from resident birds to provide adequate temporal coverage and improve the early detection objective. These samples also help to establish baseline data about avian influenza viruses in the resident population and significantly improve steps toward protecting the U.S. poultry industry. Sampling of migratory birds will increase in the fall when wild ducks and geese begin to their winter migration southward.

Bovine Spongiform Encephalopathy (BSE) Surveillance

Background: Six (6) NAHLN Laboratories currently participate in enhanced BSE surveillance testing. BSE surveillance testing by NAHLN Laboratories began in June of 2004. The National Veterinary Services Laboratories' (NVSL) Pathobiology Laboratory in Ames, Iowa performs confirmatory testing.

The table below shows sample testing performed by month for BSE by NAHLN Laboratories. The total number of samples tested for BSE by NAHLN laboratories from October 2009 through June 2010 was 35,607.

BSE Samples Tested by NAHLN Laboratories

October 2009 - June 2010

*BSE testing data provided by the USDA/APHIS/Veterinary Services, National Surveillance Unit

Classical Swine Fever (CSF) Surveillance

Background: In January 2006, USDA implemented a CSF surveillance plan developed by the National Surveillance Unit in States (and Puerto Rico) with a high risk for introduction of CSF. There are currently forty (40) NAHLN Laboratories participating in CSF surveillance testing. The NVSL's Foreign Animal Disease Diagnostic Laboratory (FADDL) located at Plum Island, New York, performs confirmatory testing. Over 30,600 samples have been tested since the inception of the program.

From October 2009 through June 2010, there were 2,700 veterinary diagnostic laboratory (VDL) specimens and 1,898 slaughter specimens tested for CSF by NAHLN Laboratories. The tables below show the number of VDL and slaughter samples tested by month for CSF surveillance.

VDL Samples Tested for CSF by NAHLN Laboratories

October 2009 - June 2010

Slaughter Samples Tested for CSF by NAHLN Laboratories

October 2009 - June 2010

*CSF testing data provided by the USDA/APHIS/Veterinary Services, National Surveillance Unit

Chronic Wasting Disease (CWD) Surveillance

Background: In September 2001, the Secretary of Agriculture released Commodity Credit Corporation (CCC) emergency funds allowing the United States Department of Agriculture (USDA) to begin implementation of a program to eradicate CWD among farmed elk populations. Subsequently, Congress approved an annual (line item) budget for the CWD Program which has since expanded to include susceptible deer species as well. The program involves surveillance strategies to detect CWD in farmed/captive cervid herds, to respond to detections of CWD- positive herds and to investigate epidemiologically linked animals. There are currently 24 NAHLN Laboratories approved for CWD surveillance testing.

Thus far in FY10 (from October 1, 2009 through June 30, 2010), 11,749 farmed/captive cervids have been tested for CWD by NAHLN Laboratories.

The table below shows the number of animals submitted for testing by month for CWD from October 2009 - June 2010.

Number of Animals Tested for CWD by NAHLN Laboratories

October 2009 - June 2010

*CWD testing data provided by the USDA/APHIS/Veterinary Services (VS), National Veterinary Services Laboratories (NVSL). Chart does not include 4,345 animals tested by NVSL.

Scrapie Surveillance

Background: The National Scrapie Eradication Program is a USDA, APHIS, VS initiative with the objective of eradicating scrapie in U.S. sheep and goat populations. Efforts to eradicate scrapie have been ongoing since 1952, with an accelerated scrapie eradication program initiated in 2001. Since 2003, surveillance for the program has been conducted primarily through the Regulatory Scrapie Slaughter Surveillance (RSSS) component. Other surveillance activities include testing of scrapie exposed and potentially exposed sheep and goats found through investigations of infected animals, clinical suspect animals and other mature sheep and goats submitted to veterinary diagnostic laboratories, rabies-suspect animals that test negative for rabies, and voluntary on-farm testing of flocks with risk factors for scrapie or as part of the Scrapie Flock Certification Program. There are currently 24 NAHLN Laboratories approved for scrapie surveillance testing.

From October 1, 2009 through June 30, 2010, 34,576 animals were submitted for scrapie testing through RSSS and 1,464 animals through other surveillance activities.

The table below shows the number of animals submitted for testing by month from October 2009 - June 2010.

Number of Animals Tested for Scrapie by NAHLN Laboratories

October 2009 - June 2010

*Scrapie testing data provided by the USDA/APHIS/VS, National Surveillance Unit and the NVSL. Chart does not include 1,176 animals tested at NVSL.

Swine Influenza Virus (SIV) Surveillance

Background:

VS has developed and implemented a surveillance plan for swine influenza virus (SIV), including the pandemic H1N1 2009 virus (pH1N1), in swine. The plan is based on the most current information available on this novel influenza virus strain. Surveillance is aimed to identify the pH1N1 strain as well as other non-typical strains of SIV in swine.

The immediate goals of the surveillance program were to: (1) determine if the pH1N1 virus strain currently exists in U.S. swine; (2) determine the distribution, if the pH1N1 strain is present, to inform further policy decisions; (3) detect other novel influenza virus strains in swine in a timely manner; and (4) determine genetic characteristics of novel viruses necessary for vaccine and diagnostics development.

Thirty-seven (37) NAHLN Laboratories are participating in SIV surveillance activities.

The table below shows the number of samples tested since the SIV Surveillance began in May of 2009. From May 22, 2009 through June 2010, a total of 1,275 swine samples were tested for SIV and 69 swine from 22 laboratory accessions have been confirmed positive for 2009 pandemic H1N1. NVSL presumptive and confirmed results for swine and other animal species are available on the web at USDA H1N1 Flu Collection Page.

The surveillance information in this article has been provided by USDA APHIS':

Veterinary Services (VS)-National Center for Animal Health Programs-Swine Health Program Staff,

VS-National Surveillance Unit,

VS-National Veterinary Services Laboratories (NVSL) and the

NAHLN Program Office,

Wildlife Services-National Wildlife Disease Program

*Charts in this article are based on information and test results available at the time of report generation. Numbers are subject to change due to later reporting of test results and updates in the database.

NVSL Update - NCAH Building Dedication

On April 19, Secretary Vilsack was in Ames, Iowa along with local, State, and Federal government officials to dedicate the National Center's for Animal Health (NCAH). More than 350 people attended the dedication ceremony, participated in facility tours, and reviewed many of the posters that were on display. Attendees included current and retired USDA employees, NAHLN Laboratory Directors, AAVLD and USAHA members, and many individuals from the industry. The NCAH is a $460-million diagnostics, biologics regulation, and research center and USDA's largest ever construction project. The dedication marks the completion of a long-term project to consolidate three USDA units previously operated separately in Ames; the Animal and Plant Health Inspection Service's (APHIS) Center for Veterinary Biologics (CVB) and National Veterinary Services Laboratories (NVSL), and the Agricultural Research Service's National Animal Disease Center (NADC). The NCAH has biosafety level (BSL)-2 and BSL-3 laboratory space, as well as animal and administrative space for some of the Nation's top animal health scientists and researchers.

Type caption text here.
The Building Dedication of the National Centers for Animal Health this past April.
Pictured above from left to right: Senator Tom Harkin, USDA Secretary Tom Vilsack, U.S. Representative

Tom Latham, and Fred Schuster, Business and Economic Liaison for Senator Chuck Grassley

The NCAH, Combined Laboratory Facility (CLF), was also awarded the Leadership in Energy and Environmental Design (LEED) Certification. The LEED green building certification program encourages and accelerates global adoption of sustainable green building and development practices through a suite of rating systems that recognize projects that implement strategies for better environmental and health performance. LEED is a third-party certification program and the nationally accepted benchmark for the design, construction, and operation of high-performance green buildings. LEED gives building owners and operators the tools they need to have an immediate and measurable impact on their buildings' performance. LEED promotes a whole-building approach to sustainability by recognizing performance in five key areas of human and environmental health: sustainable site development, water savings, energy efficiency, materials selection, and indoor environmental quality.

Article submitted by Megan Sprecher, USDA/APHIS/VS/NVSL, Director's Office, Ames, IA

Quality Assurance (QA) Update

AAVLD Accreditation and Quality Committees Update

The American Association of Veterinary Laboratory Diagnosticians (AAVLD) Accreditation Committee will be meeting again in July to review recent Accreditation Audit reports, and follow-up reports from laboratories recently visited. A pool of trained auditors, not members of the Accreditation Committee (AC), has been providing assistance to the Committee through on-site visits for the past few years. The AC members have been quite pleased with the assistance and expertise that the audit pool has provided. The audit pool has been a much needed asset to the Committee, as there are not enough Committee members to perform all the site visits on their own. In addition, the audit pool members benefit from the additional auditor training provided by the Committee and their exposure to other laboratories during the site visits. It's been a "win win" situation for each group, and has improved the quality and efficiency of the site visits overall.

The Accreditation Committee Chair, Beverly Byrum has recently released a communication to the AAVLD Committee Chairs regarding obtaining the Committee's review and confirmation that quality-related documents they wish to place on the AAVLD web site are consistent with the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory. Once the Committee review/confirmation has been completed the document may be placed on the Accreditation Committee's web page. In addition, this process requires a periodic review of these documents to assure they remain current and useful to members. AAVLD Committees are welcome to develop quality-related guidance for their respective disciplines and submit them to the Accreditation Committee.

The Quality Assurance Committee's new working group has just embarked on a project to create a guidance document for the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory. The group intends to provide some clarification of the requirements, and include examples and pitfalls to avoid. The intent is to have a draft of the guidance document available for the entire QA Committee to review before the November 2010 meeting, followed by a final draft ready for the Accreditation Committee to discuss, review and, hopefully, approve by early next year.

The California Animal Health and Food Safety Laboratory System (CAHFS) with the University of California Davis had their accreditation site visit recently. They have a large laboratory system and a well-established quality program. Laura Torchin, the CAHFS Quality Assurance Manager, and also an Accreditation Committee member, has provided some insight into the CAHFS experience with the site visit by giving her feedback to the following questions.

What did you do to initiate the re-accreditation process?

We obtained the accreditation application from the AAVLD website and our laboratory directory contacted the accreditation committee site visit chair to initiate the re-accreditation process.

How did your lab prepare for the audit?

We really didn't do anything special to prepare for the audit. In general, it's probably not a good idea to make any major changes just prior to an audit. A quality system is always evolving and we wanted a true assessment of the policies, procedures and practices that we have established over the last several years with the realization that we would probably have to make some changes to our system due to the outcome of the audit. We conducted a training session with all personnel on what to expect during the audit and suggested that personnel do a quick walk through their areas to just tidy things up, as needed, prior to the assessment.

What are your tips for what to do during the audit?

We tried to approach the audit as an opportunity for improvement as well as a way to identify gaps in our system and evaluate the effectiveness of our internal processes. This was our first assessment since implementing our Quality System and we were looking forward to obtaining feedback from AAVLD. We really tried to stress with personnel that for a successful audit, it is crucial to be open and honest when answering the assessor's questions. I feel this is the most important thing you can do during an audit and will provide the most benefit to the laboratory.

Now that the audit is over, would you have done something different to prepare, or something different during the audit?

We have a large system to audit (four labs across the state), so working out the logistics was the most difficult part and there might be a more efficient way to cover the whole system for the next time. We had a very good audit team who were flexible and accommodating. The one thing I would do different next time is have all the labs in our system participate in the final closing meeting. There were separate opening/closing meetings at each branch lab, but there were some comments at the final closing meeting that would have been nice for the whole system to hear.

What are your suggestions for a successful site visit, from the lab's viewpoint?

Audits can be very stressful, so we tried to alleviate as much stress as possible by having personnel change their mindset about the purpose of the audit. It's not a punitive process. We tried to frame it in the following context:

It as an opportunity for improvement
AAVLD is here to help
Change is good
Be proud of what we've accomplished
Just explain what you do and why
Make it a positive experience
Attitude is everything!

Article submitted by Patricia Lukens, Quality Systems Manager, Washington Animal Disease Diagnostic Laboratory, Washington State University, Pullman, WA

Information Technology (IT) Update

Background. A critical aspect of the NAHLN is the effort to standardize data, improve data quality, and maximize the efficiency of data transfer via the IT infrastructure and data repository. The NAHLN IT system has been developed with data messaging and standards to ensure that accurate and consistent diagnostic information is quickly and securely transmitted.

Routine classical swine fever (CSF) test results have been electronically and securely submitted via a web-based system for over three years. In August 2008, NAHLN Laboratories began transmitting test results through standardized electronic messaging. There are currently 36 laboratories approved for CSF testing and 29 laboratories that are receiving surveillance samples. Eleven of those are sending test results electronically.

There are currently 54 NAHLN Laboratories that are approved for avian influenza testing. Thirty-six of the avian influenza (AI) approved laboratories are participating in Wildlife Services (WS) Wild Bird AI Surveillance. The production system for the WS Wild Bird AI Surveillance module was activated in June 2009. At present, ten laboratories are messaging into the production system.

Update. The NAHLN IT team has been working to address problems with messaging and subsequent reporting that has prevented additional NAHLN laboratories from messaging into the production system. The resolution of these messaging defects is currently undergoing user-acceptance testing. We expect that the modifications will soon be released into production. The shift of several laboratories that are currently messaging into the test system to begin messaging test results into the production system should follow closely.

Messaging Data. The graphs below show the percentage of results being electronically messaged for CSF and Wildlife Services' Wild Bird AI Surveillance programs. The remaining test results are being entered via the web-based Veterinary Services Laboratory Submissions (VSLS) database for CSF or are entered into the system by WS personnel for AI.

The messaging data has been provided by the APHIS, Veterinary Services, Office of the Chief Information Officer and testing data populated through the VSLS database.

______________________________________________________

*Charts are based on information and test/messaging results available at the time of report generation. Numbers are subject to change due to later reporting of test results and updates in the database.

Article submitted by Barbara Martin, NAHLN Coordinator, and Sarah Tomlinson, NAHLN Associate Coordinator, USDA/APHIS/VS/NVSL, NAHLN Program Staff, Ames, IA

Featuring a New Laboratory Director to the NAHLN

Tammy Beckham became Director of the Texas Veterinary Medical Diagnostic Laboratory in May of 2008. Her interest in diagnostic medicine began during her service in the U.S. Army where she worked as a principal investigator while pursuing her PhD at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID). While serving as a Captain in the U.S. Army, she was fortunate to gain experience in diagnostic development and validation for both biosafety level (BSL)-3 and BSL-4 agents. In particular, she worked primarily in a BSL-4 laboratory developing rapid diagnostic tests for both Ebola and Marburg viruses.

Beckham earned her DVM in 1998 and her PhD in Biomedical Sciences in 2001, both from Auburn University. In 2002, she accepted a microbiologist position with USDA, Animal Research Service (ARS) at the Plum Island Animal Disease Center (PIADC) in New York. In that position, she performed research in pathogen genomics and developed rapid diagnostic assays to detect foreign animal diseases. Later that year she began working with the USDA, APHIS, National Veterinary Services Laboratories (NVSL), Foreign Animal Disease Diagnostic Laboratory (FADDL) as a Veterinary Medical Officer on Plum Island. During her tenure with APHIS, she was the scientific lead for the development and validation of emerging technologies to detect endemic and exotic livestock diseases. She coordinated all aspects of FADDL's role as a reference laboratory for the NAHLN and supported the NAHLN as an expert on diagnostic testing and validation of assays used to detect exotic animal diseases. In this role, she led scientific studies for the diagnostic validation of classical swine fever (CSF) and foot and mouth disease (FMD) RT-PCR assays.

In 2005, she began working for the Department of Homeland Security (DHS) as Chief of the Disease Threat and Assessment/Forensics Unit on Plum Island. In this role, she worked to coordinate all activities of the PIADC Agricultural Bioforensics Laboratory with the National Bioforensics Analysis Center (NBFAC) at Fort Detrick, MD.

In 2007, Beckham assumed the role of Director of the NVSL's Foreign Animal Disease Diagnostic Laboratory (FADDL) at PIADC.

Through Beckham's various roles, she has acquired a diverse background. Her start in diagnostics in the military and her appreciation for the numerous roles that veterinarians play in biodefense, agricultural protection, and security has given her a greater appreciation for the broad spectrum of roles and responsibilities of the veterinary profession. She is honored to have had the opportunity to serve this industry and our country as a veterinarian and diagnostician; these experiences demonstrate the many opportunities available.

Now, in her position as a State Laboratory Director, she has had the opportunity to have a more direct relationship with those industries we protect. Her daily interactions with those industries have provided her with an immense appreciation of the role our veterinary diagnostic field serves to support the industries that are vital to the Nation's food supply, way of life, and economy. Beckham has been humbled to work with the industries in such a fashion and feels that this has undoubtedly given her the most valuable experience to date.

When asked why NAHLN is important to her, she responded:

"Having worked with the NAHLN the greater part of the last 8 years, I have a real appreciation for the role that the State laboratories play and will continue to play in disease surveillance, response and recovery. Veterinary diagnostic laboratories are a national resource that, on a day to day basis work with our Federal and other State partners to perform perhaps one of the most important jobs of all: protecting our Nations' food supply and agricultural and public health sectors, all the while, doing this with excellence and limited funding.

Veterinary diagnostic laboratories are truly a national treasure and have a wealth of expertise that has largely gone unrecognized, and yet, every lab director, diagnostician and technician goes to work every day with an unparalleled commitment to the job. Since coming to TVMDL, I have had the pleasure of working with the most dedicated group of individuals I have ever met. I hear this same statement from other Laboratory Directors throughout the country. I believe this says the most about how dedicated the individuals that work in the laboratories are and is just another reason that the NAHLN is important to me. We strive daily to work with our partners, Federal, industry, etc., to provide excellence in veterinary diagnostic services."

Thank you, Tammy, for contributing such a diverse expertise to the Network.

Tammy Beckham, Director

Texas Veterinary Medical Diagnostic Laboratory

Article submitted by Jill Brown, Program Analyst, USDA/APHIS/VS/NVSL, NAHLN Program Staff, Ames, IA

Update on the Negative Cohort Study for FMD, ASF, and Rinderpest

The National Animal Health Laboratory Network (NAHLN) is coordinating negative cohort studies for foot and mouth disease (FMD), African swine fever (ASF), and rinderpest as an important component to the validation of the real time PCR assays for these diseases. The NAHLN has been working closely with the Proficiency and Validation Services and Diagnostic Services sections at NVSL's Foreign Animal Disease Diagnostic Laboratory (FADDL) on the training, development, and review of proficiency tests for 12 participating NAHLN Laboratories. Further, we have focused on coordinated communication with Veterinary Services' (VS) National Center for Animal Health Emergency Management (NCAHEM), VS' regional staff, the participating NAHLN Laboratories, and state animal health officials on the purpose of the negative cohort, expectations of false positive results, and processes for sharing the negative cohort testing results. The FMD component is currently underway. Proficiency test results will be distributed to participating laboratories for August implementation of the ASF and rinderpest components.

Submitted by Sarah Tomlinson, Associate Coordinator, USDA/APHIS/VS/NVSL, NAHLN Program Staff, Fort Collins, CO

Update on the NAHLN Methods Technical Working Group

Background: The National Animal Health Laboratory Network (NAHLN) Methods Technical Working Group (MTWG), Co-Chaired by Terry McElwain, Executive Director of the Washington Animal Disease Diagnostic Laboratory, and Barbara Martin, the NAHLN Coordinator is comprised of technical experts from NAHLN Laboratories, the National Veterinary Services Laboratories (NVSL), and other laboratories including representatives from USDA's Food Safety Inspection Service in Athens, Georgia, the United States Geological Service/National Wildlife Health Center in Madison, Wisconsin, and the National Centre for Foreign Animal Disease/Canadian Science Centre for Human & Animal Health in Winnipeg, Manitoba, Canada.

The NAHLN MTWG functions as a vehicle for communication among NAHLN Laboratories on current methods, and serves as a liaison with the Integrated Consortium of Laboratory Networks (ICLN) Methods Technical Working Group. The NAHLN MTWG provides input on various aspects of methods validation and approval of methods, meeting on a quarterly basis via conference calls and meetings.

The NAHLN MTWG met in Fort Collins, Colorado on June 29-30, 2010. Agenda items included the following:

A review and discussion of feedback from NAHLN Laboratories
A charge and charter for the MTWG
Proficiency testing and standardization
A review of the methods comparison process
Modifications to SIV surveillance and possible changes to the testing algorithm
Overview of FMD assays being validated by the NVSL's Foreign Animal Disease Diagnostic Laboratory (Plum Island, New York)

The Co-Chairs and Rich Jacobson have been invited to participate in developing a roadmap for the implementation of modern World Organisation for Animal Health (OIE) principles and methods of diagnostic test validation. They will provide an overview of the NAHLN methods validation and methods comparison process for NAHLN assays and will contribute to the development and implementation of a module-type training course manual based on the OIE concept. The meeting is jointly organized with the OIE, the Food and Agriculture Organization of the United Nations (FAO), and the International Atomic Energy Agency (IAEA). It will be held September 6-9, 2010 at the IAEA headquarters in Vienna, Austria.

Article submitted by Barbara Martin, NAHLN Coordinator, USDA/APHIS/VS/NVSL, NAHLN Program Office, Ames, IA.

Getting to Know Us

Troy Bigelow
Swine Disease Staff Officer
USDA/APHIS/VS/NCAHP/ASEP

Troy Bigelow is a Swine Disease Staff Officer at the National Center for Animal Health Programs (NCAHP) - Aquaculture, Swine, Equine and Poultry (ASEP) office in Des Moines, Iowa. Troy began his federal career in 2003 as a public health veterinarian with the Food Safety and Inspection Service (FSIS) working in a large swine plant. This gave Troy experience to become FSIS' Des Moines District Veterinary Medical Specialist where he verified humane animal handling activities for the agency. In January 2007, Troy moved to APHIS' Veterinary Services.

In his current position as a program manager for the Swine Health Programs (specifically pseudorabies and swine brucellosis). Troy is closely involved with the development and implementation of documents and policy such as the PRV Procedure Manual, and various VS memoranda. Recently, Troy became the interim Program Manager for the BSE program.

Troy earned his Doctorate in Veterinary Medicine from Iowa State University in 2001. After graduation, Troy practiced cow-calf, dairy and swine medicine in mixed- large animal clinics located in Iowa and Wisconsin before coming into Federal service.

In Troy's spare time he enjoys hunting, fishing, and wood working along with other construction activities. He likes to sing in the church choir and assists with the family's cow-calf/feed lot operation. Troy is also the proud new father of a seven month old baby boy named Carl.

Troy believes that NAHLN is vital to the success of numerous USDA programs and looks for increased NAHLN participation activities for disease detection and surveillance.

Article submitted by Traci Imlau, Program Assistant, USDA/APHIS/VS/NVSL, NAHLN Program Staff, Ames, IA

Update on NAHLN FMD Table-Top Exercises (TTX)

About the exercise

On May 18-19, 2010, the National Agriculture Biosecurity Center (NABC) at Kansas State University (KSU) hosted a table-top exercise (TTX) in Topeka, KS, called "May Day II". The TTX focused on National Animal Health Laboratory Network (NAHLN) involvement in a foot and mouth disease (FMD) outbreak. Participants included staff from the Kansas State Veterinary Diagnostic Laboratory (KSVDL) and Kansas Animal Health Department, staff from the Iowa State University Veterinary Diagnostic Laboratory (ISU VDL) and the Iowa Department of Agriculture and Land Stewardship, the NAHLN Program Office, USDA-APHIS-VS National Surveillance Unit, and the National Pork Board.

Specifically, the objectives of the TTX were to examine early, mid, and late-response activities regarding the decision-making process for NAHLN activation and de-activation; testing capacity at KSVDL and ISU VDL in light of a theoretical FMD outbreak and surveillance sample collection protocols; testing algorithms after an FMD outbreak has been confirmed and for proving freedom from disease; and communication and coordination processes.

The exercise involved a simulated disease outbreak which began with a Foreign Animal Disease Diagnostician (FADD) conducting a vesicular disease investigation on a cow-calf farm in Northeast Kansas. The exercise progressed through confirmation of FMD, spread of the disease into the cattle-dense area of southwest Kansas and then to swine in southwest Iowa. It concluded with a discussion of the outbreak recovery and the implication on NAHLN laboratories for testing for disease freedom.

Key discussion items

Official communications are well-described for the early stages of an FAD outbreak (e.g., in VS Memo 580.4 and in state response plans), and the exercise helped players practice these notification chains. Participants in "May Day II" also stressed the importance of informal, or unofficial, communication between States and agencies. As a professional courtesy, the state animal health officials said they would notify their counterparts in neighboring states at the point of a positive NAHLN laboratory diagnosis, which, in the exercise scenario, occurred before a positive NVSL diagnosis. Their thought was that this would help neighboring States make preparations, especially if animals had moved from state-to-state in the days just before FMD diagnosis.

The exercise also highlighted the need for laboratories and regulatory officials to work together on prioritization for sampling. This was a multi-layered issue, ranging from policy-level concerns about what samples should be collected to tactical-level concerns about properly marking the packages to ease the administrative handling of "high priority" samples at the laboratories.

Players also noted that sampling plans will be somewhat fluid and will need to change at different stages of the outbreak. This is due to the many factors that influence these calculations, such as: whether/how much sampling is needed to assist with permitting the movement of animals; which industries/species are primarily affected; and the capacity of field personnel to collect samples as well as of the laboratory to process them. Interestingly, the two States that participated in "May Day II" had different sample collection strategies, which affected the expected number of samples that their respective NAHLN laboratories would need to handle.

During "May Day II", exercise participants also developed a number of recommendations for their daily laboratory operations (e.g., for protocols and procedures, administrative processes, laboratory security, etc.) to increase efficiency and ideas that they can incorporate into future in-house laboratory drills.

Next Steps

The exercise analysis team is working with NAHLN to pull together the key lessons learned from the TTX and produce a summary report for the exercise participants. Following that, NAHLN, NABC, and CNA will use the lessons learned from this exercise to develop a series of follow-up exercises that will be delivered in facilitated sessions at additional NAHLN Laboratories during the summer of 2010. The upcoming exercise schedule is below.

FMD Exercise Schedule

July 21 - NY (Albany)

July 26 - OH (Reynoldsburg)

August 9 - CO (Ft Collins)

August 12 - CA (Davis)

August 17 - NC (Raleigh)

August 17 - KY (Hopkinsville)

August 19 - TX (Amarillo)

August 19 - MN (St. Paul)

August 26 - IL (Urbana)

August 27 - IN (West Lafayette)

August 30 - SD (Brookings)

September 1 - WA (Pullman)

September 8 - MO (Columbia)

September 13 - WI (Madison)

September 20 - HI (Pearl City)

Article submitted by the USDA/APHIS/VS/NVSL, NAHLN Program Office, the National Agriculture Biosecurity Center (NABC) at Kansas State University, and CNA Corporation.

Movement of Accredited Labs to Member Status

The National Animal Health Laboratory Network (NAHLN) is comprised of four laboratory designations: Adjunct, Contract Member, Member, and Core Member Laboratory. In 2009, the list of requirements was updated to further define each laboratory designation's roles and responsibilities within the Network. Click here to view the list of requirements: Laboratory Designation Table

Twelve Contract Member Laboratories have met the Member Laboratory requirements as a fully or provisionally accredited laboratory by the American Association of Veterinary Laboratory Diagnosticians (AAVLD) or by an accrediting body according to theWorld Organisation for Animal Health (OIE) and the International Organization for Standardization (ISO) 17025 standard to cover the scope of NAHLN testing. They have also actively participated in electronic messaging of surveillance test results.

In 2010, funding has been provided to these laboratories to support the following:

Development and implementation toward increased capability to electronically transmit standardized test result data to the NAHLN information technology (IT) system
Maintenance of the Quality System through accreditation by AAVLD or by an accrediting body according to OIE/ISO 17025 standard

Future funding is contingent upon the laboratory maintaining electronic messaging as well as their Quality Management System.

Article submitted by the USDA/APHIS/VS/NVSL, NAHLN Program Office, Ames, IA

NAHLN Procedure Manual References

Below you will find various NAHLN Procedure Manuals, the date of the latest version, and either a weblink or contact where they are available:

USDA/APHIS/Wildlife Services, Procedures Manual for Avian Influenza Surveillance, latest version April 2010, Contact: Seth Swafford at seth.swafford@aphis.usda.gov.

Implementation Plan for HPAI Surveillance in Wild Migratory Birds in the United States, latest version April 2010, Contact: Seth Swafford at seth.swafford@aphis.usda.gov.

USDA/APHIS/Wildlife Services, Instructions for NAHLN Laboratories Testing Wild Bird Samples,

latest version April 2010, Contact: Seth Swafford at seth.swafford@aphis.usda.gov.

Classical Swine Fever Surveillance Procedure Manual, latest version dated April 1, 2007

Pseudorabies Surveillance Procedure Manual, Version 1.2, latest version dated April 2010

Influenza Surveillance in Swine Procedures Manual, latest version dated July 15, 2010 (New version!)

Procedure Manual for Vesicular Stomatitis Viruses (VSV), latest version dated January 2008