The NAHLN Update 2018 Volume 9, No. 4 THE OFFICIAL NEWSLETTER OF THE NATIONAL ANIMAL HEALTH LABORATORY NETWORK (NAHLN) A STATE AND FEDERAL PARTNERSHIP TO SAFEGUARD ANIMAL HEALTH

Visit the NAHLN website

Log in to the APHIS Laboratory Portal

Founding Principles and Features of the NAHLN Operate within a quality management system Establish and maintain competency of laboratory personnel Use Standardized protocols, reference materials, and equipment Use facilities with biosafety/biosecurity levels requisite for testing performed Participate in communications and real time electronic reporting systems Evaluate preparedness (identify and prioritize gaps) through scenario testing

In This Issue: New Briefs Agreement for Participation in NAHLN Laboratories Veterinary Services (VS) Reformation Getting to know us Accountability Process @USDA.gov Email Changes Adding a Disease/Assay to NVSL and NAHLN Upcoming Messaging Competencies NAHLN Laboratory Director Feature African Swine Fever (ASF) Response ASF Case Selection Criteria NCAH Portal for NVSL Submissions Update NEWS BRIEFS : January 2, 10:00 – 11:00 AM CST NAHLN IT Committee – Core member call January 10, 1:00 – 2:00 PM CST NAHLN Director’s Quarterly call January 18, 11:00 – 12:00 PM CST NAHLN Exercises and Drills Working Group call January 28, 1:00 – 2:00 PM CST NAHLN Coordinating Council call January 22, 10:00 – 11:00 AM CST AMR pilot project call January 22, 11:00 – 12:00 PM CST AAVLD/NAHLN Joint Committee conference call February 6, 10:00 – 11:00 AM CST NAHLN IT Committee call February 13, 10:00 – 11:00 AM CST NAHLN Methods Technical Working Group Core call February 15, 11:00 AM – 12:00 PM CST Exercises and Drills Working Group call February 18, 1:00 – 2:00 PM CST NAHLN Coordinating Council call February 26, 10:00 – 11:00 PM CST AMR pilot project call February 26, 11:00 - 12:00 PM CST AAVLD/NAHLN Joint Committee conference call

Quick links NAHLN Homepage USDA NVSL APHIS-VS NIFA AAVLD    Current Number of Subscribers:  1216 Input Welcome!   e appreciate hearing from you!  Are there other topics that you would like to hear about? Please email your comments to us at [email protected] .

Agreement for Participation in NAHLN Laboratories

National Animal Health Laboratory Network (NAHLN) Laboratories will receive the Agreement for Participation in the NAHLN in January 2019.    The Agreement for Participation in the NAHLN is completed annually by laboratories seeking or renewing NAHLN approval. The purpose of this agreement is to transparently describe the requirements of membership in the NAHLN, and request commitment from relevant State and Federal parties in meeting these expectations. This document must be signed by the following personnel: •            Laboratory Director; •            Responsible Official (RO in Select Agent registered laboratories) or Biosafety Officer; •            Dean of College (when appropriate); •            State Animal Health Official (SAHO); •            APHIS-Veterinary Services (VS) Area-Veterinarian-In-Charge (AVIC) or Assistant AVIC; •            State Department of Agriculture Director, Agriculture Commissioner, or equivalent   Each participating laboratory and all who sign the document must understand and agree to 20 standards that cover such topics as disease approval requests, quality management, testing requirements, sample handling, communication and reporting, and support of the NAHLN mission. While several standards are the same for all laboratories, there are some standards that are worded specifically for the different levels of laboratory participation (i.e., Level 1, Level 2, Level 3, or Affiliate). Information on the 20 standards was outlined in the 5 part series With Great Partnerships Come Great Responsibilities. Agreements are due to the NAHLN Program Office during February 2019. Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS, D & B, NVSL, Ames, IA and Christina Loiacono, Coordinator, NAHLN Program Office   USDA APHIS VS D & B, NVSL, Ames, IA

Veterinary Services (VS) Reformation The world is changing. VS must, therefore, continually improve, innovate, and evolve how we effectively deliver services to our stakeholders thereby fulfilling our animal health mission.    The new VS structure will more efficiently align programs to its Strategic Plan and enhance customers’ experiences. VS is now comprised of four units: Diagnostics and Biologics (D&B), Strategy and Policy (S&P), Field Operations (FO), and Program Support Services.    The National Veterinary Services Laboratories (NVSL), Center for Veterinary Biologics, and the future National Bio & Agro-Defense Facility (NBAF) are managed within the D&B unit. The NAHLN remains a part of NVSL. Dr. Beth Lautner (D&B Associate Deputy Administrator) and Dr. Freeda Isaac (D&B Executive Director) will lead Diagnostics & Biologics.  More information on the VS Reformation can be found here . The organizational reformation will not impact the way NAHLN Laboratories and Stakeholders communicate with the NAHLN Program Office or NVSL Reference Laboratories. Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B, NVSL, Ames, IA

Getting to know US:  Dr. Freeda Isaac Dr. Freeda Isaac is the Executive Director of the Diagnostics and Biologics (D&B) Unit of Veterinary Services (VS). Dr. Isaac began her Federal career early in high school and college working part time for the Agriculture Research Services in Beltsville, Maryland, as a GS 3 Biological Technician. She completed undergrad studies education at the University of Maryland and pursued and acquired a Doctorate of Veterinary Medicine degree from the Virginia–Maryland Regional College of Veterinary Medicine in 1989. Dr. Isaac began her professional career with the Food Safety Inspection Service as a Supervising Veterinary Medical Officer (1989 to 2002). She joined VS in October 1992, working in Harrisburg, Pennsylvania, after which she moved to Maryland and worked as a field Veterinary Medical Officer through 2002. As a Field VMO, she trained to be a Foreign Animal Disease Diagnostician and conducted numerous field investigations of suspected foreign animal disease cases on farms throughout Maryland and Delaware. She is also a trained Biosafety Inspector—conducting inspections of BSL2 and BSL3 laboratories throughout the DC/MD/VA area.   After 9 years in the Maryland field office, she joined VS headquarters staff as an Import Equine Specialist with the National Centers for Import and Export and went on to become Assistant Director of Animal Imports by 2006. In January 2008, Dr. Isaac became Director of Animals, Organisms, Vectors, and Select Agents (the unit that now manages select agents and Organisms and Vectors). She managed a staff that develops regulations and policies for importing and moving organisms and vectors interstate. This unit also carries out the requirements of the Federal Select Agent Program.   By February 2018, Dr. Isaac became Executive Director with NIES providing planning, policy, program, and regulatory oversight in an integrated structure that facilitates trade in animals and animal products. Today, as Executive Director D&B, she will provide strategic and program oversight for the unit while representing APHIS and VS in interagency initiatives. She will also oversee transitioning and operational standup activities for the National Bio Agro-Defense Facility.   When asked to share her thoughts on the NAHLN program/mission, Dr. Isaac replied,   “The NAHLN laboratory system has proven repeatedly to be critical for the protection of animal health in the US and ensuring appropriate training and competence is a priority for NVSL. I look forward to learning more about the specifics of the NAHLN program!”   When asked to share an unusual or interesting job experience, Dr. Isaac replied,   “As a student intern working at ARS in Beltsville, MD, I was in charge of maintaining colonies of flies, so I was a fly breeder!”   Dr. Isaac enjoys biking, music, and plays the violin. She frequently jams to classic rock with friends. Her son, Jared, is 19 and has one large cat named Shadow.   On behalf of the NAHLN Program Staff, welcome Dr. Isaac! Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B,  NVSL, Ames, IA.

Accountability Process In 2018, NAHLN laboratories were given the NAHLN Laboratory Performance document (Policy NAHLN-0006.01) which describes general expectations for all NAHLN Laboratories. These expectations are outlined more explicitly in the Agreement for Participation and signed-off yearly by NAHLN Laboratories. Routine responsibilities for NAHLN laboratories include:   Continual demonstration of a functional quality system; Successful completion of quality audits per the laboratory’s accrediting body’s audit cycle for tests under NAHLN scope or NAHLN program office site-visit if not accredited; Annual renewal of Agreement for Participation in NAHLN; Annual completion of training and proficiency testing for approved assays under scope; Annual completion of administrative functions, such as timely invoicing; timely acknowledgment, training, and implementation of new SOP revisions; Annual completion of IT training, equipment inventory, and financial agreement requirements; Annual submission of laboratory self-assessment; and Submission of any additional information as requested by the NAHLN Coordinating Council during its overall bi/tri-annual network assessment. If a laboratory in the network is not meeting the established standards, a progressive counseling and disciplinary process, outlined below, will be enacted to address nonconforming activities as follows: Notification Process               -Counseling and education    -Work through laboratory’s own corrective action process  Disciplinary Process   -Letters of Caution or Warning    -Loss of funding, Loss of approval Appeals Process. This process will be incorporated into the annual laboratory assessment matrix beginning October 2019. The new category is titled, Laboratory Accountability/Compliance . Laboratories with no reported issues (as outlined in the Laboratory Accountability Process) will receive 4 points. Laboratories that incur issues (e.g., letters of caution or other disciplinary actions), will receive 0 points for this category. Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B,  NVSL, Ames, IA.

@USDA.gov Email Changes As part of Secretary Sonny Perdue’s Team OneUSDA campaign, on October 1, 2018, all USDA employees’ email extensions have been changed to @USDA.gov . Secretary Perdue believes we are one team notwithstanding all of the Agencies that make up the Department. The phase-in period will span 1 year to allow everyone to transition. All group emails (e.g., the NAHLN inbox is now operational as [email protected] ) will change also. During the current fiscal year, both email extensions (i.e., @USDA.gov and @APHIS.USDA.gov) will be in effect. By October 1, 2019, the @aphis.usda.gov email extension will be disabled. Please update your USDA contacts today with @USDA.gov. Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B, S NVSL, Ames, IA.

Adding a Disease/Assay to NVSL and NAHLN   Adding a program disease to NVSL:  -Need for a National oversight is identified Determination if the disease should be under NAHLN scope  -Surveillance plan is developed Active Surveillance Passive Surveillance        -Proficiency test -Funding                Adding a disease/assay to NAHLN scope -Need identified for disease or assay to be added to NAHLN scope -Proposal goes to the NAHLN Methods Technical Working Group (MTWG) -If accepted, the study is completed -Study results are presented to the NAHLN MTWG MTWG makes a recommendation to NAHLN Coordinating Council (CC) CC makes a recommendation to the NAHLN Executive Committee who either decides or takes the recommendation to the VS Deputy Administration if needed -If recommended- then VS determines how the assay may be incorporated into the NAHLN.

‌ ‌

‌ Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B, NVSL, Ames, IA and Christina Loiacono, Coordinator, NAHLN Program Office   USDA APHIS VS D & B, NVSL, Ames, IA

Upcoming Messaging Competencies

NAHLN Laboratory Director Feature Dr. Jessica Walters Director, Virginia Department of Agriculture and Consumer Services, Harrisonburg Regional Laboratory   Dr. Jessica Walters received her Bachelor of Science in Animal and Poultry Sciences from Virginia Tech in 2009 with emphases on poultry and livestock health and poultry production and business. After graduation, she started a dual DVM/PhD program at the Virginia-Maryland College of Veterinary Medicine. Her PhD in Biomedical and Veterinary Sciences focused on characterization of atypical hemolytic isolates of Ornithobacterium rhinotracheale both in vitro and in vivo. Research topics included development of an ELISA, growth and molecular characterization, and live infectivity trials. Her DVM focused on food animal medicine. After graduation in 2016, she started with the Virginia Department of Agriculture and Consumer Services as the Poultry Diagnostician. While in that role, she oversaw all poultry diagnostic testing and necropsies of both commercial poultry and backyard flocks. Dr. Walters continues to work closely with both commercial companies and backyard producers on poultry health and management problems. Dr. Walters sat for her specialty boards in poultry health and is a Diplomate of the American College of Poultry Veterinarians. In May of 2018, Dr. Walters became the Laboratory Director in addition to her current role as the Poultry Diagnostician.   Early in her career, she discovered a passion for herd health and working with farmers. Poultry testing is a primary focus of the Harrisonburg Regional Laboratory. Due to her research background and work with companies in the area, Dr. Walters was hired as the Poultry Diagnostician where she works with a wide variety of poultry cases from commercial turkeys to backyard ducks. Dr. Walters works with small backyard producers educating them on poultry disease basics and works on the regulatory side with commercial companies. Becoming the laboratory director has allowed her to become even more involved with all animal agricultural species. She also enjoys working with her staff more closely to enhance diagnostic testing and better serve their clients.   The NAHLN is an important partnership advocating for both animal health and public health between industry, government and stakeholders. Having this partnership and support is invaluable to recognize and manage disease threats. The NAHLN also serves as a solid platform to unite animal health labs throughout the country. It is amazing to be able to develop contacts to determine who offers testing, what sample types are necessary for specific tests, and what protocols are needed for new diagnostic developments. In the event of an outbreak, it is reassuring to know that the NAHLN would have the capability to offer extra support in all aspects to be able to maintain high quality testing with an increased testing load. Dr. Walters appreciates the exercises that are offered for outbreak preparedness and surge capacity management. Thanks to the NAHLN’s support, funding, and organization, she believes their laboratory can maintain quality and timely delivery for their clients.   Before working at your current position, what was the most unusual or interesting job you had?   “Well, apparently I’m pretty young, so my “job” before this was vet school and my PhD, ha! The coolest thing I can think of getting to do during vet school was to spend six weeks at the Louisville Zoo during my senior year. During my time there, I got to treat a Rock Hyrax for a prolapsed urethra, and got to assist with recovery of the neonatal Western Lowland Gorilla after a C-section. It was an awesome experience and I am so grateful that I got to be so involved.”   Are there any random facts about yourself that you want to share?   “I thoroughly enjoy doing volunteer work in Honduras with Christian Veterinary Mission and Honduras Outreach International. I have been down four times and have recently become involved in the economic development committee- focusing on giving “an egg a day” to local school children. The past two years, I have worked with villagers on recognizing signs of sick birds and exercising appropriate biosecurity. “   Do you have any hobbies that you’d like to share?   “My husband and I are definitely outdoors people, so we love to do things like kayaking, hiking and fishing. We both also love animals, so have collected quite the menagerie on our “funny farm”. Currently, we have a horse, a miniature donkey, a potbelly pig, two Boer goats, four dogs, and three cats. All of them are pets, so are quite useless but we adore them. I keep hinting to him that I want a pet cow, so we will see how that goes.”   Welcome to the NAHLN, Dr. Walters!     Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B,  NVSL, Ames, IA

African Swine Fever (ASF) Response On September 5, 2018, U.S. Department of Agriculture (APHIS Veterinary Services and the NAHLN) held a meeting with Food and Drug Administration (FDA) officials to discuss ASF with U.S. pork sector groups – including the American Association of Swine Veterinarians, the National Pork Board, the National Pork Producers Council and the Swine Health Information Center. During the meeting, the participants evaluated additional measures to prevent the spread of ASF to the United States. ASF is currently active in China and several European nations. Given the concerns centered on unofficial testing of un-validated samples, the VS Deputy Administrator sent a letter to NAHLN laboratories outlining guidance for testing, to discourage testing for NAHLN-scope diseases using unapproved assays and/or unapproved sample types. The NAHLN Program Office has surveyed the 11 ASF-approved laboratories that have capacity for 6500 PCR tests per day. Those laboratories plan to increase the number of proficiency tested analyst to increase capacity to 8000 PCR tests per day. All NAHLN laboratories have been invited to participate in ASF testing.  The sample type for live sick animal is whole blood. Effective October 1, 2018 tonsil was identified as an approved sample from dead animals to test during a foreign animal disease (FAD) investigation. Spleen has also been approved for testing as of December 10, 2018 for FAD investigations. Lymph node is expected to be an approved for testing in 2019. In response to the growing concerns related to African Swine Fever (ASF), the NAHLN Program Office is working with the Center for Epidemiology and Animal Health and the Swine Health Staff to support the development of an active ASF surveillance plan. Until a surveillance plan is implemented, testing of suspect cases should occur through FAD investigations. State animal health officials and AVICs should be notified of any instance in which pigs show clinical signs suggestive of ASF. Below is a list of sample types required and examples of clinical changes seen among swine that would suggest the possibility of an ASF infection.

Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B, NVSL, Ames, IA.

ASF Case Selection Criteria The following selection criteria is proposed to identify eligible cases for ASF surveillance testing at ASF-approved NAHLN laboratories. Any swine accession submitted would be eligible for testing if: At least one of the following specimens can be obtained: Tonsil tissue Whole blood (purple and green top tube) Spleen (approval in process) AND one or more of the following lesions or herd history is observed or reported: Herd mortality doubling in one week and at least one other ASF compatible clinical sign in the barn Dramatic acute septicemia Skin discoloration Hemorrhagic lymph nodes Enlarged hemorrhagic spleen Kidney petechia Epistaxis Recent history of receiving a new feed shipment associated with at least one other ASF compatible clinical sign Other clinically, grossly or histologically compatible cases that the pathologist wishes to submit due to suspicion of ASF   Links of interest: USDA-Industry ASF Surveillance and Response Point ASF Emerging Risk to Animal Health USDA-Industry ASF Prevention Points-

Round up:  NCAH Portal for NVSL Submissions Update   The NVSL has made the process of submitting paperwork easier for our customers. The eSubmission both modernizes our process and improves customer service for submitters. eSubmissions save time for submitters. Data entry is quick and legible which makes for greater data integrity. A submitter need only acquire a Level 1 eAuthentication username and password to access the National Centers for Animal Health (NCAH) portal for electronic submission (see hyperlinks below). The NCAH portal offers some key timesaving features for NVSL customers. Data input by submitters and owners may be quickly cloned from prior submissions, stored, and selected to populate fields in an instant by using a personalized address book after a first submission. The electronic forms also use dynamic lists and reusable data for fillable fields. Owners/submitters may add delegates to their accounts to submit on their behalf. Past submissions and associated final reports may also be accessed and viewed in the NCAH Portal for up to a year after completion. The online form will not replace the fillable PDF version of the forms. The original forms are still available for use where internet connectivity is not available or in those instances where a paper copy is preferred. The links below have been made available to our stakeholders in a recent bulletin to encourage online submissions (Level 1 eAuthentication - click HERE ; Level 1 eAuthentication signup - click HERE ; NCAH Portal - click HERE ). The following eSubmission forms available on the NCAH Portal: VS 10-4 (general submission form); VS 17-31 (Equine Import Testing Submission); VS 6-35 (Report of Tuberculosis Lesions or Thoracic Granulomas in Regular Kill Animals); VS 10-3 (Request for Salmonella Serotyping). Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS D & B, NVSL, Ames, IA.

NAHLN Facts The following link show a map and laboratory list of laboratories that have been approved as part of the  NAHLN Testing Network .

Abbreviation / Acronym Key   Click Here for Volume 9, No.4 Acronym Key