The NAHLN Update 2017
Volume 8, No. 3
THE OFFICIAL NEWSLETTER OF THE NATIONAL ANIMAL HEALTH LABORATORY NETWORK (NAHLN)
A STATE AND FEDERAL PARTNERSHIP TO SAFEGUARD ANIMAL HEALTH 
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

How to become a member of the Coordinating Council


NAHLN Laboratory Director Feature:
Dr. Pam Hullinger


NAHLN Barcoding / Messaging Exercise


Getting to know us: Cindy Chard Bergstrom


With Great Partnerships Come Great Responsibilities - Part 2


Round up
NEWS BRIEFS :
  • January 3, 2018 – 10:00 – 11:00 AM CST NAHLN IT Committee general membership call

  • January 10, 2018 – 10:00 - 11:00 AM CST NAHLN Methods Technical working group general membership call.

  • January 11, 2018 – 1:00 – 2:30 PM CST Quarterly NAHLN Laboratory Directors call

  • January 22, 2018 – 1:00 – 2:00 PM CST NAHLN Coordinating Council call

  • January 19, 2018 – 11:00 AM – 12:00 PM CST NAHLN Exercises and Drills working group call

  • January 2018 – The influenza A virus in avian and swine proficiency tests are scheduled to be announced.

  • January 2018 – The APHIS AMR pilot surveillance project is scheduled to launch.
Input Welcome! 
We appreciate hearing from you! Are there other topics that you would like to hear about? Please email your comments to us at NAHLN@aphis.usda.gov .    
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NAHLN Success Stories
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How to become a member of the Coordinating Council.
Have you wondered how the NAHLN Coordinating Council (Council) members are selected? I recently encountered a few curious folk about the process, so I’m putting pen to paper .
 
Let’s start with some background information on the Council. The Council is comprised of Federal, State and University stakeholders and provides a forum for members to discuss current and future needs of the NAHLN. The members provide input to APHIS and NIFA regarding the direction of NAHLN. 
 
The Council’s Federal members are standing members appointed based on their specific positions. State and NAHLN laboratory members serve 3-year terms that are staggered to ensure continuity. There are three NAHLN laboratory directors for each laboratory level: Level 1 (L1); Level 2 (L2); and Level 3 (L3); and four State Animal Health Officials (SAHOs) for a total of 13 State and NAHLN laboratory Council members.
 
Every year, State and NAHLN Laboratory members rotate off the Council. The NAHLN program office (NPO) analyzes the Council’s membership to determine the number of positions available at each laboratory level before making a request to the American Association of Veterinary Laboratory Diagnosticians (AAVLD) and unaccredited L3 laboratories for nominations. The NPO also notifies the National Assembly of State Animal Health Officials (NASAHO) of the number of SAHO positions available for Council nominations.
 
AAVLD and NASAHO reach out to their membership for volunteers to serve on the Council and forward nominations to our office. We also reach out to the unaccredited L3 laboratories for nominations.
 
The NPO reviews all nominations together with the remaining State and NAHLN Laboratory partners for geographic distribution, levels of State and Federal support, types and concentrations of animal industries, and other relevant factors. The NAHLN Coordinator then submits the nominations and recommendations to the APHIS Deputy Administrator and NIFA Assistant Director for Programs for approval. Once the APHIS Deputy Administrator and the NIFA Assistant Director for Programs approves the nominations, potential Council members are invited to confirm their interest and availability to participate.
 
The 3-year term begins June 1st of each year. If a Council member has to end his or her term early, then a replacement candidate may be submitted to complete the term. The NAHLN Coordinator would once again provide the proposed change to the APHIS Deputy Administrator and NIFA Assistant Director for Programs for approval. Generally, the addition, replacement, and removal of Council members are subject to the mutually agreed discretion of the APHIS-VS Deputy Administrator and the NIFA Assistant Director for Programs.
 
So, that’s how members get on the Council. Next, let’s explore what the members do upon joining the Council. Their activities include, but are not limited to:
• Review and comment on:
  1. NAHLN goals, strategic plan, and operational objectives
  2. Specific criteria that define NAHLN Laboratory levels and network structure
  3. Program or operational issues relevant to the NAHLN’s efforts to enhance the Network’s effectiveness
• Discuss NAHLN policies that are not subject to the statutory authority of the Federal or State governments
 
Council initiatives are implemented through monthly conference calls, face-to-face meetings at least once a year, and reference meeting minutes. Council members can serve on standing working groups that report to the Council.  There are several standing working groups that provide input to the Council including: Methods Technical Working Group, Exercises and Drills Working Group, Portal Working Group, and the IT Committee.

Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS STAS NVSL, Ames, IA.
NAHLN Laboratory Director Feature
Dr. Pam Hullinger,
Director, California Animal Health & Food Safety (CAHFS) Laboratory

Dr. Hullinger received her bachelor of science in animal science, doctor of veterinary medicine and her master of preventive veterinary medicine degrees from the University of California in Davis, CA (UC Davis). She is a Diplomate of the American College of Veterinary Preventive Medicine.
 
Dr. Hullinger was first introduced to CAHFS, its mission, and its importance to California veterinarians and livestock/poultry producers as a veterinary student at UC Davis. Upon graduation, she became a client of the laboratory as a private large animal practitioner in Cotati, CA. Dr. Hullinger always appreciated the professional, timely diagnostic support that CAHFS provided her practice and clients. After a few years, she left practice to complete a large animal internal medicine residency at the UC Davis Veterinary Medical Teaching Hospital (VMTH). Following the residency, Dr. Hullinger joined the California Department of Food and Agriculture (CDFA) and became a different type of CAHFS client. At CDFA she worked collaboratively with the laboratory on many regulatory issues, surveillance programs and special projects. After 10 years with CDFA, Dr. Hullinger accepted a position at the Lawrence Livermore National Laboratory (LLNL) to lead their national Agricultural Security program. At LLNL she focused on foreign animal disease detection, diagnostic assay development, and modeling for both the USDA and Department of Homeland Security. After 5 years working full-time at LLNL, Dr. Hullinger transitioned to working jointly for LLNL, as well as at UC Davis where she worked on USDA’s Secure Food Supply programs (primarily the Secure Milk Supply) and national Foot and Mouth Disease vaccination contingency planning. In 2015, Dr. Hullinger became the Large Animal Hospital Director at the UC Davis School of Veterinary Medicine VMTH and worked in that capacity until her appointment as the Director of CAHFS in November 2016.
 
Dr. Hullinger feels that her diverse veterinary career has given her an appreciation for the numerous roles that veterinarians play in agricultural protection, food security and biodefense. She enjoys mentoring the next generation of veterinarians who have a continually increasing interest in food safety, regulatory medicine and public/environmental health.

What brought you to the NAHLN laboratory?
“I have always appreciated the critical role that CAHFS has in providing diagnostic services to protect the health and welfare of California’s livestock and poultry industries and in safeguarding public health. To have the opportunity to lead such a dedicated team of faculty and staff in pursuit of such an important mission is an honor.”

Why is NAHLN important to you?
“Because of my diverse background in private practice, food and agricultural security, animal health emergency response, and foreign animal disease diagnostics I am passionate about assuring strong veterinary diagnostic infrastructure and capabilities are available to support national disease surveillance and response. The NAHLN is the backbone of our nation’s early warning system for the detection of foreign or emerging disease threats as well as the mechanism by which state and federal animal health officials obtain the timely, scalable diagnostic support for response activities. Ultimately, the NAHLN serves a critical role of providing the capacity for national surveillance, early detection, and response capabilities to help safeguard U.S. livestock and food security.”

Is there anything unique in your career that you’d like to share?
“My first-hand experience in both the UK 2001 FMD and CA 2002/3 END outbreaks were career [and] life changing opportunities and gave me a tremendous appreciation for the importance of animal health emergency preparedness and accurate, timely diagnostic support for detecting and responding to animal health events.

Since starting as Director, we have been enthusiastically preparing to open a new, state-of-the-art, veterinary diagnostic laboratory in Tulare, CA. Named for CAHFS inaugural Director, Dr. Alex Ardans, this 29–thousand square foot building offers increased space, diagnostic capabilities, and biosecurity to service our clients in California’s South Valley, the state, and nation for decades to come.”

Do you have any hobbies that you’d like to share?
“I enjoy outdoor activities including gardening, hiking with my yellow lab “Bodie,” cycling, downhill skiing, and tennis. I enjoy traveling to explore new cultures, historical sites, and places of natural beauty.”

Welcome to the NAHLN, Dr. Hullinger!

Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS STAS NVSL, Ames, IA.
NAHLN Barcoding/Messaging Exercise
During June, 2017 the NAHLN Exercises and Drills Working Group (EDWG) conducted its inaugural NAHLN Barcoding/Messaging Exercise. This exercise, which for the first time included high throughput results reporting (either by spreadsheet submission or electronic messaging) had three main objectives: (1) assess high volume barcode entry in receiving/accessioning NAHLN laboratory sections; (2) utilize the reporting process used during an outbreak situation (either electronic messaging or daily spreadsheet submissions); and (3) develop a messaging competency or messaging proficiency test template. It was a concerted team effort including NAHLN EDWG to develop the exercise; the Laboratory Messaging Services (LMS) team to support electronic messaging. NAHLN laboratories participated in the 3-day event which meant disruption of their normal routine and NAHLN program staff coordinated logistics and fielded questions during and after the exercise.

The exercise ran in a block of 3 consecutive days as determined on a lab-by-lab basis. First, a point of contact (POC) was identified by each NAHLN lab who was responsible for all communications for the duration of the exercise. The POC was asked to choose three consecutive days during the exercise week to run the drill, where submission forms with 300, 500, and 700 samples respectively would be presented to their laboratory’s receiving/accessioning sections. Information from the submission forms included a barcode for most individual samples. This information was then entered into the lab’s LIMS, and PCR tests were ordered (although not actually run). All samples were assigned negative results and these results were reported in one of two ways. Ideally NAHLN labs were encouraged to send result via an electronic message, thus providing real-time information to regulatory officials and other decision makers. These electronic messages were received into the LMS test environment to ensure that the exercise results were not interpreted as being actual test results. Alternatively, for laboratories not able to electronically message results, spreadsheets were sent to the NAHLN program office daily.

The Barcoding/Messaging Exercise revealed several strengths regarding current procedures. Communications were all done through the POCs, with strong feedback from labs, and an engaged and responsive LMS staff. In preparation for the exercise, practice submission forms were provided to the labs so they could test their barcoding equipment. Laboratories that electronically messaged results were asked to send a test message the week prior to the exercise to ensure the messaging was functioning correctly. Several laboratories developed new LIMS utilities to increase efficiency of entering data. Several IT tests and fixes were also completed which identified and rectified gaps for individual labs. In receiving and accessioning, laboratories experienced high throughput with a streamlined process and real-time training. Labs unable to message gained experience through using the required spreadsheets, while messaging labs were able to confirm their ability to message a high volume of test data. This allowed the EDWG to learn the limitations of both individual laboratory LIMS and the LMS.

The exercise also identified areas for improvement. Communication could be more efficient by providing the laboratories with all exercise information on one document, sending them client information ahead of time, providing same-day responses to spreadsheet questions, and identifying what data used in the exercise could be fabricated by the lab. Preparation can be improved with well-defined spreadsheet fields, more specific evaluation of test messages by the LMS team, and providing additional support for message preparation to those laboratories that are not quite able to message. Receiving and accessioning would benefit from an updated submission form that excludes extraneous data. Future exercises will also need to include individual premises IDs for each collection site identified on the submission forms. Utilizing the NAHLN laboratory’s premises ID for the purpose of the exercise was too confusing. Finally, the spreadsheets provided to the laboratories should be small enough to be sent via email to the NAHLN labs without going over normal attachment size limits set by most institutions, so that a completed spreadsheet could be returned to the NAHLN program office.


For future exercises, the NAHLN program staff will provide condensed and complete instructions to the POC, evaluate the submission form and reporting spreadsheet for improvements, and consider alternatives for premises IDs. The gaps identified will be considered as we develop quarterly electronic messaging competency opportunities that will allow NAHLN labs to practice sending electronic messages so they can be ready to send data in the event of an outbreak situation. 


Article submitted by Christina Loiacono, DVM, PhD , DACVP, Coordinator, NAHLN Program Office, USDA APHIS VS STAS NVSL, Ames, IA.
Getting to know US:  Cindy Chard Bergstrom
In 1999, Cindy received her bachelor of science degree in Microbiology, from Kansas State University. Cindy also has earned the Qualification in Immunohistochemistry (QIHC) and Histology Technician (HT) Certification from the American Society of Clinical Pathologists (ASCP), and Certified Public Management Certification from Kansas University Public Management Center.

Cindy spent 19 years working for the Kansas State University (KSU) Veterinary Diagnostic laboratory (VDL). She began at KSU VDL in the rabies/fluorescent antibody (FA)/rapid fluorescent focus inhibition test (RFFIT) Laboratory performing the FA test for detection of antigens including Rabies and serologic test to determine Rabies antibody titer levels. Cindy spent 15 years as KSU VDL supervising the Histology/Immunohistochemistry Laboratory. In April 2008, she joined the National Veterinary Services Laboratories, Pathobiology Laboratory working as a Supervisory Microbiologist. In December 2009, Cindy became a Microbiologist for the NAHLN program office (NPO).

Cindy spends her days for the NPO shepherding the equipment inventory and IT security training for NAHLN laboratory participants. She serves as the APHIS Laboratory Portal (ALP) Manager and Portal point of contact for over 400 laboratories and over 1750 users who participate in proficiency tests for NAHLN; the National Plant Protection Laboratory Accreditation Program (NPPLAP); and the NVSL. Cindy also provides messaging support, working with the NAHLN IT workgroup and Laboratory Messaging Services (LMS).

Cindy believes the NAHLN mission has been instrumental towards providing assurance to stakeholders, that standardized testing, performed in quality environments, is provided by all member labs. 

Cindy and Gregg have two children and six grandchildren. Currently the pets in her household include one dog and a bunch of guppies. She likes to bike, read, quilt, garden and go on walks. Cindy enjoys searching for old telephone/telegraph insulators and keeps an eye out for them during her travels.
 
Oh behalf of the NAHLN Program Staff, thank you Cindy for all you do!

Article submitted by Traci Imlau, Program Assistant, NAHLN Program Office, USDA APHIS VS STAS NVSL, Ames, IA.
With Great Partnerships Come Great Responsibilities…
Part 2 of 5
NAHLN laboratories may be involved in surveillance for early detection of 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 associated test results. The potential consequences of a foreign animal disease outbreak could be catastrophic! Therefore, it is important that the needs and expectations of the NAHLN to meet this challenge be defined and agreed to by all participating parties.

The Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) is a document that is completed annually by all laboratories requesting or renewing NAHLN approval. The purpose of this document is to serve as a transparent agreement which describes, communicates, and ensures commitment by the relevant State and Federal parties to the expectations for membership of a veterinary diagnostic laboratory in the NAHLN. By signing the Agreement to Participate in the NAHLN, all parties agree to abide by the requirements. Signatures from the following parties are required: 
  • Laboratory Director
  • Responsible Official (RO - in Select Agent registered laboratories) or Biosafety Officer
  • Dean of College (if appropriate)
  • State Animal Health Official (SAHO)
  • APHIS-Veterinary Services (VS) District Director (DD) or Assistant District Director (AD)
  • State Department of Agriculture Director, Agriculture Commissioner, or equivalent.

There are 21 standards that must be understood and agreed to by each participating laboratory, which cover such topics as disease approval requests, quality management, testing requirements, sample handling, communication and reporting, and support of the NAHLN mission. While some of the standards are the same for all laboratories, there are some standards that are worded specifically for the responsibilities at the different levels of participation (i.e., Level 1, Level 2, Level 3, or Affiliate).

While this important document is generally handled at the executive levels of management, it is important for all laboratory personnel to have an understanding of what is required in the agreement and how it may apply to them. This five part series is meant to discuss the standards that are listed in the agreement and why they are important for NAHLN participation. 

Part 2 will discuss Standards 5-8 regarding foreign animal disease (FAD)/emerging disease (ED) investigations and outbreak testing. Links are available to direct you to the specific standard for each of the different levels of participation.

Standard 5: FAD/ED Investigations, Outbreak Testing, and Reporting ( Link – L1 ) ( Link – L2/L3/Affiliate )
This standard highlights the importance of a NAHLN Laboratory’s role in the early detection of a foreign animal disease/emerging disease, and subsequent outbreak testing. In many FAD investigations, duplicate samples are collected; one set is provided to the NAHLN laboratory in the state, while the second set is sent to the National Veterinary Services Laboratories (NVSL) Reference Laboratory for confirmation. The NAHLN Laboratory is able to provide a preliminary result quickly while the confirmatory testing is being conducted. Communication among the appropriate parties is critical, as this preliminary and confirmatory information allows decisions to be made for movement, quarantine, or disposal of animals. Different NAHLN laboratory designations have different levels of responsibility:
  • Level 1 laboratories – It is expected that all Level 1 laboratories will accept and process samples for FAD investigation outbreak testing. They must also follow all required communication procedures.
  • Level 2/3/Affiliate laboratories - It is expected that all other laboratories will support FAD investigations and outbreak testing if they are approved for the requested disease and have the capability and capacity to do so. They must also follow all required communication procedures.

This is important as the NAHLN Laboratories are on the front lines and will generally be the first to identify a potential foreign/emerging disease, which must be confirmed by the NVSL Reference Laboratory. Because these preliminary results are used to make certain decisions in the field, it is critical that all communication procedures are followed to ensure that the information is shared and released in a timely and standardized manner.


Standard 6:  Restricted use of Assays/Reagents ( Link – All )
This standard restricts the use of all FAD assays under NAHLN scope, including protocols and/or reagents, to testing conducted only for active FAD investigations, surveillance and/or response plans, or APHIS-VS administered proficiency testing. There are certain disease programs where NAHLN SOPs are approved for use only during FAD investigations and outbreak testing; whereas other programs do not allow testing to be conducted by NAHLN laboratories until the disease has been confirmed in the state by NVSL.

This is important to ensure that only approved laboratories and personnel are conducting testing on behalf of APHIS. This also ensures that FAD assays are conducted on the appropriate samples only.

Standard 7: NAHLN Activation and SOPs ( Link – L1 ) ( Link – L2/L3 ) ( Link – Affiliate )
This standard requires that NAHLN laboratories understand what it means for their laboratory to be “activated”. During an outbreak situation, laboratories may be receiving hundreds of samples at a time, and it is important for the NAHLN and APHIS to know their capacities/capabilities. Limitations due to equipment or personnel may necessitate the transfer of samples to a NAHLN laboratory in another state, or sending trained personnel to the activated NAHLN laboratory to assist in outbreak testing. Different NAHLN laboratory designations have different levels of responsibility:
  • Level 1 labs – If not impacted by the outbreak, Level 1 laboratories must agree to accept and test samples from impacted states, and/or temporarily send personnel from their laboratory to an impacted laboratory or field operation center. Allowable financial compensation will be provided.
  • Level 2/Level 3 – As resources allow, Level 2 and Level 3 labs agree to accept and test samples from impacted states, or to temporarily send personnel from their laboratory to an impacted laboratory or field operation center. Allowable financial compensation will be provided.
  • Affiliate labs – As resources allow, Affiliate labs agree to accept and test samples from impacted states, or to send personnel from their laboratory to an impacted laboratory or field operation center. Allowable financial compensation will be provided.

This is important to ensure all available network resources are used as efficiently as possible. When the capacity of one laboratory is reached, the capabilities of other regional network laboratories are utilized to maintain continuity of testing operations.

Standard 8: Quarantine and Decontamination ( Link – All )
This standard restricts laboratory personnel working with positive samples from coming into contact with susceptible species and their premises for a minimum of five (5) days. In addition, appropriate laboratory biosafety and biosecurity protocols should be implemented and followed according to the individual laboratory’s policies.

This is important to prevent the unintentional spread of disease to other susceptible animals. Supporting a disease response, following quarantines, and using the proper biosafety and biosecurity protocols are the most important things that NAHLN Laboratory personnel can do to help prevent the spread of high consequence diseases.

Article submitted by Kelly Burkhart, Microbiologist, NAHLN Program Office, USDA APHIS VS STAS NVSL, Ames, IA.
Round up:
WS
  • October 2017, Kelly Burkhart traveled to Uganda to provide support and training to the Uganda agriculture laboratories in support of a six month effort between the Defense Threat Reduction Agency (DTRA) and the NVSL Foreign Animal Diagnostic Disease Laboratory FADDL.

  • November 6, 2017, Dr. Kimberly Dodd joined the FADDL as Director

  • November 13, 2017, Jenn Rodriguez joined the NAHLN program office as a Management and Program Analyst

  • December 2017, Dr. Tracy Sturgill Samayoa joined the FADDL as the Diagnostic Services Section (DSS) Head

  • January 2018, Anti-microbial resistance (AMR) proposed negative cohort pilot project design was completed in 2017. The pilot is scheduled to begin in January 2018. Results from the pilot project are expected to be reported throughout the 2018 calendar year.
NAHLN Facts

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