Source: WASHINGTON STATE UNIVERSITY submitted to
WASHINGTON ANIMAL DISEASE DIAGNOSTIC LABORATORY PARTICIPATION AS A LEVEL 1 LABORATORY IN THE NATIONAL ANIMAL HEALTH LABORATORY NETWORK.
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
EXTENDED
Funding Source
Reporting Frequency
Annual
Accession No.
1010777
Grant No.
2016-37620-25777
Project No.
WNV113186
Proposal No.
2016-08623
Multistate No.
(N/A)
Program Code
AA-G
Project Start Date
Sep 1, 2016
Project End Date
Aug 31, 2018
Grant Year
2017
Project Director
Baszler, T.
Recipient Organization
WASHINGTON STATE UNIVERSITY
240 FRENCH ADMINISTRATION BLDG
PULLMAN,WA 99164-0001
Performing Department
WADDL
Non Technical Summary
Early detection of and a rapid, coordinated response to an FAD agent, whether accidentally or deliverately introduced, are depende upon a reliable, secure network of laboratories strategically located throughout the United States. In recognition of this, the United States Department of Agriculture implemented the National Animal Health Laboratory Network (NAHLN) in 2002 consisting of twelve state animal disease diagnostic laboratories, including the Washington Animal Disease Diagnostic Laboratory (WADDL). This new proposal is for participation of WSU-WADDL (Pullman and Puyallup) in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Laboratory under the NAHLN re-structure implemented in FY2016. The project addresses the following NAHLN laboratory priorities: (1) quality system; (2) staff training for foreign and emerging animal diseases; (3) laboratory information management system (including NAHLN messaging); (4) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities); (5) inter-laboratory activities in support of the goals of the NAHLN; and (6) other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
31139991101100%
Knowledge Area
311 - Animal Diseases;

Subject Of Investigation
3999 - Animal research, general;

Field Of Science
1101 - Virology;
Goals / Objectives
This is a new proposal for participation of WSU-WADDL (Pullman and Puyallup) in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Member Laboratory in FY2016. WADDL previously participated as a Core Laboratory in the NAHLN under Cooperative Agreement titled NAHLN:WA. Objectives of the WADDL plan of work for FY16 are to: (1) maintain the current laboratory infrastructure (space and equipment) for routine surveillance and high throughput emergency response testing; (2) maintain qualified personnel who are approved and proficiency tested on all tests and platforms required by the NAHLN; (3) participate in USDA/APHIS contracted surveillance programs for Avian Influenza Virus (AIV), Swine Influenza Virus (SIV), Exotic Newcastle Disease (END), Classical Swine Fever (CSF), Bovine Spongiform Encephalopathy (BSE), Chronic Wasting Disease (CWD), Scrapie, Infectious Salmon Anemia Virus (ISAV), Viral Hemorrhagic Septicemia Virus (VHSV) and any new programs implemented by APHIS in the next year; (4) maintain full accreditation under AAVLD Accreditation Standards; (5) continue electronic messaging of all NAHLN generated data consistent with development of the NAHLN database, (6) assist with development and provision of Quality Management System training at NVSL, Ames; and (7) continue maintenance of quality management system online training modules for supplementation of course training, workshops, and distance learning. The project objectives address the following animal disease diagnostic laboratory issues identified as priorities in the request for applications: (1) quality system; (2) staff training for foreign and emerging animal diseases; (3) laboratory information management system (including NAHLN messaging); (4) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities); (5) inter-laboratory activities in support of the goals of the NAHLN; and (6) other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN and agricultural security.
Project Methods
Methods for laboratory testing for foregin animal diseases in the NAHLN must meet multiple requirements set forth by USDA and include: (1) Standard operating procedures are provided to the laboratories for all NAHLN assays to ensure appropriate and standardized testing, flow of samples, and reporting of assay results across the network; (2) NAHLN laboratories must agree to use protocols and reagents that are provided by the NAHLN Program Office only in accordance with published agent-specific USDA surveillance and/or response plans, VS Guidance (such as 12001) and current versions of SOPs when conducting NAHLN assays for suspected high consequence livestock pathogens and other bio-threat agents; (3) NAHLN laboratories are trained and proficiency tested for a variety of FAD assays, and may be asked to conduct screening tests on samples collected during an animal disease investigation. These assays must be used in accordance with the procedures and timeframes defined in the current version of the Veterinary Services Guidance 12001: Policy for the Investigation of Potential Foreign Animal Disease/Emerging Disease Incidents (FAD/EDI), Surveillance Manuals and SOPs; (4) Laboratories are expected to follow the procedures for reporting results and notifications to appropriate State and Federal officials that are detailed in the appropriate VS Guidance, Surveillance Manuals, and/or Standard Operation Procedures; (5) Laboratories are expected to have developed and/or reviewed their sample receiving and handling activities, guidelines and standard operating procedures (SOP) to ensure consistency with agent-specific issues of laboratory safety, sample and specimen handling, worker training, select agent materials and facility requirements associated with the agent-specific functional designations; (6) NAHLN laboratories may be involved with the use, transfer, and possession of high consequence livestock pathogens and toxins and select agent materials. Whether or not the NAHLN laboratory is registered to possess Select Agents, they will be required to follow notification and transfer processes and be compliant with all current regulations of the Federal Select Agent Program for the receipt, possession, use, storage, shipping, and transfer of select agents and toxins in Title 9 Code of Federal Regulations (CFR) Part 121, 7 CFR Part 331, and 42 CFR Part 73); (7) NAHLN laboratories will be expected to ship and receive samples containing hazardous materials. There are specific requirements for shipment of dangerous goods (International Air Transport Association) and shipment of organisms (Title 9 CFR, Part 122). NAHLN laboratories are expected to have personnel trained and qualified in shipping requirements for hazardous materials, and to have and maintain the permits necessary to appropriately ship and receive these samples; (8) NAHLN laboratories perform regulatory testing for a variety of purposes. Laboratories are expected to provide results for this testing through the appropriate mechanisms and according to the timelines specified in the applicable program standards, surveillance manuals, NAHLN standard operation procedures and/or VS guidance documents.

Progress 09/01/16 to 08/31/17

Outputs
Target Audience:The target audience includes agricultural animal producers in all animal commodity groups, animal and public health regulatory personnel, practicing veterinarians, and the public who would be severely impacted by animal health emergencies, whether zoonotic or animal specific. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?During FY2016, Tim Baszler (PD/PI) and Pat Lukens (lead subject matter expert) continued to design and develop on-line modules for NAHLN laboratory QMS training as part of a separately funded and now completed USDA-APHIS Cooperative agreement. The modules are available nationally and internationally as a supplement to training courses, for in-house training by certified laboratory trainers (e.g., Quality Managers who have taken a course), for courses delivered as distance education, and other uses as appropriate. Pat Lukens was an instructor at a NAHLN Quality Management Systems Training Workshop in Ames, IA in August 2016 and July 2017. Finally, the PD/PI, and Ms. Lukens will continue to serve as members of the AAVLD Accreditation Committee (Dr. Baszler as Chair) during the next funding cycle. The AAVLD AC works synchronously with NAHLN in third-party confirmation of quality assurance for NAHLN tests nation-wide. How have the results been disseminated to communities of interest?WADDL personnel were panelist presenting data for two USDA-NAHLN National Webinars: 1) "Practical aspects of biosafety level 3 operations"; and 2) and "Results of Barcoding and Messaging Exercise". Both of the webinars were sponsored by the NAHLN Exercises and Drills Working Group. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? The project addresses and supports the goals of USDA and the NAHLN to enhance the capability and capacity of State and University animal disease diagnostic laboratories for surveillance, early detection of, rapid response to, and appropriate recovery from an animal agriculture catastrophe. Project support allowed WADDL to address the following animal disease diagnostic laboratory challenges in support of the goals of the NAHLN: (1) quality system; (2) staff training form foreign and emerging animal diseases; (3) laboratory information management system (including NAHLN messaging); (4) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities); (5) interlaboratory activities in support of the goals of the NAHLN; and (6) other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN. Specific outcomes during the project period related to these challenges and objectives include the following: (1) Quality System. a. evaluation and full implementation of a commercial QMS repository for document control, personnel training, corrective actions, client complaints and equipment record management (Q-Pulse by ECL2); b. expansion of the internal auditor program at both the main Pullman laboratory and branch laboratory in Puyallup; c. improvement of equipment monitoring training program; and d. implementation of improved web-based pathology reports and LIMS corrected report processes, continued refinement of "Sample Receiving" section to optimize procedures for sample receipt, database log-in and pre-test processing that will facilitate high volume testing; (2) Staff training for foreign and emerging animal diseases. Participated and provided instruction to: a) "Evaluating Infectious Biological Risks in Aquatic Systems" and b) Practical aspects of biosafety level 3 operations in the National Animal Health Laboratory Network Laboratory Response Panel hosted by NAHLN Exercises and Drills Working Group; and c) USDA/USAHA Steering Committee for National Animal Health Reporting System: Implementing National List of Reportable Animal Diseases; (3) Laboratory Information Systems. a) Maintained stage 4 (highest stage) preparedness for IT messaging with continual improvement of HL7 messaging of HPAI test results to USDA NAHLN and Wildlife Services HPAI Wild Bird Surveillance Program; and b) Thirteen WADDL employees successfully completed "USDA IT Security Awareness and Rules of Behavior" certification. (4) NAHLN testing capabilities. a) Maintained infrastructure and preparedness for FAD and agroterrorism events, including high throughput testing, through continued personnel training, proficiency testing, and FAD surveillance; b) Participated in APHIS disease surveillance activities, including BSE (5,500 samples tested), CWD, scrapie (3,200 samples tested), AIV (15,000 samples tested), SIV, ISAV, CSF and PRV federal and state surveillance programs; and c) successfully completed all proficiency testing for AI/END, FMD/CSF/SIV, Scrapie/CWD, BSE, ISAV and PRV ELISA. (5) Inter-laboratory activities in support of NAHLN. WADDL participated in all NAHLN laboratory projects available to WADDL during FY2016. WADDL_Puyallup (branch lab) participated in the "Barcoding and Messaging activity" implemented by the NAHLN Exercises and Drills Working Group. WADDL personnel were also panelist presenting data for two NAHLN National Webinars: 1) "Practical aspects of biosafety level 3 operations"; and 2) and "Results of Barcoding and Messaging Exercise". In addition, Dan Bradway, WADDL Molecular Diagnostic Lab Manager, was chosen as a Core Member in the NAHLN Methods Technical Working Group (3-year term). Lastly, WADDL also collaborated with multiple veterinary and human clinical laboratories writing the 5th edition of "Biological Safety: Principles and Practices", 5th ed., Dawn Wooley and Karen Byers (ed.), ASM Press, Washington, DC., 2017; Baszler T and Graham T: Veterinary Diagnostic Laboratories and Necropsy, Chapter 33, pp619-646. (6) other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN. WADDL values highly its role as a Level 1 NAHLN Laboratory and takes seriously its role in providing leadership in the NAHLN for advancing the overall laboratory network. Our commitment has included national participation in IT development, the NAHLN Coordinating Council, leadership of the NAHLN Methods Technical Working Group, leadership and membership in the AAVLD Accreditation Committee, leadership and membership in the AAVLD Quality Committee and quality management systems standards development and training. WADDL personnel also served on USDA National Committees: 1) Laboratory implementation planning for the National List of Reportable Diseases (development of a draft notifiable disease reporting guidance document); and 2) AAVLD/NAHLN Antimicrobial Resistance Working Group (development and implantation of nation-wide survey and AMR surveillance plan).

Publications

  • Type: Journal Articles Status: Published Year Published: 2017 Citation: Ajithdoss DK, Torchetti MK, Badcoe L, Bradway DS, Baszler TV: Clinicopathological Findings and Virus Antigen Distribution During Natural infection of Ring-necked Pheasants in Washington State, USA With Highly Pathogenic Avian Influenza virus A (H5N2). Veterinary Pathology 54: 312-315, 2017.