Source: WASHINGTON STATE UNIVERSITY submitted to NRP
NAHLN:WA-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
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1010777
Grant No.
2016-37620-25777
Cumulative Award Amt.
$1,339,247.00
Proposal No.
2016-08623
Multistate No.
(N/A)
Project Start Date
Sep 1, 2016
Project End Date
Aug 31, 2021
Grant Year
2019
Program Code
[AA-G]- Homeland Security
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 08/31/21

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?Both Dr. Baszler and Ms. Lukens served as trainers for the AAVLD Quality Symposium in October of each project year, and AAVLD Auditor Pool in February of each project year (focused on uniform interpretation of the AAVLD Requirements, auditing techniques, and writing non-conformances). Ms. Lukens has devoted time to training of Quality Managers from other NAHLN laboratories, with particular emphasis on the Northwest region. Ms. Lukens also served as a trainer at the USDA-NAHLN Laboratory Quality System training in Ames, IA annually during the project period. With Dr. Baszler, Ms. Lukens updated and implemented during each project year global on-line modules on Quality Management Systems through a USDA funded grant for on-line QMS training based on ISO 17025. How have the results been disseminated to communities of interest?NAHLN related activities and accomplishments by WADDL have been disseminated through peer-reviewed scientific publications, presentations as scientific meetings (AAVLD/USAHA annual meeting), stakeholder hosted meetings (local, state and regional cattle and aquaculture associations, WADDL hosted seminars for poultry producers (back-yard poulty and commercial egg-layer and broiler poultry), and WADDL hosted face-to-face meetings with policymakers (WA state legislators) regarding NAHLN testing capacity and capabilities. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Outcomes of project funding as Level 1 Laboratory: The outcomes of the current FY19 (NIFA funding) and FY20 (APHIS funding) project objectives listed below address the following animal disease diagnostic laboratory issues identified as priorities in the request for applications: (1) IT electronic messaging of NAHLN scope and emerging diseases; 2) quality system; (3) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities); (4) completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and supporting NAHLN in establishing technical aspects of emerging disease detection and reporting; (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. (1) IT electronic messaging of NAHLN scope and emerging diseases. Fifteen WADDL personnel (from the main Pullman lab and branch Puyallup lab) participated in NAHLN IT security training in 2020/2021. Both laboratories also received NAHLN approval for electronic messaging of all NAHLN scope disease per the current Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Laboratory during each year. (2) Quality System. WADDL is fully accredited by the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for all assays and functions through 2021. The WADDL Quality Management System (QMS) adheres to the principle of continuous improvement under the leadership of WADDL Administrators, Ms. Jennifer Babcock, Quality Manager (1.0 FTE), and Ms. Kayleigh Carranza, Assistant Quality Manager (0.5 FTE). Annual upgrades of QMS Q-Pulse software included additional features added for test validation, trend analysis, purchasing/procurement, personnel ongoing competency, and internal audits. (3) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities). Laboratory Assay Preparedness. WADDL is at stage 4 (full capability) for all NAHLN assays under our testing scope. This includes APMV-1 (epizootic Newcastle's disease), IAV-A (avian influenza), ASF, BSE, CSF, CWD, FMD, IAV-S (swine influenza), ISAV, Pseudorabies, scrapie, SVC, and VHSV (WADDL-Pullman) and IAV-A and APMV-1 in WADDL-Puyallup. WADDL also is approved for SIV and VHSV isolation and sequencing. In addition, WADDL is one of the 4 approved BSE testing labs in the USA, and currently performs the Bio-Rad ELISA assay. Estimated WADDL high throughput capacity for real time PCR is 1,500-2000 assays/10-hour shift, depending upon the procedure, disease, and sample matrix. In addition to routine surveillance testing, WADDL continues to conduct periodic FMD testing on suspect cases, with rapid turnaround of FMD test results within 4-24 hours and provision of a diagnosis establishing the cause of clinical signs in the suspect case. We continued to allocate NAHLN funding, in concert with the Washington State Department of Agriculture as the sole state laboratory for animal health regulatory testing through official interagency agreement. (4) Completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and supporting NAHLN in establishing technical aspects of emerging disease detection and reporting. Proficiency Testing: WADDL testing staff (15) successfully completed all proficiency testing for AI/END, ASF, FMD/CSF/SIV, Scrapie/CWD, BSE, ISAV, SVCV, VHSV and PRV ELISA during the past project year. Staff currently proficiency tested and approved for NAHLN assay performance are outlined below. NIFA funding provides partial salary and benefit support for the individuals listed in the Table below. Train in support of emerging disease detection: Illumina MiSeq Local Run Manager Training by Illumina Field Application Scientist II, Geneious Prime software training MAGAN and DIAMOND software training (DIAMOND is a program for finding homologs of protein and DNA sequences in a reference database. MEGAN is a toolbox for, among other things, taxonomic analysis of gene sequences. (5) Inter-laboratory Activities in support of goals of the NAHLN. WADDL participated in all NAHLN laboratory 8 drills and surveys available to WADDL. Dan Bradway, WADDL Molecular Diagnostic Lab Manager, served as a Core Member in the NAHLN Methods Technical Working Group and both Dan and Becca Wolking (WADDL Molecular Diagnostics Assistant Lab Manager) served on a Whole Genome Sequencing sub-committee of the NAHLN Methods Technical Working Group. Abi Alaghappan (WADDL IT) serves on the NAHLN IT Working Group. WADDL annually sent to NAHLN during the project period approximately 45 isolates each of Escherichia coli, Salmonella spp, Mannheimia hemolytica, and Staphyloccus intermedius along with antibiotic sensitivity testing (AST) and epidemiologic data from multiple species of animals. In addition, whole genome sequence at WADDL-Pullman for AMR genes was expanded to NAHLN isolates in FY19-FY21. (6) Other integrated activities in support of the goals of the NAHLN and agricultural security. Dr. Baszler (PI/PD) (Past-President of AAVLD), served on AAVLD/USAHA Committees (AAVLD/USAHA Committee on NAHLN and AAVLD Government Relations Committee) that coordinated US Congress advocacy activites for maintaining NAHLN funding through NIFA-FADI appropriations and mandatory funding in the most current Farm Bill. Quality Management. Pat Lukens (recently retired WADDL Quality Manager) and Tim Baszler are members of the AAVLD Accreditation Committee (Dr. Baszler as Co-Chair). The AAVLD AC works synchronously with NAHLN in third-party confirmation of quality assurance for NAHLN tests nation-wide. Both Dr. Baszler and Ms. Lukens served as trainers for the AAVLD Quality Symposia in October 2019 and AAVLD Auditor Pool in February 2020. Ms. Lukens has devoted time to training of Quality Managers from other NAHLN laboratories, with particular emphasis on the Northwest region. Ms. Lukens also served as a trainer at the USDA-NAHLN Laboratory Quality System training in Ames, IA in August 2019. With Dr. Baszler, Ms. Lukens updates and implements global on-line modules on Quality Management Systems through a USDA funded grant for on-line QMS training based on ISO 17025.

Publications


    Progress 09/01/19 to 08/31/20

    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?Both Dr. Baszler and Ms. Lukens served as trainers for the AAVLD Quality Symposium in October 2018 (focused on corrective and preventative action, responding to an accreditation site visit, and practical value of QMS to laboratories), and AAVLD Auditor Pool in February 2020 (focused on uniform interpretation of the AAVLD Requirements, auditing techniques, and writing non-conformances). Ms. Lukens has devoted time to training of Quality Managers from other NAHLN laboratories, with particular emphasis on the Northwest region. Ms. Lukens also served as a trainer at the USDA-NAHLN Laboratory Quality System training in Ames, IA in August 2019. With Dr. Baszler, Ms. Lukens updates and implements global on-line modules on Quality Management Systems through a USDA funded grant for on-line QMS training based on ISO 17025. How have the results been disseminated to communities of interest?NAHLN related activities and accomplishments by WADDL have been disseminated through presentations as scientific meetings (AAVLD/USAHA annual meeting), stakeholder hosted meetings (local, state and regional cattle and aquaculture associations, WADDL hosted seminars for poultry producers (back-yard poulty and commercial egg-layer and broiler poultry), and WADDL hosted face-to-face meetings with policymakers (WA state legislators) regarding NAHLN testing capacity and capabilities. What do you plan to do during the next reporting period to accomplish the goals?The renewal for participation of WSU-WADDL (Pullman and Puyallup) in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Member Laboratory in 2020-21 meets the objects and plans as enunciated in the request for applications. The WADDL plan of work objectives for FY2020 are to: (1) meet all responsibilities of a Level 1 laboratory as outlined in the 2019 Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) As a Level 1 Laboratory; and 2) increase NAHLN capabilities and capacity in addressing an adverse animal health event such as may occur with an emerging disease detection or foreign animal disease outbreak. These objectives will be primarily accomplished by: 1) supporting IT personnel to electronically message all diagnostic test result under our testing scope in specified timelines using HL7 standards, participating in messaging competency events, developing new messages as needed, and comply with IT system access and connectivity requirements; 2) maintaining full accreditation by AAVLD; and 3) supporting laboratory personnel to rapidly test samples in support of disease investigations/surveillance/outbreaks, assist other laboratories during emergencies, utilize the NAHLN Portal, and maintain requirements for federal funding received for NAHLN activities. Furthermore, enhancement of NAHLN capabilities and capacity with be done by: 1) purchasing equipment to enhance laboratory capacity and emerging disease diagnostics; 2) attending training for IT personnel, and supporting electronic accessioning capability; 3) attending quality management training; and 4) completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and assisting NAHLN in establishing technical aspects of emerging disease detection and reporting.

    Impacts
    What was accomplished under these goals? Outcomes of FY19 and FY20 NAHLN Funding as Level 1 Laboratory: The outcomes of the current FY19 (NIFA funding) and FY20 (APHIS funding) project objectives listed below address the following animal disease diagnostic laboratory issues identified as priorities in the request for applications: (1) IT electronic messaging of NAHLN scope and emerging diseases; 2) quality system; (3) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities); (4) completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and supporting NAHLN in establishing technical aspects of emerging disease detection and reporting; (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. 1. IT electronic messaging of NAHLN scope and emerging diseases Fifteen WADDL personnel (from the main Pullman lab and branch Puyallup lab) participated in NAHLN IT security training in 2020. Both laboratories also received NAHLN approval for electronic messaging of all NAHLN scope disease per the current Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Laboratory during each year. 2. Quality System WADDL is fully accredited by the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for all assays and functions through 2020. The WADDL Quality Management System (QMS) adheres to the principle of continuous improvement under the leadership of WADDL Administrators, Ms. Jennifer Babcock, Quality Manager (1.0 FTE), and Ms. Kayleigh Carranza, Assistant Quality Manager (0.5 FTE). Annual upgrades of QMS Q-Pulse software for in 2019-2020 included additional features added for test validation, trend analysis, purchasing/procurement, personnel ongoing competency and internal audits. 3. Laboratory Assay Preparedness. WADDL is at stage 4 (full capability) for all NAHLN assays under our testing scope. This includes APMV-1 (epizootic Newcastle's disease), IAV-A (avian influenza), ASF, BSE, CSF, CWD, FMD, IAV-S (swine influenza), ISAV, Pseudorabies, scrapie, SVC, and VHSV (WADDL-Pullman) and IAV-A and APMV-1 in WADDL-Puyallup. WADDL also is approved for SIV and VHSV isolation and sequencing. In addition, WADDL is one of the 4 approved BSE testing labs in the USA, and currently performs the Bio-Rad ELISA assay. Estimated WADDL high throughput capacity for real time PCR is 1,500-2000 assays/10-hour shift, depending upon the procedure, disease, and sample matrix. In addition to routine surveillance testing, WADDL continues to conduct periodic FMD testing on suspect cases, with rapid turnaround of FMD test results within 4-24 hours and provision of a diagnosis establishing the cause of clinical signs in the suspect case. We continued to allocate NAHLN funding, in concert with the Washington State Department of Agriculture as the sole state laboratory for animal health regulatory testing through official interagency agreement. 4. Completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and supporting NAHLN in establishing technical aspects of emerging disease detection and reporting Proficiency Testing: WADDL testing staff (15) successfully completed all proficiency testing for AI/END, ASF, FMD/CSF/SIV, Scrapie/CWD, BSE, ISAV, SVCV, VHSV and PRV ELISA during the past project year. Staff currently proficiency tested and approved for NAHLN assay performance are outlined below. NIFA funding provides partial salary and benefit support for the individuals listed in the Table below. Train in support of emerging disease detection: 1. Illumina MiSeq Local Run Manager Training by Illumina Field Application Scientist II, 2. Geneious Prime software training 3. MAGAN and DIAMOND software training (DIAMOND is a program for finding homologs of protein and DNA sequences in a reference database. 4. MEGAN is a toolbox for, among other things, taxonomic analysis of gene sequences. 5. Inter-laboratory Activities in support of goals of the NAHLN WADDL participated in all NAHLN laboratory 8 drills and surveys available to WADDL during FY19. Dan Bradway, WADDL Molecular Diagnostic Lab Manager, served as a Core Member in the NAHLN Methods Technical Working Group and both Dan and Becca Wolking (WADDL Molecular Diagnostics Assistant Lab Manager) served on a Whole Genome Sequencing sub-committee of the NAHLN Methods Technical Working Group. Abi Alaghappan (WADDL IT) serves on the NAHLN IT Working Group. In FY19 WADDL sent to NAHLN approximately 45 isolates each of Escherichia coli, Salmonella spp, Mannheimia hemolytica, and Staphyloccus intermedius along with antibiotic sensitivity testing (AST) and epidemiologic data from multiple species of animals. In addition, whole genome sequence at WADDL-Pullman for AMR genes was expanded to NAHLN isolates in FY19. 6. Other integrated activities in support of the goals of the NAHLN and agricultural security Dr. Baszler (PI/PD) (Past-President of AAVLD), served on AAVLD/USAHA Committees (AAVLD/USAHA Committee on NAHLN and AAVLD Government Relations Committee) that coordinated US Congress advocacy activites in FY19 for maintaining NAHLN funding through NIFA-FADI appropriations and mandatory funding in the most current Farm Bill. Both Dr. Baszler and Ms. Lukens served as trainers for the AAVLD Quality Symposia in October 2019 and AAVLD Auditor Pool in February 2020. Ms. Lukens has devoted time to training of Quality Managers from other NAHLN laboratories, with particular emphasis on the Northwest region. Ms. Lukens also served as a trainer at the USDA-NAHLN Laboratory Quality System training in Ames, IA in August 2019. With Dr. Baszler, Ms. Lukens updates and implements global on-line modules on Quality Management Systems through a USDA funded grant for on-line QMS training based on ISO 17025.

    Publications


      Progress 09/01/18 to 08/31/19

      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?The PI/PD (Dr. Tim Baszler) and one professional on the project (Ms. Patricia Lukens) served as trainers for the AAVLD Quality Symposium in October 2018 (focused on corrective and preventative action, responding to an accreditation site visit, and practical value of QMS to laboratories), and AAVLD Auditor Pool in February 2019 (focused on uniform interpretation of the AAVLD Requirements, auditing techniques, and writing non-conformances). Ms. Lukens has devoted time to training of Quality Managers from other NAHLN laboratories, with particular emphasis on the Northwest region. Ms. Lukens also served as a trainer at the USDA-NAHLN Laboratory Quality System training in Ames, IA in August 2018. With Dr. Baszler, Ms. Lukens updates and implements global on-line modules on Quality Management Systems through a USDA funded grant for on-line QMS training based on ISO 17025. How have the results been disseminated to communities of interest?NAHLN related activities and accomplishments by WADDL have been disseminated through presentations as scientific meetings (AAVLD/USAHA annual meeting), stakeholder hosted meetings (local, state and regional cattle and aquaculture associations, WADDL hosted seminars for poultry producers (back-yard poulty and commercial egg-layer and broiler poultry), and WADDL hosted face-to-face meetings with policymakers (WA state legislators) regarding NAHLN testing capacity and capabilities. What do you plan to do during the next reporting period to accomplish the goals?The renewal for participation of WSU-WADDL (Pullman and Puyallup) in the National Animal Health Laboratory Network (NAHLN) as a Level 1 Member Laboratory in 2019-20 meets the objects and plans as enunciated in the request for applications. The WADDL plan of work objectives for FY2019 are to: (1) meet all responsibilities of a Level 1 laboratory as outlined in the 2019 Agreement for Participation in the National Animal Health Laboratory Network (NAHLN) As a Level 1 Laboratory; and 2) increase NAHLN capabilities and capacity in addressing an adverse animal health event such as may occur with an emerging disease detection or foreign animal disease outbreak. These objectives will be primarily accomplished by: 1) supporting IT personnel to electronically message all diagnostic test result under our testing scope in specified timelines using HL7 standards, participating in messaging competency events, developing new messages as needed, and comply with IT system access and connectivity requirements; 2) maintaining full accreditation by AAVLD; and 3) supporting laboratory personnel to rapidly test samples in support of disease investigations/surveillance/outbreaks, assist other laboratories during emergencies, utilize the NAHLN Portal, and maintain requirements for federal funding received for NAHLN activities. Furthermore, enhancement of NAHLN capabilities and capacity with be done by: 1) purchasing equipment to enhance laboratory capacity and emerging disease diagnostics; 2) attending training for IT personnel, and supporting electronic accessioning capability; 3) attending quality management training; and 4) completion of appropriate proficiency tests, training in emerging disease advanced diagnostics such as whole genome sequencing and analysis, and assisting NAHLN in establishing technical aspects of emerging disease detection and reporting.

      Impacts
      What was accomplished under these goals? 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. Specific outcomes during the project period related to these challenges and objectives include the following: (1) Quality System. The Washington Animal Disease Diagnostic Laboratory is fully accredited by the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for all assays and functions through 2020. The WADDL Quality Management System (QMS) adheres to the principle of continuous improvement under the leadership of WADDL Administrators, Ms. Pat Lukens, Quality Manager (1.0 FTE), and Ms. Jennifer Babcock, Assistant Quality Manager (0.5 FTE). WADDL purchased commercial QMS software in 2017 (Q-Pulse by ECL2) to streamline management of document control, personnel training, corrective actions, client complaints and equipment. In 2018 Q-Pulse was upgraded and additional features added for test validation, trend analysis, purchasing/procurement, personnel ongoing competency and internal audits; (2) Staff training for foreign and emerging animal diseases. In 2018-19 WADDL personnel participated in two foreign animal disease trainings by NAHLN 1) FAD response tabletop exercise by the NAHLN Exercises and Drills Working Group focuses on exotic Newcastle's Disease outbreak in August 2018; and 2) FAD Investigations and Response Testing training focused on African Swine Fever and Classical Swine Fever in May 2019; (3) Laboratory information management system (including NAHLN messaging). In FY 2017, WADDL hired two information systems personnel with primary responsibility for WADDL IT needs (Ms. Abi Alaghappan and Mr. Roy Obenchain). In 2018-19 WADDL completed NAHLN "LIMS-LMS HL7 Messaging Approval" to "LMS Production" for all diseases under our NAHLN testing scope for as indicated by our current "Participation in the National Animal Health Laboratory Network (NAHLN) As a Level 1 Laboratory". This included for WADDL-Pullman main laboratory messaging for APVM-1, ASF, BSE, CSF, FMD, IAV-A, IAV-S, and PRV, and for WADDL-Puyallup branch laboratory messaging APVM-1 and IAV-A. NAHLN diseases under our testing scope for which NAHLN cannot currently receive electronic messages include chronic wasting disease (CWD), infectious salmon anemia virus (ISAV), scrapie, spring viremia of carp (SVC) and viral hemorrhagic septicemia virus of fish (VHSV). ). In 2019-20 WADDL will continue maintaining proficiency for messaging all NAHLN diseases as available by: 1) participating in NAHLN messaging competency exercises (proficiency tests) for LMS HL7 messaging; and 2) moving to LMS production messaging for CWD, ISAV, SVC, scrapie, and VHSV as messaging for those NAHLN diseases becomes available; (4) NAHLN sample handling, processing, and testing capacities (including enhancement of biocontainment capabilities). The primary and most significant activity during the 2018-19 funding cycle was to maintain infrastructure and preparedness for FAD and agroterrorism events, including high throughput testing, continued personnel training, proficiency testing, and FAD surveillance. FAD testing infrastructure funded through NIFA was exercised through organized APHIS disease surveillance activities, including BSE, CWD, scrapie, AIV, SIV, CSF, ISAV and PRV. In CY 2018, WADDL continued TSE national surveillance activities including BSE (4,600 tests), Scrapie/CWD (3,100 tests), IAV-A (1,800 tests) and ISAV (1,800 tests). In addition to routine surveillance testing, WADDL continues to conduct periodic FMD testing on suspect cases, with rapid turnaround of FMD test results within 4-24 hours. We continued to allocate NAHLN funding, in concert with the Washington State Department of Agriculture as the sole state laboratory for animal health regulatory testing through official interagency agreement. WADDL testing staff successfully completed all proficiency testing for AI/END, FMD/CSF/SIV, Scrapie/CWD, BSE, and PRV ELISA during the past project year. Fourteen staff are currently proficiency tested and approved for NAHLN assay performance including avian influenza, exotic Newcastle's disease, foot and mouth disease, classical swine fever, African swine fever, swine influenza, scrapie, chronic wasting disease, bovine spongiform encephalopathy, infectious salmon anemia virus and viral hemorrhagic septicemia virus of fish. WADDL has available ~2,500 ASF of BSL-3 space in the Allen Center located within the College of Veterinary Medicine complex dedicated to WADDL for diagnostic activities requiring higher level biocontainment, and for NAHLN and LRN surveillance and emergency response. The Allen Center BSL-3 was inspected and approved by USDA and CDC for select agent registration in 2013, 2016 and again in 2019. Selected WADDL Molecular Diagnostics Section work, including NAHLN related testing, was conducted in the Allen Center BSL-3 space during the project period, significantly enhancing BSL-3 containment for high throughput NAHLN associated outbreak response testing. The Allen Center facility is Phase 1 (which includes the WADDL BSL-3 laboratory space) of a two-phase building process that includes in Phase 2, a new 61,000 gsf WADDL facility. Full funding was secured from the WA legislature for a new 61,000 gsf facility that is currently under construction (approximately 25% completed) for anticipated opening in early 2021. Recent purchases of new equipment enhancing NAHLN testing capacity and capability included "Illumina" whole genome sequencing package, high throughput equipment for antimicrobial resistance surveillance (BIOMIC), a third Kingfisher Flex 96-well high-throughput DNA/RNA extraction system and increased -80C freezers for NAHLN sample archiving; (5) Inter-laboratory activities in support of the NAHLN. WADDL participated in all NAHLN laboratory projects available to WADDL during 2018-19 including APMV-1 FAD tabletop (August 2018) and ASF/CSF testing and messaging training (May 2019). Dan Bradway, WADDL Molecular Diagnostic Lab Manager, served as a Core Member in the NAHLN Methods Technical Working Group (year 3 of a 3-year term) and both Dan and Becca Wolking (WADDL Molecular Diagnostics Assistant Lab Manager) served on a Whole Genome Sequencing sub-committee of the NAHLN Methods Technical Working Group. Abi Alaghappan (WADDL IT) serves on the NAHLN IT Working Group. In 2018 (the beginning of the AMR surveillance project), WADDL sent to NAHLN approximately 45 isolates each of Escherichia coli, Salmonella spp, Mannheimia hemolytica, and Staphyloccus intermedius along with antibiotic sensitivity testing (AST) and epidemiologic data from multiple species of animals; (6) other integrated activities (research, education, and/or outreach/service) in support of the goals of the NAHLN. Dr. Baszler (PI/PD) (Past-President of AAVLD), served on AAVLD/USAHA Committees (AAVLD/USAHA Committee on NAHLN and AAVLD Government Relations Committee) that coordinated US Congress advocacy activites in 2018-19 for maintaining NAHLN funding through NIFA-FADI appropriations in 2019, and mandatory funding in the 2019 Farm Bill. Ms. Lukens and Dr. Baszler are members of the AAVLD Accreditation Committee (Dr. Baszler as Co-Chair). The AAVLD AC works synchronously with NAHLN in third-party confirmation of quality assurance for NAHLN tests nation-wide.

      Publications


        Progress 09/01/17 to 08/31/18

        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 FY2017, 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-NAHLN 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 July 2017 and will be a trainer again in August 2018. Finally, the PD/PI, and Ms. Lukens will continue to serve as members of the AAVLD Accreditation Committee (Dr. Baszler as Co-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?NAHLN related activities and accomplishments by WADDL have been disseminated through peer-reviewed publications (journal articles and book chapters), presentations as scientific meetings (AAVLD/USAHA annual meeting), stakeholder hosted meetings (local, state and regional cattle and aquaculture associations, WADDL hosted seminars for poultry producers (back-yard poulty and commercial egg-layer and broiler poultry), and WADDL hosted face-to-face meetings with policymakers (WA state legislators) regarding NAHLN testing capacity and capabilities. What do you plan to do during the next reporting period to accomplish the goals?Objectives of the WADDL plan of work for FY17 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.

        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. Expanded implementation of a commercial QMS repository for document control, personnel training, corrective actions, client complaints, validation of tests 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; and c. 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 for training related to foreign and emerging diseases, including laboratory capability and capacity. This included: 1)" Improving Preparedness for Foreign Animal Diseases through the National Animal Health Laboratory Network", Area Foreign Animal Disease Diagnostician Response Training Course (District 6), Corvalis, OR, August 1-2, 2017 (Dr. Tim Baszler-trainer). (3) Laboratory Information Systems. a) maintained Stage 4 electronic messaging competency with messages successfully transmitted and automated results uploading to the NAHLN database for IAV-A, IAV-S, FMD, CSF, BSE, and APMV-1; b. successfully completed all available NAHLN IT proficiency tests (IAV-A and APMV-1); c. conducted USDA-APHIS-Wildlife Services HPAI Wild Bird Surveillance (over 10,000 birds tested) and HL7-messaged all test results; and d) 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 (1,800 samples tested), AIV (18,000 samples tested), ISAV (over 2,500 samples tested), CSF and PRV federal and state surveillance programs; and c) successfully completed all proficiency tests for AI/END, FMD/CSF/SIV, Scrapie/CWD, BSE, ISAV and PRV ELISA. (5) Inter-laboratory activities in support of NAHLN. WADDL participated in several NAHLN laboratory projects available to WADDL during FY2017: 1) WADDL_Puyallup (branch lab) participated in the "Barcoding and Messaging activity" implemented by the NAHLN Exercises and Drills Working Group; 2) Dan Bradway, WADDL Molecular Diagnostic Lab Manager, served as a Core Member in the NAHLN Methods Technical Working Group (Year 1 of a 3-year term); 3) WADDL also co-authored a Book Chapter regarding safety in veterinary diagnostic laboratories in "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; and 4) In FY 2017, WADDL was chosen to participate in the NAHLN antimicrobial resistance (AMR) surveillance project. Since Jan 2018 (the beginning of the project, WADDL has sent to NAHLN approximately 45 isolates each of Escherichia coli, Salmonella spp, Mannheimia hemolytica, and Staphyloccus intermedius along with antibiotic sensitivity testing (AST) and epidemiologic data from multiple species of animals. The goal is for NAHLN to analyze and report AMR trends from multiple animal species nationwide. (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, leadership of the NAHLN Methods Technical Working Group, leadership and membership in the AAVLD Accreditation Committee, and leadership in the AAVLD Quality Committee and quality management systems standards development and training. AAVLD Leadership (Dr. Baszler, PD/PI, serves as Past-President of AAVLD) assisted greatly in increasing NAHLN funding through NIFA-FADI appropriations in 2014, authorization of NAHLN funding in the 2014 Farm Bill, and increased NAHLN appropriations implemented in FY2017 and FY2018. Dr. Baszler served on NAHLN Cooridinating Council (2013-2017), and during FY17 served on the AAVLD/NAHLN Antimicrobial Resistance Working Group (development and implantation of nation-wide survey and AMR surveillance plan). In addition to laboratory specific NAHLN related activities, and consistent with what we consider an expectation and role for NAHLN Level 1 laboratories, during the FY2018 funding cycle we will continue to expand our NAHLN activities into other integrated areas through leveraged funding and collaboration.

        Publications

        • Type: Journal Articles Status: Published Year Published: 2017 Citation: A systematic surveillance programme for infectious salmon anaemia virus supports its absence in the Pacific Northwest of the United States. Gustafson LL, Creekmore LH, Snekvik KR, Ferguson JA, Warg JV, Blair M, Meyers TR, Stewart B, Warheit KI, Kerwin J, Goodwin AE, Rhodes LD, Whaley JE, Purcell MK, Bentz C, Shasa D, Bader J, Winton JR. J Fish Dis. 2018 Feb;41(2):337-346. doi: 10.1111/jfd.12733. Epub 2017 Nov 21.


        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.