UPDATE ON NAHLN ACTIVITIES NAT IONAL ANIMAL HEALTH LABORATORY NETWORK COORDINATORS U.S . DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECT ION SERVICE VETERINARY SERVICES OCTOBER 2016
Veterinary Services
NAHLN Restructure
APHIS and NIFA worked in conjunc8on with NAHLN Coordina8ng Council on details, transi8on and implementa8on of NAHLN restructure, based on 2012 NAHLN Concept Paper
Overall Transi8on Process: ◦ Self-‐Assessment by labs – completed September 2014 ◦ External Review (NAHLN and NIFA) – completed Dec 2014 and repeated June 2015 ◦ Needs Evalua8on (based on modeling work with CEAH) – completed April 2015 ◦ Recommenda8ons for Laboratory Distribu8on – completed April-‐September 2015 ◦ Implementa8on – completed January 2016
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NAHLN Restructure Successful Implementa8on!
Infrastructure funding provided to all laboratories designated Level 1, 2 and 3
Next for 2017: ◦ Laboratories will complete a self-‐assessment ◦ Demonstrate any major changes to last year’s assessment (Oct 2016)
◦ Assessments will be reviewed by APHIS and NIFA ◦ Each laboratory will be evaluated through the decision matrix to determine if any change in designa8on
◦ Funding will be distributed in Spring/Summer 2017.
For 2018: ◦ Overall network evalua8on of needs, process and decision criteria will be completed for 2018
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Please refer to lab list for testing capabilities. August 15, 2016
Pearl City
National Veterinary Services Laboratories
Level 3 Laboratory
Level 2 Laboratory
Level 1 Branch Laboratory
Affiliate Laboratory
Level 2 Branch Laboratory
Level 1 Laboratory
Puyallup Pullman
Corvallis
Davis
Bozeman
Laramie Logan
Fort Collins
Rocky Ford
Tucson
Fargo
Brookings
Lincoln
Manhattan
Stillwater
Amarillo
Austin
Ft. Sam Houston
College Station
Center Baton Rouge
Little Rock
Springfield
Columbia
Ames
St. Paul
Madison Lansing
Urbana West Lafayette
Hopkinsville
Pearl Auburn
Lexington
Kissimmee
Tifton
Athens
Gainesville
Columbia
Raleigh
Reynoldsburg
Ithaca
University Park
Kennett Square Harrisburg
Storrs
Trenton
Frederick Salisbury
Galesburg
Moorefield Harrisonburg
Gonzales
Albuquerque
Nashville
Newark Georgetown
Stoneville
NAHLN Laboratory Designa2ons– August 2016
Plum Island
NAHLN CodificaKon Codifica8on Work plan has been finalized and submieed through APHIS management for clearance. ◦ This process included defining and formalizing many processes across NAHLN and within the NAHLN Program Office
Next step: submission to Office of Management and Budget (OMB) for approval.
◦ Once cleared by OMB, language will be draged for publica8on as a proposed rule.
Drag NAHLN Program Standards being finalized: ◦ An8cipate circula8on to stakeholders for review and input by December 2016
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AnKmicrobial Resistance (AMR) Surveillance Pilot – Veterinary DiagnosKc Laboratories
Accomplishments ◦ Finalized survey of US vet diagnos8c labs to assess current prac8ces used to detect an8bio8c resistance, and to determine how informa8on regarding an8microbial resistance is shared. ◦ Survey administered through AAVLD in 2015 ◦ Manuscript submieed to JVDI
◦ Developed a pilot project targe8ng veterinary diagnos8c laboratories that includes recommenda8ons on best prac8ces for AMR tes8ng, standardiza8on, data collec8on and repor8ng ◦ Drag plan completed and is being circulated to addi8onal stakeholder groups for comment
◦ Plan will not be implemented un8l designated AMR funding allocated
AnKmicrobial Resistance (AMR) Surveillance Pilot – Veterinary DiagnosKc Laboratories
Part of the overall White House Na8onal Strategy USDA ◦ Na2onal Strategy for Comba2ng An2microbial Resistant Bacteria (CARB) Plan Goal 2: Strengthen Na+onal One-‐Health Surveillance Efforts to Combat Resistance
◦ USDA Proposed Surveillance Plan Objec2ve 2: Implement rou+ne an+bio+c suscep+bility tes+ng of selected animal pathogens and collate and report data across veterinary diagnos+c laboratories.
◦ VS also suppor8ng through planning of NAHMS and longitudinal studies, One Health communica8on and the Na8onal Veterinary Accredita8on Program
◦ Collabora8ng with FDA Vet-‐LiRN for coordinated efforts in vet labs
NaKonal List of Reportable Animal Diseases Cross-VS effort that addresses many different aspects of NLRAD
Comprehensive document that includes the following sections:
o SOPs for maintaining and updating NLRAD List
o Review and approval processes- routine and emergency/emerging disease
o Laboratory role in NLRAD
o Disease and Case definitions
o NLRAD communication
o Who reports to whom
o When disease should be reported
o What is to be reported
o Data management
o Reporting needs
o Mechanism for reporting
o Confidentiality issues
o Process
o Intellectual Property
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NaKonal List of Reportable Animal Diseases NLRAD, including Emerging Diseases Formed a joint working group with NAHRS Steering Commieee and NAHLN Coordina8ng Council to develop a detailed implementa8on plan for NLRAD and emerging diseases in labs
Drag plan addresses known and unknown agents including: ◦ Case defini8ons, ◦ Timelines and triggers for repor8ng, and ◦ Informa8on sharing details such as data flow, proposed mechanism, and data standards
Lab implementa8on component incorporated into overall NLRAD Framework • Published for comment via APHIS Stakeholder Registry
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Laboratory Electronic Messaging
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18 NAHLN labs and NVSL ac8vely messaging o Addi8onal 5 labs prepared to message
Messages can now be received for 10 diseases o IAV-‐A, IAV-‐S, ASF, BSE, CSF, FMD, PEDV, PRV, VSV
NVSL messaging rou8nely Integra8on of results into other VS systems that collect field data
EMRS and VSLS 2017 messaging priori8es include:
o Con8nue to expand number of labs with capability to message
o Expand messaging to include Scrapie and AMR data o Support implementa8on of NLRAD o Integra8on with other internal VS systems o Enhance u8lity of messaging standards
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3 7 8 2 16 19
2.4
373
439
0
50
100
150
200
250
300
350
400
450
500
FY14 FY15 FY16
LMS Messaging
Diseases Labs Total tests messaged (x1000)
NAHLN Support of Outbreak TesKng H7N8 HPAI/LPAI – commercial turkeys, IN (Jan 2016) ◦ 9 flocks affected, ~250,000 birds ◦ Tes8ng supported by IN NAHLN laboratory (Purdue)
H5N1 LPAI – commercial turkeys, MO (April 2016) ◦ 39,000 birds affected ◦ Tes8ng supported by MO Dept of Ag NAHLN laboratory
H5N2 LPAI, NY & NJ Live Bird Markets (June 2016) ◦ Tes8ng supported by the following NAHLN laboratories; ◦ Cornell University Animal Health Diagnos8c Center ◦ PA Dept of Agriculture and NJ Department of Agriculture
Wild bird surveillance-‐-‐ 2nd year of enhanced surveillance ◦ Tes8ng supported by 8 NAHLN laboratories ◦ Target 35,000 samples
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Quality Management System Support-‐-‐Training
Training based on AAVLD, ISO 17025 OIE standards 14 trainings have been conducted since 2010 542 par8cipants
Interac2ve learning environment ◦ Document control, records, internal audi8ng,
management review, correc8ve ac8ons, root cause analysis, equipment
◦ Workshops: Root cause analysis, SOP and associated document development, QMS Jeopardy game
◦ Mock audit: Applica8on of skills-‐ audi8ng, repor8ng, responding
Regional Training
◦ 35 par8cipants from 2 states
Gap Analysis
◦ Visit or document review 16
Surveillance and Response TesKng in NAHLN labs
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Disease/Agent FY15
FY16 (through 3rd qtr unless noted)
# of NAHLN Laboratories Currently Approved for
Testing Samples or Animals Tested
BSE 40,809 25,811* 4 CSF 5,516 3,807 41 IAV-‐S 27,474 12,621 38 PRV 25,670 15,710 14
SCRAPIE 38,135 28,117 19 HPAI 78,625** 19 have tested PEDV 341,347*** 20 have tested (no approval) PDCoV 181,980*** 20 have tested (no approval) VSV 208 181 5 tested
*complete FY16 **Dec. 14, 2014 (first HPAI outbreak) – Sept. 28, 2016 ***June 5, 2014 (start of Federal Order) – Sept. 24, 2016 No approval indicates that any NAHLN laboratory can test for this disease
Proficiency Tests currently available through the NAHLN Portal
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NAHLN Avian Influenza Virus AIV Avian Paramyxovirus APMV-‐1 African Swine Fever Virus ASF Bovine Spongiform Encephalopathy BSE Chronic WasKng Disease CWD -‐ ELISA Classical Swine Fever Virus CSF Foot and Mouth Disease Virus FMD InfecKous Salmon Anemia Virus ISA Pseudorabies virus PRV Scrapie/CWD IHC Swine Influenza Virus SIV Vesicular StomaKKs Virus CF Vesicular StomaKKs Virus -‐ PCR Viral hemorrhagic SepKcemia – PCR
APHIS Anaplasmosis cELISA Avian Influenza Serology Proficiency test Blue Tongue Bovine Leukosis Bovigam Brucella Ovis Brucellosis Contagious Equine MetriKs Equine Viral ArteriKs Johne's Direct PCR Johne's Direct PCR -‐ Pooled Johne's Liquid Media Johne's Liquid Media Pooled
Johne's Solid Media Culture Johne's Solid Media Culture -‐ Pooled Johne's Milk ELISA Johne's Serology Leptospira Check Test Piroplasmosis Equine Pseudorabies virus PRV Scrapie Genotyping Salmonella Type D Salmonella Serotyping
NPPLAP HLB -‐ Huanglongbing PPV-‐Plum Pox PRAM-‐ Phytophthora ramorum
Comprised of lab directors, sec8on heads, emergency planners from NAHLN labs and VS (open membership)
Accomplishments: Informa8onal webinars and mee8ngs ◦ Lab Capacity Es8ma8on Model (LCEM) ◦ Barcoding successes and challenges
◦ 2 Immediate Response Drills ◦ Planning bar-‐coding hands on drill for 2017
Exercises and Drills Working Group
Methods Technical Working Group
Accomplishments Implemented new membership structure-‐ Core and General Membership
Strategic Discussions ◦ Network challenges ◦ Recommenda8ons for FY2017 priori8es for valida8on and methods comparison projects
Completed Methods Comparison Projects and Reviewed Valida8on Dossiers
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2017 PrioriKes for NAHLN Complete codifica8on of the NAHLN
Begin implemen8ng pilot ac8vi8es for NLRAD and AMR surveillance (dependent on funding)
Con8nue to increase electronic messaging capacity and capability ◦ Increase data integra8on ◦ Support NLRAD ◦ Support AMR surveillance
Complete valida8on projects ◦ Oral fluids for swine FADs ◦ Equivalency tes8ng on PCR plarorms ◦ Methods standardiza8on projects 23
Portal Working Group
Current: Laboratory users are providing input on guidance documents and user friendliness of Portal
Future: Expand responsibili8es and membership of the group to create a more permanent Portal Working Group ◦ Workgroup members will help iden8fy, develop requirements, and recommend Portal improvements
NAHLN Approved Laboratories
**Scrapie/Chronic Wasting Disease (CWD)
National Veterinary Services Laboratories
Newcastle Disease (ND)/Influenza A Virus in Avian (IAV-A) *Bovine Spongiform Encephalopathy (BSE)
*Classical Swine Fever (CSF)/Foot and Mouth Disease (FMD)
Davis
Pullman
Fort Collins
Ames Lincoln
Lansing
Athens
Brookings
St. Paul
Madison
Kissimmee
Ithaca
Logan
Auburn
Galesburg
West Lafayette
Amarillo
Plum Island
Raleigh
Baton Rouge
Little Rock Tucson
Gainesville
Ewing
Stillwater
Columbia
Hopkinsville
Corvallis
Puyallup
July 20, 2016
Nashville
Pearl City
Fargo Bozeman
National Animal Health Laboratory Network (NAHLN)
Vesicular Stomatitis (VS)
Manhattan
Tifton
Reynoldsburg Urbana Moorefield
Laramie
Harrisburg
Salisbury
University Park
Storrs
Kennett Square
Influenza A Virus in Swine (IAV-‐S)
Columbia
*Pseudorabies Virus (PRV)
Rocky Ford
College Station
Center
Lexington
Frederick
Ft. Sam Houston Aus2n
Pearl
Springfield
Harrisonburg
Gonzales
Georgetown Newark
*For specified agents, not all laboratories are currently par8cipa8ng in surveillance tes8ng **Mul8ple assays conducted for this agent, refer to specific disease map/list for assay op8ons..
Stoneville
African Swine Fever
Albuquerque
Viral hemorrhagic sep8cemia (VHS)
Infec8ous salmon anemia (ISA)
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