National Aquatic Animal Health Laboratory System (NAAHLS)

INTER-AMERICAN COMMITTEE ON AQUATIC ANIMAL HEALTH June ‘07 Stephen J. Stephen, Fisheries and Oceans Canada (DFO)

2 How NAAHP fits into New and Old DFO initiatives… Federal Nationally Reportable Diseases Region / Prov Endemic Diseases of Regional Concern Prov / Aquaculture Production Diseases of Industry Concern CFIA NAAHLS & AAH

• Fish Health Protection Regs • Regional disease issues • Surveillance and research • Introductions and Transfers

(disease risk advice) DFO

• Aquaculture

Framework Agreement

Building it right…. takes time!

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National Aquatic Animal Health Laboratory System

4 NAAHLS Mission To provide quality diagnostics and research, sound scientific advice and rapid emergency response in support of the National Aquatic Animal Health Program

5 NAAHLS Mandates Establish: 1) Network of national reference laboratories 2) 3) 4) 5) 6) 7) 8) Network of counterpart testing laboratories Management system to ISO 17025 standard Security & biosecurity systems to national standards Laboratory information management system (LIMS) National standards for service delivery Diagnostic services based on validated methods Research program to address regulatory needs

Building it right…. takes time!

6 Reference Laboratories

National Aquatic Animal Health Laboratory System

DFO Reference Laboratories

EHN & IPN ISA & MSX

Perkinsus marinus Marteila refringens

Freshwater Institute Gulf Fisheries Center Pacific Biological Station IHN & VHS

Perkinsus olseni Mikrocytos mackini

7 WSSV & Emerging Diseases CAAPBL

8 Reference Laboratories

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Priority Diseases Reference Laboratory Reference Expert(s) Mandates

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Building it right…. takes time!

9 Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

10 Network Laboratories

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Participating Provinces Counterparts QA Checklist Biosecurity Checklist

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11 Provinces indicating interest

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British Columbia Alberta Ontario Quebec New Brunswick (3) Nova Scotia Prince Edward Island Newfoundland & Labrador

12 Game Plan

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Memorandum of Understanding Terms of Reference QA / Biosecurity Targets Scope of Testing Tech Transfer & Training Proficiency & Certification

Building it right…. takes time!

13 Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

14 Quality Management

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Standard Operating Procedures

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Test Method Protocols

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ISO & Audit Training Quality Manual Q Pulse

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Putting Pen to Paper 15 SOP’s PBS FWI GFC CAAPBL Control 13 (10%) 32 (50%) 18 (13%) 27 (32%) Draft 99 (72%) 15 (23%) 72 (53%) 13 (15%) Pending 25 (18%) 17 (27%) 45 (34%) Test Method Protocols – 19 at various stages 45 (53%)

16 Managing it all Q-Pulse, designed specifically to:

Building it right…. takes time!

17 Security/Biosecurity Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

Security / Biosecurity

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Lab renovations Containment Standard Laboratory SOP’s Field sampling protocols Specimen tracking Results/data security 18

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Renovation Challenges 19 Pacific Biological Station Freshwater Institute Gulf Fisheries Center CAAPBL

Building it right…. takes time!

20 Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

21 Lab Info Mgmt System (LIMS)

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RFP x 2 Product Demos Pilot Project Configuration Training (User/Admin) Deployment

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22 Surveillance Info Mgmt System (SIMS)

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Aquatic Sample Mgmt & Reporting System Submission forms Report forms Interim procedures Steering Committee Working Committee

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Building it right…. takes time!

23 Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

24 National SOP’s

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Mission and Mandate Validation requirements Designation of test methods Submission categories Turn-around-times Acceptance of new work

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National SOP’s (cont’d)

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Communications Quality certification Proficiency testing Testing certification Biosecurity certification Designation of test methods Submission categories 25

Building it right…. takes time!

26 Diagnostics Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

Diagnostic Services

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Scope of testing Test method protocols Harmonization Validation dossiers Sample flow Decision trees Proficiency & certification 27

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Building it right…. takes time!

28 Research Diagnostics Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories

National Aquatic Animal Health Laboratory System

29 CFIA NAAHP Research Priorities

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Viral strain differentiation and correlation to pathogenic significance Validation of diagnostic tools Non-lethal sampling Carrier species Disease transmission via product Processing (waste) effluent risk analysis Decontamination procedures

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