1. National Aquatic Animal Health Laboratory System (NAAHLS) INTER-AMERICAN COMMITTEE ON AQUATIC ANIMAL HEALTH June 07 National Aquatic Animal Health Laboratory System (NAAHLS) INTER-AMERICAN COMMITTEE ON AQUATIC ANIMAL HEALTH June 07 Stephen J. Stephen, Fisheries and Oceans Canada (DFO) Stephen J. Stephen, Fisheries and Oceans Canada (DFO)

2. 2 How NAAHP fits into New and Old DFO initiatives… Nationally Reportable Diseases Endemic Diseases of Regional Concern Production Diseases of Industry Concern CFIADFO Federal Region / Prov Prov / Aquaculture Fish Health Protection Regs Regional disease issues Surveillance and research Introductions and Transfers (disease risk advice) Aquaculture Framework Agreement NAAHLS & AAH

3. 3 Building it right…. takes time! National Aquatic Animal Health Laboratory System

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

6. 6 Building it right…. takes time! Reference Laboratories National Aquatic Animal Health Laboratory System

7. 7 DFO Reference Laboratories EHN & IPN WSSV & Emerging Diseases IHN & VHS Perkinsus olseni Mikrocytos mackini ISA & MSX Perkinsus marinus Marteila refringens CAAPBL Pacific Biological Station Freshwater Institute Gulf Fisheries Center

8. 8 Reference Laboratories Priority Diseases Reference Laboratory Reference Expert(s) Mandates

9. 9 Building it right…. takes time! Reference Laboratories Network Laboratories National Aquatic Animal Health Laboratory System

10. 10 Network Laboratories Participating Provinces Counterparts QA Checklist Biosecurity Checklist

11. 11 Provinces indicating interest British Columbia Alberta Ontario Quebec New Brunswick (3) Nova Scotia Prince Edward Island Newfoundland & Labrador

12. 12 Game Plan Memorandum of Understanding Terms of Reference QA / Biosecurity Targets Scope of Testing Tech Transfer & Training Proficiency & Certification

13. 13 Building it right…. takes time! Reference Laboratories Quality Management Network Laboratories National Aquatic Animal Health Laboratory System

14. 14 Quality Management Standard Operating Procedures Test Method Protocols ISO & Audit Training Quality Manual Q Pulse

15. 15 Putting Pen to Paper SOPs PBSFWIGFCCAAPBL Control13 (10%) 32 (50%) 18 (13%) 27 (32%) Draft99 (72%) 15 (23%) 72 (53%) 13 (15%) Pending25 (18%) 17 (27%) 45 (34%) 45 (53%) Test Method Protocols – 19 at various stages

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

17. 17 Building it right…. takes time! Reference Laboratories Quality Management Network Laboratories Security/Biosecurity National Aquatic Animal Health Laboratory System

18. 18 Security / Biosecurity Lab renovations Containment Standard Laboratory SOPs Field sampling protocols Specimen tracking Results/data security

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

20. 20 Building it right…. takes time! Reference Laboratories Quality Management Network Laboratories Security/Biosecurity Information Mgmt National Aquatic Animal Health Laboratory System

21. 21 Lab Info Mgmt System (LIMS) RFP x 2 Product Demos Pilot Project Configuration Training(User/Admin) Deployment

22. 22 Surveillance Info Mgmt System (SIMS) Aquatic Sample Mgmt & Reporting System Submission forms Report forms Interim procedures Steering Committee Working Committee

23. 23 Building it right…. takes time! Reference Laboratories Quality Management Natl Service Stds Network Laboratories Security/Biosecurity Information Mgmt National Aquatic Animal Health Laboratory System

24. 24 National SOPs Mission and Mandate Validation requirements Designation of test methods Submission categories Turn-around-times Acceptance of new work

25. 25 National SOPs (contd) Communications Quality certification Proficiency testing Testing certification Biosecurity certification Designation of test methods Submission categories

26. 26 Building it right…. takes time! Reference Laboratories Quality Management Natl Service Stds Network Laboratories Security/Biosecurity Diagnostics Information Mgmt National Aquatic Animal Health Laboratory System

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

28. 28 Building it right…. takes time! Reference Laboratories Quality Management Natl Service Stds Network Laboratories Security/Biosecurity Diagnostics Information Mgmt National Aquatic Animal Health Laboratory System Research

29. 29 CFIA NAAHP Research Priorities 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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