National Aquatic Animal Health Laboratory System (NAAHLS) INTER-AMERICAN COMMITTEE ON

1. 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… • Fish Health Protection Regs • Regional disease issues • Surveillance and research • Introductions and Transfers(disease risk advice) Federal Nationally Reportable Diseases CFIA DFO Region / Prov Endemic Diseases of Regional Concern Prov / Aquaculture • Aquaculture Framework Agreement NAAHLS & AAH Production Diseases of Industry Concern

3. 2008 National Aquatic Animal Health Laboratory System Building it right…. takes time!

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: • Network of national reference laboratories • 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

6. 2008 Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

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

9. 2008 Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

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

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

13. 2008 Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

15. Putting Pen to Paper Test Method Protocols – 19 at various stages

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

17. 2008 Security/Biosecurity Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

18. Security / Biosecurity • Lab renovations  • Containment Standard  • Laboratory SOP’s  • Field sampling protocols  • Specimen tracking • Results/data security

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

20. 2008 Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

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

23. 2008 Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

24. National SOP’s • Mission and Mandate • Validation requirements  • Designation of test methods  • Submission categories  • Turn-around-times  • Acceptance of new work

25. National SOP’s (cont’d) • Communications • Quality certification • Proficiency testing • Testing certification • Biosecurity certification • Designation of test methods • Submission categories

26. 2008 Diagnostics Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

28. 2008 Research Diagnostics Nat’l Service Stds Information Mgmt Security/Biosecurity Quality Management Network Laboratories Reference Laboratories National Aquatic Animal Health Laboratory System Building it right…. takes time!

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

30. 2008