Biosafety Program

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BIOSAFETY AND BIOSECURITY GOVERNANCE FRAMEWORK

This document highlights the key component of the Biosafety and Biosecurity Governance Framework; also known to the Public Health Agency of Canada as the “Plan of Administrative Oversight”. The full document is provided at the time a Biohazardous Material Use Certificate is issued, or upon request.

Objective is to achieve:
  • Biosafety: containment principles, technologies, and practices implemented to prevent unintentional exposure to infectious material and toxins, or their accidental release.
  • Biosecurity: security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens, toxins, and other related assets.
  • Biosurety: the combination of security, biosafety, agent accountability, and personnel reliability needed to prevent unauthorized access to select agents of bioterrorism.
    Through the use of:
    • Oversight & Accountability
      • Roles and Responsibilities
      • Institutional Oversight and Program Management
      • Academic and Research Activities and Facility Infrastructure
    • Corporate Policy and Directives
      • Biosafety and Biosecurity Policy
      • Institutional Biosafety Approval
      • Biorisk Management Program
    • Biorisk Program
      • Risk Identification, Assessment and Control
      • Implementation and Operational Procedures
      • Compliance Monitoring and Reporting
    The Biorisk Management Program comprises:
    • The founding principles are:
      1. Accountability/Responsibility Framework
      2. Communication/Education
      3. Compliance and Monitoring Activities
      4. Documentation and Data Management, and
      5. Security
    • These principles are then translated into thirteen operational program elements:
      1. Institutional Biosafety Approval
      2. Training /Education
      3. Compliance Verification
      4. Inventory Control (acquisition & transfers)
      5. Security
      6. Transportation
      7. Monitoring (medical, performance)
      8. Waste Management
      9. Public Awareness/Signage
      10. Decommission
      11. Inspections/Investigations/Audits
      12. Reporting (internal/external)
      13. Program Review
    • Biosafety Management Information System is used to as a recording and planning tool:
      1. Biosafety Program Overview
      2. Acts and Regulations
      3. Compliance
      4. Data Management
      5. Chronological Activity Journal
      6. Policies and Procedures
      7. Central File
      8. Archives

    Biosafety Manual

    Chapter 1. Program Framework
    Chapter 2. Legislation, Standards, Guideline

    2.1.Regulators

           2.1.1.  Public Health Agency of Canada

           2.1.2.  Canadian Food Inspection Agency

           2.1.3.  Transport Canada

           2.1.4.  Ministry of Environment and Climate Change

    2.2.Biosafety Standards

           2.2.1.  Canadian Biosafety Standard, 2nd Edition

           2.2.2.  Containment Standards for Facilities Handling Aquatic Animal Pathogens, 1st Edition

           2.2.3.  Containment Standards for Facilities Handling Plant Pests, 1st Edition

    2.3.Biosafety Handbook

           2.3.1.  Canadian Biosafety Handbook, 2nd Edition

    Chapter 3. Institutional Approval
    Chapter 4. Operational Practices

    4.1. Accident and Incident

           4.1.1. Report Accident or Incident 

    4.2. Acquisition and Transfer

           4.2.1. Authorization for the Acquisition of Biological Material

           4.2.2. Import Requirements

           4.2.3. Biohazardous Material Transfer Notification Form

           4.2.4. Biosafety Program Restriction: SSBA Acquisition

           4.2.5. Inventory Control

    4.3. Biorisk Assessment

           4.3.1. Biorisk Assessment Process *

           4.3.2. Laboratory Biorisk Assessment Template *

           4.3.3.  A Reference Guide the Multi-facets of a Biorisk Assessment

           4.3.4. Personnel Biological Agent Exposure Control Plan

           4.3.5. Pathogen Safety Data Sheet and Risk Assessment

    4.4. Biosecurity

           4.4.1. Biosecurity and Dual Use Research of Concern *

           4.4.2. Identification, Evaluation and Mitigation Guide *

    4.5. Clinical and Diagnostic Samples

           4.5.1. Blood Spill Procedures

           4.5.2. Measures to Minimize Exposure to BBP and Post Exposure Prophylaxis Policy *

           4.5.3. Good Clinical Safety (in development)

    4.6. Compliance Monitoring

           4.6.1. Evaluation of Performance Risk and Compliance Grade

           4.6.2. Biosafety Inspection Checklist *

    4.7. Containment Level

           4.7.1. CL2 Checklist – Mandatory Requirements

           4.7.2. CL2 Checklist – Additional Requirements for Prion Work

           4.7.3. Biohazard Warning Signage

    4.8. Decommissioning

           4.8.1. Biosafety Decommissioning Form

    4.9. Decontamination

           4.9.1. A Guideline for the Safe Use of Autoclaves *

           4.9.2. University of Ottawa Autoclave Procedures

           4.9.3. Use of Bleach as Disinfectant

           4.9.4. Guideline: Use of UV Lamps in Biological Safety Cabinet

    4.10. Documentation Retention *

    4.11. Experimental Protocols

           4.11.1. JoVE

           4.11.2. Protocols Online

    4.12. Emergency Response Plan

           4.12.1. Biological Spill Response Plan

           4.12.2. Response Procedure to Equipment Alarm

          4.12.3. Emergency Response Plan for CL2 Labs

    4.13. HEPA Filtration

           4.13.1. Installation of Biological Safety Cabinet

           4.13.2. Working with BSC SOP

           4.13.3. Biological Safety Cabinet (BSC) vs. Laminar Flow Hood (LFH)

           4.13.4. Guideline for the BSC/LFH Certification

           4.13.5. Use of Open Flame in BSC

    4.14. Good Microbiological Practices

    4.15. Medical Surveillance Program

           4.15.1. Medical Surveillance *

           4.15.2. Infection Risks to New and Expectant Mothers in the Workplace

           4.15.3. Health Assessment Survey *

           4.15.4. Infectious Diseases

    4.16. Personal Protective Equipment

           4.16.1. Personal Protective Equipment Guideline

           4.16.2. Lab Coat Selection

    4.17. Routine Practices and Universal Precautions

    4.18. Shipping and Transport

           4.18.1. Transport Canada – Shipping Infectious Substances

           4.18.2. TDG Training

    4.19. Waste Management

           4.19.1. University of Ottawa Biomedical Waste Management Procedures

           4.19.2. Decontamination and Biomedical Waste Management Lab Specific SOP

           4.19.3. Biomedical Waste Door-to-Door Service Request Procedures

     

    * This document is currently in translations. Due to regulatory compliance requirements, it is presently being made available in English. We expect translation to be completed in 2019.

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