Human Diagnostic Activities

Overview

This guideline describes biosafety considerations and best practices when conducting diagnostic activities with samples that may contain a human pathogen. The guideline offers risk-based recommendations that may be applicable in licensed diagnostic facilities, as well as diagnostic facilities where activities performed are excluded from the Human Pathogens and Toxins Act (HPTA) or exempted from requiring a Pathogen and Toxin Licence. The guideline is designed to promote the best risk mitigation strategies to prevent personnel exposure to infectious material and release in the community.

Who this guide is for

• Personnel in laboratories where diagnostic activities are performed
• Biological Safety Officers
• Pathogen and Toxin Licence holders

In this guide

• Preface
• Abbreviations and Acronyms
• Chapter 1 -  Introduction
  • 1.1 Human Pathogens and Toxins Excluded from the HPTA
  • 1.2 Exemption from HPTA Licensing Requirement for Identification Activities with a Human Pathogen
  • 1.3 Scope
  • 1.4 How to Use the Human Diagnostic Activities Guideline
• Chapter 2 - Risks Associated with Diagnostic Activities
  • 2.1 Inadvertent Possession
  • 2.2 Laboratory-Acquired Infections/Intoxications
  • 2.3 Pathogen Risk Assessments
  • 2.4 Local Risk Assessments
  • 2.5 Additional Considerations for Local Risk Assessments
• Chapter 3 - Considerations for Physical Containment
  • 3.1 General Physical Design Features
• Chapter 4 - Operational Practices
  • 4.1 Safe Work Practices
  • 4.2 Biosafety Program Management
• Chapter 5 - Decontamination and Waste Management
  • 5.1 Decontamination
  • 5.2 Waste Management
• Chapter 6 - Glossary
• Chapter 7 - References and Resources
• Appendix A - Licensing Requirements when only Health of Animals Regulations apply
• Appendix B - Proper Hand Hygiene

View complete guide

Download PDF (5.17 MB, 72 pages)

Details and history

• Published: June 1, 2021

For assistance

Contact the Public Health Agency of Canada (PHAC) if you need assistance:

• By phone: 1-613-957-1779
• By e-mail: pathogens.pathogenes@phac-aspc.gc.ca

The PHAC's service hours are Monday to Friday from 8 am to 4 pm (eastern time). They are closed on statutory holidays.

Contact us by mail:

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Ottawa, Ontario
K1A 0K9

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We respond to mail and email within two business days. If we can't answer your question right away, we will send you an estimated date.