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Transfusion Transmitted Injuries Section

The Surveillance and Epidemiology of Transfusions (SET) Report


The Surveillance and Epidemiology of Transfusions
Working Group

Final Report


February 28, 1999
Chair: Dr. Steven Kleinman

(987 KB) in PDF format pdf icon

Table of Contents

Introduction

  • Surveillance
  • The importance of surveillance for blood safety in Canada
  • The Surveillance and Epidemiology in Transfusions Working Group
  • Scope of the report
  • Organization of the report

1. Review of the process of collecting, processing and administering blood and blood products

  • Collection
  • Testing
  • Processing blood to components
  • Processing blood to blood products
  • Process control and good manufacturing practices (GMPs)
  • Distribution
  • Administration
  • Post administration - Adverse reaction reporting
    1. blood components
    2. plasma derivatives


2. Organization of the blood system in Canada

3. Current surveillance of blood transfusions in Canada
  • Short comings of the present reporting and surveillance system
4. Surveillance of transfusions in other countries
France
  • The hemovigilance system
  • Selected data from the hemovigilance system

United Kingdom
  • The Serious Hazards of Transfusion (SHOT) scheme
  • Selected data from the SHOT scheme

United States

Summary

5. Questions to be asked of a surveillance program

6. Types of information that are needed and their uses in risk management
  • The importance of multiple layers of surveillance
  • Epidemiologic indicators

7. Data points for the baseline surveillance data base

8. Collection of the data points for the surveillance data base

  • Access to and use of the surveillance data
  • Donor data
    • Recommendation # 1
  • Process data
  • Recipient data
    1. General
    2. Transfusion episode and transfusion utilization data
      • Recommendation # 2
    3. Adverse reaction data
      1. acute reactions
    • Recommendation # 3
      ii) delayed adverse reactions
    • Recommendation # 4
    • Recommendation # 5
9. The means of linking data points from existing data bases
a) Linkage of recipient data and data on adverse reactions
  • Recommendation # 6
b) Linking donor and recipient data elements
Options
  • Recommendation # 7
  • Recommendation # 8
10. Information to supplement the baseline surveillance data
  • The concept of sentinel centres for surveillance
    • Recommendation # 9
  • Monitoring for and surveillance of emerging infections
  • The need for rapid response capability: focused research studies
    • Recommendation # 10
11. Coordination and management of the surveillance data base
    • Recommendation # 11
    • Recommendation # 12
    • Recommendation # 13
  • The potential role and composition of a governing council
  • Funding
  • Structure
  • Implementation

Conclusion

References

Figures

Appendices


The Surveillance and Epidemiology of Transfusions
Working Group

Final Report


February 28, 1999
Chair: Dr. Steven Kleinman

(987 KB) in PDF format pdf icon