Transfusion Transmitted Injuries Surveillance System

User's Manual
Version 3.0

To be used as a guide for completion of the:
Canadian Transfusion Adverse Event Reporting Form
F100_V3.0E (November 2007)

Preface

In the 1997 Report of the Commission of Inquiry on the Blood System in Canada, Justice Krever emphasized the importance of surveillance and tracking of blood, blood components, or blood products (plasma derivatives), referring to the concept of vein-to-vein management of blood.

In response to this report the federal government launched a series of initiatives and provided additional funds to improve the safety of Canada's blood system. One such initiative is the Transfusion Transmitted Injuries Surveillance System (TTISS). TTISS is a national surveillance and monitoring system for reporting of adverse reactions to blood, blood components, or blood products (plasma derivatives). It provides data that will be used for managing the risks related to the transfusion of these products in Canada.

The Canadian Transfusion Adverse Event Reporting Form and User's Manual have been developed by a National Working Group consisting of representatives from the provinces/territories, manufacturers of blood components and Health Canada and Public Health Agency of Canada personnel. This manual is to be used as a resource for completing the Canadian Transfusion Adverse Event Reporting Form or TTISS database.

Table of Contents

• Definitions
  
• Information About the Canadian Transfusion Adverse Event Reporting Form
• Guidelines to Report Adverse Events
  
  • Guidelines for Hospitals to Report Adverse Events to Provincial/Territorial Blood Offices and Canadian Blood Services/HÉMA-QUÉBEC
  • Guidelines for Hospitals to Report Adverse Events to Manufacturers of Blood Products (Plasma Derivatives)
• Instructions to Complete the Canadian Transfusion Adverse Event Reporting Form
  • Category of Event
  • Facility Identification
  • Section 1 Recipient Identification
  • Section 2 Clinical History
  • Section 3 Date, Time and Place of Incident/Adverse Reaction
  • Section 3a Incident Information
  • Section 3b Premedication and Anesthesia
  • Section 3c Report of Possible Transfusion Related Blood Borne Infection
  • Section 4 Clinical Signs and Laboratory Results
  • Section 4a Clinical Signs and Symptoms
  • Section 4b Abnormal Tests/Laboratory Results
  • Section 5 Suspect Blood, Blood Components, or Blood Products Plasma Derivatives)
  • Section 6 Measures Taken
  • Section 7 Results of Investigation & Conclusion
    
    • Relationship of Adverse Event to Transfusion
    • Severity of Adverse Event
    • Outcome of the Adverse Event
    • Hospital Procedure Involved
    • Equipment/Supplies
    • Medical Follow-Up
    • Blood Supplier Centre/Manufacturer Notified
    • Status of Investigation
      
    Section 8 Comments
    Section 9 Comments – Completed by Canadian Blood Services (CBS)
• Appendices
  
  • Blood Component Names and Codes
  • Plasma Derivative Product Names and Codes
  • Serious Adverse Events Requested by CBS
  • Contact Lists