Transfusion Transmitted Injuries Surveillance System
Program Report 2002-2003

Introduction

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The Transfusion Transmitted Injuries Surveillance System (TTISS) is maintained by the Public Health Agency of Canada (PHAC) to collect data on adverse transfusion events (ATEs) resulting from the therapeutic use of blood, blood components, plasma derivatives and recombinant products^* across the country.

The TTISS began as a pilot project to carry out voluntary surveillance of both infectious and non-infectious transfusion related injuries in four provinces, for the period of 1999-2002. Implementation of the TTISS has continued to expand since the pilot project and it is now a national program in various stages of implementation in all provinces and territories.

The pilot provinces collaborated with PHAC to develop standardized materials for the reporting of ATEs. The primary tools developed are a Canadian Transfusion Adverse Event Reporting Form and a Canadian Transfusion Adverse Event Reporting User's Manual. These tools, along with standardized definitions for reporting ATEs, ensure consistent reporting across Canada. The Canadian Transfusion Adverse Event Reporting Form is endorsed by both blood manufacturers (Canadian Blood Services and Héma-Québec) and the two relevant regulatory directorates of Health Canada: the Marketed Health Products Directorate and the Biologics and Genetic Therapies Directorate, both of the Health Products and Food Branch.

TTISS is advised by two working groups: the National Transfusion Transmitted Injuries Surveillance System Working Group (NTTISS WG) and the National Working Party for Data Review (NWPDR).

The NTTISS Working Group advises the program on the direction, quality and effectiveness of TTISS as a national surveillance system. Its core membership is composed of representatives of each province and territory, two representatives from Health Canada's regulatory branch, as well as the two blood manufacturers.

The NWPDR reviews and evaluates the data produced by the system on the safety of blood, blood components and products intended for use in the treatment of human diseases.Members include professionals knowledgeable in the fields of public health, infectious diseases, epidemiology and transfusion medicine. The Working Party focuses on identifying, from the data submitted, from the literature and from their expertise, phenomena or unusual adverse events that require further investigation by PHAC. It also assists in developing research questions and hypotheses for investigation by PHAC.

The data presented in this report cover a two-year period (2002-2003) and are presented under three headings:

• overall results,
• events related to blood components, and
• events related to plasma derivatives and recombinant products.

Special attention is given to specific ATEs related to blood components, such as ABO incompatibility, acute hemolytic reactions, and bacterial contamination. Fatalities are also reported separately. Rate calculations were performed for blood components only, as methods for transferring denominator data for plasma derivatives and recombinant products are still under discussion. The report concludes with a discussion of the data and its limitations and recommendations for improving the surveillance system.

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* Refers to recombinant hemostatic agents distributed by blood banks