Transfusion Transmitted Injuries Surveillance System
Project Progress Report 2001-2002

1. Introduction

In order to improve adverse transfusion reaction reporting in Canada, Health Canada put together the following expert working group in March 1998: The Surveillance and Epidemiology of Transfusions (SET) Working Group. After many consultations, reviewing the literature and how adverse transfusion reactions were reported in other western countries, the SET Working Group issued its report on February 28, 1999¹. A comprehensive surveillance scheme was proposed that included estimation of the risks of adverse transfusion reactions in Canada. Surveillance indicators were proposed including rates of transfusion transmitted infections, of transfusion induced injuries and of adverse reactions, both for fresh blood components and fractionation products. Data elements to be collected by the surveillance system were also identified in that report as well as the governance mechanism for such a reporting system. One of the major recommendations of the SET report was that the federal, provincial and territorial governments develop a new surveillance system for adverse transfusion reactions and sponsor the development of definitions of such reactions, of a standardized reporting mechanism and of guidelines for the investigation of suspected adverse transfusion reactions.

In March 1999, a federal/provincial/territorial meeting was convened to address some of the SET report recommendations, particularly those related to the proposed new surveillance system. Health Canada announced its decision to fund pilot projects for surveillance of transfusion transmitted injuries (including infections) in Canada. Provinces and territories were invited to submit proposals and four did: British Columbia, Quebec, Nova Scotia and Prince Edward Island.

The new surveillance system was called the Transfusion Transmitted Injuries Surveillance System (ttiss). In the following two years, a surveillance scheme was developed by a core working group composed of representatives from Health Canada, the four pilot provinces, the Canadian Blood Services, and HÉMA-QUÉBEC. This scheme included the scope of the surveillance system, the data elements to be collected and those to transfer to Health Canada, a set of standardized definitions for the data elements, a standardized form for reporting adverse events (Appendix 1), a database for data entry, and some predefined analyses. The form and definitions were inspired by those used by the Quebec hemovigilance system, which had already developed such tools in 1998 and 1999 and started reporting adverse transfusion reactions provincially in February of 2000. Hence, there was compatibility between the two surveillance schemes, that of Quebec and the national pilot system.

Throughout this process, all the provinces were kept informed and able to provide input through the ttiss Federal/Provincial/Territorial Steering Committee that met regularly. Hence, once the pilot projects were completed, there would be the basis for a national surveillance system of adverse transfusion reactions.

After numerous discussions, there was agreement by all four pilot provinces and Health Canada on all data elements to collect on a standardized reporting form. A Microsoft (MS) Access database to be used by the participating hospitals and provinces was developed by Health Canada. The database visually reproduced the reporting form and included extensive search capabilities, predefined reports and an export mechanism to send data that had been made anonymous to Health Canada. Quebec already had developed an electronic reporting format so it did not use the Health Canada database for collection, and British Columbia developed its own electronic reporting mechanism.

The type of cases and the data elements to export to Health Canada by the provinces were agreed upon (Appendices 2 and 3) as well as the governance for the analyses which, for the duration of the pilot project, would lie with the members of the Core Working Group. Data started being sent to Health Canada in April 2002 for the period starting April 1, 2001. There were biannual transfers thereafter.

The data presented in this report cover a 15-month period (April 1, 2001 to June 30, 2002). Only descriptive analyses were performed because of the lack of denominator data from all provinces on the number of blood recipients from which the reactions arose or on the number of units transfused. All severe reactions reported during that period were included in this report even if, for reactions related to fractionated products, data were far from being complete. Special attention in the report is given to bacterial contamination and deaths. Finally, recommendations for the future of ttiss are given at the end of the report including a status on where the project stands as of March 31, 2003.

Footnote

1. Kleinman, et al. The Surveillance and Epidemiology of Transfusions Working Group, Final Report. Health Canada, February 28, 1999.

[Previous] [Table of Content] [Next]