ARCHIVED - Summative Evaluation of the Blood Safety Contribution Program - Final Report

II. Blood Safety Contribution Program

BSCP Components

The BSCP includes five components, which are described in turn below.

Component 1000: Transfusion Transmitted Injuries Surveillance System (TTISS)

Between 1999 and 2002, with funding provided through the BSCP, four provinces (Quebec, British Columbia, Nova Scotia and Prince Edward Island) participated in the Pilot Transfusion Transmitted Injuries Surveillance System (TTISS) Project to develop and implement a transfusion adverse event reporting system in Canada. The TTISS has since grown into a national system as a collaborative, voluntary effort between hospitals, provinces/territories, blood manufacturers and Health Canada to monitor adverse events to transfusions. The introduction of the TTISS across Canada resulted in a single system for reporting of adverse events following blood transfusion therapy. The single form used by hospitals to report occurrences includes copies for the hospitals, provinces/territories, blood manufacturers and Health Canada regulators. Canada is one of the few nations with a truly national surveillance program related to transfusion.

The reporting of adverse events of transfusion flows from the hospitals to the provinces/territories and subsequently on to PHAC. Reporting is done using a standard form and database developed by PHAC and supported by a user's manual containing specific directions and standardized definitions for reporting of adverse events (see Figure 2).

Figure 2 : Reporting Mechanisms for Transfusion Adverse Events

* “Health Canada Surveillance” in the above figure is now “PHAC Surveillance”

A mid-term evaluation of TTISS was conducted following renewal of the Terms and Conditions of the BSCP in March 2004 (after a one year Ministerial extension).

Current Status

TTISS is fully operational in most of the provinces and territories. To date, TTISS activities have produced a system user manual, minimum data elements, agreement for reporting on data, and annual program reports.

Committee Support

TTISS is supported through the National Working Group Transfusion Transmitted Injuries Surveillance System (NWGTTISS), which is comprised of approximately 20 members. The group’s goal is to identify and address issuesrelated to a national surveillance program on the safety of blood, blood components andplasma derivatives that are intended for use in the treatment of human diseases. Thegroup serves the function of recommending future directions, quality, efficacy andeffectiveness of the TTISS as a national surveillance program. Meetings are held 2-4 times a year to discuss ways of improving the system through upgrades to the manual, form, definitions and data transfer methods. Unexpected adverse events and unusual events are identified by this group and given to the National Working Party for Data Review (described below) for analysis (Blood Safety Surveillance & Health Care Acquired Infections Division. National Work Group Transfusion Transmitted Injuries Surveillance Systems - Terms of Reference 2004).