Results at a glance: Evaluation of the Public Health Agency of Canada’s Blood Safety Contribution Program

Program overview

Blood safety was recognized as a major issue in Canada following the contamination of the Canadian blood supply with the Human Immunodeficiency Virus (HIV) and the Hepatitis C virus, starting in the late 1970s and continuing throughout the 1980s. In the final report of the Commission of Inquiry into the Blood System in Canada (also called the Krever Inquiry), issued in November 1997, Justice Krever emphasized the importance of surveillance for blood safety in Canada. The federal government's response included a series of initiatives to support and strengthen the safety of Canada's blood system, including the Blood Safety Contribution Program (BSCP).

The Blood Safety Contribution Program (BSCP) is intended to support the development and enhancement of provincial and territorial systems that monitor adverse events associated with blood transfusions and blood products, as well as cell, organ, and tissue transplantation. The BSCP provides direct funding to provinces and territories to carry out surveillance activities using the following three systems to track the safety of blood and blood products, as well as cells, tissues, and organs (CTOs): Transfusion Error Surveillance System (TESS); Transfusion Transmitted Injuries Surveillance System (TTISS); and Cells, Tissues and Organs Surveillance System (CTOSS).

Evaluation approach

The evaluation focused primarily on the value of PHAC's Blood Safety Contribution Program (BSCP) and covered activities from 2017-18 to 2021-22.

Methods:

• Document and file review
• Data analysis
• Key informant interviews
• Comparative analysis with other jurisdictions

What the evaluation found

As the need and use of blood, blood products, and CTOs in transfusion and transplantation activities continues to increase in Canada, there is an elevated risk of adverse events related to transfusion and transplantation. Monitoring adverse events will allow for a quicker reaction in the event of a new or previously unknown blood and CTO safety issue or threat.

Evidence collected highlighted the potential value of the three surveillance systems developed by PHAC as a result of the Krever Commission's report to the overall biovigilance system. Users of these systems felt that the right type of data is being collected, but they noted that PHAC was not sharing all the information it collected. They wanted information on emerging issues and threats across the country to the safety of blood, blood products, and CTOs communicated in a timely fashion, rather than a simple summary of national-level data to better inform planning and decision making within their respective jurisdictions.

Surveillance data generated by provinces and territories was appropriate and is being used within their respective jurisdictions. However, national information provided by PHAC is not timely for users and has not been used to further inform planning and decision making within provinces and territories. In some cases, provinces and territories are undertaking some level of multi-jurisdictional analysis themselves which they feel should be PHAC's role.

It should be noted that the timeliness and usefulness of surveillance information were also identified as issues during the 2014 BSCP evaluation, as well as the expectation that all three surveillance systems would be fully operational, as originally outlined by program authorities. Although the program stated that TESS and CTOSS transitioned to fully operational sentinel systems in 2009 and 2018, respectively, no clear evidence was provided of these decisions and that these were communicated to partners. In fact, according to the Agency's public website, CTOSS is still identified as a pilot project, whereas TESS is not clearly identified as a sentinel system, which is the case for other sentinel surveillance systems.

Recommendations

Recommendation 1: Clearly define and communicate PHAC's role, responsibilities, and priorities, in collaboration with all partners, with respect to:

1. financially supporting surveillance systems monitoring adverse events and errors associated with the transfusion of blood, blood products and cell, organ and tissue transplantation in Canada.
2. monitoring, analyzing and reporting adverse events and errors linked to transfusion and transplantation activities in Canada; and

Recommendation 2: Based on the outcome of the first recommendation, determine the necessary structures to ensure the timely release of BSCP surveillance information.