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

Appendix A: Detailed Key Findings

This section presents the key findings for each of the evaluation questions.

Continued Need for the BSCP

Evaluation question 1: Is there a continued need for the BSCP?

This section discusses the extent to which there is a continued need for the BSCP, looking at the continued relevance of the original program drivers, existing risks that might be addressed by the program, the federal government’s role in surveillance, and future directions in transfusion and transplantation safety.

Original Program Drivers

Blood safety was recognized as a major issue following the contamination of the Canadian blood supply with HIV and Hepatitis C virus in the late 1970’s through the 1980’s. In the Final Report of the Commission of Inquiry on the Blood System in Canada (Krever Report), released in November 1997, Justice Krever emphasized the importance of blood surveillance in the safety of blood. The BSCP was originally triggered by the Krever Commission’s review of the blood system in Canada, following the discovery of the lack of safety measures related to testing blood and blood products for infectious diseases in the 1980’s. The Program was ultimately approved as part of the federal government’s response to the issues raised in the Krever report. The main driver behind the BSCP was the safety of those receiving blood transfusions or cell, tissue or organ transplants.

Ongoing Risks

Canada has over 800 hospitals (varying in size) serving 33 million people across the country. Each year, over 1.2 million units of red cells, plasma and platelets are distributed; 2000 organs are transplanted and over 90,000 tissue allografts are distributed for transplantation. Thus, effective surveillance of these procedures is an important aspect of public health safety.

While the safety of blood, cell, tissue, and organ recipients still appears to be the primary driver for surveillance efforts, the type of viral infection through transfusion that concerned Krever is relatively uncommon at this point (Allain, 2003; Luban, 2005). For this reason, public concerns have diminished, and the drivers to continue blood safety efforts today are of a somewhat different nature than when BSCP was originally established. Recent blood safety literature provides some insight about relevant transfusion-associated risks that continue to be of concern in Canada. These include:

• New and emerging viral infections, such as Creutzfeldt-Jakob Disease, West Nile Virus, Hepatitis A, Hepatitis G, Parvovirus B19, Cytomegalovirus, and Syphillis (Bihl et al., 2007; Busch, Kleinman, and Nemo, 2003; Dodd, Notari and Stramer 2002; Allain, 2003; Kleinman, Chan and Robillard, 2003 Luban, 2005).
• Parasitic infections, that may be brought into Canada by international travellers, immigrants or refugees (Blue Ribbon Committee on Bloodborne Parasitic Diseases, 2002; Bihl et al, 2007; Kleinman, Chan and Robillard, 2003).
• Bacterial infections, most commonly introduced from contaminations during blood collection or during handling of blood products (Allain, 2003; Bihl et al, 2007).
• Risks introduced due to deviations or errors in procedure during testing (Kleinman, Chan and Robillard, 2003).
• Risks introduced due to improper storage (Kleinman, Chan and Robillard, 2003).
• Risks introduced due to deviations or errors in ordering procedure or errors in labelling procedures (Kleinman, Chan and Robillard, 2003).
• Risks associated with blood component-recipient interactions (Kleinman, Chan and Robillard, 2003):
  • Donor characteristics, for example “unusual antibodies that are not recognized pre-transfusion and react with antigens in the recipient” (Kleinman, Chan and Robillard, 2003, p. 120), e.g., Transfusion-related acute lung injury (TRALI); or
  • Recipient characteristics, for example “presence of alloantibodies” (Kleinman, Chan and Robillard, 2003, p. 120) or medical condition of recipient, such as a cardiac condition (Kleinman, Chan and Robillard, 2003), e.g., volume overload.

As shown in Figure 4, almost all of the evaluation survey respondents indicated that the risks associated with transfusions and transplantations remain relevant or very relevant within their province/territory. Risks introduced at blood administration/transfusion and risks of blood component-recipient interactions were seen as most relevant by survey respondents.

 

Figure 4 : Continued Relevance of Risks to Blood Safety

(To what extent are the following risks relevant in your region today?)

So, while the traditionally familiar concerns associated with blood safety have diminished substantially, there remain significant risks that compel continued surveillance in Canada of transfusion related adverse events and errors.

Documentation associated with the CTOSS indicated a high level of concern that, despite growing evidence of risk from transplantation infections, Canada still lacks an efficient system for identifying adverse reactions from organ transplantation and virtually no systematic way of identifying public health threats from cell or tissue transplants. Even more strongly, it was warned that the current “cell, tissue and organ donation and transplantation system is at risk for experiencing a situation similar to that of the human immunodeficiency virus/hepatitis C crisis, which affected the Canadian blood system in the 1980’s and 1990’s” (TOSS Program Charter 2008, p. 1).

Role of the Federal Government

There was no question among survey respondents that the federal government has a crucial role to play with respect to surveillance of transfusion-related and transplant-related adverse events and errors, with all of the survey respondents indicating that it was either important or very important for the government to carry out a nationally-coordinated surveillance of transfusion-related and transplant-related adverse events.

Future Directions

In addition to the above noted risks associated with transfusion and transplantation, future directions in blood safety, according to both the literature and those interviewed, appear to involve greater international cooperation and alignment of surveillance efforts. The international hemovigilance agenda involves efforts to develop common definitions, terminology, standardized reporting and uniform matrix (Robillard, 2006) so that hemovigilance-related information can be shared and reported at the international level, thus enabling comparison of data and trends across countries. One interviewee pointed out that the World Health Organization has the intention to collaborate with the Centre for Blood safety to establish a global blood surveillance system, efforts to which PHAC and Health Canada have been asked to contribute. In this sense, Canada is seen as playing an important international leadership role in the future (additional information about Canada’s leadership role can be found at Section 2.4.2 below).

Summary

The BSCP’s purpose is still as relevant as ever. While the risks posed by known viral infections in Canada, and other parts of North America and Europe, have largely decreased, there is still the risk of other types of transfusion-transmitted infections, such as bacterial and parasitic infections. Likewise, there continues to be a risk of other errors, such as transfusing the wrong blood to the wrong patient. Hemovigilance has been in existence almost two decades, but there is still the need for improvement and change in order to improve patient and public safety.

According to stakeholders, there continue to be significant risks associated with transfusions and transplantations, and that the federal government has a role to play in monitoring transfusion and transplant related errors and adverse events. There is also increasing interest in international cooperation around surveillance, especially in light of the increased mobility of blood, blood products, cells, tissues and organs across national borders.