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

Introduction

This final summary report presents the findings of the Summative Evaluation of the Blood Safety Contribution Program (BSCP). It provides comprehensive answers to the questions explored through the evaluation, based on a synthesis across all of the data sources, including literature, program documents, surveys, interviews and expert panel.

Background

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. Blood safety was recognized as a major issue in Canada following the contamination of the Canadian blood supply with Human Immunodeficiency Virus (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.

An effective surveillance system for recipients of blood and blood products provides information to assess the magnitude of new or emerging risks, monitor the trends of known risks, develop strategies for mitigating risks, and evaluate the effectiveness of actions taken to reduce the risks.

The Blood Safety Contribution Program (BSCP) formed part of Health Canada’s “Strengthening Health Canada’s Blood Safety Program” (Blood ’98) that obtained approval in October 1998, acquiring a funding commitment of $17.5 to $29.6 million annually for the overall effort in the years to follow. Of this, an annual budget of $4 million - including $2.4 million in contributions and $1.6 million in salaries, operations, and maintenance - is allocated to the BSCP. With these funds, the BSCP:

• Provides funding, through contribution agreements, for provinces and territories to establish and maintain surveillance activities for:
  • Adverse events related to blood / blood product transfusions,
  • Errors related to blood / blood product transfusions, and
  • Adverse events and errors related to the transplant of cells, tissues and organs;
• Encourages linkages with public health, to enable identification of adverse events outside the hospital reporting system;
• Establishes national tools and standards for surveillance;
• Provides funding for research projects related to high risk populations and emerging pathogens;
• Coordinates standing committees and working groups to support the establishment, monitoring, and ongoing use of the surveillance systems; and
• Coordinates ad-hoc committees to address emerging issues.

Overall, there are five complementary components, which together form the necessary elements of a fully comprehensive transfusion/transplantation injuries surveillance system. The National Working Party for Data Review (NWPDR) supports all program elements. The five components that form the BSCP are all grants and contributions initiatives, as follows:

• Transfusion Transmitted Injuries Surveillance System (TTISS): Piloted from 1999-2002, this operational national system is a collaborative, voluntary effort between hospitals, provinces/territories, blood manufacturers and PHAC to monitor adverse events to transfusions.
• Transfusion Errors Surveillance System (TESS): A pilot beginning in 2004, the TESS focuses on the class of events related to the errors associated with various procedural and laboratory steps required for safe administration of blood products.
• Cells, Tissues and Organs Surveillance System (CTOSS): Planning began in 2005 for a Cells, Tissues and Organs Surveillance System targeted at the surveillance of transplantation adverse events. CTOSS is still under development.
• Data linkages and communications: Linkages are being established with provincial Public Health Information Networks to allow the identification of delayed adverse events detected outside the hospital reporting system.
• High risk populations and emerging pathogens: Funds support the surveillance of emerging pathogens among high risk populations who receive many transfusions. The Blood Borne Pathogens Surveillance Project (BBPSP) falls under this component. The objective of this project is to establish a secure bank of blood samples from individuals with a diagnosed hereditary bleeding disorder.

Purpose

The Public Health Agency of Canada (PHAC) undertook this summative evaluation of the Blood Safety Contribution Program (BSCP) to assess its relative impact on health surveillance activities, as well as its impact on the safety of the Canadian blood supply. The information provided through the evaluation will inform and contribute to the renewal of the Program’s Terms and Conditions, scheduled to occur in 2009. The findings from the evaluation will be used by PHAC and other stakeholders to improve and/or modify the program, thereby improving value for money and patient safety.

Scope

This evaluation was national in scope, including surveillance activities in all 13 provinces and territories. It covers the period from October 1998 to April 2008, and was carried out between April and November 2008.

The evaluation focused on the continued contextual relevance of the program, the degree to which desired outcomes have been achieved, the extent to which the program has helped achieve outcomes, value for money, and resources required to fill gaps and continue improving the program.  Though they are at varying stages of development and implementation, the evaluation covered all five components of the BSCP: 1) TTISS; 2) TESS; 3) CTOSS; 4) Data linkages and communications; and 5) High risk populations and emerging pathogens.

Methods

Methods for the evaluation included a literature review, review of program documents, surveys of key program stakeholders, key informant interviews, and an expert panel. The combination of methods and sources used provides a high level of confidence in the completeness and accuracy of the answers to most of the evaluation questions. However, there is somewhat less confidence in the completeness of the answers to evaluation questions 12, 13 and 14 due to pragmatic constraints of the evaluation (i.e., scope, budget, availability of data, etc.).