ARCHIVED - Summative Evaluation of the Blood Safety Contribution Program - Final Report
II. Blood Safety Contribution Program
Role of the BSCP within the Regulatory Context
Health Canada (HC) is responsible for national compliance monitoring and enforcement programs for all health products as well as for conducting surveillance of errors, accidents and adverse reactions related to the safety of cells, tissues and organs (Surveillance of Recipients of Organ and Tissue Transplants: An Environmental Scan for the Tissues and organs Surveillance System Core Steering Committee, 2008, p. 11). Requirements may also vary by province/territory. It is important to note that the minimum national requirements for surveillance activities are regulated, but participation in more rigorous and coordinated surveillance activities is voluntary.
The surveillance systems supported by the BSCP (TTISS, TESS and CTOSS) are voluntary systems that are intended to improve adverse event reporting associated with transfusions and transplantation of cells, tissues and organs, to better inform knowledge of the frequency of adverse events occurring in Canada and assist in planning to reduce risks associated with transfusion and transplant. These systems are in addition to, and do not replace, the current existing regulatory requirements for reporting of serious adverse events related to transfusion or transplantation, but efforts have been made to integrate the reporting requirements. The form developed for TTISS, for example, contains all fields required by HC, so hospitals can use copies of the same form when reporting on adverse events to the applicable organizations.
BSCP Logic Model
The BSCP logic model is used to graphically illustrate the logic of the BSCP programming (see Figure 3). This internal logic is based on a sequence of cause and effect relationships perceived to exist between the investment of resources in project activities, the subsequent production of outputs, and the achievement of short term outcomes that are a logical consequence of output use by beneficiaries. The chain of causality from program outputs, to the key result commitments (i.e., short term, intermediate and long term outcomes, then serves as a delivery model). The cumulative effect of each group of outputs contributes to the short term outcomes, and the cumulative effect from each group of short term outcomes contributes to the intermediate outcomes, and finally the long-term outcomes (BSCP iRMAF/RBAF, 2008).
| Activities | Outputs | Short Term Outcomes (0-5 years) | Intermediate Outcomes(5-8 years) | Long Term Outcomes(8+ years) |
|---|---|---|---|---|
Component 1000: Provincial/Territorial Adverse Events Surveillance Initiatives |
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1. A fully operational adverse event surveillance system in each province/ territory |
1. An enhanced capacity to identify and assess the risks associated with the use of blood, blood products or transplantation of cells, tissues and organs
2. An enhanced capacity to survey and assess risks for high risk populations |
1. Enhanced capacity to develop mitigation strategies for risks associated with the use of blood, blood products or transplantation of cells, tissues and organs |
Component 2000: Error Surveillance Related to Blood Transfusions |
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2. A fully operational national error surveillance system |
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Component 3000: Cells, Tissues and Organ Transplant Surveillance |
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3. A fully operational national cells, tissues and organ transplant surveillance system |
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Component 4000: Data Linkages and Communication |
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4. Linkages with Public Health Information Networks established |
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Component 5000: High Risk Populations and Emerging Pathogens |
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5. Blood sample archive for high risk populations established 6. Risk identification for high risk populations established |
Program Resources
The annual BSCP budget is approximately CAN$4 million, including CAN$2.4 million in contributions and CAN$1.6 million in salaries, operations, & maintenance.
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