ABO RBDM Framework

The project proceeded in a series of steps, in collaboration with an international project team of ABO representatives. The first step was a literature review of risk-based regulatory frameworks and the identification of elements that would be appropriate for the ABO framework. The second step was the development of a overall framework consisting of the main elements that were needed; an innovative element of this framework is that a set of foundational policy elements, including risk management principles, transparency policy, communication and stakeholder engagement, were developed, and depicted in a framework diagram as a means of making them explicit and building trust in the blood system.

The major management processes were then designed, with worksheets and decision support tools where these were helpful; these consisted of problem formulation, including clear identification of receptor and vulnerable groups; health risk, health economics and other types of assessments; ethical and risk tolerability evaluations; and a process for systematically evaluating the benefits of each potential decision option. RSI drafted guidelines and worksheets for several of the process steps.
Several workshops were held to test the utility of the draft framework elements, including an online workshop with international team members that worked through a blood decision scenario, and a workshop session at an international blood operators’ conference. Feedback and experience from these workshops were incorporated into subsequent drafts until the final format was approved.

Framework Diagram from RSI submission to Canadian Blood Services, April 2, 2015.

The foundational policy elements – risk management principles, policy for transparency, communication and stakeholder engagement, and risk tolerability - were included in the framework to orient users and the wider community to the ethical and deliberative approach of the decision-making approach.

These elements were shown in the overview graphic to illustrate their function as system-level capacities that support and inform all decision-making.