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Why Use This Framework?

Overall Purpose

As a blood service operator, you are responsible for providing an adequate supply of blood to meet the needs of medical practice and for making blood as safe as possible. You make decisions about blood safety in the context of emerging risks, evolving technology, societal issues, and economic realities. These decisions are aimed at managing the risks of blood donation, blood transfusion, and beyond.

This Risk-Based Decision-Making Framework can help you identify, assess, act on, and communicate risk in a manner suited to each situation. The framework helps organise and simplify the decision-making process by working through stages sequentially.

The framework can be used when you face a new decision about blood safety. It is flexible enough that you can adapt it to your own regulatory structures, local conditions, and needs.

The framework’s objectives are to:

  • Optimise the safety of the blood supply while recognising that elimination of all risk is not possible
  • Allocate resources in proportion to the magnitude and seriousness of the risk and the effectiveness of the interventions to reduce risk
  • Assess and incorporate the social, economic, and ethical factors that may affect decisions about risk

The framework consists of six stages. In the first stage, you review foundational material and gain understanding of how the framework is organised. The remaining stages — problem formulation, participation strategy, assessment, evaluation, and  As shown in the framework diagram, risk management principles, assessment principles, stakeholder involvement and risk communications, and risk tolerability inform the decision-making process at all stages.

Overall Process

Each stage contains several tasks, and some of the tasks are further broken down into steps. You can proceed through all the tasks/steps but have the option of condensing or omitting those that do not apply to your risk issue. You may also return to a previous task/step if more information is required or if a change in circumstances calls for a different or more detailed assessment. Finally, different situations may call for different degrees of effort and detail, depending on the level and tolerability of the risk you are facing.

Purpose of each stage

Stage 1: Preparation

Review the foundational components of risk management:

  • Risk management principles
  • Assessment types and methods
  • Stakeholder involvement and risk communication
  • Legal context within which risk management principles lie

Stage 2: Problem formulation

Define and characterise the problem so you can:

  • Identify risk management options to consider, assess, and evaluate
  • Identify the assessments needed for each option
  • Determine the expertise and resources needed to carry out the assessments

Stage 3: Participation strategy

Formulate a plan for involving:

  • Key stakeholders: the people you will consult according to their level of interest and influence
  • A broader audience: the people with whom you’ll share risk information

Stage 4: Assessment

Gather information about the risks pertaining to the situation so you can:

  • Assess the seriousness of the threat
  • Determine the consequences of exposure to the threat
  • Determine the risks, benefits, and health economic impact of the proposed interventions
  • Understand other factors that may affect the decision

Stage 5: Evaluation

Evaluate and compare the different risk management options based on:

  • Information gathered from your assessments
  • Feedback from stakeholders
  • The risk tolerability of each option

Stage 6: Decision

Make, share, and follow up on your decision:

  • Select a risk management option
  • Share the decision with stakeholders
  • Create a follow-up plan
  • Post Implementation evaluation

Framework history

This framework was created under the auspices of the Alliance of Blood Operators (ABO). It grew out of a series of activities that began with the International Consensus Conference on Risk-Based Decision-Making for Blood Safety in Toronto in 2010. Led by an ABO Risk-Based Decision-Making Steering Committee, these activities included research on a variety of risk management frameworks and health economic methodologies, stakeholder consultations, and peer review by experts in blood risk and public health risk management.

The framework has been updated based on expert peer review and user feedback. A workbook has also been developed to assist with working through the stages.