Outcomes of the risk tolerability evaluation
- The risk tolerability evaluation produces a largely qualitative tolerability profile for each option, which summarizes the assessed risks, benefits and costs, and the societal and contextual factors associated with the option. The tolerability profiles of all the risk management options are compared for the final option evaluation and selection of the recommended option.
- This evaluation may result in the selection or elimination of a particular management option, through confirming or rejecting option preferences that resulted from the risk and tolerability assessments.
- If your organisation has broad thresholds for acceptable, tolerable, and unacceptable risk regions, use these as a starting point for the evaluation.
- If not, review existing blood safety benchmarks and use them as a guide, e.g. Many blood sector articles refer to acceptable blood safety threshold being 1 in 1 million.
Actions
- Complete the Risk Tolerability Work Table as a group exercise during the Evaluation session.
- Determine the overall level of risk in your current situation using the information obtained in the assessments and existing data from related situations.
- Use the Tolerability Concept Map to assist with scoring tolerability.
- Summarize your findings in writing.
FURTHER INFORMATION ON RISK TOLERABLITY
Definition of a tolerable risk
- A tolerable risk is a managed risk at a level that is appropriate in view of benefits gained and other contextual and ethical factors.
- A tolerable risk is distinguished from an acceptable risk, which is one that is low enough that no management is needed.
- Tolerability is an informed judgement made by a public risk manager on behalf of stakeholders and society, which considers principles of human rights (to protection from unreasonable risks);utility (individual are expected to accept risk from beneficial social activities);fairness (risks are justified by benefits and distributed equitably), and consent.
- Risk tolerability is based on the acknowledgement that society cannot afford to reduce all risks: risks vary in significance and in the ease with which they may be reduced, and cost matters to the system and to society. Risk managers must ensure that risks are managed in a manner that is both ethical and sustainable for the public health system.
- Societal risk tolerability is not the same as organisational risk appetite. Risk tolerability is a public risk management concept: it relates to risk borne by the public, which the blood operator is responsible for managing. In contrast, risk appetite is an enterprise risk management concept that describes the level of risk that an organisation is willing to incur in pursuit of its own objectives.
Factors influencing the tolerability of a risk
- There are several factors that are considered in an evaluation of risk tolerability. These will be specific to each risk management situation:
- Health or safety risk to patients or blood donors, in relation to risk reduction or health benefits gained.
- The economic costs of a risk reduction or management measure: allocation of public resources should be justified by the level of risk that is managed, or the benefits gained by the measure.
- Societal and contextual factors: ethical considerations in the distribution of risks and benefits; concerns and priorities associated with a particular risk source or approach to risk management, expressed or held by stakeholders and the public.
