Acceptable risk: A risk that is generally agreed to be low enough that no management is required.
ALARA: As low as reasonably achievable (social and economic factors taken into account); in the UK, the commonly used term is “as low as reasonably practicable” (ALARP). Risk levels range from very low risks, which are acceptable without management, to high risks that are intolerable except in extraordinary circumstances. In the middle region are risk levels that should be reduced to be as low as is economically feasible (even if lower than a regulated standard) and reduced further as new technologies and improving economics permit.
Blood safety: Blood safety encompasses product safety, process safety, sufficiency of supply, patient safety, donor safety, and recipient safety.
Decision driver: An issue that determines the type of decision to be made and orients the decision-making process towards certain types of assessments and risk management activities. The significance and urgency of an issue can contribute to the importance of the issue as a decision driver.
Hazard: A source of harm; the inherent potential of a substance or situation to cause harm.
Health economics and outcomes assessment: A systematic analysis to inform decision-makers about the cost-effectiveness and cost implications of introducing a blood safety measure and to optimise the use of limited health-care resources.
Risk: The impact of exposure to a hazard, combining the probability or frequency of exposure outcomes with the seriousness of those outcomes.
Risk assessment: A formal, systematic process for estimating the level of risk that considers both the consequences of exposure to a hazard and the probability or frequency of these exposures. While risk assessments use discipline-specific methods, a core set of steps and quality expectations apply to most processes.
Risk bearers: The people or groups who experience the adverse outcomes associated with exposure to a hazard. A risk bearer may be a blood recipient or donor, the health system, or society in general. Many situations will have more than one risk bearer or bearers of different types of risk.
Risk-benefit dynamic: The balance between the risks borne — from exposure to a hazard or as a result of an intervention — and the benefits gained, with consideration of those who bear the risks and those who gain the benefits. (These two groups may be identical, may overlap, or may be entirely distinct.) Risks and benefits may be of various types, such as risks to blood recipients, risks to the supply of blood products, or risks to the health-care system in general.
Risk communication: An exchange of risk information among interested parties, including experts, stakeholders, and members of the general public. A key goal of risk communication is to prepare and disseminate risk information in a manner that facilitates understanding and supports decision-making. Although risk communication is not as interactive as stakeholder engagement, risk communicators should attend and respond to feedback.
Risk control: The measures put in place to reduce a risk to a tolerable level.
Risk issue: A risk-related matter that is or could become highly significant to stakeholders or the general public. A risk issue may emerge from several factors, such as involvement of a vulnerable population, an ethical controversy, or concerns about past management or regulatory practices. Media attention may drive or escalate social concern about risk issues.
Risk management: A systematic approach to setting the best course of action by identifying, assessing, understanding, acting on, and communicating risk. While distinct from risk assessment, risk management interacts with risk assessment processes at several points, particularly at the problem formulation stage, when the scope and urgency of a risk determine the assessments needed for the risk management decision.
Risk policy: A set of principles that express the risk-related values and priorities of the organisation. A risk policy applies to aspects of the organisation, including risk assessment, risk management, expectations for conducting risk assessments, risk tolerability guidelines, and consultation and communication with stakeholders.
Risk source: A substance or situation that has the potential to cause harm. Risk source encompasses hazard, means of exposure, and types of exposure. It does not include the probability or consequences of exposure.
Risk tolerability: The degree to which people can be expected to tolerate a risk. Tolerable risks are those that individuals and groups can be expected to tolerate for the benefit of society. Intolerable risks are too high for individuals or groups to tolerate.
Risk tolerability threshold: A predetermined upper or lower limit for risk tolerability. A lower risk tolerability threshold is a risk level low enough that no intervention is required. An upper risk tolerability threshold is a limit beyond which an intervention to reduce the risk is required. Risk tolerability thresholds can help guide decisions about the tolerability of a risk.
Social concern: The level of interest in an issue within particular social groups or society at large. Some issues have an inherent social sensitivity due to the potential for harm, the nature of the risk, or the population affected. Media interest can also drive social concern.
Societal perspective: An analysis perspective that considers the risks and benefits incurred by all of society, rather than only those borne by the blood system or the health-care system. In practical terms, the societal perspective considers health impacts on blood donors, blood recipients, blood operators, health institutions, and society in general.
Stakeholder: Any individual or group that is affected by, or has an interest in, an issue.
Stakeholder involvement: Interactions with stakeholders to share information about an issue and its management. These interactions may consist primarily of consultation or may actively solicit stakeholders’ input into the decision.
Uncertainty: A lack of information or precise measurements that leads to an inability to quantify the level of risk. Sources of uncertainty include incomplete data on a population or its behaviour, lack of scientific knowledge about the transmission of an emerging disease, or limitations in the ability to predict outcomes in complex situations. Research and data analysis can help reduce some types of uncertainty.
Variability: Diversity within a population due to factors such as individual traits, behaviours, socio-economic status, or geographical location. An inherent property of populations, variability cannot be reduced, though research and data analysis can help understand it.
Health economics primer
Haycox A. What is Health Economics? Available at: http://www.medicine.ox.ac.uk/bandolier/painres/
Health economic assessment
Briggs A, Claxton K, Schulpher M. Decision Modelling for Health Economic Evaluation. 1st Ed., Oxford University Press 2006.
Haddix AC, Teutsch SM, Corso PS, Eds. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. 2nd Ed., Oxford, Oxford University Press 2002.
Husereau D et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMC Medicine 2013. Available at: http://www.biomedcentral.com/1741-7015/11/80
Kacker S, Frick KD, Tobian AA. Data and interpretation: economic evaluations in transfusion medicine, Part 4. Transfusion, 2013.
Petitti DB. Meta-Analysis, Decision Analysis, and Cost-Effectiveness Analysis: Methods for Quantitative Synthesis in Medicine. 2nd Ed., Oxford University Press 2000.
Health economic evaluation methods
Chapman GB, Sonnenberg FA, eds. Decision Making in Health Care: Theory, Psychology, and Applications (Cambridge Series on Judgment and Decision Making). 1st Ed., Cambridge, Cambridge University Press 2003.
Custer B, Janssen MP. Health economics and outcomes methods in risk-based decision-making for blood safety. Transfusion, 2015;00:1.
Drummond M et al. Methods for the Economic Evaluation of Health Care Programmes. 3rd Ed., Oxford, Oxford University Press 2005.
Drummond, M et al. Methods for the economic evaluation of health care programmes. 2nd Ed. Oxford, Oxford University Press 1997.
Eddy, DM et al. Model transparency and validation: a report of the ISPOR-SMDM. Modeling Good Research Practices Task Force-7. Med Decis Making 2012;32:733.
Uncertainty and sensitivity assessment
Andronis L, Barton P, Bryan S. Sensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision-making. Health Technol Assess 2009;13: p. iii, ix-xi, 1-61.
Cooke RM. Experts in Uncertainty: Opinion and Subjective Probability in Science. Oxford University Press 1991. ISBN-0-19-506465-8.
O’Hagan A et al. Uncertain judgements: Eliciting experts’ probabilities. Wiley 2006. ISBN 978-0-470-02999-2.
Saltelli A et al. Global Sensitivity Analysis: The Primer. Wiley 2008. ISBN: 978-0-470-05997-5.
Walker WE et al. Defining Uncertainty: A Conceptual Basis for Uncertainty Management in Model-Based Decision Support. Integrated Assessment 2003;4:5-17.
Bier VM. On the state of the art: risk communication to the public. Reliability Engineering and System Safety 2001;71:139.
EFSA 2012. When food is cooking up a storm: proven recipes for risk communications. Risk Communications Guidelines. Available at: http://www.efsa.europa.eu/en/corporate/pub/riskcommguidelines.htm
Fischhoff B, Brewer N, Downs J. Communicating Risks and Benefits: An Evidence-Based User’s Guide. Food and Drug Administration. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/default.htm
Leiss W. Effective risk communication practice. Toxicology Letters 2004;149: 399-404.
OECD Guidance Document on Risk Communication for Chemical Risk Management. OECD Environment, Health and Safety Publications. Series on Risk Management 2002 No. 16.
A Practical Guide to Public Risk Communication; the five essentials of good practice. Risk & Regulation Advisory Council 2009. Available at: http://webarchive.nationalarchives.gov.uk/20100104183913/
Renn O. Risk communication: Towards a rational discourse with the public. Journal of Hazardous Materials 1992;29:465.
Bouder F, Slavin D, Lofstedt RD, Eds. The Tolerability of Risk: A New Framework for Risk Management. London, Earthscan 2007.
Fischhoff B. Acceptable Risk: A conceptual proposal. Risk: Health, Safety & Environment 1. Winter 1994.
Hansson SO. Ethical Criteria of Risk Acceptance. Erkenntnis 2003;59:291.
Hartford DND. Legal framework considerations in the development of risk acceptance criteria. Structural Safety 2009;31: 118.
HSE Reducing Risks, Protecting People. HSE’s decision-making process. The Health and Safety Executive Technical Report 2001.
Johansen IL. Foundations and Fallacies of Risk Acceptance Criteria. Norwegian University of Science and Technology 2010.
Vanem E. Ethics and fundamental principles of risk acceptance criteria. Safety Science 2012;50:958.
Custer, B., Janssen, M. P. for the Alliance of Blood Operators Risk-Based Decision-Making (RBDM) Initiative (2015), Health economics and outcomes methods in risk-based decision-making for blood safety. Transfusion. doi: 10.1111/trf.1308
Risk-Based Decision-Making Frequently Asked Questions
Q: What is new and different about the ABO risk-based decision making framework compared to other risk frameworks?
A: The ABO risk-based decision-making framework has been tailored for the specific needs of blood operators. It facilitates the gathering and consideration of information on health risk, economic factors, and broader societal factors in an integrated approach to decision making. It does so by outlining policy foundations needed for risk-based decision making as well as procedural guidance on risk assessment, health economics and outcomes, stakeholder engagement and consultation, risk communication and evaluation of risk tolerability.
Q: How is the RBDM framework relevant to hospitals?
A: Operators of blood services are responsible for providing an adequate supply of blood to meet the needs of medical practice and for optimizing blood safety. They make decisions about blood safety in the context of emerging risks, evolving technology, societal issues and economic constraints. These decisions are aimed at managing risks in a process that extends from blood donation to blood transfusion, and beyond.
Q: What is the regulatory role?
A: The role of the regulatory agency responsible for ensuring compliance with national regulatory requirements is not directly affected by the RBDM framework. However, because the framework guides the user to consider both quantitative data and qualitative information, to conduct assessments in according to disciplinary standards, and to fully consult with relevant stakeholders before a course of action is selected, it is our hope that the thoroughness of the assessments will give regulators confidence in the proposed course of action.
Q: What is the role of the blood operator in decisions that must be made by the regulator?
A: The systematic approach laid out in the RBDM framework enables the blood operator to provide credible scientific and technical information on the nature and significance of the risks under consideration, the benefits of the risk mitigation measures, the economic factors associated with the addition or withdrawal of interventions, and other risk management options.
Q: How will the framework deal with uncertainty?
A: The framework is a structured approach to blood safety risk management. It lays out a step by step methodology for setting the best course of action under uncertain conditions by identifying, assessing, acting on, and communicating risk.
Q: How will the framework deal with unquantifiable risk?
A: The framework provides a set of approaches to help users identify and prioritize risks to blood safety and to evaluate the effectiveness of potential risk management options, such as introducing a new intervention or withdrawing an existing one. The approaches included in the framework help the user analyse and account for a series of contextual, often qualitative, factors that affect decision making in the management of blood risks. The framework takes a societal perspective, enabling consideration of social, economic, and ethical perspectives that go beyond quantitative calculations of risk and can alter risk tolerability.
Q: How will the framework deal with contextual factors?
A: Specific guidance on conducting contextual assessments is included in the framework. This guidance helps the user determine the information to be gathered and the analysis that needs to be conducted in a contextual assessment. Some of the contextual factors touched on in the framework include social concern and risk perception; equity; trust; legal and jurisdictional factors. Contextual assessments entail gathering information on the relevant concerns and related matters, and analysing the way in which the concern shapes the risk management decision and how it affects the selection of a risk management measure.
Q: When there are many stakeholders, whose voice has the most weight?
A: The framework provides specific guidelines for stakeholder consultation. The very first guideline explains how to identify the various stakeholders who may need to be consulted given a particular topic, and it explains how to ascertain the level of interest of the stakeholder groups. When considering “whose voice has the most weight”, we can assume that those who would be most interested in – or affected by – the outcome of a particular decision as well as those who would be most influential in supporting or opposing a proposed action would demand active involvement in the engagement process. Based on this assessment, guidance is provided on how to engage each category of stakeholder.
Q: What kind of commitment does stakeholder engagement take in terms of resources?
A: This is dependent on the topic, the number of stakeholders, and the timeframe for the decision. For example, if it is an ad-hoc consultation, with 10-15 stakeholders, face-to-face, it would likely be the cost of a one-day meeting. If you choose to consult with a standing committee or network, you could tap into a pre-existing meeting if the timeframe allows. It requires a designated lead within your organization to manage the consultation and support from internal communications resource(s). And we highly recommend the use of an experienced facilitator.
Q: Where can I go for support?
A: The International Association of Public Participation (iap2.org) is a good resource to develop skills. There are resource books on different methodologies of consultation as well. The internet is a rich source of information as well.