ABSTRACT
Formal processes to assess risk are well established in numerous areas of society including the environment, transportation, energy and food production sectors as well as some areas of health care such as new drugs or other therapeutic goods. However, these processes and their associated frameworks have only recently come to be used to make decisions in blood transfusion practice or in blood system policy development. This review describes the evolution of the use of risk-based decision making and discusses the elements that should be considered in its application to blood system issues. Following the identification and characterization of the risk, a structured process is undertaken to assess the magnitude of the risk and the level of risk reduction that can reasonably be achieved in the context of the complexity of the risk management action proposed and its cost. Inputs must be sought from appropriate subject matter experts, but also from those who can consider issues of ethics and social values. Engagement of the public is an essential step. Proposed interventions should be assessed for their likelihood of mitigating the risk and the proportional resource allocation in comparison with similar risks to the blood system or health system. Examples are provided of how a risk-based decision-making framework is used to address identified risks in the blood system.
Subject(s)
Blood Safety/standards , Clinical Decision-Making , Risk Management/methods , Transfusion Medicine/standards , Blood Safety/economics , Humans , Resource Allocation/methods , Resource Allocation/standards , Risk Management/standards , Transfusion Medicine/economicsABSTRACT
Blood safety decision making has become increasingly complex, and a framework for risk-based decision making is, thus, needed. The purpose of this consensus conference was to bring together international experts in an effort to develop the foundations for such a framework. These proceedings are described with a view to making available to the transfusion medicine community the considerable amount of information and insight that was presented and that emerged through debate by the experts, panel members, and delegates.
Subject(s)
Blood Safety , Academies and Institutes , Blood Banks/legislation & jurisprudence , Blood Banks/standards , Blood Donors , Blood Safety/ethics , Blood Transfusion/ethics , Blood Transfusion/legislation & jurisprudence , Blood Transfusion/standards , Blood-Borne Pathogens , Canada , Decision Making , European Union , Humans , Mass Screening , Models, Theoretical , Risk , Risk Management/organization & administration , Risk Reduction Behavior , Transfusion Reaction , Truth Disclosure , United States , United States Food and Drug Administration/organization & administration , United States Food and Drug Administration/standards , United States National Aeronautics and Space Administration/organization & administrationABSTRACT
Over the past several years, concern for the safety of blood transfusion has evolved from a primary focus on bacterial infections such as syphilis to viral infections including hepatitis B, C, and human immunodeficiency virus (HIV), and most recently, the theoretical risk of variant Creutzfeldt-Jakob Disease (vCJD). As a result of these changes, blood bankers have found themselves faced with the dilemma of balancing the rights of transfusion recipients to receive safe blood products, with the rights of individuals wishing to donate blood as an altruistic contribution to society.
