Characterization and Assessment of Barriers and Facilitators to the Decision-Making Process for Blood and Blood Donor Safety in the United States: A Collective Case Study
Date of Degree
Marcia A. Firmani, , PhD, MSPH, MT(ASCP)MB
US Blood System; Policy Research; Decision-Making; Translational Research
Background: Over 16 million blood components are transfused to patients in need every year in the United States (Jones et al., 2021). Because of the reliance on human blood donors, the donation and transfusion of blood will always be associated with some level of risk for both donors and recipients; the tolerability of these risks may vary from stakeholder to stakeholder. While the U.S. Food and Drug Administration (FDA) concedes that attaining a blood supply with zero risk for transmission of infectious diseases may be unattainable (U.S. Food and Drug Administration, 2019), they continue to strive for the lowest reasonable achievable risk while maintaining the availability of blood for recipients. Non-regulated safety and health decisions are left to individual blood centers and there is no congruency of thought between the various centers. In an effort to create an integrated, internationally recognized, risk-based tool for blood safety that can help the industry make decisions in a consistent way, the Risk-Based Decision-Making (RBDM) Framework was developed in 2010 by the Alliance of Blood Operators. While the RBDM Framework has been used successfully in other countries, its use has been limited in the US due to the structure and scope of decision-making authority within the US industry.
Objectives: This dissertation will seek to characterize the decision-making process for U.S. blood policy and to determine if a universal framework, such as the RBDM would be useful for the U.S. blood system. This study will also aim to identify barriers and facilitators to the current decision-making process. A deep understanding of the approach to decision-making and the barriers and facilitators to that process will elucidate opportunities for improvement.
Methods: A collective case study was conducted with a purposeful sample of policy and operational decision-makers representing five decision-making groups within the U.S. blood system – federal, advisory, standards setting, blood centers, and hospitals. Semi-structured interviews allowed for insights and experiences to be gathered and the data were analyzed into overarching themes.
Results: Many of the decision-makers included in this study reported a similar process of decision-making – gathering and evaluating the best available data, listening to stakeholders, completing some sort of risk assessment and ultimately making a decision on how to maintain safety of blood and blood donors. As suggested by the literature, no formal decision-making framework or process was reported by any of the interviewed participants. Six barriers to decision-making were discovered: absence of collaboration and communication; insufficient leadership; the current regulatory process; lack of data; availability of resources; and the current structure of the U.S. blood system. Three facilitators were discovered: large-scale collaboration; strong leadership; and transparency and open communication.
Conclusion: Each decision-making body included in this study is responsible for a different focus area of transfusion medicine. While the U.S. blood system is piecemeal, siloed, and fractured in some ways, the general sentiment from participants is that “it may be broken, but it works” and safety of the US blood supply has never been higher. Due to these variances in focus areas, a one-size-fits-all decision-making framework does not seem appropriate for the U.S. context. However, there is opportunity for improvement in the processes used by each stakeholder group. Increased coordination, communication, and leadership within the U.S. blood system will improve its integrity – both in terms of safety and availability – for blood donors and recipients in need. Future work with individual decision-making groups will allow for improvements to the efficiency of decision-making at each level of the U.S. blood system.
Crowder, Lauren A., "Characterization and Assessment of Barriers and Facilitators to the Decision-Making Process for Blood and Blood Donor Safety in the United States: A Collective Case Study" (2022). Doctor of Philosophy in Translational Health Sciences Dissertations. Paper 14.
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