Case study: Consent and Disclosure in Pediatric Heart Surgery The Story of James Mannix (United States)
In this case study Consent and Disclosure in Pediatric Heart Surgery The Story of James Mannix (United States) The field of pediatric cardiac care has received worldwide recognition as a leader in quality and patient safety and has advocated for system-wide changes in organizational culture. The field has many complex procedures that depend on a sophisticated organizational structure, the coordinated efforts of a team of individuals, and high levels of cognitive and technical performance (Galvan et al., 2005). In this regard, the field shares many properties with high-technology systems in which performance and outcomes depend on complex individual, technical, and organizational factors and the interactions among them. These shared properties include the specific context of complex team-based care, the acquisition and maintenance of individual skills, the role and reliance on technology, and the impact of working conditions on enabling great team performance.
Several factors have been linked to poor outcomes in pediatric cardiac care, including institutional and surgeon- or operator-specific volumes, case complexity, team coordination and collaboration, and systems failures (deLeval et al., 2000). Safety and organizational resilience in these organizations ultimately is understood as a characteristic of the system—the sum of all its parts plus their interactions. Interventions to improve quality and strategies to implement change should be directed to improve and reduce variations in outcomes. An obstacle to achieving these objectives is a lack of appreciation of the human factors in the field, including a poor understanding of the complexity of interactions between the technical task, the stresses of the treatment settings, the consequences of rigid staff hierarchies, the lack of time to brief and debrief, and cultural norms that resist change. Technical skills are fundamental to good outcomes, but nontechnical skills—coordination, cooperation, listening, negotiating, and so on—can also markedly influence the performance of individuals and teams and the outcomes of treatment (Schraagen et al., 2011). It is only through open communication and collaboration within and between organizations that we can foster excellence in clinical practice and innovation in pediatric cardiac surgical care.
In James’s case, the system was clearly not designed for delivering reliable care. Some of what happened to James may have happened because clinicians lacked what has been called “psychological safety” and were afraid to speak up (Kennedy, 2001). This case also highlights the important role of patients and families. This case and others should stimulate discussion about the barriers that teams and organizations need to overcome and the changes that teams and organizations need to develop in order to engage families and deliver safe and resilient care.
what are the regulatory compliance issues in this case? What regulatory bodies oversee these issues?