429 K.P. Mason (ed.), Pediatric Sedation Outside of the Operating Room: A Multispecialty International Collaboration, DOI 10.1007/978-0-387-09714-5_22, © Springer Science+Business Media, LLC 2011 Background While millions of children receive sedation every day, high-profile cases have brought medical errors in pediatric sedation to the public’s atten- tion. Children of all ages feel pain and experience anxiety. Alleviating pain and anxiety in children is a key component during the care provided to hospitalized and ambulatory children. While reassurance, parental presence, distraction, and behavioral strategies may offer relief, pharmaco- logic intervention is often required, especially in the acute-care setting. Sedation for children in the operating room and increasingly outside the operating rooms has been a growing industry. This growth is attributed to the proliferation in the volume and type of procedures outside the operating room, an increase in the demand for special conditions to produce better imaging and diagnostic results (i.e., MRI and dentistry), and an increase in the complexity of cases due to an increase in survival rates of children with com- plex pathology. A clinical microsystem is a group of clinicians and staff working together with a shared clinical purpose to provide care for a population of patients. The clinical purpose of pediatric seda- tion and its setting define the essential compo- nents of the microsystem which include the clinicians and support staff, information and technology, the specific care processes, and the comptencies that are required to provide care to its patients. Examples of clinical microsystems include a cardiovascular surgical care team, a community-based outpatient care center, a neo- natal intensive care unit, and a pediatric sedation service. The clinical microsystem provides a con- ceptual and practical framework for approaching organizational learning and delivery of safe care in pediatric sedation. To understand the function- ing of these healthcare microsystems, and to improve perioperative patient safety and reliabil- ity in children, it is necessary to study the compo- nents that make up the system – humans, technologies, and their complex interactions. In health care, the premium placed on practitioner autonomy, the drive for productivity, and the eco- nomics of the system may lead to severe safety constraints and adverse medical events. Adequate pain control and sedation ensure the comfort, and cooperation of the child, influences the success of the procedure and can affect the child’s future attitudes toward healthcare providers and medical care. This chapter describes key developments in safety and reliability over the last several years – safety research, risk and reliability management approaches, the role of human factors and organizational practice models. Designing a Safe and Reliable Sedation Service: Adopting a Safety Culture Paul Barach P. Barach () Department of Anesthesia and Emergency Medicine, Utrecht Medical Centre, University of Utrecht, Netherlands e-mail: P.barach@umcutrecht.nl 22