The nomenclature of safety and quality of care for patients with congenital cardiac disease: a report of the Society of Thoracic Surgeons Congenital Database Taskforce Subcommittee on Patient Safety

Abstract

A large body of literature devoted to "patient safety" and error prevention exists and utilizes a nomenclature that can be applied specifically to the field of congenital cardiac disease and aid in the goals of increasing the safety of patients, decreasing medical error, minimizing mortality and morbidity, and evaluating quality of care. The purpose of this manuscript is to suggest and document a quality of health care taxonomy and the appropriate application of this nomenclature of "patient safety" to the specialty of congenital cardiac disease, with special emphasis on the following ten terms: morbidity, complication, medical error, adverse event, harm, near miss, iatrogenesis, iatrogenic complication, medical injury, and sentinel event. Each of these terms is commonly utilized in the medical literature without universal agreement on their meaning and relationship. It is our hope that the standardization of the definitions of these terms, as they are applied to the analysis of outcomes of the treatments applied to patients with congenital and paediatric cardiac disease, will facilitate improved methodologies to assess and improve quality of care in our profession.

Figure 1

Relationship between complications and subtypes of complications and the approaches to “Patient Safety”. In this Venn diagram, the large oval represents all types of complications. Complication is an overall encompassing term for any undesired event, under which there exist a variety of other patient safety events. Within the large oval of complications, two intersecting ovals represent the subtypes of complications named medical errors and adverse events. The union of the two ovals (representing events that are medical errors, adverse events, or both) is the subset of complications known as iatrogenic complications. The area within the large oval representing complications that is outside union of the two ovals representing medical errors and adverse events is the subset of complications associated with the patient’s underlying disease itself, independent of health care interventions. Medical errors and adverse events may be completely independent from each other. That is, medical error can occur without adverse events and adverse events can occur in absence of a medical error. At times, these two domains may intersect and a medical error may be associated with or result in an adverse event (modified from). * = All adverse events are associated with harm; only some medical errors are associated with harm. All medical errors are associated with error; only some adverse events are associated with error.

Figure 2

Classification of complications and subtypes of applications. The term “complications” is a global term that may or may not be associated with harm. Complications may be secondary to the patient’s underlying disease itself (independent of health care interventions) or complications may be secondary to health care interventions (diagnostic, palliative, therapeutic, and preventative health care interventions). Those complications that are secondary to health care interventions and are associated with adverse outcome (harm) are termed “adverse events”.