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The aim of this study is to understand the extent of which specific characteristics of children contribute in the processes of patient safety problems in children's hospital-based medical care.Initial identification of child-specific factors was performed through literature review to identify of the characteristics of children, which theoretically could lead to increased patient safety risk. These child-specific factors were then tested using patient safety problem cases collected through in-person, audio-taped, transcribed interviews with pediatric hospital-based clinicians (physicians, nurses, pharmacists). Transcripts were analyzed independently by 3 investigators to determine the extent to which any child specific factor contributed to the occurrence of the patient safety problem and if so which factor. Any discrepancies in classification were reconciled through consensus.The clinician interviews resulted in 167 independent patient safety problems for analysis. Child-specific-factors include:Physical Characteristics (small size, weight and morphology, varied physical characteristics);Development (physiological development and growth, cognitive social emotional development);Minor Legal Status (decision-making and consent, parental responsibility for medical management, confidentiality, supervision requirements).Initial independent coding of the problems into the child-specific factors resulted in 78.4% agreement. Child-specific factors were found to contribute to the occurrence of 49% of the patient safety problems. The majority of problems involving child-specific factors were related to development. Child-specific factors contributed considerably to problems in medication delivery. Overall, the mean level of harm reported in all of the cases was 2.5, including cases for which "no harm" was reported. The mean level of harm related to patient safety problems with a contributing child-specific factor was 3.3, a higher level of mean harm.Patients population specific vulnerabilities lead to patient safety risks must be accounted for in the design and implementation of patient safety improvement interventions.