TABLE 1.

Patient Safety Learning Laboratory Methods

Step	General approach
Problem analysis	Observation of actual clinical practice. Interviews and focus groups with clinicians and/or families. Study of key problem areas in the simulated clinical setting.
Design	From the problem analysis, identify key design features for modification or innovation.
Development	Create or modify equipment, physical layout, policy / procedure, or behavioral intervention. Follow an iterative process of study, re-design, and development.
Implementation	Conduct a randomized controlled trial to determine if the innovation can improve safety. For innovations ready to test in the clinical setting, implement in the appropriate unit of the hospital or clinic.
Evaluation	Analyze results of the controlled trial for both objective and subjective evidence of clinical efficacy and improved human and system performance. Follow clinical outcomes and process measures for the implementation of the innovation in the clinical setting.