participation is necessary by the leadership of tjc accredited healthcare organizations and by the persons closely involved in the systems under review. causal factors are analyzed, focusing on systems and processes, not individual performance. potential improvements, called an "action plan", are identified and implemented to decrease the likelihood of such events in the future. each accredited organization is encouraged, but not required, to report any sentinel event to the joint commission. however, the organization is expected to prepare a root cause analysis and action plan within 45 calendar days of the event. in addition, healthcare organizations are required to notify the food and drug administration (fda) and device manufacturers within 10 days of a sentinel event caused by a medical device, according to the safe medical device act of 1990. statistics of sentinel events are recorded and published by the fda's medwatch program.