Methods The approaches to patient safety, the responsibilities of key agencies, and the interaction and coordination between these agencies were studied in four countries: Australia, England, the United States and New Zealand. [...] Detailed descriptions of the patient safety activities, the roles and relationships of specific agencies and the successes and challenges faced were identified from the interviews and documentation. [...] For example, the work of the Veterans Health Administration in the US set the standard for reporting of incidents and adverse events for many other health care systems in the US. [...] In the U. S. Congress designated the Agency for Healthcare Research and Quality within the Department of Health and Human Services to have the lead on patient safety. [...] The initial new agencies in Australia and the United States came from within the healthcare community with the Australian Patient Safety Foundation and the US National Patient Safety Foundation.