On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes: The name of the patient safety coordinator; The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program; A description of the near-miss and adverse event identification and reporting process; A list of examples of adverse events that shall be reported; A description of the process for determining which near-misses warrant a root cause analysis to be conducted; A description of the near-miss and adverse event review, prioritization, evaluation, and root cause analysis process; A description of the process used to provide notification to a patient, and, if appropriate, to a patient's family whenever an outcome of care differs from an anticipated outcome; and A description of the formal written patient complaint process. The hospital shall notify the Secretary of any change in its patient safety program related to the description required by this regulation within 30 days of the effective date of the change.