; and (C) any other health care professional specified in regulations promulgated by the Secretary. (4) Healthcare Acquired Infection The term Healthcare Acquired Infection(s) (HAI) means an infection that is contracted while in a healthcare facility, such as an acute care hospital, skilled nursing care facility, or doctor’s office or clinic. (6) Medical error The term medical error means an unexpected occurrence involving death or serious physical or psychological injury, or the risk of such injury, including any process variation of which recurrence may carry significant chance of a serious adverse outcome. (7) Office The term Office means the Office of Patient Safety and Health Care Quality established under section 943, which shall be a certified patient safety organization as defined under part C. (8) Outcomes The term outcomes means any result of healthcare acquired infection and/or medical error on affected patients. (9) Patient safety data The term patient safety data means information requested by the Director of the Office to be submitted by the patient safety officer of a Program participant as described in section 945(e). (6) Patient safety event The term patient safety event means an occurrence, incident, or process that either contributes to, or has the potential to contribute to, a patient injury or degrades the ability of health care providers to provide the appropriate standard of care. (7) Patient safety officer The term patient safety officer means the individual designated by a Program participant as being responsible for ensuring that the conditions for participation in the Program are met. (8) Patient safety organization The term patient safety organization has the meaning given such term in section 921. (9) Patient safety work product The term patient safety work product has the meaning given such term in section 921. (10) Program The term Program means the National Healthcare Acquired Infections and Medical Error Reporting Program established under section 945. (11) Program participant The