The head of a hospital or day hospital (its chief executive, whatever the title) must report to the Secretary when a reportable medical device (Class III or Class 4 IVD) used in the facility has resulted in a person's death or serious deterioration in health; when such a device was not used because someone in the facility intervened and its use would likely have caused death or serious deterioration; or when a health practitioner in the facility treats a person for a serious deterioration caused by such a device. The report names or describes the device, describes what happened and contains the prescribed information, and is given within the prescribed period (10 days, or 45 days for averted use or treatment) in the prescribed electronic manner. The duty does not apply where the chief executive has reported the matter to the CEO of the Australian Commission on Safety and Quality in Health Care, the head of the State or Territory health department or another prescribed person. Failure is a civil penalty of 30 penalty units.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.