R 333.5715 Report and notification of CT medical event.

Rule 715. (1) A CT facility shall report all CT medical events. (2) The registrant shall submit a written report to the department within 15 days after a physician of the CT facility discovers the CT medical event or within 15 days after the CT facility is notified of the CT medical event by another physician, whichever comes first. (3) The written report shall include all of the following: (a) The registrant’s name, address, facility registration number, and machine registration tag number as they appear on the registration certificate. (b) The name of the physician who determined a CT medical event occurred. (c) The dates of occurrence and discovery of the CT medical event. (d) A narrative description of the CT medical event. (e) The cause of the CT medical event. (f) The effect on the individual who received the exposure. (g) A narrative detailing corrective action taken or planned to prevent a recurrence. (h) Certification that the registrant notified the individual or the individual’s responsible relative or guardian and, if not, why not. (i) The name and signature of the person preparing the report. (4) The report shall not contain the name of the individual who is the subject of the CT medical event or any other information that could lead to identification of the individual. (5) The registrant shall provide notification of the CT medical event to the referring physician and shall notify the individual who is the subject of the CT medical event not later than 1 week after its discovery, unless the referring physician personally informs the registrant that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The notification of the individual who is the subject of the CT medical event may be made instead to that individual’s responsible relative or guardian. The registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 1 week, the registrant shall notify the individual as soon as possible thereafter. The registrant shall not delay appropriate medical care for the individual, including all necessary remedial care as a result of the CT medical event, because of a delay in notification. If a verbal notification is made, the registrant shall inform the individual or appropriate responsible relative or guardian that a written description of the CT medical event can be obtained from the registrant upon request. The registrant shall provide a written description if requested.