Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event
(1)A CT facility shall notify the Authority within 48 hours of any CT medical event in which a patient who has undergone a CT study has incurred a deterministic radiation injury, such as epilation or erythema.
(2)The registrant shall submit a written report to the Authority within 30 days after the CT medical event is discovered.
(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 individual 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, including an estimated dose to the patient, if possible, and body part involved;
(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; and
(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 consult with the referring physician prior to notifying the individual that they were involved in a CT medical event.
(a)The registrant shall ensure that the individual was notified of the CT medical event no later than one week after the discovery unless unforeseen circumstances exist.
(b)The registrant shall not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the CT medical event.
(c)If verbal notification is necessary, the registrant shall inform the individual or legal guardian that a written description of the CT medical event can be obtained from the registrant.
Rule 333-106-0369 — Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event,