Reports and Notifications of Unplanned Medical Treatment
(1)A registrant must report any medical treatment event that causes an error in the treatment of a patient. Medical treatment events occur when the administration of an external beam radiation therapy dose:
(a)Administration results or will result in unintended permanent functional organ damage or physiological injury as determined by a Qualified Radiation Therapy Physician; or
(b)Involves the wrong patient, wrong treatment modality, or wrong treatment site; or
(c)Consists of 3 or fewer treatment fractions and the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose; or
(d)If the calculated weekly administered dose differs from the weekly prescribed dose by more than 30 percent; or
(e)If the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose.
(2)The registrant must notify the Authority by telephone no later than the next calendar day after the discovery of a medical treatment event.
(3)The registrant must submit a written report to the Authority within 15 days after the discovery of a medical treatment event. The written report must include:
(a)The registrant’s name; and
(b)The name of the prescribing physician; and
(c)A brief description of the event; and
(d)Why the event occurred; and
(e)The effect, if any, on the patient(s) who received the administration; and
(f)Actions, if any, that have been taken, or are planned, to prevent recurrence; and
(g)Certification that the registrant notified the patient or the patient’s legally authorized representative(s), and if not, why not; and
(h)The report may not contain the individual’s name or any other information that could lead to the identification of the individual.
(4)The registrant shall notify the referring physician and also notify, the patient who is the subject of the medical treatment event, or their lawfully authorized representative no later than 24 hours after its discovery unless:
(a)The referring physician personally informs the registrant that he or she will inform the affected patient; or
(b)Based on his or her medical judgment the affected patient will not be informed because it would be harmful to the patient.
(5)The registrant is not required to notify the affected patient without first consulting the referring physician.
(6)If the referring physician or the affected patient cannot be reached within 24 hours, the notification will be as soon as possible.
(7)The registrant may not delay any appropriate medical care for the affected patient, including any necessary remedial care taken because of the medical treatment event.
(8)If a verbal notification is made, the registrant must inform the affected patient, or the patient’s lawfully authorized representative(s), that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.
(9)Aside from the notification requirement, nothing in this rule affects any rights or duties of registrants and physicians in relation to each other, to the patient affected by the medical treatment event, or to the patient’s lawfully authorized representative(s).
(10)A copy of the record required must be provided to the referring physician if other than the registrant within 15 days after discovery of the medical treatment event.
(11)Records Of Medical Treatment Event. A registrant must retain a record of a medical treatment event, for 3 years. The record must be handled in accordance with the Health Insurance Portability and Accountability Act (HIPAA).
Rule 333-123-0020 — Reports and Notifications of Unplanned Medical Treatment,