Ohio Administrative Code
Title 3701:1 - Radiation Control
Chapter 3701:1-67 - External Beam Radiation Therapy Equipment
Section 3701:1-67-12 - Notification of medical events
Current through all regulations passed and filed through March 18, 2024
(A) A handler shall report any medical event resulting from intervention of a human patient or human research subject in which the administration of radiation from therapy equipment results, or will result, in unintended permanent functional damage to an organ or a physiological system as determined by a physician.
(B) A handler shall report, as a medical event, any treatment deviation, except for a treatment deviation that results from intervention by a human patient or human research subject, in which the administration of radiation from therapy equipment involves:
(C) For purposes of paragraphs (B)(2)(a), (B)(2)(b) and (B) (2)(c) of this rule, "administered dose" means:
(D) The handler shall notify the department by telephone no later than the next calendar day after the handler ascertains that a medical event occurred.
(E) The handler shall submit a written report to the department within fifteen days after the initial report of the medical event. The written report must include:
(F) The report shall not contain the individual's name or any other information that could lead to the identification of the individual.
(G) The handler shall provide notification of the medical event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty-four hours after its discovery, unless the authorized user and/or referring physician personally informs the handler either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The handler is not required to notify the individual without first consulting the authorized user and/or referring physician. If the referring physician or the affected individual cannot be reached within twenty-four hours, the handler shall notify the individual as soon as possible thereafter. The handler may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the handler shall inform the individual or appropriate responsible relative or guardian that a written description of the event can be obtained from the handler upon request. The handler shall provide such a written description if requested.
(H) Aside from the notification requirement, nothing in this section affects any rights or duties of handlers, registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.
(I) The handler shall retain a record of each medical event report with an identification link to the individual who is the subject of the medical event for the duration of the registration.