(A) Any unintended treatment deviation from the written directive or approved treatment plan shall be identified, evaluated, documented and appropriate action taken by the handler.
(B) 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.
(C) 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:
(1) The wrong patient; where wrong patient means administration of radiation to an individual using a treatment plan intended for another patient or human research subject; or
(2) The wrong treatment; where wrong treatment means administration of radiation to a human patient or human research subject that does not conform to the written directive and the approved treatment plan; and
(a) The administered dose over the entire treatment course differs from the prescribed dose as stated in the written directive by more than ten per cent for treatment courses consisting of three or fewer fractions; or
(b) The administered dose over the entire treatment course differs from the prescribed dose by more than twenty per cent for treatment courses consisting of more than three fractions; or
(c) The administered dose over any five consecutive fractions differs from the prescribed dose by more than thirty per cent; or
(d) The administered dose to any critical structure:
(i) Exceeds the critical dose limit established in the written directive or approved treatment plan by twenty per cent or more; and
(ii) Has the potential to cause serious harm according to the current published recommendations from a recognized national professional organization with expertise in radiation oncology.
(D) For purposes of paragraphs (C)(2)(a), (C)(2)(b) and (C)(2)(c) of this rule, "administered dose" means:
(1) The D95 (minimum dose to ninety-five per cent of the prescribed volume) for computer treatment plans; or
(2) The dose to the prescription point for treatments prescribed to a point.
(E) The handler shall notify the department by telephone no later than the next calendar day after the handler ascertains that a medical event occurred.
(F) 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:
(1) The handler or registrant name;
(2) The name of the prescribing physician;
(3) A brief description of the event;
(4) Why the event occurred;
(5) The effect, if any, on the individual who received the medical event;
(6) Actions, if any, that have been taken, or are planned, to prevent recurrence; and
(7) Certification that the handler notified the individual, or the individual's responsible relative or guardian, and if not, why not.
(G) The report shall not contain the individual's name or any other information that could lead to the identification of the individual.
(H) The handler shall provide notification of the medical event to the referring physician no later than twenty-four hours after its discovery. The handler shall also notify the individual who is the subject of the medical event no later than twenty-four hours after the initial notification, unless the authorized user or referring physician determines that, based on their medical judgment, informing the individual would be harmful. The handler 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 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.
(I) 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.
(J) The handler shall retain a record of each unintended deviation in accordance with paragraph (J) of this rule. If the unintended deviation is a medical event, a copy of the record shall be provided to the referring physician if other than the handler within fifteen days after its discovery.
(K) The handler shall retain a record of each unintended deviation for three years. The record must contain the following:
(1) The handler or registrant's name and the names of the individuals involved;
(2) The social security number or other identification number, if one has been assigned, of the individual who is the subject of the unintended deviation;
(3) A brief description of the event; why it occurred; the effect, if any, on the individual;
(4) The actions, if any, taken or planned to prevent recurrence; and
(5) Whether the handler or the registrant notified the individual, or the individual's responsible relative or guardian; and, if not, whether such failure to notify was based on guidance from the referring physician.
Five Year Review (FYR) Dates: 11/15/2020
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02, 3748.04 , 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13
Prior Effective Dates: 2/15/2001, 9/1/05, 1/14/11