3701:1-67-12 Reports and notifications of misadministrations.

(A) A handler shall report any misadministration resulting from intervention of a 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) Other than misadministrations that result from intervention by a patient or human research subject, a handler shall report any event in which the administration of radiation from therapy equipment involves:

(1) The wrong patient;

(2) The wrong treatment;

(3) The wrong treatment site;

(4) The calculated weekly administered dose differs from the weekly prescribed dose as prescribed in the treatment plan by more than thirty per cent;

(5) The calculated total administered dose differs from the total prescribed dose as prescribed in the treatment plan by more than twenty per cent of the total prescribed dose; or

(6) The calculated total administered dose differs from the total prescribed dose in the treatment plan by more than ten per cent of the total prescribed dose for treatments consisting of three or fewer fractions.

(C) Any unintended deviation from the treatment plan or written directive shall be identified, evaluated, and appropriate action taken.

(D) The handler shall notify the department by telephone no later than the next calendar day after the handler ascertains that a misadministration occurred.

(E) The handler shall submit a written report to the department within fifteen days after the initial report of the misadministration. 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 misadministration;

(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.

(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 verbal and written notification of the misadministration to the referring physician no later than twenty-four hours after the initial notification. The handler shall also notify the individual who is the subject of the misadministration no later than twenty-four hours after the initial notification, unless the 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 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 misadministration, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the misadministration 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 misadministration, or to that individual's responsible relatives or guardians.

(I) The handler shall retain a record of a misadministration in accordance with paragraph (J) of this rule. A copy of the record required shall be provided to the referring physician if other than the handler within fifteen days after discovery of the misadministration.

(J) A handler shall retain a record of misadministrations reported 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 misadministration;

(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.

Replaces: 3701:1-66-14, 3701:1-66-15

Effective: 01/14/2011
R.C. 119.032 review dates: 01/01/2016
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 , 3748.14 , 3748.15 , 3748.17 , 3748.18 , 3748.19 , 3748.20 , 3748.22 , 3748.99
Prior Effective Dates: 2/15/2001, 9/1/05