N.D. Admin. Code tit. 33.1, art. 33.1-10, ch. 33.1-10-15, app C
1. In addition to the definitions in section 33.1-10-15-02, the following definitions are applicable to this appendix C:
a. "Misadministration" means the administration of an external beam radiation therapy dose:
(1) Involving the wrong patient, wrong treatment modality, or wrong treatment site;
(2) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;
(3) When the calculated weekly administered dose differs from the weekly prescribed dose by more than thirty percent; or
(4) When the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose;
b. "Recordable event" means the administration of an external beam radiation therapy dose when the calculated weekly administered dose differs by fifteen percent or more from the weekly prescribed dose; and
c. "Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of radiation, containing the following information: total dose, dose per fraction, treatment site, and overall treatment period.
2. Each registrant shall establish and maintain a written program to provide assurance that radiation is administered to humans as directed by the authorized user. The program shall include the following elements:
a. Procedure for preparing written directives for the administration of radiation; however, a written directive is not required when an authorized user personally administers a dosage provided the pertinent facts are documented as otherwise required;
b. Procedure for verifying by more than one method the identity of the individual to be administered radiation;
c. Procedure for updating the therapy operating and emergency procedures manual;
d. Procedure for verifying that final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;
e. Procedures assuring that administration of radiation is carried out as specified in the written directive or the therapy operating and emergency procedures manual; and
f. Procedures for identifying and evaluating unintended deviations from the written directive or the therapy operating and emergency procedures manual including taking appropriate action for recordable events and misadministrations.
3. Each registrant shall evaluate each misadministration and shall take the following actions in response to a misadministration:
a. Notify the department by telephone no later than the next calendar day after discovery of the misadministration;
b. Submit a written report to the department within fifteen days after discovery of the misadministration. The written report shall include the registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient or the patient's responsible relative or guardian (this person will subsequently be referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient;
c. Notify the referring physician and also notify the patient of the misadministration no later than twenty-four hours after its discovery, unless the referring physician personally informs the registrant either that the physician will inform the patient or that, based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting with the referring physician. If the referring physician or patient cannot be reached within twenty-four hours, the registrant shall notify the patient as soon as possible. The registrant shall not delay any appropriate medical care for the patient, including any necessary medical care as a result of the misadministrations, because of any delay in notification;
d. Retain a record of each misadministration for five years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the action taken to prevent recurrence; and
e. If the patient was notified, furnish, within fifteen days after discovery of the misadministration, a written report to the patient by sending either a copy of the report that was submitted to the department, or a brief description or both the event and the consequences as they may affect the report submitted to the department can be obtained from the registrant.
4. Each registrant shall evaluate and respond to recordable events within thirty days after discovery by assembling the relevant facts, identifying the cause of the recordable event, and taking appropriate action, if any is required, to prevent recurrence.
5. Each registrant shall conduct an annual evaluation of the human administration program, including any recommendations for changes to be made as well as any modifications made since the last evaluation and, if required, revise procedures to assure that the radiation is administered as directed by the authorized user. Modifications made to the program shall not decrease the effectiveness of the program.
6. Each registrant shall retain, in auditable form, for three years:
a. Each written directive;
b. A record of each administered radiation dose where a written directive is required;
c. A record of each annual review of the program, including the evaluations and findings of the review; and
d. A record of each recordable event, the relevant facts, and any corrective actions taken.
N.D. Admin Code tit. 33.1, art. 33.1-10, ch. 33.1-10-15, app C