North Dakota Administrative Code › Title 33.1 - Department of Environmental Quality › Article 33.1-10 - Radiological Health Rules › Chapter 33.1-10-15 - Therapeutic Radiation Machines › Appendix C - ALTERNATIVE QUALITY MANAGEMENT PROGRAM

Current through Supplement No. 393, July, 2024
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.