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 B - 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 B:
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. "Prescribed dose" means the total dose and dose per
				  fraction as documented in the written directive. The prescribed dose is an
				  estimation from measured data from a specified therapeutic radiation machine
				  using assumptions that are clinically acceptable for that treatment technique
				  and historically consistent with the clinical calculations previously used for
				  patients treated with the same clinical technique.
c. "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.
d. "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. Scope and applicability. Each applicant or registrant
				  subject to section
				  33.1-10-15-06 or
				  33.1-10-15-07 shall establish
				  and maintain a written quality management program to provide high confidence
				  that radiation will be administered as directed by the authorized user. The
				  quality management program shall include written policies and procedures to
				  meet the following specific objectives:
a. Prior to administration, a written directive is prepared
				  for any external beam radiation therapy dose
(1) Notwithstanding subdivision a, a written revision to an
				  existing written directive may be made provided that the revision is dated and
				  signed by an authorized user prior to administration of the external beam
				  radiation therapy dose or the next external beam radiation therapy fractional
				  dose;
(2) Notwithstanding subdivision a, if, because of the
				  patient's condition, a delay in order to provide a written revision to an
				  existing written directive would jeopardize the patient's health, an oral
				  revision to an existing written directive shall be acceptable, provided that
				  the oral revision is documented immediately in the patient's record and a
				  revised written directive is signed by an authorized user within forty-eight
				  hours of the oral revision; and
(3) Notwithstanding subdivision a, if, because of the
				  emergent nature of the patient's condition, a delay in order to provide a
				  written directive would jeopardize the patient's health, an oral directive
				  shall be acceptable, provided that the information contained in the oral
				  directive is documented immediately in the patient's record and a written
				  directive is prepared and signed by an authorized user within twenty-four hours
				  of the oral directive;
b. Prior to the administration of each course of radiation
				  treatments, the patient's identity is verified, by more than one method, as the
				  individual named in the written directive;
c. External beam radiation therapy final plans of treatment
				  and related calculations are in accordance with the respective written
				  directives;
d. Each administration is in accordance with the written
				  directive; and
e. Any unintended deviation from the written directive is
				  identified and evaluated, and appropriate action is taken.
3. Development of quality management program.
a. Each application for registration subject to section
				  33.1-10-15-06 or
				  33.1-10-15-07 shall include a
				  quality management program, that specifies staff, duties, and responsibilities,
				  and equipment and procedures as part of the application required by 33.1-10-02.
				  The registrant shall implement the program upon issuance of a certificate of
				  registration by the department; and
b. Each existing registrant subject to section
				  33.1-10-15-06 or
				  33.1-10-15-07 shall, within
				  thirty days of January 1, 2011, submit to the department a written
				  certification that a quality management program has been implemented.
4. As a part of the quality management program, the
				  registrant shall:
a. Develop procedures for, and conduct a review of, the
				  quality management program, including since the last review, an evaluation of a
				  representative sample of patient administrations, all recordable events, and
				  all misadministrations to verify compliance with all aspects of the quality
				  management program;
b. Conduct these reviews at intervals not to exceed twelve
				  months;
c. Evaluate each of these reviews to determine the
				  effectiveness of the quality management program and, if required, make
				  modifications to meet the requirements of subsection 2; and
d. Maintain records of each review, including the evaluations
				  and findings of the review, in an auditable form, for three years.
5. The registrant shall evaluate and respond, within thirty
				  days after discovery of the recordable event, to each recordable event
				  by:
a. Assembling the relevant facts, including the cause;
b. Identifying what, if any, corrective action is required to
				  prevent recurrence; and
c. Retaining a record, in an auditable form, for three years,
				  of the relevant facts and what corrective action, if any, was taken.
6. The registrant shall retain:
a. Each written directive; and
b. A record of each administered radiation dose, in an
				  auditable form, for three years after the date of administration.
7. The registrant may make modifications to the quality
				  management program to increase the program's efficiency provided the program's
				  effectiveness is not decreased.
8. The 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
				  he/she 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 remedial
				  care as a result of the misadministration, 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 actions 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 of both the event and the consequences as they may effect the
				  patient, provided a statement is included that the report submitted to the
				  department can be obtained from the registrant.
9. Aside from the notification requirement, nothing in
				  subsection 8 of section
				  33.1-10-15-05 affects any rights
				  or duties of registrants and physicians in relation to each other, patients, or
				  the patient's responsible relatives or guardians.