N.D. Admin. Code 33.1-10-15-03

Current through Supplement No. 394, October, 2024

Section 33.1-10-15-03 - General administrative requirements

1. Administrative controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the department. The registrant or the registrant's agent shall ensure that the requirements of chapter 33.1-10-15 are met in the operation of the therapeutic radiation machines.

2. A therapeutic radiation machine that does not meet the provisions of these regulations shall not be used for irradiation of patients.

3. Training for external beam radiation therapy authorized users. The registrant for any therapeutic radiation machine subject to section 33.1-10-15-06 or 33.1-10-15-07 shall require the authorized user to be a physician who:

a. Is certified in:

(1) Radiology or therapeutic radiology by the American board of radiology;

(2) Radiation oncology by the American osteopathic board of radiology;

(3) Radiology, with specialization in radiotherapy, as a British "fellow of the faculty of radiology" or "fellow of the royal college of radiology"; or

(4) Therapeutic radiology by the Canadian royal college of physicians and surgeons; or

b. Is in the active practice of therapeutic radiology, and has completed two hundred hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, five hundred hours of supervised work experience, and a minimum of three years of supervised clinical experience.

(1) To satisfy the requirement for instruction, the classroom and laboratory training shall include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of ionization radiation; and

(d) Radiation biology.

(2) To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:

(a) Review of the full calibration measurements and periodic quality assurance checks;

(b) Evaluation of prepared treatment plans and calculation of treatment times and patient treatment settings;

(c) Using administrative controls to prevent misadministrations;

(d) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

(e) Checking and using radiation survey meters.

(3) To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the residency review committee for radiology of the accreditation council for graduate medical education or the committee on postdoctoral training of the American osteopathic association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

(a) Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations or contraindications;

(b) Selecting proper dose and how it is to be administered;

(c) Calculating the external beam radiation therapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans, or both, as warranted by patients' reaction to radiation; and

(d) Postadministration followup and review of case histories.

c. Notwithstanding the requirements of subdivision a or b, the registrant for any therapeutic radiation machine subject to section 33.1-10-15-06 may also submit the training of the prospective authorized user physician for department review on a case-by-case basis.

d. A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the facility and is determined to meet the requirements.

4. Training for radiation therapy physicist. The registrant for any therapeutic radiation machine subject to section 33.1-10-15-06 or 33.1-10-15-07 shall require the radiation therapy physicist to:

a. Be registered with the department, under the provisions of 33.1-10-02, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

b. Be certified or eligible for certification by the American board of radiology in:

(1) Therapeutic radiological physics;

(2) Roentgen-ray and gamma-ray physics;

(3) X-ray and radium physics; or

(4) Radiological physics;

c. Be certified or eligible for certification by the American board of medical physics in radiation oncology physics;

d. Be certified or eligible for certification by the Canadian college of medical physics; or

e. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full-time training in therapeutic radiological physics and also one year of full-time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in subsection 2 of section 33.1-10-15-04, subsection 16 of section 33.1-10-15-06, subsection 20 of section 33.1-10-15-07, subsection 17 of section 33.1-10-15-06, and subsection 21 of section 33.1-10-15-07 under the supervision of a radiation therapy physicist during the year of work experience.

5. Qualifications of operators.

a. Individuals who will be operating a therapeutic radiation machine for medical use shall be American registry of radiologic technologists (ARRT) registered radiation therapy technologists. Individuals who are not ARRT registered radiation therapy technologists shall submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the joint review committee on education in radiologic technology.

b. The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least two years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

6. Written safety procedures and rules shall be developed by a radiation therapy physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

7. Individuals shall not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a licensed practitioner of the healing arts who meets the requirements of subsection 3. This provision specifically prohibits deliberate exposure of an individual for training, demonstration, or other non-healing-arts purposes.

8. Visiting authorized user. Notwithstanding the provisions of subsection 7, a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's certificate of registration for up to sixty days per calendar year under the following conditions:

a. The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's radiation safety committee;

b. The visiting authorized user meets the requirements established for authorized users in subdivisions a and b of subsection 3; and

c. The registrant maintains copies of all records specified by this subsection for five years from the date of the last visit.

9. All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of this chapter, these individuals are also subject to the requirements of 33.1-10-04.2-01 [ 10 CFR 20.1203 and 10 CFR 20.1502].

10. Information and maintenance record and associated information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the department:

a. Report of acceptance testing;

b. Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this chapter, as well as the names of persons who performed such activities;

c. Records of maintenance or modifications, or both, performed on the therapeutic radiation machine on or after January 1, 2011, as well as the names of persons who performed such services; and

d. Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

11. Records retention. All records required by this chapter shall be retained until disposal is authorized by the department unless another retention period is specifically authorized in this chapter. All required records shall be retained in an active file from at least the time of generation until the next department inspection. Any required record generated prior to the last department inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the department authorizes final disposal.

N.D. Admin Code 33.1-10-15-03

Adopted by Administrative Rules Supplement 370, October 2018, effective 1/1/2019.

General Authority: NDCC 23.1-03-02; S.L. 2017, ch. 199, § 1

Law Implemented: NDCC 23.1-03-03; S.L. 2017, ch. 199, § 18