N.D. Admin. Code 33.1-10-15-04

Current through Supplement No. 394, October, 2024

Section 33.1-10-15-04 - General technical requirements

1. Protection surveys.

a. The registrant shall ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated in accordance with section 33.1-10-15-08. The radiation protection survey shall be performed by, or under the direction of, a radiation therapy physicist or a qualified expert and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation:

(1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 33.1-10-04.2-01 [ 10 CFR 20.1201 ]; and

(2) Radiation levels in unrestricted areas do not exceed the limits specified in 33.1-10-04.2-01 [ 10 CFR 20.1301 ].

b. In addition to the requirements of subdivision a, a radiation protection survey shall also be performed prior to any subsequent medical use and:

(1) After making any change in the treatment room shielding;

(2) After making any change in the location of the therapeutic radiation machine within the treatment room;

(3) After relocating the therapeutic radiation machine; or

(4) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

c. The survey record shall indicate all instances where the facility, in the opinion of the radiation therapy physicist or a qualified expert, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instruments used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey;

d. If the results of the surveys required by subdivision a or b indicate any radiation levels in excess of the respective limit specified in subdivision a, the registrant shall lock the control in the "OFF" position and not use the unit:

(1) Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

(2) Until the registrant has received a specific exemption from the department.

2. Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by subsection 1 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 33.1-10-04.2-01 [ 10 CFR 20.1301 ], before beginning the treatment program the registrant shall:

a. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 33.1-10-04.2-01 [ 10 CFR 20.1301 ];

b. Perform the survey required by subsection 1 again; and

c. Include in the report required by subsection 4 the results of the initial survey, a description of the modification made to comply with subdivision a, and the results of the second survey; or

d. Request and receive a registration amendment under 33.1-10-04.2-01 [ 10 CFR 20.1301 ] that authorizes radiation levels in unrestricted areas greater than those permitted by 33.1-10-04.2-01 [ 10 CFR 20.1301(a) and 10 CFR 20.1301(b)].

3. Dosimetry equipment.

a. The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the national institute for standards and technology (NIST) or by an American association of physicists in medicine (AAPM) accredited dosimetry calibration laboratory (ADCL). The calibration shall have been performed within the previous twenty-four months and after any servicing that may have affected system calibration. An independent survey shall be conducted by a qualified expert or radiation therapy physicist other than the person performing the original survey prior to the equipment being used except as described in subdivision d of subsection 1.

(1) For beams with energies greater than one million volts (1 Mv) or one million electron volts (1 MeV), the dosimetry system shall have been calibrated for cobalt-60; or

(2) For beams with energies equal to or less than one million volts (1 Mv) or one million electron volts (1 MeV), the dosimetry system shall have been calibrated at an energy appropriate for the radiation being measured;

b. The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with subdivision a. This comparison shall have been performed within the previous twelve months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in subdivision a; and

c. The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the registration. For each calibration, intercomparison, or comparison, the record shall include the date; the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by subdivisions a and b; the correction factors that were determined; the names of the individuals who performed the calibration, intercomparison, or comparison; and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiation therapy physicist.

4. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to section 33.1-10-15-06 or 33.1-10-15-07 shall furnish a copy of the records required in subsections 1 and 2 to the department within thirty days following completion of the action that initiated the record requirement.

N.D. Admin Code 33.1-10-15-04

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