N.D. Admin. Code § 33.1-10-15-09
33.1-10-15-09. Shielding and safety design requirements.
1. Each therapeutic radiation machine subject to section 33.1-10-15-06 or 33.1-10-15-07 shall be provided with such primary or secondary barriers, or both, as are necessary to ensure compliance with chapter 33.1-10-04.2 [10 CFR 20.1201 and 10 CFR 20.1301].
2. Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted for department approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in appendix A.
History: Effective January 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
1. All therapeutic radiation machines. a. Basic facility information, including name, telephone number, and department registration number of the individual responsible for preparation of the shielding plan; name and telephone number of the facility supervisor; and the street address (including room number) of the therapeutic radiation machine facility. The plan should also indicate whether this is a new structure or a modification to existing structures. b. All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers. c. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.
2. Therapeutic radiation machines up to 150 Kv (photons only). In addition to the requirements listed in subsection 1, therapeutic radiation machine facilities which produce only photons with a maximum energy less than or equal to 150 kilovolts shall submit shielding plans which contain, as a minimum, the following additional information: a. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors; b. Maximum design workload for the facility, including total weekly radiation output, (expressed in gray (rad) or air kerma at 1 meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week; c. A facility blueprint or drawing indicating: scale (0.25 inch = 1 foot is typical); direction of north, normal location of the therapeutic radiation machine's radiation ports, the port's travel and traverse limits, general directions of the useful beam, locations of any windows and doors, and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth shall be noted on the plan and the operator's station at the control panel shall be behind a protective barrier sufficient to ensure compliance with subsection 1 of section 33.1-10-04.2-06 [10 CFR 20.1201] of these regulations; d. The structural composition and thickness or lead or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned; e. The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, showing distance to the closest areas where it is likely that individuals may be present; and f. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e., primary and secondary leakage barriers, restricted and unrestricted areas, entry doors) and shielding material in the facility: (1) If commercial software is used to generate shielding requirements, please also identify the software used and the version or revision date. (2) If the software used to generate shielding requirements is not in the open literature, please also submit quality control sample calculations to verify the result obtained with the software.
3. Therapeutic radiation machines over 150 kilovolts.
In addition to the requirements listed in subsection 1, therapeutic radiation machine facilities that produce photons with a maximum energy in excess of 150 kilovolts or electrons shall submit shielding plans which contain, as a minimum, the following additional information:
a. Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energies and types of radiation produced (i.e., photon, electron). The target to isocenter distance shall be specified; b. Maximum design workload for the facility, including total weekly radiation output (expressed in gray (rad) at 1 meter), total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week; c. Facility blueprint or drawing (including both floor plan and elevation view) indicating relative orientation of the therapeutic radiation machine, scale (0.25 inch = 1 foot is typical), types, thickness, and minimum density of shielding materials, direction of north, the locations and size of all penetrations through each shielding barrier (ceiling, walls, and floor), as well as details of the doors and maze; d. The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the rooms concerned; e. The type of occupancy of all adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, showing distance to the closest areas where it is likely that individuals may be present; f. Description of all assumptions that were in shielding calculations, including design energy (i.e., room may be designed for 6 MV unit although only a 4 MV unit is currently proposed), workload, presence of integral beam-stop in unit, occupancy and uses of adjacent areas, fraction of time that useful beam will intercept each permanent barrier (walls, floor, and ceiling), and "allowed" radiation exposure in both restricted and unrestricted areas; and g. At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition (i.e., primary and secondary or leakage barriers, restricted and unrestricted areas, small angle scatter, entry doors and maze) and shielding material in the facility:
(1) If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and (2) If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
4. Neutron shielding.
In addition to the requirements listed in subsection 3, therapeutic radiation machine facilities that are capable of operating above 10 MV shall submit shielding plans which contain, as a minimum, the following additional information:
a. The structural composition, thickness, minimum density, and location of all neutron shielding material;
b. Description of all assumptions that were used in neutron shielding calculations, including neutron spectra as a function of energy, neutron fluence rate, absorbed dose, and dose equivalent (due to neutrons) in both restricted and unrestricted areas; c. At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition (i.e., restricted and unrestricted areas, entry doors and maze) and neutron shielding material utilized in the facility:
(1) If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and (2) If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
d. The methods and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.
a. NCRP Report 147, "Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV" (2004). b. NCRP Report 144, "Radiation Protection Design Guidelines for 0.1-100 MeV Particle Accelerator Facilities" (2003). c. NCRP Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984).
History: Effective January 1, 2019.
1. 1. In addition to the definitions in section 33.1-10-15-02, the following definitions are applicable to this appendix B:
1. a. 'Misadministration' means the administration of an external beam radiation therapy dose: 1. (1) Involving the wrong patient, wrong treatment modality, or wrong treatment site; 2. (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. (3) When the calculated weekly administered dose differs from the weekly prescribed dose by more than thirty percent; or 4. (4) When the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose.
2. 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.
3. 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.
4. 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. 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:
1. a. Prior to administration, a written directive is prepared for any external beam radiation therapy dose: 1. (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. (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
1. a. Each written directive; and
2. b. A record of each administered radiation dose, in an auditable form, for three years after the date of administration.1. 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.
2. 8. The registrant shall evaluate each misadministration and shall take the following actions in response to a misadministration:
1. a. Notify the department by telephone no later than the next calendar day after discovery of the misadministration;
2. 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;
3. 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;
4. 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
5. 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.
3. 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.
History: Effective January 1, 2019.
1. 1. In addition to the definitions in section 33.1-10-15-02, the following definitions are applicable to this appendix C:
1. a. 'Misadministration' means the administration of an external beam radiation therapy dose: 1. (1) Involving the wrong patient, wrong treatment modality, or wrong treatment site; 2. (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. (3) When the calculated weekly administered dose differs from the weekly prescribed dose by more than thirty percent; or 4. (4) When the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose;
2. 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
3. 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. 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:
1. 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;
2. b. Procedure for verifying by more than one method the identity of the individual to be administered radiation;
3. c. Procedure for updating the therapy operating and emergency procedures manual;
4. 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;
5. 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
6. 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. 3. Each registrant shall evaluate each misadministration and shall take the following actions in response to a misadministration:
1. a. Notify the department by telephone no later than the next calendar day after discovery of the misadministration;
2. 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;
3. 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;
4. 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
5. 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.1. 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.
2. 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.
3. 6. Each registrant shall retain, in auditable form, for three years:
1. a. Each written directive;
2. b. A record of each administered radiation dose where a written directive is required;
3. c. A record of each annual review of the program, including the evaluations and findings of the review; and
4. d. A record of each recordable event, the relevant facts, and any corrective actions taken.
History: Effective January 1, 2019.