N.D. Admin. Code § 33.1-10-06-12
1. Bone densitometry systems shall be: a. Certified by the manufacturer pursuant to the Medical Device Act and part C - electronic product radiation control (EPRC) of chapter V of the Federal Food, Drug and Cosmetic Act; b. Registered in accordance with chapter 33.1-10-02 of these regulations; and c. Maintained and operated in accordance with the manufacturer's specifications.
2. Equipment requirements. Systems with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond two percent of the source-image receptor distance.
3. Operators of bone densitometry systems shall complete a training course on the bone densitometry which is acceptable to the department. The training course shall include: a. Basic radiation protection; b. Operating procedures for bone densitometry systems, to include use of various system functions, safety, and maintenance; and c. Patient positioning for the type of examinations performed.
4. During the operation of any bone densitometry system: a. The operator, ancillary personnel, and members of the general public shall be positioned as far away as practical but not less than two meters from the patient and bone densitometry system during the examination. b. The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.
5. The registrant shall keep maintenance records for bone densitometry systems as prescribed by subdivision b of subsection 1 of section 33.1-10-06-03. These records shall be maintained for inspection by the department.
6. Bone densitometry on human patients shall be conducted only: a. Under a prescription of a licensed practitioner of the healing arts; or b. Under a screening program approved by the department.
7. Any person proposing to conduct a bone densitometry screening program shall submit the information outlined in appendix E.
History: Effective January 1, 2019.
General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1
Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18
In order for the department to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information shall be submitted:
1. The plans should show, as a minimum, the following: a. The normal location of the x-ray system's radiation port; the port's travel and traverse limits; general direction or directions of the useful beam; locations of any windows and doors; the location of the operator's booth; and the location of the x-ray control panel. b. Structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room or rooms concerned. c. The dimensions of the room or rooms concerned. d. The type of occupancy of all adjacent areas inclusive of space above and below the room or rooms concerned. If there is an exterior wall, show distance to the closest area or areas where it is likely that individuals may be present. e. The make and model of the x-ray equipment and the maximum technique factors. f. The type of examinations or treatments which will be performed with the equipment, e.g., dental, orthodontal, chest, gastrointestinal, fluoroscopic, podiatry, fixed therapy, rotational therapy, etc.
2. Information on the anticipated workload of the x-ray systems.
3. If the services of a qualified expert have been utilized to determine the shielding requirements, a report, including all basic assumptions used, must be submitted with the plans.
History: Effective January 1, 2019.
1. Space requirements.
a. The operator shall be allotted not less than seven and five-tenths square feet [0.697 square meter] of unobstructed floor space in the booth. b. The operator's booth may be any geometric configuration with no dimension of less than two feet [0.61 meters]. c. The space shall be allotted excluding any encumbrance by the console, such as overhang, cables, or other similar encroachments. d. The booth must be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall cassette not reach the operator's station in the booth.
2. Structural requirements.
a. The booth walls shall be permanently fixed barriers of at least seven feet [2.13 meters] high. b. When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed. c. Shielding must be provided to meet the requirements of chapter 33.1-10-04.2 of these rules.
3. X-ray control placement. The x-ray control for the system shall be fixed within the booth and:
a. Shall be at least forty inches [1.02 meters] from any open edge of the booth wall which is nearest to the examining table. b. Shall allow the operator to use the majority of the available viewing windows.
4. Viewing system requirements.
a. Each booth shall have at least one viewing device which will:
(1) Be so placed that the operator can view the patient during any exposure; and (2) The device shall be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door, which allows access to the room, cannot be seen from the booth, then that door must have an interlock controlling the exposure which will prevent the exposure if the door is not closed.
b. When the viewing system is a window, the following requirements also apply:
(1) The viewing area must be at least one square foot [0.0929 square meter]. (2) The design of the booth must be such that the operator's expected position when viewing the patient and operating the x-ray system is at least eighteen inches [0.457 meter] from the edge of the booth. (3) The material constituting the window must have the same lead equivalence as that required in the booth's wall in which it is mounted.
c. When the viewing system is by mirrors, the mirrors must be so located as to accomplish the general requirements of subdivision a.
d. When the viewing system is by electronic means:
(1) The camera shall be so located as to accomplish the general requirements in subdivision a; and
(2) There shall be an alternate viewing system as a backup for the primary system.
History: Effective January 1, 2019.
1. General requirements.
a. Each installation must be provided with such primary or secondary barriers as are necessary to assure compliance with section 33.1-10-04.2-01 [10 CFR 20.1201, 20.1207, 20.1208, and 20.1301]. This requirement must be deemed to be met if the thicknesses of such barriers are equivalent to those as computed in accordance with appendices B, C, and D of the National Council on Radiation Protection and Measurements Report No. 49, "Medical X-Ray and Gamma-Ray Protection for Energies Up to 10 MeV", modified to meet current dose limits. b. Lead barriers must be mounted in such manner that they will not sag or cold-flow because of their own weight and shall be protected against mechanical damage. c. Joints between different kinds of protective materials must be designed so that the overall protection of the barrier is not impaired. d. Joints at the floor and ceiling must be so designed that the overall protection is not impaired. e. Windows, window frames, doors, and door frames must have the same lead equivalent as that required of the adjacent wall. f. Holes in protective barriers must be covered so that overall attenuation is not impaired.
2. Fluoroscopic x-ray systems. Ordinarily only secondary barriers are necessary except combined fluoroscopic-radiographic installations.
3. Radiographic systems other than fluoroscopic, dental intraoral, or veterinarian systems:
a. All wall, floor, and ceiling areas exposed to the useful beam must have primary barriers. Primary barriers in walls must extend to a minimum height of eighty-four inches [2.13 meters] above the floor. b. Secondary barriers must be provided in all wall, floor, and ceiling areas not having primary barriers or where the primary barrier requirements are lower than the secondary requirements. c. The operator's station at the control shall be behind a protective barrier, either in a separate room, in a protected booth, or behind a shield which will intercept the useful beam and any radiation which has been scattered only once. d. A window of lead equivalent glass equal to that required by the adjacent barrier or a mirror system shall be provided large enough and so placed that the operator can see the patient without having to leave the protected area during exposure. e. For mobile and portable x-ray systems which are used for greater than one week in one location (one room or suite), the requirements of this appendix shall apply.
4. Intraoral dental radiographic systems.
a. Dental rooms containing x-ray machines shall be provided with primary barriers at all areas struck by the useful beam. Consideration shall be given to the attenuation provided by the patient.
b. When dental x-ray units are installed in adjacent rooms or areas, protective barriers shall be provided between the rooms or areas.
Note: In many cases, structural materials of ordinary walls suffice as a protective barrier without addition of special shielding material.
5. Therapeutic x-ray installations. The structural shielding requirements shall be deemed to be met if the barriers have been designed and constructed in accordance with the National Council on Radiation Protection and Measurements Report No. 49, "Medical X-Ray and Gamma-Ray Protection for Energies Up to 10 MeV", modified to meet current dose limits.
6. Veterinary medicine radiographic installations. a. All wall, floor, and ceiling areas exposed to the useful beam shall have primary barriers. Primary barriers in walls shall extend to a minimum height of eighty-four inches [2.13 meters] above the floor. b. Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers or where the primary barrier requirements are lower than the secondary requirements.
History: Effective January 1, 2019.
X-RAY FILM DEVELOPING
Time Temperature Chart
| Thermometer Readings (Degrees) | Minimum Developing Times (Minutes) | |
|---|---|---|
| C | F | |
| 27 - | 80 | 2 |
| 79 | 2 | |
| 78 | 2 1/2 | |
| 77 | 2 1/2 | |
| 24 - | 76 | 3 |
| 75 | 3 | |
| 74 | 3 1/2 | |
| 73 | 3 1/2 | |
| 22 - | 72 | 4 |
| 71 | 4 | |
| 70 | 4 1/2 | |
| 69 | 4 1/2 | |
| 20 - | 68 | 5 |
| 67 | 5 1/2 | |
| 66 | 5 1/2 | |
| 65 | 6 | |
| 18 - | 64 | 6 1/2 |
| 63 | 7 | |
| 62 | 8 | |
| 61 | 8 1/2 | |
| 16 - | 60 | 9 1/2 |
1. Manual processing of film. a. Where film is developed manually, processing tanks should be made of mechanically rigid, corrosion resistant material and the temperature of solutions in the tanks shall be maintained within the range of sixteen degrees Celsius to twenty-seven degrees Celsius [60-80 degrees Fahrenheit]. Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the above time-temperature chart. b. Devices shall be available which will give all of the following: (1) The actual temperature of the developer. (2) An audible or visible signal, after a preset time (in minutes of duration).
2. Automatic processors and other closed processing systems. a. Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer.
History: Effective January 1, 2019.
Persons requesting that the department approve a healing arts screening program shall submit the following information and evaluation:
1. Name and address of the applicant and, where applicable, the names and addresses of agents within this state.
2. Diseases or conditions for which the x-ray examinations are to be used in diagnoses.
3. A detailed description of the x-ray examinations proposed in the screening program.
4. Description of the population to be examined in the screening program, i.e., age, sex, physical condition, and other appropriate information.
5. An evaluation of any known alternate methods not involving ionizing radiation which could achieve the goals of the screening program and why these methods are not used instead of the x-ray examinations.
6. An evaluation by a qualified expert on the x-ray systems to be used in the screening program. The evaluation by the qualified expert shall show that such systems do satisfy all requirements of this article. The evaluation shall include a measurement of patient exposures from the x-ray examinations to be performed.
7. A description of the diagnostic x-ray quality control program.
8. A copy of the technique chart for the x-ray examination procedures to be used.
9. The qualifications of each individual who will be operating the x-ray systems.
10. The qualifications of the individual who will be supervising the operators of the x-ray systems. The extent of supervision and the method of work performance evaluation shall be specified.
11. The name and address of the individual who will interpret the radiographs.
12. A description of the procedures to be used in advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and any further medical needs indicated.
13. A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x-ray examinations.
14. An indication of the frequency of screening and the duration of the entire screening program.
History: Effective January 1, 2019.
The department may use interview, observation or testing, or both, to determine compliance. The following are areas in which an individual shall have expertise for the competent operation of x-ray equipment:
1. Fundamentals of radiation safety. a. Characteristics of x-radiation. b. Units of radiation dose (mrem). c. Hazards of exposure to radiation. d. Levels of radiation from sources of radiation. e. Methods of controlling radiation dose. (1) Working time. (2) Working distance. (3) Shielding. (4) Collimation. (5) Filtration. (6) Gonad shielding and other patient protection devices. (7) Restriction of x-ray beam to the image receptor. (8) Grid utilization. (9) Utilization of mechanical immobilization device.
2. Familiarization with equipment. a. Identification of controls. b. Function of each control. c. How to use a technique chart.
3. Film processing. a. Film speed as related to patient exposure. b. Film processing parameters. c. Quality assurance program.
4. Emergency procedures. Termination of exposure in event of automatic timing device failure.
5. Proper use of personnel dosimetry. a. Location of dosimeter.
b. Interpretation of personnel monitoring reports.
6. Anatomy and positioning. a. Relevant human anatomy. b. Relevant human physiology. c. Radiographic positioning.
7. The requirements of pertinent federal and state rules.
8. The licensee's or registrant's written operating and emergency procedures.
History: Effective January 1, 2019.
The following are individuals that qualify for training exemptions, approved Allied Health professions which qualify for cross-training into diagnostic x-ray as a limited x-ray machine operator and individuals who may order diagnostic x-rays to be taken by a limited x-ray machine operator outside the scope of procedures in appendix I:
1. Individuals exempt from minimum training requirements in subparagraph b of paragraph 2 of subdivision a of subsection 1 of section 33.1-10-06-03. a. Medical doctors. b. Chiropractors. c. Doctors of osteopathy. d. Podiatrists.
2. Prerequisite qualification: Individuals who qualify for cross-training as a limited x-ray machine operator. a. Nurse practitioner, registered nurse, licensed practical nurse. b. Emergency medical technician paramedic. c. Physical therapist, physical therapy assistant. d. Occupational therapist, occupational therapy assistant. e. Medical technologist, medical lab technician, clinical lab technician. f. Physician assistant. g. Orthopedic physician assistant.
3. Individuals who may order emergency x-ray examinations outside the scope of procedures in appendix I to be taken by limited x-ray machine operators: a. Medical doctor. b. Doctor of osteopathy. c. Physician assistant. d. Nurse practitioner. e. Chiropractor.
History: Effective January 1, 2019.
Students must meet the prerequisite requirements of item 1 of subparagraph b of paragraph 2 of subdivision a of subsection 1 of section 33.1-10-06-03 and complete the training requirements of this appendix.
Training requirements have been divided into two sections, didactic instruction and clinical experience/supervision. Upon completion of didactic training, the individual must complete the clinical experience requirements of either subdivision a or b of subsection 2 and demonstrate competence for examinations listed in appendix I. Records must be maintained to demonstrate compliance with these requirements.
1. Didactic instruction section: Individuals shall complete a minimum of eighty hours of didactic training at a single course providing the minimum hours of instruction in the subjects below. Correspondence coursework cannot exceed twenty percent of the eighty-hour course (sixteen hours maximum). The course content should approximate the outline below. The eighty-hour course is subject to department approval. Individuals must also complete the three-hour self study course designed by the state health department. An examination is required to demonstrate successful completion of a course.
a. Basic X-Ray Physics 12 hrs. - General description of production of x-rays - Function of filtration and effects it has on x-ray beam - Collimation - Types and function of beam-limiting devices - Design, features, and function of x-ray tube
b. Radiobiology 1 hr. - Effects of ionizing radiation to the human body - Factors that cause somatic and genetic damage
c. Radiation Protection 6 hrs. - ALARA concept - Shielding materials - Radiation quantity and units of measurement - Basic interactions of x-ray with matter - Primary and secondary scatter - Importance of time, distance, shielding - Maximum permissible dose-occupational/public - Latency period - Patient protection
d. Principles of Exposure 15 hrs. - Factors that control and influence radiographic quality - Properties of x-rays - Size distortion caused by geometric parameters - Parameters which cause shape distortion - Technique factor selection - 15% rule, mAs and kVp relationship - Grid-types, ratios, and how they affect image quality - Intensifying screens - X-ray film - Artifacts - Inverse square law
e. Darkroom Procedure and Processing 4 hrs. - Film storage and handling - Film processing and troubleshooting - Design, features, and function of a processor - Silver recovery - Quality assurance/quality control
f. Anatomy and Positioning
1. Chest 4 hrs.
2. Abdomen 4 hrs.
3. Extremity 8 hrs.
4. Spine 8 hrs.
5. Skull 8 hrs.
g. Pediatric 2 hrs.
h. Rules and Regulations 1 hr.
2. Clinical experience/supervision section. Individuals must complete either a or b below. If the individual is unable to demonstrate clinical competence in a procedure due to a lack of opportunity, the student shall complete the three prerequisite examinations required by appendix J using simulation for subdivisions a through k of subsection 1 of appendix J. Final demonstration of competence in subdivisions a through s of subsection 1 of appendix J should be completed as soon as there is a patient requiring the procedure. No individual may perform an unsupervised procedure for which they have not successfully completed the final demonstration of competence.
History: Effective January 1, 2019.
Specific examinations that are allowed in the scope of practice for limited x-ray machine operators.
| Chest: | PA, lateral, decubitus |
|---|---|
| Ribs: | AP, PA, obliques |
| Abdomen: | KUB, upright abdomen |
| Hand & fingers: | PA, lateral, oblique |
| Wrist: | PA, lateral, oblique |
| Forearm: | AP, lateral |
| Elbow: | AP, lateral |
| Humerus: | AP, lateral |
| Shoulder: | AP, internal & external rotation, y-view |
| Clavicle: | AP, AP axial |
| Pelvis: | AP |
| Hips: | AP, frog leg lateral, cross-table lateral |
| Femur: | AP, lateral |
| Knee: | AP, lateral, obliques |
| Patella: | AP, lateral, sunrise |
| Tibia-Fibula: | AP, lateral |
| Ankle: | AP, lateral, obliques |
| Calcaneous: | Plantodorsal, lateral |
| Foot & toes: | AP, lateral, obliques |
| Sinuses: | Water's, lateral |
| Skull: | AP/PA, lateral |
| Facial bones: | PA, lateral |
| Nasal bones: | Water's, lateral |
| C-spine: | AP, lateral, odontoid, (not trauma), swimmer's (not trauma) |
| T-spine: | AP, lateral, swimmer's (not trauma) |
| L-spine: | AP, lateral, L5-S1 lateral |
Any situation deemed an emergency and requiring a limited x-ray machine operator to conduct procedures not specifically listed above, requires a written order from an individual listed in part 3 of appendix G and direct supervision from the individual ordering the examination in accordance with item 1 of subparagraph c of paragraph 2 of subdivision a of subsection 1 of section 33.1-10-06-03.
History: Effective January 1, 2019.
An individual must perform at least three examinations prior to requesting a final competency evaluation for each of the limited scope examinations listed in appendix I. The three pre-evaluation examinations should be on actual patients but may be simulated if there is an insufficient number of patients requiring the procedure during the students clinical competency training period. The evaluations shall be documented on forms provided by the department. The final competency evaluation must be on an actual patient. To pass a final competency evaluation, the individual must receive an acceptable rating in each of the criteria listed below.
1. At a minimum, the following criteria must be evaluated during a procedure and image competency evaluation involving an actual patient. Simulated procedures need to evaluate only subdivisions a through k below:
a. Select appropriate film size.
b. Select appropriate technique.
c. Use correct source-to-image distance.
d. Establish proper direction of central ray.
e. Execute proper patient position.
f. Collimate if appropriate.
g. Provide gonadal shielding if appropriate.
h. Use correct film markers.
i. Give proper patient instruction.
j. Place patient information correctly on the film.
k. Complete examination in an acceptable time limit.
l. All anatomical parts included on the film.
m. Correct positioning of anatomical parts.
n. Appropriate contrast.
o. Adequate density.
p. Correct use of right and left markers.
q. Proper accessory markers as needed.
r. No visible motion.
s. Patient information correct and clearly visible.
2. If the individual is unable to demonstrate clinical competence while completing the requirements for clinical supervision in either subdivision a or b of subsection 2 of appendix H due to a lack of opportunities to conduct certain procedures, the student shall complete the three prerequisite examinations using simulation for subdivisions a through k of subsection 1. Final demonstration of competence in subdivisions a through s of subsection 1 should be
completed as soon as there is a patient requiring the procedure. No individual may perform an unsupervised procedure for which they have not successfully completed the final demonstration of competence.
History: Effective January 1, 2019.
Continuing education units (CEUs) are required for all limited x-ray machine operators and general diagnostic operators as defined by subparagraphs a and b of paragraph 2 of subdivision a of subsection 1 of section 33.1-10-06-03 of the North Dakota radiological health rules. Continuing education unit requirements will be associated with a two-year cycle (biennium).
1. General diagnostic operators shall obtain a minimum of 24 CEUs per biennium.
2. Limited x-ray machine operators shall obtain a minimum of 12 CEUs per biennium.
3. Units from one biennium cannot be carried forward or applied to the following biennium.
4. Determining the beginning of a biennium. a. For limited x-ray machine operators and general diagnostic operators not certified through an accrediting body, the biennium will begin January 1, 2009. b. For general diagnostic operators certified through an accrediting body, the biennium will be defined by the registration requirements through their accrediting body and shall begin on the first due date following January 1, 2009.
5. Continuing education unit activities must be approved by an accrediting body.
History: Effective January 1, 2019.