North Dakota Administrative Code › Title 33.1 - Department of Environmental Quality › Article 33.1-10 - Radiological Health Rules › Chapter 33.1-10-06 - X-Rays in the Healing Arts › Section 33.1-10-06-03 - General requirements

Current through Supplement No. 393, July, 2024
1.
Administrative controls.
a.
				Registrant. The registrant shall be responsible for directing the operation of
				the x-ray systems which have been registered with the department. The
				registrant or the registrant's agent shall assure that the requirements are met
				in the operation of the x-ray system.
(1) An
				x-ray system which does not meet the requirements of this article shall not be
				operated for diagnostic or therapeutic purposes.
(2) All individuals, except those listed in
				part 1 of appendix G, prior to operating the x-ray systems shall be adequately
				instructed in the safe operating procedures and be competent in the safe use of
				the equipment commensurate with the size, scope, and nature of the service as
				outlined in appendix F. In addition, all individuals shall meet the specific
				requirements as outlined in subparagraph a or b. The department may use
				interview, observation, or testing to determine compliance. Records must be
				maintained by the registrant to demonstrate compliance with this paragraph.
(a) General diagnostic operators are not
				limited in scope of practice. Obtaining general diagnostic operator status will
				consist of one of the following:
[1] Obtain
				board eligibility or board certification with the American registry of
				radiologic technologists (ARRT);
[2] Obtain board eligibility or board
				certification with the American chiropractic registry of radiologic
				technologists (ACRRT); and only perform x-ray examinations for chiropractic
				services;
[3] Receive department
				approval, through individual consideration, by demonstration of an acceptable
				level of education and clinical training; or
[4] Demonstrate current enrollment in an
				educational program accredited by a process acceptable to the department, and
				provide documentation of competency in all routine radiographic procedures and
				specialty views.
(b)
				Limited x-ray machine operators are limited in scope of practice to only those
				procedures listed in appendix I, except as allowed in subparagraph c. Limited
				x-ray machine operators must meet the prerequisite qualifications, receive
				training, and demonstrate competence as follows:
[1] Limited x-ray machine operators shall
				have successfully completed the course of training required by one of the
				allied health professions listed in part 2 of appendix G;
[2] Complete at least eighty hours of
				didactic instruction at a single training program providing didactic
				instruction in accordance with part 1 of appendix H;
[3] Complete the three hour self-study course
				designed by the department of environmental quality; and
[4] Complete the clinical experience
				requirements in part 2 of appendix H.
(c) Limited x-ray machine operators may only
				conduct diagnostic x-ray examinations outside the scope of practice of appendix
				I in accordance with the following:
[1] When
				it is determined to be an emergency and ordered by individuals listed in part 3
				of appendix G. The individual requesting the procedures must comply with
				subitems a, b, and c.
[a] The requesting
				individual must provide a written order specifying what types of diagnostic
				x-ray examinations outside the scope of procedures listed in appendix I are
				requested. The order shall contain an explanation of the emergency nature or
				medical reason for the order.
[b]
				The requesting individual must provide direct supervision during the time the
				x-ray image is obtained.
[c] The
				facility must keep records of all emergency x-ray procedures ordered under this
				subparagraph.
[2] When a
				practice requires a specific view or examination outside the scope of practice
				listed in appendix I to be conducted on a routine basis, and the facility has
				only limited x-ray machine operators, application may be made to the department
				requesting approval for a limited x-ray machine operator to perform the
				procedure. This allowance shall be limited to the facility, the specific
				individual, and the procedure requested. After an allowance has been granted,
				reapplication and reauthorization are not necessary for the same procedure. The
				application for allowance should include the following:
[a] Documentation which demonstrates the need
				for the specific view;
[b]
				Documentation on forms supplied by the department indicating that each
				individual for which the request is made has demonstrated competence in the
				procedure; and
[c] Proof of
				additional didactic instruction or completion of examination as deemed
				necessary by the department for each individual.
[3] When it is not a computed tomography
				examination.
(d) Limited
				x-ray machine operator implementation period. Individuals who begin taking
				x-rays after one year from March 1, 2003, will have to meet all of the
				requirements of this paragraph before operating the x-ray system.
(3) General diagnostic
				and limited diagnostic x-ray operators shall maintain continuing education
				units as outlined in appendix K.
(4) A chart shall be provided in the vicinity
				of the diagnostic x-ray system's control panel, which specifies for all
				examinations performed with that system the following information:
(a) Patient's body part and anatomical size
				or body thickness, or age (for pediatrics), versus technique factors to be
				utilized.
(b) Type and size of the
				film or film screen combination to be used.
(c) Type and focal distance of the grid to be
				used, if any.
(d) Source-image
				receptor distance to be used (except for dental intraoral
				radiography).
(e) Type and location
				of placement of gonad shielding to be used.
(f) For mammography, indication of
				kVp/target/filter combination.
(5) The registrant of a facility shall create
				and make available to x-ray operators written safety procedures, including
				patient holding restrictions and any restrictions of the operating technique
				required for the safe operation of the particular x-ray system. The operator
				shall be able to demonstrate familiarity with these procedures.
(6) Except for human patients who cannot be
				moved out of the room, only the staff and ancillary personnel or other persons
				required for the medical procedure or training shall be in the room during the
				radiographic exposure. Other than the patient being examined:
(a) All individuals shall be positioned such
				that no part of the body will be struck by the useful beam unless protected by
				not less than five-tenths millimeter lead equivalent material.
(b) The x-ray operator, other staff,
				ancillary personnel, and other persons required for the x-ray procedure shall
				be protected from the direct scatter radiation by protective aprons or whole
				body protective barriers of not less than twenty-five one-hundredths millimeter
				lead equivalent material.
(c) Human
				patients who cannot be removed from the room shall be protected from the direct
				scatter radiation by whole body protective barriers of not less than
				twenty-five one-hundredths millimeter lead equivalent material or shall be so
				positioned that the nearest portion of the body is at least two meters from
				both the tube head and the nearest edge of the image receptor.
(7) Gonad shielding of not less
				than five-tenths millimeter lead equivalent material must be used for human
				patients who have not passed the reproductive age during radiographic
				procedures in which the gonads are in the useful beam, except for cases in
				which this would interfere with the diagnostic procedure.
(8) Individuals may not be exposed to the
				useful beam except for healing arts purposes and when such exposure has been
				authorized by a licensed practitioner of the healing arts. This provision
				specifically prohibits deliberate exposure for the following purposes:
(a) Exposure of an individual for training,
				demonstration, or other non-healing-arts purposes.
(b) Exposure of an individual for the purpose
				of healing arts screening except as authorized by paragraph 12.
(9) When a patient or film must be
				provided with auxiliary support during a radiation exposure:
(a) Mechanical holding devices shall be used
				when the technique permits. The safety rules, required by this section shall
				list individual projections where holding devices cannot be utilized.
(b) Written safety procedures, as required by
				paragraph 4, shall indicate the requirements for selecting a holder and the
				procedure the holder shall follow.
(c) The human holder shall be instructed in
				personal radiation safety and protected as required by paragraph 6.
(d) No individual shall be used routinely to
				hold film or patients.
(e) In those
				cases where the patient must hold the film, except during intraoral
				examinations, any portion of the body other than the area of clinical interest
				struck by the useful beam shall be protected by not less than five-tenths
				millimeter lead equivalent material.
(f) A record shall be made of the examination
				and shall include the name of the human holder, date of the examination, number
				of exposures, and technique factors utilized for the exposure.
(g) Each facility shall have leaded aprons
				and gloves available in sufficient numbers to provide protection to all
				personnel who are involved with x-ray operations and who are otherwise not
				shielded.
(10) Procedures
				and auxiliary equipment designed to minimize patient and personnel exposure
				commensurate with the needed diagnostic information shall be utilized. This is
				interpreted to include:
(a) The speed of film
				and screen combinations shall be the fastest speed consistent with the
				diagnostic objective of the examinations. Film cassettes without intensifying
				screens shall not be used for any routine diagnostic radiological imaging, with
				the exception of veterinary radiography, therapeutic portal imaging, and
				standard film packets for intraoral use in dental radiography.
(b) The radiation exposure to the patient
				shall be the minimum exposure required to produce images of good diagnostic
				quality.
(c) Proper film handling
				and processing procedures. Each installation using a radiographic x-ray system
				and using analog image receptors (e.g., radiographic film) shall have available
				suitable equipment for handling and processing radiographic film in accordance
				with appendix D.
(d) Portable or
				mobile equipment shall be used only for examinations where it is impractical to
				transfer the patients to a stationary x-ray installation.
(e) X-ray systems subject to section
				33.1-10-06-06 shall not be
				utilized in procedures where the source to patient distance is less than thirty
				centimeters, except for veterinary systems.
(f) If grids are used between the patient and
				the image receptor to decrease scatter to the film and improve contrast, the
				grid shall:
[1] Be positioned properly, for
				example, tube side facing the right direction and grid centered to the central
				ray; and
[2] If the grid is of the
				focused type, be of the proper focal distance for the source-image distances
				being used.
(11) All individuals who are associated with
				the operation of an x-ray system are subject to the requirements of section
				33.1-10-04.2-01 [
				10 CFR
				20.1201,
				20.1207,
				and
				20.1208
				]. In addition:
(a) When protective clothing
				or devices are worn on portions of the body and a monitoring device is
				required, at least one such monitoring device shall be utilized as follows:
[1] When an apron is worn, the monitoring
				device shall be worn at the collar outside of the apron.
[2] The dose to the whole body based on the
				maximum dose attributed to the most critical organ shall be recorded in the
				reports required by section
				33.1-10-04.2-01 [
				10 CFR
				20.2206 ]. If more than one device is used
				and a record is made of the data, each dose shall be identified with the area
				where the device was worn on the body.
(b) Exposure of a personnel monitoring device
				to deceptively indicate a dose delivered to an individual is
				prohibited.
(12) Healing
				arts screening. Any person proposing to conduct a healing arts screening
				program shall not initiate such a program without prior approval of the
				department. When requesting such approval, that person shall submit the
				information outlined in appendix E. If any information submitted to the
				department becomes invalid or outdated, the department shall be immediately
				notified.