Current through Register Vol. 18, September 20, 2024
(1)
Diagnostic x-ray systems, for use on humans, and their associated components
certified pursuant to the federal diagnostic x-ray standard shall be maintained
in compliance with applicable requirements of such standard as set forth in 21
CFR, chapter I, subchapter J, as revised on April 1, 2003. The department may
waive compliance with the specific requirements of this subchapter by an
existing machine or installation if the registrant demonstrates, to the
department's satisfaction, achievement through other means of radiation
protection equivalent to that required by this chapter.
(2) No person shall make, sell, lease,
transfer, lend or install x-ray equipment or the supplies used in connection
with such equipment unless such supplies and equipment, when properly placed in
operation and properly used, will meet the requirements of this chapter. This
includes responsibility for the delivery of cones or collimators, diaphragms
and adjustable diaphragms, filters, adequate timers, and fluoroscopic shutters,
where applicable.
(3) Personnel
monitoring shall be performed in controlled areas for each occupationally
exposed individual for a minimum of a 13-week period starting each January.
When a protective apron is worn, the monitoring device shall be worn at the
collar outside of the apron.
(4)
Safety requirements concerning the use of radiation sources are that:
(a) The registrant shall be responsible for
radiation safety. He is responsible for assuring that radiation sources under
his jurisdiction are used only by persons competent to use them. He is
responsible for providing the instruction of personnel in safe operating
procedures.
(b) A radiation safety
officer, who may be the registrant himself, shall be designated for every
installation and shall be approved by the department as per ARM
37.14.307(1) (b),
if other than a licensed member of the healing arts.
(c) The radiation safety officer shall:
(i) establish and supervise operating
procedures and review them periodically to assure their conformity with this
chapter;
(ii) provide personnel
with instruction on proper radiation protection practices;
(iii) conduct radiation surveys and source
leak tests where indicated and keep records of such surveys and tests,
including summaries of corrective measures recommended and/or
instituted;
(iv) assure that
personal monitoring devices are used where indicated and that records are kept
of the results of such monitoring;
(v) assure that interlock switches and
warning signals are functioning and that signs are properly located;
and
(vi) investigate each known or
suspected case of excessive or abnormal exposure to determine the cause and to
take steps to prevent its recurrence.
(d) The registrant shall provide safety rules
to each individual operating x-ray equipment under his control, including any
restrictions of the operating technique required for the safe operation of the
particular x-ray apparatus, and require that the operators demonstrate
familiarity with these safety rules.
(e) Deliberate exposure of an individual to
the useful beam for training or demonstration purposes shall not be permitted
unless there is also a medical or dental indication for the exposure and the
exposure is prescribed by a practitioner of the healing arts.
(5) The general shielding safety
requirements are as follows:
(a) Before
construction, the floor plans and equipment arrangement of medical
installations (new or modifications of existing installations) utilizing x-rays
for diagnostic or therapeutic purposes shall be submitted to a qualified expert
for determination of shielding requirements consistent with National Council on
Radiation Protection (NCRP) and Measurements Reports No. 49 and 51, and 10 CFR
part 20, as revised on January 1, 2003.
(b) A letter shall be submitted by the
qualified expert to the department within 30 days of the project completion.
The letter must contain at least the following information:
(i) name, address and credentials of the
qualified expert;
(ii) facility
site name, address and telephone number;
(iii) facility owner's name, address and
telephone number;
(iv) date of
installation;
(v) name and address
of the manufacturer; or
(vi) if a
used or reconditioned device is installed, the name and address of the previous
facility or the owner of origin.
(c) Each installation shall be provided with
such primary protective barriers and/or secondary protective barriers as are
necessary to assure compliance with ARM
37.14.705,
37.14.708 and
37.14.709. This requirement shall
be deemed to be met if the thickness of such barriers are equivalent to those
as computed by a qualified expert and are consistent with the NCRP Reports No.
49 and 51 and 10 CFR part 20, as revised on January 1, 2003.
(d) Lead barriers shall be bonded to panels
of rigid supporting material in such a manner that they will not sag or
cold-flow because of their own weight and shall be protected against mechanical
damage. Lead shielding less than one mm thick shall be bonded to panels of some
rigid supporting material. The minimum allowable thickness of lead is 0.79mm
(1/32 inches or two pounds per square foot).
(e) Joints between different kinds of
protective materials shall be so designed that the overall protection afforded
by the barrier is not impaired.
(f)
Joints at the floor and ceiling shall be so designed that the overall
protection is not impaired.
(g)
Windows, window frames, doors, and door frames shall have the same lead
equivalent as that required of the adjacent wall.
(h) Holes in protective barriers shall be
covered so that overall protection is not impaired.
(6) For new and modified installations only,
the following are minimum design requirements for medical x-ray machine
operator booths in conjunction with ARM
37.14.1006,
37.14.1010,
37.14.1011,
37.14.1012,
37.14.1020,
37.14.1021 and
37.14.1022. The requirements
specified under (6), (7), (8) and their subsections do not apply to podiatry
and veterinary installations. The requirements specified under (6) through (6)
(b) (iii), (6) (d) through (6) (f) (ii) do not apply to dental installations.
See (7) and (8) for dental panoramic and cephalometric requirements.
(a) The operator shall be allotted 0.7 sq.
meters (7.5 sq. ft.) or more of unobstructed floor space in the x-ray booths.
(i) The 0.7 sq. meters (7.5 sq. ft.) of
minimum space specified under (6) (a) shall be a geometric configuration where
no dimension is less that 61.0 centimeters (2.0 ft.).
(ii) The allotted space shall exclude an
encumbrance by the console, such as an overhang, cables or other similar
encroachment.
(iii) An extension of
straight line drawn between any point on the edge of the booth shielding and
the nearest vertical edge of a vertical cassette holder, corner of the
examination table or any part of the tube housing assembly shall not impinge on
the unobstructed space.
(iv) The
booth walls shall be 2.1 meters high (7.0 ft.) or more and shall be permanently
fixed.
(v) When a door or moveable
panel is used as the integral part of the booth structure, it must have a
permissive device, which will prevent an exposure when the door panel is not
closed.
(b) The
operator's switch for the radiographic machine shall be fixed within the booth.
The switch shall:
(i) be located so that it
is impossible to make an exposure when the operator is outside of the protected
area;
(ii) allow the operator to
use the available viewing windows; and
(iii) be constructed so that a single
depression by the operator will provide a single exposure and that continuous
pressure by the operator does not provide a continuous or multiple
exposure.
(c) Each booth
shall have at least one viewing device, which shall:
(i) be placed so the operator can have full
view of the entries into the room; and
(ii) be placed so that the operator can view
the patient during exposure.
(d) When the viewing system is a window, the
following requirements also apply:
(i) the
window shall have a visible area of 930 square centimeters (1.0 square foot) or
more; and
(ii) the glass shall have
the same lead equivalence or more as that required in the booth's wall where
the glass is mounted.
(e) When the viewing system is by mirrors,
the mirrors shall be located to accomplish the general requirements under (6)
(c).
(f) When the viewing system is
by electronic means (for example, tv) :
(i)
the camera shall be located to accomplish the general requirements under (6)
(c); and
(ii) there shall be an
alternative viewing system as a backup for electronic failure.
(7) Dimensions of
primary beam shielding shall exceed the largest possible beam size by 30.5
centimeters (1.0 foot) or more in every direction. Cephalometric primary beam
shielding shall be deemed adequate if, for a maximum workload of 20 films a
week, two-pound lead is installed (for occupied areas).
(8) A viewing device shall be present in
dental panoramic and cephalometric x-ray installations, so that the
requirements of (6) (c) are met.
(9) National Council on Radiation Protection
and Measurements Reports No. 49 and 51, 10 CFR part 20, as revised on January
1, 2003 and 21 CFR, chapter I, subchapter J, as revised on April 1, 2003, are
incorporated into this chapter by this reference. The reports and CFR pertain
to requirements for radiation protection and measurements. Copies of National
Council on Radiation Protection and Measurements Reports No. 49 and 51, 10 CFR
part 20 and 21 CFR, chapter I, subchapter J are available for viewing at the
Department of Public Health and Human Services, Quality Assurance Division,
Licensure Bureau, 2401 Colonial Drive, Helena, MT.
Sec.
50-79-201,
50-79-202,
50-79-204,
75-3-201 and
75-3-204,
MCA; IMP, Sec.
50-79-101,
50-79-102,
50-79-103,
50-79-104,
50-79-105,
50-79-106,
50-79-107,
50-79-108,
50-79-201,
50-79-202,
50-79-203,
50-79-204 and
75-3-201,
MCA;
