(1) A person shall not make, sell, lease,
transfer, lend, or install x-ray equipment or the accessories used in
connection with x-ray equipment unless the accessories and equipment, if
properly placed in operation and properly used, will meet the applicable
requirements of Title R313.
(a) X-ray
equipment shall be FDA approved for use in the United States and shall be
certified in accordance with 21 CFR 1010.2 and identified in
accordance with 21 CFR
1010.3.
(2) The registrant shall be responsible for
directing the operation of the x-ray machines that are under the registrant's
administrative control. The registrant or registrant's agent shall assure that
the requirements of Subsections
R313-28-31(2)(a)
through R313-28-31(2)(i)
are met in the operation of the x-ray machines.
(a) If directed by the director an x-ray
machine that does not meet the the requirements of Rule R313-28 shall not be
operated for diagnostic purposes.
(b) Individuals who will be operating the
x-ray equipment shall be instructed in the registrant's written radiation
safety program and be qualified in the safe use of the equipment. Required
operator qualifications are listed in Section
R313-28-350.
(c) The registrant of a facility shall create
and make available to x-ray operators written safety procedures, including
patient holding and restrictions of the operating technique required for the
safe operation of the x-ray systems. Individuals who operate x-ray systems
shall be responsible for complying with the applicable requirements of Title
R313.
(d) Except for individuals
who cannot be moved out of the room and the patient being examined, only the
staff and ancillary personnel or other individuals needed for the medical
procedure or training shall be present in the room during the radiographic
exposure and shall be positioned as follows:
(i) individuals other than the patient shall
be positioned so that no part of the body will be struck by the useful beam
unless protected by not less than 0.5 mm lead equivalent material;
(ii) the x-ray operator, other staff,
ancillary personnel, and other individuals needed for the medical procedure
shall be protected from primary beam scatter by protective aprons or barriers
unless it can be shown that by virtue of distances employed, EXPOSURE levels
are reduced to the limits specified in Section
R313-15-201; and
(iii) patients who are not being examined and
cannot be removed from the room shall be protected from the primary beam
scatter by whole body protective barriers of not less than 0.25 mm 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 nearest edge of the
image receptor.
(e) For
patients who have not passed reproductive age, gonad shielding of not less than
0.5 mm lead equivalent material may be used during radiographic procedures when
the gonads are in the useful beam, except for cases when this would interfere
with the diagnostic procedure.
(f)
Individuals shall be exposed to the useful beam for healing arts purposes only
if the exposure has been specifically ordered and authorized by a licensed
practitioner of the healing arts after a medical consultation. Deliberate
exposures for the following purposes are prohibited:
(i) exposure of an individual for training,
demonstration, or other non-healing arts purposes except for low dose, whole
body scanners used for security purposes in correctional facilities;
and
(ii) exposure of an individual
for healing arts screening except as authorized by Subsection
R313-28-31(2)(i).
(g) If a patient or film must be provided
with auxiliary support during a radiation exposure:
(i) mechanical holding devices shall be used
if the technique permits. The written procedures, required by Subsection
R313-28-31(2)(c),
shall list individual projections where mechanical holding devices can be
utilized;
(ii) written safety
procedures, as required by Subsection
R313-28-31(2)(c),
shall indicate the requirements for selecting an individual to hold patients or
films and the procedure that individual shall follow;
(iii) the individual holding patients or
films during radiographic examinations shall be instructed in personal
radiation safety and protected as required by Subsection
R313-28-31(2)(d)(i);
(iv) Individuals shall not be used routinely
to hold film or patients;
(v) In
those cases when the patient must hold the film, except during intraoral
examinations, portions of the body other than the area of clinical interest
struck by the useful beam shall be protected by not less than 0.5 mm lead
equivalent material; and
(vi)
Facilities shall have protective aprons and gloves available in sufficient
numbers to provide protection to personnel who are involved with x-ray
operations and who are otherwise not shielded.
(h) Personnel monitoring. Individuals who are
associated with the operation of an x-ray system are subject to the applicable
requirements of Rule R313-15.
(i)
Healing arts screening. A person proposing to conduct a healing arts screening
program shall not initiate the program without first receiving approval from
the director. When requesting approval, that person shall submit the
information outlined in Section
R313-28-400. If information
submitted becomes invalid or outdated, the director shall be notified
immediately.
(3)
Maintenance of records and information. The registrant shall maintain at least
the following information for each x-ray machine:
(a) model numbers of major
components;
(b) record of surveys
or calculations to demonstrate compliance with Section
R313-15-302, calibration,
maintenance and modifications performed on the x-ray machine; and
(c) a shielding design report for the x-ray
suite that states assumed values for workload and use factors and includes a
drawing of surrounding areas showing assumed values for occupancy
factors.
(4) X-ray
records. Facilities shall maintain an x-ray record containing the patient's
name, the types of examinations, and the dates the examinations were performed.
If the patient or film must be provided with human auxiliary support, the name
of the human holder shall be recorded. The registrant shall retain these
records for three years after the record is made.
(5) Portable or mobile equipment shall be
used only for examinations if it is impractical to transfer the patient to a
stationary radiographic installation.
(6) Hand-held medical x-ray systems. X-ray
equipment designed to be hand-held shall comply with Section
R313-28-31, excluding Subsection
R313-28-31(5),
and Section R313-28-52, excluding
Subsections R313-28-52(8)(b)(i)
and R313-28-52(8)(b)(ii).
(a) When operating hand-held equipment if it
is not possible for the operator to remain at least six feet from the x-ray
machine during x-ray exposure, protective aprons of at least 0.5 millimeter
lead equivalence shall be provided for the operator to protect the operator's
torso and gonads from backscatter radiation.
(b) In addition to the dose limits in Section
R313-15-301, operators of
hand-held x-ray equipment shall ensure that members of the public that may be
exposed to scatter radiation or primary beam transmission from the hand-held
device are not exposed above two milliroentgen per hour.
(i) Operators will ensure that members of the
public likely to be exposed to greater than two milliroentgen per hour will be
provided protective aprons of at least 0.5 millimeter lead equivalence or are
moved to a distance where the exposure rate to the individual is below two
milliroentgen per hour.
(c) In addition to the requirements of
Subsection R313-28-350(1),
each operator of hand-held x-ray equipment shall complete the training program
supplied by the manufacturer before using the x-ray unit. Records of training
shall be maintained on file for examination by an authorized representative of
the director.
(7)
Procedures and auxiliary equipment designed to minimize patient and personnel
exposure commensurate with the needed diagnostic information shall be utilized.
(a) The speed of the screen and film
combinations used shall be the fastest speed consistent with the diagnostic
objective of the examinations. Film cassettes without intensifying screens
shall not be used for routine diagnostic radiological imaging, with the
exception of standard film packets for intraoral use in dental radiography. If
the requirements of Subsection
R313-28-31(6)(a)
cannot be met, an exemption may be requested pursuant to Section
R313-12-55.
(b) The radiation exposure to the patient
shall be the minimum exposure required to produce images of good diagnostic
quality.
(c) X-ray systems, other
than fluoroscopic, computed tomography, dental, or veterinary units, shall not
be utilized in procedures if the source to patient distance is less than 30
centimeters.