| (D) The registrant shall document that each individual
operating a radiation machine has read the operating and safety procedures
at least annually and shall maintain this documentation for inspection
by the agency. The documentation shall include the following:
(i) name and signature of individual;
(ii) date individual read the operating and safety
procedures; and
(iii) initials of the RSO.
(3) Occupational dose limits and personnel monitoring.
Except as otherwise exempted, all individuals who are associated with
the operation of a radiation machine are subject to the occupational
dose limits of §289.231(m) of this title regarding dose limits
to individuals, and the personnel monitoring requirements of §289.231(n)
of this title.
(4) Protective devices. Protective devices shall be
utilized when required, as in paragraphs (8)(B) and (C), (10), and
(13) of this subsection, and subsection (m)(8) of this section.
(A) Protective devices shall be of no less than 0.25
millimeter (mm) lead equivalent material except as specified in paragraph
(13) of this subsection and subsection (m)(8)(B)(i) of this section.
(B) Protective devices, including aprons, gloves, and
shields shall be checked annually for defects such as holes, cracks,
and tears. These checks may be performed by the registrant by visual
or tactile means, or x-ray imaging. If a defect is found, protective
devices shall be replaced or removed from service until repaired.
A record of this test shall be made and maintained by the registrant
in accordance with subsection (s)(1) of this section for inspection
by the agency.
(5) Operator credentialing. Individuals who operate
radiation machines for human use shall meet the appropriate credentialing
requirements of rules issued in accordance with the Medical Radiologic
Technologist Certification Act, Texas Occupations Code, Chapter 601.
Copies of the credentialing document shall be maintained at the location(s)
where the individual is working.
(6) Practice of medical physics. Surveys, tests, or
evaluations required by this section may constitute the practice of
medical physics and, therefore, require a license from the Texas Board
of Licensure for Professional Medical Physicists in accordance with
the Medical Physics Practice Act, Texas Occupations Code, Chapter
602.
(7) Exposure of individuals other than the patient.
No individual other than a patient, operator, and ancillary personnel
shall be in the x-ray room or area while exposures are being made
unless such individual's assistance is required.
(8) Holding of patient or image receptor.
(A) When a patient or image receptor must be held in
position during radiography, mechanical supporting or restraining
devices shall be used when the exam permits.
(B) If a patient or image receptor must be held by
an individual during an exposure, that individual shall be protected
with appropriate shielding devices described in paragraph (4) of this
subsection.
(C) In those cases where the patient must hold the
image receptor, any portion of the body other than the area of clinical
interest struck by the useful beam shall be protected by not less
than 0.25 mm lead equivalent material.
(9) Viewing system and contact with patient.
(A) Windows, mirrors, closed circuit television, or
another method shall be provided to permit the operator to continuously
observe the patient during irradiation.
(B) The operator shall be able to maintain verbal,
visual, and aural contact with the patient.
(10) Operator position. The operator position during
the exposure shall be such that the operator's exposure is as low
as reasonably achievable (ALARA) and the operator is a minimum of
6 feet from the source of radiation or protected by an apron, gloves,
or other shielding having a minimum of 0.25 mm lead equivalent material.
(11) Holding of tube. In no case shall an individual
hold the tube or tube housing assembly supports during any radiographic
exposure.
(12) Patient protection. Notwithstanding the provisions
of paragraph (7) of this subsection, other patients who are in line
with the primary beam and who cannot be removed from the room shall
be protected by whole body protective barriers of a minimum of 0.25
mm lead equivalent material or so positioned that the nearest portion
of their body is at least 6 feet from both the tube head and the nearest
edge of the image receptor.
(13) Gonadal shielding. Gonadal shielding shall be
used on patients when the gonads are in or within 5 cm of the useful
beam. This requirement does not apply if the shielding will interfere
with the diagnostic procedure. Gonadal shielding shall be of at least
0.5 mm lead equivalent material.
(14) Measurements of the radiation output for x-ray,
fluoroscopic, and CT systems. Measurements of the radiation output
of x-ray, fluoroscopic, and CT systems shall be performed with a calibrated
dosimetry system in accordance with the following.
(A) The dosimetry system calibration shall be traceable
to a national standard.
(B) Dosimetry systems shall be calibrated within 24
months from the date of the prior calibration.
(C) Measurements of radiation output shall be performed
with a dosimetry system that has been calibrated within the 24 months
preceding the date of the measurement.
(D) Record of the dosimetry system calibration shall
include:
(i) manufacturer's name, model and serial number of
each calibrated instrument;
(ii) date of the calibration; and
(iii) name of the individual recording the information.
(E) The registrant shall record the dosimetry system
calibration information specified in subparagraph (D)(i) - (iii) of
this paragraph and maintain that record in accordance with subsection
(s)(1) of this section for inspection by the agency.
(j) Radiographic entrance exposure (air kerma) limits.
The in-air exposure (air kerma) determined for the technique used
by the registrant for the specified average human adult patient thickness
for medical radiography shall not exceed the entrance exposure (air
kerma) limits in the following Table I.
Attached Graphic
(k) Machine requirements for general x-ray and fluoroscopic
systems.
(1) Warning label. The warning label will meet the
requirements of §289.231(z) of this title.
(2) Mechanical support of tube head. The tube housing
assembly shall be adjusted to remain stable during an exposure unless
tube housing movement is a designed function of the x-ray system.
(3) Battery charge indicator. On battery-powered x-ray
generators, visual means shall be provided on the control panel to
indicate whether the battery is in a state of charge adequate for
proper operation.
(4) Beam quality. The following requirements apply
to beam quality.
(A) Half-value layer.
(i) The half-value layer of the useful beam for a given
x-ray tube potential shall not be less than the values shown in the
following Table II. If it is necessary to determine such half-value
layer at an x-ray tube potential that is not listed in Table II, linear
interpolation may be made.
Attached Graphic
(ii) For capacitor energy storage equipment, compliance
with the requirements of this paragraph shall be determined with the
maximum quantity of charge per exposure.
(B) Filtration controls.
(i) For x-ray systems that have variable kVp and variable
filtration for the useful beam, a device shall link the kVp selector
with the filters and shall prevent an exposure unless the minimum
amount of filtration required by subparagraph (A) of this paragraph
is in the useful beam for the given kVp that has been selected.
(ii) Any other system having removable filters shall
be required to have the minimum amount of filtration as required by
subparagraph (A)(i) of this paragraph permanently located in the useful
beam during each exposure.
(5) Multiple tubes. Where two or more radiographic
tubes are controlled by one exposure switch, the tube or tubes that
have been selected shall be clearly indicated prior to initiation
of the exposure. This indication shall be both on the x-ray control
panel and at or near the tube housing assembly that has been selected.
(6) Technique and exposure indicators.
(A) The technique factors to be used during an exposure
shall be indicated before the exposure begins except when automatic
exposure controls are used, in which case the technique factors that
are set prior to the exposure shall be indicated.
(B) On x-ray systems having fixed technique factors,
the requirement of subparagraph (A) of this paragraph may be met by
permanent markings.
Cont'd... |
