| (ii) A signal audible to the fluoroscopist shall indicate
the completion of any preset cumulative on-time. Such signal shall
continue to sound while x rays are produced until the timing device
is reset. In lieu of such signal, the timer shall terminate the beam
after the preset cumulative on-time is completed.
(B) Fluoroscopic systems manufactured on or after June
10, 2006 shall meet the following requirements.
(i) A display of the irradiation time visible to the
fluoroscopist shall meet the following requirements.
(I) When the x-ray tube is activated, the fluoroscopic
irradiation time in minutes and tenths of minutes shall be continuously
displayed and updated at least every 6 seconds.
(II) The fluoroscopic irradiation time shall also be
displayed within 6 seconds of termination of an exposure, and remain
displayed until reset.
(ii) Means shall be provided to display the last-image-hold
(LIH) image following the termination of the fluoroscopic exposure.
(iii) A display of the exposure rate (air kerma rate)
as well as the cumulative exposure (cumulative air kerma) shall be
displayed at the fluoroscopist's working position and shall meet the
following requirements.
(I) The display of the exposure rate (air kerma rate)
shall be clearly distinguishable from the cumulative exposure (cumulative
air kerma).
(II) Means shall be provided to reset to zero the display
of cumulative exposure (cumulative air kerma) prior to the beginning
of a new examination or procedure.
(iv) A signal audible to the fluoroscopist shall sound
for each passage of 5 minutes of irradiation time during an examination
or procedure. The signal shall sound until manually reset, or if automatically
reset, for at least 2 seconds.
(8) Control of scattered radiation.
(A) Fluoroscopic system configuration, including fluoroscopic
table designs, shall not permit any portion of any individual's body,
except the head, neck, and extremities, to be exposed to scattered
radiation emanating from above or below the tabletop unless the radiation
has passed through not less than a total of 0.25 mm lead equivalent
material. The material may be, but is not limited to, drapes, self-supporting
curtains, or viewing shields, in addition to any lead equivalency
provided by a protective apron.
(B) Where sterile fields or special procedures prohibit
the use of normal protective barriers or drapes, all of the following
conditions shall be met.
(i) All persons, except the patient, in the room where
fluoroscopy is performed shall wear protective aprons that provide
a shielding equivalent of 0.35 mm of lead.
(ii) The fluoroscopic field size shall be reduced to
the absolute minimum required for the procedure being performed (area
of clinical interest).
(iii) Operating and safety procedures shall reflect
the above conditions, and fluoroscopy personnel shall exhibit awareness
of situations requiring the use and/or nonuse of the protective drapes.
(C) For image-intensified fluoroscopic systems with
only a manual mode of collimation, the x-ray field produced shall
be limited to the area of the spot-film cassette at 16 inches above
tabletop. Additionally, during fluoroscopy, the beam shall be restricted
to the area of the input phosphor.
(9) Radiation protocol committee (RPC) for fluoroscopically-guided
interventional (FGI) procedures.
(A) Development of a RPC.
(i) Each registrant utilizing FGI procedures shall
develop a RPC in accordance with the following.
(I) The registrant may establish a system-wide committee
if the registrant has more than one site.
(II) One or more registrant may form a cooperative
RPC as long as each facility has a representative on the committee.
(III) If the registrant has already established a radiation
safety committee, the requirements of this subsection may be delegated
to that committee if the members meet the requirements of subparagraph
(B) of this paragraph.
(IV) The committee shall meet as often as necessary
to conduct business but no less than once every 14 months.
(V) Interim meetings may be conducted by electronic
means.
(ii) The registrant shall make a record of each RPC
meeting to include the date, names of individuals in attendance, minutes
of the meeting, and any actions taken. The registrant shall maintain
the record in accordance with subsection (s)(1) of this section for
inspection by the agency.
(B) Members required for the RPC. Members shall include
but not be limited to the following individuals:
(i) a licensed physician of the healing arts who meets
the requirements in subparagraph (E) of this paragraph;
(ii) a licensed medical physicist;
(iii) the RSO; and
(iv) other individuals as deemed necessary by the registrant.
(C) Establish and implement FGI procedure protocols.
(i) The RPC shall establish and implement written protocols,
or protocols documented in an electronic report system, that include
but are not limited to the following.
(I) A restriction of the use of fluoroscopic systems
for interventional purposes to radiologists, radiation oncologists,
physicians, as well as individuals to whom a physician has delegated
authority pursuant to the Occupations Code, Chapter 601, and the applicable
rules of the Texas Medical Board, who have completed the radiation
safety awareness training as required in subparagraph (E) of this
paragraph.
(II) A method to be used to monitor the radiation exposure.
(III) A recommended reference level for FGI procedures
performed.
(IV) Actions to be taken for cases when the reference
level was exceeded which may include patient follow-up.
(V) A review of the established protocol at an interval
not to exceed 14 months.
(ii) The registrant shall make and maintain a record
of each RPC protocol in accordance with subsection (s)(1) of this
section for inspection by the agency. If the RPC revises a protocol,
the registrant shall maintain the previous documentation after the
revision in accordance with subsection (s)(1) of this section for
inspection by the agency.
(D) Procedures for maintaining records.
(i) The registrant shall make and maintain a record
of radiation output information so the radiation dose to the skin
may be estimated in accordance with established protocols. The record
shall include the following:
(I) patient identification;
(II) type and date of examination;
(III) identification of the fluoroscopic system used;
and
(IV) cumulative air kerma or dose area product used
if the information is available on the fluoroscopic system.
(ii) If the cumulative air kerma or dose area product
are not displayed on the fluoroscopic system, records shall include
other information necessary to estimate the radiation dose to the
skin in accordance with established protocol or the following as necessary:
(I) fluoroscopic mode, such as, high-level or pulsed
mode of operation;
(II) cumulative fluoroscopic exposure time; and
(III) number of films or recorded exposures.
(iii) The registrant shall maintain records required
by this subparagraph in accordance with record retention policies
of the facility.
(E) Radiation safety awareness training. Physicians,
other than radiologists and radiation oncologists, as well as individuals
to whom a physician has delegated authority pursuant to the Occupations
Code, Chapter 601, and the applicable rules of the Texas Medical Board,
shall complete a minimum of 8 hours of Category 1 CMEU in radiation
safety awareness training prior to performing FGI procedures.
(i) The radiation safety awareness training shall include,
but not be limited to the following topics:
(I) principles of radiation protection;
(II) biological effects of x-ray radiation;
(III) principles of fluoroscopic systems;
(IV) operation of fluoroscopic systems used for interventional
purposes;
(V) fluoroscopic exposure (air kerma) outputs;
(VI) high level control options;
(VII) dose reduction techniques; and
(VIII) procedures for recording pertinent data specified
in subparagraph (D) of this paragraph.
(ii) In addition to the 8-hour Category 1 CMEU as required
in this subparagraph, the radiation safety awareness training shall:
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