Texas Register, Volume 36, Number 31, Pages 4863-5046, August 5, 2011 Page: 909
4863-5046 p. ; 28 cm.View a full description of this periodical.
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than that of the tube housing assembly. After the unit is at operating
parameters, the shutter shall be controlled electrically by the operator
from the control panel. An indication of shutter position shall appear
at the control panel.
(xii) (No change.)
(B) (No change.)
(C) Additional facility requirements for therapeutic ra-
diation systems capable of operation above 150 kVp.
(i) - (ii) (No change.)
(iii) Interlocks shall be provided such that all en-
trance doors shall be closed, including doors to any interior booths,
before treatment can be initiated or continued. If the radiation beam is
interrupted by any door opening, it shall not be possible to restore the
machine to operation without closing the door and reinitiating irradia-
tion by manual action at the control panel. When any door is opened
while the x-ray tube is activated, the exposure at a distance of 1 m [-1
meter (m-)] from the source shall be reduced to less than 100 mR/hr
(1mGy/hr).
(D) Surveys, calibrations, and spot checks[, and addi-
tional operating predures].
(i) Surveys shall be performed as follows.
(I) All new and existing facilities not previously
surveyed shall have an initial [a] survey made by a licensed medical
physicist with a specialty in therapeutic radiological physics [er med-
iet health physics], who shall provide a written report of the survey
to the registrant. Additional surveys shall be done after any change in
the facility, facility design, or equipment that might cause a significant
increase in radiation hazard.
(II) The registrant shall maintain a copy of the
initial survey report and all subsequent survey reports required by sub-
clause (I) of this clause in accordance with subsection (1 [(k)] of this
section for inspection by the agency.
(III) (No change.)
(ii) Calibrations shall be performed as follows.
(I) The calibration of a therapeutic radiation sys-
tem shall be performed at intervals not to exceed 1 [one] year and after
any change or replacement of components that could cause a change
in the radiation output. The calibrations shall be such that the dose at
a reference point in a water or plastic phantom can be calculated to
within an uncertainty of 5.0%.
(II) (No change.)
(III) The calibration of the therapeutic radiation
system shall include, but not be limited to, the following determina-
tions:
(-a-) verification that the radiation therapy
system is operating in compliance with the design specifications;
(-b-) (No change.)
(-c-) the exposure rates (air kerma rates) as a
function of field size, technique factors, filter, and treatment distance
used; and
(-d-) (No change.)
(IV) Calibration of the radiation output of a ther-
apeutic radiation system shall be performed with a calibrated dosimetry
system. The dosimetry system calibration [shal4 be- calibrated within
the previous 24 months and] shall be traceable to a national standard.
The calibration interval shall not exceed 24 months. [During the alen-
dar year in which the dsimetry system is net ~ ,tlia~ t- an interem-a i-son teo a system eaibrate within the previous 2 months shall be
(V) Records of calibration measurements speci-
fied in clause (ii) of this subparagraph shall be maintained by the regis-
trant in accordance with subsection (1) [(k)] of this section for inspec-
tion by the agency.
(VI) (No change.)
(iii) Spot checks shall be performed on therapeutic
radiation systems capable of operation at greater than 150 kVp. Such
measurements shall meet the following requirements.
(I) The spot check procedures shall be in writing,
or documented in an electronic reporting system, and shall have been
developed by a licensed medical physicist with a specialty in therapeu-
tic radiological physics.
(II) If a licensed medical physicist does not per-
form the spot check measurements, the results of the spot check mea-
surements shall be reviewed by a licensed medical physicist with a spe-
cialty in therapeutic radiological physics within 5 [five] treatment days
and a record made of the review. If the output varies by more than 5.0%
from the expected value, a licensed medical physicist with a specialty
in therapeutic radiological physics shall be notified immediately.
(III) - (V) (No change.)
(VI) Records of written spot checks and any nec-
essary corrective actions shall be maintained by the registrant in ac-
cordance with subsection (1) [k)] of this section for inspection by the
agency. A copy of the most recent spot check shall be available at a
designated area within the therapy facility housing that therapeutic ra-
diation system.
(VII) Spot checks shall be obtained using a sys-
tem satisfying the requirements of clause (ii)(IV) of this subparagraph
[or tht has ee intereompared with a system meeting those require-
[(a hIn addition t te items listed i paragraph
ft)(D) of this subseetion' operating and safety proeeeures sha e
include procedures to ensure the following requirements are met.]
[f- -Therapeutie radiation systems shall not be
ft unattended unless the system is secured against unauthorized use]
f T ,Restraining r 1me1tcianical suppo ing de-
vices shall be used when a patient or port film must be immobilized
in psitien fe radiation therapy
[f-t% The tube ousig assembly shall not be
held by hand during operation uness the system is designed to require
suc holding and the peak tube potential of -the system does not exceed
50 kVp In such eases the holder shall wear protetive gloes atnd
apren ef int less than - mm lead equivaleney at 4100 kVp-]
[I ethapeiradiatiosystemsrat4n
at r below 450 kVp no individual other than the patient shal4 be in the
treatment reom unless such individual is protected by a barrier suffi-
eient to meet the requirements of $29.234-(C) of this titl e iNo divid-
sat ether than the patient shal be in the treatment room during xpe-
be used th-e admistration ef radiation therapy unless the require-
ments f e .ses (ii) and (i4ii)(V f this subparagraph have been met ]
(3) Therapeutic radiation machines capable of operating at
energies of 1 MeV and above.PROPOSED RULES August 5, 2011
36 TexReg 4909
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Texas. Secretary of State. Texas Register, Volume 36, Number 31, Pages 4863-5046, August 5, 2011, periodical, August 5, 2011; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth181367/m1/90/: accessed May 21, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.