| (i) Each veterinarian possessing a therapeutic radiation
machine, a simulator, or an electronic brachytherapy device shall
apply for and receive a certificate of registration from the agency
before using the device for veterinary use. A person may energize
the device for purposes of installation and acceptance testing before
receiving a certificate of registration from the agency.
(ii) The registrant for veterinary use of a therapeutic
radiation machine, a simulator, or an electronic brachytherapy device
shall be a veterinarian licensed by the Texas Board of Veterinary
Medical Examiners.
(iii) Operators of the therapeutic radiation machine,
simulator, or electronic brachytherapy device shall:
(I) complete device-specific training with a training
program provided by the manufacturer; or
(II) complete training received that is substantially
equivalent to the manufacturer's training program from a licensed
medical physicist who is trained to use the device; and
(III) retain a record of each individual's device specific
training by the registrant in accordance with subsection (k) of this
section for inspection by the agency.
(iv) Each facility shall develop a quality assurance
program in writing or in an electronic reporting system. The quality
assurance program shall be implemented as a method of minimizing deviations
from facility procedures.
(I) The quality assurance program shall include the
following topics:
(-a-) Occupational and public radiation safety during
simulation; and
(-b-) Occupational and public radiation safety during
treatment.
(II) Deviations from the operating and safety procedures
shall be investigated and brought to the attention of the veterinarian
and the RSO.
(III) The review of the quality assurance program shall
be conducted at intervals not to exceed 14 months.
(v) Written operating and safety procedures shall be
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics and shall include any restrictions required for
the safe operation of the particular therapeutic radiation device.
These procedures shall be available in the control area of the therapeutic
radiation device. The operators shall be able to demonstrate familiarity
with these procedures. These procedures shall include the following:
(I) therapeutic radiation machines shall not be left
unattended unless secured by a locking device which will prevent unauthorized
use (A computerized password system would also constitute a locking
device);
(II) when there is a need to immobilize an animal or
port film for radiation therapy, mechanical supporting or restraining
devices shall be used;
(III) no individual, other than the animal, shall be
in the treatment room during exposures from therapeutic radiation
machines operating above 150 kV;
(IV) at energies less than or equal to 150 kV, any
individual in the treatment room shall be protected by a barrier sufficient
to meet the requirements of §289.231(m) of this title;
(V) radiation dose requirements in accordance with §289.231(m)
of this title;
(VI) personnel monitoring requirements in accordance
with §289.231(m) of this title;
(VII) use of protective devices for simulators in accordance
with paragraph (3)(H) of this subsection;
(VIII) procedures for restriction and alignment of
beam for simulators in accordance with paragraph (5)(G) of this subsection.
(vi) The registrant shall perform radiation surveys
and contamination smears before the transfer or disposal of an accelerator
operating at or above 10 MeV. Such surveys shall be documented and
maintained by the registrant for inspection by the agency in accordance
with subsection (k)(2) of this section.
(B) Therapeutic radiation machines capable of operating
at energies below 1 MeV.
(i) Equipment requirements.
(I) When the tube is operated at its leakage technique
factors, the leakage radiation shall not exceed the values specified
at the distance stated for the classification of that radiation machine
system shown in the following Table II. The leakage technique factors
are the maximum-rated peak tube potential and the maximum-rated continuous
tube current for the maximum-rated peak tube potential.
Attached Graphic
(II) Permanent fixed diaphragms or cones used for limiting
the useful beam shall provide the same or a higher degree of protection
as required for the tube housing assembly.
(III) Removable and adjustable beam-limiting devices
shall meet the following requirements.
(-a-) Removable beam-limiting devices shall, for the
portion of the useful beam to be blocked by these devices, transmit
not more than 1.0 percent of the useful beam at the maximum kVp and
maximum treatment filter. This requirement does not apply to auxiliary
blocks or materials placed in the x-ray field to shape the useful
beam to the individual animal.
(-b-) Adjustable beam-limiting devices installed before
March 1, 1989, shall, for the portion of the x-ray beam to be blocked
by these devices, transmit not more than 5.0 percent of the useful
beam at the maximum kVp and maximum treatment filter.
(-c-) Adjustable beam-limiting devices installed after
March 1, 1989, shall meet the requirements of subclause (I) of this
clause.
(IV) The filter system shall be so designed that:
(-a-) the filters cannot be accidentally displaced
at any possible tube orientation;
(-b-) for equipment installed after March 1, 1989,
an interlock system prevents irradiation if the proper filter is not
in place;
(-c-) the radiation at 5 cm from the filter insertion
slot opening does not exceed 30 roentgens per hour (R/hr) (300 mGy/hr)
under any operating conditions; and
(V) The tube housing assembly shall be so marked that
it is possible to determine the location of the focal spot to within
5 millimeters (mm), and such marking shall be readily accessible for
use during calibration procedures.
(VI) Contact therapy tube housing assemblies shall
have a removable shield of at least 0.5 mm lead equivalency at 100
kVp that can be positioned over the entire useful beam exit port during
periods when the beam is not in use.
(VII) The timer shall:
(-a-) have a display provided at the treatment control
panel and a pre-set time selector; and
(-b-) not permit an exposure if set at zero;
(VIII) The control panel, in addition to the displays
required in subclause (VII)(-a-) of this clause, shall have the following:
(-a-) an indication of whether electrical power is
available at the control panel and if activation of the x-ray tube
is possible;
(-b-) an indication of whether x-rays are being produced;
(-c-) means for indicating x-ray tube potential and
current;
(-d-) means for terminating an exposure at any time;
(-e-) a locking device that will prevent unauthorized
use of the therapeutic radiation system (a computerized password system
would also constitute a locking device); and
(-f-) emergency buttons/switches that shall be clearly
labeled as to their functions.
(IX) There shall be means of determining initially
the SSD to within 1 cm.
(X) An indication of shutter position, if applicable,
shall appear at the control panel.
(ii) Facility Requirements
(I) Each installation shall be provided with primary
and secondary barriers as are necessary to assure compliance with §289.231(m)
of this title. All protective barriers shall be fixed except for entrance
doors or beam interceptors.
(II) For therapeutic radiation systems capable of operation
above 150 kVp.
(-a-) The control panel shall be located outside the
treatment room or in an enclosed booth inside the room.
(-b-) Interlocks shall be provided such that all entrance
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
irradiation by manual action at the control panel.
(iii) Surveys, Calibrations and Spot Checks.
(I) Surveys shall be performed as follows.
(-a-) All new and existing facilities not previously
surveyed shall have an initial survey made by a licensed medical physicist
with a specialty in therapeutic radiological 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 Cont'd... |
