Current through all regulations passed and filed through March 18, 2024
In addition to the rules in Chapters
3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with
paragraphs (A) to (L) of this rule.
(A) Therapy equipment subject to the rules in
Chapter 3701:1-67 of the Administrative Code shall be provided with such
primary and secondary barriers as are necessary to ensure compliance with rules
3701:1-38-12
and
3701:1-38-13
of the Administrative Code which prescribe occupational and public dose limits
respectively. Specifically:
(1) All wall,
floor, and ceiling areas struck by the useful beam shall have primary barriers;
and
(2) Secondary barriers shall be
provided in all wall, floor, and ceiling areas not having primary
barriers.
(B) Treatment
room design shall provide for:
(1) Continuous
two-way aural communication between the patient and the operator at the control
panel; and
(2) Continuous
observation of the patient during irradiation. This viewing system shall be so
located that the operator can observe the patient from the control panel.
Therapy equipment shall not be used for patient irradiation unless at least one
viewing system is operational.
(C) For therapy equipment operating above
150kV, treatment rooms shall meet the following:
(1) All protective barriers shall be fixed,
except for entrance access doors to the treatment room or movable beam
interceptors;
(2) The control panel
shall be located outside the treatment room or in a totally enclosed booth,
which has a ceiling, inside the room; and
(3) Interlocks shall be provided such that
all entrance doors, including doors to any interior booths if applicable, shall
be closed 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.
(D) For therapy equipment operating at or
above one MV, treatment rooms shall meet the following:
(1) In addition to other requirements
specified in Chapter 3701:1-67 of the Administrative Code, the control panel
shall:
(a) Be located outside the treatment
room;
(b) Provide an indication of
whether electrical power is available at the control panel and if activation of
the radiation is possible;
(c)
Provide an indication of whether radiation is being produced; and
(d) Include an access control or locking
device that will prevent unauthorized use of the therapy equipment;
(2) Treatment room entrances shall
be provided with warning lights in a readily observable position near the
outside of all access doors, which will state in words when the useful beam is
on;
(3) Interlocks shall be
provided such that all access controls are activated before treatment can be
initiated or continued. If the radiation beam is interrupted by any access
control, it shall not be possible to restore the therapy equipment to operation
without resetting the access control and reinitiating irradiation by manual
action at the control panel;
(4) If
the shielding material in any protective barrier requires the presence of a
beam interceptor to ensure compliance with paragraph (A) and paragraph (B) of
rule
3701:1-38-13
of the Administrative Code, interlocks shall be provided to prevent the
production of radiation, unless the beam interceptor is in place, whenever the
useful beam is directed at the designated barrier(s);
(5) At least one emergency power cutoff
switch shall be located in the radiation therapy room and shall terminate all
equipment electrical power including radiation and mechanical motion. This
switch is in addition to the termination switch required on the treatment
control panel. All emergency power cutoff switches shall include a manual reset
so that the therapy equipment cannot be restarted from the unit's control
console without resetting the emergency cutoff switch; and
(6) All safety interlocks shall be designed
so that any defect or component failure in the safety interlock system prevents
or terminates operation of the therapy equipment.
(E) A qualified medical physicist shall
design shielding, verify shielding design or verify that the existing shielding
is adequate for installation of therapy equipment.
(F) The facility design information for all
new installations of therapy equipment or installations of equipment of higher
energy or capable of producing a larger maximum useful beam into a room not
previously designed for that energy or beam size shall be submitted to the
department prior to installation of the therapy equipment. The minimum facility
design information that shall be submitted is listed in the appendix to this
rule.
(G)
An area radiation survey of all new facilities, and existing facilities
not previously surveyed, shall be performed by, or
under the direct supervision of a qualified medical physicist
using an
operable radiation measurement survey instrument calibrated in accordance with
rule
3701:1-67-07
of the Administrative Code.
(H)
The area
radiation survey shall be performed with the therapy equipment in the "beam-on"
condition using the largest clinically available treatment field and
a scattering phantom in the useful
beam when evaluating secondary protective barriers and no phantom in the useful
beam when evaluating primary protective barriers
to verify that:
(1) Radiation levels in restricted areas are
not likely to cause personnel exposures in excess of the limits specified in
rule
3701:1-38-12
of the Administrative Code; and
(2)
Radiation levels in unrestricted areas do not exceed the limits specified in
rule
3701:1-38-13
of the Administrative Code.
(I) In addition to the
requirements of paragraphs (G) and (H) of this rule, an area radiation
survey shall also be performed
by a qualified medical physicist or directly supervised
by a qualified medical physicist prior to any subsequent medical use and:
(1) After making any change in the treatment
room shielding;
(2) After making
any change in the location of the therapy equipment within the treatment room
except for portable contact therapy equipment, electronic brachytherapy
equipment or portable external beam radiation therapy equipment capable of
electron production only;
(3) After
relocating the therapy equipment except for portable contact therapy equipment,
electronic brachytherapy equipment or portable external beam radiation therapy
equipment capable of electron production only;
(4) Before using the therapy equipment in a
manner that could result in increased radiation levels in areas outside the
external beam radiation therapy treatment room; or
(5) After changes are made to the therapy
equipment, the therapy equipment shielding, or the treatment room shielding
following a survey that failed to ensure compliance with the requirements of
this rule.
(6) Determination of
residual activity for all therapy equipment capable of generating photon and
electron energies above ten MV shall be performed to determine compliance with
occupational dose limits prior to machining, removing, or working on therapy
equipment components which may have become activated due to photo- neutron
production.
(J) If the results of
the area radiation surveys required by paragraphs
(G) to (I)
of this rule indicate any radiation levels in excess of the respective limits,
the handler shall lock the control in the "off" position and not use the unit:
(1) Except as may be necessary to repair,
replace, or test the therapy equipment, the therapy equipment shielding, or the
treatment room shielding;
(2) Until
either the equipment is provided with appropriate beam directional interlocks
or additional radiation shielding is added to ensure compliance with rules
3701:1-38-12
and
3701:1-38-13
of the Administrative Code;
(3)
Until implementation of administrative controls to reduce radiation levels
below the respective limits; or
(4)
Until the handler has requested and received a variance from the department
that authorizes radiation levels in unrestricted areas greater than those
permitted by rules
3701:1-38-12
and
3701:1-38-13
of the Administrative Code.
(K) The
area radiation survey record shall indicate:
(1) All instances where the facility, in the
opinion of the qualified medical physicist, is in violation of applicable
regulations;
(2) The date of the
measurements;
(3) The reason the
survey is required;
(4) The
manufacturer's name, model number and serial number of the therapy
equipment;
(5) The manufacturers'
names, model numbers, serial numbers, and dates of calibration of the
instruments used to measure radiation levels;
(6) A plan of the areas surrounding the
treatment room that were surveyed;
(7) The measured dose rate at a
representative number of points in each area expressed in microsieverts
(millirem) per hour;
(8) The
calculated maximum level of radiation over a period of one week for each
restricted and unrestricted area; and
(9) The name and signature of the individual
responsible for conducting the survey.
(L)
Maintain a record of each shielding design and
area radiation survey for the duration of the
registration and make the records and measurements available upon request
during an inspection.
Click to
view Appendix