Current through all regulations passed and filed through March 18, 2024
(A) A licensee shall control access to the
treatment room by a door at each entrance.
(B) A licensee shall equip each entrance to
the treatment room with an electrical interlock system that will:
(1) Prevent the operator from initiating the
treatment cycle unless each treatment room entrance door is closed;
(2) Cause the source(s) to be shielded when
an entrance door is opened; and
(3) Prevent the source(s) from being exposed
following an interlock interruption until all treatment room entrance doors are
closed and the source(s) on-off control is reset at the console.
(C) A licensee shall require any
individual entering the treatment room to assure, through the use of
appropriate radiation monitors, that radiation levels have returned to ambient
levels.
(D) Except for low-dose
remote afterloader units, a licensee shall construct or equip each treatment
room with viewing and intercom systems to permit continuous observation of the
patient or the human research subject from the treatment console during
irradiation.
(E) For licensed
activities where sources are placed within the patient's or human research
subject's body, a licensee shall only conduct treatments which allow for
expeditious removal of a decoupled or jammed source.
(F) In addition to the requirements specified
in paragraphs (A) to (E) of this rule, a licensee shall:
(1) For medium dose-rate and pulsed dose-rate
remote afterloader units, require:
(a) An
authorized medical physicist and either an authorized user or a physician,
under the supervision of an authorized user, who has been trained in the
operation and emergency response for the unit to be physically present during
the initiation of all patient treatments involving the unit; and
(b) An authorized medical physicist and
either an authorized user or an individual, under the supervision of an
authorized user, who has been trained to remove the source applicator(s) in the
event of an emergency involving the unit, to be immediately available during
continuation of all patient treatments involving the unit.
(2) For high dose-rate remote
afterloader units, require:
(a) An authorized
user and an authorized medical physicist to be physically present during the
initiation of all patient treatments involving the unit; and
(b) An authorized medical physicist and
either an authorized user or a physician, under the supervision of an
authorized user, who has been trained in the operation and emergency response
for the unit, to be physically present during continuation of all patient
treatments involving the unit.
(3) For gamma stereotactic radiosurgery
units, require an authorized user and an authorized medical physicist to be
physically present throughout all patient treatments involving the unit.
(4) Notify the radiation safety
officer, or his/her designee, and an authorized user as soon as possible if the
patient or human research subject has a medical emergency or dies.
(G) A licensee shall have
applicable emergency response equipment available near each treatment room to
respond to a source:
(1) Remaining in the
unshielded position; or
(2) Lodged
within the patient following completion of the treatment.
Five Year Review (FYR) Dates:
06/12/2015 and
06/01/2020
Promulgated
Under: 119.03
Statutory
Authority: 3748.02,
3748.04
Rule
Amplifies: 3748.04
Prior
Effective Dates: 8/15/2005
