Current through Register 1531, September 27, 2024
(A) A licensee shall:
(1) Secure the unit, the console, the console
keys, and the treatment room when not in use or is unattended;
(2) Permit only individuals approved by
authorized user, Radiation Safety Officer, or authorized medical physicist to
be present in the treatment room during treatment with the source(s);
(3) Prevent dual operation of more than one
radiation producing device in a treatment room, if applicable; and
(4) Develop, implement, and maintain written
procedures for responding to an abnormal situation when the operator is unable
to place the source(s) in the shielded position, or remove the patient or human
research subject from the radiation field with controls from outside the
treatment room. This procedure must include:
(a) Instructions for responding to equipment
failures and the names of the individuals responsible for implementing
corrective actions;
(b) The process
for restricting access to and posting of the treatment area to minimize the
risk of inadvertent exposure; and
(c) The names and telephone numbers of the
authorized users, the authorized medical physicist, and the Radiation Safety
Officer to be contacted if the unit or console operates abnormally.
(B) A copy of the
procedures required by 105 CMR 120 573(A)(4) must be physically located at the
unit console.
(C) A licensee shall
post instructions at the unit console to inform the operator of:
(1) The location of the procedures required
by 105 CMR 120 573(A)(4); and
(2)
The names and telephone numbers of the authorized users, the authorized medical
physicist, and the Radiation Safety Officer to be contacted if the unit or
console operates abnormally.
(D)
(1)
Prior to the first use for patient treatment of a new unit or an existing unit
with a manufacturer upgrade that affects the operation and safety of the unit,
a licensee shall ensure that vendor operational and safety training is provided
to all individuals who will operate the unit. The vendor operational and safety
training must be provided by the device manufacturer or by an individual
certified by the device manufacturer to provide the operational and safety
training.
(2) A licensee shall
provide operational and safety instructions initially and at least annually to
all individuals who operate the unit at the facility, as appropriate to the
individual's assigned duties. The instructions shall include instruction in:
(a) The procedures identified in 105 CMR
120.573(A)(4); and
(b) The
operating procedures for the unit.
(E) A licensee shall ensure that operators,
authorized medical physicists, and authorized users participate in drills of
the emergency procedures, initially and at least annually.
(F) A licensee shall retain a record of
individuals receiving instruction required by 105 CMR 120.573(D), in accordance
with
105 CMR
120.590(P).
(G) A licensee shall retain a copy of the
procedures required by 105 CMR 120.573(A)(4) and (D)(2)(b) in accordance with
105 CMR
120.590(O).
