Current through Register Vol. 49, No. 13, September 23, 2024
A. This part applies to remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units.
B. A licensee must:
(1) secure the unit, the console, the console
keys, and the treatment room when not in use or unattended;
(2) permit only individuals approved by the
authorized user, radiation safety officer, or authorized medical physicist to
be present in the treatment room during treatment with the source;
(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 in the shielded position or remove the patient or human
research subject from the radiation field with controls from outside the
treatment room. These procedures 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 the treatment area to minimize the risk
of inadvertent exposure; and
(c)
the names and telephone numbers of the authorized user, authorized medical
physicist, and radiation safety officer to be contacted if the unit or console
operates abnormally.
C. A copy of the procedures required under
item B, subitem (4), must be physically located at the unit console.
D. A licensee must post instructions at the
unit console to inform the operator of:
(1)
the location of the procedures required under item B, subitem (4);
and
(2) the names and telephone
numbers of the authorized user, authorized medical physicist, and radiation
safety officer to be contacted if the unit or console operates
abnormally.
E. A
licensee must:
(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, 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; and
(2) provide operational and safety
instructions, initially and at least annually, to all individuals who operate
the unit, as appropriate to the individuals assigned duties. The instructions
must include instruction in:
(a) the
procedures identified under item B, subitem (4); and
(b) the operating procedures of the unit.
F. A licensee must
ensure that operators, authorized medical physicists, and authorized users
participate in drills of the emergency procedures, initially and at least
annually.
G. A licensee must retain
a record of individuals receiving instruction required under item E according
to part 4731.4510.
H. A licensee
must retain a copy of the procedures required under item B, subitem (4), and
item E, subitem (2), unit (b),according to part 4731.4516.
Statutory Authority: MS s
144.1202;
144.1203
