(1) Protection
Surveys.
(a) The registrant shall ensure that
radiation protection surveys of new facilities, and existing facilities not
previously surveyed are performed with an operable radiation measurement survey
instrument calibrated in accordance with
R313-30-8.
The radiation protection survey shall be performed by, or under the direction
of, a Radiation Therapy Physicist or a Certified Health Physicist and shall
verify that, with the therapeutic radiation machine in a "BEAM- ON" condition,
with the largest clinically available treatment field and with a scattering
phantom in the useful beam of radiation:
(i)
Radiation levels in restricted areas are not likely to cause personnel
exposures in excess of the limits specified in
R313-15-201(1);
and
(ii) Radiation levels in
unrestricted areas do not exceed the limits specified in
R313-15-301(1).
(b) In addition to the
requirements of R313-30-4(1)(a), a radiation protection survey shall also be
performed prior to subsequent medical use and:
(i) After making changes in the treatment
room shielding;
(ii) After making
changes in the location of the therapeutic radiation machine within the
treatment room;
(iii) After
relocation of, or modification of, the therapeutic radiation machine;
or
(iv) Before using the
therapeutic radiation machine in a manner that could result in increased
radiation levels in areas outside the external beam radiation therapy treatment
room.
(c) The survey
record shall indicate instances where the facility, in the opinion of the
Radiation Therapy Physicist or a Certified Health Physicist, is in violation of
applicable radiation protection rules. The survey record shall also include the
date of the measurements, the reason the survey is required, the manufacturer's
name, model number and serial number of the therapeutic radiation machine, the
instruments used to measure radiation levels, a plan of the areas surrounding
the treatment room that were surveyed, the measured dose rate at several points
in areas expressed in microsieverts, millirems, per hour, the calculated
maximum level of radiation over a period of one week for restricted and
unrestricted areas, and the signature of the individual responsible for
conducting the survey;
(d) If the
results of the surveys required by R313-30-4(1)(a) or R313-30-4(1)(b) indicate
radiation levels in excess of the respective limit specified in
R313-30-4(1)(a), the registrant shall lock the control in the "OFF" position
and not use the unit:
(i) Except as may be
necessary to repair, replace, or test the therapeutic radiation machine, the
therapeutic radiation machine shielding, or the treatment room shielding;
or
(ii) Until the registrant has
received a written approval from the Director.
(2) Modification of Radiation Therapy Unit or
Room Before Beginning a Treatment Program. If the survey required by
R313-30-4(1) indicates that an individual in an unrestricted area may be
exposed to levels of radiation greater than those permitted by
R313-15-301(1)
of these rules, before beginning the treatment program the registrant shall:
(a) Either equip the unit with beam direction
interlocks or add additional radiation shielding to ensure compliance with
R313-15-301(1)
of these rules;
(b) Perform the
survey required by R313-30-4(1) again; and
(c) Include in the report required by
R313-30-4(4) the results of the initial survey, a description of the
modification made to comply with R313-30-4(2)(a), and the results of the second
survey; or
(d) Request and receive
a registration amendment under
R313-15-301(3)
of these rules that authorizes radiation levels in unrestricted areas greater
than those permitted by
R313-15-301(1)
of these rules.
(3)
Possession of Survey Instruments. Facility locations authorized to use a
therapeutic radiation machine in accordance with
R313-30-6
and
R313-30-7
shall possess appropriately calibrated portable monitoring equipment. As a
minimum, the equipment shall include a portable radiation measurement survey
instrument capable of measuring dose rates over the range 10 uSv (1 mrem) per
hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable
and calibrated in accordance with
R313-30-8.
(4) Reports of External Beam Radiation
Therapy Surveys and Measurements. The registrant for a therapeutic radiation
machine subject to
R313-30-6
or
R313-30-7
shall furnish a copy of the records required in R313-30-4(1) and R313-30-4(2)
to the Director within 30 days following completion of the action that
initiated the record requirement.