Wis. Admin. Code Department of Health Services DHS 157.84 - Technical requirements for facilities using therapeutic radiation machines
(1)
RADIATION PROTECTION SURVEYS.
(a) A
registrant shall ensure that radiation protection surveys of all new facilities
and existing facilities not previously surveyed are performed with an operable,
calibrated survey instrument. The radiation protection survey shall be
performed by or under the direction of a medical 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, all of the following requirements are met:
1. Radiation levels in restricted areas are
not likely to cause personnel exposures in excess of the limits specified in s.
DHS 157.22(1)
(a).
2. Radiation levels in unrestricted areas do
not exceed the limits specified in s.
DHS 157.23(1) (a) and (b).
(b) A radiation protection survey
shall be performed prior to any subsequent medical use after making any of the
following changes:
1. Any change in the
treatment room shielding.
2. Any
change in the location of the therapeutic radiation machine within the
treatment room.
3. Relocating the
therapeutic radiation machine.
4.
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.
5. Replacing the
therapeutic radiation machine in an existing treatment room.
(c) The survey record shall
indicate all of the following:
1. Instances
where the facility, in the opinion of the medical physicist, is in violation of
applicable regulations.
2. The date
of the measurements.
3. The reason
the survey is required.
4. The
radiation therapy machine manufacturer's name.
5. The model and serial number of the
therapeutic radiation machine.
6.
The instruments used to measure radiation levels and their last date of
calibration.
7. A floor plan of the
areas surrounding the treatment room that were surveyed.
8. The radiation level at several points in
each area expressed in microsieverts or millirems per hour.
9. The calculated maximum level of radiation
over a period of one week for each restricted and unrestricted area.
10. The signature of the person responsible
for conducting the survey.
(d) If the results of radiation protection
surveys indicate any radiation levels in excess of the respective limit, the
registrant shall lock the control in the "OFF" position and may not use the
unit except under one or more of the following conditions:
1. As may be necessary to repair, replace or
test the therapeutic radiation machine, the therapeutic radiation machine
shielding or the treatment room shielding.
2. Until the registrant has received a
specific exemption from the department.
(2) MODIFICATION OF RADIATION THERAPY UNIT OR
ROOM BEFORE BEGINNING A TREATMENT PROGRAM. If the survey indicates that a
person in an unrestricted area may be exposed to levels of radiation greater
than those permitted by s.
DHS 157.23(1) (a) and (b), before
beginning the treatment program, the registrant shall do all of the following:
(a) Equip the unit with beam direction
interlocks or add additional radiation shielding to ensure compliance with s.
DHS 157.23(1) (a) and (b).
(b) Perform the survey again.
(c) Include in the report the results of the
initial survey, a description of the modification made and the results of the
second survey.
(d) Submit facility
design information to the department prior to installation of a therapeutic
radiation machine of higher energy into a room not previously approved for that
energy and receive approval from the department prior to actual installation of
the therapeutic radiation machine.
(3) DOSIMETRY EQUIPMENT.
(a)
1. A
registrant shall have a calibrated dosimetry system available for use. The
dosimetry system shall be calibrated by a certified calibration facility at
least every 24 months and after any servicing that may affect system
calibration.
2. For beams with
energies greater than one MeV, the dosimetry system shall be calibrated for
Cobalt-60.
3. For beams with
energies equal to or less than one MeV, the dosimetry system shall be
calibrated at an energy or energy range appropriate for the radiation being
measured.
(b) A
registrant shall have a dosimetry system for quality control check
measurements. The system may be compared with another system whose calibration
is traceable to the national institute of standards and technology. The
comparison shall be performed at least every 24 months and after each servicing
that may affect system calibration.
(c) A registrant shall maintain a record of
each dosimetry system calibration, intercomparison and comparison for the
duration of the registration. For each calibration, intercomparison or
comparison, the record shall include all of the following:
1. The date.
2. The model and serial numbers of the
instruments that were calibrated, inter-compared or compared.
3. The correction factors that were
determined.
4. The names of the
persons who performed the calibration, intercomparison or comparison.
5. Evidence that the intercomparison was
performed by or under the direct supervision and in the physical presence of a
medical physicist.
(4) SURVEY INSTRUMENTS. Except for
dermatology offices with systems operating at less than 150 kV, each facility
location authorized to use a therapeutic radiation machine shall possess
appropriately calibrated portable monitoring equipment. Equipment shall include
a portable radiation measurement survey instrument capable of measuring dose
rates over the range 10 mSv (one mrem) per hour to 10 mSv (1000 mrem) per hour.
The survey instruments shall be operable and calibrated.
(5) SHIELDING AND SAFETY DESIGN REQUIREMENTS.
(a) Facility design information for all new
installations of a therapeutic radiation machine or installations of a
therapeutic radiation machine of higher energy into a room not previously
approved for that energy shall be submitted to the department and approved by
the department prior to actual installation of the therapeutic radiation
machine.
(b) Observation and
communication with the patient shall be possible at all times.
Notes
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No prior version found.