Current through Register No. 40, October 3, 2024
(a) Prior to new
construction or modification of existing installations utilizing ionizing
radiation machines, a review of floor plans, shielding specifications, and
equipment arrangements shall be completed as set forth in paragraphs (b) -(d)
below to ensure that, once operational, no individual will receive a dose in
excess of the limits prescribed in He-P 4020.
(b) All prospective and existing registrants
shall utilize the design services of a registered service provider as described
in He-P
4040.07.
(c) Each prospective or existing registrant
may request the department of health and human services/radiological health
section (DHHS/RHS) to provide an evaluation of an existing shielding plan
review or to offer technical advice on shielding requirements for a radiation
machine installation.
(d) The
following information shall be submitted to DHHS/RHS with any request for a
shielding plan review:
(1) Distances where
applicable, such as:
a. From the source of
radiation to the patient;
b. From
the source of radiation to each point for which the shielding requirement is to
be calculated; and
c. From the
patient to each point for which the shielding requirement is to be
calculated;
(2) The
normal location(s) of the system's radiation port;
(3) The travel and traverse limits of the
radiation beam port(s);
(4)
Direction(s) in which the useful beam will be directed;
(5) Locations of any windows, doors or other
openings;
(6) The location of the
operator's booth;
(7) The location
of the control panel;
(8) The
structural composition and thickness or lead equivalent of all existing or
planned walls, doors, partitions, floor, and ceiling of the room(s) to be
evaluated;
(9) The dimensions of
the room(s) to be evaluated;
(10)
The type of occupancy of all adjacent areas, including the space above and
below the rooms(s), and, if there is an exterior wall, the distance to the
closest area(s) where it is likely that an individual might be
present;
(11) The make and model of
the equipment, the maximum technique factors as defined in He-P 4041, and the
output waveform;
(12) The type of
examination(s) or treatment(s) to be performed with the equipment;
and
(13) Information on the
anticipated workload of the system(s) in milliampere seconds (mAs) per week,
milliampere seconds being the product of the x-ray tube current and the
exposure time.
(e) After
installation of a radiation machine, the registrant shall keep the following
records for review during an inspection by DHHS/RHS until the registration is
terminated:
(1) The maximum rated technique
factors, as defined in He-P 4041, of each machine;
(2) A scaled drawing of the room in which
each stationary radiation machine system is located indicating the location of
tubeheads, describing the use of each area adjacent to the room, and specifying
an estimation of the extent of occupancy by an individual in such
areas;
(3) The results of a survey
for radiation levels present at the operator's position and at pertinent points
outside the room at specified test conditions; and
(4) The shielding plan review which shall
include the type and thickness of materials, or lead equivalency, of each
protective barrier.
(f)
After installation of an MRI machine and until the registration is terminated,
the registrant shall keep the following records for review during an inspection
by DHHS/RHS:
(1) A scaled drawing of the MRI
suite indicating the location of reception, patient, prescreening, control
room, MRI machine, fire extinguishers and equipment;
(2) An MRI suite safety protocol which shall
be reviewed:
a. Annually; and
b. After any change is made to the MRI suite;
and
(3) Documentation
that the local fire department is aware of the presence of MRI suite hazards in
the event of an emergency response.
#6827, eff 8-6-98; ss by #7919, eff 7-18-03; ss by
#9945-A, eff 6-22-11
