Oklahoma Administrative Code
Title 310 - Oklahoma State Department of Health
Chapter 281 - Medical Marijuana Regulations [Revoked]
Subchapter 11 - Use of X-Rays in the Healing Arts and Veterinary Medicine
Section 310:281-11-15 - Computed tomography x-ray systems
Universal Citation: OK Admin Code 310:281-11-15
Current through Vol. 42, No. 1, September 16, 2024
(a) System requirements.
(1)
Tomographic plane indication and alignment.
(A) For any single tomogram system, means
shall be provided to permit visual determination of the tomographic plane or a
reference plane offset from the tomographic plane.
(B) For any multiple tomogram system, means
shall be provided to permit visual determination of the location of a reference
plane. The reference plane can be offset from the location of the tomographic
planes.
(C) If a device using a
light source is used to satisfy 310:281-11-15(a)(1)(A) or (B), the light source
shall provide illumination levels sufficient to permit visual determination of
the location of the tomographic plane or reference plane under ambient light
conditions of up to 500 lux.
(2)
Indication of CT conditions of
operation. The CT x- ray system shall be designed such that the CT
conditions of operation to be used during a scan or a scan sequence are
indicated prior to the initiation of a scan or a scan sequence. On a system
having all or some of these conditions of operation at fixed values, this
requirement may be met by permanent markings. Indication of CT conditions of
operation shall be visible from any position from which scan initiation is
possible.
(3)
Initiation of
operation.
(A) The x-ray control and
gantry shall provide visual indication whenever x-rays are produced and, if
applicable, whether the shutter is open or closed.
(B) Means shall be provided to require
operator initiation of each individual scan or series of scans.
(C) All emergency buttons/switches shall be
clearly labeled as to their functions.
(4)
Termination of exposure.
(A) Means shall be provided to terminate the
x-ray exposure automatically by either de-energizing the x-ray source or
shuttering the x-ray beam in the event of the equipment failure affecting data
collection. Such termination shall occur within an interval that limits the
total scan time to no more than 110 percent of its preset value through the use
of either a backup timer or devices which monitor equipment function.
(B) A visible signal shall
indicate when the x-ray exposure has been terminated through the means required
by 310:281-11-15(a)(4)(A).
(C) The
operator shall be able to terminate the x-ray exposure at any time during a
scan, or series of scans under x-ray system control, of greater than 0.5 second
duration. Termination of the x-ray exposure shall necessitate resetting of the
CT conditions of operation prior to initiation of another scan.
(5)
Extraneous
radiation. The system shall perform such that the radiation produced
adjacent to the tube housing assembly, including the tube port, during periods
of time that scans are not being performed does not exceed the levels permitted
by
310:281-11-12(c).
(6)
Additional requirements applicable
to CT x-ray systems containing a gantry manufactured after September 3,
1985.
(A) The total error in the
indicated location of the tomographic plane or reference plane shall not exceed
5 millimeters.
(B) If the x-ray
production period is less than 0.5 second, the indication of x-ray production
shall be activated for at least 0.5 second. Indicators at or near the gantry
shall be discernible from any point external to the patient opening where
insertion of any part of the human body into the primary beam is
possible.
(C) The deviation of
indicated scan increment versus actual increment shall not exceed to within 1
millimeter with any mass from O to 100 kilograms resting on the support device.
The patient support device shall be incremented from a typical starting
position to the maximum incremented distance or 30 centimeters, whichever is
less, and then returned to the starting position. Measurement of actual versus
indicated scan increment can be taken anywhere along this travel.
(D) Premature termination of the x-ray
exposure by the operator shall necessitate resetting of the CT conditions of
operation prior to the initiation of another scan.
(7)
Maximum surface CTDI
identification. The angular position where the maximum surface CTDI
occurs shall be identified to allow for reproducible positioning of a CT
dosimetry phantom.
(b) Facility design requirements.
(1)
Aural communication.
Provision shall be made for two-way aural communication between the patient and
the operator at the control panel.
(2)
Viewing systems.
(A) Windows, mirrors, closed-circuit
television, or an equivalent shall be provided to permit continuous observation
of the patient during irradiation and positioned to allow the operator to
observe the patient from the control panel.
(B) When the primary viewing system is by
electronic means, an alternate viewing system (which may be electronic) shall
be available for use in the event of failure of the primary viewing system.
(c) Surveys, dose measurements, spot checks, operating procedures, and preventative maintenance services.
(1)
Surveys.
(A) All CT systems
shall have a survey made by or under the direct supervision of a medical
physicist.
(i) All dental cone beam CTs under
120 kVp are exempt from this requirement; and
(ii) CT systems not used for diagnostic
purposes are exempt from this requirement.
(B) Performance surveys by a medical
physicist shall be made:
(i) at intervals not
to exceed 1 year;
(ii) when major
maintenance, except x-ray tube replacement, that could affect radiation output
is performed; and
(iii) when a
major change in the systems operation is accomplished; for example,
introduction of a new software package.
(C) The permittee shall obtain a written
report of the survey from the medical physicist and a copy of the report shall
be made available to the Department upon request.
(2)
Dose measurements.
(A) The dose measurements of the radiation
output of the CT system will be done by a medical physicist. Dose limits for
adult head, adult abdomen, and pediatric abdomen are listed in
310:281-11-5.
(B) Any calibration or
recalibration on a CT system required by the medical physicist's survey shall
be done by a qualified service representative. Any work deemed necessary by the
permittee, other than that permitted by the manufactures' operators manual,
shall be performed by a qualified service representative.
(C) Calibration of the dose measurements of a
CT system is required for each type of head, body, or whole-body scan performed
at the facility.
(D) Dose
measurements shall meet the following requirements:
(i) The dose profile along the center axis of
the CT phantom for the minimum, maximum, and midrange values of the nominal
tomographic section thickness used by the permittee shall be measurable. Where
less than 3 nominal tomographic thicknesses can be selected, the dose profile
determination shall be performed for each available nominal tomographic section
thickness.
(ii) The CTDI along the
two axes specified in 310:281-11-15(c)(3)(A)(ii) shall be measured. The CT
dosimetry phantom shall be oriented so that the measurement point 1.0
centimeter from the outer surface and within the phantom is in the same angular
position within the gantry as the point of maximum surface CTDI identified. The
CT conditions of operation shall correspond to typical values used by the
permittee.
(E)
Calibration of the dose measurements of a CT equipment shall be performed with
a calibrated dosimetry system.
(i)
Calibration of such a system shall be traceable to the national standard. The
dosimetry system shall have been calibrated within the preceding 2 years.
(ii) Calibration procedures of the
dosimetry system shall be in writing. Records of calibration performed shall be
available for inspection by the Department.
(3)
CT dosimetry phantom(s). CT
dosimetry phantom(s)shall be used in determining the radiation output of CT
systems. Such phantom(s) shall meet the following specifications and conditions
of use:
(A) CT dosimetry phantom(s) shall be
made of a material analogous to human tissue. (Water and acrylic are
acceptable). If they are made of acrylic, they should have a density of 1.19
plus or minus 0.01 grams per cubic centimeter. The phantom(s) shall be at least
14 centimeters in length and have a diameter of 32.0 centimeters for testing CT
systems designed to image any section of the body and 16.0 centimeters for
equipment designed to image the head or for whole body equipment operated in
the head scanning mode.
(B) CT
dosimetry phantoms shall provide a means for the placement of a dosimeter(s)
along the axis of rotation and a line parallel to the axis of rotation 1.0
centimeter from the outer surface and within the phantom. Means for the
placement of dosimeter or alignment devices at other locations should be
provided.
(C) Any effects on the
doses measured due to the removal of phantom material to accommodate dosimeters
shall be accounted for through appropriate corrections to the reported data or
included in the statement of maximum deviation for the values obtained using
the phantom.
(D) All dose
measurements shall be performed with the CT phantom placed on the patient couch
or support devices without additional attenuation materials present.
(E) If contrast studies are done, the
materials used should be made of water, acrylic, polyethelene, and air. They
will be used to simulate bone and different types of tissue.
(4)
Spot checks.
(A) Spot check procedures shall be developed
by a medical physicist.
(B) All
spot checks shall be included in the medical physicist survey required by
310:281-11-15(c)(2), and otherwise at time intervals and under equipment
conditions specified by a medical physicist.
(C) Spot checks shall include acquisition of
images obtained with the CT dosimetry phantom(s) using the same processing mode
and CT conditions of operation as are used to perform dose measurements
required by 310:281-11-15(c)(2). The images shall be retained, until a new dose
measurement is performed, in two forms as follows:
(i) photographic copies of the images
obtained from the image display device; and
(ii) images stored in digital form of the
most recent spot check on a storage medium compatible with the CT x-ray system.
(D) Written records of
the spot checks performed shall be maintained for inspection by the Department.
(5)
Operating
procedures.
(A) The CT system shall
not be operated except by an individual who has been specifically trained in
its operation. Documentation of this training must be available upon request of
the Department inspector.
(B)
Information shall be available at the control panel regarding the operation and
calibration of the system. Such information shall include the following.
(i) Dates of the latest survey, preventative
maintenance service, spot checks, and location within the facility of where to
find the results of those tests;
(ii) Instructions on the use of the CT
dosimetry phantom(s) including a schedule of spot checks appropriate for the
system, allowable variations for the indicated parameters, and the results of
at least the most recent spot checks conducted on the system;
(iii) The distance in millimeters between the
tomographic plane and the reference plane if a reference plane is utilized; and
(iv) A current technique chart
available at the control panel which specifies, each routine examination, the
CT conditions of operation, and the number of scans per examination.
(C) If the medical physicist
survey or spot checks of the CT system identifies that a systems operating
parameter(s) has exceeded a tolerance established by the medical physicist, use
of the CT equipment on patients shall be limited to those uses permitted by
established written instructions of the medical physicist.
(6)
Preventative maintenance
services. Each permittee shall establish a preventative maintenance
schedule where their CT system is serviced at least once every 3 months by a
qualified service representative.
Added at 8 Ok Reg 3503, eff 8-15-91 (emergency); Added at 9 Ok Reg 1643, eff 5-29-92; Amended at 21 Ok Reg 1037, eff 5-13-04
Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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