| (a) Purpose. This section establishes the following
requirements for using accelerators, therapeutic radiation machines,
radiation therapy simulation systems, and electronic brachytherapy
(EBT) devices.
(1) Requirements for the registration of a person using
radiation machines used in healing arts.
(A) A person must not use radiation machines except
as authorized in a certificate of registration issued by the Department
of State Health Services (department) as specified in the requirements
of this section.
(B) A person who receives, possesses, uses, owns, or
acquires radiation machines before receiving a certificate of registration
is subject to the requirements of this chapter.
(2) Requirements are intended to control receipt, possession,
use, and transfer of radiation machines by any person so the total
radiation dose to an individual, excluding background radiation, does
not exceed the standards for protection against radiation prescribed
in this section. This section does not limit actions necessary to
protect public health and safety during an emergency.
(3) Requirements for specific record keeping and general
provisions of records and reports.
(b) Scope.
(1) This section applies to a person who receives,
possesses, uses, acquires, or transfers an accelerator used in industrial
operations and research and development, therapeutic radiation machines,
radiation therapy simulation systems, and EBT devices used in the
healing arts. The registrant is responsible for the administrative
control and for directing the use of the accelerators, other therapeutic
radiation machines, radiation therapy simulation systems, and EBT
devices.
(2) The requirements of this section are in addition
to and not in substitution for other applicable requirements of:
(A) §289.203 of this chapter (relating to Notices,
Instructions, and Reports to Workers; Inspections);
(B) §289.204 of this chapter (relating to Fees
for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services);
(C) §289.205 of this chapter (relating to Hearing
and Enforcement Procedures);
(D) §289.226 of this chapter (relating to Registration
of Radiation Machine Use and Services);
(E) §289.227 of this chapter (relating to Use
of Radiation Machines in the Healing Arts); and
(F) §289.231 of this chapter (relating to General
Provisions and Standards for Protection Against Machine-Produced Radiation).
(3) Registrants engaged in industrial radiographic
operations are subject to the requirements of §289.255 of this
chapter (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography).
(4) Registrants engaged in veterinary accelerator operations
are subject to the requirements of §289.233 of this chapter (relating
to Radiation Control Regulations for Radiation Machines Used in Veterinary
Medicine).
(5) An entity, defined in the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) as a "covered entity" under
45 Code of Federal Regulations (CFR) Parts 160 and 164 may be subject
to privacy standards governing how information identifying a patient
can be used and disclosed. Failure to follow HIPAA requirements may
result in the department referring a potential violation to the United
States Department of Health and Human Services.
(c) Prohibitions.
(1) The department prohibits the use of accelerators,
therapeutic radiation machines, radiation therapy simulation systems,
or EBT devices posing a significant threat or danger to occupational
and public health and safety, as specified in §289.205 and §289.231
of this chapter.
(2) An individual must not be exposed to the useful
beam of accelerators, therapeutic radiation machines, radiation therapy
simulation systems, or EBT devices except for healing arts purposes
and unless a physician of the healing arts has authorized such exposure.
This provision specifically prohibits the deliberate exposure of an
individual for training, demonstration, or other non-healing arts
purposes.
(3) Research and development using radiation machines
on humans is prohibited unless approved by an Institutional Review
Board (IRB) as required by 45 CFR Part 46 and 21 CFR Part 56. The
IRB must include at least one physician of the healing arts to direct
any use of radiation as specified in §289.231(b) of this chapter.
(4) Remote operation of radiation machines on humans
is prohibited.
(5) Use of therapeutic radiation machines in the healing
arts without the supervision of a physician of the healing arts is
prohibited.
(6) Use of EBT devices in the healing arts without
the supervision of a certified physician, as defined in subsection
(e)(12) of this section, is prohibited.
(d) Exemptions. An individual who is a sole physician,
sole operator, and the only occupationally exposed individual is exempt
from the following requirements:
(1) §289.203(b) and (c) of this chapter; and
(2) subsection (h)(1)(G) of this section.
(e) Definitions. When used in this section, the following
words and terms have the following meaning unless the context indicates
otherwise.
(1) Absorbed dose (D)--The mean energy imparted by
ionizing radiation to matter. Absorbed dose is determined as the quotient
of dE by dM, where dE is the mean energy imparted by ionizing radiation
to the mass dM. The System International (SI) unit of absorbed dose
is joule per kilogram and the special name of the unit of absorbed
dose is gray (Gy). The previously used special unit of absorbed dose
(rad) is replaced by gray.
(2) Absorbed dose rate--Absorbed dose per unit time
for machines with timers, or dose monitor unit per unit time for linear
accelerators.
(3) Accelerator beam quality--The type and penetrating
power of the ionizing radiation produced for certain machine settings.
(4) Air kerma--The kinetic energy released in air by
ionizing radiation. Kerma is the quotient of dE by dM, where dE is
the sum of the initial kinetic energies of all the charged ionizing
particles liberated by uncharged ionizing particles in air of mass
dM. The SI unit of air kerma is joule per kilogram and the special
name for the unit of kerma is Gy.
(5) Barrier--See definition for protective barrier.
(6) Beam axis--The axis of rotation of the beam limiting
device.
(7) Beam-flattening filter--See definition for field-flattening
filter.
(8) Beam-limiting device--A field-defining collimator,
integral to the therapeutic radiation machine, which provides a means
to restrict the dimensions of the useful beam.
(9) Beam monitoring system--A system designed and installed
in the radiation head to detect and measure the radiation present
in the useful beam.
(10) Beam quality--The penetrating power of the x-ray
beam identified numerically by the half-value layer and influenced
by kilovolt peak (kVp) and filtration.
(11) Central axis of the beam--An imaginary line passing
through the center of the useful beam and the center of the plane
figure formed by the edge of the first beam-limiting device.
(12) Certified physician--A physician licensed by the
Texas Medical Board and certified in radiation oncology or therapeutic
radiology.
(13) Coefficient of variation or C--The ratio of the
standard deviation to the mean value of a population of observations.
It is estimated using the following equation:
Attached Graphic
(14) Collimator--A device or mechanism by which the
x-ray beam is restricted in size.
(15) Computed tomography (CT)--The production of a
tomogram by the acquisition and computer processing of x-ray transmission
data.
(16) Continuous pressure type switch--A switch that
can only power a device when the operator maintains continuous pressure
on the switch.
(17) Control panel--The part of the radiation machine
where the switches, knobs, push buttons, and other hardware necessary
for manually setting the technique factors are located. For purposes
of this section, console is an equivalent term.
(18) Conventional radiation therapy simulator--A radiation
machine with radiographic or fluoroscopic capabilities uniquely designed
for the direct purpose of simulating radiation therapy treatment ports.
(19) CT conditions of operation--All selectable parameters
governing the operation of a CT x-ray system, including nominal tomographic
section thickness, filtration, and the technique factors as defined
in this subsection.
(20) CT radiation therapy simulator--CTs that interface
with radiation therapy linear accelerators.
Cont'd... |
