| (IV) a permit issued by an NRC master material licensee
of broad scope that authorizes the medical use of radioactive material.
(7) Brachytherapy--A method of radiation therapy in
which plated, embedded, activated, or sealed sources are utilized
to deliver a radiation dose at a distance of up to a few centimeters,
by surface, intracavitary, intraluminal, or interstitial application.
(8) Brachytherapy sealed source--A sealed source or
a manufacturer-assembled source train, or a combination of these sources
that is designed to deliver a therapeutic dose within a distance of
a few centimeters.
(9) High dose-rate remote afterloader--A device that
remotely delivers a dose rate in excess of 1200 rads (12 gray (Gy))
per hour at the point or surface where the dose is prescribed.
(10) Institutional Review Board (IRB)--Any board, committee,
or other group formally designated by an institution and approved
by the United States Food and Drug Administration (FDA) to review,
approve the initiation of, and conduct periodic review of biomedical
research involving human subjects.
(11) Low dose-rate remote afterloader--A device that
remotely delivers a dose rate of less than or equal to 200 rads (2
Gy) per hour at the point or surface where the dose is prescribed.
(12) Management--The chief executive officer or other
individual delegated the authority to manage, direct, or administer
the licensee's activities.
(13) Manual brachytherapy--A type of brachytherapy
in which the sealed sources, for example, seeds and ribbons, are manually
inserted either into the body cavities that are in close proximity
to a treatment site or directly in the tissue volume.
(14) Medical event--An event that meets the criteria
in subsection (uuu)(1) of this section.
(15) Medical institution--An organization in which
several medical disciplines are practiced.
(16) Medical use--The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to patients or human research subjects under the supervision
of an authorized user.
(17) Medium dose-rate afterloader--A device that remotely
delivers a dose rate greater than 200 rads (2 Gy) and less than or
equal to 1200 rads (12 Gy) per hour at the point or surface where
the dose is prescribed.
(18) Mobile nuclear medicine service--A licensed service
authorized to transport radioactive material to, and medical use of
the material at, the client's address. Services transporting calibration
sources only are not considered mobile nuclear medicine licensees.
(19) Ophthalmic physicist--An individual who:
(A) meets the requirements in subsections (m) and (xx)(1)(B)
of this section; and
(B) is identified as an ophthalmic physicist on:
(i) a specific medical use license issued by the department,
the NRC, or an agreement state;
(ii) a permit issued by an agency, NRC, or agreement
state broad scope medical use licensee;
(iii) a medical use permit issued by an NRC master
material licensee; or
(iv) a permit issued by an NRC master material licensee
broad scope medical use permittee.
(20) Output--The exposure rate, dose rate, or a quantity
related in a known manner to these rates from a teletherapy unit,
a brachytherapy source, a remote afterloader unit, or a gamma stereotactic
radiosurgery unit, for a specified set of exposure conditions.
(21) Patient--A human or animal under medical care
and treatment.
(22) Patient intervention--Actions by the patient or
human research subject, whether intentional or unintentional, such
as dislodging or removing treatment devices or prematurely terminating
the administration.
(23) Permanent facility--A building or buildings that
are identified on the license within the State of Texas and where
radioactive material may be prepared, received, used, or stored. This
may also include an area or areas where administrative activities
related to the license are performed.
(24) Preceptor--An individual who provides, directs,
or verifies the training and experience required for an individual
to become an authorized user, an authorized medical physicist, an
authorized nuclear pharmacist, an RSO, or an ARSO.
(25) Prescribed dosage--The specified activity or range
of activity of unsealed radioactive material as documented in a written
directive or in accordance with the directions of the authorized user
for procedures in subsections (ff) and (hh) of this section.
(26) Prescribed dose--Prescribed dose means one of
the following:
(A) for gamma stereotactic radiosurgery, the total
dose as documented in the written directive;
(B) for teletherapy, the total dose and dose per fraction
as documented in the written directive;
(C) for brachytherapy, either the total sealed source
strength and exposure time, or the total dose, as documented in the
written directive; or
(D) for remote afterloaders, the total dose and dose
per fraction as documented in the written directive.
(27) Pulsed dose-rate remote afterloader--A special
type of remote afterloading device that uses a single sealed source
capable of delivering dose rates greater than 1200 rads (12 Gy) per
hour, but is approximately one-tenth of the activity of typical high
dose-rate remote afterloader sealed sources and is used to simulate
the radiobiology of a low dose rate remote afterloader treatment by
inserting the sealed source for a given fraction of each hour.
(28) Radiation safety officer (RSO)--For purposes of
this section, an individual who:
(A) meets the requirements in subsections (h) and (m)
of this section; or
(B) is identified as an RSO on one of the following:
(i) a specific license issued by the department, the
NRC, or an agreement state that authorizes the medical or veterinary
use of radioactive material; or
(ii) a permit issued by an NRC master material licensee
that authorizes the medical or veterinary use of radioactive material.
(29) Sealed source and device registry--The national
registry that contains all the registration certificates, generated
by both the NRC and the agreement states, that summarize the radiation
safety information for sealed sources and devices and describe the
licensing and use conditions approved for the product.
(30) Stereotactic radiosurgery--The use of external
radiation in conjunction with a guidance device to very precisely
deliver a dose to a tissue volume by the use of three-dimensional
coordinates.
(31) Technologist--A person (nuclear medicine technologist)
skilled in the performance of nuclear medicine procedures under the
supervision of a physician.
(32) Teletherapy--Therapeutic irradiation in which
the sealed source is at a distance from the patient or human or animal
research subject.
(33) Therapeutic dosage--The specified activity or
range of activity of radioactive material that is intended to deliver
a radiation dose to a patient or human or animal research subject
for palliative or curative treatment.
(34) Therapeutic dose--A radiation dose delivered from
a sealed source containing radioactive material to a patient or human
or animal research subject for palliative or curative treatment.
(35) Treatment site--The anatomical description of
the tissue intended to receive a radiation dose, as described in a
written directive.
(36) Type of use--Use of radioactive material as specified
under the following subsections:
(A) uptake, dilution, and excretion studies in subsection
(ff) of this section;
(B) imaging and localization studies in subsection
(hh) of this section;
(C) therapy with unsealed radioactive material in subsection
(kk) of this section;
(D) manual brachytherapy with sealed sources in subsection
(rr) of this section;
(E) sealed sources for diagnosis in subsection (bbb)
of this section;
(F) sealed source in a remote afterloader unit, teletherapy
unit, or gamma stereotactic radiosurgery unit in subsection (ddd)
of this section; or
(G) other medical or veterinary uses of radioactive
material or a radiation source approved for medical or veterinary
use in subsection (q) of this section.
(37) Unit dosage--A dosage prepared for medical use
for administration as a single dosage to a patient or human or animal
research subject without any further modification of the dosage after
it is initially prepared.
(38) Veterinary use--The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to patients under the supervision of an authorized user.
Cont'd... |
