| (C) gamma stereotactic radiosurgery unit;
(8) that the authorized medical physicist designated
on the application is qualified in accordance with subsection (j)
of this section;
(9) of the successful completion of unit-specific,
manufacturer-provided training that includes standard clinical and
emergency procedures for remote control brachytherapy and gamma stereotactic
radiosurgery units for the following personnel:
(A) authorized medical physicist of this section;
(B) technologists; and
(C) authorized user;
(10) of the safety procedures and instructions as required
by subsection (ggg) of this section;
(11) of the spot check procedures as required by subsections
(mmm) - (ooo) of this section, as applicable; and
(12) that an RSC has been established in accordance
with subsection (i)(1) or (2) of this section if applicable.
(q) License for other medical or veterinary uses of
radioactive material or a radiation source approved for medical or
veterinary use that is not specifically addressed in this section.
A licensee may use radioactive material or a radiation source approved
for medical use which is not specifically addressed in this section
if the requirements of subsection (f) of this section have been met,
the applicant or licensee has received written approval from the agency
in a license or license amendment and the licensee uses the material
in accordance with the regulations and specific conditions the agency
considers necessary for the medical use of the material.
(r) Amendment of licenses at request of licensee.
(1) Requests for amendment of a license or deletion
of an authorized use site shall be filed in accordance with §289.252(aa)
of this title.
(2) A licensee without broad-scope authorization shall
apply for and shall receive a license amendment prior to the following:
(A) receiving or using radioactive material for a type
of use that is authorized in accordance with this section, but is
not authorized on their current license issued in accordance with
this section;
(B) permitting anyone to work as an authorized user,
authorized nuclear pharmacist or authorized medical physicist under
the license;
(C) changing RSOs, except as provided in subsection
(g)(5) of this section;
(D) receiving radioactive material in excess of the
amount or in a different form, or receiving a different radionuclide
than is authorized on the license;
(E) adding or changing the areas in which radioactive
material is used or stored and are identified in the application or
on the license;
(F) changing the address(es) of use identified in the
application or on the license; and
(G) changing operating, safety, and emergency procedures.
(3) A licensee with broad-scope authorization shall
apply for and shall receive a license amendment prior to taking actions
specified in paragraph (2)(A), (C), (D), (F) and (G) of this subsection.
(s) Supervision. A licensee may permit the receipt,
possession, use, or transfer of radioactive material by an individual
under the supervision of an authorized user, unless prohibited by
license condition.
(1) A licensee who permits the receipt, possession,
use, or transfer of radioactive material by an individual under the
supervision of an authorized user shall do the following:
(A) instruct the supervised individual in the licensee's
written operating, safety, and emergency procedures, written directive
procedures, requirements of this chapter, and license conditions with
respect to the use of radioactive material; and
(B) require the supervised individual to follow the
instructions of the supervising authorized user for medical uses of
radioactive material, written operating, safety, and emergency procedures
established by the licensee, written directive procedures, requirements
of this chapter, and license conditions with respect to the medical
use of radioactive material.
(2) A licensee who permits the preparation of radioactive
material for medical use by an individual under the supervision of
an authorized nuclear pharmacist or authorized user, shall do the
following:
(A) instruct the supervised individual in the preparation
of radioactive material for medical use, as appropriate to that individual's
involvement with radioactive material; and
(B) require the supervised individual to follow the
instructions of the supervising authorized user or authorized nuclear
pharmacist regarding the preparation of radioactive material for medical
use, the written operating, safety, and emergency procedures established
by the licensee, the requirements of this chapter, and license conditions.
(3) A licensee who permits supervised activities in
accordance with paragraphs (1) and (2) of this subsection is responsible
for the acts and omissions of the supervised individual.
(4) Only an authorized user may authorize the medical
use of radioactive material.
(t) Written directives.
(1) A written directive shall be dated and signed by
an authorized user prior to any administration of sodium iodide I-131
greater than 30 microcuries (µCi) (1.11 megabequerels (MBq)),
administration of any therapeutic dosage of unsealed radioactive material,
or administration of any therapeutic dose of radiation from radioactive
material.
(A) A written revision to an existing written directive
may be made provided that the revision is dated and signed by an authorized
user prior to the administration of the dosage of unsealed radioactive
material, the brachytherapy dose, the gamma stereotactic radiosurgery
dose, the teletherapy dose, or the next fractional dose.
(B) If, because of the emergent nature of the patient's
condition, a delay in order to provide a written directive or to revise
a written directive would jeopardize the patient's health, an oral
directive or an oral revision to an existing written directive is
acceptable. The information contained in the oral directive or oral
revision shall be documented in writing as soon as possible in the
patient's record. A written directive or revised written directive
shall be prepared and signed by the authorized user within 48 hours
of the oral directive or oral revision.
(2) The written directive shall contain the patient
or human research subject's name and the following information for
each application.
(A) For any administration of quantities greater than
30 µCi (1.11 MBq) of sodium iodide I-131, the dosage.
(B) For an administration of a therapeutic dosage of
a radiopharmaceutical other than sodium iodide I-131:
(i) the radiopharmaceutical;
(ii) the dosage; and
(iii) route of administration.
(C) For gamma stereotactic radiosurgery:
(i) the total dose;
(ii) the treatment site; and
(iii) the values for the target coordinate settings
per treatment for each anatomically distinct treatment site.
(D) For teletherapy:
(i) the total dose;
(ii) dose per fraction;
(iii) number of fractions; and
(iv) treatment site.
(E) For high-dose rate remote afterloading brachytherapy:
(i) the radionuclide;
(ii) treatment site;
(iii) dose per fraction;
(iv) number of fractions; and
(v) total dose.
(F) For all other brachytherapy, including low, medium,
and pulsed rate afterloaders:
(i) prior to implantation:
(I) treatment site;
(II) the radionuclide; and
(III) dose;
(ii) after implantation but prior to completion of
the procedure:
(I) the radionuclide;
(II) treatment site;
(III) number of sealed sources;
(IV) total sealed source strength; and
(V) exposure time or, the total dose.
(3) The licensee shall retain the written directive
in accordance with subsection (www) of this section for inspection
by the agency.
(4) Procedures for administrations requiring a written
directive.
(A) For any administration requiring a written directive,
the licensee shall develop, implement, and maintain written procedures
to ensure that:
(i) the patient's or human research subject's identity
is verified before each administration; and
Cont'd... |
