| (1) is certified by a medical specialty board whose
certification process has been recognized by the department, the NRC
or an agreement state. The names of board certifications that have
been recognized by the department, the NRC, or an agreement state
are posted on the NRC's Medical Uses Licensee Toolkit web page. To
have its certification recognized, a specialty board shall require
all candidates for certification to:
(A) successfully complete a minimum of three years
of residency training in a radiation oncology program approved by
the Residency Review Committee of the Accreditation Council for Graduate
Medical Education, the Royal College of Physicians and Surgeons of
Canada, or the Committee on Post-Graduate Training of the American
Osteopathic Association; and
(B) pass an examination, administered by diplomates
of the specialty board, that assesses knowledge and competence in
radiation safety, radionuclide handling, treatment planning, quality
assurance, and clinical use of manual brachytherapy; or
(2) has completed:
(A) a structured educational program in basic radionuclide
handling techniques applicable to the use of manual brachytherapy
sources including the following:
(i) 200 hours of classroom and laboratory training
in the following areas:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity; and
(IV) radiation biology; and
(ii) 500 hours of work experience, under the supervision
of an authorized user who meets the requirements of subsection (l)
of this section, this subsection, or equivalent NRC or agreement state
requirements at a medical facility authorized to use radioactive material
under subsection (rr) of this section, involving the following:
(I) ordering, receiving, and unpacking radioactive
materials safely and performing the related radiation surveys;
(II) checking survey meters for proper operation;
(III) preparing, implanting, and removing brachytherapy
sources;
(IV) maintaining running inventories of material on
hand;
(V) using administrative controls to prevent a medical
event involving the use of radioactive material; and
(VI) using emergency procedures to control radioactive
material; and
(B) three years of supervised clinical experience in
radiation oncology, under an authorized user who meets the requirements
of subsection (l) of this section, this subsection, or equivalent
NRC or agreement state requirements, as part of a formal training
program approved by the Residency Review Committee for Radiation Oncology
of the Accreditation Council for Graduate Medical Education, the Royal
College of Physicians and Surgeons of Canada, or the Committee on
Postdoctoral Training of the American Osteopathic Association. This
experience may be obtained concurrently with the supervised work experience
required by subparagraph (A)(ii) of this paragraph; and
(3) has obtained written attestation that the individual
has satisfactorily completed the requirements in paragraph (2) of
this subsection and is able to independently fulfill the radiation
safety-related duties as an authorized user of manual brachytherapy
sources for the medical uses authorized under subsection (rr) of this
section. The attestation must be obtained from either:
(A) a preceptor authorized user who meets the requirements
of subsection (l) of this section, this subsection, or equivalent
NRC or agreement state requirements; or
(B) a residency program director who affirms in writing
that the attestation represents the consensus of the residency program
faculty where at least one faculty member is an authorized user who
meets the requirements in subsection (l) of this section, this subsection,
or equivalent NRC or agreement state requirements, and concurs with
the attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee
of the Accreditation Council for Graduate Medical Education or the
Royal College of Physicians and Surgeons of Canada or the Council
on Postdoctoral Training of the American Osteopathic Association and
must include training and experience specified in paragraph (2) of
this subsection.
(aaa) Training for ophthalmic use of strontium-90.
Except as provided in subsection (l) of this section, the licensee
shall require an authorized user of strontium-90 for ophthalmic radiotherapy
to be a physician who:
(1) is an authorized user under subsection (zz) of
this section or equivalent NRC or agreement state requirements; or
(2) has completed 24 hours of classroom and laboratory
training applicable to the medical use of strontium-90 for ophthalmic
radiotherapy.
(A) The training shall include the following.
(i) classroom training shall include the following:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity; and
(IV) radiation biology; and
(ii) supervised clinical training in ophthalmic radiotherapy
under the supervision of an authorized user at a medical institution,
clinic, or private practice that includes the use of strontium-90
for the ophthalmic treatment of five individuals. This supervised
clinical training shall involve:
(I) examination of each individual to be treated;
(II) calculation of the dose to be administered;
(III) administration of the dose; and
(IV) follow-up and review of each individual's case
history; and
(3) has obtained written attestation, signed by a preceptor
authorized user who meets the requirements of subsection (l) of this
section, subsection (zz) of this section or this subsection, or equivalent
NRC or agreement state requirements, that the individual has satisfactorily
completed the requirements of paragraph (2)(A) of this subsection
and is able to independently fulfill the radiation safety-related
duties as an authorized user of strontium-90 for ophthalmic use.
(bbb) Use of sealed sources and medical devices for
diagnosis.
(1) The licensee shall use only sealed sources that
are not in medical devices for diagnostic medical uses if the sealed
sources are approved in the Sealed Source and Device Registry for
diagnostic medicine. The sealed sources may be used for diagnostic
medical uses that are not explicitly listed in the Sealed Source and
Device Registry but must be used in accordance with the radiation
safety conditions and limitations described in the Sealed Source and
Device Registry.
(2) The licensee must only use medical devices containing
sealed sources for diagnostic medical uses if both the sealed sources
and medical devices are approved in the Sealed Source and Device Registry
for diagnostic medical uses. The diagnostic medical devices may be
used for diagnostic medical uses that are not explicitly listed in
the Sealed Source and Device Registry but must be used in accordance
with the radiation safety conditions and limitations described in
the Sealed Source and Device Registry.
(3) Sealed sources and devices for diagnostic medical
uses may be used in research in accordance with an active Investigational
Device Exemption (IDE) application accepted by the FDA provided the
requirements of subsection (u)(1) of this section are met.
(4) The licensee shall ensure that installation or
exchange of sealed source(s) in medical imaging equipment is performed
only by the manufacturer or persons specifically authorized to perform
these services by the department, the NRC, or another agreement state.
The licensee shall maintain a record for each installation or exchange
for inspection by the department in accordance with subsection (xxx)
of this section. The record shall include the date, the installer's
radioactive material license number, and the regulatory agency that
issued the license to the installer.
(ccc) Training for use of sealed sources for diagnosis.
Except as provided in subsection (l) of this section, the licensee
shall require the authorized user of a diagnostic sealed source or
a device authorized in accordance with subsection (bbb) of this section
to be a physician, dentist, or podiatrist who:
(1) is certified by a specialty board whose certification
process includes all of the requirements of paragraphs (3) and (4)
of this subsection and whose certification has been recognized by
the department, the NRC, or an agreement state. The names of board
certifications that have been recognized by the department, the NRC,
or an agreement state are posted on the NRC's Medical Uses Licensee
Toolkit web page; or
(2) is an authorized user for uses listed in subsection
(hh) of this section or equivalent NRC or agreement state requirements;
or
Cont'd... |
