| (ii) 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 subsections (l) or (nn) of this section,
or equivalent NRC or agreement state requirements, has experience
in administering dosages in the same dosage category or categories
as the individual requesting authorized user status, 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 this paragraph.
(oo) Training for the oral administration of sodium
iodide I-131 requiring a written directive in quantities less than
or equal to 33 mCi (1.22 GBq). Except as provided in subsection (l)
of this section, the licensee shall require an authorized user for
the oral administration of sodium iodide I-131 requiring a written
directive in quantities less than or equal to 33 mCi (1.22 GBq) to
be a physician who:
(1) is certified by a medical specialty board whose
certification process includes all of the requirements of paragraph
(3)(A) 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 in accordance with subsection
(nn) of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-a-)
or (-b-) of this section, or subsection (pp) of this section, or equivalent
NRC or agreement state requirements; or
(3) has successfully completed 80 hours of classroom
and laboratory training and work experience applicable to the medical
use of sodium iodide I-131 for procedures requiring a written directive.
(A) The training and experience shall include the following.
(i) classroom and laboratory training shall include
the following:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity;
(IV) chemistry of radioactive material for medical
use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
user who meets the requirements of subsection (l) of this section,
this subsection, subsection (nn) or subsection (pp) of this section,
or equivalent NRC or agreement state requirements. A supervising authorized
user who meets the requirements in subsection (nn)(2) of this section,
shall also have experience in administering dosages as specified in
subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section. The work
experience shall involve the following:
(I) ordering, receiving, and unpacking radioactive
materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
used to determine the activity of dosages and performing checks for
proper operation of survey meters;
(III) calculating, measuring, and safely preparing
patient or human research subject dosages;
(IV) using administrative controls to prevent a medical
event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
patients or human research subjects that includes at least three cases
involving the oral administration of less than or equal to 33mCi (1.22
GBq) of sodium iodide I-131; and
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraph (3)(A)
of this subsection, and is able to independently fulfill the radiation
safety-related duties as an authorized user for oral administration
of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131
for medical uses authorized under subsection (kk) of this section.
The attestation must be obtained from either:
(i) a preceptor authorized user who meets the requirements
of subsection (l) of this section, this subsection, subsection (nn)
or subsection (pp) of this section or equivalent NRC or agreement
state requirements and has experience in administering dosages as
specified in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section;
or
(ii) 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 subsections (l), (nn), (oo) or (pp) of this
section, or equivalent NRC or agreement state requirements, has experience
in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-a-)
or (-b-), 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 this paragraph.
(pp) Training for the oral administration of sodium
iodide I-131 requiring a written directive in quantities greater than
33 mCi (1.22 GBq). Except as provided in subsection (l) of this section,
the licensee shall require an authorized user for the oral administration
of sodium iodide I-131 requiring a written directive in quantities
greater than 33 mCi (1.22 GBq) to be a physician who:
(1) is certified by a medical specialty board whose
certification process includes all of the requirements in paragraph
(3)(A) 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 in accordance with subsection
(nn) of this section or equivalent NRC or agreement state requirements
for uses listed in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section;
or
(3) has training and experience including, successful
completion of 80 hours of classroom and laboratory training applicable
to the medical use of sodium iodide I-131 for procedures requiring
a written directive.
(A) The training and experience shall include the following.
(i) classroom and laboratory training shall include
the following:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity;
(IV) chemistry of radioactive material for medical
use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
user who meets the requirements of subsection (l) of this section,
subsections (nn) or (pp) of this section or equivalent NRC or agreement
state requirements. A supervising authorized user who meets the requirements
of subsection (nn)(2) of this section, shall also have experience
in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-)
of this section. The work experience shall involve the following:
(I) ordering, receiving, and unpacking radioactive
materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
used to determine the activity of dosages and performing checks for
proper operation of survey meters;
(III) calculating, measuring, and safely preparing
patient or human research subject dosages;
(IV) using administrative controls to prevent a medical
event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
patients or human research subjects that includes at least three cases
involving the oral administration of greater than 33 mCi (1.22 GBq)
of sodium iodide I-131; and
Cont'd... |
