Except as provided in Section
335.9160,
the licensee shall require the authorized user for oral administration of
sodium iodide I-131 requiring a written directive in quantities less than or
equal to
1.22
GBq (33 mCi) to be a physician who:
a)
Is certified by a medical specialty board whose certification process includes
all of the requirements in subsections (c)(1) and (c)(2) and whose
certification has been recognized by the Agency, the U.S. Nuclear Regulatory
Commission or an Agreement State; or
b) Is an authorized user who meets the
requirements of Section
335.9070
or Section
335.9050
for the uses identified in subsection
335.9050(b)(2)(F)(i)
or (ii) or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements; or
c) Has successfully completed a structured
educational program consisting of:
1) 80
hours of classroom and laboratory training applicable to the medical use of
sodium iodide I-131 for procedures requiring a written directive. The training
shall include:
A) Radiation physics and
instrumentation;
B) Radiation
protection;
C) Mathematics
pertaining to the use and measurement of radioactivity;
D) Chemistry of radioactive material for
medical use;
E) Radiation biology;
and
2) Work experience
under the supervision of an authorized user who meets the requirements of this
Section, Section 335.9050, 335.9070, 335.9160 or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements. A supervising authorized
user who meets the requirements of subsection
335.9050(b)
shall have experience in administering the dosages identified in subsection
335.9050(b)(2)(F)(i)
or (ii). The work experience shall involve:
A) Ordering, receiving and unpacking
radioactive materials safely, and performing the related radiation
monitoring;
B) Performing quality
control procedures on instruments used to determine the activity of dosages,
and performing checks for proper operation of survey instruments;
C) Calculating, measuring and safely
preparing patient or human research subject dosages;
D) Using administrative controls to prevent a
medical event involving the use of radioactive material;
E) Using procedures to contain spilled
radioactive material safely and using proper decontamination
procedures;
F) Administering
dosages to patients or human research subjects and shall include at least 3
cases involving the oral administration of less than or equal to
1.22
GBq (33 mCi) of sodium iodide I-131; and
3) Written attestation that the individual
has satisfactorily completed the requirements in subsections (c)(1) and (c)(2)
and is able to independently fulfill the radiation safety-related duties as an
authorized user for oral administration of less than or equal to
1.22
GBq (33 mCi) of sodium iodide I-131 for medical uses authorized under Section
335.5010.
The attestation shall be obtained from either:
A) A preceptor authorized user who meets the
requirements in this Section, Section 335.9050, 335.9070, 335.9160 or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements
and has experience in administering the dosages identified in subsection
335.9050(b)(2)(F)(i)
or (ii); 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 Section 335.9050, 335.9070, 335.9160, or equivalent
U.S. Nuclear Regulatory Commission or Agreement State requirements and has
experience in administering the dosages identified in subsection
335.9050(b)(2)(F)(i)
or (ii) and concurs with the attestation
provided by the residency program director. The residency training program
shall be 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 Council on Postdoctoral Training of the American
Osteopathic Association and shall include training and experience specified in
subsections (c)(1) and (c)(2).