Current through Register Vol. 48, No. 12, March 22, 2024
Except as provided in Section
335.9160,
the licensee shall require the authorized user for the oral administration of
sodium iodide I-131 requiring a written directive in quantities greater than
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
AGENCY NOTE: Specialty boards whose certification processes
have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or
an Agreement State will be posted on the NRC's website.
b) Is an authorized user who meets the
requirements of Section
335.9050
for the uses identified in subsection
335.9050(b)(2)(F)(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 in this
Section, Section 335.9050, 335.9160 or equivalent U.S. Nuclear Regulatory
Commission or Agreement State requirements. A supervising authorized user who
meets the requirements of Section
335.9050(b)
shall have experience in administering the dosages identified in subsection
335.9050(b)(2)(F)(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 greater than
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 (2) and
is able to independently fulfill the radiation safety-related duties as an
authorized user for oral administration of greater than
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, 335.9160, 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)(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 this Section, Section 335.9050, 335.9160, or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements,
has experience in administering the dosages identified in subsection
335.9050(b)(2)(F)(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).
AGENCY NOTE: Specialty boards whose certification processes
have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or
an Agreement State will be posted on the NRC's
website.