Except as provided in rule
3701:1-58-21
of the Administrative Code, the licensee shall require an authorized user for
the oral administration of sodium iodide iodine-131 requiring a written
directive in quantities greater than
1.22 gigabecquerels
(thirty-three millicuries) to be a physician who:
(A) Is certified by a medical specialty board
whose certification process includes all of the requirements in paragraphs
(C)(1) and (C)(2) of this rule, and whose certification has been recognized by
the director, the United States nuclear
regulatory commission, or an agreement state. The names
of board certifications which have been recognized by the director,
the United States nuclear regulatory commission,
or an agreement state will be posted on the United States nuclear regulatory
commission's "Medical Uses Licensee Toolkit" web
page at www.nrc.gov.; or
(B) Is an authorized user under rule
3701:1-58-40
of the Administrative Code, for uses listed in paragraph (B)(1)(b)(vi)(b) of
rule
3701:1-58-40
of the Administrative Code, or equivalent United States nuclear regulatory
commission or agreement state requirements; or
(C) Has achieved the following requirements:
(1) Has successfully completed eighty hours
of classroom and laboratory training, applicable to the medical use of sodium
iodide iodine-131 for procedures requiring a written directive. The training
must 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; and
(e) Radiation
biology;
(2) Has work
experience, under the supervision of an authorized user who meets the
requirements in rule
3701:1-58-21,
3701:1-58-40,
or this rule of the Administrative Code, or equivalent United States nuclear
regulatory commission or agreement state requirements. A supervising authorized
user who meets the requirements in paragraph (B) of rule
3701:1-58-40
of the Administrative Code, must have experience in administering dosages as
specified in paragraph (B)(1)(b)(vi)(b) of rule
3701:1-58-40
of the Administrative Code. The work experience must involve:
(a) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(b) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(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;
and
(f) Administering dosages to
patients or human research subjects, that includes at least three cases
involving the oral administration of greater than
1.22 gigabecquerels
(thirty-three millicuries) of sodium iodide iodine-131; and
(3) Has obtained written
attestation that the individual has satisfactorily completed the requirements
in paragraphs (C)(1) and (C)(2) of this rule, and is able to independently fulfill the radiation safety-related duties as an
authorized user for oral administration
of greater than 1.22 gigabecquerels
(thirty-three millicuries) of sodium iodide I-131 for medical uses authorized
under rule
3701:1-58-37
of the Administrative Code. The attestation must be obtained from
either:.
(a)
A preceptor authorized user who meets the requirements
in rule
3701:1-58-21,
3701:1-58-40,
or this rule of the Administrative Code, or equivalent United States nuclear
regulatory commission or agreement state requirements, and has experience in
administering dosages as specified in paragraph (B)(1)(b)(vii)(b) of rule
3701:1-58-40
of the Administrative Code; 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 rule
3701:1-58-21,
3701:1-58-40,
or this rule of the Administrative Code, or equivalent United States nuclear
regulatory commission or agreement state requirements, has experience in
administering dosages as specified in paragraph (B)(1)(b)(vii)(b) of rule
3701:1-58-40
of the Administrative Code, 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," 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 paragraphs
(C)(1) and (C)(2) of this rule.