Ohio Admin. Code 3701:1-58-41 - Training for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (thirty-three millicuries)
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 less than or equal to 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 process has been
recognized by the director, the United States
nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (C) (3) of this
rule. 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)(a) or
(B)(1)(b)(vi)(b) of rule
3701:1-58-40
of the Administrative Code, rule
3701:1-58-42
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,
this rule, or rule
3701:1-58-42
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)(a) or (B)(1)(b) (vi)(a) 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 less than or equal to
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
has achieved a level of competency sufficient to function
and is able to independently
fulfill the radiation safety-related duties
as an authorized user for medical uses authorized
under rule
3701:1-58-37
of the Administrative Code. The written attestation must be signed by a
preceptor authorized user who meets the requirements in this rule, rule
3701:1-58-21,
3701:1-58-40,
or
3701:1-58-42
of the Administrative Code, or equivalent United States nuclear regulatory
commission or agreement state requirements. A preceptor authorized user, who
meets the requirement in paragraph (B) of rule
3701:1-58-40
of the Administrative Code, must also have experience in administering dosages
as specified in paragraph (B)(1)(b)(vi)(a) or (B)(1)(b)(vi)(b) of rule
3701:1-58-40
of the Administrative Code.
for oral
administration of less than or equal to
1.22 gigabecquerels
(thirty-three millicuries) of sodium iodide iodine-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,
this rule, or rule
3701:1-58-42
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)(vi)(a) or (B) (1)(b)(vi)(b) 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 inrule
3701:1-58-21,
3701:1-58-40,
this rule, or rule
3701:1-58-42
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) (vi)(a) or (B)(1)(b)(vi)(b) 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.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008, 01/01/2012
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