Section 3701:1-58-42 - Training for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities greater than 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 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(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.Ohio Admin. Code 3701:1-58-42
Effective: 8/15/2021
Five Year Review (FYR) Dates: 11/13/2020 and 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008, 01/01/2012