Section 3701:1-58-104 - Training for the parenteral administration of unsealed radioactive material requiring a written directive(A) Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive, to be a physician who: (1) Is an authorized user under rule 3701:1-58-40 of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or(2) Is an authorized user under rule 3701:1-58-51 or 3701:1-58-71 of the Administrative code, or equivalent United States nuclear regulatory commission or agreement state requirements and who meets the requirements in paragraph (B) of this rule; or(3) Is certified by a medical specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state under rule 3701:1-58-51 or 3701:1-58-71 of the Administrative Code, and who meets the requirements in paragraph (B) of this rule.(B) The physician: (1) Has successfully completed eighty hours of classroom and laboratory training, applicable to parenteral administrations listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements. 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; and(2) Has work experience, under the supervision of an authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, in the parenteral administrations listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements. A supervising authorized user who meets the requirements in rule 3701:1-58-40 of the Administrative Code, this rule, or equivalent United States nuclear regulatory commission or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. 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 unsealed 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 include at least three cases involving the parenteral administration, as specified in paragraphs (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code; and(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (B)(2) of this rule, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The attestation must be obtained from either: (a) A preceptor authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, or equivalent agreement state requirements. A preceptor authorized user who meets the requirements in this rule, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; 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 rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, 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 (B)(1) and (B)(2) of this rule. Replaces: 3701:1-58-104
Ohio Admin. Code 3701:1-58-104
Effective: 8/15/2021
Five Year Review (FYR) Dates: 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 12/22/2008, 01/01/2012