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) or (B)(1)(b)(vi)(d) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements;

(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, 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) An authorized user satisfying paragraph (A)(2) or (A)(3) of this rule, shall be a physician who:

(1) Has successfully completed eighty hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than one hundred fifty keV, and/or parenteral administration of any other radionuclide for which a written directive is required. 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 administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than one hundred fifty keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in rule 3701:1-58-40 of the Administrative Code must have experience in administering dosages as specified in paragraphs (B)(1)(b)(vi)(c) and/or (B)(1)(b)(vi)(d) 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 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, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than one hundred fifty keV and/or at least three cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (A)(2) or (A)(3) of this rule, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation must be signed by 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. A preceptor authorized user, who meets the requirements in rule 3701:1-58-40 of the Administrative Code must have experience in administering dosages as specified in paragraphs (B)(1)(b)(vi)(c) and/or (B)(1)(b)(vi)(d) of rule 3701:1-58-40 of the Administrative Code.

Five Year Review (FYR) Dates: 03/09/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 12/22/2008, 1/1/12

Prior History: (Effective: 01/01/2012
R.C. 119.032 review dates: 08/31/2011 and 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 12/22/2008 )