3701:1-58-36. Training for imaging and localization studies

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized in rule 3701:1-58-34 of the Administrative Code to be a physician who:

(A) 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 and who meets the requirements in paragraph (C)(2) of this rule. The names of board certifications which have been recognized by the director, United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete seven hundred hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes the topics listed in paragraphs (C)(1)(a) and (C)(1)(b) of this rule; and

(2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(B) Is an authorized user under rule 3701:1-58-40 of the Administrative Code and meets the requirements in paragraph (C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C)

(1) Has completed seven hundred hours of training and experience, including a minimum of eighty hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:

(a) Classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) 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 and paragraph (C)(1)(b)(vii) of this rule, or equivalent United States nuclear regulatory commission or agreement state requirements, involving:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(v) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(vi) Administering dosages of radioactive drugs to patients or human research subjects; and

(vii) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(2) Has obtained written attestation, 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 and paragraph (C)(1)(b)(vii) of this rule, or equivalent United States nuclear regulatory commission or agreement state requirements, that the individual has satisfactorily completed the requirements in paragraph (A)(1) or (C)(1) of this rule and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under rules 3701:1-58-32 and 3701:1-58-34 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: 8/15/2005, 12/22/08, 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: 8/15/2005, 12/22/08 )