Ohio Admin. Code 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, 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. 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: . An authorized nuclear pharmacist who meets the requirements in rule 3701:1-58-20 or 3701:1-58-21 of the Administrative Code may provide the supervised work experience for paragraph (C)(1)(b)(vii) of this rule. Work experience must involve:

(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 is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under rules 3701:1-58-32 and 3701:1-58-34 of the Administrative Code. 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 and paragraph (C)(1)(b)(vii) of this rule, or United States nuclear regulatory commission or agreement state requirements; 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 and paragraph (C)(1)(b)(vii) of this rule, or United States nuclear regulatory commission or agreement state requirements, 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 paragraph (C)(1) of this rule.

Notes

Ohio Admin. Code 3701:1-58-36

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