3701:1-58-40 Training for use of unsealed radioactive material for which a written directive is required.

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 under rule 3701:1-58-37 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 paragraphs (B)(1)(b)(vi) and (B)(2) of this rule. Specialty boards whose certification processes 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 be recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include seven hundred hours of training and experience as described in paragraphs (B)(1)(a) to (B)(1)(b)(v) of this rule. Eligible training programs 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 "Committee on Post-Graduate Training of the American Osteopathic Association;" and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or

(B)

(1) Has completed seven hundred hours of training and experience, including a minimum of two hundred hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:

(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 or rule 3701:1-58-21 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 this rule, must also have experience in administering dosages in the same dosage category or categories, such as paragraph (B)(1)(b)(vi) of this rule, as the individual requesting authorized user status. The 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 contain spilled radioactive material safely and using proper decontamination procedures; and

(vi) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

(a) Oral administration of less than or equal to 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide I-131, for which a written directive is required;

(b) Oral administration of greater than 1.22 gigabecquerels, (thirty-three millicuries) of sodium iodide I-131. Experience with at least three cases in this paragraph also satisfies the requirement in paragraph (B)(1)(b)(vi)(a) of this rule;

(c) Parenteral administration of any beta emitter, or a photon- emitting radionuclide with a photon energy less than one hundred fifty keV, for which a written directive is required; and/or

(d) Parenteral administration of any other radionuclide, for which a written directive is required; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (A)(1) and (B)(1)(b)(vi), or (B)(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 rule 3701:1-58-37 of the Administrative Code. The written attestation must be signed by a preceptor authorized user who meets the requirements in this ruleor rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements. The preceptor authorized user, who meets the requirements in paragraph (B) of this rule must have experience in administering dosages in the same dosage category or categories, such as paragraph (B)(1)(b)(vi) of this rule, as the individual requesting authorized user status.

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