Section 335.9050  Training for Use of Unsealed Radioactive Material for Which a Written Directive is Required

Except as provided in Sections 335.9060, 335.9070 and 335.9160 of this Part, a licensee shall require the authorized user of unsealed radioactive material for the uses authorized under Section 335.3010, 335.4010, or 335.5010 of this Part requiring a written directive to be a physician who:

a)         Is certified by a medical specialty board whose certification process has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State and who meets the requirements in subsections (b)(2)(F) and (b)(3) of this section.  To be recognized, a specialty board shall require all candidates for certification to meet the following requirements:

A)        Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty that includes 700 hours of training and experience as described in subsections (b)(1) through (b)(2)(E) of this Section.  Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association;

B)        Pass an examination, administered by diplomate of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, quality assurance and clinical use of unsealed radioactive materials; or

AGENCY NOTE:  Specialty boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be posted on the NRC's Web page. 

b)         Has completed 700 hours of training and experience, including a minimum of 200 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 shall include:

1)         Classroom and laboratory training in the following areas:

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;

E)         Radiation biology; and

2)         Work experience, under the supervision of an authorized user who meets the requirements in this Section or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements.  A supervising authorized user, who meets the requirements in Section 335.9050(b) of this Part, shall have experience in administering dosages in the same dosage category or categories (i.e., Section 335.9050(b)(2)(F) of this Part) as the individual requesting authorized user status.  The work experience shall involve:

A)        Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation monitoring;

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

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;

            F)         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:

i)          Oral administration of less than or equal to 1.22 GBq (33 mCi) of sodium iodide I-131, for which a written directive is required;

ii)         Oral administration of greater than 1.22 GBq (33 mCi) of sodium iodide I-131;

AGENCY NOTE:  Experience with at least 3 cases in subsection (b)(2)(F)(ii) also satisfies the requirement in subsection (b)(2)(F)(i).

iii)         Parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required; and/or

iv)        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 subsections (a)(1) and (b)(2)(F) or (b) of this Section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Section 335.5010 of this Part.  The written attestation shall be signed by a preceptor authorized user who meets the requirements in this Section, or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements.  The preceptor authorized user who meets the requirements in Section 335.9050(b) of this Part must have experience in administering dosages in the same dosage category or categories (i.e., subsection (b)(2)(F)) as the individual requesting authorized user status.

AGENCY NOTE:  Specially Boards whose certification processes have been recognized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be posted on the NRC's web page.

(Source:  Amended at 32 Ill. Reg. 9247, effective June 13, 2008)