Section 335.9140  Training for Use of Remote Afterloader Units, Intravascular Brachytherapy Units, Teletherapy Units and Gamma Stereotactic Radiosurgery Units

Except as provided in Section 335.9160 of this Part, the licensee shall require the authorized user of a sealed source for a use authorized under Section 335.8010 of this Part to be a physician who:

a)         Is certified by a medical specialty board whose certification process includes all of the requirements in subsection (b)(3) and (b)(4) of this Section and whose certification 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)(3) and (b)(4) of this Section.  To be recognized, a specialty board shall require all candidates for certification to:

1)         Successfully complete a minimum of 3 years of residency training in a radiation therapy program 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;

2)         Pass an examination, administered by diplomate of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; 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:

1)         Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

A)        200 hours of 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)        Radiation biology; and

B)        500 hours of work experience under the supervision of an authorized user who meets the requirements in this Part or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements at a medical institution that involves:

i)          Reviewing full calibration measurements and periodic spot-checks;

ii)         Preparing treatment plans and calculating treatment doses and times;

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

iv)        Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

v)         Checking and using survey instruments;

vi)        Selecting the proper dose and how it is to be administered; and

2)         Completed 3 years of supervised clinical experience in radiation therapy under an authorized user who meets the requirements of this Section or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements as a part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Postdoctoral Training of the American Osteopathic Association.  This experience may be obtained concurrently with the supervised work experience required by subsection (b)(1)(B) of this Section; and

3)         Obtained written attestation that the individual has satisfactorily completed the requirements in subsection (a)(1), or (b)(1-2) and (b)(4), of this Section and has achieved a level of competency sufficient to function independently as an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.  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 for each type of therapeutic medical unit for which the individual is requesting authorized user status; and

4)         Has received training in device operation, safety procedures and clinical use for the types of use for which authorization is sought.  This training requirement may be met by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the types of use for which the individual is seeking authorization.

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