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, the licensee shall require the authorized user of a sealed source under the provisions and requirements of Subpart I 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 or an Agreement State and who has obtained the attestation described in subsection (c) of this Section and the training required by subsection (d) 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 evaluates 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 or an Agreement State will be posted on the NRC's website.

b)         Has obtained the attestation described in subsection (c) of this Section, the training required by subsection (d) of this Section and 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 at a medical institution under the supervision of an authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.  The work experience shall include:

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 Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State or requirements.  The experience shall be obtained as 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.

c)         Has obtained written attestation that the individual has satisfactorily completed the requirements in subsection (a)(1) and (d) or (b) and (d) of this Section and has achieved a level of competency sufficient to function independently as an authorized user for the type of therapeutic medical unit for which the individual is requesting authorized user status.  The attestation shall be signed by a preceptor authorized user who meets the requirements in this Section or Section 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for each type of therapeutic medical unit for which the individual is requesting authorized user status.

d)         Has received training in device operation, safety procedures and clinical use for the type of therapeutic medical unit for which authorization is sought.  This training requirement may be met by satisfactory completion of a training program provided for new users by the equipment supplier 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.

AGENCY NOTE:  The term "type of therapeutic medical unit" refers to a type of use identified in this Section.  It applies to this Section only.  Training for therapeutic medical units is not manufacturer-specific.  Training for one brand of therapeutic medical unit is acceptable for another brand of the same type of unit.

(Source:  Amended at 35 Ill. Reg. 884, effective December 30, 2010)