Section 335.9040  Training for Imaging and Localization Studies

Except as provided in Section 335.9160 of this Part, a licensee shall require the authorized user of unsealed radioactive material for the uses authorized under Section 335.4010 of this Part not 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 subsection (c)(2).  To be recognized, a specialty board shall require all candidates for certification to meet the following requirements:

1)         Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies that includes the topics listed in subsections (c)(1)(A) and (c)(1)(B) of this section; and

2)         Pass an examination, administered by diplomate of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling and quality control; or

b)         Is an authorized user under Section 335.9050 and meets the requirements of 335.9040(c)(1)(B)(vii) or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements; or

c)         Has completed a structured educational program consisting of:

1)         700 hours of training and experience, including 80 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 shall 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;

v)         Radiation biology; and

B)        Work experience, under the supervision of an authorized user who meets the requirements in this Section, or Section 335.9050 and 335.9040 (c)(1)(B)(vii) of this Section, or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements, involving:

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

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

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;

vi)        Administering dosages of radioactive drugs to patients or human research subjects;

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 Section or Section 335.9050 and 335.9040 (c)(1)(B)(vii) of this Part, or equivalent U.S. Nuclear Regulatory Commission, Agreement State or Licensing State requirements, that the individual has satisfactorily completed the requirements in subsection (a)(1) or (c)(1) 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 335.3010 and 335.4010 of this Part for those procedures not requiring a written directive.

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.

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