Section 335.9080  Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Except as provided in Section 335.9160, the licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician who:

a)         Is an authorized user under Section 335.9050 for uses listed in subsections 335.9050(b)(2)(F)(iii) or 335.9050(b)(2)(F)(iv), or equivalent U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State requirements; or

b)         Is an authorized user under Section 335.9100 or 335.9140, or equivalent U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State requirements and who meets the requirements in subsection (d) of this section; or

c)         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 under Section 335.9100 or 335.9140, and who meets the requirements in subsection (d) of this section; or

d)         Has:

1)         Successfully completed 80 hours of classroom and laboratory training applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required.  The training must include:

A)        Radiation physics and instrumentation;

B)        Radiation protection;

C)        Mathematics pertaining to the use and measurement of radioactivity;

D)        Chemistry of byproduct material for medical use; and

E)         Radiation biology; and

2)         Work experience, under the supervision of an authorized user who meets the requirements in this Section, Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required.  A supervising authorized user who meets the requirements in Section 335.9050 must have experience in administering dosages as specified in Section 335.9050(b)(2)(F)(iii) or 335.9050(b)(2)(F)(iv).  The work experience must involve:

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

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

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 byproduct material;

E)         Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and

F)         Administering dosages to patients or human research subjects that include at least 3 cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or at least 3 cases involving the parenteral administration of any other radionuclide for which a written directive is required; and

3)         Obtained written attestation that the individual has satisfactorily completed the requirements in subsection (b) or (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive.  The written attestation must be signed by a preceptor authorized user who meets the requirements in this section and Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State requirements.  A preceptor authorized user who meets the requirements in Section 335.9050 must have experience in administering dosages as specified in Section 335.9050(b)(2)(F)(iii) 335.9050(b)(2)(F) (iv).

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