Section 335.9080  Training for the Parenteral Administration of Unsealed Radioactive 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 who meets the requirements of Section 335.9050 for a use identified in subsection 335.9050(b)(2)(F)(iii) or (iv) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or

b)         Is an authorized user under Section 335.9100 or 335.9140 or 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and who meets the requirements in subsection (d) of this Section and has obtained the attestation described in subsection (e) of this Section; or

c)         Is certified by a medical specialty board whose certification process has been recognized by the Agency under Section 335.9100 or 335.9140 or by the U.S. Nuclear Regulatory Commission or an Agreement State.  The individual shall meet the requirements in subsection (d) of this Section and have obtained the attestation described in subsection (e) of this Section; or

d)         Has obtained the attestation described in subsection (e) of this Section and has:

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

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; 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, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements in the parenteral administration of radioactive material for which a written directive is required.  The experience shall include administration of any beta emitter, any photon-emitting radionuclide with a photon energy less than 150 keV 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 shall have experience in administering dosages as identified in Section 335.9050(b)(2)(F)(iii) or (iv).  The work experience shall 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 radioactive material;

E)         Using procedures to contain spilled radioactive 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 of radioactive material for which a written directive is required.  This experience shall include administration of any beta emitter, any photon-emitting radionuclide with a photon energy less than 150 keV or at least 3 cases involving the parenteral administration of any other radionuclide for which a written directive is required.

e)         Has obtained written attestation that the individual has satisfactorily completed the requirements in subsection (b), (c) or (d) of this Section and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive.  The attestation shall be signed by a preceptor authorized user who meets the requirements in this Section, Section 335.9050, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.  The preceptor authorized user who meets the requirements in Section 335.9050 shall have experience in administering dosages identified in subsections 335.9050(b)(2)(F)(iii) or (iv).

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.

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