Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 GBq (33 mCi)

Section 335 Section 335.9060  Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 GBq (33 mCi) Except as provided in Section 335.9160, the licensee shall require the authorized user for oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 GBq (33 mCi) to be a physician who: a)         Is certified by a medical specialty board whose certification process includes all of the requirements in subsections (c)(1) and (c)(2) and whose certification has been recognized by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State; or b)         Is an authorized user who meets the requirements of Section 335.9070 or Section 335.9050 for the uses identified in subsection 335.9050(b)(2)(F)(i) or (ii) or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or c)         Has successfully completed a structured educational program consisting of: 1)         80 hours of classroom and laboratory training applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive.  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; E)        Radiation biology; and 2)        Work experience under the supervision of an authorized user who meets the requirements of this Section, Section 335.9050, 335.9070, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements.  A supervising authorized user who meets the requirements of subsection 335.9050(b) shall have experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii).  The work experience shall involve: A)       Ordering, receiving and unpacking radioactive materials safely, and performing the related radiation monitoring; B)        Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey instruments; 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 radioactive material; E)        Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; F)         Administering dosages to patients or human research subjects and shall include at least 3 cases involving the oral administration of less than or equal to 1.22 GBq (33 mCi) of sodium iodide I-131; and 3)         Written attestation that the individual has satisfactorily completed the requirements in subsections (c)(1) and (c)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 GBq (33 mCi) of sodium iodide I-131 for medical uses authorized under Section 335.5010.  The attestation shall be obtained from either: A)        A preceptor authorized user who meets the requirements in this Section, Section 335.9050, 335.9070, 335.9160 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii); or B)        A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Section 335.9050, 335.9070, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and has experience in administering the dosages identified in subsection 335.9050(b)(2)(F)(i) or (ii) and concurs with the attestation provided by the residency program director.  The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in subsections (c)(1) and (c)(2). 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.