Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive

Section 335 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 equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements; or b)         Is an authorized user under Section 335.9100 or 335.9140 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements and who meets the requirements in subsection (d); 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 and who meets the requirements in subsection (d). d)         The physician shall have: 1)         Successfully completed 80 hours of classroom and laboratory training applicable to parenteral administrations listed in subsection 335.9050(b)(2)(F)(iii).  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. 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 administrations listed in subsection 335.9050(b)(2)(F)(iii).  A supervising authorized user who meets the requirements in this Section, Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status.  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 of the parenteral administrations as specified in subsection 335.9050(b)(2)(F)(iii); and 3)         Obtained written attestation that the individual has satisfactorily completed the requirements in subsections (d)(1) and (d)(2) and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive.  The attestation shall be obtained from either: A)        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.  A preceptor authorized user who meets the requirements in this Section or Section 335.9050, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; 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 this Section, Section 335.9050, 335.9160, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, 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 subsection (d)(1) and (d)(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.