South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart E - UNSEALED RADIOACTIVE MATERIAL-WRITTEN DIRECTIVE REQUIRED › Section 61-63.IV.E.RHA 4.45 - Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater Than 1.22 Gigabecquerels (33 Millicuries)

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in RHA 4.23, the licensee shall require an
					 authorized user for the oral administration of sodium iodide I-131 requiring a
					 written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries),
					 to be a physician who-
4.45.1 Is certified
				  by a medical specialty board whose certification process includes all of the
				  requirements in paragraphs 4.45.1.3 and 4.45.1.4 of this section, and whose
				  certification has been recognized by the Nuclear Regulatory Commission or an
				  Agreement State. The names of board certifications that have been recognized by the
				  Nuclear Regulatory Commission or an Agreement State are posted on the NRC's Medical
				  Uses Licensee Toolkit Web page; or
4.45.2 Is an authorized user under RHA 4.43.1,
				  4.43.2 for uses listed in RHA 4.43.2.2.7.2, or equivalent NRC requirements;
				  or
4.45.3 Has successfully completed 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 must
				  include-
4.45.3.1 Radiation physics and
				  instrumentation;
4.45.3.2 Radiation
				  protection;
4.45.3.3 Mathematics
				  pertaining to the use and measurement of radioactivity;
4.45.3.4 Chemistry of radioactive material for
				  medical use; and
4.45.3.5 Radiation
				  biology; and
4.45.3.6 Has work
				  experience, under the supervision of an authorized user who meets the requirements
				  in RHA 4.23, 4.43, 4.45, or equivalent NRC requirements. A supervising authorized
				  user, who meets the requirements in RHA 4.43.2, must also have experience in
				  administering dosages as specified in RHA 4.43.2.2.7.2. The work experience must
				  involve-
4.45.3.6.1 Ordering, receiving, and
				  unpacking radioactive materials safely and performing the related radiation
				  surveys;
4.45.3.6.2 Performing quality
				  control procedures on instruments used to determine the activity of dosages and
				  performing checks for proper operation for survey meters;
4.45.3.6.3 Calculating, measuring, and safely
				  preparing patient or human research subject dosages;
4.45.3.6.4 Using administrative controls to
				  prevent a medical event involving the use of radioactive material;
4.45.3.6.5 Using procedures to contain spilled
				  radioactive material safely and using proper decontamination procedures;
				  and
4.45.3.6.6 Administering dosages to
				  patients or human research subjects, that includes at least 3 cases involving the
				  oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium
				  iodide I-131; and
4.45.3.7 Has
				  obtained written attestation that the individual has satisfactorily completed the
				  requirements in paragraphs 4.45.3 of this section, and is able to independently
				  fulfill the radiation safety-related duties as an authorized user for oral
				  administration of greater than or equal to 1.22 gigabecquerels (33 millicuries) of
				  sodium iodide I-131 for medical uses authorized under
				  RHA 4.40. The attestation must be
				  obtained from either:
4.45.3.7.1 A preceptor
				  authorized user who meets the requirements in RHA 4.23, 4.43, 4.45, or equivalent
				  Nuclear Regulatory Commission or Agreement State requirements and has experience in
				  administering dosages as specified in 4.43.2.2.7.2; or
4.45.3.7.2 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 RHA 4.23, 4.43, 4.45, or equivalent Nuclear Regulatory
				  Commission or Agreement State requirements, has experience in administering dosages
				  as specified in 4.43.2.2.7.2, and concurs with the attestation provided by the
				  residency program director. The residency training program must be approved by the
				  Residency Review Committee of the Accreditation Council for Graduate Medical
				  Education or the Royal College of Physicians and Surgeons of Canada or the Council
				  on Postdoctoral Training of the American Osteopathic Association and must include
				  training and experience specified in paragraphs 4.45.3 of this
				  section.