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 4.44 - Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 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 less than or equal to 1.22 Gigabecquerels (33
					 millicuries), to be a physician who-
4.44.1
				  Is certified by a medical specialty board whose certification process includes all
				  of the requirements in paragraphs 4.44.1.3 and 4.44.1.4 of this section and whose
				  certification process 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
4.44.2 Is an authorized user under
				  RHA 4.43, for uses listed in RHA
				  4.43.2.2.7.1 or 4.43.2.2.7.2, RHA 4.45, or equivalent NRC requirements; or
4.44.3 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-
4.44.3.1 Radiation physics and
				  instrumentation;
4.44.3.2 Radiation
				  protection;
4.44.3.3 Mathematics
				  pertaining to the use and measurement of radioactivity;
4.44.3.4 Chemistry of radioactive material for
				  medical use; and
4.44.3.5 Radiation
				  biology; and
4.44.3.6 Has work
				  experience, under the supervision of an authorized user who meets the requirements
				  in RHA 4.23, 4.43, RHA 4.44, RHA 4.45, or equivalent NRC requirements. A supervising
				  authorized user who meets the requirements in RHA 4.43.2 must have experience in
				  administering dosages as specified in RHA 4.43.2.2.7.1 or 4.43.2.2.7.2. The work
				  experience must involve-
4.44.3.6.1 Ordering,
				  receiving, and unpacking radioactive materials safely and performing the related
				  radiation surveys;
4.44.3.6.2 Performing
				  quality control procedures on instruments used to determine the activity of dosages
				  and performing checks for proper operation for survey meters;
4.44.3.6.3 Calculating, measuring, and safely
				  preparing patient or human research subject dosages;
4.44.3.6.4 Using administrative controls to
				  prevent a medical event involving the use of radioactive material;
4.44.3.6.5 Using procedures to contain spilled
				  radioactive material safely and using proper decontamination procedures;
				  and
4.44.3.6.6 Administering dosages to
				  patients or human research subjects, that includes at least 3 cases involving the
				  oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of
				  sodium iodide I-131; and
4.44.3.7 Has obtained written attestation that the
				  individual has satisfactorily completed the requirements in paragraphs 4.44.3 of
				  this section, 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
				  gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized
				  under
				  RHA 4.40. The attestation must be
				  obtained from either:
4.44.3.7.1 A preceptor
				  authorized user who meets the requirements in RHA 4.23, RHA 4.43, RHA 4.44, RHA
				  4.45, or equivalent Nuclear Regulatory Commission or Agreement State requirements
				  and has experience in administering dosages as specified in RHA 4.43.2.2.7.1 or RHA
				  4.43.2.2.7.2; or
4.44.3.7.2 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, RHA 4.43, RHA 4.44, RHA
				  4.45, or equivalent Agreement State requirements, has experience in administering
				  dosages as specified in RHA 4.43.2.2.7.1 or RHA 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 4.44.1.3 and 4.44.1.4 of this section.