Section 0400-20-07-.49 - TRAINING FOR THE ORAL ADMINISTRATION OF SODIUM IODINE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES GREATER THAN 1.22 GIGABECQUERELS (33 MILLICURRIES)(1) Except as provided in Rule 0400-20-07-.26, a 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:(a) Is certified by a medical specialty board whose certification process includes all of the requirements of parts (c)1 and (c)2 of this paragraph and whose certification has been recognized by the Division, the U.S. Nuclear Regulatory Commission, or an Agreement State. The names of board certifications that have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State are posted on the U.S. Nuclear Regulatory Commission's Medical Uses Licensee Toolkit Web page; or(b) Is an authorized user under Rule 0400-20-07-.47 for uses listed in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or(c)1. 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: (i) Radiation physics and instrumentation;(ii) Radiation protection;(iii) Mathematics pertaining to the use and measurement of radioactivity;(iv) Chemistry of radioactive material for medical use; and(v) Radiation biology; and2. Has work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, Rule 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A supervising authorized user, who meets the requirements in subparagraph (1)(b) of Rule 0400-20-07-.47, must have experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47. The work experience must involve:(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;(iv) Using administrative controls to prevent a misadministration involving the use of radioactive material;(v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and(vi) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and3. Has obtained written attestation that the individual has satisfactorily completed the requirements of parts 1 and 2 of this subparagraph and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under Rule 0400-20-07-.44. The written attestation must be signed by a preceptor authorized user who meets the requirements of Rule 0400-20-07-.26, Rule 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. A preceptor authorized user who meets the requirements of subparagraph (1)(b) of Rule 0400-20-07-.47 must have experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)II of Rule 0400-20-07-.47.(d) Has obtained written attestation that the individual has satisfactorily completed the requirements of parts (c)1 and (c)2 of this paragraph 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 iodine I-131 for medical uses authorized under Rule 0400-20-07-.44. The attestation must be obtained from either: 1. A preceptor authorized user who meets the requirements of Rule 0400-20-07-.26, Rule 0400-20-07-.47, Rule 0400-20-07-.48, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements and who has experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)I or II of Rule 0400-20-07-.47; or2. 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 of Rule 0400-20-07-.26, Rule 0400-20-07-.47, Rule 0400-20-07-.48, this rule, or equivalent Agreement State requirements, who has experience in administering dosages as specified in subitem (1)(b)1(ii)(VI)I or II of Rule 0400-20-07-.47, and who 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 parts (c)1 and (c)2 of this paragraph.Tenn. Comp. R. & Regs. 0400-20-07-.49
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.