Tenn. Comp. R. & Regs. 0400-20-07-.43

Current through October 22, 2024

Section 0400-20-07-.43 - TRAINING FOR IMAGING AND LOCALIZATION STUDIES

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Rule 0400-20-07-.40 to be a physician who:

(a) Is certified by a medical specialty board whose certification process 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. To have its certification process recognized, a specialty board shall require all candidates for certification to:

1. Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies as described in subparts (c)1(i) and (ii) of this paragraph; and

2. Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Is an authorized user under Rule 0400-20-07-.47 and meets the requirements in item (c)1(ii)(VII) of this paragraph or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or

(c)

1. Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:

(i) Classroom and laboratory training in the following areas:

(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; and

(ii) Work experience, under the supervision of an authorized user, who meets the requirements in this rule, Rule 0400-20-07-.26, or item (VII) of this subpart and Rule 0400-20-07-.47 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements. An authorized nuclear pharmacist who meets the requirements in Rule 0400-20-07-.25 or 0400-20-07-.26 may provide the supervised work experience for item (VII) of this subpart. 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 unsealed radioactive material;

(V) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(VI) Administering dosages of radioactive drugs to patients or human research subjects; and

(VII) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

2. Has obtained written attestation that the individual has satisfactorily completed the requirements in part 1 of this subparagraph and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under Rules 0400-20-07-.39 and 0400-20-07-.40. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, this rule, or Rule 0400-20-07-.47, and item 1(ii)(VII) of this subparagraph, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or

(ii) 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 Rule 0400-20-07-.26, this rule, or Rule 0400-20-07-.47 and item 1(ii)(VII) of this subparagraph, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, and concurs with the attestation provided by the residency program director. The residency training 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 part 1 of this subparagraph.

Tenn. Comp. R. & Regs. 0400-20-07-.43

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.