Tenn. Comp. R. & Regs. 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 and who meets the requirements in part (c)2 of this paragraph. To be 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;

(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, involving:

(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, signed by a preceptor authorized user who meets the requirements in this rule, Rule 0400-02-07-.26, 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, that the individual has satisfactorily completed the requirements in parts (a)1 or (c)1 of this paragraph and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Rules 0400-20-07-.38 and 0400-20-07-.40.

Notes

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

Original rule filed February 22, 2012; effective May 22, 2012.

Authority: T.C.A. §§ 68-202-101 et seq., 68-202-201 et seq. and 4-5-201 et seq.