Tenn. Comp. R. & Regs. 0400-20-07-.50 - TRAINING FOR THE PARENTERAL ADMINISTRATION OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE

(1) Except as provided in Rule 0400-20-07-.26, a licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who: .

(a) Is an authorized user under Rule 0400-20-07-.47 for uses listed in subitem (1)(b)1(ii)(VI)III or IV of Rule 0400-20-07-.47, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements; or

(b) Is an authorized user under Rule 0400-20-07-.59 or 0400-20-07-.80, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements and who meets the requirements in subparagraph (d) of this paragraph; or

(c) Is certified by a medical specialty board whose certification process has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State under Rule 0400-20-07-.59 or 0400-20-07-.80, and who meets the requirements in subparagraph (d) of this paragraph.

(d)

1. Has successfully completed 80 hours of classroom and laboratory training , applicable to parenteral administrations, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. 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; and

2. Has work experience, under the supervision of an authorized user who meets the requirements in Rule 0400-20-07-.26, 0400-20-07-.47 or this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, in the parenteral administration, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in Rule 0400-20-07-.47 must have experience in administering dosages as specified in subitems (1)(b)1(ii)(VI)III and/or IV 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 unsealed 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 include at least 3 cases involving the parenteral administration, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and

3. Has obtained written attestation that the individual has satisfactorily completed the requirements in subparagraphs (b) or (c) of this paragraph, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in Rule 0400-20-07-.26, 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 in Rule 0400-20-07-.47, must have experience in administering dosages as specified in subitems (1)(b)1(ii)(VI)III and/or IV of Rule 0400-20-07-.47.

Notes

Tenn. Comp. R. & Regs. 0400-20-07-.50

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.