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

Current through June 26, 2024

Section 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;

(b) Is an authorized user under Rule 0400-20-07-.59 or Rule 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;

(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 Rule 0400-20-07-.80, and who meets the requirements in subparagraph (d) of this paragraph; or

(d)

1. Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in subitem (1)(b)1(ii)(VI)III of Rule 0400-20-07-.47. 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, Rule 0400-20-07-.47 or this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, in the parenteral administration listed in subitem (1)(b)1(ii)(VI)III of Rule 0400-20-07-.47. A supervising authorized user who meets the requirements in Rule 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. 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 administrations as specified in subitem (1)(b)1(ii)(VI)III of Rule 0400-20-07-.47; 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 obtained from either:

(i) A preceptor 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 preceptor authorized user, who meets the requirements in Rule 0400-20-07-.47, this rule, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; 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, Rule 0400-20-07-.47, Rule 0400-20-07-.50, or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, 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 parts 1 and 2 of this subparagraph.

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

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.