Tenn. Comp. R. & Regs. 0400-20-07-.47

Current through June 26, 2024

Section 0400-20-07-.47 - TRAINING FOR USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED

(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-.44 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 an Agreement State and who meets the requirements in item (1)(b)1(ii)(VI) of this rule. 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 be recognized, a specialty board shall require a candidate for certification to:

1. Successfully complete a residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty that includes 700 hours of training and experience as described in subpart (b)1(i) through item (b)1(ii)(V) of this paragraph. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and

2. Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed by-product material; or

(b)

1. Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:

(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 of this rule, Rule 0400-20-07-.26, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user, who meets the requirements in this subparagraph, must also have experience in administering dosages in the same dosage category or categories (i.e., item (VI) of this subpart) 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 of radioactive drugs to patients or human research subjects from the four categories in this item. Radioactive drugs containing radionuclides in categories not included in this item are regulated under Rule 0400-20-07-.81. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

I. Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required;

II. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;

III. Parenteral administration of any radioactive drug that contains a radionuclide primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and

IV. Parenteral administration of any other radionuclide for which a written directive is required; and

2. Has obtained written attestation that the individual has satisfactorily completed the requirements in part (a)1 and item (b)1(ii)(VI) of this paragraph or part 1 of this subparagraph and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under Rule 0400-20-07-.44 for which the individual is requesting authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in this rule, Rule 0400-20-07-.26, or equivalent Agreement State or equivalent U.S. Nuclear Regulatory Commission requirements and who has experience in administering dosages in the same dosage 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 this rule, Rule 0400-20-07-.26, or equivalent Agreement State or equivalent U.S. Nuclear Regulatory Commission requirements, who has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, 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, 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-.47

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.