64E-5.662. Training for the Oral Administration of Sodium Iodide I-131 Requiring A Written Directive in Quantities Greater Than 1.22 Gigabecquerels (33 Millicuries)

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to:

(1) Be certified by a medical specialty board whose certification process includes all of the requirements in paragraphs 64E-5.662(3)(a) and 64E-5.662(3)(b), F.A.C., of this section, and whose certification has been recognized by the NRC or an agreement state, and who meets the requirements in paragraph 64E-5.662(3)(c), F.A.C., of this section. (The names of board certifications which have been recognized by the NRC or an agreement state will be posted on the NRC's Web page at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.); or

(2) Be an authorized user under Rule 64E-5.660, F.A.C., for uses listed in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C., NRC or equivalent Agreement State requirements; or

(3)(a) Have successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of radioactive material for medical use; and

5. Radiation biology; and

(b) Have work experience, under the supervision of an authorized user who meets the requirements in Rules 64E-5.657, 64E-5.660 or 64E-5.662, F.A.C., NRC or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C. The work experience must involve the following:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring, and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of radioactive material;

5. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

6. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs 64E-5.662(3)(a) and 64E-5.662(3)(b), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee authorized under Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., that require written directives. Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.660 or 64E-5.662, F.A.C., NRC or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C.

Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 2-11-10, Amended 12-26-13.