64E-5.649. Training for Uptake, Dilution, or Excretion Studies

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a radiopharmaceutical listed in subsection 64E-5.626(1), F.A.C., to:

(1) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in paragraph 64E-5.649(3)(b), 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.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies that includes the topics listed in paragraph 64E-5.649(3)(a) and subparagraph 64E-5.649(3)(a)2., F.A.C., of this section; and

(b) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(2) Be an authorized user under Rule 64E-5.650 or 64E-5.660, F.A.C., NRC or equivalent Agreement State requirements; or

(3)(a) Have completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include the following:

1. Classroom and laboratory training in the following areas:

a. Radiation physics and instrumentation;

b. Radiation protection;

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

d. Chemistry of radioactive material for medical use;

e. Radiation biology; and

2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657, 64E-5.649, 64E-5.650 or 64E-5.660, F.A.C., NRC or equivalent Agreement State requirements, involving the following:

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

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

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

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

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

f. Administering dosages of radioactive drugs to patients or human research subjects.

(b) 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-5.649, 64E-5.650 or 64E-5.660, F.A.C., NRC or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph 64E-5.649(1)(a) or 64E-5.649(3)(a), F.A.C., of this section and has demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for medical uses authorized under subsection 64E-5.626(1), 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 8-25-91, Formerly 10D-91.769, Amended 2-11-10, 12-26-13.