(a) Have 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 the following:
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 Rule
64E-5.657,
64E-5.660 or
64E-5.663, F.A.C., NRC or
equivalent Agreement State 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
64E-5.660, F.A.C., NRC or
equivalent Agreement State requirements, must have experience in administering
dosages as specified in sub-sub-subparagraph
64E-5.660(2)(a)
2.g.(III) or
64E-5.660(2)(a)
2.g.(IV), F.A.C., NRC or equivalent Agreement State requirements. 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 unsealed 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 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
(c) Have obtained
written attestation that the individual has satisfactorily completed the
requirements in subsection
64E-5.663(2) or
64E-5.663(3),
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 for the parenteral administration
of unsealed radioactive material requiring a written directive. 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-5.663, F.A.C., NRC or
equivalent Agreement State requirements. A preceptor authorized user, who meets
the requirements in Rule
64E-5.660, F.A.C., must have
experience in administering dosages as specified in sub-sub-subparagraph
64E-5.660(2)(a)
2.g.(III) or
64E-5.660(2)(a)
2.g.(IV), F.A.C.