Florida Regulations 64E-5.663: Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive
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Except as provided in Fl. Admin. Code R. 64E-5.657, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to:
(1) Be an authorized user under Fl. Admin. Code R. 64E-5.660, for uses listed 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; or
(2) Be an authorized user under Rule 64E-5.652 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements and who meets the requirements in subsection 64E-5.663(4), F.A.C. of this section; or
(3) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state under Rule 64E-5.652 or 64E-5.655, F.A.C., and who meets the requirements in subsection 64E-5.663(4), F.A.C., of this section.
(4)(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 Fl. Admin. Code R. 64E-5.660, 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 Fl. Admin. Code R. 64E-5.660, 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.
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.
(1) Be an authorized user under Fl. Admin. Code R. 64E-5.660, for uses listed 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; or
(2) Be an authorized user under Rule 64E-5.652 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements and who meets the requirements in subsection 64E-5.663(4), F.A.C. of this section; or
(3) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state under Rule 64E-5.652 or 64E-5.655, F.A.C., and who meets the requirements in subsection 64E-5.663(4), F.A.C., of this section.
(4)(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 Fl. Admin. Code R. 64E-5.660, 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 Fl. Admin. Code R. 64E-5.660, 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.
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.