Florida Regulations 64E-5.660: Training for Use of Unsealed Radioactive Material for Which A Written Directive is Required in Rule 63E-5.626, 64E-5.627 or 64E-5.630, F.A.C.
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Except as provided in Fl. Admin. Code R. 64E-5.657, the licensee shall require the authorized user of unsealed radioactive materials specified in Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., which require a written directive 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 sub-subparagraphs 64E-5.660(2)(a)2.g. and Fl. Admin. Code R. 64E-5.660(2)(b), of this section. (Specialty boards whose certification processes 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 be recognized, a specialty board shall require all candidates for certification to:
(a) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in subparagraph 64E-5.660(2)(a)1. through sub-subFl. Admin. Code R. 64E-5.660(2)(a)2.e., of this section. Eligible training programs 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 Committee on Post-Graduate Training of the American Osteopathic Association; and
(b) Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or
(2)(a) Have 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 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; and
e. Radiation biology; and
2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 4E-5.660, 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 in the same dosage category or categories (i.e., sub-subFl. Admin. Code R. 64E-5.660(2)(a)2.g.,) as the individual requesting authorized user status. The work experience must involve 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;
f. Performing checks for proper operation of survey meters; and
g. Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status as listed below:
(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 or sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C.;
(II) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;
(III) Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or
(IV) Parenteral administration of any other radionuclide, for which a written directive is required; and
(b) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.660(1)(a), sub-subparagraph 64E-5.660(2)(a)2.g. or Fl. Admin. Code R. 64E-5.660(2)(a), 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 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 or 64E-5.660, F.A.C., NRC or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must have experience in administering dosages in the same dosage category or categories specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C., as the individual requesting authorized user status.
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.
(a) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in subparagraph 64E-5.660(2)(a)1. through sub-subFl. Admin. Code R. 64E-5.660(2)(a)2.e., of this section. Eligible training programs 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 Committee on Post-Graduate Training of the American Osteopathic Association; and
(b) Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or
(2)(a) Have 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 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; and
e. Radiation biology; and
2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 4E-5.660, 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 in the same dosage category or categories (i.e., sub-subFl. Admin. Code R. 64E-5.660(2)(a)2.g.,) as the individual requesting authorized user status. The work experience must involve 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;
f. Performing checks for proper operation of survey meters; and
g. Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status as listed below:
(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 or sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C.;
(II) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;
(III) Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or
(IV) Parenteral administration of any other radionuclide, for which a written directive is required; and
(b) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.660(1)(a), sub-subparagraph 64E-5.660(2)(a)2.g. or Fl. Admin. Code R. 64E-5.660(2)(a), 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 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 or 64E-5.660, F.A.C., NRC or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must have experience in administering dosages in the same dosage category or categories specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C., as the individual requesting authorized user status.
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.