Florida Regulations 64E-5.655: Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
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Except as provided in Fl. Admin. Code R. 64E-5.657, the licensee shall require the authorized user of a sealed source specified in Fl. Admin. Code R. 64E-5.634, 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-5.655(2)(c) and subsection 64E-5.655(3), 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) Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or 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 diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or
(2)(a) Have completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes the following:
1. 200 hours of 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; and
d. Radiation biology; and
2. 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements at a medical institution, clinic, or private practice facility, involving the following:
a. Reviewing full calibration measurements and periodic spot-checks;
b. Preparing treatment plans and calculating treatment doses and times;
c. Using administrative controls to prevent a medical event involving the use of radioactive material;
d. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
e. Checking and using survey meters;
f. Selecting the proper dose and how it is to be administered; and
(b) Have completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subFl. Admin. Code R. 64E-5.655(2)(a)2., of this section; and
(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.655(1)(a) or 64E-5.655(2)(a) and 64E-5.655(2)(b) and subsection 64E-5.655(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 for each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be 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-5.655, F.A.C., NRC or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and
(3) Have received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.
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-91.775, Amended 2-11-10, 12-26-13.
(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-5.655(2)(c) and subsection 64E-5.655(3), 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) Successfully complete a minimum of 3 years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or 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 diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or
(2)(a) Have completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes the following:
1. 200 hours of 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; and
d. Radiation biology; and
2. 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements at a medical institution, clinic, or private practice facility, involving the following:
a. Reviewing full calibration measurements and periodic spot-checks;
b. Preparing treatment plans and calculating treatment doses and times;
c. Using administrative controls to prevent a medical event involving the use of radioactive material;
d. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;
e. Checking and using survey meters;
f. Selecting the proper dose and how it is to be administered; and
(b) Have completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Agreement State requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subFl. Admin. Code R. 64E-5.655(2)(a)2., of this section; and
(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.655(1)(a) or 64E-5.655(2)(a) and 64E-5.655(2)(b) and subsection 64E-5.655(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 for each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be 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-5.655, F.A.C., NRC or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and
(3) Have received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.
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-91.775, Amended 2-11-10, 12-26-13.