Fla. Admin. Code Ann. R. 64E-5.655 - Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source specified in Rule 64E-5.634, 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-5.655(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 subparagraph
64E-5.655(2)(a)
2., F.A.C., 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.
Notes
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.
New 8-25-91, Formerly 10D-91.775, Amended 2-11-10, 12-26-13.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source specified in Rule 64E-5.634, 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-5.655(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 subparagraph 64E-5.655(2)(a) 2., F.A.C., 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.
Notes
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.
New 8-25-91, Formerly 10D-91.775, Amended 2-11-10, 12-26-13.