Ariz. Admin. Code § R9-7-727 - Training for Use of Manual Brachytherapy Sources and Training for the Use of Strontium-90 Sources for Treatment of Ophthalmic Disease
A. Except as provided in
R9-7-710,
the licensee shall require an authorized user of a manual brachytherapy source
for the uses authorized under this Article to be a physician who:
1. Is 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 subsection (A)(2). The names of board
certifications that have been recognized by the NRC or an Agreement State are
specified in the NRC's Medical Uses Licensee Toolkit available through
https://www.nrc.gov. To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
a.
Successfully complete a minimum of three years of residency training in a
radiation oncology 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 Council on Postdoctoral Training of
the American Osteopathic Association; and
b. Pass an examination, administered by
diplomates of the specialty board, that tests knowledge and competence in
radiation safety, radionuclide handling, treatment planning, quality assurance,
and clinical use of manual brachytherapy; or
2. Has completed a structured educational
program in basic radionuclide handling techniques applicable to the use of
manual brachytherapy sources that includes:
a.
200 hours of classroom and laboratory training in the following areas:
i. Radiation physics and
instrumentation;
ii. Radiation
protection;
iii. Mathematics
pertaining to the use and measurement of radioactivity;
iv. Radiation biology;
b. 500 hours of work experience, under the
supervision of an authorized user who meets the requirements in this Section,
or equivalent NRC or Agreement State requirements at a medical institution,
involving:
i. Ordering, receiving, and
unpacking radioactive materials safely and performing the related radiation
surveys;
ii. Checking survey meters
for proper operation;
iii.
Preparing, implanting, and removing brachytherapy sources;
iv. Maintaining running inventories of
material on hand;
v. Using
administrative controls to prevent a medical event involving the use of
radioactive material;
vi. Using
emergency procedures to control radioactive material;
c. Completing three years of supervised
clinical experience in radiation oncology, under an authorized user who meets
the requirements in this Section, 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
Council on Postdoctoral Training of the American Osteopathic Association. This
experience may be obtained concurrently with the supervised work experience
required by subsection (A)(2)(b); and
d. Obtaining written attestation that the
individual has satisfactorily completed the requirements in subsections
(A)(2)(a) through (c) and is able to independently fulfill the radiation
safety-related duties as an authorized user of manual brachytherapy sources for
the medical uses authorized under Exhibit A, Medical Use Groups of this
Article. The attestation must be obtained from either:
i. A preceptor authorized user who meets the
requirements in this Section or equivalent Agreement State or NRC requirements;
or
ii. A residency program director
who affirms in writing that the attestation represents the consensus of the
residency program faculty where at least one faculty member is an authorized
user who meets the requirements in this Section or equivalent Agreement State
or NRC requirements, and concurs with the attestation provided by the residency
program director. The residency training program must be 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
Council on Postdoctoral Training of the American Osteopathic Association and
must include training and experience specified in subsection (A)(2)(a) and
(b).
B. A licensee who uses strontium-90 for
ophthalmic treatments must ensure that certain activities as specified in
subsection (C) are performed by either:
1. An
authorized medical physicist; or
2.
An individual who:
a. Is identified as an
ophthalmic physicist on a:
i. Specific medical
use license issued by the Department, the NRC, or another Agreement
State,
ii. Permit issued by an NRC
or other Agreement State broad scope medical use licensee,
iii. Medical use permit issued by a NRC
master material licensee, or
iv.
Permit issued by a NRC master material license broad scope medical use
permittee;
b. Holds a
master's or doctor's degree in physics, medical physics, other physical
sciences, engineering, or applied mathematics from an accredited college or
university;
c. Has successfully
completed one year of full-time training in medical physics and an additional
year of full-time work experience under the supervision of a medical physicist;
and
d. Has documented training in:
i. The creation, modification, and completion
of written directives;
ii.
Procedures for administrations requiring a written directive; and
iii. Performing the calibration measurements
of brachytherapy sources as detailed in
R9-7-726.
C. The individuals who
are identified in subsection (B)(1) or (2) shall:
1. Calculate the activity of each
strontium-90 source that is used to determine the treatment times for
ophthalmic treatments. The decay must be based on the activity determined under
R9-7-726; and
2. Assist the
licensee in developing, implementing, and maintaining written procedures to
provide high confidence that the administration is in accordance with the
written directive. These procedures must include the frequencies that the
individual meeting the requirements in paragraph (a) of this Section will
observe treatments, review the treatment methodology, calculate treatment time
for the prescribed dose, and review records to verify that the administrations
were in accordance with the written directives.
D. Licensees shall retain a record of the
activity of each strontium-90 source in accordance with
R9-7-313.
E. The training and experience shall have
been obtained within the seven years preceding the date of application or the
individual shall have had related continuing education and experience since the
required training and experience was completed.
Notes
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