Arizona Administrative Code (Last Updated: November 17, 2016) |
Title 12. NATURAL RESOURCES |
Chapter 1. RADIATION REGULATORY AGENCY |
Article 7. MEDICAL USES OF RADIOACTIVE MATERIAL |
Section R12-1-723. Training for Use of Unsealed Radioactive Mate- rial Requiring a Written Directive, Including Treatment of Hyperthyroidism, and Treatment of Thyroid Carcinoma
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A. Except as provided in R12-1-710, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under Group 300 to be a physician who:
1.
Is certified by a medical specialty board whose certifica-
least three cases in Category
tion process has been recognized by the NRC or an
(A)(2)(b)(vi)(2) also satisfies this require-
Agreement State and who meets the requirements in sub-
ment);
section (A)(2). To have its certification process recog-
(2) Oral administration of greater than 1.22
nized, a specialty board shall require all candidates for
gigabecquerels (33 millicuries) of sodium
certification to:
iodide I-131;
a. Successfully complete residency training in a radia-
(3) Parenteral administration of any beta emit-
tion therapy or nuclear medicine training program or
ter, or a photon-emitting radionuclide with
a program in a related medical specialty. These resi-
a photon energy less than 150 keV, for
dency training programs must include 700 hours of
which a written directive is required; and/
training and experience as described in (A)(2). Eligi-
or
ble training programs must be approved by the Resi-
(4) Parenteral administration of any other
dency Review Committee of the Accreditation
radionuclide, for which a written directive
Council for Graduate Medical Education, the Royal
is required; and
College of Physicians and Surgeons of Canada, or
c. Has obtained written attestation, signed by a precep-
the Committee on Post-Graduate Training of the
tor authorized user who meets the requirements as
American Osteopathic Association; and
an authorized user for Exhibit A group 300 nuclides,
b. Pass an examination, administered by diplomates of
NRC, or equivalent Agreement State requirements,
the specialty board, which tests knowledge and com-
that the individual has satisfactorily completed the
petence in radiation safety, radionuclide handling,
requirements in subsection (A)(1) or (A)(2) and has
and quality assurance, and clinical use of unsealed
achieved a level of competency sufficient to func-
radioactive material for which a written directive is
tion independently as an authorized user for the
required; or
medical uses authorized under Exhibit A of this
2.
Has completed 700 hours of training and experience,
Article. The written attestation must be signed by a
including a minimum of 200 hours of classroom and lab-
preceptor authorized user who meets the require-
oratory training, in basic radionuclide handling tech-
ments in this Section, NRC, or equivalent Agree-
niques applicable to the medical use of unsealed
ment State requirements. The preceptor authorized
radioactive material requiring a written directive. The
user, who meets the requirements in subsection (B)
training and experience must include:
must have experience in administering dosages in
a. Classroom and laboratory training in the following
the same dosage category or categories as the indi-
areas:
vidual requesting authorized user status.
i. Radiation physics and instrumentation;
B.
Except as provided in R12-1-710, a licensee shall require an
ii. Radiation protection;
authorized user of iodine-131 for the oral administration of
iii. Mathematics pertaining to the use and measure-
sodium iodide I-131 requiring a written directive in quantities
ment of radioactivity;
less than or equal to 1.22 gigabecquerels (33 millicuries) to be
iv. Chemistry of radioactive material for medical
a physician who has completed the training requirements in 10
use; and
CFR 35.392, January 1, 2013, incorporated by reference, and
v. Radiation biology; and
available under R12-1-101. This incorporated material con-
b. Work experience, under the supervision of an autho-
tains no future editions or amendments.
rized user who meets the requirements in this Arti-
C.
Except as provided in R12-1-710, a licensee shall require an
cle, NRC, or equivalent Agreement State
authorized user of iodine-131 for the oral administration of
requirements, involving:
sodium iodide I-131 requiring a written directive in quantities
i. Ordering, receiving, and unpacking radioactive
greater than 1.22 gigabecquerels (33 millicuries) to be a physi-
materials safely and performing the related
cian who has completed the training requirements in 10 CFR
radiation surveys;
35.394, January 1, 2013, incorporated by reference, and avail-
ii. Performing quality control procedures on
able under R12-1-101. This incorporated material contains no
instruments used to determine the activity of
future editions or amendments.
dosages and performing checks for proper
D.
Except as provided in R12-1-710, a licensee shall require an
operation of survey meters;
authorized user for the parenteral administration of unsealed
iii. Calculating, measuring, and safely preparing
radioactive material requiring a written directive to be a physi-
patient or human research subject dosages;
cian who has completed the training requirements in 10 CFR
iv. Using administrative controls to prevent a med-
35.396, January 1, 2013, incorporated by reference, and avail-
ical event involving the use of unsealed radio-
able under R12-1-101. This incorporated material contains no
active material;
future editions or amendments.
v. Using procedures to contain spilled radioactive
E.
The training and experience shall have been obtained within
material safely and using proper decontamina-
the seven years preceding the date of application or the indi-
tion procedures;
vidual shall have had related continuing education and experi-
vi. Administering dosages of radioactive drugs to
ence since the required training and experience was
patients or human research subjects involving a
completed.
minimum of three cases in each of the follow- ing categories for which the individual is requesting authorized user status:
(1) 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 (Experience with at
Historical Note
New Section made by final rulemaking at 13 A.A.R. 1217, effective May 5, 2007 (Supp. 07-1). Amended by
final rulemaking at 20 A.A.R. 324, effective March 8,
2014 (Supp. 14-1).