Current through Register No. 40, October 3, 2024
Except as provided in
He-P
4035.71, the licensee shall require an authorized user
of a sealed source for use authorized under
He-P
4035.47 to be a physician who:
(a) Is certified by a medical specialty board
whose certification process has been recognized by the DHHS/RHS, an agreement
state, or the Nuclear Regulatory Commission and who meets the requirements in
He-P 4035.59(c). The names of board certifications that have been recognized by
DHHS/RHS, and agreement state, or the Nuclear Regulatory Commission are posted
on the NRC's Medical Uses Licensee Toolkit webpage. To have its certification
process recognized, a specialty board shall require all candidates for
certification to:
(1) 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
(2) Pass an
examination, administered by diplomats 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
(b) Has completed a structured educational
program in basic radionuclide techniques applicable to the use of a sealed
source in a therapeutic medical unit that includes:
(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 He-P 4035.59,
He-P
4035.71, the equivalent requirements of an agreement
state, or the Nuclear Regulatory Commission at a medical facility that is
authorized to use byproduct materials in
He-P
4035.47, involving:
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 byproduct 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; and
f. Selecting the
proper dose and how it is to be administered; and
(3) Has completed 3 years of supervised
clinical experience in radiation therapy, under an authorized user who meets
the requirements in He-P 4035.59,
He-P
4035.71, the equivalent requirements of an agreement
state, or the Nuclear Regulatory Commission, 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 He-P
4035.59(b)(2); and
(4) Has obtained
written attestation that the individual has satisfactorily completed the
requirements in He-P 4035.59(b)(1), (b) (2), and (b)(3), and He-P 4035.59(c),
and is able to independently fulfill the radiation safety-related duties as an
authorized user of each type of therapeutic medical unit for which the
individual is requesting authorized user status. The written attestation shall
obtained from either:
a. A preceptor
authorized user who meets the requirements in He-P 4035.59,
He-P
4035.71, the equivalent requirements of an agreement
state, or the Nuclear Regulatory Commission for type(s) of therapeutic medical
unit for which the individual is requesting authorized user status;
or
b. 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 He-P 4035.59,
He-P
4035.71, or the equivalent requirements of an
agreement state, or the Nuclear Regulatory Commission, for the type(s) of
therapeutic medical unit for which the individual is requesting authorized user
status, and concurs with the attestation provided by the residency program
director. The residency training program shall 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 shall include
training and experience specified in He-P 4035.59(b), (b) (1), (b)(2), and
(b)(3).
(c)
Has 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.
(See Revision Note at part heading for He-P 4035) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
