Current through Register Vol. 48, No. 12, March 22, 2024
Except as provided in Section
335.9160,
the licensee shall require the authorized user of a sealed source under the
provisions and requirements of Subpart I to be a physician who:
a) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission or an Agreement State and who meets the requirements in
subsection (d). 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,
the Royal College of Physicians and Surgeons of Canada, or the Council on
Postdoctoral Training of the American Osteopathic Association; and
2) Pass an examination administered by
diplomates of the specialty board that evaluates 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
AGENCY NOTE: Specialty boards whose certification processes
have been recognized by the Agency, the U.S. Nuclear Regulatory Commission or
an Agreement State will be posted on the NRC's website.
b) Has:
1) Completed a structured educational program
in basic radionuclide techniques applicable to the use of a sealed source in a
therapeutic medical unit 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; and
B) 500 hours of work experience,
under the supervision of an authorized user who meets the requirements in this
Section, Section 335.9160, or equivalent U.S. Nuclear Regulatory Commission or
Agreement State requirements, at a medical institution that is authorized to
use radioactive materials under Subpart I. The work experience shall include:
i) Reviewing full calibration measurements
and periodic spot-checks;
ii)
Preparing treatment plans and calculating treatment doses and times;
iii) Using administrative controls to prevent
a medical event involving the use of radioactive material;
iv) Implementing emergency procedures to be
followed in the event of the abnormal operation of the medical unit or
console;
v) Checking and using
survey instruments;
vi) Selecting
the proper dose and how it is to be administered; and
2) Completed 3 years of supervised
clinical experience in radiation therapy under an authorized user who meets the
requirements of this Section or Section
335.9160
or equivalent U.S. Nuclear Regulatory Commission or Agreement State or
requirements. The experience shall be obtained as part of a formal training
program approved by the Residency Review Committee for Radiation Oncology of
the Accreditation Council for Graduate Medical Education, 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
(b)(1)(B); and
3) Obtained written
attestation that the individual has satisfactorily completed the requirements
in subsections (b)(1), (b)(2), and (c) and is able to independently fulfill the
radiation safety-related duties as an authorized user for the type of
therapeutic medical unit for which the individual is requesting authorized user
status. The attestation shall be obtained from either:
A) A preceptor authorized user who meets the
requirements in this Section, Section 335.9160, or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements for each type 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 this Section, Section 335.9160,
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements for the types 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, 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 subsections
(b)(1) and (b)(2).
c) Has received training in device operation,
safety procedures and clinical use for the types of therapeutic medical unit
for which authorization is sought. This training requirement may be met 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 types of use for
which the individual is seeking authorization.
AGENCY NOTE: The term "type of therapeutic medical unit"
refers to a type of use identified in this Section. It applies to this Section
only. Training for therapeutic medical units is not manufacturer-specific.
Training for one brand of therapeutic medical unit is acceptable for another
brand of the same type of unit.