Current through Register Vol. 48, No. 9, September 27, 2024
Except as provided in
RHA 4.23, the licensee shall
require an authorized user of a sealed source for a use authorized under
RHA 4.58 to be a physician
who-
4.74.1 Is certified by a medical
specialty board whose certification process has been recognized by the Nuclear
Regulatory Commission or an Agreement State and who meets the requirements in
paragraph 4.74.3 of this section. The names of board certifications that have
been recognized by the Nuclear Regulatory Commission or an Agreement State are
posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
4.74.1.1
Successfully complete a minimum of 3 years of residency training in radiation
therapy program approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of Physician and
Surgeons of Canada or the Council on Postdoctoral Training of the American
Osteopathic Association; and
4.74.1.2 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
4.74.2
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-
4.74.2.1 200 hours of classroom and
laboratory training in the following areas-
4.74.2.1.1 Radiation physics and
instrumentation;
4.74.2.1.2
Radiation protection;
4.74.2.1.3
Mathematics pertaining to the use and measurement of radioactivity;
and
4.74.2.1.4 Radiation biology;
and
4.74.2.2 500 hours of
work experience, under the supervision of an authorized user who meets the
requirements in
RHA 4.23, 4.74, or
equivalent NRC or Agreement State requirements at a medical facility that is
authorized to use radioactive materials in
RHA 4.58, involving-
4.74.2.2.1 Reviewing full calibration
measurements and periodic spot-checks;
4.74.2.2.2 Preparing treatment plans and
calculating treatment doses and times;
4.74.2.2.3 Using administrative controls to
prevent a medical event involving the use of radioactive material;
4.74.2.2.4 Implementing emergency procedures
to be followed in the event of the abnormal operation of the medical unit or
console;
4.74.2.2.5 Checking and
using survey meters; and
4.74.2.2.6
Selecting the proper dose and how it is to be administered; and
4.74.2.3 Have completed 3 years of
supervised clinical experience in radiation therapy, under an authorized user
who meets the requirements in
RHA 4.23, 4.74, or
equivalent NRC or 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
RHA 4.74.2.2;
and
4.74.2.4 Has obtained written
attestation that the individual has satisfactorily completed the requirements
in paragraphs 4.74.2.1, 4.74.2.2, 4.74.2.3, and 4.74.3 of this section; 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 attestation must be
obtained from either:
4.74.2.4.1 A preceptor
authorized user who meets the requirements in
RHA 4.23, 4.74, or
equivalent Nuclear Regulatory Commission or Agreement State requirements for
the type(s) of therapeutic medical unit for which the individual is requesting
authorized user status; or
4.74.2.4.2 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
RHA 4.23, 4.74, or
equivalent Nuclear Regulatory Commission or Agreement State requirements, 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 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 paragraphs 4.74.2.1,
4.74.2.2, and 4.74.2.3 of this section.
4.74.3 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.