Current through Register 1531, September 27, 2024
Except as provided in
105
CMR 120.528, the licensee shall require an
authorized user of a sealed source for a use authorized under
105
CMR 120.570 to be a physician who:
(A) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, an Agreement
State or the Nuclear Regulatory Commission and who meets the requirements in
105 CMR 120.587(C). The names of board certifications that have been recognized
by the Agency, Nuclear Regulatory Commission or an Agreement State will be
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:
(1)
Successfully complete a minimum of three 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
diplomates 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)
(1) 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:
(a) 200 hours of classroom and laboratory
training in the following areas:
1. Radiation
physics and instrumentation;
2.
Radiation protection;
3.
Mathematics pertaining to the use and measurement of radioactivity;
and
4. Radiation biology;
and
(b) 500 hours of work
experience, under the supervision of an authorized user who meets the
requirements in
105
CMR 120.528, 120.587 or equivalent Agreement
State or Nuclear Regulatory Commission requirements at a medical facility that
is authorized to use byproduct materials in
105
CMR 120.570, involving:
1. Reviewing full calibration measurements
and periodic spot checks;
2.
Preparing treatment plans and calculating treatment doses and times;
3. Using administrative controls to prevent a
medical event involving the use of radioactive material;
4. Implementing emergency procedures to be
followed in the event of the abnormal operation of the medical unit or
console;
5. Checking and using
survey meters; and
6. Selecting the
proper dose and how it is to be administered; and
(2) Has completed three years of
supervised clinical experience in radiation therapy, under an authorized user
who meets the requirements in
105
CMR 120.528, 120.587 or equivalent Agreement
State or Nuclear Regulatory Commission 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 Committee on
Postdoctoral Training of the American Osteopathic Association. This experience
may be obtained concurrently with the supervised work experience required by
105 CMR 120.587(B)(1)(b); and
(3)
Has obtained written attestation that the individual has satisfactorily
completed the requirements in 105 CMR 120.587(B)(1) and (2) and (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 attestation must be
obtained from either:
(a) A preceptor
authorized user who meets the requirements in
105
CMR 120.528, 120.587, 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
(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
105
CMR 120.528, 120.587, 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 105 CMR 120.587(B)(1) and
(2).
(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.
