Except as provided in Section
335.9160,
the licensee shall require the authorized user of a manual brachytherapy source
under the provisions and requirements of Subpart H 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. 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
oncology 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 manual brachytherapy sources; 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) The physician has:
1) Completed a structured educational program
in basic radionuclide handling techniques applicable to the use of manual
brachytherapy sources 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 or Section
335.9160
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements, at a medical facility authorized to use radioactive material
under Subpart H. The work experience shall include:
i) Ordering, receiving and unpacking
radioactive materials safely and performing the related radiation
monitoring;
ii) Checking survey
instruments for proper operation;
iii) Preparing, implanting and removing
brachytherapy sources;
iv)
Maintaining running inventories of material on hand;
v) Using administrative controls to prevent
medical events involving radioactive material;
vi) Using emergency procedures to control
radioactive material; and
2) Completed 3 years of supervised clinical
experience in radiation oncology under an authorized user who meets the
requirements in this Section or Section
335.9160
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
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) and (b)(2) and is able to independently fulfill the
radiation safety-related duties as an authorized user of manual brachytherapy
sources under Subpart H. 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; 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 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).