| (1) a physician who is certified by a medical specialty
board whose certification process has been recognized by the department,
the NRC, or an agreement state and who meets the requirements of paragraph
(3) of this subsection. The names of board certifications that have
been recognized by the department, the NRC, or an agreement state
are posted on the NRC's Medical Uses Licensee Toolkit web page. To
have its certification recognized, a specialty board shall require
all candidates for certification to:
(A) 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, the Royal College of Physicians and Surgeons of
Canada, or the Committee on Post-Graduate Training of the American
Osteopathic Association; and
(B) pass an examination, administered by diplomates
of the specialty board, that assesses 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
(2) the physician must meet the following requirements:
(A) has completed a structured educational program
in basic radionuclide handling techniques applicable to the use of
a sealed source in a therapeutic medical unit including the following:
(i) 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; and
(IV) radiation biology; and
(ii) 500 hours of work experience, under the supervision
of an authorized user who meets the requirements of subsection (l)
of this section, this subsection, or equivalent NRC or agreement state
requirements at a medical facility that is authorized to use radioactive
material in subsection (ddd) of this section involving the following:
(I) reviewing full calibration measurements and periodic
spot checks;
(II) preparing treatment plans and calculating treatment
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 a medical unit or console;
(V) checking and using survey meters; and
(VI) selecting the proper dose and how it is to be
administered; and
(iii) completion of three years of supervised clinical
experience in radiation therapy, under an authorized user who meets
the requirements of subsection (l) of this section, this subsection,
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,
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 clause (ii) of this subparagraph; and
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraphs (2)(A)
and (3) of this subsection, 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:
(i) a preceptor authorized user who meets the requirements
in subsection (l) of this section, this subsection, or equivalent
NRC or agreement state requirements for the type(s) of therapeutic
medical unit for which the individual is requesting authorized user
status; or
(ii) 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 subsection (l) of this section, this subsection,
or equivalent NRC 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 subparagraph (A) of this paragraph; and
(3) the physician 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.
(uuu) Report and notification of a medical event.
(1) The licensee shall report any event as a medical
event, except for an event that results from patient intervention,
in which the administration of radioactive material, or radiation
from radioactive material, except permanent implant brachytherapy,
results in the following:
(A) a dose that differs from the prescribed dose or
dose that would have resulted from the prescribed dosage by more than
5 rem (0.05 Sievert (Sv)) effective dose equivalent, 50 rem (0.5 Sv)
to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent
to the skin; and
(i) the total dose delivered differs from the prescribed
dose by 20 percent or more;
(ii) the total dosage delivered differs from the prescribed
dosage by 20 percent or more or falls outside the prescribed dosage
range; or
(iii) the fractionated dose delivered differs from
the prescribed dose, for a single fraction, by 50 percent or more;
(B) a dose that exceeds 5 rem (0.05 Sv) effective dose
equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5
Sv) shallow dose equivalent to the skin from any of the following:
(i) an administration of a wrong radioactive drug containing
radioactive material or the wrong radionuclide for a brachytherapy
procedure;
(ii) an administration of a radioactive drug containing
radioactive material by the wrong route of administration;
(iii) an administration of a dose or dosage to the
wrong individual or human research subject;
(iv) an administration of a dose or dosage delivered
by the wrong mode of treatment; or
(v) a leaking sealed source; or
(C) a dose to the skin or an organ or tissue other
than the treatment site that exceeds by
(i) 50 rem (0.5 Sv) or more the expected dose to that
site from the procedure if the administration had been given in accordance
with the written directive prepared or revised before administration;
and
(ii) 50 percent or more of the expected dose to that
site from the procedure if the administration had been given in accordance
with the written directive prepared or revised before administration.
(2) For permanent implant brachytherapy, the licensee
shall report the administration of radioactive material or radiation
from radioactive material (excluding sources that were implanted in
the correct site but migrated outside the treatment site) that results
in:
(A) the total source strength administered differing
by 20 percent or more from the total source strength documented in
the post-implantation portion of the written directive;
(B) the total source strength administered outside
of the treatment site exceeding 20 percent of the total source strength
documented in the post-implantation portion of the written directive;
or
(C) an administration that includes any of the following:
(i) the wrong radionuclide;
(ii) the wrong individual or human research subject;
(iii) sealed source(s) implanted directly into a location
discontiguous from the treatment site, as documented in the post-implantation
portion of the written directive; or
(iv) a leaking sealed source resulting in a dose that
exceeds 50 rem (0.5 Sv) to an organ or tissue.
(3) The licensee shall report any event resulting from
patient intervention in which the administration of radioactive material,
or radiation from radioactive material, results or will result in
an unintended permanent functional damage to an organ or a physiological
system, as determined by a physician.
Cont'd... |
