| (B) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraph (3)(A)
of this subsection, and is able to independently fulfill the radiation
safety-related duties as an authorized user for oral administration
of greater than 33 mCi (1.22 GBq) of sodium iodide I-131 for medical
uses authorized under subsection (kk) of this section. The attestation
must be obtained from either:
(i) a preceptor authorized user who meets the requirements
in subsections (l) or (nn) of this section, this subsection, or equivalent
NRC or agreement state requirements, and has experience in administering
dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-) of this
section; 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 subsections (l), (nn), or (pp) of this section,
or equivalent NRC, or agreement state requirements, has experience
in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-)
of this section, 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 this paragraph.
(qq) Training for the parenteral administration of
unsealed radioactive material requiring a written directive.
(1) Except as provided in subsection (l) of this section,
the licensee shall require an authorized user for the parenteral administration
of unsealed radioactive materials requiring a written directive to
be a physician who:
(A) is an authorized user in accordance with subsection
(nn) of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-c-)
of this section or equivalent NRC or agreement state requirements;
or
(B) is an authorized user under subsections (zz) or
(ttt) of this section or equivalent NRC or agreement state requirements
and who meets the requirements of paragraph (2) of this subsection;
or
(C) is certified by a medical specialty board whose
certification process has been recognized by the department, the NRC,
or an agreement state in accordance with subsections (zz) or (ttt)
of this section, and who meets the requirements of paragraph (2) of
this subsection.
(2) The physician must also meet the following requirements:
(A) has successfully completed 80 hours of classroom
and laboratory training applicable to parenteral administrations listed
in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section.
(B) has the training and experience that shall include
the following:
(i) classroom and laboratory training shall include
the following:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity;
(IV) chemistry of radioactive material for medical
use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
user who meets the requirements of subsection (l) of this section,
this subsection or subsection (nn) of this section or equivalent NRC
or agreement state requirements in the parenteral administration listed
in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section. A supervising
authorized user who meets the requirements of subsection (nn) of this
section, this subsection, or equivalent NRC or agreement state requirements
shall have experience in administering dosages in the same category
or categories as the individual requesting authorized user status.
The work experience shall involve the following:
(I) ordering, receiving, and unpacking radioactive
materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
used to determine the activity of dosages and performing checks for
proper operation of survey meters;
(III) calculating, measuring, and safely preparing
patient or human research subject dosages;
(IV) using administrative controls to prevent a medical
event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
material safely and using proper decontamination procedures; and
(VI) administering dosages to patients or human research
subjects that include at least three cases involving the parenteral
administration specified in subsection (nn)(2)(A)(ii)(VI)(-c-) of
this section; and
(C) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraph (2)(A)
and (B) of this subsection, and is able to independently fulfill the
radiation safety-related duties as an authorized user for the parenteral
administration of unsealed radioactive material requiring a written
directive. The attestation must be obtained from either:
(i) a preceptor authorized user who meets the requirements
of subsection (l) of this section, subsection (nn) of this section,
or this subsection, or equivalent NRC or agreement state requirements.
A preceptor authorized user who meets the requirements in subsection
(nn) of this section, this section, or equivalent Agreement State
requirements, must have experience in administering dosages in the
same category or categories as the individual requesting authorized
user status; or, and shall have experience in administering dosages
in the same category or categories as the individual 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 subsections (l), (nn) or (qq) of this section,
or equivalent NRC or agreement state requirements, has experience
in administering dosages in the same dosage category or categories
as the individual 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 this paragraph.
(rr) Use of sealed sources for manual brachytherapy.
The licensee shall use only brachytherapy sources as follows:
(1) as approved in the Sealed Source and Device Registry
for manual brachytherapy medical use. The manual brachytherapy sources
may be used for manual brachytherapy uses that are not explicitly
listed in the Sealed Source and Device Registry, but must be used
in accordance with the radiation safety conditions and limitations
described in the Sealed Source and Device Registry; or
(2) in research to deliver therapeutic doses for medical
use in accordance with an active Investigational Device Exemption
application accepted by the FDA provided the requirements of subsection
(u)(1) of this section are met.
(ss) Surveys after sealed source implants and removal.
(1) Immediately after implanting sealed sources in
a patient or a human or animal research subject, the licensee shall
perform a survey to locate and account for all sealed sources that
have not been implanted.
(2) Immediately after removing the last temporary implant
sealed source from a patient or a human or animal research subject,
the licensee shall perform a survey of the patient or the human or
animal research subject with a radiation detection survey instrument
to confirm that all sealed sources have been removed.
(3) A record of each survey shall be retained, for
inspection by the department, in accordance with subsection (xxx)
of this section. The record shall include the following:
(A) date of the survey;
(B) results of the survey;
(C) manufacturer's name and model and serial number
of the instrument used to make the survey; and
(D) name of the individual who performed the survey.
(tt) Brachytherapy sealed sources accountability.
(1) The licensee shall maintain accountability at all
times for all brachytherapy sealed sources in storage or use.
(2) Promptly after removing sealed sources from a patient
or a human or animal research subject, the licensee shall return brachytherapy
sealed sources to a secure storage area.
(3) The licensee shall maintain a record of the brachytherapy
sealed source accountability in accordance with subsection (xxx) of
this section for inspection by the department.
Cont'd... |
