Current through Register Vol. 49, No. 13, September 23, 2024
Except as provided under part 4731.4414, a licensee must
require an authorized user for the oral administration of sodium iodide (I-131)
requiring a written directive in quantities greater than 33 millicuries (1.22
GBq) to be a physician who:
A. is
certified by a medical specialty board whose certification process has been
recognized by the NRC or an agreement state and includes all the requirements
in item C, subitems (1) and (2). The names of board certifications that have
been recognized by the NRC or an agreement state are posted on the NRCs Medical
Use Licensee Toolkit web page;
B.
is an authorized user for the oral administration of I-131 in quantities
greater than 33 millicuries under part 4731.4443, subpart 1, item B, subitem
(1), unit (b), subunit vi; or equivalent requirements of the NRC or an
agreement state; or
C. has:
(1) successfully completed 80 hours of
classroom and laboratory training, applicable to the medical use of I-131 for
procedures requiring a written directive. The training must include:
(a) radiation physics and
instrumentation;
(b) radiation
protection;
(c) mathematics
pertaining to the use and measurement of radioactivity;
(d) chemistry of radioactive materials for
medical use; and
(e) radiation
biology;
(2) has work
experience, under the supervision of an authorized user who meets the
requirements of this part, part 4731.4414 or 4731.4443, or equivalent
requirements of the NRC or an agreement state. A supervising authorized user
who meets the requirements in part 4731.4443, subpart 1, item B, must also have
experience in the oral administration of I-131 in quantities greater than 33
millicuries under part 4731.4443, subpart 1, item B, subitem (1), unit (b),
subunit vi. The work experience must involve:
(a) ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(b) performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(c) calculating, measuring, and safely
preparing patient or human research subject dosages;
(d) using administrative controls to prevent
a medical event involving the use of radioactive material;
(e) using procedures to safely contain
spilled radioactive material and using proper decontamination procedures;
and
(f) administering dosages to
patients or human research subjects, including at least three cases involving
the oral administration of greater than 33 millicuries (1.22 GBq) of I-131;
and
(3) obtained written
attestation that the individual has satisfactorily completed the requirements
of this item and is able to independently fulfill the radiation-related duties
as an authorized user for oral administration of greater than 33 millicuries
(1.22 GBq) of sodium iodide I-131 for medical uses authorized under part
4731.4440. The written attestation must be obtained from either:
(a) a preceptor authorized user who meets the
requirements in this part, part 4731.4414 or 4731.4443, or equivalent
requirements of the NRC or an agreement state, and has experience in the oral
administration of I-131 in quantities greater than 33 millicuries (1.22 GBq) as
specified in part 4731.4443, subpart 1, item B, subitem (1), unit (b), subunit
vi; 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 part, part 4731.4414 or
4731.4443, or equivalent requirements of the NRC or an agreement state, has
experience in the oral administration of I-131 in quantities greater than 33
millicuries (1.22 GBq) as specified in part 4731.4443, subpart 1, item B,
subitem (1), unit (b), subunit vi, 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 subitems (1) and
(2).
