Except as provided in
105
CMR 120.528, the licensee shall require an
authorized user for the oral administration of sodium iodide I-131 in
quantities greater than 1.22 gigabecquerels (33 millicuries), for which a
written directive is required, to be a physician who:
(A) Is certified by a medical specialty board
whose certification process includes all of the requirements in 105 CMR
120.558(C)(1) and (2) and whose certification has been recognized by the
Agency, an Agreement State or the Nuclear Regulatory Commission. The names of
board certifications that have been recognized by the Agency, Nuclear
Regulatory Commission or an Agreement State are posted on the NRC's Medical
Uses License Toolkit Web page; or
(B) Is an authorized user under
105
CMR 120.556, for uses listed in
105
CMR 120.556(B)(1)(b)6.b. or
equivalent Agreement State, or Nuclear Regulatory Commission requirements;
or
(C)
(1) Has successfully completed 80 hours
classroom and laboratory training, applicable to the medical use of sodium
iodide 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 material for
medical use; and,
(e) Radiation
biology; and,
(2) Has
work experience, under the supervision of an authorized user who meets the
requirements in
105
CMR 120.528,
120.556,
or 120.558, or equivalent Agreement State, or Nuclear Regulatory Commission
requirements. A supervising authorized user who meets the requirements of
105
CMR 120.556(B), must also
have experience in administering dosages as specified in
105
CMR 120.556(B)(1)(b)6.b.;
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 byproduct material;
(e) Using procedures to contain spilled
radioactive material safely and using proper decontamination procedures;
and
(f) Administering dosages to
patients or human research subjects that includes at least three cases
involving the oral administration greater than 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131; and
(3) Has obtained written attestation that the
individual has satisfactorily completed the requirements in 105 CMR
120.558(C)(1) and (2), and is able to independently fulfill the radiation
safety-related duties as an authorized user for oral administration of greater
than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical
uses authorized under
105
CMR 120.552. The attestation must be obtained
from either:
(a) A preceptor authorized user
who meets the requirements in
105
CMR 120.528,
120.556,
120.558, or equivalent Nuclear Regulatory Commission or Agreement State
requirements, and has experience in administering dosages as specified in
105
CMR 120.556(B)(1)(b)6.b.;
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,
120.556,
120.558, or equivalent Nuclear Regulatory Commission or Agreement State
requirements, has experience in administering dosages as specified in
105
CMR 120.556(B)(1)(b)6.b.,
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 120.558(C)(1) and (2).
