Current through Register No. 40, October 3, 2024
(a) Except as
provided in He-P 4035.71, the licensee shall
require the authorized user of unsealed byproduct material listed in
He-P
4035.35 to be a physician who:
(1) Is certified by a medical specialty board
whose certification process has been recognized by DHHS/RHS, or an agreement
state, or the Nuclear Regulatory Commission. The names of board certifications
that have been recognized by DHHS\RHS, an agreement state, or the Nuclear
Regulatory Commission are posted on the NRC's Medical Uses Licensee Toolkit web
page; and
(2) Meets the
requirements in He-P 4035.65(c)(2)b. and He-P 4035.65(d) through (e).
(b) To have its certification
process recognized, a specialty board shall require all candidates for
certification to:
(1) Successfully complete
residency training in a radiation therapy or nuclear medicine training program
or a related medical specialty. These residency training programs shall include
700 hours of training and experience as described in He-P 4035.65(c)(1) through
He-P 4035.65(c)(2)a.5. Eligible training programs 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
Committee on Post-Graduate Training of the American Osteopathic Association;
and,
(2) Pass an examination,
administered by diplomats of the specialty board, which assesses knowledge and
competence in radiation safety, radionuclide handling, and quality assurance
and clinical use of unsealed byproduct material for which a written directive
is required; or
(c)
Except as provided in
He-P
4035.71, an authorized user of unsealed byproduct
material for the uses authorized under
He-P
4035.35 shall be a physician who has:
(1) Completed 700 hours of training and
experience, including a minimum of 200 hours of classroom and laboratory
training, in basic radionuclide handling techniques applicable to the medical
use of unsealed byproduct material requiring a written directive. The classroom
and laboratory training shall include:
a.
Radiation physics and instrumentation;
b. Radiation protection;
c. Mathematics pertaining to the use and
measurement of radioactivity;
d.
Chemistry of byproduct material for medical use;
e. Radiation biology; and
(2) Work experience, under the
supervision of an authorized user who meets the requirements in He-P 4035.65 or
He-P
4035.71, or the equivalent requirements of an
agreement state, or the Nuclear Regulatory Commission. A supervising authorized
user, who meets the requirements in He-P 4035.65(c) through (e), shall also
have experience in administering dosages in the same dosage category or
categories (i.e., He-P 4035.65(c)(2)b.) as the individual requesting authorized
user status.
a. The work experience shall
involve:
1. Ordering, receiving, and
unpacking radioactive materials safely and performing the related radiation
surveys;
2. Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
3. Calculating, measuring, and safely
preparing patient or human research subject dosages;
4. Using administrative controls to prevent a
medical event involving the use of unsealed byproduct material;
5. Using procedures to contain spilled
byproduct material safely and using proper decontamination
procedures;
b.
Administering dosages of radioactive drugs to patients or human research
subjects from the 3 categories in this paragraph. Radioactive drugs containing
radionuclides in categories not included in this paragraph are regulated under
He-P
4035.29. This work experience shall involve a minimum
of 3 cases in each of the following categories for which the individual is
requesting authorized user status:
1. Oral
administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of
sodium iodine I-131, for which a written directive is required;
2. Oral administration of greater than 1.22
gigabecquerels (33 millicuries) of sodium iodine I-131[Experience with at least
3 cases in Category (c)(2)b.2. also satisfies the requirement in
Category(c)(2)b.1.]; or
3.
Parenteral administration of any radioactive drug that contains a radionuclide
that is primarily used for its electron emission, beta radiation
characteristics, alpha radiation characteristics, or a a photon energy less
than 150 keV, for which a written directive is required; and
(d) In
addition to meeting the requirements of (a) or (b) or (c) above, a licensee
shall require an authorized user to obtain a written attestation that the
individual has satisfactorily completed the requirements in He-P 4035.65(c) and
is able to independently fulfill the radiation safety-related duties as an
authorized user for the medical uses authorized under
He-P
4035.35 for which the individual is requesting
authorized user status.
(e) The
written attestation shall be obtained from either:
(1) A preceptor authorized user who meets the
requirements in He-P 4035.65 or
He-P
4035.71, or the equivalent requirements of an
agreement state, or the Nuclear Regulatory Commission and has experience in
administering dosages in the same dosage category or categories as the
individual requesting authorized user status; or
(2) 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 He-P 4035.65 or
He-P
4035.71, or the equivalent requirements of an
agreement state, or the Nuclear Regulatory Commission, has experience in
administering dosages in the same dosage category or categories as the
individual authorized user status, 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 or the Royal College of Physicians and Surgeons of
Canada, or the Council on Postdoctoral Training of the American Osteopathic
Association and shall include and experience specified in He-P
4035.65(c).
(See Revision Note at part heading for He-P 4035) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff
8-7-07