Except as provided in Section
335.9160,
a licensee shall require the authorized user of unsealed radioactive material
for the uses authorized under Section
335.3010
not requiring a written directive to be a physician who:
a) Is certified by a medical specialty board
whose certification process has been recognized by the Agency, the U.S. Nuclear
Regulatory Commission, or an Agreement State. To have its certification process
recognized, a specialty board shall require all candidates for certification to
meet the following requirements:
1) Complete
60 hours of training and experience in basic radionuclide handling techniques
and radiation safety applicable to the medical use of unsealed radioactive
material for uptake, dilution and excretion studies as described in subsections
(c)(1) and (2); and
2) Pass an
examination administered by diplomates of the specialty board, that evaluates
knowledge and competence in radiation safety, radionuclide handling and quality
control; or
b) Is an
authorized user who meets the requirements of Section
335.9040
or
335.9050
or equivalent U.S. Nuclear Regulatory Commission or Agreement State
requirements; or
c) Has
successfully completed a structured educational program consisting of:
1) 60 hours of training and experience,
including a minimum of 8 hours of classroom and laboratory training, in basic
radionuclide handling techniques applicable to the medical use of unsealed
radioactive material for uptake, dilution and excretion studies. The classroom
and laboratory training shall include, at a minimum:
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;
E) Radiation biology;
and
2) Work experience
under the supervision of an authorized user who meets the requirements in this
Section, Section 335.9040, 335.9050 or 335.9160, or equivalent U.S. Nuclear
Regulatory Commission or Agreement State requirements involving:
A) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
monitoring;
B) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey instruments;
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 unsealed radioactive material;
E) Using procedures to contain spilled
radioactive material safely and using proper decontamination procedures;
and
F) Administering dosages of
radioactive drugs to patients or human research subjects; and
3) Has obtained written
attestation that the individual has satisfactorily completed the requirements
in subsection (c) and is able to independently fulfill the radiation
safety-related duties as an authorized user for the medical uses authorized by
Section 335.3010. The attestation shall be obtained from either:
A) A preceptor authorized user who meets the
requirements in this Section or Section 335.9040, 335.9050 or 335.9160, or
equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
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 Section, Sections 335.9040, 335.9050 or
335.9160, or equivalent Agreement State requirements, 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, the Royal College of
Physicians and Surgeons of Canada, or the Council on Postdoctoral Training of
the American Osteopathic Association and shall include training and work
experience specified in subsections (c)(1) and (c)(2).