Current through Register Vol. 48, No. 9, September 27, 2024
Except as provided in RHA 4.23, the licensee shall require an
authorized user of unsealed radioactive material for the uses authorized under
RHA 4.35 to be a physician
who-
4.36.1 Is certified by a medical
specialty board whose certification process has been recognized by the Nuclear
Regulatory Commission or an Agreement State. The names of board certifications that
have been recognized by the NRC or an Agreement State are posted on the NRC's
Medical Uses Licensee Toolkit web page. To have its certification process
recognized, a specialty board shall require all candidates for certification to:
4.36.1.1 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 that includes the topics listed in paragraphs 4.36.3 through
4.36.3.2.6 of this section; and
4.36.1.2
Pass an examination, administered by diplomats of the specialty board, that assesses
knowledge and competence in radiation safety, radionuclide handling, and quality
control; or
4.36.2 Is an
authorized user under
RHA 4.39 or 4.43 or equivalent
NRC requirements; or 4.36.3-
4.36.3 Has
completed 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 training and experience must include-
4.36.3.1 Classroom and laboratory training in the
following areas-
4.36.3.1.1 Radiation physics and
instrumentation;
4.36.3.1.2 Radiation
protection;
4.36.3.1.3 Mathematics
pertaining to the use and measurement of radioactivity;
4.36.3.1.4 Chemistry of radioactive material for
medical use; and
4.36.3.1.5 Radiation
biology; and
4.36.3.2 Work
experience, under the supervision of an authorized user who meets the requirements
in RHA 4.23, 4.36, 4.39 or 4.43 or equivalent NRC requirements, involving-
4.36.3.2.1 Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation surveys;
4.36.3.2.2 Performing quality control procedures
on instruments used to determine the activity of dosages and performing checks for
proper operation of survey meters;
4.36.3.2.3 Calculating, measuring, and safely
preparing patient or human research subject dosages;
4.36.3.2.4 Using administrative controls to
prevent a medical event involving the use of unsealed radioactive
material;
4.36.3.2.5 Using procedures to
contain spilled radioactive material safely and using proper decontamination
procedures; and
4.36.3.2.6 Administering
dosages of radioactive drugs to patients or human research subjects;
and
4.36.3.3 Has obtained
written attestation that the individual has satisfactorily completed the
requirements in paragraph 4.36.3 of this section and is able to independently
fulfill the radiation safety-related duties as an authorized user for the medical
uses authorized under 4.35. The attestation must be obtained from either:
4.36.3.3.1 A preceptor authorized user who meets
the requirements in RHA 4.23, 4.36, 4.39, or 4.43, or equivalent Agreement State
requirements; or
4.36.3.3.2 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 RHA 4.23, 4.36, 4.39, or 4.43, or
equivalent Agreement State requirements, 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 paragraph 4.36.3 of this
section.
