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 4.37 to be a physician
who-
4.39.1 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 Nuclear Regulatory Commission 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:
4.39.1.1 Complete 700 hours of
training and experience in basic radionuclide handling techniques and radiation
safety applicable to the medical use of unsealed radioactive material for imaging
and localization studies that includes the topics listed in paragraphs RHA 4.39.3
through 4.39.3.2.7; and
4.39.1.2 Pass an
examination, administered by diplomats of the specialty board, which assesses
knowledge and competence in radiation safety, radionuclide handling, and quality
control; or
4.39.2 Is an
authorized user under RHA 4.43 and meets the requirements in RHA 4.39.3.2.7 or
equivalent NRC requirements; or
4.39.3
Has completed 700 hours of training and experience, including a minimum of 80 hours
of classroom and laboratory training, in basic radionuclide handling techniques
applicable to the medical use of unsealed radioactive material for imaging and
localization studies. The training and experience must include, at a minimum,-
4.39.3.1 Classroom and laboratory training in the
following areas-
4.39.3.1.1 Radiation physics and
instrumentation;
4.39.3.1.2 Radiation
protection;
4.39.3.1.3 Mathematics
pertaining to the use and measurement of radioactivity;
4.39.3.1.4 Chemistry of radioactive material for
medical use;
4.39.3.1.5 Radiation
biology; and
4.39.3.2 Work
experience, under the supervision of an authorized user who meets the requirements
in RHA 4.23, 4.39 or 4.43 and 4.39.3.2.7 or equivalent NRC or Agreement State
requirements. An authorized nuclear pharmacist who meets the requirements in RHA
4.22 or RHA 4.23 may provide the supervised work experience for paragraph 4.39.3.2.7
of this section. Work experience must involve-
4.39.3.2.1 Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation surveys;
4.39.3.2.2 Performing quality control procedures
on instruments used to determine the activity of dosages and performing checks for
proper operation of survey meters;
4.39.3.2.3 Calculating, measuring, and safely
preparing patient or human research subject dosages;
4.39.3.2.4 Using administrative controls to
prevent a medical event involving the use of unsealed radioactive
material;
4.39.3.2.5 Using procedures to
safely contain spilled radioactive material and using proper decontamination
procedures;
4.39.3.2.6 Administering
dosages of radioactive drugs to patients or human research subjects; and
4.39.3.2.7 Eluting generator systems appropriate
for preparation of radioactive drugs for imaging and localization studies, measuring
and testing the eluate for radionuclidic purity, and processing the eluate with
reagent kits to prepare labeled radioactive drugs; and
4.39.3.3 Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraph 4.39.3 of this
section and is able to independently fulfill the radiation safety-related duties as
an authorized user for the medical uses authorized under
RHA 4.35 and 4.37. The
attestation must be obtained from either:
4.39.3.3.1 A preceptor authorized user who meets
the requirements in RHA 4.23, RHA 4.39, or RHA 4.43 and RHA 4.39.3.2.7, or
equivalent Nuclear Regulatory Commission or Agreement State requirements;
or
4.39.3.3.2 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, RHA 4.39, or RHA 4.43 and RHA 4.39.3.2.7, or
equivalent Nuclear Regulatory Commission or 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 4.39.3 of this section.
