Ohio Admin. Code 3701:1-58-36 - Training for imaging and localization studies
Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized in rule 3701:1-58-34 of the Administrative Code to be a physician who:
(A) Is certified by a medical specialty board
whose certification process has been recognized by the director, United States
nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (C)(2) of this
rule. The names of board certifications which have been recognized by
the director, the United States nuclear
regulatory commission, or an agreement state will be posted on the United
States nuclear regulatory commission's "Medical Uses
Licensee Toolkit" web page at www.nrc.gov. To have its certification process
recognized, a specialty board shall require all candidates for certification
to:
(1) Complete seven hundred 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
(C)(1)(a) and (C)(1)(b) of this rule; and
(2) Pass an examination, administered by
diplomates of the specialty board, which assesses knowledge and competence in
radiation safety, radionuclide handling, and quality control; or
(B) Is an authorized user under
rule
3701:1-58-40
of the Administrative Code and meets the requirements in paragraph
(C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code, or equivalent
United States nuclear regulatory commission or agreement state requirements;
or
(C)
(1) Has completed seven hundred hours of
training and experience, including a minimum of eighty 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:
(a) Classroom and laboratory training in the
following areas:
(i) Radiation physics and
instrumentation;
(ii) Radiation
protection;
(iii) Mathematics
pertaining to the use and measurement of radioactivity;
(iv) Chemistry of radioactive material for
medical use; and
(v) Radiation
biology; and
(b) Work
experience, under the supervision of an authorized user, who meets the
requirements in this rule, rule
3701:1-58-21,
or
3701:1-58-40
of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or
equivalent United States nuclear regulatory commission or agreement state
requirements, involving:
. An authorized nuclear pharmacist who meets the
requirements in rule
3701:1-58-20
or
3701:1-58-21
of the Administrative Code may provide the supervised work experience for
paragraph (C)(1)(b)(vii) of this rule. Work experience must involve:
(i) Ordering, receiving, and unpacking
radioactive materials safely and performing the related radiation
surveys;
(ii) Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
(iii) Calculating, measuring, and safely
preparing patient or human research subject dosages;
(iv) Using administrative controls to prevent
a medical event involving the use of unsealed radioactive material;
(v) Using procedures to safely contain
spilled radioactive material and using proper decontamination
procedures;
(vi) Administering
dosages of radioactive drugs to patients or human research subjects;
and
(vii) 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
(2) Has
obtained written attestation, signed by a preceptor
authorized user who meets the requirements in this rule, rule
3701:1-58-21,
or
3701:1-58-40
of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or
equivalent United States nuclear regulatory commission or agreement state
requirements, that the individual has satisfactorily completed the
requirements in paragraph (A)(1) or (C)(1)
of this rule and has achieved a level of competency
sufficient to function
is able to
independently fulfill the radiation safety-related
duties as an authorized user for the medical uses authorized under rules
3701:1-58-32
and
3701:1-58-34
of the Administrative Code. The attestation must be
obtained from either:
(a)
A preceptor authorized user who meets the requirements
in this rule, rule
3701:1-58-21,
or
3701:1-58-40
of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or United
States 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 rule, rule
3701:1-58-21,
or
3701:1-58-40
of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or United
States 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," 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 (C)(1) of this rule.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008, 01/01/2012
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