Ohio Admin. Code 3701:1-58-40 - Training for use of unsealed radioactive material for which a written directive is required
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 under rule 3701:1-58-37 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 (B)(1)(b)(vi) of this rule. Specialty boards whose
certification processes 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 be 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 program in a
related medical specialty. These residency training programs must include seven
hundred hours of training and experience as described in paragraphs (B)(1)(a)
to (B)(1)(b)(v) of this rule. Eligible training programs 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 "Committee on Post-Graduate
Council on Postdoctoral Training of the American
Osteopathic Association;" and
(2)
Pass an examination, administered by diplomats of the specialty board, which
tests knowledge and competence in radiation safety, radionuclide handling,
quality assurance, and clinical use of unsealed radioactive material for which
a written directive is required; or
(B)
(1) Has
completed seven hundred hours of training and experience, including a minimum
of two hundred hours of classroom and laboratory training, in basic
radionuclide handling techniques applicable to the medical use of unsealed
radioactive material requiring a written directive. The training and experience
must include:
(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 or rule
3701:1-58-21
of the Administrative Code, or equivalent United States nuclear regulatory
commission or agreement state requirements. A supervising authorized user, who
meets the requirements in paragraph (B) of this rule, must also have experience
in administering dosages in the same dosage category or categories, such as
paragraph (B)(1)(b)(vi) of this rule, as the individual requesting authorized
user status. The 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 contain spilled
radioactive material safely and using proper decontamination procedures;
and
(vi) Administering dosages of
radioactive drugs to patients or human research subjects from the three
categories in this paragraph. Radioactive drugs containing radionuclides in
categories not included in this paragraph are regulated under rule
3701:1-58-72
of the Administrative Code. This work experience must involve a minimum of
three cases in each of the following categories for which the individual is
requesting authorized user status:
(a) Oral
administration of less than or equal to
1.22
gigabecquerels (thirty-three millicuries) of sodium iodide I-131, for which a
written directive is required;
(b)
Oral administration of greater than
1.22
gigabecquerels, (thirty-three millicuries) of sodium iodide I-131. Experience
with at least three cases in this paragraph also satisfies the requirement in
paragraph (B)(1)(b)(vi)(a) of this rule;
(c) 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 photon energy of less than one hundred fifty keV, for which
a written directive is required; and
(2) Has obtained written attestation that the
individual has satisfactorily completed the requirements in paragraph (B)(1) of
this rule and is able to independently fulfill the radiation safety-related
duties as an authorized user for the medical uses authorized under rule
3701:1-58-37
of the Administrative Code for which the individual is requesting authorized
user status. The attestation must be obtained from either:
(a) A preceptor authorized user who meets the
requirements in rule
3701:1-58-21
of the Administrative Code, rule 3701:1-58-40 of the Administrative Code, or
equivalent United States nuclear regulatory commission or agreement state
requirements and has experience in administering dosages in the same dosage
category or categories as the individual requesting authorized user status;
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 rule
3701:1-58-21
of the Administrative Code, rule 3701:1-58-40 of the Administrative Code, or
equivalent United States nuclear regulatory commission or agreement state
requirements, has experience in administering dosages in the same dosage
category or categories as the individual requesting authorized user status, 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 (B)(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, 08/15/2021
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