Ohio Admin. Code 3701:1-58-104 - Training for the parenteral administration of unsealed radioactive material requiring a written directive
(A)
Except as
provided in rule
3701:1-58-21
of the Administrative Code, the licensee shall require an authorized user for
the parenteral administration of unsealed radioactive material requiring a
written directive, to be a physician who:
(1)
Is an authorized
user under rule
3701:1-58-40
of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(c) of
rule
3701:1-58-40
of the Administrative Code or equivalent United States nuclear regulatory
commission or agreement state requirements; or
(2)
Is an authorized
user under rule
3701:1-58-51
or
3701:1-58-71
of the Administrative code, or equivalent United States nuclear regulatory
commission or agreement state requirements and who meets the requirements in
paragraph (B) of this rule; or
(3)
Is certified by a
medical specialty board whose certification process has been recognized by the
director, the United States nuclear regulatory commission, or an agreement
state under rule
3701:1-58-51
or
3701:1-58-71
of the Administrative Code, and who meets the requirements in paragraph (B) of
this rule.
(B)
The physician:
(1)
Has successfully
completed eighty hours of classroom and laboratory training, applicable to
parenteral administrations listed in paragraph (B)(1)(b)(vi)(c) of rule
3701:1-58-40
of the Administrative Code or equivalent United States nuclear regulatory
commission or agreement state requirements. The training must include:
(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; and
(e)
Radiation
biology; and
(2)
Has 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, or equivalent United States nuclear regulatory
commission or agreement state requirements, in the parenteral administrations
listed in paragraph (B)(1)(b)(vi)(c) of rule
3701:1-58-40
of the Administrative Code or equivalent United States nuclear regulatory
commission or agreement state requirements. A supervising authorized user who
meets the requirements in rule
3701:1-58-40
of the Administrative Code, this rule, or equivalent United States nuclear
regulatory commission or agreement state requirements, must have experience in
administering dosages in the same category or categories as the individual
requesting authorized user status. The work experience must involve:
(a)
Ordering,
receiving, and unpacking radioactive materials safely, and performing the
related radiation surveys;
(b)
Performing
quality control procedures on instruments used to determine the activity of
dosages, and performing checks for proper operation of survey
meters;
(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 to patients or human research subjects, that include at least three
cases involving the parenteral administration, as specified in paragraphs
(B)(1)(b)(vi)(c) of rule
3701:1-58-40
of the Administrative Code; and
(3)
Has obtained
written attestation that the individual has satisfactorily completed the
requirements in paragraphs (B)(1) and (B)(2) of this rule, and is able to
independently fulfill the radiation safety-related duties as an authorized user
for the parenteral administration of unsealed radioactive material requiring a
written directive. 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, or equivalent United States nuclear regulatory
commission or agreement state requirements, or equivalent agreement state
requirements. A preceptor authorized user who meets the requirements in this
rule, or
3701:1-58-40
of the Administrative Code, or equivalent United States nuclear regulatory
commission or agreement state requirements, must have experience in
administering dosages in the same 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 this rule, rule
3701:1-58-21,
or
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 paragraphs
(B)(1) and (B)(2) of this rule.
Replaces: 3701:1-58-104
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 12/22/2008, 01/01/2012
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