Ohio Admin. Code 3701:1-58-15 - Written directives
(A) A written directive must be dated and
signed by an authorized user before the administration of iodine-131 sodium
iodide greater than 1.11 megabecquerels (thirty
microcuries), any therapeutic dosage of unsealed radioactive material or any
therapeutic dose of radiation from radioactive material. If, because of the
emergent nature of the patient's condition, a delay in order to provide a
written directive would jeopardize the patient's health, an oral directive is
acceptable. The information contained in the oral directive must be documented
as soon as possible in writing in the patient's record. A written directive
must be prepared within forty-eight hours of the oral directive.
(B) The written directive must contain the
patient or human research subject's name and the following information:
(1) For any administration of quantities
greater than 1.11 megabecquerels (thirty
microcuries) of sodium iodide iodine-131: the dosage;
(2) For an administration of a therapeutic
dosage of unsealed radioactive material other than sodium iodide iodine-131:
the radioactive drug, dosage, and route of administration;
(3) For gamma stereotactic radiosurgery: the
total dose, treatment site, and values for the target coordinate settings per
treatment for each anatomically distinct treatment site;
(4) For teletherapy: the total dose, dose per
fraction, number of fractions, and treatment site;
(5) For high dose-rate remote afterloading
brachytherapy: the radionuclide, treatment site, dose per fraction, number of
fractions, and total dose; or
(6) For all other
brachytherapy, including low, medium, and pulsed dose rate remote
afterloaders
permanent implant
brachytherapy :
(a) Before implantation:
treatment site, the radionuclide, and dose
the total source
strength ; and
(b) After
implantation but before completion of the
procedure
the patient leaves the post-treatment
recovery area : the radionuclide,
the treatment site, the number of sources implanted , and
the total source strength implanted, and exposure
time (or the total dose)
the date when the
licensee assessed the patient's implantation; or
.
(7)
For all other
brachytherapy, including low, medium, and pulsed dose rate remote
afterloaders:
(a)
Before implantation: The treatment site, radionuclide,
and dose; and
(b)
After implantation but before completion of the
procedure: The radionuclide; treatment site; number of sources; total source
strength and exposure time (or the total dose); and the date when the licensee
assessed the patient's implantation.
(C) A written revision to an existing written
directive may be made if the revision is dated and signed by an authorized user
before the administration of the dosage of unsealed radioactive material, the
brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy
dose, or the next fractional dose. If, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive is acceptable. The oral revision must be documented as soon as
possible in the patient's record. A revised written directive must be signed by
the authorized user within forty-eight hours of the oral revision.
(D) The licensee shall retain a copy of the
written directive in accordance with rule
3701:1-58-75
of the Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 10/04/2010
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