Current through all regulations passed and filed through March 18, 2024
(A) Each handler of therapy equipment subject
to the requirements of Chapter 3701:1-67 of the Administrative Code, shall
develop, implement, and maintain a quality management program to provide high
confidence that radiation will be administered as directed by the physician or
veterinarian authorizing its use.
(B) The quality management program shall
address, as a minimum, the following specific objectives regarding written
directives:
(1) A written directive must be
dated and signed by a physician or veterinarian authorizing its use prior to
the administration of radiation. If because of the patient's condition, a delay
in the 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 will be acceptable, provided that the oral revision is documented as
soon as possible in the patient's record and a revised written directive is
signed by an authorized user within forty-eight hours of the oral
revision;
(2) The written directive
must contain the patient or human research subject's name, the type and energy
of the beam, the total dose, dose per fraction, treatment site, and number of
fractions;
(3) A written revision
to an existing written directive may be made provided that the revision is
dated and signed by an authorized user prior to the administration of the
therapy equipment dose, or the next fractional dose; and
(4) The handler shall retain a copy of the
written directive for seven years.
(C) The handler shall develop, implement, and
maintain for the duration of the registration, written procedures to provide
high confidence that:
(1) Prior to the
administration of each radiation treatment, the patient's or human research
subject's identity is verified by more than one method as the individual named
in the written directive;
(2) Each
administration is in accordance with the written directive;
(3) The final plans of treatment and related
calculations are in accordance with the respective written directives by:
(a) Checking the parameters and the results
of the primary calculation with a secondary method to verify they are correct
and in accordance with the written directive; and
(b) Verifying that the planned parameters are
correctly transferred to the treatment charts; and
(4)
Unintended treatment deviations
from the written directive, approved treatment plan, or
errors in the approved treatment plan or process that was identified after the
administration of radiation
are identified, documented, evaluated and appropriate
action is taken.
(D)
The handler shall retain records of unintended
treatment deviations from the written directive or approved treatment plan for
seven years. The record must contain the following:
(1)
The
identification number of the individual who is the subject of the unintended
deviation;
(2)
A brief description of the deviation and why it
occurred; and
(3)
The actions, if any, taken to prevent
recurrence.