Written protocols for the purpose of this section shall mean
physician's order, standing delegation order, standing medical order, or other
written order that is maintained on site. A written protocol must be provided
to the Board upon request and must provide, at a minimum, the following:
(1) A statement identifying the individual
physician authorized to utilize the specified device and responsible for the
delegation of the performance of the specified procedure, including proof of
the physician's training in accordance with these rules;
(2) A statement of the activities, decision
criteria, and plan the Level 1 or 2 Delegate shall follow when performing
delegated procedures;
(3) Selection
criteria to screen patients for the appropriateness of non-ablative
treatments;
(4) Identification of
devices and settings to be used for patients who meet selection
criteria;
(5) Methods by which the
specified device is to be operated;
(6) A description of appropriate care and
follow-up for common complications, serious injury, or emergencies as a result
of the non-ablative treatment;
(7)
Procedures for obtaining proper consent forms signed by the patient or legal
guardian;
(8) Instructions for
maintaining a patient's chart, which should include, at a minimum, the patient
intake form, the executed informed consent, the treatment sheet and progress
notes, and before and after instructions;
(9) Instructions for documentation of a
patient's treatment, decisions made, and a plan for communication or feedback
to the authorizing physician concerning specific decisions made. Documentation
shall be recorded within a reasonable time after each procedure and may be
performed on the patient's record or medical chart; and
(10) Instructions to contact the supervising
physician immediately if complications or complaints from the patient
arise.
(11) Written protocols
should be signed by both the supervising physician and the corresponding Legal
1 or 2 Delegate.
