Ohio Admin. Code 4731-18-03 - Delegation of the use of light based medical devices for specified non-ablative procedures
(A)
A physician may
delegate the application of a vascular laser for non-ablative dermatologic
procedures only if all the following conditions are met:
(1)
The vascular
laser has been specifically cleared or approved by the United States food and
drug administration for the specific intended non-ablative dermatologic
procedure;
(2)
The use of the vascular laser for the specific
non-ablative dermatologic use is within the physician's normal course of
practice and expertise;
(3)
The physician has seen and evaluated the patient to
determine whether the proposed application of the specific vascular laser is
appropriate;
(4)
The physician has seen and evaluated the patient
following the initial application of the specific vascular laser, but prior to
any continuation of treatment in order to determine that the patient responded
well to the initial application of the specific vascular laser;
(5)
The person to
whom the delegation is made is one of the following:
(a)
A physician
assistant licensed under Chapter 4730. of the Revised Code with whom the
physician has an effective supervision agreement; or,
(b)
A registered
nurse or licensed practical nurse licensed under Chapter 4723. of the Revised
Code;
(6)
For a physician assistant, the authorization must meet
the requirements of section
4730.21 of the Revised
Code.
(7)
For a registered nurse or licensed practical nurse, the
physician must ensure that the person to whom the delegation is made has
received adequate education and training to provide the level of skill and care
required including;
(a)
Eight hours of basic education that must include the
following topics: light based procedure physics, tissue interaction in light
based procedures, light based procedure safety including use of proper safety
equipment, clinical application of light based procedures, pre and
post-operative care of light based procedure patients, and reporting of adverse
events;
(b)
Observation of fifteen procedures for each specific
type of vascular laser non-ablative procedure delegated. The procedures
observed must be performed by a physician for whom the use of this specific
vascular laser procedure is within the physician's normal course of practice
and expertise; and
(c)
Performance of twenty procedures under the direct
physical oversight of the physician on each specific type of vascular laser
non-ablative procedure delegated. The physician overseeing the performance of
these procedures must use this specific vascular laser procedure within the
physician's normal course of practice and expertise;
(d)
Satisfactory
completion of training shall be documented and retained by each physician
delegating and the delegate. The education requirement in paragraph (A)(7)(a)
of this rule must only be completed once by the delegate regardless of the
number of types of specific vascular laser procedures delegated and the number
of delegating physicians. The training requirements in paragraphs (A)(7)(b) and
(A)(7)(c) of this rule must be completed by the delegate once for each specific
type of vascular laser procedure delegated regardless of the number of
delegating physicians;
(8)
For delegation to
a registered nurse or licensed practical nurse, the physician provides on-site
supervision at all times that the person to whom the delegation is made is
applying the vascular laser; and,
(9)
For delegation to
a registered nurse or licensed practical nurse, the physician supervises no
more than two persons pursuant to this rule at the same time.
(B)
A
physician may delegate the application of light based medical devices for the
purpose of hair removal in accordance with the requirements of section
4731.33 of the Revised
Code.
(C)
The physician assistant, registered nurse or licensed
practical nurse shall immediately report to the supervising physician any
clinically significant side effect following the application of the light based
medical device or any failure of the treatment to progress as was expected at
the time the delegation was made. The physician shall see and personally
evaluate the patient who has experienced the clinically significant side effect
or whose treatment is not progressing as expected as soon as
practicable.
(D)
A violation of paragraph (A), (B), or (C) of this rule
by a physician shall constitute "a departure from, or the failure to conform
to, minimal standards of care of similar practitioners under the same or
similar circumstances, whether or not actual injury to a patient is
established," as that clause is used in division (B)(6) of section
4731.22 of the Revised
Code.
(E)
A violation of division (A)(5) of this rule shall
constitute "violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of, or conspiring to violate, any
provisions of this chapter or any rule promulgated by the board," as that
clause is used in division (B)(20) of section
4731.22 of the Revised Code, to
wit: section 4731.41 of the Revised
Code.
(F)
A violation of paragraph (C) of this rule by a
physician assistant shall constitute "a departure from, or failure to conform
to, minimal standards of care of similar physician assistants under the same or
similar circumstances, regardless of whether actual injury to patient is
established," as that clause is used in division (B)(19) of section
4730.25 of the Revised
Code.
Replaces: 4731-18-03
Notes
Promulgated Under: 119.03
Statutory Authority: 4730.07, 4731.05
Rule Amplifies: 4730.07, 4730.21, 4730.25, 4731.05, 4731.22, 4731.33, 4731.41
Prior Effective Dates: 06/30/2000, 04/09/2021 (Emer.), 07/31/2021
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