Rule 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.
Last updated May 1, 2023 at 8:41 AM
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