246-918-120  <<  246-918-125 >>   246-918-126

Use of laser, light, radiofrequency, and plasma devices as applied to the skin.

(1) For the purposes of this rule, laser, light, radiofrequency, and plasma devices (hereafter LLRP devices) are medical devices that:
(a) Use a laser, noncoherent light, intense pulsed light, radiofrequency, or plasma to topically penetrate skin and alter human tissue; and
(b) Are classified by the federal Food and Drug Administration as prescription devices.
(2) Because an LLRP device penetrates and alters human tissue, the use of an LLRP device is the practice of medicine under RCW 18.71.011. The use of an LLRP device can result in complications such as visual impairment, blindness, inflammation, burns, scarring, hypopigmentation and hyperpigmentation.
(3) Use of medical devices using any form of energy to penetrate or alter human tissue for a purpose other than the purpose set forth in subsection (1) of this section constitutes surgery and is outside the scope of this section.
(4) A physician assistant must be appropriately trained in the physics, safety and techniques of using LLRP devices prior to using such a device, and must remain competent for as long as the device is used.
(5) A physician assistant may use an LLRP device so long as it is with the consent of the sponsoring or supervising physician, it is in compliance with the practice arrangement plan approved by the commission, and it is in accordance with standard medical practice.
(6) Prior to authorizing treatment with an LLRP device, a physician assistant must take a history, perform an appropriate physical examination, make an appropriate diagnosis, recommend appropriate treatment, obtain the patient's informed consent (including informing the patient that a nonphysician may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.
(7) A physician assistant who meets the above requirements may delegate an LLRP device procedure to a properly trained and licensed professional, whose licensure and scope of practice allow the use of an LLRP device provided all the following conditions are met:
(a) The treatment in no way involves surgery as that term is understood in the practice of medicine;
(b) Such delegated use falls within the supervised professional's lawful scope of practice;
(c) The LLRP device is not used on the globe of the eye; and
(d) The supervised professional has appropriate training in, at a minimum, application techniques of each LLRP device, cutaneous medicine, indications and contraindications for such procedures, preprocedural and postprocedural care, potential complications and infectious disease control involved with each treatment.
(e) The delegating physician assistant has written office protocol for the supervised professional to follow in using the LLRP device. A written office protocol must include at a minimum the following:
(i) The identity of the individual physician assistant authorized to use the device and responsible for the delegation of the procedure;
(ii) A statement of the activities, decision criteria, and plan the supervised professional must follow when performing procedures delegated pursuant to this rule;
(iii) Selection criteria to screen patients for the appropriateness of treatments;
(iv) Identification of devices and settings to be used for patients who meet selection criteria;
(v) Methods by which the specified device is to be operated and maintained;
(vi) A description of appropriate care and follow-up for common complications, serious injury, or emergencies; and
(vii) A statement of the activities, decision criteria, and plan the supervised professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician assistant concerning specific decisions made. Documentation shall be recorded after each procedure, and may be performed on the patient's record or medical chart.
(f) The physician assistant is responsible for ensuring that the supervised professional uses the LLRP device only in accordance with the written office protocol, and does not exercise independent medical judgment when using the device.
(g) The physician assistant shall be on the immediate premises during any use of an LLRP device and be able to treat complications, provide consultation, or resolve problems, if indicated.
[Statutory Authority: RCW 18.71.017, 18.71A.020 and 18.130.050(12). WSR 07-03-177, ยง 246-918-125, filed 1/24/07, effective 3/1/07.]
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