WSR 08-20-125

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Osteopathic Medicine and Surgery)

[ Filed October 1, 2008, 8:47 a.m. , effective November 1, 2008 ]


     Effective Date of Rule: Thirty-one days after filing.

     Purpose: The adopted rules will clarify that the use of laser, light, radiofrequency, and plasma (LLRP) devices classified as prescriptive medical devices by the Food and Drug Administration are the practice of osteopathic medicine. The adopted rules define delegation and supervision for the use of LLRP devices by osteopathic physicians and osteopathic physician assistants.

     Statutory Authority for Adoption: RCW 18.57.005, 18.57A.020, 18.130.050.

      Adopted under notice filed as WSR 08-13-093 on June 18, 2008.

     A final cost-benefit analysis is available by contacting Erin Obenland, Board of Osteopathic Medicine and Surgery, P.O. Box 47866, phone (360) 236-4945, fax (360) 236-2406, e-mail erin.obenland@doh.wa.gov.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 2, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 2, Amended 0, Repealed 0.

     Date Adopted: July 25, 2008.

Blake T. Maresh

Executive Director

OTS-9865.3


NEW SECTION
WAC 246-853-630   Use of laser, light, radiofrequency, and plasma devices as applied to the skin.   (1) For the purposes of this section, laser, light, radiofrequency, and plasma (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 prescriptive devices.

     (2) Because an LLRP device is used to treat disease, injuries, deformities, and other physical conditions in human beings, the use of an LLRP device is the practice of osteopathic medicine under RCW 18.57.001. 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 those in subsection (1) of this section constitutes surgery and is outside the scope of this section.


     OSTEOPATHIC PHYSICIAN RESPONSIBILITIES


     (4) An osteopathic physician 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) An osteopathic physician must use an LLRP device in accordance with standard medical practice.

     (6) Prior to authorizing treatment with an LLRP device, an osteopathic physician 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 an allied health care professional may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.

     (7) Regardless of who performs LLRP device treatment, the osteopathic physician is ultimately responsible for the safety of the patient.

     (8) Regardless of who performs LLRP device treatment, the osteopathic physician is responsible for assuring that each treatment is documented in the patient's medical record.

     (9) The osteopathic physician must ensure that there is a quality assurance program for the facility at which LLRP device procedures are performed regarding the selection and treatment of patients. An appropriate quality assurance program shall include the following:

     (a) A mechanism to identify complications and problematic effects of treatment and to determine their cause;

     (b) A mechanism to review the adherence of supervised allied health care professionals to written protocols;

     (c) A mechanism to monitor the quality of treatments;

     (d) A mechanism by which the findings of the quality assurance program are reviewed and incorporated into future protocols required by subsection (10)(d) of this section and osteopathic physician supervising practices; and

     (e) Ongoing training to maintain and improve the quality of treatment and performance of the treating allied health care professionals.


     OSTEOPATHIC PHYSICIAN DELEGATION OF LLRP TREATMENT


     (10) An osteopathic physician who meets the requirements in subsections (1) through (9) of this section may delegate an LLRP device procedure to a properly trained allied health care professional licensed under the authority of RCW 18.130.040, whose scope of practice allows the use of a prescriptive LLRP medical 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 osteopathic medicine;

     (b) Such delegated use falls within the supervised allied health care professional's lawful scope of practice;

     (c) The LLRP device is not used on the globe of the eye;

     (d) An osteopathic physician has a written office protocol for the supervised allied health care 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 osteopathic physician authorized to use the LLRP device and responsible for the delegation of the procedure;

     (ii) A statement of the activities, decision criteria, and plan the supervised allied health care 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 allied health care professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing osteopathic physician concerning specific decisions made;

     (e) The supervised allied health care professional has appropriate training including, but not limited to:

     (i) Application techniques of each LLRP device;

     (ii) Cutaneous medicine;

     (iii) Indications and contraindications for such procedures;

     (iv) Preprocedural and postprocedural care;

     (v) Potential complications; and

     (vi) Infectious disease control involved with each treatment;

     (f) The delegating osteopathic physician ensures that the supervised allied health care 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 delegating osteopathic physician shall be on the immediate premises during the patient's initial treatment and be able to treat complications, provide consultation, or resolve problems, if indicated. The supervised allied health care professional may complete the initial treatment if the physician is called away to attend to an emergency;

     (h) Existing patients with an established treatment plan may continue to receive care during temporary absences of the delegating osteopathic physician provided there is a local back-up physician, licensed under chapter 18.57 or 18.71 RCW, who satisfies the requirements of subsection (4) of this section. The local back-up physician must agree in writing to treat complications, provide consultation or resolve problems if medically indicated. In case of an emergency the delegating osteopathic physician or a back-up physician shall be reachable by phone and able to see the patient within sixty minutes.

     (11) The use of, or the delegation of the use of, an LLRP device by an osteopathic physician assistant is covered by WAC 246-854-220.

     (12) This section only applies to the use of LLRP devices by osteopathic physicians and osteopathic physician assistants.

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OTS-9866.3


NEW SECTION
WAC 246-854-220   Use of laser, light, radiofrequency, and plasma devices as applied to the skin.   (1) For the purposes of this section, laser, light, radiofrequency, and plasma (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 prescriptive devices.

     (2) Because an LLRP device is used to treat disease, injuries, deformities and other physical conditions of human beings, the use of an LLRP device is the practice of osteopathic medicine under RCW 18.57.001. 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 those in subsection (1) of this section constitutes surgery and is outside the scope of this section.


     OSTEOPATHIC PHYSICIAN ASSISTANT RESPONSIBILITIES


     (4) An osteopathic physician assistant may use an LLRP device with the consent of the sponsoring or supervising osteopathic physician who meets the requirements under WAC 246-853-630, is in compliance with the practice arrangement plan approved by the board, and in accordance with standard medical practice.

     (5) An osteopathic 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.

     (6) Prior to authorizing treatment with an LLRP device, an osteopathic 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 an allied health care practitioner may operate the device), provide instructions for emergency and follow-up care, and prepare an appropriate medical record.


     OSTEOPATHIC PHYSICIAN ASSISTANT DELEGATION OF LLRP TREATMENT


     (7) An osteopathic physician assistant who meets the above requirements may delegate an LLRP device procedure to a properly trained allied health care professional licensed under the authorization of RCW 18.130.040, whose scope of practice allows the use of a prescriptive LLRP medical 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 allied health care professional's lawful scope of practice;

     (c) The LLRP device is not used on the globe of the eye; and

     (d) The supervised allied health care professional has appropriate training including, but not limited to:

     (i) Application techniques of each LLRP device;

     (ii) Cutaneous medicine;

     (iii) Indications and contraindications for such procedures;

     (iv) Preprocedural and postprocedural care;

     (v) Potential complications; and

     (vi) Infectious disease control involved with each treatment;

     (e) The delegating osteopathic physician assistant has written office protocol for the supervised allied health care 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 osteopathic 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 allied health care 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 allied health care professional shall follow when performing delegated procedures, including the method for documenting decisions made and a plan for communication or feedback to the authorizing osteopathic physician assistant concerning specific decisions made. Documentation shall be recorded after each procedure on the patient's record or medical chart;

     (f) The osteopathic physician assistant is responsible for ensuring that the supervised allied health care 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 osteopathic 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.

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