Current through Register Vol. 24-18, September 15, 2024
(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, radio-frequency, or plasma to
topically penetrate skin and alter human tissue, or use high frequency
ultrasound or other technologies to deliver energy to or through the skin;
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, hypo-pigmentation 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 osteo-pathic 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 a nonphysician 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 osteo-pathic physician is
ultimately responsible for the safety of the patient.
(8) Regardless of who performs LLRP device
treatment, the osteo-pathic 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 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
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 and licensed professional, whose
li-censure and 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 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 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 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 osteopathic physician
concerning specific decisions made.
(e) The supervised 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 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 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 os-teopathic 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 60 minutes.
Statutory Authority:
RCW
18.57.005,
18.57A.020,
18.130.050. 08-20-125, §
246-853-630, filed 10/1/08, effective
11/1/08.
