Current through Register Vol. 43, No. 12, March 20, 2024
(a)
(1) The phrase "class III or class IV device"
shall mean a medical instrument that meets either of the following conditions:
(A) Is a class IIIa, class IIIb, or class IV
laser product as defined by 21 C.F.R. §
1040.10, as in
effect on March 31, 2000; or
(B)
emits radiation in a continuous wave of more than one milliwatt or at a pulsed
rate of more than five milliwatts.
(2) The phrase "immediately available" shall
mean that the licensee either is physically present in the same building or can
be present at the location where the service is performed within five minutes.
(3) "Licensee" shall mean a person
licensed to practice medicine and surgery or osteopathic medicine and surgery
in this state.
(4) The phrase
"light-based medical device" shall mean any instrument that produces or
amplifies electromagnetic radiation at wavelengths equal to or greater than 180
nanometers, but less than or equal to 1.0 X 106 nanometers, for the purpose of
affecting the structure or function of any part of the living human body.
(5) The phrase "physically
present" shall mean that the licensee is capable of constant, direct
communication and is in the same office within the building where the service
is performed throughout the entire time during which the service is performed.
(b) A licensee shall
not authorize another person to perform a professional service using a
light-based medical device unless either the licensee is immediately available
or, except as limited by subsection (c), there is a written practice protocol
signed by the licensee and the person performing the treatment that requires
all of the following:
(1) The person
performing the treatment will not provide any service for which the person is
not competent by training, education, and experience.
(2) The person receiving the treatment is
required to give consent to the treatment, after being informed of the nature
and purpose of the treatment, risks, and expected consequences of treatment,
alternatives to light-based medical treatment, and identification of the
treatment as a medical and surgical procedure.
(3) The person performing the treatment is
required to inform the person receiving the treatment of the licensee's
identity, emergency telephone number, and practice location, if different from
the location at which the treatment is performed.
(4) Each treatment is required to be
performed only at a location that the licensee maintains for the practice of
the branch of the healing arts for which the licensee is licensed.
(5) Each treatment provided while the
licensee is not physically present is required to be performed within written
operating parameters.
(6) Creation
of an adequate patient record is required.
(7) The licensee is required to review the
patient record and authenticate this review within 14 days following the
treatment.
(8) The person
performing the treatment is prohibited from delegating the use of the
light-based medical device to another person.
(c) A licensee shall not authorize another
person to perform a professional service using a class III or class IV device
or an intense pulsed-light device substantially equivalent to a laser surgical
device as defined by 21
C.F.R. §
878.4810, as in effect on
January 16, 1996, unless either of the following conditions is met:
(1) The licensee is physically present.
(2) The licensee is immediately
available, and there is a written protocol signed by the licensee and the
person performing the treatment that meets the requirements of paragraphs
(b)(1) through (b)(8).
(d) This regulation shall not apply to an
order by a licensee to any appropriate person for the application of
light-based medical devices for phototherapy in the treatment of
hyperbilirubinemia in neonates.
(e) This regulation shall not apply to any of
the following:
(1) Any person licensed under
the healing arts act to practice chiropractic who engages in light-based
physiotherapy;
(2) any licensed
physical therapist who provides treatments as authorized by law; or
(3) any licensed occupational therapist who
provides treatments as authorized by law.
