SF 3625

as introduced - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; regulating the use of lasers, intense pulsed light devices, and
radio frequency devices; amending Minnesota Statutes 2006, section 147.081,
subdivision 3; proposing coding for new law in Minnesota Statutes, chapter 147.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2006, section 147.081, subdivision 3, is amended to read:

Subd. 3.

Practice of medicine defined.

For purposes of this chapter, a person not
exempted under section 147.09 is "practicing medicine" or engaged in the "practice of
medicine" if the person does any of the following:

(1) advertises, holds out to the public, or represents in any manner that the person is
authorized to practice medicine in this state;

(2) offers or undertakes to prescribe, give, or administer any drug or medicine for
the use of another;

(3) offers or undertakes to prevent or to diagnose, correct, or treat in any manner or
by any means, methods, devices, or instrumentalities, any disease, illness, pain, wound,
fracture, infirmity, deformity or defect of any person;

(4) offers or undertakes to perform any surgical operation including any invasive
or noninvasive procedures involving the use of a laser or laser assisted device, upon any
person new text begin unless authorized under section 147.38 new text end ;

(5) offers to undertake to use hypnosis for the treatment or relief of any wound,
fracture, or bodily injury, infirmity, or disease; or

(6) uses in the conduct of any occupation or profession pertaining to the diagnosis
of human disease or conditions, the designation "doctor of medicine," "medical doctor,"
"doctor of osteopathy," "osteopath," "osteopathic physician," "physician," "surgeon,"
"M.D.," "D.O.," or any combination of these designations.

Sec. 2.

new text begin [147.38] USE OF LASERS.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For the purpose of this section, the following
definitions have the meanings given.
new text end

new text begin (b) "Ablative treatment" means treatment that is expected or intended to remove,
burn, or vaporize the epithelium, or its supporting structures, the dermis or subcutaneous
tissues, including fat.
new text end

new text begin (c) "Health practitioner" means a physician assistant registered under chapter 147A;
a licensed advanced practice registered nurse, registered nurse, or licensed practical nurse
licensed under sections 148.171 to 148.285; a licensed clinical esthetician licensed under
chapter 154; or a medical technician who has complied with the training requirements
described under subdivision 4.
new text end

new text begin (d) "Nonablative treatment" means treatment using a laser, intense pulsed light
device, or radio frequency device that is not expected or intended to remove, burn, or
vaporize the epidermal surface of the skin. This definition includes treatments related to
laser hair removal.
new text end

new text begin (e) "Physician" means a physician or osteopath licensed under this chapter.
new text end

new text begin (f) "Supervisor" means a physician experienced in ablative and nonablative
treatment.
new text end

new text begin (g) "Supervision" means the process of control and direction by which the supervisor
accepts full professional responsibility for the supervisee, instructs the supervisee, and
oversees or directs the work of the supervisee. The process must meet the following
conditions:
new text end

new text begin (1) the supervisor must be present and available on the premise more than 50 percent
of the time the supervisee is performing the treatment procedure and must be immediately
available for consultation, assistance, and direction as needed;
new text end

new text begin (2) the supervisor must review, approve, and sign the treatment plan if developed
by the supervisee before the treatment is performed; and
new text end

new text begin (3) the supervisor must review and countersign the patient's medical record of
treatment provided by the supervisee within five working days after the treatment is
performed.
new text end

new text begin (h) "Written protocol" means an ongoing order by the physician that is maintained
on-site at the facility at which the treatment is to be performed. The written protocol
must provide, at a minimum, the following:
new text end

new text begin (1) a statement identifying the physician who is authorized to use the specific device
and to delegate the use;
new text end

new text begin (2) specific criteria to screen patients for the appropriateness of a nonablative
treatment;
new text end

new text begin (3) for patients who meet the selection criteria, the identification of devices and
setting to be used;
new text end

new text begin (4) a description of appropriate care and follow-up for common complications,
serious injury, or emergencies that may result from the nonablative treatment; and
new text end

new text begin (5) a description of the plan to be followed when a treatment procedure is to be
delegated to a health practitioner, including the method to be used for documenting
decisions, communicating with the delegating physician, and recording all treatment
provided in the patient's medical record.
new text end

new text begin Subd. 2. new text end

new text begin General restrictions on the use of lasers, intense pulsed light devices,
and radio frequency devices. new text end

new text begin (a) The use of a laser, intense pulsed light device, or radio
frequency device for ablative treatments for the purpose of treating a physical disease,
disorder, deformity, or injury shall constitute the practice of medicine under section
147.081 and may only be performed by a physician.
new text end

new text begin (b) The use of a laser, intense pulsed light device, or radio frequency device for
nonablative treatments may be performed by a health practitioner if the treatment has been
delegated to the health practitioner by a physician according to subdivision 3 and the
health practitioner has met the training requirements described in subdivision 4.
new text end

new text begin (c) The use of a laser, nonlaser medical light-emitting device, or radio frequency
device on the eye or ocular adnexa shall only be performed by a physician.
new text end

new text begin Subd. 3. new text end

new text begin Delegation of nonablative treatment. new text end

new text begin (a) A supervising physician may
delegate the performance of a nonablative treatment to a health practitioner through the
use of a written protocol if the following requirements are met:
new text end

new text begin (1) a written protocol is in place at the facility where the treatment procedure is to
be performed;
new text end

new text begin (2) the supervising physician agrees to supervise the performance of the health
practitioner who is performing the nonablative treatment;
new text end

new text begin (3) prior to the performance of the initial nonablative treatment, the patient is initially
examined by the supervising physician who is to perform the treatment. If the patient is
examined by the health practitioner, the diagnosis and treatment plan must be reviewed
and approved by the supervising physician before the treatment is performed; and
new text end

new text begin (4) the supervising physician receives periodic status reports, as established in the
written protocol.
new text end

new text begin (b) If the supervising physician is unavailable to supervise the health practitioner as
required under this section, supervision may be delegated to another physician who has
the same level of training in nonablative treatment procedures as the supervising physician
and is associated with the supervising physician or the facility where the treatment is to be
performed. The physician providing supervision must affirm in writing that the physician
is familiar with the written protocols in use at the facility and will be responsible for
providing supervisory care according to those protocols and the requirements of this
section.
new text end

new text begin Subd. 4. new text end

new text begin Training requirements for health practitioners. new text end

new text begin (a) The supervising
physician must ensure prior to delegating the performance of any nonablative treatment to
a health practitioner that the health practitioner has complied with the following training
requirements:
new text end

new text begin (1) the health practitioner has completed and documented clinical and academic
training as established by the Board of Medical Practice in the following subjects:
new text end

new text begin (i) the fundamentals of laser operation;
new text end

new text begin (ii) the bioeffects of laser radiation on the eye and skin;
new text end

new text begin (iii) the significance of specular and diffuse reflections;
new text end

new text begin (iv) the nonbeam hazards of lasers;
new text end

new text begin (v) the nonionizing radiation hazards;
new text end

new text begin (vi) laser and laser system classifications; and
new text end

new text begin (vii) control measures; and
new text end

new text begin (2) the health practitioner has documented that they have completed training in
nonablative devices as established by the board and in each procedure that the health
practitioner may be performing using the devices.
new text end

new text begin (b) Before a health practitioner can perform any nonablative treatments, the health
practitioner must perform at least five treatments under the direct observation of the
supervising physician. For purposes of this section, "direct supervision" means that the
physician is present when the treatment is being performed.
new text end

new text begin Subd. 5. new text end

new text begin Quality assurance. new text end

new text begin Prior to delegating the performance of a nonablative
treatment procedure, the supervising physician must ensure that there is a quality
assurance program at the facility at which the procedure is to be performed. The quality
assurance program, at a minimum, must include the following elements:
new text end

new text begin (1) a mechanism to identify and determine the cause of complications and
unintended effects of nonablative treatments;
new text end

new text begin (2) a mechanism to review the adherence to the written protocol under which the
delegated procedure is being performed;
new text end

new text begin (3) a mechanism to monitor the quality of the nonablative treatment performed;
new text end

new text begin (4) a mechanism by which the findings of the quality assurance program are
reviewed and incorporated into future written protocols and delegation orders; and
new text end

new text begin (5) ongoing training of health practitioners to improve the quality and performance
of nonablative treatments.
new text end

Sec. 3. new text begin REVISOR'S INSTRUCTION.
new text end

new text begin The revisor of statutes shall change "sections 147.01 to 147.22" to "this chapter"
wherever it appears in Minnesota Statutes.
new text end