This rule establishes standards of practice for a physician or
surgeon or osteopathic physician or surgeon who serves as a medical director at
a medical spa. This rule does not apply to the standards of practice for a
nonphysician licensed health professional who serves as a medical director at a
medical spa pursuant to the rules of the professional's licensing
authority.
(1)
Definitions. As used in this rule:
"Alter" means to change the cellular structure
of living tissue.
"Capable of" means any means, method, device
or instrument that, if used as intended or otherwise to its greatest strength,
has the potential to alter or damage living tissue below the superficial
epidermal cells.
"Damage" means to cause a harmful change in
the cellular structure of living tissue.
"Delegate" means to entrust or transfer the
performance of a medical aesthetic service to qualified licensed or certified
nonphysician persons or qualified laser technicians.
"Medical aesthetic service" means the
diagnosis, treatment, or correction of human conditions, ailments, diseases,
injuries, or infirmities of the skin, hair, nails and mucous membranes by any
means, methods, devices, or instruments including the use of a biological or
synthetic material, chemical application, mechanical device, or displaced
energy form of any kind if it alters or damages or is capable of altering or
damaging living tissue below the superficial epidermal cells, with the
exception of hair removal. Medical aesthetic service includes, but is not
limited to, the following services: ablative laser therapy; vaporizing laser
therapy; nonsuperficial light device therapy; injectables; tissue alteration
services; nonsuperficial light-emitting diode therapy; nonsuperficial intense
pulse light therapy; nonsuperficial radiofrequency therapy; nonsuperficial
ultrasonic therapy; nonsuperficial exfoliation; nonsuperficial
microdermabrasion; nonsuperficial dermaplane exfoliation; nonsuperficial
lymphatic drainage; collagen induction therapy (microneedling); fat-freezing
treatment (cool sculpting); botox injections; collagen injections; and tattoo
removal.
"Medical director" means a physician who
assumes the role of, or holds oneself out as, medical director at a medical
spa. The medical director is responsible for implementing policies and
procedures to ensure quality patient care and for the delegation and
supervision of medical aesthetic services performed by qualified licensed or
certified nonphysician persons or qualified laser technicians at a medical spa.
The medical director is ultimately responsible for all medical aesthetic
services performed by qualified licensed or certified nonphysician persons or
qualified laser technicians at a medical spa.
"Medical spa" means any entity, however
organized, that is advertised, announced, established, or maintained for the
purpose of providing medical aesthetic services. Medical spa shall not include
a dermatology practice that is wholly owned and controlled by one or more
Iowa-licensed physicians if at least one of the owners is actively practicing
at each location.
"Nonsuperficial" means that the therapy alters
or damages or is capable of altering or damaging living tissue below the
superficial epidermal cells.
"Qualified laser technician" means any person,
licensed or unlicensed, who has successfully completed a minimum of 120 hours
of training, including a minimum of 40 hours of didactic study and 80 hours of
clinical training, in the safe and effective use of lasers in the performance
of medical aesthetic services at an accredited laser training program. For the
purposes of this rule, a qualified laser technician may only use lasers in the
performance of delegated medical aesthetic services under the supervision of a
qualified supervising physician at a medical spa. An unlicensed qualified laser
technician may not perform any other medical aesthetic services defined in this
rule.
"Qualified licensed or certified nonphysician
person" means any person who is not licensed to practice medicine and
surgery or osteopathic medicine and surgery but who is licensed or certified by
another health- or skin care-related licensing board in Iowa and is qualified
to perform delegated medical aesthetic services under the supervision of a
qualified supervising physician at a medical spa.
"Supervision" means the oversight of qualified
licensed or certified nonphysician persons or qualified laser technicians who
perform medical aesthetic services delegated by a medical director.
(2)
Delegation by a
medical director. A medical aesthetic service shall only be performed
by qualified licensed or certified nonphysician persons or qualified laser
technicians if the service has been delegated by a medical director who is
responsible for supervision of the services performed at a medical spa in Iowa.
Nothing in this rule shall be interpreted to prevent a qualified nonphysician
licensed health professional from serving as a medical director at a medical
spa or from appropriately delegating medical aesthetic services pursuant to the
rules of the professional's licensing authority.
(3)
Medical director. A
medical director at a medical spa shall:
a.
Hold an active unrestricted Iowa medical license to supervise each delegated
medical aesthetic service;
b.
Possess the appropriate education, training, experience and competence to
safely supervise each delegated medical aesthetic service;
c. Retain responsibility for the supervision
of each medical aesthetic service performed by qualified licensed or certified
nonphysician persons or qualified laser technicians;
d. Ensure that advertising activities do not
include false, misleading, or deceptive representations; and
e. Be clearly identified as the medical
director in all advertising activities, Internet websites and signage related
to the medical spa.
(4)
Delegated medical aesthetic service. When a medical director
delegates a medical aesthetic service to qualified licensed or certified
nonphysician persons or qualified laser technicians, the service shall be:
a. Within the medical director's scope of
practice and medical competence to supervise;
b. Of the type that a reasonable and prudent
physician would conclude is within the scope of sound medical judgment to
delegate; and
c. A routine and
technical service, the performance of which does not require the skill of a
licensed physician.
(5)
Supervision. A medical director who delegates performance of a
medical aesthetic service to qualified licensed or certified nonphysician
persons or qualified laser technicians is responsible for providing appropriate
supervision. The medical director shall:
a.
Ensure that all licensed or certified nonphysician persons or qualified laser
technicians are qualified and competent to safely perform each delegated
medical aesthetic service by personally assessing the person's education,
training, experience and ability;
b. Ensure that a qualified licensed or
certified nonphysician person does not perform any medical aesthetic services
that are beyond the scope of that person's license or certification unless the
person is supervised by a qualified supervising physician or other qualified
supervising nonphysician licensed health professional;
c. Ensure that all qualified licensed or
certified nonphysician persons or qualified laser technicians receive direct,
in-person, on-site supervision from the medical director or other qualified
licensed physician or other qualified supervising nonphysician licensed health
professional at least four hours each week and that the regular supervision is
documented;
d. Provide on-site
review of medical aesthetic services performed by qualified licensed or
certified nonphysician persons or qualified laser technicians each week and
review at least 10 percent of patient charts for medical aesthetic services
performed by qualified licensed or certified nonphysician persons or qualified
laser technicians;
e. Be physically
located, at all times, within 60 miles of the location where delegated medical
aesthetic services are performed;
f. Be available, in person or electronically,
at all times, to consult with qualified licensed or certified nonphysician
persons or qualified laser technicians who perform delegated medical aesthetic
services, particularly in case of injury or an emergency;
g. Assess the legitimacy and safety of all
equipment or other technologies being used by qualified licensed or certified
nonphysician persons or qualified laser technicians who perform delegated
medical aesthetic services;
h.
Develop and implement protocols for responding to emergencies or other injuries
suffered by persons receiving delegated medical aesthetic services performed by
qualified licensed or certified nonphysician persons or qualified laser
technicians;
i. Ensure that all
qualified licensed or certified nonphysician persons or qualified laser
technicians maintain accurate and timely medical records for the delegated
medical aesthetic services they perform;
j. Ensure that each patient provides
appropriate informed consent for medical aesthetic services performed by the
medical director or other qualified licensed physician and all qualified
licensed or certified nonphysician persons or qualified laser technicians and
that such informed consent is timely documented in the patient's medical
record;
k. Ensure that the identity
and licensure and certification of the medical director, other qualified
licensed physicians, and all qualified licensed or certified nonphysician
persons or qualified laser technicians are visibly displayed at each medical
spa where they perform medical aesthetic services and provided in writing to
each patient receiving medical aesthetic services at a medical spa;
and
l. Ensure that the board
receives written verification of the education and training of all qualified
licensed or certified nonphysician persons or qualified laser technicians who
perform delegated medical aesthetic services at a medical spa, within 14 days
of a request by the board.
(6)
Continuing medical
education. A medical director shall complete and shall ensure that all
other physicians, qualified licensed or certified nonphysician persons, and
qualified laser technicians who practice at the medical spa complete a minimum
of 20 hours of continuing medical education in the safe and effective
performance of medical aesthetic services each year.
(7)
Exceptions. This rule is
not intended to apply to physicians who serve as medical directors of licensed
medical facilities, clinics or practices that provide medical aesthetic
services as part of or incident to their other medical services.
(8)
Other qualified nonphysician
licensed health professionals. Nothing in this rule shall be
interpreted to contradict or supersede the rules established in 481-Chapters
780 and 781 and 655-Chapter 7.
