Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose. The purpose of this section is
to establish the duties and responsibilities of a physician who performs or who
delegates the performance of a nonsurgical medical cosmetic procedure
(hereafter referred to as "Procedure"). These procedures can result in
complications and the performance of these procedures is the practice of
medicine. This rule shall not be interpreted to allow individuals to perform
procedures without either a physician or midlevel practitioner being onsite, or
a physician being available for emergency consultation or appointment in the
event of an adverse outcome.
(b)
Definitions.
(1)
(1) Midlevel practitioner--A physician
assistant or advanced practice registered nurse.
(2) Prescription medical device--A device
that the federal Food and Drug Administration has designated as a prescription
medical device, and can be sold only to persons with prescriptive authority in
the state in which they reside.
(3)
Procedure--A nonsurgical medical cosmetic procedure, including but not limited
to the injection of medication or substances for cosmetic purposes, the
administration of colonic irrigations, and the use of a prescription medical
device for cosmetic purposes.
(c) Applicability. This section does not
apply to:
(1) surgery as defined under Texas
Occupations Code, §
151.002(a)(14);
(2) the practice of a profession by a
licensed health care professional under methods or means within the scope of
practice permitted by such license;
(3) the use of nonprescription
devices;
(4) intravenous
therapy;
(5) procedures performed
at a physician's practice by the physician or midlevel practitioners acting
under the physicians supervision; or
(6) laser hair removal procedures performed
in accordance with Texas Health and Safety Code, Chapter 401, Subchapter
M.
(d) Physician
Responsibilities.
(1) A physician must be
appropriately trained, including hands-on training, in a Procedure prior to
performing the Procedure or delegating the performance of a Procedure. The
physician must keep a record of his or her training in the office and have it
available for review upon request by a patient or a representative of the
board.
(2) Prior to authorizing a
Procedure, a physician, or a midlevel practitioner acting under the delegation
of a physician, must:
(A) take a
history;
(B) perform an appropriate
physical examination;
(C) make an
appropriate diagnosis;
(D)
recommend appropriate treatment;
(E) develop a detailed and written treatment
plan;
(F) obtain the patient's
informed consent;
(G) provide
instructions for emergency and follow-up care;
(H) prepare and maintain an appropriate
medical record;
(I) have signed and
dated written protocols as described in paragraph (7) of this subsection that
are detailed to a level of specificity that the person performing the Procedure
may readily follow; and
(J) have
signed and dated written standing orders.
(K) The performance of the items listed in
subparagraphs (A) - (J) of this paragraph must be documented in the patient's
medical record.
(3) After
a patient has been evaluated and diagnosed, as described in paragraph (2) of
this subsection, qualified unlicensed personnel may perform a procedure only
if:
(A) a physician or midlevel practitioner
is onsite during the procedure; or
(B) a delegating physician is available for
emergency consultation in the event of an adverse outcome, and if the physician
considers it necessary, be able to conduct an emergency appointment with the
patient.
(4) Regardless
of who performs the Procedure, the physician is ultimately responsible for the
safety of the patient and all aspects of the Procedure.
(5) Regardless of who performs the Procedure,
the physician is responsible for ensuring that each Procedure is documented in
the patient's medical record. A Procedure performed by unlicensed personnel
must be timely co-signed by a supervising physician.
(6) The physician must ensure that the
facility at which Procedures are performed, there is a quality assurance
program pertaining to Procedures that includes the following:
(A) a mechanism to identify complications and
adverse effects of treatment and to determine their cause;
(B) a mechanism to review the adherence to
written protocols by all health care personnel;
(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; and
(E) ongoing training to maintain and improve
the quality of treatment and performance of Procedures by health care
personnel.
(7) A
physician may delegate Procedures only at a facility at which the physician has
either:
(A) approved in writing the
facility's written protocols pertaining to the Procedures; or
(B) developed his own protocols for the
Procedures as described in paragraph (2)(I) of this subsection.
(8) The physician must ensure that
a person performing a Procedure has appropriate training in, at a minimum:
(A) techniques for each Procedure;
(B) cosmetic or cutaneous medicine;
(C) indications and contraindications for
each Procedure;
(D) pre-procedural
and post-procedural care;
(E)
recognition and acute management of potential complications that may result
from the Procedure; and
(F)
infectious disease control involved with each treatment.
(9) The physician has a written office
protocol for the person performing the Procedure to follow in performing
Procedure delegated. A written office protocol must include, at a minimum, the
following:
(A) the identity of the physician
responsible for the delegation of the Procedure;
(B) selection criteria to screen patients by
the physician or midlevel practitioner for the appropriateness of
treatment;
(C) a description of
appropriate care and follow-up for common complications, serious injury, or
emergencies;
(D) a statement of the
activities, decision criteria, and plan the physician, or midlevel
practitioner, shall follow when performing or delegating the performance of a
Procedure, including the method for documenting decisions made and a plan for
communication or feedback to the authorizing physician or midlevel practitioner
concerning specific decisions made; and
(E) a description of what information must be
documented by the person performing the Procedure.
(10) The physician ensures that each person
performs each Procedure in accordance with the written office
protocol.
(11) Each patient signs a
consent form prior to treatment that lists potential side effects and
complications, and the identity and titles of the individual who will perform
the Procedure.
(12) Each person
performing a Procedure must be readily identified by a name tag or similar
means that clearly delineates the identity and credentials of the
person.
(13) Any time a Procedure
is performed, at least one person trained in basic life support must be
onsite.
(e) Notice
Provisions.
(1) Each facility providing
Nonsurgical Medical Cosmetic Procedures must post a Notice Concerning
Complaints in compliance with 22 TAC Chapter 178.
(2) Each facility providing Nonsurgical
Medical Cosmetic Procedures must post in each public area and treatment room or
area a Notice in the format found in Rule §
178.3 of
this title (relating to Complaint Notification), including the name(s) of the
delegating physician(s) for that facility including their Texas Medical License
Number.