| (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) 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.
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