22 TAC §§192.1 - 192.6
The Texas State Board of Medical Examiners adopts on an emergency
basis new Chapter 192, §§192.1-192.6, concerning responsibilities
of physicians providing, or overseeing by proper delegation, anesthesia services
in outpatient settings and to provide the minimum acceptable standards for
the provision of anesthesia services in outpatient settings, as mandated by
Senate Bill 1340, 76th Legislature.
These rules will protect the public by assuring that physicians adhere
to acceptable standards in the provision of anesthesia services in office-based
settings.
These sections are being adopted on an emergency basis due to the legislature
mandating a January 7, 2000, deadline for the new sections to be effective.
The new sections are adopted on an emergency basis under the
authority of the Occupations Code, §153.001, which provides the Texas
State Board of Medical Examiners to adopt rules and bylaws as necessary to:
govern its own proceedings; perform its duties; regulate the practice of medicine
in this state; and enforce this subtitle.
The Occupations Code, §153.001 is affected by the adopted new sections.
§192.1.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the contents indicate otherwise.
(1)
Anesthesiologist's assistant - A graduate of an approved
anesthesiologist's assistant training program.
(2)
Anesthesiology resident - A physician who is presently
in an approved Texas anesthesiology residency program who is either licensed
as a physician in Texas or holds a postgraduate resident permit issued by
the Texas State Board of Medical Examiners.
(3)
Certified registered nurse anesthetist - A person
licensed by the Board of Nurse Examiners for the State of Texas (BNE) as a
registered professional nurse, authorized by the BNE as an advanced practice
nurse in the role of nurse anesthetist, and certified by a national certifying
body recognized by the BNE.
(4)
Monitored anesthesia care - Situations where a patient
undergoing a diagnostic or therapeutic procedure receives doses of medication
that create a risk of loss of normal protective reflexes or loss of consciousness
and the patient remains able to protect the airway for the majority of the
procedure. If, for an extended period of time, the patient is rendered unconscious
and/or loses normal protective reflexes, then anesthesia care shall be considered
a general anesthetic.
(5)
Outpatient setting - Any facility, clinic, center,
office, or other setting that is not a part of a licensed hospital or a licensed
ambulatory surgical center with the exception of all of the following listed
in subparagraphs (A)-(D) of this paragraph:
(A)
a clinic located on land recognized as tribal land by the
federal government and maintained or operated by a federally recognized Indian
tribe or tribal organization as listed by the United States secretary of the
interior under 25 U.S.C. §479-1 or as listed under a successor federal
statute or regulation;
(B)
a facility maintained or operated by a state or governmental
entity;
(C)
a clinic directly maintained or operated by the United
States or by any of its departments, officers, or agencies; and
(D)
an outpatient setting accredited by either the Joint Commission
on Accreditation of Healthcare Organizations relating to ambulatory surgical
centers, the American Association for the Accreditation of Ambulatory Surgery
Facilities, or the Accreditation Association for Ambulatory Health Care.
(6)
Board - The Texas State Board of Medical Examiners.
(7)
Physician - A person licensed by the Texas State Board
of Medical Examiners as a medical doctor or doctor of osteopathic medicine
who diagnoses, treats, or offers to treat any disease or disorder, mental
or physical, or any physical deformity or injury by any system or method or
effects cures thereof and charges therefor, directly or indirectly, money
or other compensation. "Physician" and "surgeon" shall be construed as synonymous.
§192.2.Provision of Anesthesia in Outpatient Settings.
(a)
The purpose of these rules is to identify the roles and
responsibilities of physicians providing, or overseeing by proper delegation,
anesthesia services in outpatient settings and to provide the minimum acceptable
standards for the provision of anesthesia services in outpatient settings.
(b)
Beginning September 1, 2000, physicians shall comply with
the rules promulgated under this title in order to be authorized to provide
general anesthesia, regional anesthesia, or monitored anesthesia care in outpatient
settings.
(c)
The rules promulgated under this title do not apply to
physicians who practice in the following settings listed in paragraphs (1)-(8)
of this subsection:
(1)
an outpatient setting in which only local anesthesia, peripheral
nerve blocks, or both are used;
(2)
an outpatient setting in which only anxiolytics and
analgesics are used and only in doses that do not have the significant probability
of placing the patient at risk for loss of the patient's life-preserving protective
reflexes;
(3)
a licensed hospital, including an outpatient facility
of the hospital that is separately located apart from the hospital;
(4)
a licensed ambulatory surgical center;
(5)
a clinic located on land recognized as tribal land
by the federal government and maintained or operated by a federally recognized
Indian tribe or tribal organization as listed by the United States secretary
of the interior under 25 U.S.C. §479-1 or as listed under a successor
federal statute or regulation;
(6)
a facility maintained or operated by a state or governmental
entity;
(7)
a clinic directly maintained or operated by the United
States or by any of its departments, officers, or agencies; and
(8)
an outpatient setting accredited by:
(A)
the Joint Commission on Accreditation of Healthcare Organizations
relating to ambulatory surgical centers;
(B)
the American Association for the Accreditation of Ambulatory
Surgery Facilities; or
(C)
the Accreditation Association for Ambulatory Health Care.
(d)
Physicians who practice medicine in this state and who
administer anesthesia or perform a surgical procedure for which anesthesia
services are provided in an outpatient settings shall follow current, applicable
standards and guidelines as put forth by the American Society of Anesthesiologists
(ASA) including, but not limited to, the following listed in paragraphs (1)-(8)
of this subsection:
(1)
Basic Standards for Preanesthesia Care;
(2)
Standards for Basic Anesthetic Monitoring;
(3)
Standards for Postanesthesia Care;
(4)
Position on Monitored Anesthesia Care;
(5)
The ASA Physical Status Classification System;
(6)
Guidelines for Nonoperating Room Anesthetizing Locations;
(7)
Guidelines for Ambulatory Anesthesia and Surgery;
and
(8)
Guidelines for Office-Based Anesthesia.
(e)
A physician delegating the provision of anesthesia or anesthesia-related
services to a certified registered nurse anesthetist shall be in compliance
with ASA standards and guidelines when the certified registered nurse anesthetist
provides a service specified in the ASA standards and guidelines to be provided
by an anesthesiologist.
(f)
In an outpatient setting, where a physician has delegated
to a certified registered nurse anesthetist the ordering of drugs and devices
necessary for the nurse anesthetist to administer an anesthetic or an anesthesia-related
service ordered by a physician, a certified registered nurse anesthetist may
select, obtain and administer drugs, including determination of appropriate
dosages, techniques and medical devices for their administration and in maintaining
the patient in sound physiologic status. This order need not be drug-specific,
dosage specific, or administration-technique specific. Pursuant to a physician's
order for anesthesia or an anesthesia-related service, the certified registered
nurse anesthetist may order anesthesia-related medications during perianesthesia
periods in the preparation for or recovery from anesthesia. In providing anesthesia
or an anesthesia-related service, the certified registered nurse anesthetist
shall select, order, obtain and administer drugs which fall within categories
of drugs generally utilized for anesthesia or anesthesia-related services
and provide the concomitant care required to maintain the patient in sound
physiologic status during those experiences.
(g)
The anesthesiologist or physician providing anesthesia
or anesthesia-related services in an outpatient setting shall perform a pre-anesthetic
evaluation, counsel the patient, and prepare the patient for anesthesia per
current ASA standards. If the physician has delegated the provision of anesthesia
or anesthesia-related services to a CRNA, the CRNA may perform those services
within the scope of practice of the CRNA. Informed consent for the planned
anesthetic intervention shall be obtained from the patient/legal guardian
and maintained as part of the medical record. The consent must include explanation
of the technique, expected results, and potential risks/complications. Appropriate
pre-anesthesia diagnostic testing and consults shall be obtained per indications
and assessment findings. Pre-anesthetic diagnostic testing and specialist
consultation should be obtained as indicated by the pre-anesthetic evaluation
by the anesthesiologist or suggested by the nurse anesthetist's pre-anesthetic
assessment as reviewed by the surgeon. If responsibility for a patient's care
is to be shared with other physicians or non-physician anesthesia providers,
this arrangement should be explained to the patient.
(h)
Physiologic monitoring of the patient shall be determined
by the type of anesthesia and individual patient needs. Minimum monitoring
shall include continuous monitoring of ventilation, oxygenation, and cardiovascular
status. Monitors shall include, but not be limited to, pulse oximetry and
EKG continuously and non-invasive blood pressure to be measured at least every
five minutes. If general anesthesia is utilized, then an O2 analyzer and end-tidal
CO2 analyzer must also be used. A means to measure temperature shall be readily
available and utilized for continuous monitoring when indicated per current
ASA standards. An audible signal alarm device capable of detecting disconnection
of any component of the breathing system shall be utilized. The patient shall
be monitored continuously throughout the duration of the procedure. Postoperatively,
the patient shall be evaluated by continuous monitoring and clinical observation
until stable by a licensed health care provider. Monitoring and observations
shall be documented per current ASA standards. In the event of an electrical
outage which disrupts the capability to continuously monitor all specified
patient parameters, at a minimum, heart rate and breath sounds will be monitored
on a continuous basis using a precordial stethoscope or similar device, and
blood pressure measurements will be reestablished using a non-electrical blood
pressure measuring device until electricity is restored. There should be in
each location, sufficient electrical outlets to satisfy anesthesia machine
and monitoring equipment requirements, including clearly labeled outlets connected
to an emergency power supply. A two-way communication source not dependent
on electrical current shall be available. Sites shall also have a secondary
power source as appropriate for equipment in use in case of power failure.
(i)
All anesthesia-related equipment and monitors shall be
maintained to current operating room standards. All devices shall have regular
service/maintenance checks at least annually or per manufacturer recommendations.
Service/maintenance checks shall be performed by appropriately qualified biomedical
personnel. Prior to the administration of anesthesia, all equipment/monitors
shall be checked using the current FDA recommendations as a guideline. Records
of equipment checks shall be maintained in a separate, dedicated log which
must be made available upon request. Documentation of any criteria deemed
to be substandard shall include a clear description of the problem and the
intervention. If equipment is utilized despite the problem, documentation
must clearly indicate that patient safety is not in jeopardy. All documentation
relating to equipment shall be maintained for seven years or for a period
of time as determined by the board.
(j)
Each location must have emergency supplies immediately
available. Supplies should include emergency drugs and equipment appropriate
for the purpose of cardiopulmonary resuscitation. This must include a defibrillator,
difficult airway equipment, and drugs and equipment necessary for the treatment
of malignant hyperthermia if "triggering agents" associated with malignant
hyperthermia are used or if the patient is at risk for malignant hyperthermia.
Equipment shall be appropriately sized for the patient population being served.
Resources for determining appropriate drug dosages shall be readily available.
The emergency supplies shall be maintained and inspected by qualified personnel
for presence and function of all appropriate equipment and drugs at intervals
established by protocol to ensure that equipment is functional and present,
drugs are not expired, and office personnel are familiar with equipment and
supplies. Records of emergency supply checks shall be maintained in a separate,
dedicated log and made available upon request. Records of emergency supply
checks shall be maintained for seven years or for a period of time as determined
by the board.
(k)
The operating surgeon shall verify that the appropriate
policies or procedures are in place. Policies, procedure, or protocols shall
be evaluated and reviewed at least annually. Agreements with local emergency
medical service (EMS) shall be in place for purposes of transfer of patients
to the hospital in case of an emergency. EMS agreements shall be evaluated
and re-signed at least annually. Policies, procedure, and transfer agreements
shall be kept on file in the setting where procedures are performed and shall
be made available upon request. Policies or procedures must include, but are
not limited to the following listed in paragraphs (1)-(2) of this subsection:
(1)
Management of outpatient anesthesia. At a minimum, these
must address:
(A)
patient selection criteria;
(B)
patients/providers with latex allergy;
(C)
pediatric drug dosage calculations, where applicable;
(D)
ACLS (advanced cardiac life support) or PALS (pediatric
advanced life support) algorithms;
(E)
infection control;
(F)
documentation and tracking use of pharmaceuticals, including
controlled substances, expired drugs and wasting of drugs; and
(G)
discharge criteria.
(2)
Management of emergencies. At a minimum, these
must include, but not be limited to:
(A)
cardiopulmonary emergencies;
(B)
fire;
(C)
bomb threat;
(D)
chemical spill; and
(E)
natural disasters.
(l)
Operating surgeons or anesthesiologists shall maintain
current competency in ACLS, PALS, or a course approved by the board. In all
settings under these rules, at a minimum, at least two persons, including
the surgeon or anesthesiologist, shall maintain current competency in basic
life support.
(m)
Physicians or surgeons must notify the board in writing
within 15 days if a procedure performed in any of the settings under these
rules resulted in an unanticipated and unplanned transport of the patient
to a hospital for observation or treatment for a period in excess of 24 hours,
or a patient's death intraoperatively or within the immediate postoperative
period. Immediate postoperative period is defined as 72 hours.
§192.3.Compliance with Office-Based Anesthesia Rules.
(a)
On or after August 31, 2000, a physician who practices
medicine in this state and who administers anesthesia or performs a surgical
procedure for which anesthesia services are provided in an outpatient setting
shall comply with the rules adopted under this title.
(b)
The board may require a physician to submit and comply
with a corrective action plan to remedy or address any current or potential
deficiencies with the physician's provision of anesthesia in a outpatient
setting in accordance with the Medical Practice Act, Article 4495b, Texas
Revised Civil Statutes, or rules of the board.
(c)
Any physician who violates these rules shall be subject
to disciplinary action and/or termination of the registration issued by the
board as authorized by the Medical Practice Act, Article 4495b, Texas Revised
Civil Statutes.
§192.4.Annual Registration.
(a)
Beginning September 1, 2000, the board shall require each
physician who administers anesthesia or performs a surgical procedure for
which anesthesia services are provided in an outpatient setting to annually
register with the board on a form prescribed by the board and to pay a fee
to the board in an amount established by the board.
(b)
The board shall coordinate the registration required under
this section with the registration required under the Medical Practice Act,
Article 4495b, Texas Revised Civil Statutes, §3.01, so that the times
of registration, payment, notice, and imposition of penalties for late payment
are similar and provide a minimum of administrative burden to the board and
to physicians.
§192.5.Inspections.
(a)
The board may conduct inspections to enforce these rules,
including inspections of an office site and of documents of a physician's
practice that relate to the provision of anesthesia in an outpatient setting.
The board may contract with another state agency or qualified person to conduct
these inspections.
(b)
Unless it would jeopardize an ongoing investigation, the
board shall provide at least five business days' notice before conducting
an on-site inspection under this section. (c) This section does not require
the board to make an on-site inspection of a physician's office.
§192.6.Requests for Inspection and Advisory Opinion.
(a)
The board may consider a request by a physician for an
on-site inspection. The board may, in its discretion and on payment of a fee
in an amount established by the board, conduct the inspection and issue an
advisory opinion.
(b)
An advisory opinion issued by the board under this section
is no binding on the board, and the board, except as provided by subsection
(c) of this section, may take any action under the Medical Practice Act, Article
4495b, Texas Revised Civil Statutes, in relation to the situation addressed
by the advisory opinion that the board considers appropriate.
(c)
A physician who requests and relies on an advisory opinion
of the board may use the opinion as mitigating evidence in an action or proceeding
to impose an administrative or civil penalty under the Medical Practice Act,
Article 4495b, Texas Revised Civil Statutes. The board or court, as appropriate,
shall take proof of reliance on an advisory opinion into consideration and
mitigate the imposition of administrative or civil penalties accordingly.
Filed with the Office
of the Secretary of State, on February 14, 2000.
TRD-200001179
Bruce A. Levy, M.D., J.D.
Executive Director
Texas State Board of Medical Examiners
Effective date: February 14, 2000
Expiration date: June 13, 2000
For further information, please call: (512) 305-7016