| (a) The purpose of this chapter 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) The rules promulgated under this title do not apply
to:
(1) an outpatient setting in which only local anesthesia,
peripheral nerve blocks, or both are used in a total dosage amount
that does not exceed 50 percent of the recommended maximum safe dosage
per outpatient visit;
(2) any setting physically located outside the State
of Texas;
(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;
(8) an outpatient setting where the facility itself
is accredited as an office-based surgery facility or treatment room
by:
(A) The Joint Commission relating to ambulatory surgical
centers;
(B) the American Association for Accreditation of Ambulatory
Surgery Facilities; or
(C) the Accreditation Association for Ambulatory Health
Care; and
(9) the performance of Mohs micrographic surgery.
(c) Standards for Anesthesia Services. The following
standards are required for outpatient settings providing anesthesia
services that are administered within two hours before an outpatient
procedure. If personnel and equipment meet the requirements of a higher
level, lower level anesthesia services may also be provided.
(1) Level I services:
(A) at least two personnel must be present, including
the physician who must be currently certified by AHA or ASHI, at a
minimum, in BLS; and
(B) the following age-appropriate equipment must be
present:
(i) bag mask valve; and
(ii) oxygen.
(2) Level II services:
(A) at least two personnel must be present, including
the physician who must be currently certified by AHA or ASHI, at a
minimum, in ACLS or PALS, as appropriate;
(i) another person must be currently certified by AHA
or ASHI, at a minimum, in BLS; and
(ii) a licensed health care provider, who may be one
of the two required personnel, must attend the patient, until the
patient is ready for discharge; and
(B) a crash cart must be present containing drugs and
equipment necessary to carry out ACLS protocols, including, but not
limited to, the following age-appropriate equipment:
(i) bag mask valve and appropriate airway maintenance
devices;
(ii) oxygen;
(iii) AED or other defibrillator;
(iv) pre-measured doses of first line cardiac medications,
including epinephrine, atropine, adreno-corticoids, and antihistamines;
(v) IV equipment;
(vi) pulse oximeter;
(vii) EKG Monitor;
(viii) benzodiazepines for intravenous or intramuscular
administration; and lipid emulsion if, (except as provided by subsection
(b)(9) of this section) administering local anesthesia, peripheral
nerve blocks, or both in a total dosage amount that exceeds 50 percent
of the recommended maximum safe dosage per outpatient visit, or if
administering tumescent anesthesia, for treating local anesthetic
systemic toxicity; and
(ix) specific reversal agents, Flumazenil and Naloxone,
if benzodiazepines or narcotics are used for sedation.
(3) Level III services:
(A) at least two personnel must be present, including
the physician who must be currently certified by AHA or ASHI, at a
minimum, in ACLS or PALS, as appropriate;
(i) another person must be currently certified by AHA
or ASHI, at a minimum, in BLS;
(ii) a licensed health care provider, which may be
either of the two required personnel, must attend the patient, until
the patient is ready for discharge; and
(iii) a person, who may be either of the two required
personnel, must be responsible for monitoring the patient during the
procedure; and
(B) except for lipid emulsion, the same drugs and equipment
required for Level II;
(C) establishment of a working intravenous feed;
(D) the presence of appropriate antagonists (i.e. Naloxone
and Flumazenil); and
(E) adherence to ASA Standards for Postanesthesia Care.
(4) Level IV services: Physicians who practice medicine
in this state and who administer anesthesia or perform a procedure
for which anesthesia services are provided in outpatient settings
at Level IV are not required to stock lipid emulsion. Physicians who
practice medicine in this state and who administer anesthesia or perform
a procedure for which anesthesia services are provided in outpatient
settings at Level IV 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 subparagraphs
(A) - (H) of this paragraph:
(A) Basic Standards for Preanesthesia Care;
(B) Standards for Basic Anesthetic Monitoring;
(C) Standards for Postanesthesia Care;
(D) Position on Monitored Anesthesia Care;
(E) The ASA Physical Status Classification System;
(F) Guidelines for Nonoperating Room Anesthetizing
Locations;
(G) Guidelines for Ambulatory Anesthesia and Surgery;
and
(H) Guidelines for Office-Based Anesthesia.
(d) 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.
(e) 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.
(f) 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.
(g) 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.
(h) 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.
(i) Each location must have emergency supplies immediately
available as required by subsection (c) of this section. Supplies
should include emergency drugs and equipment appropriate for the purpose
of cardiopulmonary resuscitation. If, (except as provided by subsection
(b)(9) of this section) administering local anesthesia, peripheral
nerve blocks, or both in a total dosage amount that exceeds 50 percent
of the recommended maximum safe dosage per outpatient visit, or if
administering tumescent anesthesia, emergency drugs and equipment
maintained at the location must include at a minimum lipid emulsion
for treating local anesthetic systemic toxicity. If "triggering agents"
associated with malignant hyperthermia are used or if the patient
is at risk for malignant hyperthermia, required equipment must include
a defibrillator, difficult airway equipment, as well as the medication
and equipment necessary for the treatment of 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.
Cont'd... |
