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(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.
(j) 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. Operating surgeons
are responsible for verifying the level of advanced life support services
the local, county-based emergency medical service (EMS) providers
are licensed to provide. Operating surgeons who do not practice in
counties with 9-1-1 service entities supported by EMS providers licensed
at the advanced life support (ALS) level must enter into agreements
with a local licensed EMS provider or accredited hospital-based EMS
for purposes of transfer of patients to the hospital in case of an
emergency. The EMS agreements must include terms delineating requirements
and responsibilities for advanced life support services, including,
but not limited to advanced airway management, and at a minimum must
provide that the EMS provider or hospital-based EMS bring staff and
equipment necessary for advanced airway management equal to or exceeding
that which is in place at the surgeon's office. The EMS agreements
shall be evaluated and re-signed at least annually. Regardless of
the level of advanced life support services furnished by EMS providers,
the operating surgeon is responsible for having appropriate advanced
life support measures available in the office, sufficient to rescue
and stabilize the patient until EMS arrives. 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 include written policies, procedures, or protocols that
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 life-threatening emergencies. At
a minimum, these must include, but not be limited to:
(A) cardiopulmonary emergencies, which must include
at a minimum a specific plan for securing a patient's airway pending
EMS transfer to the hospital;
(B) fire;
(C) bomb threat;
(D) chemical spill; and
(E) natural disasters.
(k) An anesthesia provider must perform a presedation
assessment of each patient having anesthesia services. The assessment
must include, at a minimum:
(1) an airway evaluation; and
(2) an ASA physical status classification.
(l) All equipment and anesthesia-related services must
remain available at the office-based anesthesia site until the patient
is discharged.
(m) Physicians or surgeons must notify the board in
writing within 15 days if a procedure performed in any of the settings
under this chapter resulted in:
(1) an unanticipated and unplanned transport of the
patient to a hospital for observation or treatment for a period in
excess of 24 hours;
(2) an intraoperative death;
(3) a death occurring within the first 24 hours of
the postoperative time period.
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| Source Note: The provisions of this §192.2 adopted to be effective May 21, 2000, 25 TexReg 4350; amended to be effective November 30, 2003, 28 TexReg 10498; amended to be effective June 29, 2006, 31 TexReg 5107; amended to be effective January 20, 2009, 34 TexReg 342; amended to be effective May 2, 2010, 35 TexReg 3281; amended to be effective May 15, 2012, 37 TexReg 3583; amended to be effective March 18, 2013, 38 TexReg 1875; amended to be effective January 23, 2014, 39 TexReg 290; amended to be effective March 16, 2015, 40 TexReg 1380 |
