| (a) General Standards. When providing or delegating
anesthesia services in an outpatient setting, physicians must ensure:
(1) compliance with delegation and supervision laws
under Chapter 157 of the Act, including §157.058, regarding CRNAs;
(2) counseling and preparing patients for anesthesia
per ASA standards;
(3) performing:
(A) a pre-anesthetic evaluation; and
(B) a pre-sedation evaluation, that includes at a minimum
an airway evaluation and an ASA physical status classification;
(4) obtaining informed consent in accordance with state
law, which includes communicating with the patient any sharing of
responsibility for a patient's care with other physicians or non-physician
anesthesia providers; and
(5) providing continuous appropriate physiologic monitoring
of the patient, determined by the type of anesthesia and individual
patient needs, both during and post procedure until ready for discharge,
with continuous monitoring of:
(A) ventilation,
(B) oxygenation; and
(C) cardiovascular status.
(b) Minimum Equipment Requirements and Standards.
(1) Minimum equipment required. The outpatient setting
must have the following equipment and drugs onsite for the handling
of emergencies:
(A) monitoring equipment for Level II through Level
IV procedures:
(i) pulse oximetry;
(ii) continuous EKG;
(iii) non-invasive blood pressure measured at least
every five minutes; and
(iv) if deep sedation or general anesthesia is utilized,
an end-tidal CO2 analyzer;
(v) if general anesthesia utilizing a closed circuit,
an O2 analyzer;
(B) appropriate intravenous therapy equipment;
(C) a precordial stethoscope or similar device, and
non-electrical blood pressure measuring device, for use in the event
of an electrical outage;
(D) emergency equipment appropriate for the purpose
of cardiopulmonary resuscitation;
(E) AED or other defibrillator, difficult airway equipment,
as well as the drugs and equipment necessary for the treatment of
malignant hyperthermia, if using triggering agents associated with
malignant hyperthermia or if the patient is at risk for malignant
hyperthermia; and
(F) a means to measure temperature, which shall be
readily available and utilized for continuous monitoring when indicated
per current ASA standards.
(2) Equipment Standards.
(A) Equipment must be appropriately sized for the patient
population being served.
(B) All anesthesia-related equipment and monitors must
be maintained to current operating room standards.
(C) Regular service or maintenance checks must be completed
by appropriately qualified biomedical personnel, at least annually
or per manufacturer recommendations.
(D) A separate equipment maintenance log must contain:
(i) service check information including date performed;
(ii) a clear description of any equipment problems
and the corrective action; and
(iii) if substandard equipment was utilized without
corrective action, a description of how patient safety was protected.
(E) The equipment maintenance log must be retained
for seven years from the date of inspection.
(F) An audible signal alarm device capable of detecting
disconnection of any component of the breathing system shall be utilized.
(3) Emergency Supplies.
(A) All required emergency supplies must be maintained
and inspected by qualified personnel for presence and proper function
intervals established by protocol.
(B) All medication, drugs, and supplies must not be
expired.
(C) Personnel must be trained on the use of emergency
equipment and supplies.
(D) A separate emergency supply log must include dates
of inspections. The log must be retained for seven years from the
date of inspection.
(4) Emergency Power Supply and Communication Source.
(A) Outpatient settings must have a secondary power
source as appropriate for equipment in use, in case of power failure.
(B) A two-way communication source not dependent on
electrical current shall be available.
(5) Protocols.
(A) The outpatient setting must have written protocols
regarding:
(i) patient selection criteria;
(ii) patients or providers with latex allergy;
(iii) pediatric drug dosage calculations, where applicable;
(iv) ACLS or PALS algorithms;
(v) infection control;
(vi) documentation and tracking use of pharmaceuticals,
including controlled substances, expired drugs and wasting of drugs;
and
(vii) discharge criteria.
(B) The outpatient setting must have written protocols
regarding emergency transfer procedures for cardiopulmonary emergencies
that include:
(i) a specific plan for securing a patient's airway
pending EMS transfer to the hospital; and
(ii) have appropriate ACLS algorithms available in
the office to assist with patient stabilization until EMS arrives.
(C) For outpatient settings that are located in counties
lacking 9-1-1 service entities supported by EMS providers licensed
at the advanced life support level, physicians must enter into emergency
transfer agreements with a local licensed EMS provider or accredited
hospital-based EMS. The agreement's terms must require EMS to bring
staff and equipment necessary for advanced airway management equal
to or exceeding that which is in place at the outpatient setting.
(D) The written protocols, including the emergency
transfer agreements, must be evaluated and reviewed at least annually.
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