(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.
Cont'd...
(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.

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