SECTION 221.16. Provision of Anesthesia Services by Nurse Anesthetists in Outpatient Settings

(a) Purpose. The purpose of these rules is to identify the roles, and responsibilities of certified registered nurse anesthetists authorized to provide anesthesia services in outpatient settings and to provide the minimum acceptable standards for the provision of anesthesia services in outpatient settings.

(1) On or after August 31, 2000 certified registered nurse anesthetists shall comply with subsections (b)(2)-(e) of this section in order to be authorized to provide general anesthesia, regional anesthesia, or monitored anesthesia care in outpatient settings. This requirement shall include certified registered nurse anesthetists administering any inhaled anesthetic agents, including, but not limited to, nitrous oxide, due to the significant variability in patient response to such drugs.

(2) Subsections (b)(2)-(e) of this section do not apply to the registered nurse anesthetist who practices in the following:

(A) an outpatient setting in which only local anesthesia, peripheral nerve blocks, or both are used;

(B) an outpatient setting in which only anxiolytics and analgesics are used and only in doses that do not have the probability of placing the patient at risk for loss of the patient's life-preserving protective reflexes;

(C) a licensed hospital, including an outpatient facility of the hospital that is separately located apart from the hospital;

(D) a licensed ambulatory surgical center;

(E) 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. Section 479-1 or as listed under a successor federal statute or regulation

(F) a facility maintained or operated by a state or governmental entity;

(G) a clinic directly maintained or operated by the United States or by any of its departments, officers, or agencies; and

(H) an outpatient setting accredited by

(i) the Joint Commission on Accreditation of Healthcare Organizations relating to ambulatory surgical centers;

(ii) the American Association for the Accreditation of Ambulatory Surgery Facilities,

(iii) the Accreditation Association for Ambulatory Health Care.

(b) Roles and Responsibilities

(1) Certified registered nurse anesthetists shall follow current, applicable standards and guidelines as put forth by the American Association of Nurse Anesthetists (AANA) and other relevant national standards regarding the practice of nurse anesthesia as adopted by the AANA or the Board.

(2) Certified registered nurse anesthetists shall comply with all building, fire, and safety codes. A two-way communication source not dependent on electrical current shall be available. Each location should have sufficient electrical outlets to satisfy anesthesia machine and monitoring equipment requirements, including clearly labeled outlets connected to an emergency power supply. Sites shall also have a secondary power source as appropriate for equipment in use in case of power failure.

(3) 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.

(c) Standards

(1) The certified registered nurse anesthetist shall perform a pre-anesthetic assessment, counsel the patient, and prepare the patient for anesthesia per current AANA standards. 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.

(2) 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 O ₂ 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 AANA 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 by the certified registered nurse anesthetist. 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 AANA 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.

(3) 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 a period of time as determined by board guidelines.

(4) 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 a period of time as determined by board guidelines.

(5) Certified registered nurse anesthetists shall maintain current competency in advanced cardiac life support and must demonstrate proof of continued competency upon re-registration with the Board. Competency in pediatric advanced life support shall be maintained for those certified registered nurse anesthetists whose practice includes pediatric patients. Certified registered nurse anesthetists shall verify that at least one person in the setting other than the person performing the operative procedure maintains current competency in basic life support (BLS) at a minimum.

(6) Certified registered nurse anesthetists shall verify that the appropriate policies or procedures are in place. Policies, procedures, 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, procedures, 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:

(A) Management of outpatient anesthesia-At a minimum, these must address:

(i) Patient selection criteria

(ii) Patients/providers with latex allergy

(iii) Pediatric drug dosage calculations, where applicable

(iv) ACLS algorithms

(v) Infection control

(vi) Documentation and tracking use of pharmaceuticals: including controlled substances, expired drugs and wasting of drugs

(vii) Discharge criteria

(B) Management of emergencies to include, but not be limited to:

(i) Cardiopulmonary emergencies

(ii) Fire

(iii) Bomb threat

(iv) Chemical spill

(v) Natural disasters

(vi) Power outage

(C) EMS response and transport--Delineation of responsibilities of the certified registered nurse anesthetist and person performing the procedure upon arrival of EMS personnel. This policy should be developed jointly with EMS personnel to allow for greater accuracy.

(D) Pursuant to §217.11(16) of this title (relating to Standards of Professional Nursing Practice), adverse reactions/events, including but not limited to those resulting in a patient's death intraoperatively or within the immediate postoperative period shall be reported in writing to the Board and other applicable agencies within 15 days. Immediate postoperative period shall be defined as 72 hours.

(d) Registration.

(1) Beginning April 1, 2000, each certified registered nurse anesthetist who intends to provide anesthesia services in an outpatient setting must register with the board and submit the required registration fee, which is non-refundable. The information provided on the registration form shall include, but not be limited to, the name and business address of each outpatient setting(s) and proof of current competency in advanced life support.

(2) Registration as an outpatient anesthesia provider must be renewed and the registration renewal fee paid on a biennial basis, at the time of registered nurse licensure renewal.

(e) Inspections and Advisory Opinions.

(1) The Board may conduct on-site inspections of outpatient settings, including inspections of the equipment owned or leased by a certified registered nurse anesthetist and of documents that relate to provision of anesthesia in an outpatient setting, for the purpose of enforcing compliance with the minimum standards. Inspections may be conducted as an audit to determine compliance with the minimum standards or in response to a complaint. The Board may contract with another state agency or qualified person to conduct these inspections. Unless it would jeopardize an ongoing investigation, the board shall provide the certified registered nurse anesthetist at least five business days' notice before conducting an on-site inspection.

(2) The Board may, at its discretion and on payment of a fee, conduct on-site inspections of outpatient settings in response to a request from a certified registered nurse anesthetist for an inspection and advisory opinion.

(A) The Board may require a certified registered nurse anesthetist to submit and comply with a corrective action plan to remedy or address current or potential deficiencies with the nurse anesthetist's provision of anesthesia in an outpatient setting.

(B) A certified registered nurse anesthetist who requests and relies on an advisory opinion of the board may use the opinion as mitigating evidence in an action or proceeding by the board to impose an administrative penalty or assess a monetary fine. The board shall take proof of reliance on an advisory opinion into consideration and mitigate the imposition of administrative penalties or the assessment of a monetary fine accordingly.

(C) An advisory opinion issued by the board is not binding on the board and the board except as provided for in subsection (a) of this section, may take any action in relation to the situation addressed by the advisory opinion that the Board considers appropriate.

Source Note: The provisions of this §221.16 adopted to be effective February 25, 2001, 26 TexReg 1509