Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 135 - AMBULATORY SURGICAL CENTERS
Subchapter A - OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
Section 135.11 - Anesthesia and Surgical Services
Universal Citation: 25 TX Admin Code ยง 135.11
Current through Reg. 49, No. 38; September 20, 2024
(a) Anesthesia services.
(1) Anesthesia services
provided in the ambulatory surgical center (ASC) shall be limited to those that
are approved by the governing body, which may include the following.
(A) Topical anesthesia--An anesthetic agent
applied directly or by spray to the skin or mucous membranes, intended to
produce transient and reversible loss of sensation to the circumscribed
area.
(B) Local
anesthesia--Administration of an agent that produces a transient and reversible
loss of sensation to a circumscribed portion of the body.
(C) Regional anesthesia--Anesthetic injected
around a single nerve, a network of nerves, or vein that serves the area
involved in a surgical procedure to block pain.
(D) Minimal sedation (anxiolysis)--A
drug-induced state during which patients respond normally to verbal commands.
Although cognitive function and coordination may be impaired, ventilatory and
cardiovascular functions are unaffected.
(E) Moderate sedation/analgesia ("conscious
sedation")--A drug-induced depression of consciousness during which patients
respond purposefully to verbal commands, either alone or accompanied by light
tactile stimulation. No interventions are required to maintain a patent airway,
and spontaneous ventilation is adequate. Cardiovascular function is usually
maintained. (Reflex withdrawal from a painful stimulus is NOT considered a
purposeful response.)
(F) Deep
sedation/analgesia--A drug-induced depression of consciousness during which
patients cannot be easily aroused but respond purposefully following repeated
or painful stimulation. The ability to independently maintain ventilatory
function may be impaired. Patients may require assistance in maintaining a
patent airway, and spontaneous ventilation may be inadequate. Cardiovascular
function is usually maintained. (Reflex withdrawal from a painful stimulus is
NOT considered a purposeful response.)
(G) General anesthesia--A drug-induced loss
of consciousness during which patients are not arousable, even by painful
stimulation. The ability to independently maintain ventilatory function is
often impaired. Patients often require assistance in maintaining a patent
airway, and positive pressure ventilation may be required because of depressed
spontaneous ventilation or drug-induced depression of neuromuscular function.
Cardiovascular function may be impaired.
(2) The anesthesia department shall be under
the medical direction of a physician approved by the governing body upon the
recommendation of the ASC medical staff.
(3) The medical staff shall develop written
policies and practice guidelines for the anesthesia service, which shall be
approved, implemented and enforced by the governing body. The policies and
guidelines shall include consideration of the applicable practice standards and
guidelines of the American Society of Anesthesiologists, the American
Association of Nurse Anesthetists, and the licensing rules and standards
applicable to those categories of licensed professionals qualified to
administer anesthesia.
(4) Only
personnel who have been approved by the facility to provide anesthesia services
shall administer anesthesia. All approvals or delegations of anesthesia
services as authorized by law shall be documented and include the training,
experience, and qualifications of the person who provided the service. A
qualified registered nurse (RN) who is not a certified registered nurse
anesthetist (CRNA), in accordance with the orders of the operating surgeon,
anesthesiologist, or CRNA, may administer topical anesthesia, local anesthesia,
minimal sedation and moderate sedation, in accordance with all applicable
rules, polices, directives and guidelines issued by the Texas Board of Nursing.
When an RN who is not a CRNA administers sedation, as permitted in this
paragraph, the facility shall:
(A) verify
that the registered nurse has the requisite training, education, and
experience;
(B) maintain
documentation to support that the registered nurse has demonstrated competency
in the administration of sedation;
(C) with input from the facility's qualified
anesthesia providers, develop, implement and enforce detailed, written policies
and procedures to guide the registered nurse; and
(D) ensure that, when administering sedation
during a procedure, the registered nurse has no other duties except to monitor
the patient.
(5)
Anesthesia shall not be administered unless the operating surgeon has evaluated
the patient immediately prior to the procedure to assess the risk of the
anesthesia and of the procedure to be performed.
(6) The advanced practice registered nurse,
the anesthesiologist, or the operating surgeon shall be available until all of
his or her patients operated on that day have been discharged from the
postanesthesia care unit.
(7)
Patients who have received anesthesia shall be evaluated for proper anesthesia
recovery by the operating surgeon or the person administering the anesthesia
prior to discharge from the postanesthesia care unit using criteria approved by
the medical staff.
(8) Patients who
remain in the facility for extended observation following discharge from the
postanesthesia care unit shall be evaluated immediately prior to leaving the
facility by a physician, the person administering the anesthesia, or a
registered nurse acting in accordance with physician's orders and written
policies, procedures, and criteria developed by the medical staff.
(9) A physician shall be on call and able to
respond physically or by telephone within 30 minutes until all patients have
been discharged from the ASC.
(10)
Emergency equipment and supplies appropriate for the type of anesthesia
services provided shall be maintained and accessible to staff at all times.
(A) Functioning equipment and supplies which
are required for all facilities include:
(i)
suctioning equipment, including a source of suction and suction catheters in
appropriate sizes for the population being served;
(ii) source of compressed oxygen;
(iii) basic airway management equipment,
including oral and nasal airways, face masks, and self-inflating breathing bag
valve set;
(iv) blood pressure
monitoring equipment; and
(v)
emergency medications specified by the medical staff and appropriate to the
type of surgical procedures and anesthesia services provided by the
facility.
(B) In
addition to the equipment and supplies required under subparagraph (A) of this
paragraph, facilities which provide moderate sedation/analgesia, deep
sedation/analgesia, regional analgesia and/or general anesthesia shall provide
the following:
(i) intravenous equipment,
including catheters, tubing, fluids, dressing supplies, and appropriately sized
needles and syringes;
(ii) advanced
airway management equipment, including laryngoscopes and an assortment of
blades, endotracheal tubes and stylets in appropriate sizes for the population
being served;
(iii) a mechanism for
monitoring blood oxygenation, such as pulse oximetry;
(iv) electrocardiographic monitoring
equipment;
(v)
cardiovertor-defibrillator; and
(vi) pharmacologic antagonists as specified
by the medical staff and appropriate to the type of anesthesia services
provided.
(b) Surgical services.
(1) Surgical procedures performed in the ASC
shall be limited to those procedures that are approved by the governing body
upon the recommendation of qualified medical personnel.
(2) Adequate supervision of surgery conducted
in the ASC shall be a responsibility of the governing body, shall be
recommended by qualified medical personnel, and shall be provided by
appropriate personnel.
(3) Surgical
procedures shall be performed only by health care practitioners who are
licensed to perform such procedures within Texas and who have been granted
privileges to perform those procedures by the governing body of the ASC, upon
the recommendation of qualified medical personnel and after medical review of
the practitioner's documented education, training, experience, and current
competence.
(4) Surgical procedures
to be performed in the ASC shall be reviewed periodically as part of the peer
review portion of the ASC's quality assurance program.
(5) An appropriate history, physical
examination, and pertinent preoperative diagnostic studies shall be
incorporated into the patient's medical record prior to surgery.
(6) The necessity or appropriateness of the
proposed surgery, as well as any available alternative treatment techniques,
shall be discussed with the patient prior to scheduling the patient for
surgery.
(7) Licensed nurses and
other personnel assisting in the provision of surgical services shall be
appropriately trained and supervised and shall be available in sufficient
numbers for the surgical care provided.
(8) Each operating room shall be designed and
equipped so that the types of surgery conducted can be performed in a manner
that protects the lives and assures the physical safety of all persons in the
area.
(A) If flammable agents are present in
an operating room the room shall be constructed and equipped in compliance with
standards established by the National Fire Protection Association (NFPA 99,
Annex 2, Flammable Anesthetizing Locations, 1999) and with applicable state and
local fire codes.
(B) If
nonflammable agents are present in an operating room the room shall be
constructed and equipped in compliance with standards established by the
National Fire Protection Association (NFPA 99, Chapters 4 and 8, 1999) and with
applicable state and local fire codes.
(9) With the exception of those tissues
exempted by the governing body after medical review, tissues removed during
surgery shall be examined by a pathologist, whose signed report of the
examination shall be made a part of the patient's medical record.
(10) A description of the findings and
techniques of an operation shall be accurately and completely written or
dictated immediately after the procedure by the health care practitioner who
performed the operation. If the description is dictated, an accurate written
summary shall be immediately available to the health care practitioners
providing patient care and shall become part of the patient's medical record.
Refer to §
135.9(p)
of this title (relating to Medical Records).
(11) A safe environment for treating surgical
patients, including adequate safeguards to protect the patient from cross
infection, shall be assured through the provision of adequate space, equipment,
and personnel.
(A) Provisions shall be made
for the isolation or immediate transfer of patients with communicable
diseases.
(B) All persons entering
operating rooms shall be properly attired.
(C) Acceptable aseptic techniques shall be
used by all persons in the surgical area.
(D) Only authorized persons shall be allowed
in the surgical area.
(E) Suitable
equipment for rapid and routine sterilization shall be available to assure that
operating room materials are sterile.
(F) Environmental controls shall be
implemented to assure a safe and sanitary environment.
(G) Operating rooms shall be appropriately
cleaned before each operation.
(12) Written policies and procedures for
decontamination, disinfection, sterilization, and storage of sterile supplies
shall be developed, implemented and enforced. Policies shall include, but not
be limited to, the receiving, cleaning, decontaminating, disinfecting,
preparing, and sterilization of critical items (reusable items), as well as for
the assembly, wrapping, storage, distribution, and the monitoring and control
of sterile items and equipment.
(A) Policies
and procedures shall be developed following standards, guidelines, and
recommendations issued by the Association of periOperative Registered Nurses
(AORN), the Association for Professionals in Infection Control and Epidemiology
(APIC), the Centers for Disease Control and Prevention (CDC) and, if
applicable, the Society of Gastroenterology Nurses and Associates (SGNA).
Standards, guidelines, and recommendations of these organizations are available
for review at the Department of State Health Services, Exchange Building, 8407
Wall Street, Austin, Texas. Copies may also be obtained directly from each
organization, as follows: AORN, 2170 South Parker Road, Suite 300, Denver
Colorado, 80231, (800) 755-2676; APIC, 1275 K Street, Northwest, Suite 1000,
Washington, District of Columbia, 20005-4006, (202) 789-1890; CDC, 1600 Clifton
Road, Atlanta, Georgia, 30333, (800) 311-3435; SGNA, 401 North Michigan Avenue,
Chicago, Illinois, 60611-4267, (312) 321-5165.
(B) Policies and procedures shall also
address proper use of external chemical indicators and biological
indicators.
(C) Performance records
for all sterilizers shall be maintained for a period of six months.
(D) Preventive maintenance of all sterilizers
shall be completed according to manufacturer's recommendations on a scheduled
basis. A preventive maintenance record shall be maintained for each sterilizer.
These records shall be retained at least one year and shall be available for
review to the facility within two hours of request by the department.
(13) Emergency power adequate for
the type of surgery performed shall be available in the operative and
postoperative recovery areas.
(14)
Periodic calibration and/or preventive maintenance of all equipment shall be
provided in accordance with manufacturer's guidelines.
(15) The informed consent of the patient or,
if applicable, of the patient's legal representative shall be obtained before
an operation is performed.
(16) A
written procedure shall be established for observation and care of the patient
during the preoperative preparation and postoperative recovery
period.
(17) Written protocols
shall be established for instructing patients in self-care after surgery,
including written instructions to be given to patients who receive conscious
sedation, regional, and general anesthesia.
(18) Patients who have received anesthesia
shall only be allowed to leave the facility in the company of a responsible
adult, unless the operating surgeon or an advanced practice registered nurse
writes an order that the patient may leave without the company of a responsible
adult.
(19) An effective written
procedure for the immediate transfer to a hospital of patients requiring
emergency care beyond the capabilities of the ASC shall be developed. The ASC
shall have a written transfer agreement with a hospital, or all physicians on
staff at the ASC shall have admitting privileges at a local hospital.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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