| (a) Surgical procedures performed in the facility shall
be limited to those emergency procedures that are approved by the
governing body on the recommendation of medical staff.
(b) Adequate supervision of surgical procedures conducted
in the facility shall be a responsibility of the governing body, recommended
by medical staff, and provided by appropriate medical staff.
(c) Surgical procedures shall be performed only by
physicians, podiatrists, dentists, or other practitioners, who are
practicing within the scope of their license and education, who are
licensed to perform surgical procedures in Texas and who have been
granted privileges to perform those procedures by the governing body,
on the recommendation of the medical staff, and after medical review
of the physician's, podiatrist's, dentist's, or practitioner's documented
education, training, experience, and current competence.
(d) Surgical procedures to be performed in the facility
shall be reviewed periodically as part of the peer review portion
of the facility's quality assessment and performance improvement program.
(e) An appropriate history, physical examination, and
pertinent preoperative diagnostic studies shall be incorporated into
the patient's medical record before a surgical procedure.
(f) Unless otherwise provided by law, the necessity
or appropriateness of the proposed surgical procedure, as well as
any available alternative treatment techniques, shall be discussed
with the patient, or if applicable, with the patient's legal representative
before the surgical procedure.
(g) Licensed nurses and other personnel assisting in
the provision of surgical services shall be appropriately trained
and supervised and available in sufficient numbers for the surgical
care provided.
(h) Each treatment or examination room shall be designed
and equipped so that the types of surgical procedures conducted can
be performed in a manner that protects the lives and ensures the physical
safety of all persons in the area.
(1) If flammable agents are present in a treatment
or examination 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.
(2) If nonflammable agents are present in a treatment
or examination 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.
(i) With the exception of those tissues exempted by
the governing body after medical review, tissues removed shall be
examined by a pathologist, whose signed or authenticated report of
the examination shall be made a part of the patient's medical record.
(j) A description of the findings and techniques of
surgical procedures shall be accurately and completely incorporated
into the patient's medical record immediately after the procedure
by the physician, podiatrist, dentist, or other practitioner, acting
within the scope of their license and education, who performed the
procedure. If the description is dictated, an accurate written summary
shall be immediately available to the physicians and practitioners
providing patient care and shall become a part of the patient's medical
record.
(k) The facility shall provide adequate space, equipment,
and personnel to ensure a safe environment for treating patients during
surgical procedures, including adequate safeguards to protect the
patient from cross infection.
(1) The facility shall isolate patients with communicable
diseases.
(2) Acceptable aseptic techniques shall be used by
all persons.
(3) Suitable equipment for rapid and routine sterilization
shall be available.
(4) The facility shall implement environmental controls
that ensure a safe and sanitary environment.
(l) Written policies and procedures for decontaminating,
disinfecting, sterilizing, and storing sterile supplies shall be adopted,
implemented, and enforced as described in §509.57 of this subchapter
(relating to Sterilization).
(m) Emergency power adequate for the type of surgical
procedures performed shall be available.
(n) Periodic calibration and preventive maintenance
of all equipment shall be provided in accordance with manufacturer's
guidelines.
(o) Unless otherwise provided by law, the informed
consent of the patient or, if applicable, of the patient's legal representative
shall be obtained before a surgical procedure is performed.
(p) The facility shall establish a written procedure
for observing and caring for the patient during and after surgical
procedures.
(q) The facility shall establish written protocols
for instructing patients in self-care after surgical procedures, including
written instructions to be given to patients who receive conscious
sedation or regional anesthesia.
(r) Patients who have received anesthesia, other than
solely topical anesthesia, shall be allowed to leave the facility
only in the company of a responsible adult, unless the physician,
physician assistant, or an advanced practice registered nurse writes
an order that the patient may leave without the company of a responsible
adult.
(s) The facility shall develop an effective written
procedure for the immediately transferring to a hospital patients
requiring emergency care beyond the capabilities of the facility.
The facility shall have a written transfer agreement with a hospital
as set forth in §509.65 of this subchapter (relating to Patient
Transfer Policy).
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