| (a) If a limited services rural hospital (LSRH) performs
outpatient surgical services, emergency surgical services, or both,
the LSRH shall comply with this section.
(b) The LSRH's governing body, on recommendation of
the LSRH's medical staff, shall approve surgical procedures performed
in the LSRH.
(c) Surgical services shall be well-organized and provided
in accordance with acceptable standards of practice.
(d) An LSRH 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.
(e) The organization of the surgical services shall
be appropriate for the scope of the services offered.
(f) The LSRH shall periodically review surgical procedures
performed in the LSRH as part of the LSRH's quality assessment and
performance improvement program.
(g) Appropriate medical staff shall provide adequate
supervision of surgical procedures conducted in the LSRH under the
recommendation of medical staff and approval of the governing body.
(h) The LSRH shall establish a written procedure for
observation and care of the patient during and after surgical procedures.
(i) The LSRH 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, regional anesthesia, or both.
(j) The LSRH shall develop an effective written procedure
for the immediate transfer to a hospital of patients requiring emergency
care beyond the capabilities of the LSRH. The LSRH shall have a written
transfer agreement with a hospital as set forth in §511.65 of
this subchapter (relating to Patient Transfer Policy).
(k) Surgical procedures shall be performed only by
a physician, dentist, podiatrist, or practitioner, practicing within
the scope of their license and education, who:
(1) is licensed to perform surgical procedures in Texas;
and
(2) has been granted privileges to perform those procedures
by the governing body, upon the recommendation of the medical staff,
and after medical review of the physician's, dentist's, podiatrist's,
or practitioner's documented education, training, experience, and
current competence.
(l) The LSRH shall designate the practitioners who
are allowed to perform surgery for LSRH patients, in accordance with
its approved policies and procedures, and with state scope of practice
laws.
(m) The LSRH shall provide adequate staff during surgical
procedures.
(1) The operating rooms shall be supervised by an experienced
registered nurse (RN) or physician.
(2) Licensed vocational nurses (LVNs) and surgical
technologists (operating room technicians) may serve as scrub nurses
or technologists only under the supervision of an RN.
(3) Circulating duties in the operating room must be
performed by qualified RNs. In accordance with approved medical staff
policies and procedures, LVNs and surgical technologists may assist
in circulatory duties only under the direct supervision of a qualified
RN circulator.
(4) The LSRH shall delineate surgical privileges for
all physicians, podiatrists, and dentists performing surgery in accordance
with the competencies of each. The surgical services department shall
maintain a roster specifying the surgical privileges of each.
(5) If the LSRH employs surgical technologists, the
LSRH shall adopt, implement, and enforce policies and procedures to
comply with Texas Health and Safety Code Chapter 259 (relating to
Surgical Technologists at Health Care Facilities).
(6) 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.
(n) Preoperative laboratory procedures may be required
as follows.
(1) It shall be at the discretion of the governing
body and the medical staff to require preoperative laboratory orders.
(2) If specific preoperative laboratory work is required,
the medical staff shall approve them in accordance with the medical
staff bylaws. Specific preoperative laboratory work shall be performed
only on the order of a physician, podiatrist, dentist, or other practitioner,
who is practicing within the scope of their license and education,
and written on the patient's chart.
(3) These services shall be provided either directly
within or through an effective contract arrangement with a Medicare-approved
reference laboratory.
(4) The contractual agreement with the Medicare-approved
reference laboratory shall provide for routine and stat work to include
pathology, clinical, and blood bank services, and shall be available
for review.
(o) Surgical services shall be consistent with needs
and resources. Written policies governing surgical care that are designed
to ensure the achievement and maintenance of high standards of medical
practice and patient care shall be adopted, implemented, and enforced.
(p) There shall be a complete medical history and physical
examination, as required under subsections (s) and (t) of this section,
in the medical record of every patient prior to surgery, except in
emergencies. If this has been dictated verbally, but not yet transcribed
in the patient's medical record, there shall be a statement to that
effect and an admission note in the record by the individual who admitted
the patient.
(q) A properly executed informed consent form for the
operation shall be in the patient's medical record before surgery,
except in emergencies.
(r) A "time out" shall be conducted before starting
the procedure to confirm that the correct patient, site, and procedure
have been identified, and that all required documents and equipment
are available and ready for use.
(s) A qualified practitioner, as specified in subsection
(k) of this section, must examine the patient immediately before surgery
to evaluate the risk of the procedure to be performed.
(t) A qualified practitioner, as specified in subsection
(k) of this section, must examine each patient before surgery to evaluate
the risk of anesthesia.
(u) All persons shall use acceptable aseptic techniques
in accordance with the LSRH's chosen infection control standards.
(v) 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.
(w) The facility shall implement environmental controls
that ensure a safe and sanitary environment.
(x) Written policies and procedures for decontamination,
disinfection, sterilization, and storage of sterile supplies shall
be adopted, implemented, and enforced as described in §511.73
of this subchapter (relating to Sterilization).
(1) Performance records for all sterilizers shall be
maintained for a period of six months.
(2) The LSRH shall maintain appropriate supplies to
prevent immediate use sterilization.
(3) 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. An LSRH shall retain these records for at least one year
and shall ensure their availability for review at the facility within
two hours of HHSC's request.
(y) Emergency power adequate for the type of surgical
procedures performed shall be available.
(z) Periodic calibration and preventive maintenance
of all equipment shall be provided in accordance with manufacturer's
guidelines.
(aa) The following equipment shall be available in
the operating room suites:
(1) communication system;
(2) cardiac monitor;
(3) resuscitator;
(4) defibrillator;
(5) aspirator; and
(6) tracheotomy set.
(bb) If flammable agents are present in a treatment/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.
(cc) If nonflammable agents are present in a treatment/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.
(dd) There shall be adequate provisions for immediate
postoperative care.
Cont'd... |
