(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...
(ee) The operating room register shall be complete and up-to-date. The register shall contain, but not be limited to, the following:
  (1) patient's name and hospital identification number;
  (2) date of operation;
  (3) operation performed;
  (4) operating surgeon and assistant(s);
  (5) type of anesthesia used and name of person administering it;
  (6) time operation began and ended;
  (7) time anesthesia began and ended;
  (8) disposition of specimens;
  (9) names of scrub and circulating personnel;
  (10) unusual occurrences; and
  (11) disposition of the patient.
(ff) An operative report describing techniques, findings, and tissue removed or altered shall be written or dictated immediately following surgery and signed by the surgeon.
(gg) Before discharge from the LSRH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in subsection (k) of this section, as applicable.
(hh) All patients are discharged in the company of a responsible adult, except those exempted by the practitioner who performed the surgical procedure.

Source Note: The provisions of this §511.55 adopted to be effective October 5, 2023, 48 TexReg 5668