1. (1) Surgical Department. Each Class I and Class II hospital, and each Class III hospital providing operative and other invasive procedures, shall have a functionally and physically distinct surgical department within the hospital, organized under written policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation and recording of treatment of the patient. The surgical department shall have a physician member of the organized medical staff serve as medical advisor to the surgical department and a registered nurse to direct nursing services within the operating rooms of a surgical department. All surgical department policies and procedures shall be available to the Agency, shall be reviewed annually, dated to indicate time of last review, revised as necessary, and enforced.

   1. (a) The determination of the appropriateness of the procedure for a patient shall be based on:

      1. The patient’s medical, anesthetic, and drug history;

      2. The patient’s physical status;

      3. Diagnostic data;

      4. The risks and benefits of the procedure; and,

      5. The need to administer blood or blood components.

   2. (b) The risks and benefits of the procedure shall be discussed with the patient prior to documenting informed consent and include:

      1. Other treatment options, if they exist;

      2. The need and risk of blood transfusions and available alternatives; and

      3. Anesthesia options and risks.

   3. (c) A preanesthesia evaluation of the patient shall be performed prior to surgery, except in the case of extreme emergency.
   4. (d) Plans of care for the patient shall be formulated and documented in the medical record prior to the performance of surgery and shall include a plan for anesthesia, nursing care, the operative or invasive procedure, and the level of post-procedure care.
   5. (e) The measurement of the patient’s physiological status shall be assessed during the administration of anesthesia and the surgical procedure.
   6. (f) The post-procedure status of the patient shall be assessed on admission to the recovery area and prior to discharge from the recovery area.
   7. (g) The patient shall be discharged from the recovery area by a member of the organized medical staff.
   8. (h) The operating room and accessory services shall be located in a manner to prevent through traffic, control traffic in and out, and maximize infection control.
   9. (i) All infections of clean surgical cases shall be recorded and reported to the appropriate infections control authority, and a procedure shall exist for the investigation of such cases.
   10. (j) The registered nurse shall document that all surgical nursing staff have received annual continuing education in safety, infection control and cardiopulmonary resuscitation.
   11. (k) A roster of members of the organized medical staff specifying the surgical privileges of each, shall be maintained, reviewed annually and revised as necessary.
   12. (l) A roster of “on-call” surgeons shall be promptly available at the operating room nursing stations. An on-call surgeon must be available to the hospital when a call for services has been placed.

   13. (m) A record shall be maintained on a current basis that contains the following information:

       1. Patient’s name;

       2. Hospital number;

       3. Preoperative diagnosis;

       4. Post-operative diagnosis;

       5. Procedure;

       6. Names of surgeon, first assistant, and anesthetist;

       7. Type of anesthetic; and,

       8. Complications, if any.

   14. (n) Regardless of whether surgery is classified as major or minor, the surgical department shall ensure, prior to any surgery being performed, except in emergency situations:

       1. That there is a complete history and physical workup in the chart of every patient or, if such has been transcribed, but not yet recorded in the patient’s chart, that there is a statement to that effect in the chart; and,

       2. That there is evidence of informed consent for the operation in the patient’s chart.

   15. (o) The surgical department shall ensure that immediately following each surgery, there is an operative report describing techniques and findings that is written or dictated and signed by the surgeon.

   16. (p) The following equipment shall be in each operating room suite:

       1. Call-in system;

       2. Oxygen, and means of administration;

       3. Mechanical ventilatory assistance equipment, including airways, manual breathing bag, and ventilator and respirator;

       4. Cardiac defibrillator with synchronization capability;

       5. Respiratory and cardiac monitoring equipment;

       6. Thoracentesis and closed thoracostomy sets;

       7. Tracheostomy set, tourniquets, vascular cutdown sets, infusion pumps, laryngoscopes and endotracheal tubes;

       8. Tracheobronchial and gastric suction equipment; and

       9. A portable x-ray which shall be available, but need not be physically present in the operating suite.

2. (2) Anesthesia Department. Each Class I and Class II hospital, and each Class III hospital providing surgical or obstetrical services, shall have an anesthesia department, service or similarly titled unit directed by a physician member of the organized professional staff.

   1. (a) The anesthesia department of each hospital shall have written policies and procedures that are approved by the organized medical staff, are reviewed annually, dated at time of last review, revised, and enforced as necessary. Such written policies and procedures shall include the following requirements:

      1. A preanesthesia evaluation of the patient by the physician, or qualified oral surgeon in the case of patients without medical problems admitted for dental procedures, or certified registered nurse anesthetist where authorized by established protocol approved by the medical staff, except in the case of emergencies.

      2. A review of the patient’s condition immediately prior to induction of anesthesia.

      3. A mechanism for release of patients from postanesthesia care.

      4. A recording of all pertinent events taking place during the induction of, maintenance of, and emergence from anesthesia.

      5. Guidelines for the safe use of all general anesthetic agents used in the hospital.

   2. (b) The responsibilities and qualifications of all anesthesia personnel, including physician, nurse and dentist anesthetists and all trainees, must be defined in a policy statement, job description, or other appropriate document.

   3. (c) Anesthetic safety regulations shall be developed, posted, and enforced. Such regulations shall include the following:

      1. A requirement that all operating room electrical and anesthesia equipment be inspected on an annual basis and at intervals not exceeding the manufacturer’s recommendations. A written record of the inspection results and corrective action shall be maintained by the hospital.

      2. A requirement that flammable anesthetic agents be employed only in areas in which a conductive pathway can be maintained between the patient and a conductive floor.

      3. A requirement that each anesthetic gas machine have a pin-index or equivalent safety system.

      4. A requirement that all reusable anesthesia equipment coming in direct contact with the patient be cleaned or sterilized in the manner prescribed by current medical standards.

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 8-15-18.