(1) Surgical department. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.
    (a) A qualified person designated by the administrator shall be responsible for the daily functioning and maintenance of the surgical suite.
    (b) A surgery record shall be maintained on a current basis that contains the following information:
    1. Patient’s name, patient number, pre-operative diagnosis, post-operative diagnosis, surgical procedure, anesthetic, and complications, if any; and,
    2. Name of each member of the surgical team, including the surgeon, first assistant, anesthesiologist, nurse anesthetist, anesthesiologist assistant, circulating nurse and operating room technician.
    (c) Each center shall ensure, prior to any surgery being performed, that the signed informed consent for the procedure, verification of the identity of patient, operative site, and operative procedure to be performed are in the patient’s medical record.
    (d) All infections of surgical cases shall be recorded and reported to the governing board or its designee and a procedure shall exist for the investigation of such cases.
    (e) Emergency equipment shall be provided as needed commensurate with the services of the center, maintained in functional condition, and capable of providing and maintaining cardiorespiratory functioning.
    (f) Written procedures in implementation of policies shall relate specifically to the functional activities of the surgical suite and include the following:
    1. Surgical asepsis: preparation, handling, and maintenance of sterile equipment and supplies.
    2. Medical asepsis: patients, staff, equipment, traffic, and equipment flow patterns.
    3. Sterilization and disinfection standards and controls; equipment and supplies.
    4. Housekeeping.
    (2) Anesthesia service. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.
    (a) All anesthesia shall be administered by an anesthesiologist, a credentialed and privileged physician, certified registered nurse anesthetist or anesthesiologist assistant, except for local anesthesia administered by a podiatrist, and except for local anesthesia administered by a dentist, and such other anesthesia administered by a dentist in accordance with Florida Statutes § 466.017 and Fl. Admin. Code Chapter 64B5-14
    (b) An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist, shall be in the center during the anesthesia and post-anesthesia recovery period until all patients are cleared for discharge.
    (c) At least one registered professional nurse shall be in the recovery area during the patient’s recovery period.
    (d) Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated.
    (e) Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing board, and be reviewed annually, dated at time of each review, revised as necessary, and enforced.
    (f) Anesthetic safety regulations shall be developed, posted and enforced. Such regulations shall include the following requirements:
    1. All operating room electrical and anesthesia equipment shall be inspected on no less than a semi-annual basis, and a written record of the results and corrective actions be maintained;
    2. Flammable anesthetic agents shall not be employed in centers;
    3. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor;
    4. Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and,
    5. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use;
    6. The following monitors shall be applied to all patients receiving conduction or general anesthesia:
    a. Blood pressure cuff;
    b. A continuous temperature device, readily available to measure the patient’s temperature;
    c. Pulse Oximeter; and,
    d. Electrocardiogram.
    e. An Inspired Oxygen Concentration Monitor and a Capnograph shall be applied to all patients receiving general anesthesia.
    (3) Nursing service. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.
    (a) A registered professional nurse designated by the administrator shall be responsible for coordinating and supervising all nursing services.
    (b) There shall be a sufficient staffing pattern of registered professional nurses to provide quality nursing care to each surgical patient from admission through discharge. Such additional trained nursing service personnel shall be on duty as may be needed commensurate with the service of the center.
    (c) A registered professional nurse shall be assigned as the circulating nurse for one patient at a time for the duration of the surgical procedure for any procedure performed in the center.
    (d) A registered professional nurse shall be present in the recovery area at all times when a patient is present.
    (e) A record shall be currently maintained of all nursing personnel and include regular and relief as well as full-time and part-time staff. The record shall include the current license number of each licensed person.
    (f) A current job description delineating duties and responsibilities shall be maintained for each nursing service position.
    (g) Written procedures in implementation of policies and to assure quality nursing care shall relate specifically to the functional activities of nursing service and include the following:
    1. Patient admission;
    2. Pre- and Post-Operative care;
    3. Medical orders from physicians and other members of the medical staff;
    4. Standing orders with required signatures;
    5. Medications; storage and administration;
    6. Treatments;
    7. Surgical asepsis;
    8. Medical asepsis;
    9. Sterilization and disinfection;
    10. Documentation: medical records and center records;
    11. Patient discharge;
    12. Patient transfer;
    13. Emergency measures;
    14. Isolation measures;
    15. Incident reports;
    16. Personnel orientation;
    17. Inservice education record;
    18. Equipment and supplies: availability and maintenance; and,
    19. Visitors.
    (4) Clinical laboratory services. The ambulatory surgical center laboratory, and any contracted laboratory providing services for ambulatory surgical center patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed.
    (5) Radiological services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.
    (a) If radiological services are provided by center staff, the service shall be maintained free of hazards for patients and personnel.
    (b) New installations of radiological equipment, and subsequent inspections for the identification of radiation hazards shall be made as required by Fl. Admin. Code Chapter 64E-5
    (c) Personnel monitoring shall be maintained for each individual working in the area of radiation. Readings shall be on at least a monthly basis and reports kept on file and available for review.
    1. Personnel – The center shall have a licensed practitioner, as defined in Florida Statutes § 468.301(11), to supervise the service and to discharge professional radiological services.
    2. A technologist shall be on duty or on call at all times when there are patients within the center.
    3. The use of all radiological apparatus shall be limited to appropriately licensed personnel; and use of fluoroscopes shall be limited to appropriately licensed, credentialed and privileged personnel.
    (d) If provided under arrangement with an outside provider, the radiological services must be directed by a qualified radiologist and meet the standards as required by Fl. Admin. Code Chapter 64E-5
    (6) Housekeeping service. The Housekeeping Service shall be organized under effective written policies and procedures relating to personnel, equipment, materials, maintenance, and cleaning of all areas of the center.
    (7) Pediatric services.
    (a) A center providing surgical services to patients under the age of 18 years (pediatric) must include age- and size-appropriate criteria in written policies and procedures regarding admissions, surgical services, anesthesia services, post-operative recovery, and discharge planning. The policies and procedures must be approved by the medical staff and the governing board, and be reviewed annually, dated at the time of each review, revised as necessary, and enforced.
    1. All patients shall meet admission and preoperative clearance criteria established by the medical staff and approved by the governing board. However, no patient may be admitted prior to age 30 days.
    2. Patients who were born less than 37 completed weeks gestation (premature) must be at least 60 weeks of age post conception, weaned off apnea monitors, and cleared by an anesthesiologist or certified registered nurse anesthetist under the on-site medical direction of a licensed physician.
    3. Patients must not be oxygen dependent at baseline.
    (b) Accommodations must be made for the parent or guardian to remain at the center from admission through discharge.
    (c) Surgical services may be provided to patients for conditions that are not emergency medical conditions.
    (d) Each center must include its pediatric cases in the quality assessment and improvement system as described in Fl. Admin. Code R. 59A-5.019 that includes peer review, multidisciplinary review and the monitoring of processes and outcomes.
    (e) One or more persons currently certified in Pediatric Advanced Life Support (PALS) must be present and available to the pediatric patient who is sedated, anesthetized, recovering from anesthesia, or receiving perioperative opioids.
    (f) Each center providing surgical services requiring a length of stay past midnight must be staffed with the following professionals with specialized training and expertise in the treatment of pediatric patients:
    1. A surgeon who is board-certified or eligible in a pediatric surgical subspecialty or a board-certified or eligible surgeon with additional training and expertise with pediatric patients acceptable to the governing board.
    2. An anesthesiologist or other physician or a certified registered nurse anesthetist under the on-site medical direction of a licensed physician or an anesthesiologist assistant under the direct supervision of an anesthesiologist shall be present in the room with the pediatric patient throughout all general anesthesia, regional anesthesia and monitored anesthesia care.
    3. Nursing and other direct care staff must have specialized training and experience with pediatric patients. Nursing personnel must be PALS and/or Advanced Cardiac Life Support certified. There must be at least one registered professional nurse on duty at all times.
    (g) Each center providing surgical services requiring a length of stay past midnight must have facilities and equipment available to store ready-to-eat foods and beverages. Equipment must include handwashing facilities and a refrigerator.
    (h) Age- and size-appropriate equipment and resources related to the care of pediatric patients must be available on site, including
    1. Operating tables;
    2. Pre- and post-operative beds;
    3. Anesthesia equipment and supplies;
    4. Resuscitation devices;
    5. Oxygen saturation monitors;
    6. Pharmacologic supplies; and
    7. Blood pressure cuffs.
    (8) The Agency will review this rule five years from the effective date and re-promulgate, amend or repeal the rule as appropriate, in accordance with Florida Statutes § 120.54, and Fl. Admin. Code Chapter 1-1
Rulemaking Authority 395.1055 FS. Law Implemented 395.009, 395.1055, 395.1011 FS. History-New 12-12-96, Amended 9-28-14, 4-7-21.