Each hospital with an obstetrical department as described in subsection 59A-3.244(2), F.A.C. must have a neonatal nursery to provide Level I neonatal services. Level I neonatal services means well-baby care services including sub-ventilation care, intravenous feedings, intravenous medications, and gavage to neonates, as needed. Services in a Level I neonatal nursery are restricted to neonates born at 35 weeks gestation or later and who are considered low risk and physiologically stable. Ventilation assistance must not be provided except for resuscitation and stabilization. Upon beginning ventilation, the hospital must implement a patient treatment plan which includes the transfer of the neonate to a hospital providing Level II, III, or IV NICU services at such time that it becomes apparent that ventilation assistance will be required beyond the neonate’s resuscitation and stabilization. A hospital only providing Level I neonatal services must establish a triage procedure to assess the need for transfer of obstetrical patients to hospitals providing Level II, III, or IV NICU services prior to their delivery when there is an obstetrical indication that resuscitation will be required for their neonates.
    (1) Definitions. As used in this section:
    (a) “”Telemedicine”” means on call and readily available for remote consultation, diagnosis, and treatment by means of audiovisual telecommunications technology.
    (b) “”Onsite”” means on call and readily available for consultation and continuous patient management.
    (2) Licensure.
    (a) A hospital may not provide neonatal intensive care services prior to obtaining licensure of NICU beds as evidenced by the bed type appearing on the face of the hospital’s license. A hospital authorized to provide neonatal intensive care services as of the effective date of this rule shall be licensed to provide the same level of care for neonatal intensive care services and must meet all of the requirements of this rule within one year from the effective date. This does not preclude a hospital from qualifying for a higher level during the transition year.
    (b) A hospital establishing neonatal intensive care services must apply for licensure of Level II, III, or IV NICU services and NICU beds by submitting a hospital licensure application as specified in subsection 59A-3.066(2), F.A.C.
    (c) A hospital may utilize any licensed NICU bed at the level of neonatal intensive care services required to meet the patient’s needs if the licensure, staffing, equipment, and supplies requirements established by this rule for the necessary level of service is met.
    (3) Emergency Transportation. A hospital providing Level II, III, or IV neonatal intensive care services must have, directly or by contract, an emergency 24-hour neonatal transportation system in accordance with Fl. Admin. Code R. 64J-1.006 administered by the Department of Health. Hospitals providing Level II neonatal intensive care services must have a written transfer agreement with a hospital providing Level III or Level IV neonatal intensive care services, and hospitals providing Level III neonatal intensive care services must have a written transfer agreement with a hospital providing Level IV neonatal intensive care services. A hospital providing Level IV neonatal intensive care services that does not provide pediatric cardiovascular surgery and pediatric cardiothoracic surgery onsite must have a written transfer agreement with a hospital providing Level IV neonatal intensive care services including onsite pediatric cardiovascular surgery and pediatric cardiothoracic surgery as specified in paragraph (7)(h).
    (4) Transfer agreements. A hospital providing Level II, III, or IV neonatal intensive care services must have transfer agreements for all neonatal intensive care services that are not provided by the hospital with another hospital that provides such services. A transfer agreement must specifically address the services included in the transfer agreement. The hospital must maintain a policy requiring that such transfer agreements be made with other hospitals in reasonable geographic proximity, taking into account the services in question, the location of the hospital, and other factors relevant to the care of the patient. Medically necessary transfers shall be made in accordance with section 395.1041(3)(e), F.S.
    (5) Level II Neonatal Intensive Care Services.
    (a) Hospitals that are licensed for Level II NICU services may only provide care for infants at greater than or equal to 30 weeks’ gestation and/or have reached a weight of greater than or equal to 1250 grams.
    (b) Hospitals that are licensed for Level II NICU services, but not Level III or Level IV NICU services, may perform only Level II NICU services.
    (c) Each Level II NICU must be capable of providing invasive ventilation up to 72 hours, or continuous positive airway pressure as needed.
    (d) An infant in a Level II NICU must be transferred to a higher level NICU if the infant requires more than 72 hours of invasive ventilation.
    (e) Director. Each Level II NICU must be directed by a board certified pediatrician with experience in the care of newborn infants including intubation and invasive ventilation, or a board certified neonatologist.
    (f) Personnel. Each Level II NICU must have physically present in the facility at all times, a board certified or board eligible neonatologist or other neonatal provider with demonstrated competence in the management of severely ill infants as evidenced by completion of the Neonatal Resuscitation Program and continuing education requirements specific to the care of infants. Other neonatal providers, for the purposes of this subsection, must be either pediatric hospitalists, neonatal physician assistants, or neonatal advanced practice registered nurses. If the personnel present at the facility at any time pursuant to this paragraph is not a board certified or board eligible neonatologist, at all such times a neonatologist must be available for consultation and must be available to arrive onsite within 30 minutes of an urgent request. If the neonatologist designated to be either at the facility or available for consultation and arrival upon an urgent request is covering more than one facility, the facility must ensure that a back-up neonatologist be available, documented in an on-call schedule and readily available to facility staff, for consultation or to arrive within 30 minutes upon an urgent request.
    (g) Pediatric Medical Subspecialties. Each Level II NICU must have the following pediatric medical subspecialties available onsite or via telemedicine:
    1. Cardiology;
    2. Maternal-fetal medicine, including a board certified obstetrician who is qualified by training, experience, or special competent certification in maternal-fetal medicine, if the hospital provides delivery services;
    3. Neurology; and
    4. Ophthalmologist or retinal specialist with expertise in retinopathy of prematurity.
    (h) Onsite Pediatric Services. Each Level II NICU must have the following pediatric services available onsite:
    1. Echocardiogram;
    2. Electroencephalogram;
    3. Laboratory services;
    4. Lactation;
    5. Nutrition;
    6. Pastoral care;
    7. Pharmacy;
    8. Physician-led multidisciplinary NICU follow up clinic or affiliation with a clinic and referral system;
    9. Radiology, including magnetic resonance imaging, computed tomography, and ultrasound;
    10. Rehabilitation therapy;
    11. Retinopathy of prematurity screening (screening may be reviewed via telemedicine);
    12. Respiratory therapy; and
    13. Social work.
    (i) Neonatal Nursing.
    1. Supervision. The nursing staff must be under the supervision of a registered professional nurse with experience and training in neonatal intensive care nursing.
    2. Training and Qualifications. Nurses must be trained to administer cardio-respiratory monitoring, assist in ventilation, administer intravenous fluids, provide pre-operative and post-operative care of patients requiring surgery, manage patients being transported, and provide emergency treatment of conditions such as apnea, seizures, and respiratory distress. All nurses must maintain current certification in the Neonatal Resuscitation Program.
    3. Staffing.
    a. There must be at least one nurse for every four patients receiving Level II neonatal intensive care services.
    b. At least one-half of the nursing personnel assigned to each work shift in Level II NICUs must be registered professional nurses.
    (j) Respiratory Therapist. There must be at least one certified respiratory therapist with current certification in the Neonatal Resuscitation Program and expertise in the care of neonates continuously available in the hospital at all times. There must be at least one respiratory therapy technician for every four patients receiving assisted ventilation.
    (k) Level II NICU Bed Equipment. Each bed must have:
    1. One cardiopulmonary monitor and pulse oximeter;
    2. At least one resuscitation bag and mask; and
    3. At least one infusion pump.
    (l) Level II NICU Equipment. Each unit must have available on demand:
    1. At least one oxygen analyzer for every three occupied beds;
    2. At least one non-invasive blood pressure monitoring device for every three occupied beds;
    3. At least one ventilator for every three occupied beds;
    4. An EKG machine with printout capability;
    5. Continuous blood pressure measurement equipment;
    6. A portable digital x-ray capable of directly displaying radiography and digital images in the NICU;
    7. An incubator or radiant warmer for each occupied bed;
    8. One heated humidifier and humidified oxygen delivery systems for each occupied bed; and
    9. At least one neonatal fixed or portable suction device for each occupied bed.
    (6) Level III Neonatal Intensive Care Services.
    (a) Hospitals providing Level III NICU services must meet the staffing and personnel, equipment, and service standards required of hospitals providing Level II NICU services, in addition to the standards set forth within this subsection. Hospitals providing Level III NICU services may perform Level II and Level III NICU services.
    (b) Director. Each Level III NICU must be directed by a full-time, board certified neonatologist.
    (c) Onsite Medical Subspecialties. Each Level III NICU must provide an anesthesiologist onsite with sufficient expertise in pediatric anesthesiology and with the ability to consult with a pediatric anesthesiologist through a prearranged and documented consultative agreement.
    (d) Other Pediatric Medical Subspecialties. Each Level III NICU must provide the pediatric medical subspecialties required of Level II NICUs. In addition, each Level III NICU must provide the following pediatric medical subspecialties onsite or via telemedicine:
    1. Endocrinology;
    2. Gastroenterology;
    3. Genetics;
    4. Hematology-oncology;
    5. Infectious disease;
    6. Nephrology;
    7. Otolaryngology;
    8. Pulmonary;
    9. Radiology; and
    10. Urology.
    (e) Onsite Surgical Subspecialties. Each Level III NICU must provide pediatric general surgery onsite or provide onsite a general surgeon with sufficient expertise in pediatric general surgery with the ability to consult with a pediatric general surgeon through a prearranged and documented consultative agreement.
    (f) Pediatric Services. Each Level III NICU must provide the pediatric services required of a Level II NICU. In addition, a Level III NICU must provide therapeutic hypothermia services onsite and may provide inhaled nitric oxide services.
    (g) Neonatal Nursing.
    1. Each Level III NICU must meet the supervision, training, and qualifications standards for neonatal nurses for Level II NICUs.
    2. There must be at least one nurse for every two patients receiving Level III neonatal intensive care services. Patients requiring neonatal surgery or multi-system support must have at least one nurse for every patient during the immediate preoperative, intraoperative, and immediate postoperative periods.
    (h) Level III NICU Equipment. A Level III NICU must be capable of life support as needed. Level III NICUs must have the equipment and services required of a Level II NICU.
    (7) Level IV Neonatal Intensive Care Services.
    (a) Hospitals providing Level IV NICU services must meet the staffing and personnel, equipment, and service standards required of Level III NICUs in addition to the standards set forth within this subsection.
    (b) Hospitals providing Level IV NICU services may perform Level II, Level III and Level IV NICU services.
    (c) Director. Each Level IV NICU must be directed by a full-time, board certified neonatologist.
    (d) Personnel. Each Level IV NICU must have a board certified or board eligible neonatologist available at all times at the facility.
    (e) Onsite Pediatric Medical Subspecialties. Each Level IV NICU must provide the following pediatric medical subspecialties onsite:
    1. Anesthesiology;
    2. Cardiology;
    3. Endocrinology;
    4. Gastroenterology;
    5. Hematology-oncology;
    6. Infectious Disease;
    7. Maternal-fetal medicine, including a board certified obstetrician who is qualified by training, experience, or special competent certification in maternal-fetal medicine, if the hospital provides delivery services;
    8. Nephrology;
    9. Neurology;
    10. Ophthalmologist or retinal specialist with expertise in retinopathy of prematurity;
    11. Orthopedics;
    12. Otolaryngology;
    13. Palliative care;
    14. Pulmonology;
    15. Radiology; and
    16. Urology.
    (f) Other Pediatric Medical Subspecialties. Each Level IV NICU must provide genetics services onsite or via telemedicine.
    (g) Onsite Pediatric Surgical Subspecialties. Each Level IV NICU must provide the following pediatric surgical subspecialties onsite:
    1. Craniofacial surgery;
    2. General surgery; and
    3. Neurosurgery.
    (h) If a hospital providing Level IV NICU services does not provide pediatric cardiovascular surgery and pediatric cardiothoracic surgery onsite, it must have a transfer agreement for such surgeries.
    (i) Onsite Pediatric Services. Each Level IV NICU must provide the following pediatric services onsite:
    1. Echocardiogram;
    2. Electroencephalogram;
    3. Extracorporeal membrane oxygenation;
    4. Inhaled nitric oxide;
    5. Laboratory services;
    6. Lactation;
    7. Nutrition;
    8. Pastoral care;
    9. Pharmacy;
    10. Physician-led multidisciplinary NICU follow up clinic
    11. Radiology, including magnetic resonance imaging, computed tomography, and ultrasound;
    12. Rehabilitation therapy;
    13. Respiratory therapy;
    14. Retinopathy prematurity screening;
    15. Social work; and
    16. Therapeutic hypothermia.
    (j) Other Pediatric Services. A Level IV may provide pediatric dialysis onsite or, if it does not provide pediatric dialysis onsite, must have a transfer agreement for pediatric dialysis.
    (k) General hospitals providing Level IV NICU services must provide obstetric services for women with high risk pregnancies onsite, on a 24-hour basis. Specialty children’s hospitals are excluded from this requirement.
    (l) Hospitals providing Level IV NICU services must:
    1. Maintain continuous availability of neonatal surgery;
    2. Assure age and size appropriate transport to and from other facilities;
    3. Coordinate continuing education programs for staff; and
    4. Provide outreach education for other hospitals in their service area.
Rulemaking Authority 395.1055 FS. Law Implemented 395.1055, 408.0455 FS. History-New 5-19-22.