Current through Reg. 50, No. 187; September 24, 2024
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 Rule
64J-1.006, F.A.C. 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.
New 5-19-22.
