|(a) Level IV (Advanced Neonatal Intensive Care Unit).
The Level IV neonatal designated facility will:
(1) provide care for the mothers and comprehensive
care of their infants of all gestational ages with the most complex
and critically ill neonates/infants with any medical problems, and/or
requiring sustained life support;
(2) ensure that a comprehensive range of pediatric
medical subspecialists and pediatric surgical subspecialists are available
to arrive on-site for face to face consultation and care, and the
capability to perform major pediatric surgery including the surgical
repair of complex conditions;
(3) have skilled personnel with documented training,
competencies and continuing education specific for the patient population
(4) facilitate transports; and
(5) provide outreach education to lower level designated
(b) Neonatal Medical Director (NMD). The NMD shall
be a physician who is a board eligible/certified neonatologist and
demonstrates a current status on successful completion of the Neonatal
Resuscitation Program (NRP).
(c) If the facility has its own transport program,
there shall be an identified Transport Medical Director (TMD). The
TMD and/or Co-Director shall be a physician who is a board eligible/certified
(d) Program Functions and Services.
(1) Triage and assessment of all patients admitted
to the perinatal service with identification of pregnant patients
who are at high risk of delivering a neonate that requires a higher
level of care who will be transferred to another facility prior to
delivery unless the transfer is unsafe.
(2) Supportive and emergency care shall be delivered
by appropriately trained personnel, for unanticipated maternal-fetal
problems that occur during labor and delivery, through the disposition
of the patient.
(3) The ability to perform an emergency cesarean delivery
within 30 minutes.
(4) Board certified/board eligible neonatologists whose
credentials have been reviewed by the NMD and is on call, and who:
(A) shall demonstrate a current status on successful
completion of the NRP;
(B) have completed continuing education annually, specific
to the care of neonates; and
(C) shall be on-site and immediately available at the
neonate/infant bedside as requested.
(5) Pediatric anesthesiologists shall directly provide
anesthesia care to the neonate, in compliance with the requirements
in §133.41(a) of this title.
(6) A dietitian or nutritionist who has special training
in perinatal and neonatal nutrition and can plan diets that meet the
special needs of neonates in compliance with the requirements in §133.41(d)
of this title.
(7) A comprehensive range of pediatric medical subspecialists
and pediatric surgical subspecialists will be immediately available
to arrive on-site for face to face consultation and care for an urgent
(8) Laboratory services shall be in compliance with
the requirements in §133.41(h) of this title and shall have:
(A) appropriately trained and qualified laboratory
personnel on-site at all times;
(B) perinatal pathology services;
(C) a blood bank capable of providing blood and blood
component therapy; and
(D) neonatal/infant blood gas monitoring capabilities.
(9) Pharmacy services shall be in compliance with the
requirements in §133.41(q) of this title and shall have a pharmacist,
with experience in neonatal/pediatric and perinatal pharmacology available
on-site at all times.
(A) If medication compounding is done by a pharmacy
technician for neonates/infants, a pharmacist will provide immediate
supervision of the compounding process.
(B) If medication compounding is done for neonates/infants,
the pharmacist shall develop and implement checks and balances to
ensure the accuracy of the final product.
(C) Total parenteral nutrition appropriate for neonates/infants
shall be available.
(10) An occupational or physical therapist with neonatal
expertise shall be available to meet the needs of the population served.
(11) Medical Imaging. Radiology services shall be in
compliance with the requirements in §133.41(s) of this title
will incorporate the "As Low as Reasonably Achievable" principle when
obtaining imaging in neonatal and maternal patients; and shall have:
(A) personnel appropriately trained in the use of x-ray
equipment shall be on-site and available at all times; personnel appropriately
trained in ultrasound, computed tomography, magnetic resonance imaging,
echocardiography and/or cranial ultrasound equipment shall be on-site
within one hour of an urgent request; and fluoroscopy shall be available
at all times;
(B) neonatal and perinatal diagnostic imaging studies
available at all times with interpretation by radiologists with pediatric
expertise, available within one hour of an urgent request; and
(C) pediatric echocardiography with pediatric cardiology
interpretation and consultation within one hour of an urgent request.
(12) Speech language pathologist with neonatal expertise
shall be available to evaluate and manage feeding and/or swallowing
(13) A respiratory therapist, with experience and specialized
training in the respiratory support of neonates/infants, whose credentials
have been reviewed by the Neonatal Medical Director, shall be on-site
and immediately available.
(14) Resuscitation. The facility shall have written
policies and procedures specific to the facility for the stabilization
and resuscitation of neonates/infants based on current standards of
(A) Each birth shall be attended by at least one provider
who demonstrates current status of successful completion of the NRP
whose primary responsibility is the management of the neonate and
(B) At least one person must be immediately available
on-site with the skills to perform a complete neonatal resuscitation
including endotracheal intubation, establishment of vascular access
and administration of medications.
(C) Additional providers who demonstrate current status
of successful completion of the NRP shall attend each neonate in the
event of multiple births.
(D) Each high-risk delivery shall have in attendance
at least two providers who demonstrate current status of successful
completion of the NRP whose only responsibility is the management
of the neonate.
(E) A full range of resuscitative equipment, supplies
and medications shall be immediately available for trained staff to
perform resuscitation and stabilization on each neonate/infant.
(15) Perinatal Education. A registered nurse with experience
in neonatal care, including neonatal intensive care, shall provide
supervision and coordination of staff education.
(16) Pastoral care and/or counseling shall be provided
as appropriate to the patient population served.
(17) Social services shall be provided as appropriate
to the patient population served.
(18) The facility must ensure the timely evaluation
and treatment of retinopathy of prematurity on-site by a pediatric
ophthalmologist or retinal specialist with expertise in retinopathy
of prematurity in the event that an infant at risk is present, and
a documented policy for the monitoring, treatment and follow-up of
retinopathy of prematurity.
(19) A certified lactation consultant shall be available
at all times.
(20) Ensure provisions for follow up care at discharge
for infants at high risk for neurodevelopmental, medical, or psychosocial