|(a) Level III (Neonatal Intensive Care Unit (ICU)).
The Level III neonatal designated facility will:
(1) provide care for mothers and comprehensive care
of their infants of all gestational ages with mild to critical illnesses
or requiring sustained life support;
(2) provide for consultation to a full range of pediatric
medical subspecialists and pediatric surgical specialists, and the
capability to perform major pediatric surgery on-site or at another
appropriate designated facility;
(3) have skilled medical staff and personnel with documented
training, competencies and continuing education specific for the patient
(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 or Co-Director shall be a physician who is a board eligible/certified
neonatologist or pediatrician with expertise and experience in neonatal/infant
(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 a higher level 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) At least one of the following neonatal providers
shall be on-site and available at all times and includes pediatric
hospitalists, neonatologists, and/or neonatal nurse practitioners
or neonatal physician assistants, as appropriate, who have demonstrated
competence in management of severely ill neonates/infants, whose credentials
have been reviewed by the NMD and is on call, and:
(A) has a current status of successful completion of
(B) has completed continuing education annually, specific
to the care of neonates;
(C) if the on-site provider is not a neonatologist,
a neonatologist shall be available for consultation at all times and
shall arrive on-site within 30 minutes of an urgent request;
(D) if the neonatologist 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; and
(E) ensure that the neonatologist providing back-up
coverage shall arrive on-site within 30 minutes.
(5) Anesthesiologists with pediatric expertise, shall
directly provide the anesthesia care to the neonate, in compliance
with the requirements found in §133.41(a) of this title (relating
to Hospital Functions and Services).
(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/infants is available at all times, in compliance
with the requirements found in §133.41(d) of this title.
(7) Laboratory services shall be in compliance with
the requirements found at §133.41(h) of this title and shall
(A) laboratory personnel on-site at all times;
(B) perinatal pathology services available;
(C) a blood bank capable of providing blood and blood
component therapy; and
(D) neonatal blood gas monitoring capabilities.
(8) Pharmacy services shall be in compliance with the
requirements found in §133.41(q) of this title and will have
a pharmacist, with experience in neonatal/pediatric and perinatal
pharmacology, available 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 will develop checks and balances to ensure the accuracy
of the final product.
(C) Total parenteral nutrition appropriate for neonates/infants
shall be available.
(9) An occupational or physical therapist with sufficient
neonatal expertise shall be available to meet the needs of the population
(10) Medical Imaging. Radiology services shall be in
compliance with the requirements found 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
(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; fluoroscopy shall be available;
(B) interpretation of neonatal and perinatal diagnostic
imaging studies by radiologists with pediatric expertise at all times;
(C) pediatric echocardiography with pediatric cardiology
interpretation and consultation within one hour of an urgent request.
(11) Speech language pathologist, an occupational therapist,
or a physical therapist with neonatal/infant experience shall be available
to evaluate and manage feeding and/or swallowing disorders.
(12) A respiratory therapist, with experience and specialized
training in the respiratory support of neonates/infants, whose credentials
have been reviewed by the NMD, shall be immediately available on-site.
(13) Resuscitation. Written policies and procedures
shall be specific to the facility for the stabilization and resuscitation
of neonates based on current standards of professional practice.
(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 complete resuscitation and stabilization on each neonate/infant.
(14) Perinatal education. A registered nurse with experience
in neonatal care, including neonatal intensive care, shall provide
supervision and coordination of staff education.
(15) Pastoral care and/or counseling shall be provided
as appropriate to the patient population served.
(16) Social services shall be provided as appropriate
to the patient population served.
(17) Ensure the timely evaluation of retinopathy of
prematurity, monitoring, referral for treatment and follow-up, in
the case of an at-risk infant.
(18) A certified lactation consultant shall be available
at all times.
(19) Ensure provisions for follow up care at discharge
for infants at high risk for neurodevelopmental, medical, or psychosocial