|(a) Level IV (Advanced Neonatal Intensive Care). The
Level IV neonatal designated facility must:
(1) provide care for the mothers and comprehensive
care for their infants of all gestational ages with the most complex
and critical medical and surgical conditions or requiring sustained
(2) ensure access to a comprehensive range of pediatric
medical subspecialists and pediatric surgical subspecialists are available
to arrive on-site in person for consultation and care, and the capability
to perform major pediatric surgery including the surgical repair of
complex conditions on-site;
(3) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served;
(4) facilitate neonatal transports; and
(5) provide outreach education related to trends identified
through the neonatal QAPI Plan, specific requests, and system needs
to lower-level neonatal designated facilities, and as appropriate
and applicable, to non-designated facilities, birthing centers, independent
midwife practices, and prehospital providers.
(b) Neonatal Medical Director (NMD). The NMD must be
a physician who is a board-eligible/certified neonatologist and maintains
a current status of successful completion of the Neonatal Resuscitation
Program (NRP) or a department-approved equivalent course.
(c) If the facility has its own transport program,
there must be an identified Transport Medical Director (TMD). The
TMD or Transport Medical Co-Director must be a physician who is a
board-eligible/certified neonatologist with expertise and experience
in neonatal/infant transport.
(d) Program Functions and Services.
(1) The neonatal program must collaborate with the
maternal program, consulting physicians, and nursing leadership to
ensure pregnant patients who are at high risk of delivering a neonate
that requires specialized care are transferred to a facility with
specialized care capabilities before delivery unless the transfer
would be unsafe.
(2) The facility provides appropriate, supportive,
and emergency care delivered by trained personnel for unanticipated
maternal-fetal or neonatal problems that occur during labor and delivery,
through the disposition of the patient.
(3) A board-eligible/certified neonatologist, with
documented competence in the management of the most complex and critically
ill neonates/infants, with neonatal privileges and credentials reviewed
by the NMD, must be on-site and immediately available at the neonate/infant
bedside as requested. The neonatologist:
(A) must maintain a current status of successful completion
of the NRP or a department-approved equivalent course;
(B) must complete annual continuing education specific
to the care of neonates; and
(C) must ensure the facility has a back-up neonatal
provider if the neonatologist is not immediately available.
(4) Pediatric anesthesiologists must direct and evaluate
anesthesia care provided to neonates in compliance with the requirements
in §133.41 of this title (relating to Hospital Functions and
(5) A comprehensive range of pediatric medical subspecialists
and pediatric surgical subspecialists privileged and credentialed
to participate in neonatal/infant care must be available to arrive
on-site for in-person consultation and care within a time period consistent
with current standards of professional practice and neonatal care.
The pediatric medical and pediatric surgical subspecialists' response
times must be reviewed and monitored through the neonatal QAPI Plan.
(6) Dietitian or nutritionist with appropriate training
and experience in neonatal nutrition, plans diets that meet the needs
of the neonate/infant and critically ill neonatal patient and provides
services for the population served, in compliance with the requirements
in §133.41 of this title.
(7) Laboratory services must be in compliance with
the requirements in §133.41 of this title and must have:
(A) appropriately trained and qualified laboratory
personnel on-site at all times;
(B) pediatric pathology services available for the
(C) pediatric surgical or intra-operative frozen section
pathology services available in the operative suite at the request
of the operating surgeon; and
(D) a blood bank capable of providing blood and blood
component therapy within the timelines defined in approved blood transfusion
(8) The facility must provide neonatal/infant blood
gas monitoring capabilities.
(9) Pharmacy services must be in compliance with the
requirements in §133.41 of this title and must have a pharmacist
with experience in neonatal/pediatric pharmacology available on-site
at all times.
(A) If medication compounding is done by a pharmacy
technician for neonates/infants, a pharmacist must provide immediate
supervision of the compounding process.
(B) When medication compounding is done for neonates/infants,
the pharmacist must implement guidelines to ensure the accuracy of
the compounded final product and must ensure:
(i) the process is monitored through the pharmacy QAPI
(ii) summary reports of activities are presented at
the Neonatal Program Oversight.
(C) Total parenteral nutrition appropriate for neonates/infants
must be available.
(10) Radiology services must be in compliance with
the requirements in §133.41 of this title, incorporate the "As
Low as Reasonably Achievable" principle when obtaining imaging in
neonatal patients, and must have:
(A) personnel appropriately trained in the use of x-ray
equipment on-site and available at all times;
(B) personnel appropriately trained in ultrasound,
computed tomography, and cranial ultrasound equipment be on-site within
a time period consistent with current standards of professional practice;
(C) fluoroscopy be available at all times;
(D) neonatal diagnostic imaging studies and radiologists
with pediatric expertise to interpret neonatal diagnostic imaging
studies, available at all times;
(E) a radiologist with pediatric expertise to interpret
images consistent with the patient condition and within a time period
consistent with current standards of professional practice with monitoring
of variances through the neonatal QAPI Plan and process;
(F) preliminary findings documented in the medical
record, if preliminary reading of imaging studies pending formal interpretation
is performed; and
(G) regular monitoring and comparison of the preliminary
and final readings through the radiology QAPI Plan and provide a summary
report of activities at the Neonatal Program Oversight.
(11) Pediatric echocardiography with pediatric cardiology
interpretation and consultation completed within a time period consistent
with current standards of professional practice.
(12) Speech, occupational, or physical therapists with
neonatal/infant expertise and experience must:
(A) evaluate and recommend management of feeding and
swallowing disorders as appropriate for the patient's condition; and
(B) provide therapy services to meet the needs of the
(13) A respiratory therapist, with experience and specialized
training in the respiratory support of neonates/infants, whose credentials
have been reviewed and approved by the Neonatal Medical Director,
must be on-site and immediately available.
(14) The facility must have staff with appropriate
training for managing neonates/infants, written policies, procedures,
and guidelines specific to the facility for the stabilization and
resuscitation of neonates/infants based on current standards of professional
practice. Variances from these standards are monitored through the
neonatal QAPI Plan.
(A) Each birth must be attended by at least one person
who maintains a current status of successful completion of the NRP
or a department-approved equivalent course and whose primary focus
is management of the neonate and initiating resuscitation.
(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 personnel who maintain a current status
of successful completion of the NRP or a department-approved equivalent
course must be on-site and immediately available upon request for
(i) multiple birth deliveries, to care for each neonate;
(ii) deliveries with unanticipated maternal-fetal problems
that occur during labor and delivery; and
(iii) deliveries determined or suspected to be high-risk
for the pregnant patient or neonate.
(D) Variances from these standards are monitored through
the neonatal QAPI Plan and process and reported at the Neonatal Program
(E) Neonatal resuscitative equipment, supplies, and
medications must be immediately available for trained staff to perform
complete resuscitation and stabilization for each neonate/infant.
(15) A registered nurse with experience in neonatal
care, including advanced neonatal intensive care, must provide supervision
and coordination of staff education.
(16) Social services, supportive spiritual care, and
counseling must be provided as appropriate to meet the needs of the
patient population served.
(17) Written and implemented policies and procedures
to ensure timely evaluation and treatment of retinopathy of prematurity
on-site by a pediatric ophthalmologist or retinal specialist with
expertise in retinopathy of prematurity of an at-risk infant. Patient
follow-up of retinopathy of prematurity must be documented and monitored
through the neonatal QAPI Plan.
(18) The neonatal program ensures a certified lactation
consultant must be available at all times to assist and counsel mothers.
(19) The neonatal program ensures provisions for follow-through
care at discharge for infants at high risk for neurodevelopmental,
medical, or psychosocial complications.