| (a) Level III (Neonatal Intensive Care). The Level
III neonatal designated facility must:
(1) provide care for mothers and comprehensive care
for their infants of all gestational ages with mild to critical illnesses
or requiring sustained life support;
(2) ensure access to 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 neonatal designated facility;
(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 with experience
in the care of neonates/infants 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 or pediatrician 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 a higher-level of care are transferred to a higher-level
facility 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) At least one of the following neonatal providers
must be on-site and available at all times: pediatric hospitalists,
neonatologists, neonatal nurse practitioners, or neonatal physician
assistants, as appropriate, who must have documented competence in
the management of severely ill neonates/infants, and privileges and
credentials to participate in neonatal/infant care reviewed by the
NMD and:
(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;
(C) must have a neonatologist available for consultation
at all times that arrives on-site within 30 minutes of an urgent request,
if the on-site provider is not a neonatologist; and
(D) if the neonatologist is covering more than one
facility, must ensure the facility has a back-up neonatologist available,
the back-up neonatologist is documented in the neonatal on-call schedule,
and readily available to respond to the facility staff and arrive
at the patient bedside within 30 minutes of an urgent request.
(4) The neonatal program that performs surgeries for
neonates/infants must have a surgeon privileged and credentialed to
perform surgery on a neonate/infant on-call. The surgeon on-call must
be available to arrive at the patient bedside within a time period
consistent with current standards of professional practice and neonatal
care. Surgeon response times must be reviewed and monitored through
the neonatal QAPI Plan.
(5) Anesthesiologists with pediatric expertise and
competence must direct and evaluate anesthesia care provided to neonates
in compliance with the requirements in §133.41 of this title.
(6) Dietitian or nutritionist with appropriate training
and experience in neonatal nutrition, plans diets that meet the needs
of the neonate/infant 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) laboratory personnel on-site at all times;
(B) pediatric pathology services available for the
population served;
(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
guidelines.
(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 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 ensure:
(i) the process is monitored through the pharmacy QAPI
Plan; and
(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 available on-site
within a time period consistent with current standards of professional
practice;
(C) fluoroscopy available at all times;
(D) neonatal diagnostic imaging studies and radiologists
with pediatric expertise to interpret the 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 summary
reports 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 or
swallowing disorders as appropriate for the patient's condition; and
(B) provide therapy services to meet the needs of the
population served.
(13) A respiratory therapist, with experience and specialized
training in the respiratory support of neonates/infants, whose credentials
have been reviewed by the NMD, must be on-site and immediately available.
(14) The facility must have staff with appropriate
training for managing neonates/infants and written policies, procedures,
and guidelines specific to the facility for the stabilization and
resuscitation of neonates 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
the following:
Cont'd... |
