|(a) Level II (Special Care Nursery).
(1) The Level II neonatal designated facility will:
(A) provide care for mothers and their infants of generally ≥32
weeks gestational age and birth weight ≥1500 grams who have physiologic
immaturity or who have problems that are expected to resolve rapidly
and are not anticipated to require subspecialty services on an urgent
(B) either provide care, including assisted endotracheal
ventilation for less than 24 hours or nasal continuous positive airway
pressure (NCPAP) until the infant's condition improves, or arrange
for appropriate transfer to a higher level designated facility. If
the facility performs neonatal surgery, the facility shall provide
the same level of care that the neonate would receive at a higher
level designated facility and shall, through the QAPI Program, complete
an in depth critical review of the care provided; and
(C) provide skilled personnel that have documented
training, competencies and annual continuing education specific for
the patient population served.
(2) If a facility is located more than 75 miles from
the nearest Level III or IV designated neonatal facility, and retains
a neonate between 30 and 32 weeks of gestation having a birth weight
of between 1250 - 1500 grams, the facility shall provide the same
level of care that the neonate would receive at a higher level designated
neonatal facility and shall, through the QAPI Program, complete an
in depth critical review of the care provided.
(b) Neonatal Medical Director (NMD). The NMD shall
be a physician who is:
(1) a board eligible/certified neonatologist, with
experience in the care of neonates/infants and demonstrates a current
status on successful completion of the Neonatal Resuscitation Program
(2) by the effective date of this rule, a pediatrician
or neonatologist who:
(A) has continuously provided neonatal care for the
last consecutive two years; has experience and training in the care
of neonates/infants including assisted endotracheal ventilation and
(B) maintains a consultative relationship with a board
(C) demonstrates effective administrative skills and
oversight of the QAPI Program;
(D) demonstrates a current status on successful completion
of the NRP; and
(E) has completed continuing medical education annually
specific to the care of neonates.
(c) Program Functions and Services.
(1) Triage and assessment of all patients admitted
to the perinatal service with the identification of pregnant women
with a high likelihood of delivering a neonate requiring a higher
level of care be transferred prior to delivery unless the transfer
(2) Supportive and emergency care 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.
(4) The physician, advanced practice nurse and/or physician
assistant with special competence in the care of neonates, whose credentials
have been reviewed by the NMD and is on call, and:
(A) shall demonstrate a current status on successful
completion of the NRP;
(B) shall have completed continuing education annually
specific to the care of neonates;
(C) shall arrive at the patient bedside within 30 minutes
of an urgent request;
(D) if not immediately available to respond or is covering
more than one facility, appropriate back-up coverage shall be available,
documented in an on call schedule and readily available to facility
(E) the physician, advanced practice nurse and/or physician
assistant providing backup coverage shall arrive at the patient bedside
within 30 minutes of urgent request; and
(F) shall be on-site to provide ongoing care and to
respond to emergencies when a neonate/infant is maintained on endotracheal
(5) Anesthesia services with pediatric experience will
be provided in compliance with the requirements found in §133.41(a)
of this title (relating to Hospital Functions and Services).
(6) Dietitian or nutritionist with sufficient training
and experience in neonatal and maternal nutrition, appropriate to
meet the needs of the population served, shall be available and in
compliance with the requirements found in §133.41(d) of this
(7) Laboratory services shall be in compliance with
the requirements found in §133.41(h) of this title and shall
(A) personnel on-site at all times when a neonate/infant
is maintained on endotracheal ventilation;
(B) a blood bank capable of providing blood and blood
component therapy; and
(C) neonatal/infant blood gas monitoring capabilities.
(8) Pharmacy services shall be in compliance with the
requirements found in §133.41(q) of this title and shall have
a pharmacist with experience in neonatal/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 and 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 and ultrasound equipment;
(B) personnel at the bedside within 30 minutes of an
(C) appropriately trained personnel shall be available
on-site to provide ongoing care and to respond to emergencies when
an infant is maintained on endotracheal ventilation; and
(D) interpretation capability of neonatal and perinatal
x-rays and ultrasound studies available at all times.
(11) 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
(A) a neonate/infant is on a respiratory ventilator
to provide ongoing care and to respond to emergencies; or
(B) a neonate/infant is on a Continuous Positive Airway
Pressure (CPAP) apparatus.
(12) Resuscitation. The facility shall have written
policies and procedures specific to the facility for the stabilization
and resuscitation of neonates based on current standards of professional
(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 with current status of successful
completion of the NRP shall be on-site and immediately available upon
(D) Additional providers who demonstrate current status
of successful completion of the NRP shall attend each neonate in the
event of multiple births.
(E) A full range of NRP equipment and supplies shall
be immediately available for trained staff to perform resuscitation
and stabilization on any neonate/infant.
(13) Perinatal Education. A registered nurse with experience
in neonatal care, including special care nursery, and/or perinatal
care shall provide supervision and coordination of staff education.
(14) Social services and pastoral care shall be provided
as appropriate to the patient population served.
(15) Ensure the timely evaluation of retinopathy of
prematurity, monitoring, referral for treatment and follow-up, in
the case of an at-risk infant.
(16) Ensure the availability of support personnel with
knowledge and expertise in lactation to meet the needs of new mothers
(17) Ensure provisions for follow up care at discharge
for infants at high risk for neurodevelopmental, medical or psychosocial