|(a) Level I (Well Nursery). The Level I neonatal designated
(1) provide care for mothers and their infants generally
of >=35 weeks gestational age who have routine, transient perinatal
(2) have skilled personnel with documented training,
competencies and continuing education specific for the patient population
(3) if an infant <35 weeks gestational age is retained,
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
(b) Neonatal Medical Director (NMD). The NMD shall
be a physician who:
(1) is a currently practicing pediatrician, family
medicine physician, or physician specializing in obstetrics and gynecology
with experience in the care of neonates/infants;
(2) demonstrates a current status on successful completion
of the Neonatal Resuscitation Program (NRP);
(3) demonstrates effective administrative skills and
oversight of the QAPI Program; and
(4) 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 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 would be unsafe.
(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 primary 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
(A) shall demonstrate a current status on successful
completion of the American Heart Association/American Academy of Pediatrics
for the resuscitation of all infants NRP;
(B) has 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, be provided appropriate backup coverage who
shall be available, documented in an on call schedule and readily
available to facility staff; and
(E) if the physician, advanced practice nurse and/or
physician assistant is providing backup coverage, shall arrive at
the patient bedside within 30 minutes of an urgent request.
(5) Availability of appropriate anesthesia, laboratory,
radiology, ultrasonography and blood bank services on a 24 hour basis
as described in §133.41(a), (h), and (s) of this title, respectively.
(A) If preliminary reading of imaging studies pending
formal interpretation is performed, the preliminary findings must
be documented in the medical record.
(B) There must be regular monitoring of the preliminary
versus final reading in the QAPI Program.
(6) A pharmacist shall be available for consultation
on a 24 hour basis.
(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.
(7) Resuscitation. The facility shall have appropriately
trained staff, policies and procedures for the stabilization and resuscitation
of neonates based on current standards of professional practice; shall
ensure the availability of personnel who can stabilize distressed
neonates including those <35 weeks gestation until they can be
transferred to a higher level facility.
(A) Each birth shall be attended by at least one person
who demonstrates a current status of successful completion of the
NRP whose primary responsibility is for the 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 providers with current status of successful
completion of the NRP shall be on-site and immediately available upon
(D) Basic NRP equipment and supplies shall be immediately
available for trained staff to perform resuscitation and stabilization
on any neonate/infant.
(8) Perinatal Education. A registered nurse with experience
in neonatal and/or perinatal care shall provide supervision and coordination
of staff education.
(9) Ensures the availability of support personnel with
knowledge and skills in breastfeeding to meet the needs of new mothers.
(10) Social services and pastoral care shall be provided
as appropriate to meet the needs of the patient population served.