| (a) Level I (Well Care). The Level I neonatal designated
facility must:
(1) provide care for mothers and their infants of generally
more than or equal to 35 weeks gestational age who have routine, transient
perinatal problems;
(2) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served; and
(3) provide the same level of care that the neonate
would receive at a higher-level designated neonatal facility and complete
an in-depth critical review and assessment of the care provided to
these infants through the neonatal QAPI Plan and process if an infant
less than 35 weeks gestational age is retained.
(b) Neonatal Medical Director (NMD). The NMD must 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 and with privileges
in neonatal care;
(2) maintains a current status of successful completion
of the Neonatal Resuscitation Program (NRP) or a department-approved
equivalent course;
(3) demonstrates effective administrative skills and
oversight of the neonatal QAPI Plan; and
(4) completes annual continuing medical education specific
to the care of neonates.
(c) Program Functions and Services.
(1) The neonatal program must collaborate with the
maternal program, consulting physicians, and nursing leadership to
ensure pregnant mothers 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) The on-call physician, advanced practice nurse,
or physician assistant must have documented special competence in
the care of neonates, 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 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, must ensure appropriate back-up coverage is
available, back-up call providers are documented in the neonatal on-call
schedule and must be readily available to respond to the facility
staff; and
(E) the back-up call physician, advanced practice nurse,
or physician assistant must arrive at the patient bedside within 30
minutes of an urgent request.
(4) The facility must have written guidelines defining
the availability of appropriate anesthesia, laboratory, radiology,
respiratory, ultrasonography, and blood bank services on a 24-hour
basis as described in §133.41 of this title (relating to Hospital
Functions and Services).
(A) If preliminary reading of imaging studies pending
formal interpretation is performed, the preliminary findings must
be documented in the medical record.
(B) The facility must ensure regular monitoring and
comparison of the preliminary and final readings through the radiology
QAPI Plan. Summary reports of activities must be presented at the
Neonatal Program Oversight.
(5) Pharmacy services must be in compliance with the
requirements in §133.41 of this title and must have a pharmacist
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 to
the Neonatal Program Oversight.
(6) The facility must have personnel with appropriate
training for managing neonates/infants, written policies, procedures,
and guidelines specific to the facility for the stabilization and
resuscitation of neonates based on current standards of professional
practice. The facility must ensure the availability of personnel who
can stabilize distressed neonates, including those less than 35 weeks
gestation until they are transferred to a higher-level facility. Variances
from these standards are monitored through the neonatal QAPI Plan
and process.
(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-equivalent course, 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 with current status of successful
completion of the NRP, or a department-equivalent course, must be
on-site and immediately available upon request for the following:
(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
Oversight.
(E) Neonatal resuscitative equipment, supplies, and
medications must be immediately available for trained personnel to
perform resuscitation and stabilization on any neonate/infant.
(7) A registered nurse with experience in neonatal
or perinatal care must provide supervision and coordination of staff
education.
(8) The neonatal program ensures the availability of
support personnel with knowledge and skills in breastfeeding and lactation
to assist and counsel mothers.
(9) Social services, supportive spiritual care, and
counseling must be provided as appropriate to meet the needs of the
patient population served.
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