| (a) Level II (Special Care). The Level II neonatal
designated facility must:
(1) provide care for mothers and their infants of generally
more than or equal to 32 weeks gestational age and birth weight more
than or equal to 1500 grams who have physiologic immaturity or problems
that are expected to resolve rapidly and are not anticipated to require
subspecialty services on an urgent basis; and
(A) if a facility is located more than 75 miles from
the nearest Level III or IV designated neonatal facility and retains
a neonate less than 32 weeks of gestation or having a birth weight
of less than 1500 grams, the facility must provide the same level
of care that the neonate would receive at a higher-level designated
neonatal facility; and
(B) any facility that retains a neonate less than 32
weeks of gestation or a birth weight less than 1500 grams, must, through
the neonatal QAPI Plan, complete an in-depth critical review and assessment
of the care provided;
(2) provide care, either by 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; and
(A) if the facility performs neonatal surgery, it must
provide the same level of care that the neonate would receive at a
higher-level designated facility; and
(B) the neonatal surgical procedure and follow-up must
be reviewed through the neonatal QAPI Plan; and
(3) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served.
(b) Neonatal Medical Director (NMD). The NMD must be
a physician who:
(1) 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; or
(2) is a pediatrician or neonatologist by the effective
date of this section who:
(A) continuously provided neonatal care for the last
consecutive two years and has experience and training in the care
of neonates/infants, including assisted endotracheal ventilation and
NCPAP management;
(B) maintains a consultative relationship with a board-eligible/certified
neonatologist;
(C) demonstrates effective administrative skills and
oversight of the neonatal QAPI Plan;
(D) maintains a current status of successful completion
of the NRP or a department-approved equivalent course; and
(E) must complete 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 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) 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;
(i) the back-up call physician, advanced practice nurse,
or physician assistant must arrive at the patient bedside within 30
minutes of an urgent request; and
(ii) the on-call staff must be on-site to provide ongoing
care and to respond to emergencies when a neonate/infant is maintained
on endotracheal ventilation.
(4) The neonatal program ensures if surgeries are performed
for neonates/infants, a surgeon privileged and credentialed to perform
surgery on a neonate/infant is on-call and must 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) Anesthesia providers with pediatric experience
and competence must provide services in compliance with the requirements
in §133.41 of this title (relating to Hospital Functions and
Services).
(6) Dietitian or nutritionist with appropriate training
and experience in neonatal nutrition 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) personnel on-site at all times as defined by written
management guidelines, which may include when a neonate/infant is
maintained on endotracheal ventilation; and
(B) 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, if requested.
(10) A speech, occupational, or physical therapist
with sufficient neonatal expertise must provide therapy services to
meet the needs of the population served.
(11) 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
and ultrasound equipment;
(B) personnel at the bedside within 30 minutes of an
urgent request;
(C) personnel appropriately trained, available on-site
to provide ongoing care and to respond to emergencies when an infant
is maintained on endotracheal ventilation;
(D) interpretation capability of neonatal and perinatal
x-rays and ultrasound studies are available at all times;
(E) if preliminary reading of imaging studies pending
formal interpretation is performed, the preliminary findings must
be documented in the medical record; and
(F) regular monitoring and comparison of preliminary
and final readings through the radiology QAPI Plan and provide summary
reports of activities at the Neonatal Program Oversight.
(12) 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 immediately available on-site
when:
(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.
(13) 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 based on current standards of professional
practice. Variances from these standards are monitored through the
neonatal QAPI Plan.
Cont'd... |
