Current through Reg. 49, No. 38; September 20, 2024
(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:
(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 staff to
perform complete resuscitation and stabilization for each
neonate/infant.
(15) A
registered nurse with experience in neonatal care, including neonatal intensive
care, must provide supervision and coordination of staff education.
(16) Social services, supportive spiritual
care, and counseling must be provided as appropriate to meet the needs of the
patient population served.
(17)
Written and implemented policies and procedures to ensure timely evaluation of
retinopathy of prematurity, documented referral for treatment and follow-up of
an at-risk infant, which must be monitored through the neonatal QAPI
Plan.
(18) The neonatal program
ensures a certified lactation consultant must be available at all times to
assist and counsel mothers.
(19)
The neonatal program ensures provisions for follow-through care at discharge
for infants at high risk for neurodevelopmental, medical, or psychosocial
complications.