Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133 - HOSPITAL LICENSING
Subchapter J - HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE
Section 133.189 - Neonatal Designation Level IV
Universal Citation: 25 TX Admin Code ยง 133.189
Current through Reg. 49, No. 38; September 20, 2024
(a) Level IV (Advanced Neonatal Intensive Care). The Level IV neonatal designated facility must:
(1) provide care for the mothers and
comprehensive care for their infants of all gestational ages with the most
complex and critical medical and surgical conditions or requiring sustained
life support;
(2) ensure access to
a comprehensive range of pediatric medical subspecialists and pediatric
surgical subspecialists are available to arrive on-site in person for
consultation and care, and the capability to perform major pediatric surgery
including the surgical repair of complex conditions on-site;
(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 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 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 specialized care are transferred to
a facility with specialized care capabilities 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) A
board-eligible/certified neonatologist, with documented competence in the
management of the most complex and critically ill neonates/infants, with
neonatal privileges and credentials reviewed by the NMD, must be on-site and
immediately available at the neonate/infant bedside as requested. The
neonatologist:
(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; and
(C) must ensure the facility has a back-up
neonatal provider if the neonatologist is not immediately available.
(4) Pediatric anesthesiologists
must direct and evaluate anesthesia care provided to neonates in compliance
with the requirements in §
133.41 of this title (relating to
Hospital Functions and Services).
(5) A comprehensive range of pediatric
medical subspecialists and pediatric surgical subspecialists privileged and
credentialed to participate in neonatal/infant care must be available to arrive
on-site for in-person consultation and care within a time period consistent
with current standards of professional practice and neonatal care. The
pediatric medical and pediatric surgical subspecialists' response times must be
reviewed and monitored through the neonatal QAPI Plan.
(6) Dietitian or nutritionist with
appropriate training and experience in neonatal nutrition, plans diets that
meet the needs of the neonate/infant and critically ill neonatal patient 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) appropriately trained and qualified
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
on-site 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 must 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 be on-site within a time period consistent with current
standards of professional practice;
(C) fluoroscopy be available at all
times;
(D) neonatal diagnostic
imaging studies and radiologists with pediatric expertise to interpret 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 a
summary report 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 and 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 and approved by the Neonatal Medical Director,
must be on-site and immediately available.
(14) 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/infants 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 advanced 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 and
treatment of retinopathy of prematurity on-site by a pediatric ophthalmologist
or retinal specialist with expertise in retinopathy of prematurity of an
at-risk infant. Patient follow-up of retinopathy of prematurity must be
documented and 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.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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