SECTION 133.189. Neonatal Designation Level IV

(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.

Source Note: The provisions of this §133.189 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226