(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.

Source Note: The provisions of this §133.186 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226