(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...
(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, 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 resuscitation and stabilization on any neonate/infant.
  (14) A registered nurse with experience in neonatal care, including special care, or perinatal care must provide supervision and coordination of staff education.
  (15) Social services, supportive spiritual care, and counseling must be provided as appropriate to meet the needs of the patient population served.
  (16) Written and implemented policies and procedures to ensure the 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.
  (17) The neonatal program ensures the availability of support personnel with knowledge and expertise in breastfeeding and lactation to assist and counsel mothers.
  (18) 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 §133.187 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226