(a) The department reviews the applicant documents and approves the appropriate level of facility designation.
(b) A facility is defined under this subchapter as a single location where inpatients receive hospital services; or each location, if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.
(c) Each location must be considered separately for designation and the department approves the designation level for each location based on the location's ability to demonstrate designation criteria are met. A stand-alone children's facility that does not provide obstetrical services is exempt from obstetrical requirements.
(d) The department determines requirements for the levels of neonatal designation. Facilities seeking Levels II, III, and IV neonatal designation must meet department-approved requirements validated by a department-approved survey organization.
(e) Facilities seeking Level I neonatal designation must submit a self-survey and attest to meeting department-approved requirements.
(f) The four levels of neonatal designation are:
  (1) Level I (Well Care). The Level I neonatal designated facility must:
    (A) provide care for mothers and their infants of generally more than or equal to 35 weeks gestational age who have routine, transient perinatal problems;
    (B) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served; and
    (C) 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.
  (2) Level II (Special Care). The Level II neonatal designated facility must:
    (A) 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;
    (B) 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
    (C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served.
  (3) Level III (Neonatal Intensive Care). The Level III neonatal designated facility must:
    (A) provide care for mothers and comprehensive care for their infants of all gestational ages with mild to critical illnesses or requiring sustained life support;
    (B) 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;
    (C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;
    (D) facilitate neonatal transports; and
    (E) 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.
  (4) Level IV (Advanced Neonatal Intensive Care). The Level IV neonatal designated facility must:
    (A) provide care for 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;
    (B) ensure access to a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists 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;
    (C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;
    (D) facilitate neonatal transports; and
    (E) 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.
(g) Facilities seeking neonatal designation must undergo an on-site or virtual survey as outlined in this section and:
  (1) are responsible for scheduling a neonatal designation survey through a department-approved survey organization;
  (2) must notify the department of the neonatal designation survey date;
  (3) are responsible for expenses associated with the neonatal designation survey;
  (4) must not accept surveyors with any known conflict of interest; and
  (5) must provide the survey team access to records and documentation regarding the neonatal QAPI Plan and process related to neonatal patients. The department may determine that failure by a facility to provide access to these records does not meet the requirements of this subchapter.
(h) If a known conflict of interest is present for the facility seeking neonatal designation, the facility must decline the assigned surveyor through the surveying organization. A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor who personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership team professionally, participated in a designation consultation with the facility, had a previous working relationship with the facility or facility leaders, or conducted a designation survey for the facility within the past four years.
  (1) Surveyors cannot be from the same PCR or TSA region or a contiguous region of the facility's location.
  (2) Designation site survey summary and medical record reviews performed by a surveyor with an identified conflict of interest may not be accepted by the department.
(i) The department, at its sole discretion, may appoint an observer to accompany the survey team with the observer costs borne by the department.
(j) The survey team evaluates the facility's evidence that department-approved designation requirements are met and documents all requirements that are not met in the neonatal designation site survey summary and medical record reviews.

Source Note: The provisions of this §133.183 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226