(a) Neonatal Program Philosophy. Designated facilities must have a family-centered philosophy. Parents must have reasonable access to their infants at all times and be encouraged to participate in the care of their infants. The facility environment for perinatal care must meet the physiologic and psychosocial needs of the mothers, infants, and families.
(b) Neonatal Program Plan. The facility must develop a written neonatal operational plan for the neonatal program that includes a detailed description of the scope of services and clinical resources available for all neonatal patients, mothers, and families. The plan must define the neonatal patient population evaluated, treated, transferred, or transported by the facility consistent with clinical guidelines based on current standards of neonatal practice ensuring the health and safety of patients.
  (1) The written Neonatal Program Plan must be reviewed and approved by Neonatal Program Oversight and be submitted to the facility's governing body for review and approval. The governing body must ensure the requirements of this section are implemented and enforced.
  (2) The written Neonatal Program Plan must include, at a minimum:
    (A) clinical guidelines based on current standards of neonatal practice, and policies and procedures that are adopted, implemented, and enforced by the neonatal program;
    (B) a process to ensure and validate these clinical guidelines based on current standards of neonatal practice, policies, and procedures, are reviewed and revised a minimum of every three years;
    (C) written triage, stabilization, and transfer guidelines for neonatal patients that include consultation and transport services;
    (D) the role and scope of telehealth/telemedicine practices, if utilized, including:
      (i) documented and approved written policies and procedures that outline the use of telehealth/telemedicine for inpatient hospital care or for consultation, including appropriate situations, scope of care, and documentation that is monitored through the neonatal QAPI Plan and process; and
      (ii) written and approved procedures to gain informed consent from the patient or designee for the use of telehealth/telemedicine, if utilized, that are monitored for variances;
    (E) written guidelines for discharge planning instructions and appropriate follow-up appointments for all neonates/infants;
    (F) written guidelines for the hospital disaster response, including a defined neonatal evacuation plan and process to relocate mothers and infants to appropriate levels of care with identified resources, and this process must be evaluated annually to ensure neonatal care can be sustained and adequate resources are available;
    (G) written minimal education and credentialing requirements for all staff participating in the care of neonatal patients, which are documented and monitored by the managers who have oversight of staff;
    (H) written requirements for providing continuing staff education, including annual competencies and skills assessment that is appropriate for the patient population served, which are documented and monitored by the managers who have oversight of staff;
    (I) documentation of meeting the requirement for a perinatal staff registered nurse to serve as a representative on the nurse staffing committee under §133.41 of this title (relating to Hospital Functions and Services);
    (J) measures to monitor the availability of all necessary equipment and services required to provide the appropriate level of care and support for the patient population served; and
    (K) documented guidelines for consulting support personnel with knowledge and skills in breastfeeding and lactation, which includes expected response times, defined roles, responsibilities, and expectations.
  (3) The facility must have a documented and approved neonatal QAPI Plan.
    (A) The Chief Executive Officer, Chief Medical Officer, and Chief Nursing Officer must implement a culture of safety for the facility and ensure adequate resources are allocated to support a concurrent, data-driven neonatal QAPI Plan.
    (B) The facility must demonstrate that the neonatal QAPI Plan consistently assesses the provision of neonatal care provided. The assessment must identify variances in care, the impact to the patient, and the appropriate levels of review. This process must identify opportunities for improvement and develop a plan of correction to address the variances in care or the system response. An action plan will track and analyze data through resolution or correction of the identified variance.
    (C) The neonatal program must measure, analyze, and track performance through defined quality indicators, core performance measures, and other aspects of performance that the facility adopts or develops to evaluate processes of care and patient outcomes. Summary reports of these findings are reported through the Neonatal Program Oversight.
    (D) All neonatal facilities must participate in a neonatal data initiative. Level III and IV neonatal facilities must participate in benchmarking programs to assess their outcomes as an element of the neonatal QAPI Plan.
    (E) The Neonatal Medical Director (NMD) must have the authority to make referrals for peer review, receive feedback from the peer review process, and ensure neonatal physician representation in the peer review process for neonatal cases.
    (F) The NMD and Neonatal Program Manager (NPM) must participate in PCR meetings, regional QAPI initiatives, and regional collaboratives, and submit requested data to assist with data analysis to evaluate regional outcomes as an element of the facility's neonatal QAPI Plan.
    (G) The facility must have documented evidence of neonatal QAPI summary reports reviewed and reported by Neonatal Program Oversight that monitor and ensure the provision of services or procedures through telehealth and telemedicine, if utilized, is in accordance with the standards of care applicable to the provision of the same service or procedure in an in-person setting.
    (H) The facility must have documented evidence of neonatal QAPI summary reports to support that aggregate neonatal data are consistently reviewed to identify developing trends, opportunities for improvement, and necessary corrective actions. Summary reports must be provided through the Neonatal Program Oversight, available for site surveyors, and submitted to the department as requested.
(c) Medical Staff. The facility must have an organized, effective neonatal program that is recognized by the facility's medical staff and approved by the facility's governing body.
  (1) The credentialing of the neonatal medical staff must include a process for the delineation of privileges for neonatal care.
  (2) The neonatal medical staff must participate in ongoing staff and team-based education and training in the care of the neonatal patient.
(d) Medical Director. There must be an identified NMD and an identified Transport Medical Director (TMD) if the facility has its own transport program. The NMD and TMD must be credentialed by the facility for treatment of neonatal patients and have their responsibilities and authority defined in a job description. The NMD and TMD must maintain a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.
  (1) The NMD is responsible for the provision of neonatal care services and must:
    (A) examine qualifications of medical staff and advanced practice providers requesting privileges to participate in neonatal/infant care, and make recommendations to the appropriate committee for such privileges;
    (B) ensure neonatal medical staff and advanced practice provider competencies in managing neonatal emergencies, complications, and resuscitation techniques;
    (C) monitor neonatal patient care from transport, to admission, stabilization, and operative intervention(s), as applicable, through discharge, and review variances in care through the neonatal QAPI Plan;
    (D) participate in ongoing neonatal staff and team-based education and training in the care of the neonatal patient;
    (E) oversee the inter-facility neonatal transport as appropriate;
    (F) collaborate with the NPM, maternal teams, consulting physicians, and nursing leaders and units providing neonatal care to include developing, implementing, or revising:
      (i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for variances;
      (ii) the neonatal QAPI Plan, specific reviews, and data initiatives;
      (iii) criteria for transfer, consultation, or higher-level of care; and
Cont'd...
(iv) medical staff, advanced practice providers, and personnel competencies, education, and training;
    (G) participate as a clinically active and practicing physician in neonatal care at the facility where medical director services are provided;
    (H) ensure that the neonatal QAPI Plan is specific to neonatal/infant care, is ongoing, data driven, and outcome based;
    (I) frequently lead the neonatal QAPI meetings with the NPM and participate in the Neonatal Program Oversight and other neonatal meetings, as appropriate;
    (J) maintain active staff privileges as defined in the facility's medical staff bylaws; and
    (K) develop and maintain collaborative relationships with other NMDs of designated neonatal facilities within the applicable PCR.
  (2) The TMD is responsible for the facility neonatal transport program and must:
    (A) collaborate with the transport team to develop, revise, and implement written policies, procedures, and guidelines, for neonatal care that are implemented and monitored for variances;
    (B) participate in ongoing transport staff competencies, education, and training;
    (C) review and evaluate transports from initial activation of the transport team through delivery of patient, resources, quality of patient care provided, and patient outcomes; and
    (D) integrate review findings into the overall neonatal QAPI Plan and process.
  (3) The NMD may also serve as the TMD.
(e) NPM. The facility must identify an NPM who has the authority and oversight responsibilities written in his or her job description, for the provision of neonatal services through all phases of care, including discharge, and identifying variances in care for inclusion in the neonatal QAPI Plan.
  (1) The NPM must be a registered nurse with defined education, credentials, and experience for neonatal care applicable to the level of care being provided.
  (2) The NPM must maintain a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.
  (3) The NPM must:
    (A) ensure staff competency in resuscitation techniques;
    (B) participate in ongoing staff and team-based education and training in the care of the neonatal patient;
    (C) monitor utilization of telehealth/telemedicine, if used;
    (D) collaborate with the NMD, maternal program, consulting physicians, and nursing leaders and units providing neonatal care to include developing, implementing, or revising:
      (i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for variances;
      (ii) the neonatal QAPI Plan, specific reviews, and data initiatives;
      (iii) criteria for transfer, consultation, or higher-level of care; and
      (iv) staff competencies, education, and training;
    (E) regularly and actively participate in neonatal care at the facility where program manager services are provided;
    (F) consistently review the neonatal care provided and ensure the neonatal QAPI Plan is specific to neonatal/infant care, data driven, and outcome-based;
    (G) frequently lead the meetings and participate in Neonatal Program Oversight and other neonatal meetings as appropriate; and
    (H) develop and maintain collaborative relationships with other NPMs of designated neonatal facilities within the applicable PCR.

Source Note: The provisions of this §133.185 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226