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RULE §133.184Designation Process

  (1) A designated neonatal facility must provide written or electronic notification of any significant change to the neonatal program impacting patient care. The notification must be provided to the following:

    (A) all emergency medical services (EMS) providers that transfer neonatal patients to or from the designated neonatal facility;

    (B) the hospitals to which it customarily transfers out or transfers in neonatal patients;

    (C) applicable PCRs and RACs; and

    (D) the department.

  (2) If the designated neonatal facility is unable to meet the requirements to maintain its current designation, it must submit to the department a POC as described in subsection (a)(1)(D) of this section, and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the facility's Chief Executive Officer and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC, and either grants the exception with a specific timeline based on the public interest, geographic maternal care capabilities, and access to care, or denies the exception. If the facility is not granted an exception or it does not meet the designation requirements at the end of the exception period, the department will elect one of the following:

    (A) re-designate the facility at the level appropriate to its revised capabilities;

    (B) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or

    (C) waive one specific designation requirement for a level of care designation if the facility meets all other designation requirements for the level of care designation and the department determines the waiver is justified considering:

      (i) the expected impact on accessibility of neonatal care in the geographic area served by the facility if the waiver is not granted and the expected impact on the quality of care and patient safety; or

      (ii) whether these services can be met by other facilities in the area or with telehealth/telemedicine services.

  (3) Waivers expire with the expiration of the current designation but may be renewed. The department may specify any conditions for ongoing reporting during this time.

  (4) The department maintains a current list on its internet website of facilities that have contingency agreements or an approved waiver with the department and an aggregated list of the designation requirements conditionally met or waived.

  (5) Facilities that have contingency agreements or an approved waiver with the department must post on the facility's internet website the nature and general terms of the agreement.

(s) An application for a higher or lower level of neonatal designation may be submitted to the department at any time.

  (1) A designated neonatal facility that is increasing its neonatal capabilities may choose to apply for a higher-level of designation at any time. The facility must follow the designation process as described in subsection (a)(1) and (2) of this section to apply for the higher-level.

  (2) A designated neonatal facility that is unable to maintain the facility's current level of neonatal designation may choose to apply for a lower level of designation at any time.

(t) If the facility is relinquishing its neonatal designation, the facility must provide 30 days written, advance notice of the relinquishment to the department, the applicable PCRs/RACs, EMS providers, and facilities it customarily transfers out or transfers in neonatal patients. The facility is responsible for continuing to provide neonatal care services or ensuring a plan for neonatal care continuity for the 30 days following the written notice of relinquishing its neonatal designation.

(u) A hospital providing neonatal services must not use the terms "designated neonatal facility" or similar terminology in its signs, advertisements, facility internet website, social media, or in the printed materials and information it provides to the public, unless the facility is currently designated at that level of neonatal care.

(v) During a virtual, on-site, or focused designation review, conducted by the department or survey organization, the department or surveyor has the right to review and evaluate neonatal patient records, neonatal multidisciplinary QAPI Plan documents, and any action specific to improving neonatal care and outcomes, as well as any other documents relevant to neonatal care in a designated neonatal facility or facility seeking neonatal designation to validate designation requirements are met.

(w) The department and survey organization will comply with all relevant laws related to the confidentiality of records.

(x) The department may deny, suspend, or revoke designation if a designated neonatal facility ceases to provide services to meet or maintain the designation requirements of this section.

Source Note: The provisions of this §133.184 adopted to be effective June 9, 2016, 41 TexReg 4011; amended to be effective June 22, 2023, 48 TexReg 3226

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