SECTION 133.184. Designation Process

(a) A facility seeking neonatal designation or renewal of designation must submit a completed application packet.

(1) The completed application packet includes:

(A) an accurate and complete neonatal designation application for the requested level of designation;

(B) a completed neonatal attestation and self-survey report for Level I applicants, or the documented neonatal designation site survey summary that validates the department requirements are met and the medical record reviews for Levels II, III and IV applicants, submitted to the department no later than 90 days after the neonatal designation site survey date;

(C) if the facility has three or more department-approved designation requirements that are defined as not met in the neonatal designation site survey summary, the facility must contact the department's designation unit within 10 business days to discuss the Plan of Correction (POC);

(D) the POC, if required by the department, which must include:

(i) a statement of the cited designation requirement not met;

(ii) a statement describing the corrective action taken by the facility seeking neonatal designation to meet the requirement;

(iii) the title of the individuals responsible for ensuring the corrective actions are implemented;

(iv) the date the corrective actions were implemented;

(v) how the corrective actions will be monitored; and

(vi) documented evidence that the POC was implemented within 90 days of the designation survey;

(E) written evidence of annual participation in the applicable PCRs; and

(F) any subsequent documents submitted by the date requested by the department.

(2) The application includes full payment of the non-refundable, non-transferrable designation fee listed:

(A) Level I neonatal facility applicants, the fees are as follows:

(i) less than or equal to 100 licensed beds, the fee is $250.00; or

(ii) more than 100 licensed beds, the fee is $750.00.

(B) Level II neonatal facility applicants, the fee is $1,500.00.

(C) Level III neonatal facility applicants, the fee is $2,000.00.

(D) Level IV neonatal facility applicants, the fee is $2,500.00.

(b) The application will not be processed if a facility seeking neonatal designation fails to submit the required application documents and total designation fee.

(c) The neonatal designation renewal process, or a request to designate at a different level of care, or a change in ownership, or a change in physical address require the facility to notify the department and submit a complete designation application packet outlined in subsection (a)(1) and (2) of this section.

(d) The facility must submit the required documents described in subsection (a)(1) and (2) of this section to the department no later than 90 days before the facility's current neonatal designation expiration date for all designation renewals.

(e) The facility has the right to withdraw its application for neonatal designation any time before a designation approval.

(f) The facility must seek neonatal designation renewal to maintain continual designation and prevent an interruption in designation.

(g) The facility's neonatal designation will expire if the facility fails to provide a complete neonatal designation application packet to the department.

(h) The neonatal designation application packet in its entirety, including any recommendations or follow-up from the department, and any opportunities for improvement, must be a written element of the facility's neonatal QAPI Plan and must be reviewed through this process, which is all subject to confidentiality as described in Texas Health and Safety Code, §241.184, Confidentiality; Privilege.

(i) The department reviews the application packet to determine and approve the facility's level of neonatal designation.

(j) The department defines the final neonatal designation level awarded to the facility, and this designation may be different than the level requested based on the neonatal designation site survey summary.

(k) If the department determines the facility meets the requirements for neonatal designation, the department provides the facility with a designation award letter and a designation certificate.

(1) The facility must display its neonatal designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.

(2) The facility must not alter the neonatal designation certificate. Any alteration voids neonatal designation for the remainder of that designation period.

(l) The survey organization must provide the facility with a written, signed neonatal designation site survey summary, including medical record reviews, regarding their evaluation and validation of the facility's demonstration that neonatal designation requirements are met. The neonatal designation site survey summary must be forwarded to the facility no later than 30 days after the completion date of the survey. The facility is responsible for submitting a copy of the neonatal designation site survey summary and medical record reviews to the department, with the required documents to continue the designation process, within 90 days of completion of the site survey.

(m) The department will approve designation of a facility that demonstrates the requirements are met.

(n) A neonatal level of care designation must not be denied to a facility that meets the designation requirements for that level of care designation.

(o) If a facility does not meet the designation requirements for the level of designation requested, the department will designate the facility at the highest level for which designation requirements are met.

(p) If the department determines a facility does not meet the designation requirements for the level of designation requested, the department must provide written notification to the facility of the designation requirements not met and provide a Corrective Action Plan (CAP) to assist the facility in meeting the designation requirements. The CAP may include requiring the facility to have a focused survey or a complete re-survey.

(1) The facility must submit to the department reports as required and outlined in the CAP. The department may require a second survey to ensure they meet the designation requirements. The cost of the second survey will be at the expense of the facility.

(2) If the department substantiates actions taken by the facility demonstrating documented evidence that designation requirements are met, the department removes the contingencies.

(q) If a facility disagrees with the designation level awarded by the department, it may request an appeal in writing to the EMS/Trauma Systems Section Director not later than 30 days after the designation award. The written appeal must be from the facility's Chief Executive Officer, Chief Medical Officer, or Chief Nursing Officer with documented evidence of how the facility meets the requirements for the requested designation level.

(1) The EMS/Trauma Systems Section will establish a three-person appeal panel and follow approved appeal panel guidelines to assess the facility's designation appeal as referenced in Texas Health and Safety Code §241.1836.

(2) If the designation appeal panel recommends the original determination, the EMS/Trauma Systems Section Director will give written notice of such to the facility not later than 30 days after the appeal panel's recommendation.

(3) If the designation appeal panel disagrees with the department's original designation determination, the panel will recommend the appropriate level of neonatal designation to the department.

(4) If a facility disagrees with the designation appeal panel's recommendation regarding its designation level, the facility can request a second appeal review with the department's Associate Commissioner for Consumer Protection Division. If the Associate Commissioner upholds the designation appeal panel's recommendation, the designation status will remain the same. If the Associate Commissioner disagrees with the designation appeal panel's recommendation, the Associate Commissioner will define the appropriate level and award designation. The department will send a notification letter of the second appeal decision within 30 days of receiving the second appeal request.

(5) If the facility continues to disagree with the second level of appeal, the facility has a right to a hearing in the manner referenced in §133.121 of this title (relating to Enforcement Action).

(r) Exceptions and Notifications

(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