(a) Designation application packet. The applicant shall submit the packet that includes the following documents, to the Office of EMS/Trauma Systems (office) within 120 days of the facility's verification for maternal-fetal surgical care:
  (1) an accurate and complete designation application form for designation, including full payment of the designation fee as listed in subsection (d) of this section;
  (2) evidence of current Level IV Neonatal designation;
  (3) evidence of current Level IV Maternal designation;
  (4) evidence of current verification for maternal-fetal surgical care, including patient case reviews;
  (5) evidence of current verification from the American College of Surgeons as a Level I Children's Surgery Center, including patient case reviews;
  (6) a letter of support from the facility's governing board supporting provisions for the collection and evaluation of short-term and long-term outcomes;
  (7) evidence of participation in the CEFDT meetings twice a year;
  (8) evidence of outcomes posted for public access; and
  (9) any subsequent documents requested by the office.
(b) Renewal of designation. The applicant shall submit the documents described in subsection (a)(1) - (9) of this section to the office not more than 180 days prior to the designation expiration date and at least 60 days prior to the designation expiration date.
(c) If a facility seeking designation fails to meet the requirements in subsection (a)(1) - (9) of this section, the application shall be denied.
(d) Non-refundable application fee of $2,500.00 for the three-year designation period shall be submitted with the application or renewal.
(e) If a facility disagrees with the designation determination by the office for initial designation or renewal of designation, it may make an appeal in writing not later than 60 days after issuance of the determination to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation of the basis for its appeal.
  (1) If the office upholds its original determination, the director of the office will give written notice of such to the facility not later than 30 days of its receipt of the applicant's complete written appeal.
  (2) The facility may, not later than 30 days of the office's issuance of written notification of its denial, submit a written request for further review. Such written appeal shall be submitted to the Associate Commissioner of the Consumer Protection Division (associate commissioner).
(f) The survey organization shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements. This survey report shall be forwarded to the facility no later than 30 days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process.
(g) The office shall review the application packet documents submitted by the facility, to determine compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements.
  (1) A recommendation for designation shall be made to the executive commissioner based on compliance with the designation requirements.
  (2) A Centers of Excellence for Fetal Diagnosis and Therapy designation shall not be denied to a facility that meets the minimum requirements for designation.
    (A) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee.
    (B) Membership on a designation review committee will:
      (i) be voluntary;
      (ii) be appointed by the office director;
      (iii) be representative of fetal diagnosis and therapy providers, and the highest levels of neonatal and maternal care designated facilities;
      (iv) exclude any representative with a conflict of interest; and
      (v) include representation from the office.
    (C) If a designation review committee disagrees with the office's recommendation, the records shall be referred to the associate commissioner for recommendation.
    (D) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with a hearing request referenced in §133.121(9) of this title (relating to Enforcement Action), and Government Code, Chapter 2001.

Source Note: The provisions of this §133.224 adopted to be effective March 1, 2018, 43 TexReg 887