| (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.
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