Current through Reg. 49, No. 38; September 20, 2024
(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.
