| (a) Designation application packet. The applicant shall
submit the packet, inclusive of the following documents to the Office
of EMS/Trauma Systems Coordination (office) within 120 days of the
facility's survey date:
(1) an accurate and complete designation application
form for the appropriate level of designation, including full payment
of the designation fee as listed in subsection (d) of this section;
(2) any subsequent documents submitted by the date
requested by the office;
(3) a completed neonatal attestation and self-survey
report for Level I applicants or a designation survey report, including
patient care reviews if required by the office, for Level II, III
and IV applicants;
(4) a plan of correction (POC), detailing how the facility
will correct any deficiencies cited in the survey report, to include:
the corrective action; the title of the person responsible for ensuring
the correction(s) is implemented; how the corrective action will be
monitored; and the date by which the POC will be completed; and
(5) evidence of participation in the applicable Perinatal
Care Region (PCR).
(b) Renewal of designation. The applicant shall submit
the documents described in subsection (a)(1) - (5) 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) - (5) of this section, the application
shall be denied.
(d) Non-refundable application fees for the three year
designation period are as follows:
(1) Level I neonatal facility applicants, the fees
are as follows:
(A) ≤100 licensed beds, the fee is $250.00; or
(B) >100 licensed beds, the fee is $750.00.
(2) Level II neonatal facility applicants, the fee
is $1,500.00.
(3) Level III neonatal facility applicants, the fee
is $2,000.00.
(4) Level IV neonatal facility applicants, the fee
is $2,500.00.
(A) All completed applications, received on or before
July 1, 2018, including the application fee, evidence of participation
in the PCR, an appropriate attestation if required, survey report,
and that meet the requirements of the requested designation level,
will be issued a designation for the full three-year term.
(B) Any facility that has not completed an on-site
survey to verify compliance with the requirements for a Level II,
III or IV designation at the time of application must provide a self-survey
and attestation and will receive a Level I designation. The office,
at its sole discretion may recommend a designation for less than the
full three-year term. A designation for less than the full three-year
term will have a pro-rated application fee consistent with the one,
two or three-year term length.
(C) A facility applying for Level I designation requiring
an attestation may receive a shorter term designation at the discretion
of the office. A designation for less than the full three-year term
will have a pro-rated application fee.
(D) The office, at its discretion, may designate a
facility for a shorter term designation for any application received
prior to September 1, 2018.
(E) An application for a higher or lower level designation
may be submitted at any time.
(e) If a facility disagrees with the level(s) determined
by the office to be appropriate for initial designation or re-designation,
it may make an appeal in writing not later than 60 days to the director
of the office. The written appeal must include a signed letter from
the facility's governing board with an explanation of how the facility
meets the requirements for the designation level.
(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 sending written notification of its denial, submit a written
request for further review. Such written appeal shall then go to the
Assistant Commissioner of the Division for Regulatory Services (assistant
commissioner).
(f) The surveyor(s) shall provide the facility with
a written, signed survey report regarding their evaluation of the
facility's compliance with neonatal program 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 findings of the survey
report and any POC submitted by the facility, to determine compliance
with the neonatal program requirements.
(1) A recommendation for designation shall be made
to the executive commissioner based on compliance with the requirements.
(2) A neonatal level of care designation shall not
be denied to a facility that meets the minimum requirements for that
level of care designation.
(3) If a facility does not meet the requirements for
the level of designation requested, the office shall recommend designation
for the facility at the highest level for which it qualifies and notify
the facility of the requirements it must meet to achieve the requested
level of designation.
(4) If a facility does not comply with requirements,
the office shall notify the facility of deficiencies and required
corrective action(s) plan (CAP).
(A) The facility shall submit to the office reports
as required and outlined in the CAP. The office may require a second
survey to ensure compliance with the requirements. The cost of the
survey will be at the expense of the facility.
(B) If the office substantiates action that brings
the facility into compliance with the requirements, the office shall
recommend designation to the executive commissioner.
(C) 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. Membership on
a designation review committee will:
(i) be voluntary;
(ii) be appointed by the office director;
(iii) be representative of neonatal care providers
and appropriate levels of designated neonatal facilities; and
(iv) include representation from the office and the
Perinatal Advisory Council.
(D) If a designation review committee disagrees with
the office's recommendation for corrective action, the records shall
be referred to the assistant commissioner for recommendation to the
executive commissioner.
(E) 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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