| (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
Cont'd... |
