Current through Reg. 49, No. 38; September 20, 2024
(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
(1) A designated
neonatal facility must provide written or electronic notification of any
significant change to the neonatal program impacting patient care. The
notification must be provided to the following:
(A) all emergency medical services (EMS)
providers that transfer neonatal patients to or from the designated neonatal
facility;
(B) the hospitals to
which it customarily transfers out or transfers in neonatal patients;
(C) applicable PCRs and RACs; and
(D) the department.
(2) If the designated neonatal facility is
unable to meet the requirements to maintain its current designation, it must
submit to the department a POC as described in subsection (a)(1)(D) of this
section, and a request for a temporary exception to the designation
requirements. Any request for an exception must be submitted in writing from
the facility's Chief Executive Officer and define the facility's timeline to
meet the designation requirements. The department reviews the request and the
POC, and either grants the exception with a specific timeline based on the
public interest, geographic maternal care capabilities, and access to care, or
denies the exception. If the facility is not granted an exception or it does
not meet the designation requirements at the end of the exception period, the
department will elect one of the following:
(A) re-designate the facility at the level
appropriate to its revised capabilities;
(B) outline an agreement with the facility to
satisfy all designation requirements for the level of care designation within a
time specified under the agreement, which may not exceed the first anniversary
of the effective date of the agreement; or
(C) waive one specific designation
requirement for a level of care designation if the facility meets all other
designation requirements for the level of care designation and the department
determines the waiver is justified considering:
(i) the expected impact on accessibility of
neonatal care in the geographic area served by the facility if the waiver is
not granted and the expected impact on the quality of care and patient safety;
or
(ii) whether these services can
be met by other facilities in the area or with telehealth/telemedicine
services.
(3)
Waivers expire with the expiration of the current designation but may be
renewed. The department may specify any conditions for ongoing reporting during
this time.
(4) The department
maintains a current list on its internet website of facilities that have
contingency agreements or an approved waiver with the department and an
aggregated list of the designation requirements conditionally met or
waived.
(5) Facilities that have
contingency agreements or an approved waiver with the department must post on
the facility's internet website the nature and general terms of the
agreement.
(s) An
application for a higher or lower level of neonatal designation may be
submitted to the department at any time.
(1) A
designated neonatal facility that is increasing its neonatal capabilities may
choose to apply for a higher-level of designation at any time. The facility
must follow the designation process as described in subsection (a)(1) and (2)
of this section to apply for the higher-level.
(2) A designated neonatal facility that is
unable to maintain the facility's current level of neonatal designation may
choose to apply for a lower level of designation at any time.
(t) If the facility is
relinquishing its neonatal designation, the facility must provide 30 days
written, advance notice of the relinquishment to the department, the applicable
PCRs/RACs, EMS providers, and facilities it customarily transfers out or
transfers in neonatal patients. The facility is responsible for continuing to
provide neonatal care services or ensuring a plan for neonatal care continuity
for the 30 days following the written notice of relinquishing its neonatal
designation.
(u) A hospital
providing neonatal services must not use the terms "designated neonatal
facility" or similar terminology in its signs, advertisements, facility
internet website, social media, or in the printed materials and information it
provides to the public, unless the facility is currently designated at that
level of neonatal care.
(v) During
a virtual, on-site, or focused designation review, conducted by the department
or survey organization, the department or surveyor has the right to review and
evaluate neonatal patient records, neonatal multidisciplinary QAPI Plan
documents, and any action specific to improving neonatal care and outcomes, as
well as any other documents relevant to neonatal care in a designated neonatal
facility or facility seeking neonatal designation to validate designation
requirements are met.
(w) The
department and survey organization will comply with all relevant laws related
to the confidentiality of records.
(x) The department may deny, suspend, or
revoke designation if a designated neonatal facility ceases to provide services
to meet or maintain the designation requirements of this section.
