| (a) A facility seeking maternal designation or renewal
of designation must submit a completed application packet.
(1) The completed application packet includes:
(A) an accurate and complete maternal designation application
for the requested level of designation;
(B) a completed maternal attestation and self-survey
report for Level I applicants or the documented maternal designation
site survey summary that validates that department-approved designation
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 maternal designation site survey date;
(C) If the facility has three or more department-approved
designation requirements that are defined as not met, the facility
must contact the department's designation unit within 10 business
days to discuss the Plan of Correction (POC).
(D) if required by the department, a POC that addresses
all designation requirements defined as "not met" in the maternal
designation site survey summary. The POC must include:
(i) a statement of the cited designation requirement
not met;
(ii) a statement describing the corrective action taken
by the facility seeking maternal 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 maternal facility applicants, the fees
are as follows:
(i) ≤100 licensed beds, the fee is $250.00; or
(ii) >100 licensed beds, the fee is $750.00.
(B) Level II maternal facility applicants, the fee
is $1,500.00.
(C) Level III maternal facility applicants, the fee
is $2,000.00.
(D) Level IV maternal facility applicants, the fee
is $2,500.00.
(b) The application will not be processed if a facility
seeking maternal designation fails to submit the required application
documents and total designation fee.
(c) The maternal designation renewal process, or a
request to designate at a different level of care, or a change in
ownership, or change in physical address requires the facility to
complete a designation renewal, which follows the same requirements
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 maternal designation
expiration date for all designation renewals.
(e) The facility has the right to withdraw its application
for maternal designation any time before a designation approval.
(f) The facility must seek maternal designation renewal
to maintain continual designation and prevent an interruption in designation.
(g) The facility's maternal designation will expire
if the facility fails to provide a complete maternal designation application
packet to the department.
(h) The maternal 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 maternal 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 maternal designation.
(j) The department defines the final maternal designation
level awarded to the facility and this designation may be different
than the level requested based on the maternal designation site survey
summary.
(k) If the department determines the facility meets
the requirements for maternal designation, the department provides
the facility with a designation award letter and a designation certificate.
(1) The facility must display its maternal 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 maternal designation
certificate. Any alteration voids maternal designation for the remainder
of that designation period.
(l) The survey organization must provide the facility
with a written, signed maternal designation site survey summary, including
medical record reviews, regarding their evaluation and validation
of the facility's demonstration that maternal designation requirements
are met. This maternal 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
maternal 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 maternal 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 requirement.
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
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 maternal 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 maternal facility must provide written
or electronic notification of any significant change to the maternal
program impacting patient care. The notification must be provided
to the following:
(A) all emergency medical services (EMS) providers
that transfer maternal patients to or from the designated maternal
facility;
(B) the hospitals to which it customarily transfers
out or transfers in maternal patients;
(C) applicable PCRs and RACs; and
(D) the department.
(2) If the designated maternal facility is unable to
comply with requirements to maintain its current designation, it must
submit to the department a POC as described in subsection (a)(1)(D)(i)
- (vi) 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 Chief Executive Officer of the facility
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 maternal
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 their
internet website of designated facilities that have an approved waiver
with the department and an aggregated list of the requirements 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 maternal
designation may be submitted to the department at any time.
(1) A designated maternal facility that is increasing
its maternal 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 maternal facility that is unable to
maintain the facility's current level of maternal designation may
choose to apply for a lower level of designation at any time.
(t) If the facility is relinquishing its maternal 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 maternal patients. The
facility is responsible for continuing to provide maternal care services
or ensuring a plan for maternal care continuity for the 30 days following
the written notice of relinquishing its maternal designation.
(u) A hospital providing maternal services must not
use the terms "designated maternal 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 maternal
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 maternal patient
records, maternal multidisciplinary QAPI Plan documents, and any action
specific to improving maternal care and outcomes, as well as any other
documents relevant to maternal care in a designated maternal facility
or facility seeking maternal facility 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 maternal facility ceases to provide services to meet
or maintain the designation requirements of this section.
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