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