| (vii) corrective actions that will be implemented within
60 days from the date the facility seeking stroke facility designation
received the official survey summary report;
(F) written evidence of participation in the applicable
RACs; and
(G) any additional documents requested by the department.
(2) If a hospital seeking stroke facility designation
fails to submit the required application documents and fee listed
in paragraph (1) of this subsection, the application will not be processed.
(3) The stroke facility designation renewal process,
a request to change the level of designation, or a change in ownership
requiring re-designation follows the same requirements outlined in
paragraph (1) of this subsection.
(A) The hospital must submit the required documents
described in paragraph (1) of this subsection to the department no
later than 90 days before the facility's stroke designation expiration
date.
(B) The hospital must submit the stroke designation
fee in full payment with the required application documents.
(4) The hospital has the right to withdraw its application
for stroke facility designation any time before being recommended
for designation by the department.
(5) The hospital must submit an application packet
to renew its stroke facility designation no later than 90 days before
the facility's stroke designation expiration date.
(6) The facility's stroke designation will expire if
the facility fails to provide a complete stroke designation application
packet to the department by its current designation's expiration date.
(7) The stroke designation application packet, in its
entirety, must be written as an element of the facility's QAPI plan
and subject to confidentiality as described in Texas Health and Safety
Code, §773.095.
(8) The department reviews the application packet to
determine the recommended stroke facility designation.
(9) The department determines the final stroke facility
designation level awarded to the hospital. The designation level may
be different than the level requested based on the documented stroke
designation site survey summary that includes the requirement compliance
findings and the medical record summaries.
(10) If the department determines the hospital meets
the requirements for stroke facility designation, the department provides
the hospital with a designation award letter and a designation certificate.
(A) The hospital shall display its stroke facility
designation certificate in a public area of the licensed premises
that is readily visible to patients, employees, and visitors.
(B) The hospital shall not alter the stroke facility
designation certificate. Any alteration voids stroke designation for
the remainder of that designation period.
(h) If a hospital disagrees with the department's decision
regarding its designation status, the hospital has a right to a hearing,
in accordance with Texas Government Code, Chapter 2001.
(i) Exceptions and Notifications.
(1) A designated stroke facility must provide written
or electronic notification of any temporary event or decision preventing
the facility from complying with requirements of its current stroke
designation level. This notification shall outline the stroke facility
requirements the facility is not able to maintain compliance with
and be provided to the following:
(A) all emergency medical services (EMS) providers
that transfer stroke patients to or from the designated stroke facility;
(B) the health care facilities to which it customarily
transfers-out or transfers-in stroke patients;
(C) applicable RACs; and
(D) the department.
(2) If the designated stroke facility has an interruption
in capabilities or capacity critical to the evaluation and treatment
of a stroke patient, the facility will immediately notify local EMS
providers, referring facilities, and their RAC by written or electronic
communication with time-stamp capabilities, a phone call to their
local medical control, and change their status through the RAC communication
system such as EMResources or WEBEOC. This notification must occur
within 60 minutes of the recognition of the loss in capabilities.
(3) If the designated stroke facility is unable to
comply with requirements to maintain its current designation status,
it shall submit to the department a POC as described in subsection
(g)(1)(E) of this section, and a request for a temporary exception
to the requirements. Any request for an exception shall be submitted
in writing from the chief executive officer of the facility and define
the facility's plan of correction with a timeline to become compliant
with the stroke facility requirements. The department shall review
the request and the POC, and either grant the exception, with a specific
timeline based on the public interest, or deny the exception. If the
facility is not granted an exception, or it is not compliant to the
requirements at the end of the exception period, the department shall
elect one of the following:
(A) re-designate the facility at the level appropriate
to its revised capabilities; or
(B) accept the facility's surrender of its stroke facility
designation certificate and designation award letter after the requirements
in subsection (k) of this section have been completed.
(j) An application for a higher or lower level of stroke
facility designation may be submitted to the department at any time.
(1) A designated stroke facility that is increasing
its stroke 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 (g)(1) of this section to apply
for the higher level.
(2) A designated stroke facility that is unable to
maintain compliance with the facility's current level of stroke designation
may choose to apply for a lower level of designation at any time.
(k) If the facility chooses to relinquish its stroke
facility designation, the facility shall provide a 30 days written,
advance notice prior to the relinquishment of the designation to the
department, the applicable RACs, EMS providers, and health care facilities
it customarily transfers-out or transfers-in stroke patients. The
facility is responsible to continue providing stroke care services
and ensure that stroke care continuity for the region remains in place
for the 30 days following the notice of relinquishing its stroke designation.
(l) A hospital shall not use or authorize the use of
any public communication or advertising containing false, misleading,
or deceptive claims regarding its stroke designation status. Public
communication or advertising shall be deemed false, misleading, or
deceptive if the facility uses these terms:
(1) "stroke facility," "stroke hospital," "stroke center,"
or similar terminology and the facility is not currently designated
as a stroke facility in accordance with this section; or
(2) "comprehensive Level I stroke center," "advanced
Level II stroke center," "primary Level III stroke center," "acute
stroke ready Level IV center," or similar terminology in its signs,
advertisements or in the printed materials the facility provides to
the public, unless the hospital is currently designated at that defined
level of stroke facility in accordance with this section.
(m) The department has the right to review, inspect,
evaluate, and audit all stroke patient records, stroke multidisciplinary
QAPI plan documents, and peer review activities, as well as, any other
documents relevant to stroke care in a designated stroke facility
or facility seeking stroke facility designation at any time to verify
compliance with the Texas Health and Safety Code, Chapter 773 and
this section.
(n) The department maintains confidentiality of such
records to the extent authorized by Texas Government Code, Chapter
552.
(o) Stroke designation site review of the hospital
applying for stroke facility designation will be scheduled with the
department-approved survey organization and follow the department
survey guidelines.
(p) The department may deny, suspend, or revoke a stroke
facility designation if a designated stroke facility ceases to provide
services to meet or maintain compliance with the requirements of this
section or if it violates the Chapter 133 of this title, concerning
requirements resulting in enforcement action.
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