Current through Reg. 49, No. 38; September 20, 2024
(a) The department ensures that stroke
facility designation promotes the goal, objective, and purpose of the stroke
system.
(1) The goal of the stroke system is
to reduce the morbidity and mortality of the stroke victim, subsequently
referred to as a stroke patient.
(2) The objective of the stroke system is to
improve the overall care of stroke patients by rapidly recognizing the signs of
a stroke and transporting the potential stroke patient to the appropriate level
of stroke facility, in the appropriate time, with the appropriate level of
resources.
(b) The
department determines requirements for the levels of stroke facility
designation. Hospitals seeking stroke facility designation must demonstrate
compliance to department-approved national stroke standard requirements located
on the DSHS EMS/Trauma Systems Stroke Designation Webpage:
https://dshs.texas.gov/emstraumasystems/stroke.shtm.
Hospitals must have compliance with the requirements validated by a
department-approved survey organization. The hospital must submit:
(1) a completed application for the stroke
facility designation, and an annual summary of the stroke Quality Assessment
and Performance Improvement (QAPI) plan;
(2) the documented stroke designation site
survey summary that includes the requirement compliance findings and the
medical record summaries;
(3)
evidence of successful verification issued by the survey organization;
and
(4) full payment of the
non-refundable, non-transferrable designation fee located on the DSHS
EMS/Trauma Systems Stroke Designation Webpage:
https://dshs.texas.gov/emstraumasystems/stroke.shtm.
(c) Minimum requirements for
stroke designation.
(1) Health care
facilities eligible for stroke designation include:
(A) a hospital in Texas, licensed or
otherwise meeting the description in accordance with Chapter 133 of this title
(relating to Hospital Licensing);
(B) a hospital owned and operated by the
State of Texas; or
(C) a hospital
owned and operated by the federal government in Texas.
(2) Each hospital shall demonstrate the
capability to provide stabilization and transfer or treatment for an acute
stroke patient, written stroke standards of care, and a written stroke QAPI
plan.
(3) Each hospital operating
on a single hospital license with multiple locations (multi-location license)
may apply for stroke designation separately by physical location for each
designation.
(A) Hospital departments or
services within a hospital shall not be designated separately.
(B) Hospital departments located in a
separate building, which is not contiguous with the designated facility, shall
not be designated separately.
(C)
Each emergency department of a hospital operating on a single hospital license
must provide the same level of emergency stroke care for patients.
(D) Stroke designation is issued for the
physical location and to the legal owner of the operations of the designated
facility and is non-transferable.
(4) If applicable, the designated stroke
facility shall include stroke patients received at the non-contiguous
departments in the facility's stroke database and stroke performance
improvement process.
(d)
The four levels of stroke designation and the requirements for each are:
(1) Comprehensive (Level I) stroke
designation. The hospital must meet the department-approved national stroke
standards of care for a Comprehensive Stroke Center, participate in the
hospital's Regional Advisory Council (RAC) and regional stroke plan, and submit
data to the department as requested.
(2) Advanced (Level II) stroke designation.
The hospital must meet the department-approved national stroke standards of
care for a non-Comprehensive Thrombectomy Stroke Center, participate in the
hospital's RAC and regional stroke plan, and submit data to the department as
requested.
(3) Primary (Level III)
stroke designation. The hospital must meet the department-approved national
stroke standards of care for a Primary Stroke Center, participate in the
hospital's RAC and regional stroke plan, and submit data to the department as
requested.
(4) Acute Stroke-Ready
(Level IV) stroke designation. The hospital must meet the department-approved
national stroke standards of care for an Acute Stroke-Ready Center, participate
in the hospital's RAC and regional stroke plan, and submit data to the
department as requested.
(e) Designation of a hospital as a stroke
facility is valid for the length of the approved stroke survey organization's
stroke certification.
(f) A
hospital seeking stroke facility designation must undergo an onsite or virtual
survey as outlined in this section.
(1) The
hospital is responsible for scheduling a stroke designation survey through a
department-approved survey organization. Approved survey organizations are
located on the DSHS EMS/Trauma Systems Stroke Designation Webpage:
https://dshs.texas.gov/emstraumasystems/stroke.shtm.
(2) The hospital provides written or
electronic notification to the department of the stroke designation survey date
a minimum of 30 days prior to the survey.
(3) The hospital is responsible for expenses
associated with the stroke designation survey.
(4) The hospital does not accept surveyors
with any conflict of interest. If a conflict of interest is present, the
hospital must decline the assigned surveyor through the surveying organization.
A conflict of interest exists when the surveyor has a current or past
relationship with the hospital or key hospital staff members to the degree that
the relationship may appear to cause bias. The conflict of interest includes a
previous working relationship, residency training, or participation in a
consultation program for the hospital within the past five years.
(5) The department, at its discretion, may
appoint an observer to accompany the survey team, with the observer costs borne
by the department.
(6) The survey
team evaluates the hospital's compliance with the department-approved national
stroke standards of care requirements and documents all noncompliance issues
identified in the survey report and patient care reviews. The surveyors must
review ten stroke patient medical record reviews and the associated QAPI
related documents and summarize these reviews to include in the hospital's
stroke facility designation application.
(7) The hospital shall provide the survey
team access to records regarding the QAPI plan to include peer review
activities related to the stroke patient. Failure to provide access to these
records will result in a determination by the department that the hospital
seeking stroke facility designation is not in compliance with Texas Health and
Safety Code, Chapter 773, and the rules in this chapter.
(g) A hospital seeking stroke facility
designation must submit a completed application packet.
(1) The completed application packet
includes:
(A) an accurate and complete stroke
designation application for the requested level of designation and an annual
summary of the stroke QAPI plan;
(B) full payment of the non-refundable,
non-transferrable designation fee located on the DSHS EMS/Trauma Systems Stroke
Designation Webpage:
https://dshs.texas.gov/emstraumasystems/stroke.shtm;
(C) the documented stroke designation site
survey summary that includes the requirement compliance findings and the
medical record summaries, and the report is submitted to the department no
later than 60 days after the stroke site survey date;
(D) evidence of successful verification
issued by the survey organization;
(E) if required by the department, a plan of
correction (POC) that addresses all requirements with identified non-compliance
findings in the survey report and the POC shall include:
(i) a statement identifying the specific
designation requirement the facility has not met or is in
non-compliance;
(ii) a statement
describing the corrective action by the facility seeking stroke facility
designation to ensure compliance with the defined requirement;
(iii) the title of the individuals
responsible for ensuring the corrective actions are implemented;
(iv) the date the corrective actions will be
implemented;
(v) how the corrective
actions will be monitored;
(vi)
supporting documentation of the requirement reaching compliance; and
(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.
