| (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 Cont'd... |
