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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 157EMERGENCY MEDICAL CARE
SUBCHAPTER GEMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
RULE §157.133Requirements for Stroke Facility Designation

(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

Cont'd...

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