PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 157. EMERGENCY MEDICAL CARE
SUBCHAPTER G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
The Executive Commissioner of the Health and Human Services Commission (commission) on behalf of the Department of State Health Services (department) adopts new §157.133, concerning the requirements for stroke facility designation. New §157.133 is adopted with changes to the proposed text as published in the April 10, 2009, issue of the Texas Register (34 TexReg 2366).
BACKGROUND AND PURPOSE
The new rule is necessary to comply with Senate Bill 330, 79th Legislature, 2005, Regular Session, that amended Health and Safety Code, §773.204 and §773.205, which require the Governor's Emergency Medical Services (EMS) and Trauma Advisory Council (GETAC), with the assistance of its Stroke Committee and in collaboration with the Texas Council on Cardiovascular Disease and Stroke (TCCDS), to develop stroke facility criteria and a statewide stroke emergency transport plan; and Acts, 2003, 78th Legislature, Regular Session, Chapter 198 (House Bill 2292), §2.42, added Health and Safety Code, §12.0111, which requires the department to charge a fee sufficient to cover the cost of administering and enforcing the stroke designation program.
SECTION-BY-SECTION SUMMARY
The rule describes how hospitals will qualify for stroke facility designation after they have been accredited by The Joint Commission and how the 22 regional advisory councils may develop regional stroke system plans to include stroke emergency transport plans that must include: (1) training requirements on stroke recognition and treatment, including emergency screening procedures; (2) a list of appropriate early treatments to stabilize patients; (3) protocols for rapid transport to a stroke facility when rapid transport is appropriate and it is safe to bypass another health care facility; (4) plans for coordination with statewide agencies or committees on programs for stroke prevention and community education regarding stroke and stroke emergency transport; and (5) a $100 nonrefundable application fee for each hospital seeking stroke designation.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rule during the comment period, which the commission has reviewed and accepts. The department received comments from two individuals during the comment period. The commenters were not against the rule in its entirety; however, one commenter recommended changes, while the second commenter asked for clarification of the rule.
Comment: Concerning the Support (Level III) Stroke Facility Designation Criteria table in Figure 25 TAC, §157.133(a)(3), (Part A.2.e.iii.- iv.), one commenter recommended that the Stroke Nurse Coordinator continuing education and the National Institutes of Health Stroke Scale (NHISS) certification requirements be incorporated into Figure 25 TAC, §157.133(a)(3) (Part 2.c.).
Response: The commission agrees and language has been revised to reflect the changes.
Comment: Concerning the Support (Level III) Stroke Facility Designation Criteria table in Figure 25 TAC, §157.133(a)(3), (Part A.1.), one commenter suggested a change to include the following language, "All Stroke Medical Director responsibilities and qualifications shall be incorporated in the Stroke Medical Director's job description."
Response: The commission disagrees with the suggested revision to the rule language. It is the responsibility of the facility's governing body to determine the content of the job description. No change was made as a result of the comment.
Comment: Concerning the Support (Level III) Stroke Facility Designation Criteria in Figure 25 TAC, §157.133(a)(3), (Part D.5.), one commenter suggested a change to include language that assigns a timeline from 6 to 12 months for nursing staff to achieve credentials and/or competencies in Advanced Cardiac Life Support (ACLS), NIHSS, dysphagia screening and thrombolytic therapy administration.
Response: The commission disagrees with the suggested revision to the rule language, as the current language is not time sensitive. No change was made as a result of the comment.
Comment: Concerning the Support (Level III) Stroke Facility Designation Criteria in Figure 25 TAC, §157.133(a)(3), (Part G.1.), one commenter suggested that to achieve consistency with other documents/rules on a three-year rolling period for re-designating hospitals, and on-site re-certification visits should occur every four years.
Response: The commission disagrees with the suggested change, as submitted. However, the comment did point out confusion concerning facilities seeking initial versus designated facilities; therefore, changes were made to clarify the criteria in §157.133(a)(3) as follows: (Part G.1.), the phrase "seeking initial designation" was added to clarify performance improvement (PI) limited to facilities seeking initial designation; (Part G.2.), the statement "A designated stroke facility must have an ongoing PI program that includes at a minimum" was added to clarify the minimums for designated facilities; and in (Part G.3.), a paragraph was added to clarify the parameters for performance improvement for both initial and designated facilities.
Comment: Concerning the two-year designation of a healthcare facility as a stroke facility in §157.133(d), one commenter suggested that the rule designate stroke facilities for a period of three or four years. Further, the commenter suggested that at the mid-point of the designation cycle, the hospital should provide an attestation from the Chief Executive Officer that the program remains functional, meets essential criterion, and that there have been no significant changes in the program and/or leadership. The commenter asserted that a two-year certification requirement would place the hospital in a near perpetual state of survey preparation and readiness, and the expense would be demanding for many small-town low-volume hospitals.
Response: The commission disagrees with the suggested revision to the rule language. Language in §157.33(k) requires a facility seeking designation to be surveyed by The Joint Commission (TJC) stroke certification program or other organization approved by the department. TJC certification is currently issued for a two-year period, resulting in a two-year resurvey schedule for the facility to maintain certification. The department's designation program will remain consistent with TJC schedule. By becoming designated, the facility agrees to maintain compliance with the requirements for designation at all times, not just at the time of survey. No changes were made as a result of the comments.
Comment: One commenter suggested the inclusion of a definition of "stroke patient" based on specific International Classification of Disease (ICD) -9 codes.
Response: The commission disagrees with the suggested change because of the potential for these codes to change. Including a definition based on other parameters and taking into account the current controversy related to the inclusion/exclusion of transient ischemic attack (TIA) as stroke, the department feels this would be a substantive change. No change was made as a result of the comment.
Comment: Concerning §157.133(f)(4) and (5), one commenter asked for clarification concerning what is in the "survey" ("stroke designation survey" and "complete survey report") that the hospitals need to submit for designation or re-designation.
Response: The survey is conducted by an external organization identified in §157.133(k) as, "The Joint Commission or other organization approved by the department." The completed survey report is the survey organization's report and includes the facility's responses to any identified deficiencies or recommendations.
Comment: Concerning §157.133(r), one commenter requested clarification concerning denial, suspension or revocation of designation, and asked, "How will the department know if a stroke facility does or does not 'meet and maintain standards'?"
Response: This is accomplished in two ways. First, the purpose of the survey activity is to verify compliance with the requirements. A survey is required every two years as part of the "re-designation" process. Secondly, §157.133(m) outlines self-reporting requirements for a facility failing to maintain critical essential criteria outlined in subsection (m).
Comment: Concerning §157.133(t)(3)(I)(iv), one commenter requested clarification concerning regional stroke guidelines, and asked, "What is the "individual entity" whose medical director will review the data for appropriateness and quality of care? Who reviews each stroke patient's case?"
Response: The individual entity is the designated stroke facility. The medical director is the physician responsible for the clinical oversight of the stroke program.
Comment: Concerning the table in §157.133(a)(3), Figure 25 TAC §157.133(a)(3), one commenter wrote that no figure appeared in the document, therefore no description of the criteria and no definition for "support stroke facility" could be found.
Response: Graphic images included in the PDF (Adobe) version of the rule are published separately in a tables and graphics section in the Texas Register. To access the table with the criteria for §157.133(a)(3), go to http://www.sos.state.tx.us/texreg/index.shtml, then to Previous Issues (right side of page - HTML version), go to the April 10, 2009 issue, then select the "Tables and Graphics" link and the table will appear. The HTML version has a clickable link within the rule language that will take the reader to the table containing the criteria part of this rule.
The following changes have been made to provide consistency of terms to further clarify the intent of the rule.
Concerning §157.133(a)(1) and (2), the phrase "essential criteria for an accredited comprehensive stroke center" was removed and replaced with "recommendations" to reflect that the criteria will be the current Brain Attack Coalition recommendations; the title of the table in Figure 25 TAC, §157.133(a)(3) was amended to clarify the intent of the document; and the rule text in subsection (a)(3) was amended to reflect the title of the table in Figure 25 TAC, §157.133(a)(3).
Concerning §157.133(k), the words "a comparable" were deleted and replaced with the word "other" and the phrase "...to verify that the facility is meeting department...standards" was added to allow the department to review other survey organizations that may not necessarily be comparable to TJC, but yet are capable of verifying the facility's meeting of department standards.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rule, as adopted, has been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
SUBCHAPTER G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS.
STATUTORY AUTHORITY
The new rule is authorized by Health and Safety Code, Chapter 773, Emergency Medical Services, which provides the department with the authority to adopt rules to implement the Emergency Medical Services Act; Health and Safety Code, §12.0111, which requires the department to charge a fee sufficient to cover the cost of administering and enforcing the stroke designation program; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
§157.133.Requirements for Stroke Facility Designation.
(a) The Office of Emergency Medical Services (EMS)/Trauma Systems Coordination (office) shall recommend to the Commissioner of the department (commissioner) the designation of an applicant/healthcare facility (facility) as a stroke facility at the level(s) for each location of a facility the office deems appropriate.
(1) Comprehensive Stroke Facility designation, Level I--The facility, including a free-standing children's facility, meets the current Brain Attack Coalition recommendations; actively participates on the appropriate Regional Advisory Council (RAC); and submits data to the department as requested.
(2) Primary Stroke Facility designation, Level II--The facility, including a free-standing children's facility, meets the current Brain Attack Coalition recommendations; actively participates on the appropriate RAC; and submits data to the department as requested.
(3) Support Stroke Facility designation, Level III--The facility, including a free-standing children's facility, meets the Support Stroke Facility Designation Criteria (in the following Figure) for an accredited support stroke facility; actively participates on the appropriate RAC; and submits data to the department as requested.
(b) A healthcare facility is defined under these rules as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license. Each location shall be considered separately for designation.
(c) The designation process shall consist of three phases.
(1) First phase. The application phase begins with submitting to the office a timely and sufficient application for designation as a stroke facility and ends when the survey report is received by the office.
(2) Second phase. The review phase begins with the office's review of the survey report and ends with its recommendation to the commissioner whether or not to designate the facility.
(3) Third phase. The final phase begins with the commissioner reviewing the recommendation and ends with his/her final decision.
(d) Designation of a healthcare facility as a stroke facility is valid for two years.
(e) It shall be necessary to repeat the stroke designation process as described in this section prior to expiration of a facility's designation or the designation expires.
(f) A timely and sufficient application for a facility seeking initial designation shall include:
(1) the department's current "Complete Application" for the requested level of stroke facility designation, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered or sent by postal services to the office;
(2) full payment of the non-refundable $100 designation fee enclosed with the submitted "Complete Application" form;
(3) any subsequent documents submitted by the date requested by the office;
(4) a stroke designation survey completed within one year of the date of the receipt of the application by the office; and
(5) a complete survey report, including patient care reviews, that is within 180 days of the date of the survey and is hand-delivered or sent by postal services to the office.
(g) If a healthcare facility seeking initial designation fails to meet the requirements in subsection (f)(1) - (5) of this section, the application shall be denied.
(h) A timely and sufficient application for a stroke facility seeking redesignation shall include:
(1) the department's current "Complete Application" form for the requested level of stroke facility designation, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered or sent by postal services to the office one year or greater before the designation expiration date;
(2) full payment of the non-refundable $100 designation fee enclosed with the submitted "Complete Application" form;
(3) any subsequent documents submitted by the date requested by the office; and
(4) a complete survey report, including patient care reviews, that is within 180 days of the date of the survey and is hand-delivered or sent by postal services to the office no less than 60 days prior to the designation expiration date.
(i) If a healthcare facility seeking redesignation fails to meet the requirements outlined in subsection (h)(1) - (4) of this section, the original designation will expire on its expiration date.
(j) The office's analysis of the submitted "Complete Application" form may result in recommendations for corrective action when deficiencies are noted and shall also include a review of:
(1) evidence of current participation in RAC/regional system planning; and
(2) the completeness and appropriateness of the application materials submitted, including the submission of a non-refundable application fee of $100.
(k) Facilities seeking Comprehensive, Primary or Support stroke facility designation shall be surveyed through The Joint Commission's stroke certification program or other organization approved by the department to verify that the facility is meeting department-approved relevant stroke facility standards.
(l) A designated stroke facility shall:
(1) comply with the provisions within this rule, all current state and regional stroke system standards as described in this chapter, and all policies, protocols, and procedures as set forth in the state stroke system plan; and
(2) continue to provide the resources, personnel, equipment, and response as required by its designation level.
(m) Designated stroke facilities failing to meet and/or maintain critical essential criteria outlined in this subsection, shall provide notification about such failings within five days to the office, its RAC, plus other affected RACs, EMS providers, and the healthcare facilities from which it receives and to which it transfers stroke patients:
(1) neurosurgery capabilities (Level I);
(2) neurointerventional surgery capabilities (Level I);
(3) neurology capabilities (Level I, II);
(4) anesthesiology (Levels I);
(5) emergency physicians (all levels);
(6) stroke medical director (all levels);
(7) stroke nurse coordinator/program manager (all levels); and
(8) stroke registry (all levels).
(n) If the facility chooses to apply for a lower level of stroke designation, it may do so at any time; however, it may be necessary to repeat the designation process. There shall be a paper review by the office to determine if and when a full survey shall be required.
(o) If the facility chooses to relinquish or change its stroke designation, it shall provide at least 30 days notice to the RAC and the office.
(p) A healthcare facility may not use the terms "stroke facility," "stroke hospital," "stroke center," "comprehensive stroke center," "primary stroke center," "support stroke facility" or similar terminology in its signs or advertisements or in the printed materials and information it provides to the public unless the healthcare facility is currently designated as that level of stroke facility according to the process described in this section.
(q) The office may review, inspect, evaluate, and audit all stroke patient records, stroke performance improvement, committee minutes, and other documents relevant to stroke care in any designated stroke facility or applicant/healthcare facility at any time to verify compliance with the statute and this rule, including the designation criteria.
(r) If a designated stroke facility fails to meet and/or maintain standards, outlined herein, or if it violates the department hospital licensing regulations, the department may deny, suspend or revoke the designation.
(s) A RAC should develop a stroke system plan based on standard guidelines for comprehensive system development. The stroke system plan is subject to review and approval by the department.
(t) The department may review the RAC's stroke system plan to assure that:
(1) all counties within the trauma service area (TSA) have been included unless a specific county, or portion thereof, has been aligned within an adjacent system;
(2) all health care entities and interested specialty centers have been given an opportunity to participate in the planning process; and
(3) the following components have been addressed:
(A) stroke prevention;
(B) access to the system;
(C) communications;
(D) medical oversight;
(E) pre-hospital triage criteria;
(F) diversion policies;
(G) bypass protocols--guidelines for the emergency transport of patients, who are eligible within the timeframe for United States Food and Drug Administration (FDA) approved stroke care therapies, to the highest state designated stroke center;
(H) regional medical control;
(I) regional stroke treatment guidelines:
(i) guidelines consistent with current standards shall be developed, implemented, and evaluated;
(ii) individual agencies and medical directors may, and are encouraged, to exceed the minimum standards;
(iii) stroke patients will be cared for by health professionals with documented education and skill in the assessment and care of stroke throughout their pre-hospital and hospital course;
(iv) stroke patients will have their medical care, as documented by pre-hospital run forms and hospital charts, reviewed by the individual entity's medical director for appropriateness and quality of care; and
(v) stroke patients will have deviations from standard of care addressed through a documented stroke performance improvement process.
(J) facility triage criteria;
(K) inter-hospital transfers;
(L) planning for the designation of stroke facilities, including the identification of the comprehensive, primary, and support stroke facilities; and
(M) a performance improvement program that evaluates processes and outcomes from a system perspective.
(u) Department approval of the completed stroke system plan may qualify health care entities participating in the system to receive state funding for stroke care if funding is available.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on August 10, 2009.
TRD-200903469
Lisa Hernandez
General Counsel
Texas Department of Health Services
Effective date: August 30, 2009
Proposal publication date: April 10, 2009
For further information, please call: (512) 458-7111 x6972