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 on behalf of the Department of State Health Services (department) proposes new §157.133, concerning the requirements for stroke facility designation.
BACKGROUND AND PURPOSE
The proposed 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 proposed 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.
FISCAL NOTE
Renee Clack, Section Director, Health Care Quality Section, has determined that for each year of the first five years that the section will be in effect, there may be an increase in revenue to state government. Since stroke designation is a voluntary process, it cannot be determined which year will have an increase in revenue because it depends upon when the stroke facilities will seek the stroke facility designation. The department estimates that 25 stroke facilities will seek stroke facility designation lasting for a period of two years. The 25 facilities will have to pay a $100 fee to redesignate every two years which will be an increase to the state. Existing resources within the department will be utilized to process and review applications, provide technical assistance, and recommend designation to the Commissioner.
There will be no fiscal implication to local governments as a result of enforcing or administering the section as proposed unless a local government operates a healthcare facility and voluntarily chooses to seek stroke designation. In that case, the local government will be required to comply with the rule and submit a $100 nonrefundable application fee. Once the rule is adopted, a local government that voluntarily seeks stroke facility designation will incur costs to become accredited by the Joint Commission. The cost associated with these proposed requirements, other than the $100 application fee, cannot be determined since the local market in which the local government resides will determine the fiscal impact on each healthcare facility.
MICRO-BUSINESS AND SMALL BUSINESS ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS
Ms. Clack has also determined that the number of healthcare facilities meeting the definition of a micro-business would likely be very low, but there could be a number of healthcare facilities meeting the definition of a small business. There will be no fiscal impact on micro-businesses and small businesses or persons unless they operate a healthcare facility and voluntarily choose to seek stroke designation. In that case, the micro-businesses and small businesses or persons will be required to comply with the rule and submit a $100 application fee. Once the rule is adopted, a micro-business or small business that seeks stroke facility designation will incur costs to become accredited by the Joint Commission. The cost associated with the proposed requirements, other than the $100 application fee, cannot be determined since the local market in which the small businesses or micro-businesses resides will determine the fiscal impact on each healthcare facility. Since the seeking of a stroke facility designation from the department would be a voluntary endeavor and not a requirement, there would be no fiscal impact to healthcare facilities not seeking designation and, therefore, a regulatory flexibility analysis is not required. There is no anticipated negative impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Clack has also determined that for each year of the first five years the section is in effect, the public will benefit from adoption of the section. The public benefit anticipated as a result of enforcing or administering the section is to construct a statewide emergency treatment system so that stroke victims may be rapidly identified and then transported to and treated in appropriate stroke treatment facilities. The proposed rule will allow for the development of an effective and resource-efficient plan to reduce the morbidity, mortality, and economic burden of cardiovascular disease and stroke in the state.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed new rule does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Jane Guerrero, Office of EMS/Trauma Systems Coordination, Health Care Quality Section, Division of Regulatory Services, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, (512) 834-6700, or by e-mail to jane.guerrero@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rule has been reviewed by legal counsel and found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed 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.
The proposed new rule affects Health and Safety Code, Chapters 12, 773, and 1001; and Government Code, Chapter 531.
§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 essential criteria for an accredited comprehensive stroke center; 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 essential criteria for an accredited primary stroke center; 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 essential 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.
Figure: 25 TAC §157.133(a)(3) (.pdf)
(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 request a survey through the Joint Commission's stroke certification program or a comparable organization approved by the department.
(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 proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 24, 2009.
TRD-200901168
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: May 10, 2009
For further information, please call: (512) 458-7111 x6972