HB 0889

1
A bill to be entitled
2An act relating to certified stroke treatment centers;
3providing legislative intent; providing definitions;
4directing the Department of Health to adopt, by a
5specified date, certain guidelines as minimal clinical
6standards for stroke treatment centers; directing the
7department to notify hospitals that are eligible to become
8certified stroke treatment centers; requiring a hospital
9wishing to become a stroke treatment center to file a
10letter of intent; directing such hospitals to file
11completed applications with the department by a specified
12date; directing the department to issue certificates to
13stroke treatment centers that meet the guidelines;
14authorizing the department to issue provisional
15certifications; providing that a stroke treatment center's
16certification automatically expires 2 years after the date
17of issuance; providing that a certification may be
18renewed; limiting the certification to the hospital to
19which it was issued; directing the department to post a
20listing of certified stroke treatment centers on its
21Internet website; requiring the department to mail the
22list to certain persons and entities; requiring a hospital
23to notify the department at least 6 months in advance of
24its decision to terminate stroke treatment; providing an
25exception; authorizing the department to collect stroke
26registry data for certain purposes; prohibiting a person
27from claiming that a facility is a stroke treatment center
28unless the facility is certified as provided by law;
29authorizing the department to inspect stroke treatment
30centers; requiring emergency medical services to transport
31identified stroke victims to certified stroke treatment
32centers; requiring the department to adopt rules;
33providing an effective date.
34
35     WHEREAS, stroke is the third leading killer in the United
36States and in Florida, and
37     WHEREAS, stroke is also the leading cause of serious long-
38term disability in this state, and
39     WHEREAS, 165,000 people die from stroke in the United
40States every year, including 10,000 persons in this state, and
41     WHEREAS, 60 percent of death from strokes occurs in women,
42and
43     WHEREAS, approximately 4.5 million survivors of stroke are
44alive today, and as many as 25 percent are permanently disabled,
45and
46     WHEREAS, nearly 30 percent of all people who suffer a
47stroke are under age 65, and
48     WHEREAS, it is estimated that strokes cost the United
49States nearly $50 billion a year in total costs, with direct
50costs estimated at $28 billion, and
51     WHEREAS, the state Medicaid budget pays a significant share
52of the direct cost of stroke, and
53     WHEREAS, as the population ages, death and disability from
54stroke will increase dramatically if this state does not
55implement strategies that will improve the survival of victims
56of stroke in all communities across this state, and
57     WHEREAS, emergency medical services may be transporting
58stroke victims to hospitals that are not properly equipped to
59provide timely and effective treatment for stroke victims, and
60     WHEREAS, many hospitals are not properly equipped to render
61timely and effective treatment for stroke victims, and
62     WHEREAS, many hospitals that treat stroke victims do not
63discharge stroke patients with the proper information and tools
64on how to prevent recurrent strokes, NOW, THEREFORE,
65
66Be It Enacted by the Legislature of the State of Florida:
67
68     Section 1.  Legislative intent.--
69     (1)  The Legislature finds that rapid identification,
70diagnosis, and treatment of ischemic stroke can save the lives
71of stroke victims and in many cases can reverse paralysis,
72leaving them with few or no neurological deficits.
73     (2)  The Legislature further finds that a strong system for
74stroke survival is needed in the state's communities in order to
75treat stroke victims in a timely manner and to improve the
76overall treatment of stroke victims. Therefore, the Legislature
77intends to construct an emergency treatment system in this state
78in order that stroke victims may be quickly identified and
79transported to and treated in appropriate stroke treatment
80facilities.
81     Section 2.  Definitions.--As used in this act, the term:
82     (1)  "Accrediting organization" means the Joint Commission
83on Accreditation of Healthcare Organizations, the American
84Osteopathic Association, the Commission on Accreditation of
85Rehabilitation Facilities, or the Accreditation Association for
86Ambulatory Health Care, Inc.
87     (2)  "Certified stroke treatment center" or "stroke
88treatment center" means any hospital licensed under chapter 395,
89Florida Statutes, that meets the guidelines adopted by the
90department to provide minimum standards for the 24-hour-a-day,
91year-round emergency treatment of ischemic stroke. The term
92includes all levels of stroke treatment centers certified by the
93department, including primary and comprehensive stroke centers.
94     (3)  "Comprehensive stroke center" means any hospital
95licensed under chapter 395, Florida Statutes, that meets the
96guidelines adopted by the department to treat stroke patients
97who require a high intensity of medical and surgical care. These
98standards shall include, but not be limited to, the hospital's
99meeting all criteria for a primary stroke center and having
100health care personnel available with specific expertise in
101neurosurgery and vascular neurology, advanced neuroimaging
102capabilities, surgical and endovascular techniques, and other
103specific infrastructure and programmatic elements such as an
104intensive care unit.
105     (4)  "Department" means the Department of Health.
106     (5)  "Hospital" means any establishment that:
107     (a)  Offers services more intensive than those required for
108room, board, personal services, and general nursing care and
109offers facilities and beds for use beyond 24 hours by
110individuals requiring diagnosis, treatment, or care for illness,
111injury, deformity, infirmity, abnormality, disease, or
112pregnancy.
113     (b)  Regularly makes available, at a minimum, clinical
114laboratory services, diagnostic X-ray services, and treatment
115facilities for surgery or obstetrical care, or other definitive
116medical treatment of a similar extent.
117
118The term does not include an institution conducted by or for the
119adherents of any well-recognized church or religious
120denomination that depends exclusively upon prayer or spiritual
121means to heal, care for, or treat any person.
122     (6)  "Primary stroke center" means any hospital licensed
123under chapter 395, Florida Statutes, that meets the guidelines
124adopted by the department to provide minimum standards for the
12524-hour emergency treatment of stroke victims. These standards
126shall include, but not be limited to, the hospital's having on
127duty acute stroke teams with the ability to administer
128intravenous thrombolytics, the availability and interpretation
129of computed tomography scans 24 hours each day, rapid laboratory
130testing, and use of a stroke registry in order to monitor
131performance of stroke care.
132     (7)  "Validation inspection" means an inspection of the
133premises of a certified stroke treatment center by the
134department to assess whether a review by an accrediting
135organization has adequately evaluated the certified stroke
136treatment center according to the department's minimum
137standards.
138     Section 3.  Stroke treatment center hospitals;
139certification guidelines.--The department shall adopt by rule
140one or more sets of guidelines published by nationally
141recognized stroke centers no later than January 1, 2005. The
142guidelines adopted by the department shall be the minimum
143clinical standards in this state for treating ischemic stroke
144patients. The department may adopt guidelines for certifying
145different levels of stroke treatment centers, including primary
146and comprehensive stroke centers.
147     Section 4.  Certified stroke treatment centers; selection;
148quality assurance; records.--
149     (1)(a)  The department shall annually notify each acute
150care general hospital in the state that the department is
151accepting letters of intent from any hospital that proposes to
152become a stroke treatment center. To be eligible for
153certification as a stroke treatment center, a hospital must
154state that its intent to operate as a stroke treatment center is
155consistent with the certification guidelines adopted by the
156department. Letters of intent must be postmarked by midnight on
157October 1 of each year.
158     (b)  The department shall send an application package to
159any hospital submitting a letter of intent by October 15. The
160application package shall include instructions for submitting
161specified information to the department in order to become a
162stroke treatment center. The certification guidelines adopted by
163the department shall be the basis for these instructions.
164     (c)  Completed applications from a hospital must be
165received by the department by April 1 of each year. The
166department shall review each application to determine whether
167the hospital's application is complete and whether the hospital
168meets the department's guidelines for certification as a stroke
169treatment center as either a primary or comprehensive stroke
170center.
171     (d)  On April 30 of each year, a hospital must be certified
172as a stroke treatment center if the hospital meets the
173requirements set forth in this act.
174     (e)  The department may issue a provisional certification
175to a new stroke treatment center or to a renewing stroke
176treatment center that is in substantial compliance with this act
177and the rules of the department. A provisional certification may
178be granted for not more than 1 year and expires automatically at
179the end of its term. A provisional certification may not be
180renewed.
181     (f)  A hospital may protest a decision made by the
182department based on the department's review of an application
183pursuant to this section and shall proceed as provided in
184chapter 120, Florida Statutes. A hearing held under this section
185shall be conducted in the same manner as provided in ss. 120.569
186and 120.57, Florida Statutes. The case filed under chapter 120,
187Florida Statutes, may combine all disputes between parties.
188     (2)  A stroke treatment center's certification, unless
189sooner suspended or revoked, automatically expires 2 years after
190the date of issuance. The certification may be renewed
191biennially upon application by the stroke treatment center. The
192certification shall be renewed if the center continues to meet
193the requirements set forth in this act and in the rules adopted
194by the department. An application for renewal of a certification
195must be completed on forms provided by the department and must
196be received by the department 90 days before expiration of the
197current certification.
198     (3)(a)  A stroke treatment center's certification is valid
199only for the hospital to which it was issued and may not be
200sold, assigned, or otherwise transferred, voluntarily or
201involuntarily, to any other hospital. A certification is valid
202only for the location for which it was originally issued.
203     (b)  An application for a new certification is required if:
204     1.  A majority of the ownership or the controlling interest
205of a stroke treatment center is transferred or assigned; or
206     2.  A lessee agrees to undertake or provide services to the
207extent that legal liability for operation of the facility rests
208with the lessee.
209
210An application for certification showing these changes must be
211made at least 60 days before the date of the sale, transfer,
212assignment, or lease.
213     (4)  A current list of all certified stroke treatment
214centers shall be published on the department's Internet website
215with a clearly marked link on the website's front page. The
216department shall send, by certified mail, the current list of
217certified stroke treatment centers to the medical directors of
218all emergency medical service providers, fire departments, and
219private ambulance companies in the state. Whenever the list
220changes, the revised list must be sent to the designated
221recipients as soon as possible.
222     (5)(a)  Notwithstanding any provision of chapter 381,
223Florida Statutes, a hospital licensed under ss. 395.001-
224395.3025, Florida Statutes, that operates a certified stroke
225treatment center may not permanently terminate stroke treatment
226services without providing the department at least 6 months'
227written notice of its intent to terminate such services. The
228notice must be given to the department, to all hospitals and
229emergency medical service providers, and to the medical
230directors of emergency medical services located in the service
231area of the stroke treatment center.
232     (b)  This subsection does not apply to a short-term
233unavailability of stroke treatment services. A hospital shall
234notify all local emergency medical service providers whenever a
235stroke treatment center is unable to provide stroke treatment
236services.
237     (6)  Except as otherwise provided by law, the department or
238its agent may collect stroke registry data, as prescribed by
239rule of the department, for the purposes of evaluating stroke
240triage, evaluating transportation and treatment effectiveness,
241ensuring compliance with the standards of verification, and
242monitoring patient outcomes.
243     (7)  An onsite visit by the department or its agent may be
244conducted at any reasonable time and may include, but need not
245be limited to, a review of records in the possession of a stroke
246treatment center, emergency medical service provider, or medical
247examiner regarding the care, transportation, examination, or
248treatment of stroke patients. A visit must be announced in
249advance and incorporated as a part of regular inspection of
250emergency medical services whenever possible.
251     Section 5.  Prohibition; renewal, denial, modification,
252suspension, and revocation of certification.--
253     (1)  A person may not advertise to the public, by way of
254any medium whatsoever, that a hospital is a stroke treatment
255center, a certified stroke treatment center, or a cerebral
256vascular specialty treatment facility unless the hospital has
257first been certified as required by law.
258     (2)  If the department finds that a stroke treatment center
259fails to comply with the requirements of this act or the rules
260adopted by the department, the department may deny, modify,
261suspend, or revoke the stroke treatment center's certification.
262     Section 6.  Certification inspections of stroke treatment
263centers.--
264     (1)  The department shall make, or cause to be made, any
265inspection or investigation of a stroke treatment center that it
266deems necessary, including:
267     (a)  An inspection directed by the department.
268     (b)  A validation inspection.
269     (c)  A complaint investigation, including a full
270investigation of the certification of a stroke treatment center,
271which includes a review of all certification guidelines. All
272complaints received by the department are subject to review and
273investigation by the department.
274     (d)  An investigation of a stroke treatment center's
275emergency access.
276     (2)  The department shall accept, in place of its own
277periodic inspections for certification, the survey or inspection
278of an accrediting organization if the certification of the
279stroke treatment center is not provisional and the stroke
280treatment center authorizes release of, and the department
281receives, proof of certification by the accrediting
282organization. The department shall adopt by rule criteria for
283accepting proof of certification by an accrediting organization
284in place of the certification inspection conducted by the
285department.
286     Section 7.  Emergency medical service providers;
287transportation of stroke victims to stroke treatment centers.--
288     (1)  Each emergency medical service provider licensed under
289chapter 401, Florida Statutes, shall transport identified stroke
290victims to a certified stroke treatment center, except as
291otherwise provided for in the provider's protocol for
292transporting stroke victims.
293     (2)  All emergency medical service providers operating in
294the state must develop a transportation protocol detailing how
295identified stroke patients will be transported to designated
296stroke treatment center hospitals. Emergency medical service
297providers must provide a copy of their stroke transportation
298protocol to the department within 90 days after the effective
299date of this act. The department must keep the transportation
300protocols on file and make them available to any person upon
301request. If a provider's stroke transportation protocol is
302changed at any time, the new protocol must be filed with the
303department within 30 days after its implementation.
304     (3)  The department shall adopt guidelines for identifying
305stroke victims. Each emergency medical service provider must
306develop a stroke triage protocol based on the published
307guidelines. The guidelines must include requirements of licensed
308emergency medical service providers for performing and
309documenting identification of stroke victims. Review of stroke
310triage protocols shall be conducted every 3 years by the
311department and shall be conducted through consultation with
312interested parties, including, but not limited to, each approved
313stroke center, physicians specializing in stroke care and
314emergency care, emergency medical service providers licensed
315under chapter 401, Florida Statutes, and the providers'
316respective medical directors. The department shall make model
317stroke triage protocols available to any person.
318     (4)  The department shall adopt and enforce all rules
319necessary to administer this section.
320     Section 8.  This act shall take effect July 1, 2004.


CODING: Words stricken are deletions; words underlined are additions.