Senate Bill sb1590

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    Florida Senate - 2004                                  SB 1590

    By Senator Fasano





    11-1064A-04

  1                      A bill to be entitled

  2         An act relating to certified stroke treatment

  3         centers; providing legislative intent with

  4         respect to certified stroke treatment centers;

  5         providing definitions; directing the Department

  6         of Health to adopt, by a specified date,

  7         certain guidelines as minimal clinical

  8         standards for stroke centers; directing the

  9         department to notify hospitals that are

10         eligible to become certified stroke treatment

11         centers; requiring a hospital to file a letter

12         of intent; directing hospitals to file

13         completed applications with the department by a

14         specified date; directing the department to

15         issue certificates to stroke treatment centers

16         that meet the guidelines; authorizing the

17         department to issue provisional certifications;

18         providing that a stroke center's certification

19         automatically expires 2 years after the date of

20         issuance; providing that a certification may be

21         renewed; limiting the certification to the

22         hospital to which it was issued; directing the

23         department to post a listing of certified

24         stroke treatment centers on its website;

25         requiring the department to mail the list to

26         certain persons and entities; requiring a

27         hospital to notify the department at least 6

28         months in advance of its decision to terminate

29         stroke treatment; prohibiting a person from

30         claiming that a facility is a stroke treatment

31         center unless the facility is certified as

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    Florida Senate - 2004                                  SB 1590
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 1         provided by law; authorizing the department to

 2         inspect stroke treatment centers; requiring

 3         emergency medical services to transport

 4         identified stroke victims to certified stroke

 5         treatment centers; requiring the department to

 6         adopt rules; providing an effective date.

 7  

 8         WHEREAS, stroke is the third leading killer in the

 9  United States and in Florida, and

10         WHEREAS, stroke is also the leading cause of serious

11  long-term disability in this state, and

12         WHEREAS, 165,000 people die from stroke in the United

13  States every year, including 10,000 persons in this state, and

14         WHEREAS, 60 percent of death from strokes occur in

15  women, and

16         WHEREAS, approximately 4.5 million survivors of a

17  stroke are alive today, and as many as 25 percent are

18  permanently disabled, and

19         WHEREAS, nearly 30 percent of all people who suffer a

20  stroke are under age 65, and

21         WHEREAS, it is estimated that strokes cost the United

22  States nearly $50 billion a year in total costs, with direct

23  costs estimated at $28 billion, and

24         WHEREAS, the state Medicaid budget pays a significant

25  share of the direct cost of stroke, and

26         WHEREAS, as the population ages, death and disability

27  from stroke will increase dramatically if this state does not

28  implement strategies that will improve the survival of victims

29  of stroke in all communities across this state, and

30  

31  

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    Florida Senate - 2004                                  SB 1590
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 1         WHEREAS, emergency medical services may be transporting

 2  stroke victims to hospitals that are not properly equipped to

 3  provide timely and effective treatment for stroke victims, and

 4         WHEREAS, many hospitals are not properly equipped to

 5  render timely and effective treatment for stroke victims, and

 6         WHEREAS, many hospitals that treat stroke victims do

 7  not discharge stroke patients with the proper information and

 8  tools on how to prevent recurrent strokes, NOW, THEREFORE,

 9  

10  Be It Enacted by the Legislature of the State of Florida:

11  

12         Section 1.  Legislative intent.--

13         (1)  The Legislature finds that rapid identification,

14  diagnosis, and treatment of ischemic stroke can save the lives

15  of stroke victims and in many cases can reverse paralysis,

16  leaving them with few or no neurological deficits.

17         (2)  The Legislature further finds that a strong system

18  for stroke survival is needed in our communities in order to

19  treat stroke victims in a timely manner and to improve the

20  overall treatment of stroke victims. Therefore, the

21  Legislature intends to construct an emergency treatment system

22  in this state in order that stroke victims may be quickly

23  identified and transported to and treated in appropriate

24  stroke treatment facilities.

25         Section 2.  Definitions.--As used in this act, the

26  term:

27         (1)  "Accrediting organization" means the Joint

28  Commission on Accreditation of Healthcare Organizations, the

29  American Osteopathic Association, the Commission on

30  Accreditation of Rehabilitation Facilities, or the

31  Accreditation Association for Ambulatory Health Care, Inc.

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    Florida Senate - 2004                                  SB 1590
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 1         (2)  "Certified stroke treatment center" or "stroke

 2  treatment center" means any hospital licensed under chapter

 3  395, Florida Statutes, which meets the guidelines adopted by

 4  the department to provide minimum standards for the

 5  24-hour-a-day, year-round emergency treatment of ischemic

 6  stroke. The term includes all levels of stroke treatment

 7  centers certified by the department including primary and

 8  comprehensive stroke centers.

 9         (3)  "Comprehensive stroke center" means any hospital

10  licensed under chapter 395, Florida Statutes, which meets the

11  guidelines adopted by the department to treat stroke patients

12  who require a high intensity of medical and surgical care.

13  These standards shall include, but not be limited to, the

14  hospital meeting all criteria for a primary stroke center and

15  having health care personnel available with specific expertise

16  in neurosurgery and vascular neurology, advanced neuroimaging

17  capabilities, surgical and endovascular techniques, and other

18  specific infrastructure and programmatic elements such as an

19  intensive care unit.

20         (4)  "Department" means the Department of Health.

21         (5)  "Hospital" means any establishment that:

22         (a)  Offers services more intensive than those required

23  for room, board, personal services, and general nursing care,

24  and offers facilities and beds for use beyond 24 hours by

25  individuals requiring diagnosis, treatment, or care for

26  illness, injury, deformity, infirmity, abnormality, disease,

27  or pregnancy; and

28         (b)  Regularly makes available at least clinical

29  laboratory services, diagnostic X-ray services, and treatment

30  facilities for surgery or obstetrical care, or other

31  definitive medical treatment of similar extent.

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 1  

 2  The term does not include an institution conducted by or for

 3  the adherents of any well-recognized church or religious

 4  denomination that depends exclusively upon prayer or spiritual

 5  means to heal, care for, or treat any person.

 6         (6)  "Primary stroke center" means any hospital

 7  licensed under chapter 395, Florida Statutes, which meets the

 8  guidelines adopted by the department to provide minimum

 9  standards for the 24-hour emergency treatment of stroke

10  victims. These standards shall include, but not be limited to,

11  hospitals having on duty acute stroke teams with the ability

12  to administer intravenous thrombolytics, the availability and

13  interpretation of computed tomography scans 24 hours each day,

14  rapid laboratory testing, and use of a stroke registry in

15  order to monitor performance of stroke care.

16         (7)  "Validation inspection" means an inspection of the

17  premises of a certified stroke treatment center by the

18  department to assess whether a review by an accrediting

19  organization has adequately evaluated the certified stroke

20  treatment center according to the department's minimum

21  standards.

22         Section 3.  Stroke treatment center hospitals;

23  certification guidelines.--The department shall adopt by rule

24  one or more sets of guidelines published by nationally

25  recognized stroke centers no later than January 1, 2005. The

26  guidelines adopted by the department shall be the minimum

27  clinical standards in this state for treating ischemic stroke

28  patients. The department may adopt guidelines for certifying

29  different levels of stroke treatment including primary and

30  comprehensive stroke centers.

31  

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 1         Section 4.  Certified stroke treatment centers;

 2  selection; quality assurance; records.--

 3         (1)(a)  The department shall annually notify each acute

 4  care general hospital in the state that the department is

 5  accepting letters of intent from any hospital that proposes to

 6  become a stroke treatment center. To be eligible for

 7  certification as a stroke treatment center, a hospital must

 8  state that its intent to operate as a stroke treatment center

 9  is consistent with the certification guidelines adopted by the

10  department. Letters of intent must be postmarked by midnight

11  on October 1 of each year.

12         (b)  The department shall send an application package

13  to any hospital submitting a letter of intent by October 15.

14  The application package shall include instructions for

15  submitting specified information to the department in order to

16  become a stroke treatment center. The certification guidelines

17  adopted by the department shall be the basis for these

18  instructions.

19         (c)  Completed applications from a hospital must be

20  received by the department by April 1 of each year. The

21  department shall review each application to determine if the

22  hospital's application is complete and whether the hospital

23  meets the department's guidelines for certification as a

24  stroke treatment center as either a primary or comprehensive

25  stroke center.

26         (d)  On April 30 of each year, a hospital must be

27  certified as a stroke treatment center if the hospital meets

28  the requirements set forth in this act.

29         (e)  The department may issue a provisional

30  certification to a new stroke treatment center or to a

31  renewing stroke treatment center that is in substantial

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    Florida Senate - 2004                                  SB 1590
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 1  compliance with this act and the rules of the department. A

 2  provisional certification may be granted for not more than 1

 3  year and expires automatically at the end of its term. A

 4  provisional certification may not be renewed.

 5         (f)  A hospital may protest a decision made by the

 6  department based on the department's review of an application

 7  pursuant to this section and shall proceed as provided in

 8  chapter 120, Florida Statutes. A hearing held under this

 9  section shall be conducted in the same manner as provided in

10  ss. 120.569 and 120.57, Florida Statutes. The case filed under

11  chapter 120, Florida Statutes, may combine all disputes

12  between parties.

13         (2)  A stroke center's certification, unless sooner

14  suspended or revoked, automatically expires 2 years after the

15  date of issuance. The certification may be renewed biennially

16  upon application by the stroke treatment center. The

17  certification shall be renewed if the center continues to meet

18  the requirements set forth in this act and in the rules

19  adopted by the department. An application for renewal of a

20  certification must be received by the department 90 days

21  before expiration of the current certification on forms

22  provided by the department.

23         (3)(a)  A stroke treatment center's certification is

24  valid only for the hospital to which it was issued and may not

25  be sold, assigned, or otherwise transferred, voluntarily or

26  involuntarily, to any other hospital. A certification is valid

27  only for the location for which it was originally issued.

28         (b)  An application for a new certification is required

29  if:

30  

31  

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 1         1.  A majority of the ownership or the controlling

 2  interest of a stroke treatment center is transferred or

 3  assigned; or

 4         2.  A lessee agrees to undertake or provide services to

 5  the extent that legal liability for operation of the facility

 6  rests with the lessee.

 7  

 8  An application for certification showing these changes must be

 9  made at least 60 days before the date of the sale, transfer,

10  assignment, or lease.

11         (4)  A current list of all certified stroke treatment

12  centers shall be published on the department's website with a

13  clearly marked link on the website's front page. The

14  department shall send, by certified mail, the current list of

15  certified stroke treatment centers to the medical director of

16  all emergency medical services providers, fire departments,

17  and

18         (5)  Except as provided in this subsection, property

19  assessed under this section shall be assessed at just value as

20  of January 1 of the year following a change of ownership.

21  Thereafter, the annual changes in the assessed value of the

22  property are subject to the limitations in subsections (1) and

23  (2). For the purpose of this section, a change in ownership

24  means any sale, foreclosure, or transfer of legal title or

25  beneficial title in equity to any person, except as provided

26  in this subsection. There is no change of ownership if:

27         (a)  Subsequent to the change or transfer, the same

28  person is entitled to the homestead exemption as was

29  previously entitled and:

30         1.  The transfer of title is to correct an error; or

31         2.  The transfer is between legal and equitable title;

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 1         (b)  The transfer is between husband and wife,

 2  including a transfer to a surviving spouse or a transfer due

 3  to a dissolution of marriage;

 4         (c)  The transfer occurs by operation of law under s.

 5  732.4015; or

 6         (d)  Upon the death of the owner, the transfer is

 7  between the owner and another who is a permanent resident and

 8  is legally or naturally dependent upon the owner. private

 9  ambulance companies in the state. Whenever the list changes,

10  the revised list must be sent to the designated recipients as

11  soon as possible.

12         (6)(a)  Notwithstanding any provision of chapter 381,

13  Florida Statutes, a hospital licensed under ss.

14  395.001-395.3025, Florida Statutes, which operates a certified

15  stroke treatment center may not permanently terminate stroke

16  treatment services without providing the department at least 6

17  months' written notice of its intent to terminate these

18  services. The notice must be given to the department, to all

19  hospitals and emergency medical service providers, and to the

20  medical directors of emergency medical services located in the

21  service area of the state treatment center.

22         (b)  This subsection does not apply to a short-term

23  unavailability of stroke treatment services. A hospital shall

24  notify all local emergency medical services providers whenever

25  a stroke treatment center is unable to provide stroke

26  treatment services.

27         (7)  Except as otherwise provided by law, the

28  department or its agent may collect stroke registry data, as

29  prescribed by rule of the department, for the purposes of

30  evaluating stroke triage, evaluating transportation and

31  

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 1  treatment effectiveness, ensuring compliance with the

 2  standards of verification, and monitoring patient outcomes.

 3         (8)  An onsite visit by the department or its agent may

 4  be conducted at any reasonable time and may include, but need

 5  not be limited to, a review of records in the possession of a

 6  stroke treatment center, emergency medical service provider,

 7  or medical examiner regarding the care, transportation,

 8  examination, or treatment of stroke patients. A visit must be

 9  announced in advance and incorporated as a part of regular

10  inspection of emergency medical services whenever possible.

11         Section 5.  Prohibition; renewal, denial, modification,

12  suspension, and revocation of certification.--

13         (1)  A person may not advertise to the public, by way

14  of any medium whatsoever, that a hospital is a stroke

15  treatment center, a certified stroke treatment center, or a

16  cerebral vascular specialty treatment facility unless the

17  hospital has first been certified as required by law.

18         (2)  If the department finds that a stroke treatment

19  center fails to comply with the requirements of this act or

20  the rules adopted by the department, the department may deny,

21  modify, suspend, or revoke the stroke treatment center's

22  certification.

23         Section 6.  Certification inspections of stroke

24  treatment centers.--

25         (1)  The department shall make, or cause to be made,

26  any inspection or investigation of a stroke treatment center

27  which it deems necessary, including:

28         (a)  An inspection directed by the department.

29         (b)  A validation inspection.

30         (c)  A complaint investigation, including a full

31  investigation of the certification of a stroke treatment

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 1  center, which includes a review of all certification

 2  guidelines. All complaints received by the department are

 3  subject to review and investigation by the department.

 4         (d)  An investigation of a stroke treatment center's

 5  emergency access.

 6         (2)  The department shall accept, in place of its own

 7  periodic inspections for certification, the survey or

 8  inspection of an accrediting organization if the certification

 9  of the stroke treatment center is not provisional and the

10  stroke treatment center authorizes release of, and the

11  department receives, proof of certification by the accrediting

12  organization. The department shall adopt by rule criteria for

13  accepting proof of certification by an accrediting

14  organization in place of the certification inspection

15  conducted by the department.

16         Section 7.  Emergency medical service providers;

17  transportation of stroke victims to stroke treatment

18  centers.--

19         (1)  Each emergency medical services provider licensed

20  under chapter 401, Florida Statutes, shall transport

21  identified stroke victims to a certified stroke treatment

22  center, except as otherwise provided for in the provider's

23  protocol for transporting stroke victims.

24         (2)  All emergency medical services providers operating

25  in the state must develop a transportation protocol detailing

26  how identified stroke patients will be transported to

27  designated stroke center hospitals. Emergency medical services

28  providers must provide a copy of their stroke transportation

29  protocol to the department within 90 days after this act

30  becoming a law. The department must keep the transportation

31  protocols on file and make them available to any person upon

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 1  request. If a provider's stroke transportation protocol is

 2  changed at any time, the new protocol must be filed with the

 3  department within 30 days after its implementation.

 4         (3)  The department shall adopt guidelines for

 5  identifying stroke victims. Each emergency medical services

 6  provider must develop a stroke triage protocol based on the

 7  published guidelines. The guidelines must include requirements

 8  of licensed emergency medical services providers for

 9  performing and documenting identification of stroke victims.

10  Review of stroke triage protocols shall be conducted every 3

11  years by the department and shall be conducted through

12  consultation with interested persons, including, but not

13  limited to, each approved stroke center; physicians

14  specializing in stroke care and emergency care; emergency

15  medical service providers licensed under chapter 401, Florida

16  Statutes; and the providers' respective medical directors. The

17  department shall make model stroke triage protocols available

18  to any person.

19         (4)  The department shall adopt and enforce all rules

20  necessary to administer this section.

21         Section 8.  This act shall take effect July 1, 2004.

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 1            *****************************************

 2                          SENATE SUMMARY

 3    Provides legislative intent with respect to certified
      stroke treatment centers. Directs the Department of
 4    Health to adopt certain stroke-center guidelines as
      minimal clinical standards. Directs the department to
 5    notify hospitals that might choose to become certified
      stroke treatment centers. Requires hospitals to file a
 6    letter of intent. Directs hospitals to file completed
      applications with the department. Directs the department
 7    to issue certificates to stroke treatment centers that
      meet the stroke-center guidelines. Authorizes the
 8    department to issue provisional certifications. Provides
      that a stroke center's certification automatically
 9    expires 2 years after the date of issuance. Provides that
      a stroke center's certification may be renewed. Limits a
10    stroke center's certification to the hospital to which it
      was issued. Directs the department to post a listing of
11    certified stroke treatment centers on its website and to
      mail the list to certain persons and entities. Requires a
12    hospital to notify the department at least 6 months in
      advance of its decision to terminate stroke treatment.
13    Authorizes the department to inspect stroke treatment
      centers. Requires emergency medical service providers to
14    transport identified stroke victims to certified stroke
      treatment centers. (See bill for details.)
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