Senate Bill sb2444

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    Florida Senate - 2006                                  SB 2444

    By Senator Peaden





    2-1457-06

  1                      A bill to be entitled

  2         An act relating to clinical perfusionists;

  3         creating ss. 458.3476 and 459.025, F.S.;

  4         providing definitions; requiring that a

  5         supervising physician be qualified in the

  6         medical area in which the clinical perfusionist

  7         performs; prescribing duties of a clinical

  8         perfusionist; requiring a clinical perfusionist

  9         to convey that he or she is a clinical

10         perfusionist to a patient; authorizing a

11         clinical perfusionist to perform medical tasks

12         and services within a certain protocol;

13         prohibiting a clinical perfusionist from

14         prescribing, ordering, compounding, or

15         dispensing certain drugs or a medical device;

16         providing that a clinical perfusionist may

17         administer certain drugs, fluids, and blood

18         products under the supervision of a physician;

19         exempting a trainee from requirements of a

20         clinical perfusionist; requiring board approval

21         of training programs for clinical

22         perfusionists; providing licensure

23         requirements; providing provisional licensing

24         requirements; providing for a temporary license

25         as a clinical perfusionist; authorizing the

26         Board of Medicine and the Board of Osteopathic

27         Medicine to impose a penalty against a clinical

28         perfusionist found guilty of or investigated

29         for violating ch. 456, ch. 458, or ch. 459,

30         F.S.; authorizing the chair of each board to

31         appoint certain persons to advise the board

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    Florida Senate - 2006                                  SB 2444
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 1         regarding rules for the licensure of clinical

 2         perfusionists; providing duties of each board;

 3         providing for the denial, suspension, or

 4         revocation of a license; requiring each board

 5         to adopt rules; requiring the Department of

 6         Health to allocate fees collected to each

 7         board; providing exemptions from clinical

 8         perfusionist licensure requirements; excluding

 9         hospitals from payment of certain costs;

10         amending s. 456.048, F.S.; specifying financial

11         responsibility requirements for clinical

12         perfusionists; providing an effective date.

13  

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

15  

16         Section 1.  Section 458.3476, Florida Statutes, is

17  created to read:

18         458.3476  Clinical perfusionist.--

19         (1)  DEFINITIONS.--As used in this section, the term:

20         (a)  "Approved program" means a program for the

21  education and training of clinical perfusionists which has

22  been approved by the boards as provided in subsection (5).

23         (b)  "Boards" means the Board of Medicine and the Board

24  of Osteopathic Medicine.

25         (c)  "Clinical perfusionist" means a person who has

26  graduated from an approved program, who is licensed to perform

27  medical services, and who is prescribed, delegated, or

28  supervised by a licensed physician.

29         (d)  "Clinical perfusion" means the functions necessary

30  for the support, treatment, measurement, or supplementation of

31  the cardiovascular, circulatory, or respiratory systems or

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    Florida Senate - 2006                                  SB 2444
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 1  other organs, or a combination of those activities, and the

 2  safe management of physiologic functions by monitoring and

 3  analyzing the parameters of the systems under an order of and

 4  supervision by a licensed physician, through extracorporeal

 5  circulation, long-term clinical support techniques, including

 6  extracorporeal carbon-dioxide removal and extracorporeal

 7  membrane oxygenation, and associated therapeutic and

 8  diagnostic technologies, such as counter pulsation,

 9  ventricular assistance, auto transfusion, blood conservation

10  techniques, myocardial and organ preservation, extracorporeal

11  life support, isolated limb perfusion, therapeutic aphaeresis,

12  and platelet-rich plasma sequestration.

13         (e)  "Clinical perfusionists' licensing committee"

14  means the clinical perfusion licensing committee appointed by

15  the board.

16         (f)  "Continuing medical education" means courses

17  recognized and approved by the boards, the American Academy of

18  Physician Assistants, the American Medical Association, the

19  American Osteopathic Association, the American Board of

20  Cardiovascular Perfusion, or the Accreditation Council on

21  Continuing Medical Education.

22         (g)  "Direct supervision" means on-site, personal

23  supervision by a licensed clinical perfusionist who is present

24  when a procedure is being performed and who is in all

25  instances immediately available to provide assistance and

26  direction to the clinical perfusionist while clinical

27  perfusion services are being performed.

28         (h)  "Extracorporeal circulation" means the diversion

29  of a patient's blood through a heart-lung machine or a similar

30  device that assumes the functions of the patient's heart,

31  lungs, kidney, liver, or other organs.

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 1         (i)  "Trainee" means a person who is currently enrolled

 2  in an approved program.

 3         (j)  "Perfusion protocols" means perfusion-related

 4  policies and protocols developed or approved by a licensed

 5  health facility or a physician through collaboration with

 6  administrators, licensed clinical perfusionists, and other

 7  health care professionals.

 8         (k)  "Proficiency examination" means an entry-level

 9  examination approved by the boards, including examinations

10  administered by the American Board of Cardiovascular Perfusion

11  (ABCP).

12         (l)  "Provisionally licensed perfusionist" means a

13  person provisionally licensed under this section.

14         (m)  "Supervising physician" means an allopathic

15  physician who holds an active license.

16         (n)  "Temporarily licensed perfusionist" means a person

17  granted a temporary license under this section.

18         (2)  PERFORMANCE OF A SUPERVISING PHYSICIAN.--A

19  physician who supervises a clinical perfusionist must be

20  qualified in the medical areas in which the clinical

21  perfusionist performs.

22         (3)(a)  PERFORMANCE OF CLINICAL PERFUSIONISTS.--A

23  clinical perfusionist may perform duties established by rule

24  by the board, including the following duties that are included

25  in the clinical perfusionist's protocol, while prescribed by a

26  physician or under the supervision of a physician:

27         1.  Perform extracorporeal circulation/clinical

28  support;

29         2.  Perform or administer counter pulsation;

30         3.  Perform circulatory support and ventricular

31  assistance;

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 1         4.  Perform extracorporeal membrane oxygenation (ECMO)

 2  and extracorporeal life support (ECLS);

 3         5.  Perform blood conservation techniques,

 4  autotransfusion, and blood component sequestration;

 5         6.  Perform myocardial preservation;

 6         7.  Perform coagulation and hemotalogic monitoring;

 7         8.  Perform physiological monitoring;

 8         9.  Perform blood gas analysis and blood chemistry

 9  monitoring;

10         10.  Perform induction of hypothermia or hyperthermia

11  with reversal;

12         11.  Perform hemodilution;

13         12.  Perform hemofiltration;

14         13.  Administer blood, blood products, supportive

15  fluids, and anesthetic agents via the extracorporeal circuit;

16         14.  Complete documentation associated with described

17  duties;

18         15.  Perform isolated limb and organ perfusion;

19         16.  Provide surgical assistance;

20         17.  Perform organ preservation;

21         18.  Perform dialysis while the patient is on clinical

22  bypass;

23         19.  Perform therapeutic apheresis;

24         20.  Administer blood, blood products, and supportive

25  fluids via the therapeutic apheresis circuit; and

26         21.  Perform pacemaker lead and battery analysis.

27         (b)  This section or chapter does not prevent

28  third-party payors from reimbursing employers of clinical

29  perfusionists for covered services rendered by such clinical

30  perfusionists.

31  

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 1         (c)  A clinical perfusionist shall clearly convey to a

 2  patient that he or she is a clinical perfusionist.

 3         (d)  A clinical perfusionist may perform medical tasks

 4  and services within the framework of a written practice

 5  protocol developed between the supervising physician and the

 6  clinical perfusionist.

 7         (e)  A clinical perfusionist may not prescribe, order,

 8  compound, or dispense any controlled substance, legend drug,

 9  or medical device to any patient. This paragraph does not

10  prohibit a clinical perfusionist from administering legend

11  drugs, controlled substances, intravenous drugs, fluids, or

12  blood products that are ordered by the physician and

13  administered to a patient while under the orders of such

14  physician.

15         (4)  PERFORMANCE BY TRAINEES.--The practice of a

16  trainee is exempt from the requirements of this chapter while

17  the trainee is performing assigned tasks as a trainee in

18  conjunction with an approved program. Before providing

19  clinical perfusion in conjunction with the requirements of an

20  approved program, the trainee shall clearly convey to the

21  patient that he or she is a trainee and is under direct

22  supervision.

23         (5)  PROGRAM APPROVAL.--The boards shall approve

24  programs for the education and training of clinical

25  perfusionists which meet standards established by board rules.

26  The boards may recommend only those programs for clinical

27  perfusionists' training which hold full accreditation or

28  provisional accreditation from the Commission on Accreditation

29  of Allied Health Education Programs.

30         (6)  CLINICAL PERFUSIONIST LICENSURE.--

31  

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    Florida Senate - 2006                                  SB 2444
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 1         (a)  Any person seeking to be licensed as a clinical

 2  perfusionist must apply to the department. The department

 3  shall issue a license to any person certified by the board to:

 4         1.  Be at least 18 years of age.

 5         2.  Have satisfactorily passed a proficiency

 6  examination approved by the board. The board, on receipt of an

 7  application and application fee, shall waive the examination

 8  requirement for an applicant who at the time of application:

 9         a.  Is appropriately licensed or certified by another

10  state, territory, or possession of the United States if the

11  requirements of that state, territory, or possession for the

12  license or certificate are the substantial equivalent of the

13  requirements of this section as determined by the board; or

14         b.  Holds a current certificate as a certified clinical

15  perfusionist issued by a certifying agency approved by the

16  board. The certification shall include an examination approved

17  by the board.

18         3.  Be certified in basic cardiac life support.

19         4.  Have completed the application form and remitted an

20  application fee, not to exceed $1,500, as set by the board. An

21  application must include:

22         a.  A certificate of completion of an approved program;

23         b.  A sworn statement of any prior felony convictions;

24         c.  A sworn statement of any prior discipline or denial

25  of licensure or certification in any state; and

26         d.  Two letters of recommendation, one from a physician

27  and one from a certified or licensed clinical perfusionist.

28  

29  Before July 1, 2006, a person is eligible to apply to the

30  board and receive a license notwithstanding the requirements

31  of this subsection if the person was actively engaged in the

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 1  practice of perfusion consistent with applicable law, and if

 2  the person was operating cardiopulmonary bypass systems during

 3  cardiac surgical cases in a licensed health care facility as

 4  the person's primary function and had been operating the

 5  system for 8 of the 10 years preceding application for

 6  licensure.

 7         (b)  Between July 1, 2006, and June 30, 2008, an

 8  applicant who was not a graduate of an accredited program

 9  before 1981 but met the then-current eligibility requirements

10  for certification as a certified clinical perfusionist and

11  subsequently was certified, shall be licensed as a

12  perfusionist if the application otherwise complies with the

13  provisions of this section.

14         (c)  A license must be renewed biennially. Each renewal

15  must include:

16         1.  A renewal fee, not to exceed $1,500, as set by the

17  board; and

18         2.  A sworn statement of no felony convictions in the

19  immediately preceding 2 years.

20         (d)  Each licensed clinical perfusionist shall

21  biennially complete continuing medical education as required

22  by the board.

23         (e)1.  A license as a provisionally licensed

24  perfusionist may be issued by the board to a person who has

25  successfully completed an approved perfusion education program

26  and the filing of an application, payment of the application

27  fee, and submission of evidence satisfactory to the board of

28  the successful completion of the requisite education

29  requirements.

30         2.  A provisionally licensed perfusionist must be under

31  the supervision and direction of a licensed perfusionist at

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 1  all times during which the provisionally licensed perfusionist

 2  performs perfusion. Rules adopted by the board governing such

 3  supervision and direction may not require the immediate

 4  physical presence of the supervising licensed perfusionist.

 5         3.  A provisional license is valid for 2 years from the

 6  date it is issued and may be extended subject to rule by the

 7  board. The application for extension must be signed by a

 8  supervising licensed perfusionist. Upon notification by the

 9  approved testing service, or the board, that any portion of

10  the licensing examination has been failed after the 2-year

11  provisional license term, the provisional license must be

12  surrendered to the board.

13         (f)  A license as a temporarily licensed perfusionist

14  may be issued by the department to a person who has

15  successfully completed the perfusion licensure application.

16         (g)  The Board of Medicine may impose upon a clinical

17  perfusionist any penalty specified in s. 456.072 or s.

18  458.331(2) if the clinical perfusionist is found guilty of or

19  is investigated for an act that constitutes a violation of

20  this chapter or chapter 456.

21         (7)  CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST

22  TO ADVISE THE BOARD.--

23         (a)  The chairperson of the board may appoint a

24  cardiovascular surgeon and a certified clinical perfusionist

25  to advise the board as to the adoption of rules for the

26  licensure of clinical perfusionists. The board may use a

27  committee structure that is most practicable in order to

28  receive any recommendations to the board regarding rules and

29  all matters relating to clinical perfusionists, including, but

30  not limited to, recommendations to improve safety in the

31  clinical practices of licensed clinical perfusionists.

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 1         (b)  In addition to its other duties and

 2  responsibilities as prescribed by law, the board shall:

 3         1.  Recommend to the department the licensure of

 4  clinical perfusionists.

 5         2.  Develop rules regulating the use of clinical

 6  perfusionists under this chapter and chapter 459, except for

 7  rules relating to the formulary developed under s. 458.347(4).

 8  The board shall also develop rules to ensure that the

 9  continuity of supervision is maintained in each practice

10  setting. The boards shall consider adopting a proposed rule at

11  the regularly scheduled meeting immediately following the

12  submission of the proposed rule. A proposed rule may not be

13  adopted by either board unless both boards have accepted and

14  approved the identical language contained in the proposed

15  rule. The language of all proposed rules must be approved by

16  both boards pursuant to each respective board's guidelines and

17  standards regarding the adoption of proposed rules.

18         3.  Address concerns and problems of clinical

19  perfusionists to improve safety in the clinical practices of

20  licensed clinical perfusionists.

21         (c)  When the board finds that an applicant for

22  licensure has failed to meet, to the board's satisfaction,

23  each of the requirements for licensure set forth in this

24  section, the board may enter an order to:

25         1.  Refuse to certify the applicant for licensure;

26         2.  Approve the applicant for licensure with

27  restrictions on the scope of practice or license; or

28         3.  Approve the applicant for conditional licensure.

29  Such conditions may include placement of the applicant on

30  probation for a period of time and subject to such conditions

31  as the board specifies, including, but not limited to,

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 1  requiring the applicant to undergo treatment, to attend

 2  continuing education courses, or to take corrective action.

 3         (8)  DENIAL, SUSPENSION, OR REVOCATION OF

 4  LICENSURE.--The boards may deny, suspend, or revoke the

 5  license of a clinical perfusionist whom one of the boards

 6  determines has violated any provision of this section or

 7  chapter or any rule adopted pursuant thereto.

 8         (9)  RULES.--The boards shall adopt rules to administer

 9  this section.

10         (10)  FEES.--The department shall allocate the fees

11  collected under this section to the boards.

12         (11)  EXEMPTIONS.--

13         (a)  This section may not be construed to limit the

14  practice of a physician licensed under this chapter or a

15  respiratory therapist licensed under chapter 468, so long as

16  that person does not hold himself or herself out to the public

17  as possessing a license, provisional license, registration, or

18  certificate issued under this section or use a professional

19  title protected by this section.

20         (b)  This section may not be construed to limit the

21  practice of nursing or to prevent qualified members of other

22  professions from doing work of a nature consistent with their

23  training and licensure, so long as those persons do not hold

24  themselves out to the public as possessing a license,

25  provisional license, registration, or certificate issued under

26  this section or use a professional title protected by this

27  section.

28         (c)  A person need not be licensed under this section

29  who:

30  

31  

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 1         1.  Is licensed in this state under any other law and

 2  is engaging in the profession or occupation for which he or

 3  she is licensed.

 4         2.  Is a qualified person in this state or another

 5  state or territory who is employed by the United States

 6  Government or an agency thereof while discharging his or her

 7  official duties.

 8         3.  Is a student providing services regulated under

 9  this chapter who is:

10         a.  Pursuing a course of study that leads to a degree

11  in a profession regulated by this chapter;

12         b.  Providing services in a training setting, as long

13  as such services and associated activities constitute part of

14  a supervised course of study; and

15         c.  Designated by the title "trainee."

16         4.  Is not a resident of this state but offers services

17  in this state, provided that:

18         a.  Such services are performed in this state for no

19  more than 30 days in any calendar year; and

20         b.  Such nonresident is licensed or certified by a

21  state or territory of the United States.

22         (d)  Except as stipulated by the board, the exemptions

23  in this subsection do not apply to any person licensed under

24  this section whose license has been revoked or suspended by

25  the board or whose license or certification in another

26  jurisdiction has been revoked or suspended by the licensing or

27  certifying authority in that jurisdiction.

28         (e)  This subsection may not be construed to exempt a

29  person from meeting the minimum standards of performance in

30  professional activities when measured against generally

31  prevailing peer performance, including the undertaking of

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 1  activities for which the person is not qualified by training

 2  or experience.

 3         (12) PAYMENT OR REIMBURSEMENT BY HOSPITALS OF COSTS OF

 4  COMPLIANCE WITH PART.--A hospital is not required to pay for,

 5  or reimburse any person for, the costs of compliance with any

 6  requirement of this part, including costs of continuing

 7  education.

 8         Section 2.  Section 456.048, Florida Statutes, is

 9  amended to read:

10         456.048  Financial responsibility requirements for

11  certain health care practitioners.--

12         (1)  As a prerequisite for licensure or license

13  renewal, the Board of Acupuncture, the Board of Chiropractic

14  Medicine, the Board of Podiatric Medicine, and the Board of

15  Dentistry shall, by rule, require that all health care

16  practitioners licensed under the respective board, and the

17  Board of Medicine and the Board of Osteopathic Medicine shall,

18  by rule, require that all anesthesiologist assistants licensed

19  pursuant to s. 458.3475 or s. 459.023 and clinical

20  perfusionists licensed pursuant to s. 458.3476 or s. 459.025,

21  and the Board of Nursing shall, by rule, require that advanced

22  registered nurse practitioners certified under s. 464.012, and

23  the department shall, by rule, require that midwives maintain

24  medical malpractice insurance or provide proof of financial

25  responsibility in an amount and in a manner determined by the

26  board or department to be sufficient to cover claims arising

27  out of the rendering of or failure to render professional care

28  and services in this state.

29         (2)  The board or department may grant exemptions upon

30  application by practitioners meeting any of the following

31  criteria:

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 1         (a)  Any person licensed under chapter 457, s.

 2  458.3475, s. 458.3476, s. 459.023, s. 459.025, chapter 460,

 3  chapter 461, s. 464.012, chapter 466, or chapter 467 who

 4  practices exclusively as an officer, employee, or agent of the

 5  Federal Government or of the state or its agencies or its

 6  subdivisions.  For the purposes of this subsection, an agent

 7  of the state, its agencies, or its subdivisions is a person

 8  who is eligible for coverage under any self-insurance or

 9  insurance program authorized by the provisions of s.

10  768.28(16) or who is a volunteer under s. 110.501(1).

11         (b)  Any person whose license or certification has

12  become inactive under chapter 457, s. 458.3475, s. 458.3476,

13  s. 459.023, s. 459.025, chapter 460, chapter 461, part I of

14  chapter 464, chapter 466, or chapter 467 and who is not

15  practicing in this state.  Any person applying for

16  reactivation of a license must show either that such licensee

17  maintained tail insurance coverage which provided liability

18  coverage for incidents that occurred on or after October 1,

19  1993, or the initial date of licensure in this state,

20  whichever is later, and incidents that occurred before the

21  date on which the license became inactive; or such licensee

22  must submit an affidavit stating that such licensee has no

23  unsatisfied medical malpractice judgments or settlements at

24  the time of application for reactivation.

25         (c)  Any person holding a limited license pursuant to

26  s. 456.015, and practicing under the scope of such limited

27  license.

28         (d)  Any person licensed or certified under chapter

29  457, s. 458.3475, s. 458.3476, s. 459.023, s. 459.025 chapter

30  460, chapter 461, s. 464.012, chapter 466, or chapter 467 who

31  practices only in conjunction with his or her teaching duties

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 1  at an accredited school or in its main teaching hospitals.

 2  Such person may engage in the practice of medicine to the

 3  extent that such practice is incidental to and a necessary

 4  part of duties in connection with the teaching position in the

 5  school.

 6         (e)  Any person holding an active license or

 7  certification under chapter 457, s. 458.3475, s. 458.3476, s.

 8  459.023, s. 459.025, chapter 460, chapter 461, s. 464.012,

 9  chapter 466, or chapter 467 who is not practicing in this

10  state.  If such person initiates or resumes practice in this

11  state, he or she must notify the department of such activity.

12         (f)  Any person who can demonstrate to the board or

13  department that he or she has no malpractice exposure in the

14  state.

15         (3)  Notwithstanding the provisions of this section,

16  the financial responsibility requirements of ss. 458.320 and

17  459.0085 shall continue to apply to practitioners licensed

18  under those chapters, except for clinical perfusionists

19  licensed pursuant to s. 458.3476 or s. 459.025 and

20  anesthesiologist assistants licensed pursuant to s. 458.3475

21  or s. 459.023 who must meet the requirements of this section.

22         Section 3.  Section 459.025, Florida Statutes, is

23  created to read:

24         459.025  Clinical perfusionist.--

25         (1)  DEFINITIONS.--As used in this section, the term:

26         (a)  "Approved program" means a program for the

27  education and training of clinical perfusionists which has

28  been approved by the boards as provided in subsection (5).

29         (b)  "Boards" means the Board of Medicine and the Board

30  of Osteopathic Medicine.

31  

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 1         (c)  "Clinical perfusionist" means a person who has

 2  graduated from an approved program, who is licensed to perform

 3  medical services, and who is prescribed, delegated, or

 4  supervised by a licensed physician.

 5         (d)  "Clinical perfusion" means the functions necessary

 6  for the support, treatment, measurement, or supplementation of

 7  the cardiovascular, circulatory, or respiratory systems or

 8  other organs, or a combination of those activities, and the

 9  safe management of physiologic functions by monitoring and

10  analyzing the parameters of the systems under an order of and

11  supervision by a licensed physician, through extracorporeal

12  circulation, long-term clinical support techniques, including

13  extracorporeal carbon-dioxide removal and extracorporeal

14  membrane oxygenation, and associated therapeutic and

15  diagnostic technologies, such as counter pulsation,

16  ventricular assistance, auto transfusion, blood conservation

17  techniques, myocardial and organ preservation, extracorporeal

18  life support, isolated limb perfusion, therapeutic aphaeresis,

19  and platelet-rich plasma sequestration.

20         (e)  "Clinical perfusionists' licensing committee"

21  means the clinical perfusion licensing committee appointed by

22  the board.

23         (f)  "Continuing medical education" means courses

24  recognized and approved by the boards, the American Academy of

25  Physician Assistants, the American Medical Association, the

26  American Osteopathic Association, the American Board of

27  Cardiovascular Perfusion, or the Accreditation Council on

28  Continuing Medical Education.

29         (g)  "Direct supervision" means on-site, personal

30  supervision by a licensed clinical perfusionist who is present

31  when a procedure is being performed and who is in all

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 1  instances immediately available to provide assistance and

 2  direction to the clinical perfusionist while clinical

 3  perfusion services are being performed.

 4         (h)  "Extracorporeal circulation" means the diversion

 5  of a patient's blood through a heart-lung machine or a similar

 6  device that assumes the functions of the patient's heart,

 7  lungs, kidneys, liver, or other organs.

 8         (i)  "Trainee" means a person who is currently enrolled

 9  in an approved program.

10         (j)  "Perfusion protocols" means perfusion-related

11  policies and protocols developed or approved by a licensed

12  health facility or a physician through collaboration with

13  administrators, licensed clinical perfusionists, and other

14  health care professionals.

15         (k)  "Proficiency examination" means an entry-level

16  examination approved by the boards, including examinations

17  administered by the American Board of Cardiovascular Perfusion

18  (ABCP).

19         (l)  "Provisionally licensed perfusionist" means a

20  person provisionally licensed under this section.

21         (m)  "Supervising physician" means an allopathic

22  physician who holds an active license.

23         (n)  "Temporarily licensed perfusionist" means a person

24  granted a temporary license under this section.

25         (2)  PERFORMANCE OF A SUPERVISING PHYSICIAN.--A

26  physician who supervises a clinical perfusionist must be

27  qualified in the medical areas in which the clinical

28  perfusionist performs.

29         (3)(a)  PERFORMANCE OF CLINICAL PERFUSIONISTS.--A

30  clinical perfusionist may perform duties established by rule

31  by the board, including the following duties that are included

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 1  in the clinical perfusionist's protocol, while prescribed by

 2  an osteopathic physician or under the supervision of an

 3  osteopathic physician:

 4         1.  Perform extracorporeal circulation/clinical

 5  support;

 6         2.  Perform or administer counter pulsation;

 7         3.  Perform circulatory support and ventricular

 8  assistance;

 9         4.  Perform extracorporeal membrane oxygenation (ECMO)

10  and extracorporeal life support (ECLS);

11         5.  Perform blood conservation techniques,

12  autotransfusion, and blood component sequestration;

13         6.  Perform myocardial preservation;

14         7.  Perform coagulation and hemotalogic monitoring;

15         8.  Perform physiological monitoring;

16         9.  Perform blood gas analysis and blood chemistry

17  monitoring;

18         10.  Perform induction of hypothermia or hyperthermia

19  with reversal;

20         11.  Perform hemodilution;

21         12.  Perform hemofiltration;

22         13.  Administer blood, blood products, supportive

23  fluids, and anesthetic agents via the extracorporeal circuit;

24         14.  Complete documentation associated with described

25  duties;

26         15.  Perform isolated limb and organ perfusion;

27         16.  Provide surgical assistance;

28         17.  Perform organ preservation;

29         18.  Perform dialysis while the patient is on clinical

30  bypass;

31         19.  Perform therapeutic apheresis;

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 1         20.  Administer blood, blood products, and supportive

 2  fluids via the therapeutic apheresis circuit; and

 3         21.  Perform pacemaker lead and battery analysis.

 4         (b)  This section or chapter does not prevent

 5  third-party payors from reimbursing employers of clinical

 6  perfusionists for covered services rendered by such clinical

 7  perfusionists.

 8         (c)  A clinical perfusionist shall clearly convey to a

 9  patient that he or she is a clinical perfusionist.

10         (d)  A clinical perfusionist may perform medical tasks

11  and services within the framework of a written practice

12  protocol developed between the supervising physician and the

13  clinical perfusionist.

14         (e)  A clinical perfusionist may not prescribe, order,

15  compound, or dispense any controlled substance, legend drug,

16  or medical device to any patient. This paragraph does not

17  prohibit a clinical perfusionist from administering legend

18  drugs, controlled substances, intravenous drugs, fluids, or

19  blood products that are ordered by the physician and

20  administered to a patient while under the orders of such

21  physician.

22         (4)  PERFORMANCE BY TRAINEES.--The practice of a

23  trainee is exempt from the requirements of this chapter while

24  the trainee is performing assigned tasks as a trainee in

25  conjunction with an approved program. Before providing

26  clinical perfusion in conjunction with the requirements of an

27  approved program, the trainee shall clearly convey to the

28  patient that he or she is a trainee and is under direct

29  supervision.

30         (5)  PROGRAM APPROVAL.--The boards shall approve

31  programs for the education and training of clinical

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 1  perfusionists which meet standards established by board rules.

 2  The boards may recommend only those programs for clinical

 3  perfusionists' training which hold full accreditation or

 4  provisional accreditation from the Commission on Accreditation

 5  of Allied Health Education Programs.

 6         (6)  CLINICAL PERFUSIONIST LICENSURE.--

 7         (a)  Any person seeking to be licensed as a clinical

 8  perfusionist must apply to the department. The department

 9  shall issue a license to any person certified by the board to:

10         1.  Be at least 18 years of age.

11         2.  Have satisfactorily passed a proficiency

12  examination approved by the board. The board, on receipt of an

13  application and application fee, shall waive the examination

14  requirement for an applicant who at the time of application:

15         a.  Is appropriately licensed or certified by another

16  state, territory, or possession of the United States if the

17  requirements of that state, territory, or possession for the

18  license or certificate are the substantial equivalent of the

19  requirements of this section as determined by the board; or

20         b.  Holds a current certificate as a certified clinical

21  perfusionist issued by a certifying agency approved by the

22  board. The certification shall include an examination approved

23  by the board.

24         3.  Be certified in basic cardiac life support.

25         4.  Have completed the application form and remitted an

26  application fee, not to exceed $1,500, as set by the board. An

27  application must include:

28         a.  A certificate of completion of an approved program;

29         b.  A sworn statement of any prior felony convictions;

30         c.  A sworn statement of any prior discipline or denial

31  of licensure or certification in any state; and

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 1         d.  Two letters of recommendation, one from a physician

 2  and one from a certified or licensed clinical perfusionist.

 3  

 4  Before July 1, 2006, a person is eligible to apply to the

 5  board and receive a license notwithstanding the requirements

 6  of this subsection if the person was actively engaged in the

 7  practice of perfusion consistent with applicable law, and if

 8  the person was operating cardiopulmonary bypass systems during

 9  cardiac surgical cases in a licensed health care facility as

10  the person's primary function and had been operating the

11  system for 8 of the 10 years preceding application for

12  licensure.

13         (b)  Between July 1, 2006, and June 30, 2008, an

14  applicant who was not a graduate of an accredited program

15  before 1981 but met the then-current eligibility requirements

16  for certification as a certified clinical perfusionist and

17  subsequently was certified, shall be licensed as a

18  perfusionist if the application otherwise complies with the

19  provisions of this section.

20         (c)  A license must be renewed biennially. Each renewal

21  must include:

22         1.  A renewal fee, not to exceed $1,500, as set by the

23  board; and

24         2.  A sworn statement of no felony convictions in the

25  immediately preceding 2 years.

26         (d)  Each licensed clinical perfusionist shall

27  biennially complete continuing medical education as required

28  by the board.

29         (e)1.  A license as a provisionally licensed

30  perfusionist may be issued by the board to a person who has

31  successfully completed an approved perfusion education program

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 1  and the filing of an application, payment of the application

 2  fee, and submission of evidence satisfactory to the board of

 3  the successful completion of the requisite education

 4  requirements.

 5         2.  A provisionally licensed perfusionist must be under

 6  the supervision and direction of a licensed perfusionist at

 7  all times during which the provisional licensed perfusionist

 8  performs perfusion. Rules adopted by the board governing such

 9  supervision and direction may not require the immediate

10  physical presence of the supervising licensed perfusionist.

11         3.  A provisional license is valid for 2 years from the

12  date it is issued and may be extended subject to rule by the

13  board. The application for extension must be signed by a

14  supervising licensed perfusionist. Upon notification by the

15  approved testing service, or the board, that any portion of

16  the licensing examination has been failed after the 2-year

17  provisional license term, the provisional license must be

18  surrendered to the board.

19         (f)  A license as a temporarily licensed perfusionist

20  may be issued by the department to a person who has

21  successfully completed the perfusion licensure application.

22         (g)  The Board of Osteopathic Medicine may impose upon

23  a clinical perfusionist any penalty specified in s. 456.072 or

24  s. 458.331(2) if the clinical perfusionist is found guilty of

25  or is investigated for an act that constitutes a violation of

26  this chapter or chapter 456.

27         (7)  CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST

28  TO ADVISE THE BOARD.--

29         (a)  The chairperson of the board may appoint a

30  cardiovascular surgeon and a certified clinical perfusionist

31  to advise the board as to the adoption of rules for the

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 1  licensure of clinical perfusionists. The board may use a

 2  committee structure that is most practicable in order to

 3  receive any recommendations to the board regarding rules and

 4  all matters relating to clinical perfusionists, including, but

 5  not limited to, recommendations to improve safety in the

 6  clinical practices of licensed clinical perfusionists.

 7         (b)  In addition to its other duties and

 8  responsibilities as prescribed by law, the board shall:

 9         1.  Recommend to the department the licensure of

10  clinical perfusionists.

11         2.  Develop rules regulating the use of clinical

12  perfusionists under this chapter and chapter 458, except for

13  rules relating to the formulary developed under s. 458.347(4).

14  The board shall also develop rules to ensure that the

15  continuity of supervision is maintained in each practice

16  setting. The boards shall consider adopting a proposed rule at

17  the regularly scheduled meeting immediately following the

18  submission of the proposed rule. A proposed rule may not be

19  adopted by either board unless both boards have accepted and

20  approved the identical language contained in the proposed

21  rule. The language of all proposed rules must be approved by

22  both boards pursuant to each respective board's guidelines and

23  standards regarding the adoption of proposed rules.

24         3.  Address concerns and problems of clinical

25  perfusionists to improve safety in the clinical practices of

26  licensed clinical perfusionists.

27         (c)  When the board finds that an applicant for

28  licensure has failed to meet, to the board's satisfaction,

29  each of the requirements for licensure set forth in this

30  section, the board may enter an order to:

31         1.  Refuse to certify the applicant for licensure;

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 1         2.  Approve the applicant for licensure with

 2  restrictions on the scope of practice or license; or

 3         3.  Approve the applicant for conditional licensure.

 4  Such conditions may include placement of the applicant on

 5  probation for a period of time and subject to such conditions

 6  as the board specifies, including, but not limited to,

 7  requiring the applicant to undergo treatment, to attend

 8  continuing education courses, or to take corrective action.

 9         (8)  DENIAL, SUSPENSION, OR REVOCATION OF

10  LICENSURE.--The boards may deny, suspend, or revoke the

11  license of a clinical perfusionist whom one of the boards

12  determines has violated any provision of this section or

13  chapter or any rule adopted pursuant thereto.

14         (9)  RULES.--The boards shall adopt rules to administer

15  this section.

16         (10)  FEES.--The department shall allocate the fees

17  collected under this section to the boards.

18         (11)  EXEMPTIONS.--

19         (a)  This section may not be construed to limit the

20  practice of an osteopathic physician licensed under this

21  chapter or a respiratory therapist licensed under chapter 468,

22  so long as that person does not hold himself or herself out to

23  the public as possessing a license, provisional license,

24  registration, or certificate issued under this section or use

25  a professional title protected by this section.

26         (b)  This section may not be construed to limit the

27  practice of nursing or to prevent qualified members of other

28  professions from doing work of a nature consistent with their

29  training and licensure, so long as those persons do not hold

30  themselves out to the public as possessing a license,

31  provisional license, registration, or certificate issued under

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 1  this section or use a professional title protected by this

 2  section.

 3         (c)  A person need not be licensed under this section

 4  who:

 5         1.  Is licensed in this state under any other law and

 6  is engaging in the profession or occupation for which he or

 7  she is licensed.

 8         2.  Is a qualified person in this state or another

 9  state or territory who is employed by the United States

10  Government or an agency thereof while discharging his or her

11  official duties.

12         3.  Is a student providing services regulated under

13  this chapter who is:

14         a.  Pursuing a course of study that leads to a degree

15  in a profession regulated by this chapter;

16         b.  Providing services in a training setting, as long

17  as such services and associated activities constitute part of

18  a supervised course of study; and

19         c.  Designated by the title "trainee."

20         4.  Is not a resident of this state but offers services

21  in this state, provided that:

22         a.  Such services are performed in this state for no

23  more than 30 days in any calendar year; and

24         b.  Such nonresident is licensed or certified by a

25  state or territory of the United States.

26         (d)  Except as stipulated by the board, the exemptions

27  in this subsection do not apply to any person licensed under

28  this section whose license has been revoked or suspended by

29  the board or whose license or certification in another

30  jurisdiction has been revoked or suspended by the licensing or

31  certifying authority in that jurisdiction.

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 1         (e)  This subsection may not be construed to exempt a

 2  person from meeting the minimum standards of performance in

 3  professional activities when measured against generally

 4  prevailing peer performance, including the undertaking of

 5  activities for which the person is not qualified by training

 6  or experience.

 7         Section 4.  This act shall take effect July 1, 2006.

 8  

 9            *****************************************

10                          SENATE SUMMARY

11    Requires a supervising physician to be qualified in the
      medical area in which the clinical perfusionist performs.
12    Prescribes duties of a clinical perfusionist. Requires a
      clinical perfusionist to convey that he or she is a
13    clinical perfusionist to a patient. Authorizes a clinical
      perfusionist to perform medical tasks and services within
14    a certain protocol. Prohibits a clinical perfusionist
      from prescribing, ordering, compounding, or dispensing
15    certain drugs or a medical device. Provides that a
      clinical perfusionist may administer certain drugs,
16    fluids, and blood products under the supervision of a
      physician. Exempts a trainee from requirements of a
17    clinical perfusionist. Requires board approval of
      training programs for clinical perfusionists. Provides
18    licensure requirements. Provides provisional licensing
      requirements. Provides for a temporary license as a
19    clinical perfusionist. Authorizes the Board of Medicine
      and the Board of Osteopathic Medicine to impose a penalty
20    if a clinical perfusionist is found guilty of certain
      violations. Provides for the denial, suspension, or
21    revocation of a license as a clinical perfusionist.
      Requires the Department of Health to allocate fees
22    collected to each board. Applies financial responsibility
      requirements to clinical perfusionists. Provides that the
23    failure to adequately supervise the activities of a
      clinical perfusionist is grounds for denial of the
24    license of a medical doctor or osteopathic physician or
      disciplinary action.
25  

26  

27  

28  

29  

30  

31  

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