Senate Bill sb2372c1
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Florida Senate - 2005 CS for SB 2372
By the Committee on Health Care; and Senator Peaden
587-2359-05
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 a supervising
5 physician to be qualified in the medical area
6 in which the clinical perfusionist performs;
7 prescribing duties of a clinical perfusionist;
8 requiring a clinical perfusionist to convey
9 that he or she is a clinical perfusionist to a
10 patient; authorizing a clinical perfusionist to
11 perform medical tasks and services within a
12 certain protocol; prohibiting a clinical
13 perfusionist from prescribing, ordering,
14 compounding, or dispensing certain drugs or a
15 medical device; providing that a clinical
16 perfusionist may administer certain drugs,
17 fluids, and blood products under the
18 supervision of a physician; exempting a trainee
19 from requirements of a clinical perfusionist;
20 requiring board approval of training programs
21 for clinical perfusionists; providing licensure
22 requirements; providing provisional licensing
23 requirements; providing for a temporary license
24 as a clinical perfusionist; authorizing the
25 Board of Medicine and the Board of Osteopathic
26 Medicine to impose a penalty against a clinical
27 perfusionist found guilty of or investigated
28 for violating ch. 456, ch. 458, or ch. 459,
29 F.S.; authorizing the chair of each board to
30 appoint certain persons to advise the board
31 regarding rules for the licensure of clinical
1
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1 perfusionists; providing duties of each board;
2 providing a penalty for any person who falsely
3 holds himself or herself out as a clinical
4 perfusionist; providing for the denial,
5 suspension, or revocation of a license;
6 requiring each board to adopt rules; requiring
7 the Department of Health to allocate fees
8 collected to each board; providing exemptions
9 from clinical perfusionist licensure
10 requirements; excluding hospitals from payment
11 of certain costs; amending s. 456.048, F.S.;
12 specifying financial responsibility
13 requirements for clinical perfusionists;
14 providing an effective date.
15
16 Be It Enacted by the Legislature of the State of Florida:
17
18 Section 1. Section 458.3476, Florida Statutes, is
19 created to read:
20 458.3476 Clinical perfusionist.--
21 (1) DEFINITIONS.--As used in this section, the term:
22 (a) "Approved program" means a program for the
23 education and training of clinical perfusion which has been
24 approved by the boards as provided in subsection (5).
25 (b) "Boards" means the Board of Medicine and the Board
26 of Osteopathic Medicine.
27 (c) "Clinical perfusionist" means a person who has
28 graduated from an approved program, who is licensed to perform
29 medical services, and who is prescribed, delegated, or
30 supervised by a licensed physician.
31
2
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1 (d) "Clinical perfusion" means the functions necessary
2 for the support, treatment, measurement, or supplementation of
3 the cardiovascular, circulatory, or respiratory systems or
4 other organs, or a combination of those activities, and the
5 safe management of physiologic functions by monitoring and
6 analyzing the parameters of the systems under an order and the
7 supervision of a licensed physician, through extracorporeal
8 circulation, long-term clinical support techniques, including
9 extracorporeal carbon-dioxide removal and extracorporeal
10 membrane oxygenation, and associated therapeutic and
11 diagnostic technologies, such as counter pulsation,
12 ventricular assistance, auto transfusion, blood conservation
13 techniques, myocardial and organ preservation, extracorporeal
14 life support, isolated limb perfusion, therapeutic aphaeresis,
15 and platelet rich plasma sequestration.
16 (e) "Clinical perfusionists' licensing committee"
17 means the clinical perfusion licensing committee appointed by
18 the board.
19 (f) "Continuing medical education" means courses
20 recognized and approved by the boards, the American Academy of
21 Physician Assistants, the American Medical Association, the
22 American Osteopathic Association, the American Board of
23 Cardiovascular Perfusion, or the Accreditation Council on
24 Continuing Medical Education.
25 (g) "Direct supervision" means the on-site, personal
26 supervision by a licensed clinical perfusionist who is present
27 when a procedure is being performed and who is in all
28 instances immediately available to provide assistance and
29 direction to the clinical perfusionist while clinical
30 perfusion services are being performed.
31
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1 (h) "Extracorporeal circulation" means the diversion
2 of a patient's blood through a heart-lung machine or a similar
3 device that assumes the functions of the patient's heart,
4 lungs, kidney, liver, or other organs.
5 (i) "Trainee" means a person who is currently enrolled
6 in an approved program.
7 (j) "Perfusion protocols" means perfusion-related
8 policies and protocols developed or approved by a licensed
9 health facility or a physician through collaboration with
10 administrators, licensed clinical perfusionists, and other
11 health care professionals.
12 (k) "Proficiency examination" means an entry-level
13 examination approved by the boards, including examinations
14 administered by the American Board of Cardiovascular Perfusion
15 (ABCP).
16 (l) "Provisional licensed perfusionist" means a person
17 provisionally licensed under this section.
18 (m) "Supervising physician" means an allopathic
19 physician who holds an active license.
20 (n) "Temporarily licensed perfusionist" means a person
21 granted a temporary license under this section.
22 (2) PERFORMANCE OF A SUPERVISING PHYSICIAN.--A
23 physician who supervises a clinical perfusionist must be
24 qualified in the medical areas in which the clinical
25 perfusionist performs.
26 (3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.--A
27 clinical perfusionist may perform duties established by rule
28 by the board, including the following duties that are included
29 in the clinical perfusionist's protocol, while prescribed by a
30 physician or under the supervision of a physician:
31
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1 1. Perform extracorporeal circulation/clinical
2 support;
3 2. Perform or administer counter pulsation;
4 3. Perform circulatory support and ventricular
5 assistance;
6 4. Perform extracorporeal membrane oxygenation (ECMO)
7 and extracorporeal life support (ECLS);
8 5. Perform blood conservation techniques,
9 autotransfusion, and blood component sequestration;
10 6. Perform myocardial preservation;
11 7. Perform coagulation and hemotalogic monitoring;
12 8. Perform physiological monitoring;
13 9. Perform blood gas and blood chemistry monitoring;
14 10. Perform induction of hypothermia or hyperthermia
15 with reversal;
16 11. Perform hemodilution;
17 12. Perform hemofiltration;
18 13. Administer blood, blood products, supportive
19 fluids, and anesthetic agents via the extracorporeal circuit;
20 14. Complete documentation associated with described
21 duties;
22 15. Perform isolated limb and organ perfusion;
23 16. Provide surgical assistance;
24 17. Perform organ preservation;
25 18. Perform dialysis while on clinical bypass;
26 19. Perform therapeutic apheresis;
27 20. Administer blood, blood products and supportive
28 fluids via the therapeutic apheresis circuit; and
29 21. Perform pacemaker lead and battery analysis.
30 (b) This section or chapter does not prevent
31 third-party payors from reimbursing employers of clinical
5
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1 perfusionists for covered services rendered by such clinical
2 perfusionists.
3 (c) A clinical perfusionist shall clearly convey to a
4 patient that he or she is a clinical perfusionist.
5 (d) A clinical perfusionist may perform medical tasks
6 and services within the framework of a written practice
7 protocol developed between the supervising physician and the
8 clinical perfusionist.
9 (e) A clinical perfusionist may not prescribe, order,
10 compound, or dispense any controlled substance, legend drug,
11 or medical device to any patient. This paragraph does not
12 prohibit a clinical perfusionist from administering legend
13 drugs, controlled substances, intravenous drugs, fluids, or
14 blood products that are ordered by the physician and
15 administered to a patient while under the orders of such
16 physician.
17 (4) PERFORMANCE BY TRAINEES.--The practice of a
18 trainee is exempt from the requirements of this chapter while
19 the trainee is performing assigned tasks as a trainee in
20 conjunction with an approved program. Before providing
21 clinical perfusion in conjunction with the requirements of an
22 approved program, the trainee shall clearly convey to the
23 patient that he or she is a trainee and is under direct
24 supervision.
25 (5) PROGRAM APPROVAL.--The boards shall approve
26 programs for the education and training of clinical
27 perfusionists which meet standards established by board rules.
28 The boards may recommend only those programs for clinical
29 perfusionists training which hold full accreditation or
30 provisional accreditation from the Commission on Accreditation
31 of Allied Health Education Programs.
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1 (6) CLINICAL PERFUSIONIST LICENSURE.--
2 (a) Any person seeking to be licensed as a clinical
3 perfusionist must apply to the department. The department
4 shall issue a license to any person certified by the board to:
5 1. Be at least 18 years of age.
6 2. Have satisfactorily passed a proficiency
7 examination established by the American Board of
8 Cardiovascular Perfusion (ABCP). The board, on receipt of an
9 application and application fee, shall waive the examination
10 requirement for an applicant who at the time of application:
11 a. Is appropriately licensed or certified by another
12 state, territory, or possession of the United States if the
13 requirements of that state, territory, or possession for the
14 license or certificate are the substantial equivalent of the
15 requirements of this section determined by the board; or
16 b. Holds a current certificate as a certified clinical
17 perfusionist issued by the American Board of Cardiovascular
18 Perfusion (ABCP), or its successor before July 1, 2005.
19 3. Be certified in basic cardiac life support.
20 4. Have completed the application form and remitted an
21 application fee, not to exceed $1,500, as set by the
22 department. An application must include:
23 a. A certificate of completion of an approved program;
24 b. A sworn statement of any prior felony convictions;
25 c. A sworn statement of any prior discipline or denial
26 of licensure or certification in any state; and
27 d. Two letters of recommendation, one from a physician
28 and one from a certified or licensed clinical perfusionist.
29
30 Before January 1, 2006, a person is eligible to apply to the
31 board and receive a license notwithstanding the requirements
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1 of this subsection if the person was actively engaged in the
2 practice of perfusion consistent with applicable law, and if
3 the person was operating cardiopulmonary bypass systems during
4 cardiac surgical cases in a licensed health care facility as
5 the person's primary function and had been operating the
6 system for 10 of the 12 years preceding application for
7 licensure.
8 (b) A license must be renewed biennially. Each renewal
9 must include:
10 1. A renewal fee, not to exceed $1,500, as set by the
11 department; and
12 2. A sworn statement of no felony convictions in the
13 immediately preceding 2 years.
14 (c) Each licensed clinical perfusionist shall
15 biennially complete continuing medical education as required
16 by the board.
17 (d)1. A license as a provisional licensed perfusionist
18 may be issued by the board to a person who has successfully
19 completed an approved perfusion education program and the
20 filing of an application, payment of an application fee, and
21 the submission of evidence satisfactory to the board of the
22 successful completion of the requisite education requirements.
23 2. A provisional licensed perfusionist is under the
24 supervision and direction of a licensed perfusionist at all
25 times during which the provisional licensed perfusionist
26 performs perfusion. Rules adopted by the board governing such
27 supervision and direction may not require the immediate
28 physical presence of the supervising licensed perfusionist.
29 3. A provisional license is valid for 2 years from the
30 date it is issued and may be extended subject to rule by the
31 board. The application for extension must be signed by a
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1 supervising licensed perfusionist. Upon notification by the
2 approved testing service, or the board, that any portion of
3 the licensing examination has been failed after the 2-year
4 provisional license term, the provisional license must be
5 surrendered to the board.
6 (e) A license as a temporarily licensed perfusionist
7 may be issued by the department to a person who has
8 successfully completed the perfusion licensure application.
9 (f) The Board of Medicine may impose upon a clinical
10 perfusionist any penalty specified in s. 456.072 or s.
11 458.331(2) if the clinical perfusionist is found guilty of or
12 is investigated for an act that constitutes a violation of
13 this chapter or chapter 456.
14 (7) CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST
15 TO ADVISE THE BOARD.--
16 (a) The chairperson of the board may appoint a
17 cardiovascular surgeon and a certified clinical perfusionist
18 to advise the board as to the adoption of rules for the
19 licensure of clinical perfusionists. The board may use a
20 committee structure that is most practicable in order to
21 receive any recommendations to the board regarding rules and
22 all matters relating to clinical perfusionists, including, but
23 not limited to, recommendations to improve safety in the
24 clinical practices of licensed clinical perfusionists.
25 (b) In addition to its other duties and
26 responsibilities as prescribed by law, the board shall:
27 1. Recommend to the department the licensure of
28 clinical perfusionists.
29 2. Develop rules regulating the use of clinical
30 perfusionists under this chapter and chapter 459, except for
31 rules relating to the formulary developed under s. 458.347(4).
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1 The board shall also develop rules to ensure that the
2 continuity of supervision is maintained in each practice
3 setting. The boards shall consider adopting a proposed rule at
4 the regularly scheduled meeting immediately following the
5 submission of the proposed rule. A proposed rule may not be
6 adopted by either board unless both boards have accepted and
7 approved the identical language contained in the proposed
8 rule. The language of all proposed rules must be approved by
9 both boards pursuant to each respective board's guidelines and
10 standards regarding the adoption of proposed rules.
11 3. Address concerns and problems of clinical
12 perfusionists to improve safety in the clinical practices of
13 licensed clinical perfusionists.
14 (c) When the board finds that an applicant for
15 licensure has failed to meet, to the board's satisfaction,
16 each of the requirements for licensure set forth in this
17 section, the board may enter an order to:
18 1. Refuse to certify the applicant for licensure;
19 2. Approve the applicant for licensure with
20 restrictions on the scope of practice or license; or
21 3. Approve the applicant for conditional licensure.
22 Such conditions may include placement of the applicant on
23 probation for a period of time and subject to such conditions
24 as the board specifies, including, but not limited to,
25 requiring the applicant to undergo treatment, to attend
26 continuing education courses, or to take corrective action.
27 (8) PENALTY.--A person who falsely holds himself or
28 herself out as a clinical perfusionist commits a felony of the
29 third degree, punishable as provided in s. 775.082, s.
30 775.083, or s. 775.084.
31
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1 (9) DENIAL, SUSPENSION, OR REVOCATION OF
2 LICENSURE.--The boards may deny, suspend, or revoke the
3 license of a clinical perfusionist whom the board determines
4 has violated any provision of this section, chapter, or any
5 rule adopted pursuant thereto.
6 (10) RULES.--The boards shall adopt rules to
7 administer this section.
8 (11) FEES.--The department shall allocate the fees
9 collected under this section to the boards.
10 (12) EXEMPTIONS.--
11 (a) This section may not be construed to limit the
12 practice of a physician licensed under this chapter or a
13 respiratory therapist licensed under chapter 468, so long as
14 that person does not hold himself or herself out to the public
15 as possessing a license, provisional license, registration, or
16 certificate issued under this section or use a professional
17 title protected by this section.
18 (b) This section may not be construed to limit the
19 practice of nursing or to prevent qualified members of other
20 professions from doing work of a nature consistent with their
21 training and licensure, so long as those persons do not hold
22 themselves out to the public as possessing a license,
23 provisional license, registration, or certificate issued under
24 this section or use a professional title protected by this
25 section.
26 (c) A person need not be licensed under this section
27 who:
28 1. Is licensed in this state under any other law and
29 is engaging in the profession or occupation for which he or
30 she is licensed.
31
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1 2. Is a qualified person in this state or another
2 state or territory who is employed by the United States
3 Government or an agency thereof while discharging his or her
4 official duties.
5 3. Is a student providing services regulated under
6 this chapter who is:
7 a. Pursuing a course of study that leads to a degree
8 in a profession regulated by this chapter;
9 b. Providing services in a training setting, as long
10 as such services and associated activities constitute part of
11 a supervised course of study; and
12 c. Designated by the title "trainee."
13 4. Is not a resident of this state but offers services
14 in this state, provided that:
15 a. Such services are performed in this state for no
16 more than 15 days in any calendar year; and
17 b. Such nonresident is licensed or certified by a
18 state or territory of the United States or by a foreign
19 country or province.
20 (d) Except as stipulated by the board, the exemptions
21 in this subsection do not apply to any person licensed under
22 this section whose license has been revoked or suspended by
23 the board or whose license or certification in another
24 jurisdiction has been revoked or suspended by the licensing or
25 certifying authority in that jurisdiction.
26 (e) This subsection may not be construed to exempt a
27 person from meeting the minimum standards of performance in
28 professional activities when measured against generally
29 prevailing peer performance, including the undertaking of
30 activities for which the person is not qualified by training
31 or experience.
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1 (13) PAYMENT OR REIMBURSEMENT BY HOSPITALS OF COSTS OF
2 COMPLIANCE WITH PART.--A hospital is not required to pay for,
3 or reimburse any person for, the costs of compliance with any
4 requirement of this part, including costs of continuing
5 education.
6 Section 2. Section 456.048, Florida Statutes, is
7 amended to read:
8 456.048 Financial responsibility requirements for
9 certain health care practitioners.--
10 (1) As a prerequisite for licensure or license
11 renewal, the Board of Acupuncture, the Board of Chiropractic
12 Medicine, the Board of Podiatric Medicine, and the Board of
13 Dentistry shall, by rule, require that all health care
14 practitioners licensed under the respective board, and the
15 Board of Medicine and the Board of Osteopathic Medicine shall,
16 by rule, require that all anesthesiologist assistants licensed
17 pursuant to s. 458.3475 or s. 459.023 and clinical
18 perfusionists licensed pursuant to s. 458.3476 or s. 459.025,
19 and the Board of Nursing shall, by rule, require that advanced
20 registered nurse practitioners certified under s. 464.012, and
21 the department shall, by rule, require that midwives maintain
22 medical malpractice insurance or provide proof of financial
23 responsibility in an amount and in a manner determined by the
24 board or department to be sufficient to cover claims arising
25 out of the rendering of or failure to render professional care
26 and services in this state.
27 (2) The board or department may grant exemptions upon
28 application by practitioners meeting any of the following
29 criteria:
30 (a) Any person licensed under chapter 457, s.
31 458.3475, s. 458.3476, s. 459.023, s. 459.025, chapter 460,
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1 chapter 461, s. 464.012, chapter 466, or chapter 467 who
2 practices exclusively as an officer, employee, or agent of the
3 Federal Government or of the state or its agencies or its
4 subdivisions. For the purposes of this subsection, an agent
5 of the state, its agencies, or its subdivisions is a person
6 who is eligible for coverage under any self-insurance or
7 insurance program authorized by the provisions of s.
8 768.28(16) or who is a volunteer under s. 110.501(1).
9 (b) Any person whose license or certification has
10 become inactive under chapter 457, s. 458.3475, s. 458.3476,
11 s. 459.023, s. 459.025, chapter 460, chapter 461, part I of
12 chapter 464, chapter 466, or chapter 467 and who is not
13 practicing in this state. Any person applying for
14 reactivation of a license must show either that such licensee
15 maintained tail insurance coverage which provided liability
16 coverage for incidents that occurred on or after October 1,
17 1993, or the initial date of licensure in this state,
18 whichever is later, and incidents that occurred before the
19 date on which the license became inactive; or such licensee
20 must submit an affidavit stating that such licensee has no
21 unsatisfied medical malpractice judgments or settlements at
22 the time of application for reactivation.
23 (c) Any person holding a limited license pursuant to
24 s. 456.015, and practicing under the scope of such limited
25 license.
26 (d) Any person licensed or certified under chapter
27 457, s. 458.3475, s. 458.3476, s. 459.023, s. 459.025 chapter
28 460, chapter 461, s. 464.012, chapter 466, or chapter 467 who
29 practices only in conjunction with his or her teaching duties
30 at an accredited school or in its main teaching hospitals.
31 Such person may engage in the practice of medicine to the
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1 extent that such practice is incidental to and a necessary
2 part of duties in connection with the teaching position in the
3 school.
4 (e) Any person holding an active license or
5 certification under chapter 457, s. 458.3475, s. 458.3476, s.
6 459.023, s. 459.025, chapter 460, chapter 461, s. 464.012,
7 chapter 466, or chapter 467 who is not practicing in this
8 state. If such person initiates or resumes practice in this
9 state, he or she must notify the department of such activity.
10 (f) Any person who can demonstrate to the board or
11 department that he or she has no malpractice exposure in the
12 state.
13 (3) Notwithstanding the provisions of this section,
14 the financial responsibility requirements of ss. 458.320 and
15 459.0085 shall continue to apply to practitioners licensed
16 under those chapters, except for clinical perfusionists
17 licensed pursuant to s. 458.3476 or s. 459.025 and
18 anesthesiologist assistants licensed pursuant to s. 458.3475
19 or s. 459.023 who must meet the requirements of this section.
20 Section 3. Section 459.025, Florida Statutes, is
21 created to read:
22 459.025 Clinical perfusionist.--
23 (1) DEFINITIONS.--As used in this section, the term:
24 (a) "Approved program" means a program for the
25 education and training of clinical perfusion which has been
26 approved by the boards as provided in subsection (5).
27 (b) "Boards" means the Board of Medicine and the Board
28 of Osteopathic Medicine.
29 (c) "Clinical perfusionist" means a person who has
30 graduated from an approved program, who is licensed to perform
31
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1 medical services, and who is prescribed, delegated, or
2 supervised by a licensed physician.
3 (d) "Clinical perfusion" means the functions necessary
4 for the support, treatment, measurement, or supplementation of
5 the cardiovascular, circulatory, or respiratory systems or
6 other organs, or a combination of those activities, and the
7 safe management of physiologic functions by monitoring and
8 analyzing the parameters of the systems under an order and the
9 supervision of a licensed osteopathic physician, through
10 extracorporeal circulation, long-term clinical support
11 techniques, including extracorporeal carbon-dioxide removal
12 and extracorporeal membrane oxygenation, and associated
13 therapeutic and diagnostic technologies, such as counter
14 pulsation, ventricular assistance, auto transfusion, blood
15 conservation techniques, myocardial and organ preservation,
16 extracorporeal life support, isolated limb perfusion,
17 therapeutic aphaeresis, and platelet rich plasma
18 sequestration.
19 (e) "Clinical perfusionists' licensing committee"
20 means the clinical perfusion licensing committee appointed by
21 the board.
22 (f) "Continuing medical education" means courses
23 recognized and approved by the boards, the American Academy of
24 Physician Assistants, the American Medical Association, the
25 American Osteopathic Association, the American Board of
26 Cardiovascular Perfusion, or the Accreditation Council on
27 Continuing Medical Education.
28 (g) "Direct supervision" means the on-site, personal
29 supervision by a licensed clinical perfusionist who is present
30 when a procedure is being performed and who is in all
31 instances immediately available to provide assistance and
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1 direction to the clinical perfusionist while clinical
2 perfusion services are being performed.
3 (h) "Extracorporeal circulation" means the diversion
4 of a patient's blood through a heart-lung machine or a similar
5 device that assumes the functions of the patient's heart,
6 lungs, kidneys, liver, or other organs.
7 (i) "Trainee" means a person who is currently enrolled
8 in an approved program.
9 (j) "Perfusion protocols" means perfusion-related
10 policies and protocols developed or approved by a licensed
11 health facility or a physician through collaboration with
12 administrators, licensed clinical perfusionists, and other
13 health care professionals.
14 (k) "Proficiency examination" means an entry-level
15 examination approved by the boards, including examinations
16 administered by the American Board of Cardiovascular Perfusion
17 (ABCP).
18 (l) "Provisional licensed perfusionist" means a person
19 provisionally licensed under this section.
20 (m) "Supervising physician" means an osteopathic
21 physician who holds an active license.
22 (n) "Temporarily licensed perfusionist" means a person
23 granted a temporary license under this section.
24 (2) PERFORMANCE OF A SUPERVISING PHYSICIAN.--A
25 physician who supervises a clinical perfusionist must be
26 qualified in the medical areas in which the clinical
27 perfusionist performs.
28 (3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.--A
29 clinical perfusionist may perform duties established by rule
30 by the board, including the following duties that are included
31 in the clinical perfusionist's protocol, while prescribed by a
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1 physician or under the supervision of an osteopathic
2 physician:
3 1. Perform extracorporeal circulation/clinical
4 support;
5 2. Perform or administer counter pulsation;
6 3. Perform circulatory support and ventricular
7 assistance;
8 4. Perform extracorporeal membrane oxygenation (ECMO)
9 and extracorporeal life support (ECLS);
10 5. Perform blood conservation techniques,
11 autotransfusion, and blood component sequestration;
12 6. Perform myocardial preservation;
13 7. Perform coagulation and hemotalogic monitoring;
14 8. Perform physiological monitoring;
15 9. Perform blood gas and blood chemistry monitoring;
16 10. Perform induction of hypothermia or hyperthermia
17 with reversal;
18 11. Perform hemodilution;
19 12. Perform hemofiltration;
20 13. Administer blood, blood products, supportive
21 fluids, and anesthetic agents via the extracorporeal circuit;
22 14. Complete documentation associated with described
23 duties;
24 15. Perform isolated limb and organ perfusion;
25 16. Provide surgical assistance;
26 17. Perform organ preservation;
27 18. Perform dialysis while on clinical bypass;
28 19. Perform therapeutic apheresis;
29 20. Administer blood, blood products and supportive
30 fluids via the therapeutic apheresis circuit; and
31 21. Perform pacemaker lead and battery analysis.
18
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1 (b) This section or chapter does not prevent
2 third-party payors from reimbursing employers of clinical
3 perfusionists for covered services rendered by such clinical
4 perfusionists.
5 (c) A clinical perfusionist shall clearly convey to a
6 patient that he or she is a clinical perfusionist.
7 (d) A clinical perfusionist may perform medical tasks
8 and services within the framework of a written practice
9 protocol developed between the supervising physician and the
10 clinical perfusionist.
11 (e) A clinical perfusionist may not prescribe, order,
12 compound, or dispense any controlled substance, legend drug,
13 or medical device to any patient. This paragraph does not
14 prohibit a clinical perfusionist from administering legend
15 drugs, controlled substances, intravenous drugs, fluids, or
16 blood products that are ordered by the physician and
17 administered to a patient while under the orders of such
18 physician.
19 (4) PERFORMANCE BY TRAINEES.--The practice of a
20 trainee is exempt from the requirements of this chapter while
21 the trainee is performing assigned tasks as a trainee in
22 conjunction with an approved program. Before providing
23 clinical perfusion in conjunction with the requirements of an
24 approved program, the trainee shall clearly convey to the
25 patient that he or she is a trainee and is under direct
26 supervision.
27 (5) PROGRAM APPROVAL.--The boards shall approve
28 programs for the education and training of clinical
29 perfusionists which meet standards established by board rules.
30 The boards may recommend only those programs for clinical
31 perfusionists training which hold full accreditation or
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1 provisional accreditation from the Commission on Accreditation
2 of Allied Health Education Programs.
3 (6) CLINICAL PERFUSIONIST LICENSURE.--
4 (a) Any person seeking to be licensed as a clinical
5 perfusionist must apply to the department. The department
6 shall issue a license to any person certified by the board to:
7 1. Be at least 18 years of age.
8 2. Have satisfactorily passed a proficiency
9 examination established by the American Board of
10 Cardiovascular Perfusion (ABCP). The board, on receipt of an
11 application and application fee, shall waive the examination
12 requirement for an applicant who at the time of application:
13 a. Is appropriately licensed or certified by another
14 state, territory, or possession of the United States if the
15 requirements of that state, territory, or possession for the
16 license or certificate are the substantial equivalent of the
17 requirements of this section determined by the board; or
18 b. Holds a current certificate as a certified clinical
19 perfusionist issued by the American Board of Cardiovascular
20 Perfusion (ABCP), or its successor before July 1, 2005.
21 3. Be certified in basic cardiac life support.
22 4. Have completed the application form and remitted an
23 application fee, not to exceed $1,500, as set by the
24 department. An application must include:
25 a. A certificate of completion of an approved program;
26 b. A sworn statement of any prior felony convictions;
27 c. A sworn statement of any prior discipline or denial
28 of licensure or certification in any state; and
29 d. Two letters of recommendation, one from a physician
30 and one from a certified or licensed clinical perfusionist.
31
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1 Before January 1, 2006, a person is eligible to apply to the
2 board and receive a license notwithstanding the requirements
3 of this subsection if the person was actively engaged in the
4 practice of perfusion consistent with applicable law, and if
5 the person was operating cardiopulmonary bypass systems during
6 cardiac surgical cases in a licensed health care facility as
7 the person's primary function and had been operating the
8 system for 10 of the 12 years preceding application for
9 licensure.
10 (b) A license must be renewed biennially. Each renewal
11 must include:
12 1. A renewal fee, not to exceed $1,500, as set by the
13 department; and
14 2. A sworn statement of no felony convictions in the
15 immediately preceding 2 years.
16 (c) Each licensed clinical perfusionist shall
17 biennially complete continuing medical education as required
18 by the board.
19 (d)1. A license as a provisional licensed perfusionist
20 may be issued by the board to a person who has successfully
21 completed an approved perfusion education program and the
22 filing of an application, payment of an application fee, and
23 the submission of evidence satisfactory to the board of the
24 successful completion of the requisite education requirements.
25 2. A provisional licensed perfusionist is under the
26 supervision and direction of a licensed perfusionist at all
27 times during which the provisional licensed perfusionist
28 performs perfusion. Rules adopted by the board governing such
29 supervision and direction may not require the immediate
30 physical presence of the supervising licensed perfusionist.
31
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1 3. A provisional license is valid for 2 years from the
2 date it is issued and may be extended subject to rule by the
3 board. The application for extension must be signed by a
4 supervising licensed perfusionist. Upon notification by the
5 approved testing service, or the board, that any portion of
6 the licensing examination has been failed after the 2-year
7 provisional license term, the provisional license must be
8 surrendered to the board.
9 (e) A license as a temporarily licensed perfusionist
10 may be issued by the department to a person who has
11 successfully completed the perfusion licensure application.
12 (f) The Board of Osteopathic Medicine may impose upon
13 a clinical perfusionist any penalty specified in s. 456.072 or
14 s. 458.331(2) if the clinical perfusionist is found guilty of
15 or is investigated for an act that constitutes a violation of
16 this chapter or chapter 456.
17 (7) CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST
18 TO ADVISE THE BOARD.--
19 (a) The chairperson of the board may appoint a
20 cardiovascular surgeon and a certified clinical perfusionist
21 to advise the board as to the adoption of rules for the
22 licensure of clinical perfusionists. The board may use a
23 committee structure that is most practicable in order to
24 receive any recommendations to the board regarding rules and
25 all matters relating to clinical perfusionists, including, but
26 not limited to, recommendations to improve safety in the
27 clinical practices of licensed clinical perfusionists.
28 (b) In addition to its other duties and
29 responsibilities as prescribed by law, the board shall:
30 1. Recommend to the department the licensure of
31 clinical perfusionists.
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1 2. Develop rules regulating the use of clinical
2 perfusionists under this chapter and chapter 458, except for
3 rules relating to the formulary developed under s. 458.347(4).
4 The board shall also develop rules to ensure that the
5 continuity of supervision is maintained in each practice
6 setting. The boards shall consider adopting a proposed rule at
7 the regularly scheduled meeting immediately following the
8 submission of the proposed rule. A proposed rule may not be
9 adopted by either board unless both boards have accepted and
10 approved the identical language contained in the proposed
11 rule. The language of all proposed rules must be approved by
12 both boards pursuant to each respective board's guidelines and
13 standards regarding the adoption of proposed rules.
14 3. Address concerns and problems of clinical
15 perfusionists to improve safety in the clinical practices of
16 licensed clinical perfusionists.
17 (c) When the board finds that an applicant for
18 licensure has failed to meet, to the board's satisfaction,
19 each of the requirements for licensure set forth in this
20 section, the board may enter an order to:
21 1. Refuse to certify the applicant for licensure;
22 2. Approve the applicant for licensure with
23 restrictions on the scope of practice or license; or
24 3. Approve the applicant for conditional licensure.
25 Such conditions may include placement of the applicant on
26 probation for a period of time and subject to such conditions
27 as the board specifies, including, but not limited to,
28 requiring the applicant to undergo treatment, to attend
29 continuing education courses, or to take corrective action.
30 (8) PENALTY.--A person who falsely holds himself or
31 herself out as a clinical perfusionist commits:
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1 (a) For the first offense, a misdemeanor of the first
2 degree, punishable as provided in s. 775.082, s. 775.083, or
3 s. 775.084.
4 (b) For the second or subsequent offense, a felony of
5 the third degree, punishable as provided in s. 775.082, s.
6 775.083, or s. 775.084.
7 (9) DENIAL, SUSPENSION, OR REVOCATION OF
8 LICENSURE.--The boards may deny, suspend, or revoke the
9 license of a clinical perfusionist whom the board determines
10 has violated any provision of this section, chapter, or any
11 rule adopted pursuant thereto.
12 (10) RULES.--The boards shall adopt rules to
13 administer this section.
14 (11) FEES.--The department shall allocate the fees
15 collected under this section to the boards.
16 (12) EXEMPTIONS.--
17 (a) This section may not be construed to limit the
18 practice of an osteopathic physician licensed under this
19 chapter or a respiratory therapist licensed under chapter 468,
20 so long as that person does not hold himself or herself out to
21 the public as possessing a license, provisional license,
22 registration, or certificate issued under this section or use
23 a professional title protected by this section.
24 (b) This section may not be construed to limit the
25 practice of nursing or to prevent qualified members of other
26 professions from doing work of a nature consistent with their
27 training and licensure, so long as those persons do not hold
28 themselves out to the public as possessing a license,
29 provisional license, registration, or certificate issued under
30 this section or use a professional title protected by this
31 section.
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1 (c) A person need not be licensed under this section
2 who:
3 1. Is licensed in this state under any other law and
4 is engaging in the profession or occupation for which he or
5 she is licensed.
6 2. Is a qualified person in this state or another
7 state or territory who is employed by the United States
8 Government or an agency thereof while discharging his or her
9 official duties.
10 3. Is a student providing services regulated under
11 this chapter who is:
12 a. Pursuing a course of study that leads to a degree
13 in a profession regulated by this chapter;
14 b. Providing services in a training setting, as long
15 as such services and associated activities constitute part of
16 a supervised course of study; and
17 c. Designated by the title "trainee."
18 4. Is not a resident of this state but offers services
19 in this state, provided that:
20 a. Such services are performed in this state for no
21 more than 15 days in any calendar year; and
22 b. Such nonresident is licensed or certified by a
23 state or territory of the United States or by a foreign
24 country or province.
25 (d) Except as stipulated by the board, the exemptions
26 in this subsection do not apply to any person licensed under
27 this section whose license has been revoked or suspended by
28 the board or whose license or certification in another
29 jurisdiction has been revoked or suspended by the licensing or
30 certifying authority in that jurisdiction.
31
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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 (13) PAYMENT OR REIMBURSEMENT BY HOSPITALS OF COSTS OF
8 COMPLIANCE WITH PART.--A hospital is not required to pay for,
9 or reimburse any person for, the costs of compliance with any
10 requirement of this part, including costs of continuing
11 education.
12 Section 4. This act shall take effect January 1, 2006.
13
14 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
15 Senate Bill 2372
16
17 The Committee Substitute makes the following changes:
18 -- Revises requirements for the licensure of clinical
perfusionists;
19
-- Revises the definition of "clinical perfusion,"
20 "extracorporeal circulation," and "supervising physician";
21 -- Increases the application fee for a clinical
perfusionist's license from $1,000 to $1,500 as set by the
22 Department of Health rather than the Board of Medicine and
Board of Osteopathic Medicine;
23
-- Revises requirements for continuing education as a
24 condition of licensure renewal so that 40 hours of continuing
education are not required to be completed each 2 years;
25
-- Deletes grounds for which a medical or osteopathic
26 physician may be disciplined for failing to adequately
supervise a clinical perfusionist;
27
-- Creates exemptions from the clinical perfusionist
28 licensure requirements;
29 -- Revises the functions that a clinical perfusionist may
perform to exclude hemotalogic analysis and blood gas
30 analysis; and
31 -- Requires trainees to be under the direct supervision of a
clinical perfusionist to perform assigned tasks.
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