Senate Bill sb2372
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Florida Senate - 2005 SB 2372
By Senator Peaden
2-1474-05
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
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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; amending s. 456.048,
9 F.S.; specifying financial responsibility
10 requirements for clinical perfusionists;
11 amending ss. 458.331 and 459.015, F.S.;
12 providing that the failure to adequately
13 supervise the activities of a clinical
14 perfusionist is grounds for denial of a medical
15 doctor's or osteopathic physician's license or
16 disciplinary action; providing an effective
17 date.
18
19 Be It Enacted by the Legislature of the State of Florida:
20
21 Section 1. Section 458.3476, Florida Statutes, is
22 created to read:
23 458.3476 Clinical perfusionist.--
24 (1) DEFINITIONS.--As used in this section, the term:
25 (a) "Approved program" means a program for the
26 education and training of clinical perfusion which has been
27 approved by the boards as provided in subsection (5).
28 (b) "Boards" means the Board of Medicine and the Board
29 of Osteopathic Medicine.
30 (c) "Clinical perfusionist" means a person who has
31 graduated from an approved program, who is licensed to perform
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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 physician, including:
10 1. The use of extracorporeal circulation, long-term
11 clinical support techniques, including extracorporeal
12 carbon-dioxide removal and extracorporeal membrane
13 oxygenation, and associated therapeutic and diagnostic
14 technologies, such as counter pulsation, ventricular
15 assistance, auto transfusion, blood conservation techniques,
16 myocardial and organ preservation, extracorporeal life
17 support, isolated limb perfusion, therapeutic aphaeresis, and
18 platelet rich plasma sequestration.
19 2. The use of techniques involving blood management,
20 advanced life support, and other related functions.
21 3. The administration of:
22 (I) Pharmacological and therapeutic agents; and
23 (II) Blood products or anesthetic agents through the
24 extracorporeal circuit or through an intravenous line as
25 ordered by a physician.
26 4. The performance and use of:
27 (I) Coagulation monitoring and analysis;
28 (II) Physiologic monitoring and analysis;
29 (III) Blood gas and chemistry monitoring and analysis;
30 (IV) Hematologic monitoring and analysis;
31 (V) Hypothermia;
3
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1 (VI) Hyperthermia;
2 (VII) Hemoconcentration and hemodilution; and
3 (VIII) Hemodialysis.
4 5. The observation of signs and symptoms related to
5 perfusion services, the determination of whether the signs and
6 symptoms exhibit abnormal characteristics and the
7 implementation of appropriate reporting, perfusion protocols,
8 or changes in or the initiation of emergency procedures.
9 (e) "Clinical perfusionists' licensing committee"
10 means the clinical perfusion licensing committee appointed by
11 the board.
12 (f) "Continuing medical education" means courses
13 recognized and approved by the boards, the American Academy of
14 Physician Assistants, the American Medical Association, the
15 American Osteopathic Association, the American Board of
16 Clinical Perfusion, or the Accreditation Council on Continuing
17 Medical Education.
18 (g) "Direct supervision" means the on-site, personal
19 supervision by a physician who is present when a procedure is
20 being performed and who is in all instances immediately
21 available to provide assistance and direction to the clinical
22 perfusionist while clinical perfusion services are being
23 performed.
24 (h) "Extracorporeal circulation" means the diversion
25 of a patient's blood through a heart-lung machine or a similar
26 device that assumes the functions of the patient's heart,
27 lungs, kidney, liver, or other organs.
28 (i) "Trainee" means a person who is currently enrolled
29 in an approved program.
30 (j) "Perfusion protocols" means perfusion-related
31 policies and protocols developed or approved by a licensed
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1 health facility or a physician through collaboration with
2 administrators, licensed cardiovascular perfusionists, and
3 other health care professionals.
4 (k) "Proficiency examination" means an entry-level
5 examination approved by the boards, including examinations
6 administered by the American Board of Cardiovascular Perfusion
7 (ABCP).
8 (l) "Provisional licensed perfusionist" means a person
9 provisionally licensed under this section.
10 (m) "Supervising physician" means an allopathic
11 physician who holds an active, unrestricted license and who
12 has successfully completed a training program approved by the
13 Accreditation Council on Graduate Medical Education or its
14 equivalent.
15 (n) "Temporarily licensed perfusionist" means a person
16 granted a temporary license under this section.
17 (2) PERFORMANCE OF A SUPERVISING PHYSICIAN.--A
18 physician who supervises a clinical perfusionist must be
19 qualified in the medical areas in which the clinical
20 perfusionist performs.
21 (3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.--A
22 clinical perfusionist may perform duties established by rule
23 by the board, including the following duties that are included
24 in the clinical perfusionist's protocol, while prescribed by a
25 physician or under the supervision of a physician:
26 1. Perform extracorporeal circulation/clinical
27 support;
28 2. Perform or administer counter pulsation;
29 3. Perform circulatory support and ventricular
30 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
7 monitoring/analysis;
8 8. Perform physiological analysis and monitoring;
9 9. Perform blood gas and blood chemistry analysis and
10 monitoring;
11 10. Perform induction of hypothermia or hyperthermia
12 with reversal;
13 11. Perform hemodilution;
14 12. Perform hemofiltration;
15 13. Administer blood, blood products, supportive
16 fluids, and anesthetic agents via the extracorporeal circuit;
17 14. Complete documentation associated with described
18 duties;
19 15. Perform isolated limb and organ perfusion;
20 16. Provide surgical assistance;
21 17. Perform organ preservation;
22 18. Perform dialysis while on clinical 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.
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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 supervising physician
13 and administered to a patient while under the supervision of
14 such 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.
22 (5) PROGRAM APPROVAL.--The boards shall approve
23 programs for the education and training of clinical
24 perfusionists which meet standards established by board rules.
25 The boards may recommend only those programs for clinical
26 perfusionists training which hold full accreditation or
27 provisional accreditation from the Commission on Accreditation
28 of Allied Health Education Programs.
29 (6) CLINICAL PERFUSIONIST LICENSURE.--
30
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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 established by the American Board of
7 Cardiovascular Perfusion (ABCP). The board, on receipt of an
8 application and application fee, shall waive the examination
9 requirement for an applicant who at the time of application:
10 a. Is appropriately licensed or certified by another
11 state, territory, or possession of the United States if the
12 requirements of that state, territory, or possession for the
13 license or certificate are the substantial equivalent of the
14 requirements of this section determined by the board; or
15 b. Holds a current certificate as a certified clinical
16 perfusionist issued by the American Board of Cardiovascular
17 Perfusion (ABCP), or its successor before July 1, 2005.
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 $1,000, as set by the boards.
21 An 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 January 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 10 of the 12 years preceding application for
6 licensure.
7 (b) A license must be renewed biennially. Each renewal
8 must include:
9 1. A renewal fee, not to exceed $1,000, as set by the
10 boards; and
11 2. A sworn statement of no felony convictions in the
12 immediately preceding 2 years.
13 (c) Each licensed clinical perfusionist shall
14 biennially complete 40 hours of continuing medical education
15 or hold a current certificate issued by the American Board of
16 Cardiovascular Perfusion or its successor.
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 clinical perfusionist to advise
18 the board as to the adoption of rules for the licensure of
19 clinical perfusionists. The board may use a committee
20 structure that is most practicable in order to receive any
21 recommendations to the board regarding rules and all matters
22 relating to clinical perfusionists, including, but not limited
23 to, recommendations to improve safety in the clinical
24 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 all 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.
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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 Section 2. Section 456.048, Florida Statutes, is
11 amended to read:
12 456.048 Financial responsibility requirements for
13 certain health care practitioners.--
14 (1) As a prerequisite for licensure or license
15 renewal, the Board of Acupuncture, the Board of Chiropractic
16 Medicine, the Board of Podiatric Medicine, and the Board of
17 Dentistry shall, by rule, require that all health care
18 practitioners licensed under the respective board, and the
19 Board of Medicine and the Board of Osteopathic Medicine shall,
20 by rule, require that all anesthesiologist assistants licensed
21 pursuant to s. 458.3475 or s. 459.023 and clinical
22 perfusionists licensed pursuant to s. 458.3476 or s. 459.025,
23 and the Board of Nursing shall, by rule, require that advanced
24 registered nurse practitioners certified under s. 464.012, and
25 the department shall, by rule, require that midwives maintain
26 medical malpractice insurance or provide proof of financial
27 responsibility in an amount and in a manner determined by the
28 board or department to be sufficient to cover claims arising
29 out of the rendering of or failure to render professional care
30 and services in this state.
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1 (2) The board or department may grant exemptions upon
2 application by practitioners meeting any of the following
3 criteria:
4 (a) Any person licensed under chapter 457, s.
5 458.3475, s. 458.3476, s. 459.023, s. 459.025, chapter 460,
6 chapter 461, s. 464.012, chapter 466, or chapter 467 who
7 practices exclusively as an officer, employee, or agent of the
8 Federal Government or of the state or its agencies or its
9 subdivisions. For the purposes of this subsection, an agent
10 of the state, its agencies, or its subdivisions is a person
11 who is eligible for coverage under any self-insurance or
12 insurance program authorized by the provisions of s.
13 768.28(16) or who is a volunteer under s. 110.501(1).
14 (b) Any person whose license or certification has
15 become inactive under chapter 457, s. 458.3475, s. 458.3476,
16 s. 459.023, s. 459.025, chapter 460, chapter 461, part I of
17 chapter 464, chapter 466, or chapter 467 and who is not
18 practicing in this state. Any person applying for
19 reactivation of a license must show either that such licensee
20 maintained tail insurance coverage which provided liability
21 coverage for incidents that occurred on or after October 1,
22 1993, or the initial date of licensure in this state,
23 whichever is later, and incidents that occurred before the
24 date on which the license became inactive; or such licensee
25 must submit an affidavit stating that such licensee has no
26 unsatisfied medical malpractice judgments or settlements at
27 the time of application for reactivation.
28 (c) Any person holding a limited license pursuant to
29 s. 456.015, and practicing under the scope of such limited
30 license.
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1 (d) Any person licensed or certified under chapter
2 457, s. 458.3475, s. 458.3476, s. 459.023, s. 459.025 chapter
3 460, chapter 461, s. 464.012, chapter 466, or chapter 467 who
4 practices only in conjunction with his or her teaching duties
5 at an accredited school or in its main teaching hospitals.
6 Such person may engage in the practice of medicine to the
7 extent that such practice is incidental to and a necessary
8 part of duties in connection with the teaching position in the
9 school.
10 (e) Any person holding an active license or
11 certification under chapter 457, s. 458.3475, s. 458.3476, s.
12 459.023, s. 459.025, chapter 460, chapter 461, s. 464.012,
13 chapter 466, or chapter 467 who is not practicing in this
14 state. If such person initiates or resumes practice in this
15 state, he or she must notify the department of such activity.
16 (f) Any person who can demonstrate to the board or
17 department that he or she has no malpractice exposure in the
18 state.
19 (3) Notwithstanding the provisions of this section,
20 the financial responsibility requirements of ss. 458.320 and
21 459.0085 shall continue to apply to practitioners licensed
22 under those chapters, except for clinical perfusionists
23 licensed pursuant to s. 458.3476 or s. 459.025 and
24 anesthesiologist assistants licensed pursuant to s. 458.3475
25 or s. 459.023 who must meet the requirements of this section.
26 Section 3. Paragraph (dd) of subsection (1) of section
27 458.331, Florida Statutes, is amended to read:
28 458.331 Grounds for disciplinary action; action by the
29 board and department.--
30
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1 (1) The following acts constitute grounds for denial
2 of a license or disciplinary action, as specified in s.
3 456.072(2):
4 (dd) Failing to supervise adequately the activities of
5 those physician assistants, paramedics, emergency medical
6 technicians, advanced registered nurse practitioners, clinical
7 perfusionists, or anesthesiologist assistants acting under the
8 supervision of the physician.
9 Section 4. Paragraph (hh) of subsection (1) of section
10 459.015, Florida Statutes, is amended to read:
11 459.015 Grounds for disciplinary action; action by the
12 board and department.--
13 (1) The following acts constitute grounds for denial
14 of a license or disciplinary action, as specified in s.
15 456.072(2):
16 (hh) Failing to supervise adequately the activities of
17 those physician assistants, paramedics, emergency medical
18 technicians, advanced registered nurse practitioners,
19 anesthesiologist assistants, clinical perfusionists, or other
20 persons acting under the supervision of the osteopathic
21 physician.
22 Section 5. 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 perfusion which has been
28 approved by the boards as provided in subsection (5).
29 (b) "Boards" means the Board of Medicine and the Board
30 of Osteopathic Medicine.
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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 and the
11 supervision of a licensed physician, including:
12 1. The use of extracorporeal circulation, long-term
13 clinical support techniques, including extracorporeal
14 carbon-dioxide removal and extracorporeal membrane
15 oxygenation, and associated therapeutic and diagnostic
16 technologies, such as counter pulsation, ventricular
17 assistance, auto transfusion, blood conservation techniques,
18 myocardial and organ preservation, extracorporeal life
19 support, isolated limb perfusion, therapeutic aphaeresis, and
20 platelet rich plasma sequestration.
21 2. The use of techniques involving blood management,
22 advanced life support, and other related functions.
23 3. The administration of:
24 (I) Pharmacological and therapeutic agents; and
25 (II) Blood products or anesthetic agents through the
26 extracorporeal circuit or through an intravenous line as
27 ordered by a physician.
28 4. The performance and use of:
29 (I) Coagulation monitoring and analysis;
30 (II) Physiologic monitoring and analysis;
31 (III) Blood gas and chemistry monitoring and analysis;
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1 (IV) Hematologic monitoring and analysis;
2 (V) Hypothermia;
3 (VI) Hyperthermia;
4 (VII) Hemoconcentration and hemodilution; and
5 (VIII) Hemodialysis.
6 5. The observation of signs and symptoms related to
7 perfusion services, the determination of whether the signs and
8 symptoms exhibit abnormal characteristics and the
9 implementation of appropriate reporting, perfusion protocols,
10 or changes in or the initiation of emergency procedures.
11 (e) "Clinical perfusionists' licensing committee"
12 means the clinical perfusion licensing committee appointed by
13 the board.
14 (f) "Continuing medical education" means courses
15 recognized and approved by the boards, the American Academy of
16 Physician Assistants, the American Medical Association, the
17 American Osteopathic Association, the American Board of
18 Clinical Perfusion, or the Accreditation Council on Continuing
19 Medical Education.
20 (g) "Direct supervision" means the on-site, personal
21 supervision by a physician who is present when a procedure is
22 being performed and who is in all instances immediately
23 available to provide assistance and direction to the clinical
24 perfusionist while clinical perfusion services are being
25 performed.
26 (h) "Extracorporeal circulation" means the diversion
27 of a patient's blood through a heart-lung machine or a similar
28 device that assumes the functions of the patient's heart,
29 lungs, kidneys, liver, or other organs.
30 (i) "Trainee" means a person who is currently enrolled
31 in an approved program.
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1 (j) "Perfusion protocols" means perfusion-related
2 policies and protocols developed or approved by a licensed
3 health facility or a physician through collaboration with
4 administrators, licensed cardiovascular perfusionists, and
5 other health care professionals.
6 (k) "Proficiency examination" means an entry-level
7 examination approved by the boards, including examinations
8 administered by the American Board of Cardiovascular Perfusion
9 (ABCP).
10 (l) "Provisional licensed perfusionist" means a person
11 provisionally licensed under this section.
12 (m) "Supervising physician" means an allopathic
13 physician who holds an active, unrestricted license and who
14 has successfully completed a training program approved by the
15 Accreditation Council on Graduate Medical Education or its
16 equivalent.
17 (n) "Temporarily licensed perfusionist" means a person
18 granted a temporary license under this section.
19 (2) PERFORMANCE OF A SUPERVISING PHYSICIAN.--A
20 physician who supervises a clinical perfusionist must be
21 qualified in the medical areas in which the clinical
22 perfusionist performs.
23 (3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.--A
24 clinical perfusionist may perform duties established by rule
25 by the board, including the following duties that are included
26 in the clinical perfusionist's protocol, while prescribed by a
27 physician or under the supervision of a physician:
28 1. Perform extracorporeal circulation/clinical
29 support;
30 2. Perform or administer counter pulsation;
31
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1 3. Perform circulatory support and ventricular
2 assistance;
3 4. Perform extracorporeal membrane oxygenation (ECMO)
4 and extracorporeal life support (ECLS);
5 5. Perform blood conservation techniques,
6 autotransfusion, and blood component sequestration;
7 6. Perform myocardial preservation;
8 7. Perform coagulation and hemotalogic
9 monitoring/analysis;
10 8. Perform physiological analysis and monitoring;
11 9. Perform blood gas and blood chemistry analysis and
12 monitoring;
13 10. Perform induction of hypothermia or hyperthermia
14 with reversal;
15 11. Perform hemodilution;
16 12. Perform hemofiltration;
17 13. Administer blood, blood products, supportive
18 fluids, and anesthetic agents via the extracorporeal circuit;
19 14. Complete documentation associated with described
20 duties;
21 15. Perform isolated limb and organ perfusion;
22 16. Provide surgical assistance;
23 17. Perform organ preservation;
24 18. Perform dialysis while on clinical bypass;
25 19. Perform therapeutic apheresis;
26 20. Administer blood, blood products and supportive
27 fluids via the therapeutic apheresis circuit; and
28 21. Perform pacemaker lead and battery analysis.
29 (b) This section or chapter does not prevent
30 third-party payors from reimbursing employers of clinical
31
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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 supervising physician
15 and administered to a patient while under the supervision of
16 such 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.
24 (5) PROGRAM APPROVAL.--The boards shall approve
25 programs for the education and training of clinical
26 perfusionists which meet standards established by board rules.
27 The boards may recommend only those programs for clinical
28 perfusionists training which hold full accreditation or
29 provisional accreditation from the Commission on Accreditation
30 of Allied Health Education Programs.
31 (6) CLINICAL PERFUSIONIST LICENSURE.--
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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 established by the American Board of
7 Cardiovascular Perfusion (ABCP). The board, on receipt of an
8 application and application fee, shall waive the examination
9 requirement for an applicant who at the time of application:
10 a. Is appropriately licensed or certified by another
11 state, territory, or possession of the United States if the
12 requirements of that state, territory, or possession for the
13 license or certificate are the substantial equivalent of the
14 requirements of this section determined by the board; or
15 b. Holds a current certificate as a certified clinical
16 perfusionist issued by the American Board of Cardiovascular
17 Perfusion (ABCP), or its successor before July 1, 2005.
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 $1,000, as set by the boards.
21 An 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 January 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 10 of the 12 years preceding application for
6 licensure.
7 (b) A license must be renewed biennially. Each renewal
8 must include:
9 1. A renewal fee, not to exceed $1,000, as set by the
10 boards; and
11 2. A sworn statement of no felony convictions in the
12 immediately preceding 2 years.
13 (c) Each licensed clinical perfusionist shall
14 biennially complete 40 hours of continuing medical education
15 or hold a current certificate issued by the American Board of
16 Cardiovascular Perfusion or its successor.
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 Osteopathic Medicine may impose upon
10 a clinical perfusionist any penalty specified in s. 456.072 or
11 s. 458.331(2) if the clinical perfusionist is found guilty of
12 or 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 clinical perfusionist to advise
18 the board as to the adoption of rules for the licensure of
19 clinical perfusionists. The board may use a committee
20 structure that is most practicable in order to receive any
21 recommendations to the board regarding rules and all matters
22 relating to clinical perfusionists, including, but not limited
23 to, recommendations to improve safety in the clinical
24 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 all rules regulating the use of clinical
30 perfusionists under this chapter and chapter 458, 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.
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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 Section 6. This act shall take effect July 1, 2005.
11
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13 SENATE SUMMARY
14 Requires a supervising physician to be qualified in the
medical area in which the clinical perfusionist performs.
15 Prescribes duties of a clinical perfusionist. Requires a
clinical perfusionist to convey that he or she is a
16 clinical perfusionist to a patient. Authorizes a clinical
perfusionist to perform medical tasks and services within
17 a certain protocol. Prohibits a clinical perfusionist
from prescribing, ordering, compounding, or dispensing
18 certain drugs or a medical device. Provides that a
clinical perfusionist may administer certain drugs,
19 fluids, and blood products under the supervision of a
physician. Exempts a trainee from requirements of a
20 clinical perfusionist. Requires board approval of
training programs for clinical perfusionists. Provides
21 licensure requirements. Provides provisional licensing
requirements. Provides for a temporary license as a
22 clinical perfusionist. Authorizes the Board of Medicine
and the Board of Osteopathic Medicine to impose a penalty
23 if a clinical perfusionist is found guilty of certain
violations. Provides a penalty for any person who falsely
24 holds himself or herself out as a clinical perfusionist.
Provides for the denial, suspension, or revocation of a
25 license as a clinical perfusionist. Requires the
Department of Health to allocate fees collected to each
26 board. Applies financial responsibility requirements to
clinical perfusionists. Provides that the failure to
27 adequately supervise the activities of a clinical
perfusionist is grounds for denial of the license of a
28 medical doctor or osteopathic physician or disciplinary
action.
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31
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