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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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
2
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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.
3
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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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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
14
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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
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31
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