HB 1403

1
A bill to be entitled
2An act relating to clinical perfusionists; amending s.
3456.048, F.S.; specifying financial responsibility
4requirements for clinical perfusionists; creating s.
5468.901, F.S.; providing definitions; requiring a
6supervising physician to be qualified in the medical area
7in which the clinical perfusionist performs; prescribing
8duties of a clinical perfusionist; requiring a clinical
9perfusionist to convey that he or she is a clinical
10perfusionist to a patient; authorizing a clinical
11perfusionist to perform medical tasks and services within
12a certain protocol; prohibiting a clinical perfusionist
13from prescribing, ordering, compounding, or dispensing
14certain drugs or medical devices; providing that a
15clinical perfusionist may administer certain drugs,
16fluids, and blood products under the supervision of a
17physician; exempting a perfusionist in training from
18requirements of a clinical perfusionist; requiring board
19approval of training programs for clinical perfusionists;
20providing certification requirements; providing
21provisional certification requirements; providing for a
22temporary certificate as a clinical perfusionist;
23authorizing the Board of Medicine and the Board of
24Osteopathic Medicine to impose a penalty against a
25clinical perfusionist found guilty of or investigated for
26violating ch. 456, ch. 457, or ch. 458, F.S.; authorizing
27the chairs of the Board of Medicine and the Board of
28Osteopathic Medicine to appoint certain persons to advise
29the boards regarding rules for the certification of
30clinical perfusionists; providing duties of the boards;
31providing for the denial, suspension, or revocation of a
32certification; requiring the boards to adopt rules;
33requiring the Department of Health to allocate fees
34collected to the boards; providing exemptions from
35certification requirements for clinical perfusionists;
36excluding hospitals from payment of certain costs;
37providing that the act does not prevent reimbursement of
38the employers of clinical perfusionists; providing an
39effective date.
40
41Be It Enacted by the Legislature of the State of Florida:
42
43     Section 1.  Section 456.048, Florida Statutes, is amended
44to read:
45     456.048  Financial responsibility requirements for certain
46health care practitioners.--
47     (1)  As a prerequisite for licensure or license renewal,
48the Board of Acupuncture, the Board of Chiropractic Medicine,
49the Board of Podiatric Medicine, and the Board of Dentistry
50shall, by rule, require that all health care practitioners
51licensed under the respective board, and the Board of Medicine
52and the Board of Osteopathic Medicine shall, by rule, require
53that all anesthesiologist assistants licensed pursuant to s.
54458.3475 or s. 459.023, and clinical perfusionists certified
55pursuant to s. 468.901, and the Board of Nursing shall, by rule,
56require that advanced registered nurse practitioners certified
57under s. 464.012, and the department shall, by rule, require
58that midwives maintain medical malpractice insurance or provide
59proof of financial responsibility in an amount and in a manner
60determined by the board or department to be sufficient to cover
61claims arising out of the rendering of or failure to render
62professional care and services in this state.
63     (2)  The board or department may grant exemptions upon
64application by practitioners meeting any of the following
65criteria:
66     (a)  Any person licensed under chapter 457, s. 458.3475, s.
67459.023, chapter 460, chapter 461, s. 464.012, chapter 466, or
68chapter 467, or certified under s. 468.901 who practices
69exclusively as an officer, employee, or agent of the Federal
70Government or of the state or its agencies or its subdivisions.
71For the purposes of this subsection, an agent of the state, its
72agencies, or its subdivisions is a person who is eligible for
73coverage under any self-insurance or insurance program
74authorized by the provisions of s. 768.28(16) or who is a
75volunteer under s. 110.501(1).
76     (b)  Any person whose license or certification has become
77inactive under chapter 457, s. 458.3475, s. 459.023, chapter
78460, chapter 461, part I of chapter 464, chapter 466, or chapter
79467, or s. 468.901 and who is not practicing in this state. Any
80person applying for reactivation of a license must show either
81that such licensee maintained tail insurance coverage which
82provided liability coverage for incidents that occurred on or
83after October 1, 1993, or the initial date of licensure in this
84state, whichever is later, and incidents that occurred before
85the date on which the license became inactive; or such licensee
86must submit an affidavit stating that such licensee has no
87unsatisfied medical malpractice judgments or settlements at the
88time of application for reactivation.
89     (c)  Any person holding a limited license pursuant to s.
90456.015, and practicing under the scope of such limited license.
91     (d)  Any person licensed or certified under chapter 457, s.
92458.3475, s. 459.023, chapter 460, chapter 461, s. 464.012,
93chapter 466, or chapter 467, or s. 468.901 who practices only in
94conjunction with his or her teaching duties at an accredited
95school or in its main teaching hospitals. Such person may engage
96in the practice of medicine to the extent that such practice is
97incidental to and a necessary part of duties in connection with
98the teaching position in the school.
99     (e)  Any person holding an active license or certification
100under chapter 457, s. 458.3475, s. 459.023, chapter 460, chapter
101461, s. 464.012, chapter 466, or chapter 467, or s. 468.901 who
102is not practicing in this state. If such person initiates or
103resumes practice in this state, he or she must notify the
104department of such activity.
105     (f)  Any person who can demonstrate to the board or
106department that he or she has no malpractice exposure in the
107state.
108     (3)  Notwithstanding the provisions of this section, the
109financial responsibility requirements of ss. 458.320 and
110459.0085 shall continue to apply to practitioners licensed under
111those chapters, except for anesthesiologist assistants licensed
112pursuant to s. 458.3475 or s. 459.023 who must meet the
113requirements of this section.
114     Section 2.  Section 468.901, Florida Statutes, is created
115to read:
116     468.901  Clinical perfusionists.--
117     (1)  DEFINITIONS.--As used in this section, the term:
118     (a)  "Approved program" means a program for the education
119and training of clinical perfusion which is approved by the
120boards as provided in subsection (5).
121     (b)  "Boards" means the Board of Medicine and the Board of
122Osteopathic Medicine.
123     (c)  "Clinical perfusionist" means a person who has
124graduated from an approved program, who is certified pursuant to
125this section to perform medical services, and who is prescribed,
126delegated, or supervised by a licensed physician.
127     (d)  "Clinical perfusion" means the functions necessary for
128the support, treatment, measurement, or supplementation of the
129cardiovascular, circulatory, or respiratory systems or other
130organs, or a combination of those activities, and the safe
131management of physiologic functions by monitoring and analyzing
132the parameters of the systems, under an order and the
133supervision of a physician licensed under chapter 458 or chapter
134459, through extracorporeal circulation, long-term clinical
135support techniques, including extracorporeal carbon-dioxide
136removal and extracorporeal membrane oxygenation, and associated
137therapeutic and diagnostic technologies, such as counter
138pulsation, ventricular assistance, auto transfusion, blood
139conservation techniques, myocardial and organ preservation,
140extracorporeal life support, isolated limb perfusion,
141therapeutic aphaeresis, and platelet rich plasma sequestration.
142     (e)  "Clinical perfusionists' certifying committee" means
143the clinical perfusion certifying committee appointed by the
144boards.
145     (f)  "Continuing medical education" means courses
146recognized and approved by the boards, the American Academy of
147Physician Assistants, the American Medical Association, the
148American Osteopathic Association, the American Board of
149Cardiovascular Perfusion, or the Accreditation Council on
150Continuing Medical Education.
151     (g)  "Department" means the Department of Health.
152     (h)  "Direct supervision" means the onsite, personal
153supervision by a clinical perfusionist who is present when a
154procedure is being performed and who is in all instances
155immediately available to provide assistance and direction to the
156clinical perfusionist while clinical perfusion services are
157being performed.
158     (i)  "Extracorporeal circulation" means the diversion of a
159patient's blood through a heart-lung machine or a similar device
160that assumes the functions of the patient's heart, lungs,
161kidneys, liver, or other organs.
162     (j)  "Perfusionist in training" means a student enrolled in
163an approved program who has not yet passed the proficiency
164examination and works under the direct supervision of a clinical
165perfusionist.
166     (k)  "Perfusion protocols" means perfusion-related policies
167and protocols developed or approved by a licensed health
168facility or a physician through collaboration with
169administrators, clinical perfusionists, and other health care
170professionals.
171     (l)  "Proficiency examination" means an entry-level
172examination administered by the American Board of Cardiovascular
173Perfusion.
174     (m)  "Provisional clinical perfusionist" means a person
175provisionally certified under this section.
176     (n)  "Supervising physician" means a physician licensed
177under chapter 458 or chapter 459 who holds an active license.
178     (o)  "Temporary clinical perfusionist" means a person
179granted a temporary certificate under this section.
180     (2)  PERFORMANCE OF A SUPERVISING PHYSICIAN.--A physician
181who supervises a clinical perfusionist must be qualified in the
182medical areas in which the clinical perfusionist performs.
183     (3)(a)  PERFORMANCE OF CLINICAL PERFUSIONISTS.--A clinical
184perfusionist may perform duties established by rule by the
185boards, including the following duties that are included in the
186clinical perfusionist's protocol, if prescribed by a physician
187or under the supervision of a physician:
188     1.  Perform extracorporeal circulation and its clinical
189support.
190     2.  Perform or administer counter pulsation.
191     3.  Perform circulatory support and ventricular assistance.
192     4.  Perform extracorporeal membrane oxygenation and
193extracorporeal life support.
194     5.  Perform blood conservation techniques, autotransfusion,
195and blood component sequestration.
196     6.  Perform myocardial preservation.
197     7.  Perform coagulation and hematologic monitoring.
198     8.  Perform physiological monitoring.
199     9.  Perform blood gas and blood chemistry monitoring.
200     10.  Perform induction of hypothermia or hyperthermia with
201reversal.
202     11.  Perform hemodilution.
203     12.  Perform hemofiltration.
204     13.  Administer blood, blood products, supportive fluids,
205and anesthetic agents via the extracorporeal circuit.
206     14.  Perform isolated limb and organ perfusion.
207     15.  Provide surgical assistance.
208     16.  Perform organ preservation.
209     17.  Perform dialysis while on clinical bypass.
210     18.  Perform therapeutic apheresis.
211     19.  Administer blood, blood products, and supportive
212fluids via the therapeutic apheresis circuit.
213     20.  Perform pacemaker lead and battery analysis.
214     (b)  A clinical perfusionist shall clearly convey to a
215patient that he or she is a clinical perfusionist.
216     (c)  A clinical perfusionist may perform medical tasks and
217services within the framework of a written practice protocol
218developed between the supervising physician and the clinical
219perfusionist.
220     (d)  A clinical perfusionist may not prescribe, order,
221compound, or dispense any controlled substance, legend drug, or
222medical device to any patient. This paragraph does not prohibit
223a clinical perfusionist from administering legend drugs,
224controlled substances, intravenous drugs, fluids, or blood
225products that are ordered by the physician and administered to a
226patient while under the orders of such physician.
227     (4)  PERFORMANCE BY PERFUSIONISTS IN TRAINING.--The
228practice of a perfusionist in training is exempt from the
229requirements of this section while the perfusionist in training
230is performing assigned tasks in conjunction with an approved
231program. Before providing clinical perfusion in conjunction with
232the requirements of an approved program, the perfusionist in
233training shall clearly convey to the patient that he or she is a
234perfusionist in training and is under direct supervision.
235     (5)  PROGRAM APPROVAL.--The boards shall approve programs
236for the education and training of clinical perfusionists which
237hold full accreditation or provisional accreditation from the
238Commission on Accreditation of Allied Health Education Programs
239or a successor organization, as approved by the boards.
240     (6)  CLINICAL PERFUSIONIST CERTIFICATION.--
241     (a)  Any person seeking to be certified as a clinical
242perfusionist must apply to the department. The department shall
243issue a certificate to any person certified by the boards to:
244     1.  Be at least 21 years of age.
245     2.  Have satisfactorily passed a proficiency examination
246approved by the boards. The boards, on receipt of an application
247and application fee, shall waive the examination requirement for
248an applicant who at the time of application holds a current
249certificate issued by a certifying agency approved by the
250boards.
251     3.  Be certified in basic cardiac life support.
252     4.  Have completed the application form and remitted an
253application fee, not to exceed $1,000, as set by the department.
254An application must include:
255     a.  A certificate of completion of an approved program or
256its equivalent.
257     b.  A sworn statement of any prior felony convictions.
258     c.  A sworn statement of any prior discipline or denial of
259certification or license in any state.
260     d.  Two letters of recommendation, one from a physician and
261one from a clinical perfusionist.
262     e.  A set of fingerprints on a form and under procedures
263specified by the department, along with payment in an amount
264equal to the costs incurred by the department for a national
265criminal history check of the applicant.
266
267Before January 1, 2010, a person is eligible to apply to the
268boards and receive a certification notwithstanding the
269requirements of this subsection if the person was actively
270engaged in the practice of perfusion consistent with applicable
271law, the person was operating cardiopulmonary bypass systems
272during cardiac surgical cases in a licensed health care facility
273in this state as the person's primary function, and had been
274operating the system for at least 9 of the 10 years preceding
275the application for certification.
276     (b)  Between October 1, 2009, and June 30, 2010, an
277applicant who was not a graduate of an accredited program before
2781981, but met the then-current eligibility requirements for
279certification as a clinical perfusionist and subsequently was
280certified, shall be certified as a clinical perfusionist if the
281application otherwise complies with this section.
282     (c)  A certificate must be renewed biennially. Each renewal
283must include:
284     1.  A renewal fee, not to exceed $1,000, as set by the
285department.
286     2.  A sworn statement of no felony convictions in the
287immediately preceding 2 years.
288     (d)  Each clinical perfusionist shall biennially complete
289continuing medical education as required by the boards.
290     (e)1.  A certificate as a provisional clinical perfusionist
291may be issued by the boards to a person who has successfully
292completed an approved perfusion education program, completed an
293application and remitted an application fee, and submitted
294evidence satisfactory to the boards of the successful completion
295of the requisite education requirements.
296     2.  A provisional certificate is valid for 2 years from the
297date it is issued and may be extended subject to rule by the
298boards. The application for extension must be signed by a
299supervising clinical perfusionist. However, if a provisional
300clinical perfusionist fails any portion of the certifying
301examination during an extension of the 2-year validity period,
302he or she must surrender the provisional certificate to the
303boards.
304     (f)  A certificate as a temporary clinical perfusionist may
305be issued by the department to a person who has successfully
306completed the perfusion certification application and met other
307requirements established by the boards.
308     (g)  At all times, a provisional clinical perfusionist,
309temporary clinical perfusionist, or perfusionist in training may
310only practice clinical perfusion under the supervision and
311direction of a clinical perfusionist. The boards shall adopt
312rules governing a clinical perfusionist's supervision of
313provisional clinical perfusionists, temporary clinical
314perfusionists, and perfusionists in training.
315     (h)  The boards may impose upon a clinical perfusionist any
316penalty specified in s. 456.072 or s. 458.331(2) if the clinical
317perfusionist is found guilty of or is investigated for an act
318that constitutes a violation of chapter 456, chapter 457, or
319chapter 458.
320     (7)  CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST TO
321ADVISE THE BOARDS.--
322     (a)  The chairs of the Board of Medicine and the Board of
323Osteopathic Medicine may appoint a cardiovascular surgeon and a
324clinical perfusionist to advise the boards as to the adoption of
325rules for the certification of clinical perfusionists. The
326boards may use a committee structure that is most practicable in
327order to receive any recommendations regarding rules and all
328matters relating to clinical perfusionists, including, but not
329limited to, recommendations to improve safety in the practice of
330clinical perfusion.
331     (b)  In addition to its other duties and responsibilities
332as prescribed by law, the boards shall:
333     1.  Recommend to the department the certification of
334clinical perfusionists.
335     2.  Develop rules regulating the use of clinical
336perfusionists under chapter 458 or chapter 459, except for rules
337relating to the formulary developed under s. 458.347(4). The
338boards shall also develop rules to ensure that the continuity of
339supervision is maintained in each practice setting. The boards
340shall consider adopting a proposed rule at the regularly
341scheduled meeting immediately following the submission of the
342proposed rule. A proposed rule may not be adopted by either
343board unless both boards have accepted and approved the
344identical language contained in the proposed rule. The
345provisions of all the proposed rules must be approved by both
346boards pursuant to each respective board's guidelines and
347standards regarding the adoption of proposed rules.
348     3.  Address concerns and problems of clinical perfusionists
349to improve safety in the practice of clinical perfusion.
350     (c)  When the boards find that an applicant for
351certification has failed to meet, to the boards' satisfaction,
352any of the requirements for certification set forth in this
353section, the boards may enter an order to:
354     1.  Refuse to certify the applicant;
355     2.  Approve the applicant for certification with
356restrictions on the scope of practice; or
357     3.  Approve the applicant for provisional or temporary
358certification. Such conditions may include placement of the
359applicant on probation for a period of time and subject to such
360conditions as the boards specify, including, but not limited to,
361requiring the applicant to undergo treatment, to attend
362continuing medical education courses, or to take corrective
363action.
364     (8)  DENIAL, SUSPENSION, OR REVOCATION OF
365CERTIFICATION.--The boards may deny, suspend, or revoke the
366certification of a clinical perfusionist whom the boards
367determine has violated any provision of this section, chapter
368456, chapter 458, or chapter 459 or any rule adopted pursuant
369thereto.
370     (9)  RULES.--The boards shall adopt rules to administer
371this section.
372     (10)  FEES.--The department shall allocate the fees
373collected under this section to the boards for the sole purpose
374of administering the provisions of this section.
375     (11)  EXEMPTIONS.--
376     (a)  This section does not limit the practice of a
377physician licensed under chapter 458 or chapter 459 or a
378respiratory therapist licensed under chapter 468, so long as
379that person does not hold himself or herself out to the public
380as possessing a certificate, provisional certificate, or
381temporary certificate issued under this section or use a
382professional title protected by this section.
383     (b)  This section does not limit the practice of nursing or
384prevent qualified members of other regulated health professions
385from doing work of a nature consistent with the state laws and
386rules that govern their respective health professions, so long
387as those persons do not hold themselves out to the public as
388possessing a certificate, provisional certificate, or temporary
389certificate issued under this section or use a professional
390title protected by this section.
391     (c)  A person need not be certified under this section who:
392     1.  Is a qualified person in this state or another state or
393territory who is employed by the United States Government or an
394agency thereof while discharging his or her official duties.
395     2.  Is a student providing services regulated under this
396chapter who is:
397     a.  Pursuing a course of study that leads to a degree in a
398profession regulated by this chapter.
399     b.  Providing services in a training setting, as long as
400such services and associated activities constitute part of a
401supervised course of study.
402     c.  Designated by the title "perfusionist in training."
403     (d)  The boards shall establish by rule the qualifications
404necessary for a clinical perfusionist who is not a resident of
405this state and is licensed or certified by any other state or
406territory of the United States. Such clinical perfusionist may
407not offer services in this state for more than 30 days in any
408calendar year.
409     (e)  Except as stipulated by the boards, the exemptions in
410this subsection do not apply to any person certified under this
411section whose certificate has been revoked or suspended by
412either of the boards or whose license or certification in
413another jurisdiction has been revoked or suspended by the
414licensing or certifying authority in that jurisdiction.
415     (f)  This subsection does not exempt a person from meeting
416the minimum standards of performance in professional activities
417when measured against generally prevailing peer performance,
418including the undertaking of activities for which the person is
419not qualified by training or experience.
420     (12)  PAYMENTS AND REIMBURSEMENTS.--
421     (a)  A hospital is not required to pay for, or reimburse
422any person for, the costs of compliance with any requirement of
423this section, including costs of continuing medical education.
424     (b)  This section does not prevent third-party payors from
425reimbursing employers of clinical perfusionists for covered
426services rendered by such clinical perfusionists.
427     Section 3.  This act shall take effect October 1, 2009.


CODING: Words stricken are deletions; words underlined are additions.