HB 1625

1	A bill to be entitled
2	An act relating to clinical perfusionists; amending s.
3	456.048, F.S.; specifying financial responsibility
4	requirements for clinical perfusionists; creating ss.
5	458.3476 and 459.025, F.S.; providing definitions;
6	requiring a supervising physician or osteopathic physician
7	to be qualified in the medical areas in which the clinical
8	perfusionist performs; prescribing duties of a clinical
9	perfusionist; requiring a clinical perfusionist to convey
10	to a patient that he or she is a clinical perfusionist;
11	authorizing a clinical perfusionist to perform medical
12	tasks and services within a certain protocol; prohibiting
13	a clinical perfusionist from prescribing, ordering,
14	compounding, or dispensing certain drugs or medical
15	devices; providing that a clinical perfusionist may
16	administer certain drugs, fluids, and blood products under
17	the supervision of a physician or an osteopathic
18	physician; exempting a trainee from the requirements of a
19	clinical perfusionist; requiring approval by the Board of
20	Medicine and the Board of Osteopathic Medicine of training
21	programs for clinical perfusionists; providing licensure
22	requirements; providing provisional licensing
23	requirements; providing for a temporary license as a
24	clinical perfusionist; authorizing each board to impose a
25	penalty against a clinical perfusionist found guilty of or
26	investigated for violating ch. 456, ch. 458, or ch. 459,
27	F.S.; authorizing the chairperson of each board to appoint
28	certain persons to advise the respective boards regarding
29	rules for the licensure of clinical perfusionists;
30	providing duties of each board; providing for the denial,
31	suspension, or revocation of a license; requiring each
32	board to adopt rules; requiring the Department of Health
33	to allocate collected fees to each board; providing
34	exemptions from clinical perfusionist licensure
35	requirements; providing that hospitals are not obligated
36	to pay certain costs; providing an effective date.
37
38	Be It Enacted by the Legislature of the State of Florida:
39
40	Section 1.  Section 456.048, Florida Statutes, is amended
41	to read:
42	456.048  Financial responsibility requirements for certain
43	health care practitioners.--
44	(1)  As a prerequisite for licensure or license renewal,
45	the Board of Acupuncture, the Board of Chiropractic Medicine,
46	the Board of Podiatric Medicine, and the Board of Dentistry
47	shall, by rule, require that all health care practitioners
48	licensed under the respective board, and the Board of Medicine
49	and the Board of Osteopathic Medicine shall, by rule, require
50	that all anesthesiologist assistants licensed under pursuant to
51	s. 458.3475 or s. 459.023 and clinical perfusionists licensed
52	under s. 458.3476 or s. 459.025, and the Board of Nursing shall,
53	by rule, require that advanced registered nurse practitioners
54	certified under s. 464.012, and the department shall, by rule,
55	require that midwives maintain medical malpractice insurance or
56	provide proof of financial responsibility in an amount and in a
57	manner determined by the board or department to be sufficient to
58	cover claims arising out of the rendering of or failure to
59	render professional care and services in this state.
60	(2)  The board or department may grant exemptions upon
61	application by practitioners meeting any of the following
62	criteria:
63	(a)  Any person licensed under chapter 457, s. 458.3475, s.
64	458.3476, s. 459.023, s. 459.025, chapter 460, chapter 461, s.
65	464.012, chapter 466, or chapter 467 who practices exclusively
66	as an officer, employee, or agent of the Federal Government or
67	of the state or its agencies or its subdivisions. For the
68	purposes of this subsection, an agent of the state, its
69	agencies, or its subdivisions is a person who is eligible for
70	coverage under any self-insurance or insurance program
71	authorized by the provisions of s. 768.28(16) or who is a
72	volunteer under s. 110.501(1).
73	(b)  Any person whose license or certification has become
74	inactive under chapter 457, s. 458.3475, s. 458.3476, s.
75	459.023, s. 459.025, chapter 460, chapter 461, part I of chapter
76	464, chapter 466, or chapter 467 and who is not practicing in
77	this state. Any person applying for reactivation of a license
78	must show either that such licensee maintained tail insurance
79	coverage which provided liability coverage for incidents that
80	occurred on or after October 1, 1993, or the initial date of
81	licensure in this state, whichever is later, and incidents that
82	occurred before the date on which the license became inactive;
83	or such licensee must submit an affidavit stating that such
84	licensee has no unsatisfied medical malpractice judgments or
85	settlements at the time of application for reactivation.
86	(c)  Any person holding a limited license pursuant to s.
87	456.015, and practicing under the scope of such limited license.
88	(d)  Any person licensed or certified under chapter 457, s.
89	458.3475, s. 458.3476, s. 459.023, s. 459.025, chapter 460,
90	chapter 461, s. 464.012, chapter 466, or chapter 467 who
91	practices only in conjunction with his or her teaching duties at
92	an accredited school or in its main teaching hospitals. Such
93	person may engage in the practice of medicine to the extent that
94	such practice is incidental to and a necessary part of duties in
95	connection with the teaching position in the school.
96	(e)  Any person holding an active license or certification
97	under chapter 457, s. 458.3475, s. 458.3476, s. 459.023, s.
98	459.025, chapter 460, chapter 461, s. 464.012, chapter 466, or
99	chapter 467 who is not practicing in this state. If such person
100	initiates or resumes practice in this state, he or she must
101	notify the department of such activity.
102	(f)  Any person who can demonstrate to the board or
103	department that he or she has no malpractice exposure in the
104	state.
105	(3)  Notwithstanding the provisions of this section, the
106	financial responsibility requirements of ss. 458.320 and
107	459.0085 shall continue to apply to practitioners licensed under
108	those chapters, except for clinical perfusionists licensed under
109	s. 458.3476 or s. 459.025 and anesthesiologist assistants
110	licensed under pursuant to s. 458.3475 or s. 459.023 who must
111	meet the requirements of this section.
112	Section 2.  Section 458.3476, Florida Statutes, is created
113	to read:
114	458.3476  Clinical perfusionist.--
115	(1)  DEFINITIONS.--As used in this section, the term:
116	(a)  "Approved program" means a program for the education
117	and training of clinical perfusion which has been approved by
118	the board as provided in subsection (5).
119	(b)  "Board" means the Board of Medicine.
120	(c)  "Clinical perfusionist" means a person who has
121	graduated from an approved program, who is licensed to perform
122	medical services, and who is prescribed, delegated, or
123	supervised by a licensed physician.
124	(d)  "Clinical perfusion" means the functions necessary for
125	the support, treatment, measurement, or supplementation of the
126	cardiovascular, circulatory, or respiratory systems or other
127	organs, or a combination of those activities, and the safe
128	management of physiologic functions by monitoring and analyzing
129	the parameters of the systems under an order and the supervision
130	of a licensed physician through extracorporeal circulation,
131	long-term clinical support techniques, including extracorporeal
132	carbon dioxide removal and extracorporeal membrane oxygenation,
133	and associated therapeutic and diagnostic technologies, such as
134	counter-pulsation, ventricular assistance, auto-transfusion,
135	blood conservation techniques, myocardial and organ
136	preservation, extracorporeal life support, isolated limb
137	perfusion, therapeutic aphaeresis, and platelet-rich plasma
138	sequestration.
139	(e)  "Continuing medical education" means courses
140	recognized and approved by the board, the American Academy of
141	Physician Assistants, the American Medical Association, the
142	American Osteopathic Association, the American Board of
143	Cardiovascular Perfusion, or the Accreditation Council on
144	Continuing Medical Education.
145	(f)  "Direct supervision" means on-site, personal
146	supervision by a licensed clinical perfusionist who is present
147	when a procedure is being performed and who is in all instances
148	immediately available to provide assistance and direction to a
149	trainee while clinical perfusion services are being performed.
150	(g)  "Extracorporeal circulation" means the diversion of a
151	patient's blood through a heart-lung machine or a similar device
152	that assumes the functions of the patient's heart, lungs,
153	kidneys, liver, or other organs.
154	(h)  "Trainee" means a person who is currently enrolled in
155	an approved program.
156	(i)  "Perfusion protocols" means perfusion-related policies
157	and protocols developed or approved by a licensed health
158	facility or a physician through collaboration with
159	administrators, licensed clinical perfusionists, and other
160	health care professionals.
161	(j)  "Proficiency examination" means an entry-level
162	examination approved by the board, including examinations
163	administered by the American Board of Cardiovascular Perfusion.
164	(k)  "Provisionally licensed clinical perfusionist" means a
165	person provisionally licensed under this section.
166	(l)  "Supervising physician" means a physician who holds an
167	active license under chapter 458.
168	(m)  "Temporarily licensed clinical perfusionist" means a
169	person granted a temporary license under this section.
170	(2)  PERFORMANCE OF SUPERVISING PHYSICIANS.--A physician
171	who supervises a clinical perfusionist shall be qualified in the
172	medical areas in which the clinical perfusionist performs.
173	(3)  PERFORMANCE OF CLINICAL PERFUSIONISTS.--
174	(a)  A clinical perfusionist may perform duties established
175	by rule by the board while prescribed by a physician or under
176	the supervision of a physician, including the following duties
177	that are included in the clinical perfusionist's protocol:
178	1.  Perform extracorporeal circulation or clinical support.
179	2.  Perform or administer counter-pulsation.
180	3.  Perform circulatory support and ventricular assistance.
181	4.  Perform extracorporeal membrane oxygenation and
182	extracorporeal life support.
183	5.  Perform blood conservation techniques, auto-
184	transfusion, and blood component sequestration.
185	6.  Perform myocardial preservation.
186	7.  Perform coagulation and hematologic monitoring.
187	8.  Perform physiological monitoring.
188	9.  Perform blood gas analysis and blood chemistry
189	monitoring.
190	10.  Perform induction of hypothermia or hyperthermia with
191	reversal.
192	11.  Perform hemodilution.
193	12.  Perform hemofiltration.
194	13.  Administer blood, blood products, supportive fluids,
195	and anesthetic agents via the extracorporeal circuit.
196	14.  Complete documentation associated with described
197	duties.
198	15.  Perform isolated limb and organ perfusion.
199	16.  Provide surgical assistance.
200	17.  Perform organ preservation.
201	18.  Perform dialysis while the patient is on clinical
202	bypass.
203	19.  Perform therapeutic aphaeresis.
204	20.  Administer blood, blood products, and supportive
205	fluids via the therapeutic aphaeresis circuit.
206	21.  Perform pacemaker lead and battery analysis.
207	(b)  This section does not prevent third-party payors from
208	reimbursing employers of clinical perfusionists for covered
209	services rendered by the clinical perfusionists.
210	(c)  A clinical perfusionist shall clearly convey to a
211	patient that he or she is a clinical perfusionist.
212	(d)  A clinical perfusionist may perform medical tasks and
213	services within the framework of a written practice protocol
214	developed between the supervising physician and the clinical
215	perfusionist.
216	(e)  A clinical perfusionist may not prescribe, order,
217	compound, or dispense any controlled substance, legend drug, or
218	medical device to any patient. This paragraph does not prohibit
219	a clinical perfusionist from administering legend drugs,
220	controlled substances, or intravenous drugs, fluids, or blood
221	products that are ordered by the physician and administered to a
222	patient while under the orders of the physician.
223	(4)  PERFORMANCE OF TRAINEES.--The practice of a trainee is
224	exempt from the requirements of this section while the trainee
225	is performing assigned tasks as a trainee in conjunction with an
226	approved program. Before providing clinical perfusion in
227	conjunction with the requirements of an approved program, the
228	trainee shall clearly convey to the patient that he or she is a
229	trainee and is under the direct supervision of a licensed
230	clinical perfusionist.
231	(5)  PROGRAM APPROVAL.--The board shall approve programs
232	for the education and training of clinical perfusionists that
233	meet standards established by board rules. The board may
234	recommend only those programs for clinical perfusionist training
235	that hold full accreditation or provisional accreditation from
236	the Commission on Accreditation of Allied Health Education
237	Programs.
238	(6)  CLINICAL PERFUSIONIST LICENSURE.--
239	(a)  Any person seeking to be licensed as a clinical
240	perfusionist shall apply to the department. The department shall
241	issue a license to any person certified by the board to:
242	1.  Be at least 18 years of age.
243	2.  Have satisfactorily passed a proficiency examination
244	approved by the board. The board, on receipt of an application
245	and application fee, shall waive the examination requirement for
246	an applicant who at the time of application:
247	a.  Is appropriately licensed or certified by another
248	state, territory, or possession of the United States if the
249	requirements for the license or certificate of that state,
250	territory, or possession are the substantial equivalent of the
251	requirements of this section determined by the board;
252	b.  Holds a current certificate as a certified clinical
253	perfusionist issued by a certifying agency approved by the board
254	that includes as a requirement for certification an examination
255	approved by the board; or
256	c.  Was not a graduate of an accredited program prior to
257	1981 but met the then-current eligibility requirements for
258	certification as a certified clinical perfusionist and
259	subsequently was certified, if the applicant applies before July
260	1, 2008, and otherwise complies with the provisions of this
261	section.
262	3.  Be certified in basic cardiac life support.
263	4.  Have completed the application form and remitted an
264	application fee, not to exceed $1,500 as set by the board. An
265	application shall include:
266	a.  A certificate of completion of an approved program.
267	b.  A sworn statement of any prior felony convictions.
268	c.  A sworn statement of any prior discipline or denial of
269	licensure or certification in any state.
270	d.  Two letters of recommendation, one from a physician and
271	one from a certified or licensed clinical perfusionist.
272
273	Before July 1, 2007, a person is eligible to apply to the board
274	and receive a license, notwithstanding the requirements of this
275	subsection, if the person was actively engaged in the practice
276	of perfusion consistent with applicable law and if the person
277	was operating cardiopulmonary bypass systems during cardiac
278	surgical cases in a licensed health care facility as the
279	person's primary function and had been operating the system for
280	8 of the 10 years preceding application for licensure.
281	(b)  A license shall be renewed biennially. Each renewal
282	shall include:
283	1.  A renewal fee, not to exceed $1,500, as set by the
284	board.
285	2.  A sworn statement of no felony convictions in the
286	immediately preceding 2 years.
287	(c)  Each licensed clinical perfusionist shall biennially
288	complete continuing medical education as required by the board.
289	(d)1.  A license as a provisionally licensed clinical
290	perfusionist may be issued by the board to a person who has
291	successfully completed an approved perfusion education program
292	and the filing of an application, payment of an application fee,
293	and the submission of evidence satisfactory to the board of the
294	successful completion of the requisite education requirements.
295	2.  A provisionally licensed clinical perfusionist shall be
296	under the supervision and direction of a licensed clinical
297	perfusionist at all times during which the provisionally
298	licensed clinical perfusionist performs clinical perfusion.
299	Rules adopted by the board governing the supervision and
300	direction may not require the immediate physical presence of the
301	supervising clinical perfusionist.
302	3.  A provisional license is valid for 2 years from the
303	date it is issued and may be extended subject to rule by the
304	board. The application for extension shall be signed by a
305	supervising clinical perfusionist. Upon notification by the
306	approved testing service or the board that any portion of the
307	licensing examination has been failed after the 2-year
308	provisional license term, the provisional license shall be
309	surrendered to the board.
310	(e)  A license as a temporarily licensed clinical
311	perfusionist may be issued by the department to a person who has
312	successfully completed the licensure application.
313	(f)  The board may impose upon a clinical perfusionist any
314	penalty specified in s. 456.072 or s. 458.331(2) if the clinical
315	perfusionist is found guilty of or is investigated for an act
316	that constitutes a violation of this chapter or chapter 456.
317	(7)  CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST TO
318	ADVISE THE BOARD.--
319	(a)  The chairperson of the board may appoint a
320	cardiovascular surgeon and a clinical perfusionist to advise the
321	board as to the adoption of rules for the licensure of clinical
322	perfusionists. The board may use a committee structure that is
323	most practicable in order to receive any recommendations to the
324	board regarding rules and all matters relating to clinical
325	perfusionists, including, but not limited to, recommendations to
326	improve safety in the clinical practices of clinical
327	perfusionists.
328	(b)  In addition to its other duties and responsibilities
329	as prescribed by law, the board shall:
330	1.  Recommend to the department the licensure of clinical
331	perfusionists.
332	2.  Develop rules regulating the use of clinical
333	perfusionists under this chapter and chapter 459, except for
334	rules relating to the formulary developed under s. 458.347(4).
335	The board shall also develop rules to ensure that continuity of
336	supervision is maintained in each practice setting. The board
337	shall consider adopting a proposed rule at the board's regularly
338	scheduled meeting immediately following the submission of the
339	proposed rule. A proposed rule may not be adopted by either the
340	board or the Board of Osteopathic Medicine under s. 459.025
341	unless both boards have accepted and approved the identical
342	language contained in the proposed rule. The language of all
343	proposed rules shall be approved by both boards pursuant to each
344	respective board's guidelines and standards regarding the
345	adoption of proposed rules.
346	3.  Address concerns and problems of clinical perfusionists
347	to improve safety in the clinical practices of licensed clinical
348	perfusionists.
349	(c)  When the board finds that an applicant for licensure
350	has failed to meet, to the board's satisfaction, each of the
351	requirements for licensure set forth in this section, the board
352	may enter an order to:
353	1.  Refuse to certify the applicant for licensure;
354	2.  Approve the applicant for licensure with restrictions
355	on the scope of practice or license; or
356	3.  Approve the applicant for conditional licensure. The
357	conditions may include placement of the applicant on probation
358	for a period of time and subject to the conditions as the board
359	specifies, including, but not limited to, requiring the
360	applicant to undergo treatment, to attend continuing education
361	courses, or to take corrective action.
362	(8)  DENIAL, SUSPENSION, OR REVOCATION OF LICENSURE.--The
363	board may deny, suspend, or revoke the license of a clinical
364	perfusionist who the board determines has violated any provision
365	of this section or any rule adopted pursuant thereto.
366	(9)  RULES.--The board shall adopt rules to administer this
367	section.
368	(10)  FEES.--The department shall allocate the fees
369	collected under this section to the board.
370	(11)  EXEMPTIONS.--
371	(a)  This section may not be construed to limit the
372	practice of a physician licensed under this chapter or a
373	respiratory therapist licensed under this chapter as long as
374	that person does not hold himself or herself out to the public
375	as possessing a license, provisional license, or registration
376	issued under this section or use a professional title protected
377	by this section.
378	(b)  This section may not be construed to limit the
379	practice of nursing or to prevent qualified members of other
380	professions from doing work of a nature consistent with their
381	training and licensure as long as those persons do not hold
382	themselves out to the public as possessing a license,
383	provisional license, or registration issued under this section
384	or use a professional title protected by this section.
385	(c)  A person need not be licensed under this section who:
386	1.  Is licensed in this state under any other law and is
387	engaging in the profession or occupation for which he or she is
388	licensed.
389	2.  Is a qualified person in this state or another state or
390	territory who is employed by the United States Government or an
391	agency thereof while discharging his or her official duties.
392	3.  Is a student providing services regulated under this
393	section who is:
394	a.  Pursuing a course of study that leads to a degree in a
395	profession regulated under this section.
396	b.  Providing services in a training setting as long as the
397	services and associated activities constitute part of a
398	supervised course of study.
399	c.  Designated by the title "trainee."
400	4.  Is not a resident of this state but offers clinical
401	perfusion services in this state, provided that:
402	a.  The services are performed in this state for no more
403	than 30 days in any calendar year; and
404	b.  The nonresident is licensed or certified by a state or
405	territory of the United States.
406	(d)  Except as stipulated by the board, the exemptions in
407	this subsection do not apply to any person licensed under this
408	section whose license has been revoked or suspended by the board
409	or whose license or certification in another jurisdiction has
410	been revoked or suspended by the licensing or certifying
411	authority in that jurisdiction.
412	(e)  This subsection may not be construed to exempt a
413	person from meeting the minimum standards of performance in
414	professional activities when measured against generally
415	prevailing peer performance, including the undertaking of
416	activities for which the person is not qualified by training or
417	experience.
418	(12)  PAYMENT OR REIMBURSEMENT BY HOSPITALS OF COSTS OF
419	COMPLIANCE.--A hospital is not required to pay for or reimburse
420	any person for the costs of compliance with any requirement of
421	this section, including costs of continuing education.
422	Section 3.  Section 459.025, Florida Statutes, is created
423	to read:
424	459.025  Clinical perfusionist.--
425	(1)  DEFINITIONS.--As used in this section, the term:
426	(a)  "Approved program" means a program for the education
427	and training of clinical perfusion which has been approved by
428	the board as provided in subsection (5).
429	(b)  "Board" means the Board of Osteopathic Medicine.
430	(c)  "Clinical perfusionist" means a person who has
431	graduated from an approved program, who is licensed to perform
432	medical services, and who is prescribed, delegated, or
433	supervised by a licensed osteopathic physician.
434	(d)  "Clinical perfusion" means the functions necessary for
435	the support, treatment, measurement, or supplementation of the
436	cardiovascular, circulatory, or respiratory systems or other
437	organs, or a combination of those activities, and the safe
438	management of physiologic functions by monitoring and analyzing
439	the parameters of the systems under an order and the supervision
440	of a licensed osteopathic physician through extracorporeal
441	circulation, long-term clinical support techniques, including
442	extracorporeal carbon dioxide removal and extracorporeal
443	membrane oxygenation, and associated therapeutic and diagnostic
444	technologies, such as counter-pulsation, ventricular assistance,
445	auto-transfusion, blood conservation techniques, myocardial and
446	organ preservation, extracorporeal life support, isolated limb
447	perfusion, therapeutic aphaeresis, and platelet-rich plasma
448	sequestration.
449	(e)  "Continuing medical education" means courses
450	recognized and approved by the board, the American Academy of
451	Physician Assistants, the American Medical Association, the
452	American Osteopathic Association, the American Board of
453	Cardiovascular Perfusion, or the Accreditation Council on
454	Continuing Medical Education.
455	(f)  "Direct supervision" means on-site, personal
456	supervision by a licensed clinical perfusionist who is present
457	when a procedure is being performed and who is in all instances
458	immediately available to provide assistance and direction to a
459	trainee while clinical perfusion services are being performed.
460	(g)  "Extracorporeal circulation" means the diversion of a
461	patient's blood through a heart-lung machine or a similar device
462	that assumes the functions of the patient's heart, lungs,
463	kidneys, liver, or other organs.
464	(h)  "Trainee" means a person who is currently enrolled in
465	an approved program.
466	(i)  "Perfusion protocols" means perfusion-related policies
467	and protocols developed or approved by a licensed health
468	facility or an osteopathic physician through collaboration with
469	administrators, licensed clinical perfusionists, and other
470	health care professionals.
471	(j)  "Proficiency examination" means an entry-level
472	examination approved by the board, including examinations
473	administered by the American Board of Cardiovascular Perfusion.
474	(k)  "Provisionally licensed clinical perfusionist" means a
475	person provisionally licensed under this section.
476	(l)  "Supervising physician" means an osteopathic physician
477	who holds an active license under chapter 459.
478	(m)  "Temporarily licensed clinical perfusionist" means a
479	person granted a temporary license under this section.
480	(2)  PERFORMANCE OF SUPERVISING PHYSICIANS.--An osteopathic
481	physician who supervises a clinical perfusionist shall be
482	qualified in the medical areas in which the clinical
483	perfusionist performs.
484	(3)  PERFORMANCE OF CLINICAL PERFUSIONISTS.--
485	(a)  A clinical perfusionist may perform duties established
486	by rule by the board while prescribed by an osteopathic
487	physician or under the supervision of an osteopathic physician,
488	including the following duties that are included in the clinical
489	perfusionist's protocol:
490	1.  Perform extracorporeal circulation or clinical support.
491	2.  Perform or administer counter-pulsation.
492	3.  Perform circulatory support and ventricular assistance.
493	4.  Perform extracorporeal membrane oxygenation and
494	extracorporeal life support.
495	5.  Perform blood conservation techniques, auto-
496	transfusion, and blood component sequestration.
497	6.  Perform myocardial preservation.
498	7.  Perform coagulation and hematologic monitoring.
499	8.  Perform physiological monitoring.
500	9.  Perform blood gas analysis and blood chemistry
501	monitoring.
502	10.  Perform induction of hypothermia or hyperthermia with
503	reversal.
504	11.  Perform hemodilution.
505	12.  Perform hemofiltration.
506	13.  Administer blood, blood products, supportive fluids,
507	and anesthetic agents via the extracorporeal circuit.
508	14.  Complete documentation associated with described
509	duties.
510	15.  Perform isolated limb and organ perfusion.
511	16.  Provide surgical assistance.
512	17.  Perform organ preservation.
513	18.  Perform dialysis while the patient is on clinical
514	bypass.
515	19.  Perform therapeutic aphaeresis.
516	20.  Administer blood, blood products, and supportive
517	fluids via the therapeutic aphaeresis circuit.
518	21.  Perform pacemaker lead and battery analysis.
519	(b)  This section does not prevent third-party payors from
520	reimbursing employers of clinical perfusionists for covered
521	services rendered by the clinical perfusionists.
522	(c)  A clinical perfusionist shall clearly convey to a
523	patient that he or she is a clinical perfusionist.
524	(d)  A clinical perfusionist may perform medical tasks and
525	services within the framework of a written practice protocol
526	developed between the supervising physician and the clinical
527	perfusionist.
528	(e)  A clinical perfusionist may not prescribe, order,
529	compound, or dispense any controlled substance, legend drug, or
530	medical device to any patient. This paragraph does not prohibit
531	a clinical perfusionist from administering legend drugs,
532	controlled substances, or intravenous drugs, fluids, or blood
533	products that are ordered by the osteopathic physician and
534	administered to a patient while under the orders of the
535	physician.
536	(4)  PERFORMANCE OF TRAINEES.--The practice of a trainee is
537	exempt from the requirements of this section while the trainee
538	is performing assigned tasks as a trainee in conjunction with an
539	approved program. Before providing clinical perfusion in
540	conjunction with the requirements of an approved program, the
541	trainee shall clearly convey to the patient that he or she is a
542	trainee and is under the direct supervision of a licensed
543	clinical perfusionist.
544	(5)  PROGRAM APPROVAL.--The board shall approve programs
545	for the education and training of clinical perfusionists that
546	meet standards established by board rules. The board may
547	recommend only those programs for clinical perfusionist training
548	that hold full accreditation or provisional accreditation from
549	the Commission on Accreditation of Allied Health Education
550	Programs.
551	(6)  CLINICAL PERFUSIONIST LICENSURE.--
552	(a)  Any person seeking to be licensed as a clinical
553	perfusionist shall apply to the department. The department shall
554	issue a license to any person certified by the board to:
555	1.  Be at least 18 years of age.
556	2.  Have satisfactorily passed a proficiency examination
557	approved by the board. The board, on receipt of an application
558	and application fee, shall waive the examination requirement for
559	an applicant who at the time of application:
560	a.  Is appropriately licensed or certified by another
561	state, territory, or possession of the United States if the
562	requirements for the license or certificate of that state,
563	territory, or possession are the substantial equivalent of the
564	requirements of this section determined by the board;
565	b.  Holds a current certificate as a certified clinical
566	perfusionist issued by a certifying agency approved by the board
567	that includes as a requirement for certification an examination
568	approved by the board; or
569	c.  Was not a graduate of an accredited program prior to
570	1981 but met the then-current eligibility requirements for
571	certification as a certified clinical perfusionist and
572	subsequently was certified, if the applicant applies before July
573	1, 2008, and otherwise complies with the provisions of this
574	section.
575	3.  Be certified in basic cardiac life support.
576	4.  Have completed the application form and remitted an
577	application fee, not to exceed $1,500 as set by the board. An
578	application shall include:
579	a.  A certificate of completion of an approved program.
580	b.  A sworn statement of any prior felony convictions.
581	c.  A sworn statement of any prior discipline or denial of
582	licensure or certification in any state.
583	d.  Two letters of recommendation, one from an osteopathic
584	physician and one from a certified or licensed clinical
585	perfusionist.
586
587	Before July 1, 2007, a person is eligible to apply to the board
588	and receive a license, notwithstanding the requirements of this
589	subsection, if the person was actively engaged in the practice
590	of perfusion consistent with applicable law and if the person
591	was operating cardiopulmonary bypass systems during cardiac
592	surgical cases in a licensed health care facility as the
593	person's primary function and had been operating the system for
594	8 of the 10 years preceding application for licensure.
595	(b)  A license shall be renewed biennially. Each renewal
596	shall include:
597	1.  A renewal fee, not to exceed $1,500, as set by the
598	board.
599	2.  A sworn statement of no felony convictions in the
600	immediately preceding 2 years.
601	(c)  Each licensed clinical perfusionist shall biennially
602	complete continuing medical education as required by the board.
603	(d)1.  A license as a provisionally licensed clinical
604	perfusionist may be issued by the board to a person who has
605	successfully completed an approved perfusion education program
606	and the filing of an application, payment of an application fee,
607	and the submission of evidence satisfactory to the board of the
608	successful completion of the requisite education requirements.
609	2.  A provisionally licensed clinical perfusionist shall be
610	under the supervision and direction of a licensed clinical
611	perfusionist at all times during which the provisionally
612	licensed clinical perfusionist performs clinical perfusion.
613	Rules adopted by the board governing the supervision and
614	direction may not require the immediate physical presence of the
615	supervising clinical perfusionist.
616	3.  A provisional license is valid for 2 years from the
617	date it is issued and may be extended subject to rule by the
618	board. The application for extension shall be signed by a
619	supervising clinical perfusionist. Upon notification by the
620	approved testing service or the board that any portion of the
621	licensing examination has been failed after the 2-year
622	provisional license term, the provisional license shall be
623	surrendered to the board.
624	(e)  A license as a temporarily licensed clinical
625	perfusionist may be issued by the department to a person who has
626	successfully completed the licensure application.
627	(f)  The board may impose upon a clinical perfusionist any
628	penalty specified in s. 456.072 or s. 458.331(2) if the clinical
629	perfusionist is found guilty of or is investigated for an act
630	that constitutes a violation of this chapter or chapter 456.
631	(7)  CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST TO
632	ADVISE THE BOARD.--
633	(a)  The chairperson of the board may appoint a
634	cardiovascular surgeon and a clinical perfusionist to advise the
635	board as to the adoption of rules for the licensure of clinical
636	perfusionists. The board may use a committee structure that is
637	most practicable in order to receive any recommendations to the
638	board regarding rules and all matters relating to clinical
639	perfusionists, including, but not limited to, recommendations to
640	improve safety in the clinical practices of clinical
641	perfusionists.
642	(b)  In addition to its other duties and responsibilities
643	as prescribed by law, the board shall:
644	1.  Recommend to the department the licensure of clinical
645	perfusionists.
646	2.  Develop rules regulating the use of clinical
647	perfusionists under this chapter and chapter 458, except for
648	rules relating to the formulary developed under s. 458.347(4).
649	The board shall also develop rules to ensure that continuity of
650	supervision is maintained in each practice setting. The board
651	shall consider adopting a proposed rule at the board's regularly
652	scheduled meeting immediately following the submission of the
653	proposed rule. A proposed rule may not be adopted by either the
654	board or the Board of Medicine under s. 458.3476 unless both
655	boards have accepted and approved the identical language
656	contained in the proposed rule. The language of all proposed
657	rules shall be approved by both boards pursuant to each
658	respective board's guidelines and standards regarding the
659	adoption of proposed rules.
660	3.  Address concerns and problems of clinical perfusionists
661	to improve safety in the clinical practices of licensed clinical
662	perfusionists.
663	(c)  When the board finds that an applicant for licensure
664	has failed to meet, to the board's satisfaction, each of the
665	requirements for licensure set forth in this section, the board
666	may enter an order to:
667	1.  Refuse to certify the applicant for licensure;
668	2.  Approve the applicant for licensure with restrictions
669	on the scope of practice or license; or
670	3.  Approve the applicant for conditional licensure. The
671	conditions may include placement of the applicant on probation
672	for a period of time and subject to the conditions as the board
673	specifies, including, but not limited to, requiring the
674	applicant to undergo treatment, to attend continuing education
675	courses, or to take corrective action.
676	(8)  DENIAL, SUSPENSION, OR REVOCATION OF LICENSURE.--The
677	board may deny, suspend, or revoke the license of a clinical
678	perfusionist who the board determines has violated any provision
679	of this section or any rule adopted pursuant thereto.
680	(9)  RULES.--The board shall adopt rules to administer this
681	section.
682	(10)  FEES.--The department shall allocate the fees
683	collected under this section to the board.
684	(11)  EXEMPTIONS.--
685	(a)  This section may not be construed to limit the
686	practice of an osteopathic physician licensed under this chapter
687	or a respiratory therapist licensed under chapter 468 as long as
688	that person does not hold himself or herself out to the public
689	as possessing a license, provisional license, or registration
690	issued under this section or use a professional title protected
691	by this section.
692	(b)  This section may not be construed to limit the
693	practice of nursing or to prevent qualified members of other
694	professions from doing work of a nature consistent with their
695	training and licensure as long as those persons do not hold
696	themselves out to the public as possessing a license,
697	provisional license, or registration issued under this section
698	or use a professional title protected by this section.
699	(c)  A person need not be licensed under this section who:
700	1.  Is licensed in this state under any other law and is
701	engaging in the profession or occupation for which he or she is
702	licensed.
703	2.  Is a qualified person in this state or another state or
704	territory who is employed by the United States Government or an
705	agency thereof while discharging his or her official duties.
706	3.  Is a student providing services regulated under this
707	section who is:
708	a.  Pursuing a course of study that leads to a degree in a
709	profession regulated under this section.
710	b.  Providing services in a training setting as long as the
711	services and associated activities constitute part of a
712	supervised course of study.
713	c.  Designated by the title "trainee."
714	4.  Is not a resident of this state but offers clinical
715	perfusion services in this state, provided that:
716	a.  The services are performed in this state for no more
717	than 30 days in any calendar year; and
718	b.  The nonresident is licensed or certified by a state or
719	territory of the United States.
720	(d)  Except as stipulated by the board, the exemptions in
721	this subsection do not apply to any person licensed under this
722	section whose license has been revoked or suspended by the board
723	or whose license or certification in another jurisdiction has
724	been revoked or suspended by the licensing or certifying
725	authority in that jurisdiction.
726	(e)  This subsection may not be construed to exempt a
727	person from meeting the minimum standards of performance in
728	professional activities when measured against generally
729	prevailing peer performance, including the undertaking of
730	activities for which the person is not qualified by training or
731	experience.
732	(12)  PAYMENT OR REIMBURSEMENT BY HOSPITALS OF COSTS OF
733	COMPLIANCE.--A hospital is not required to pay for or reimburse
734	any person for the costs of compliance with any requirement of
735	this section, including costs of continuing education.
736	Section 4.  This act shall take effect July 1, 2006.

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