Bill Text: FL H0251 | 2010 | Regular Session | Introduced

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Bill Title: Clinical Perfusionists

Spectrum: Partisan Bill (Republican 3-0)

Status: (Failed) 2010-04-30 - Died in Committee on Health Care Regulation Policy (HFPC) [H0251 Detail]

Download: Florida-2010-H0251-Introduced.html

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HB 251

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 s.
5	468.901, F.S.; providing definitions; requiring a
6	supervising physician to be qualified in the medical area
7	in which the clinical perfusionist performs; prescribing
8	duties of a clinical perfusionist; requiring a clinical
9	perfusionist to convey that he or she is a clinical
10	perfusionist to a patient; authorizing a clinical
11	perfusionist to perform medical tasks and services within
12	a certain protocol; prohibiting a clinical perfusionist
13	from prescribing, ordering, compounding, or dispensing
14	certain drugs or medical devices; providing that a
15	clinical perfusionist may administer certain drugs,
16	fluids, and blood products under the supervision of a
17	physician; exempting a perfusionist in training from
18	requirements of a clinical perfusionist; requiring board
19	approval of training programs for clinical perfusionists;
20	providing certification requirements; providing
21	provisional certification requirements; providing for a
22	temporary certificate as a clinical perfusionist;
23	authorizing the Board of Medicine and the Board of
24	Osteopathic Medicine to impose a penalty against a
25	clinical perfusionist found guilty of or investigated for
26	violating ch. 456, ch. 457, or ch. 458, F.S.; authorizing
27	the chairs of the Board of Medicine and the Board of
28	Osteopathic Medicine to appoint certain persons to advise
29	the boards regarding rules for the certification of
30	clinical perfusionists; providing duties of the boards;
31	providing for the denial, suspension, or revocation of a
32	certification; requiring the boards to adopt rules;
33	requiring the Department of Health to allocate fees
34	collected to the boards; providing exemptions from
35	certification requirements for clinical perfusionists;
36	excluding hospitals from payment of certain costs;
37	providing that the act does not prevent reimbursement of
38	the employers of clinical perfusionists; providing an
39	effective date.
40
41	Be It Enacted by the Legislature of the State of Florida:
42
43	Section 1. Section 456.048, Florida Statutes, is amended
44	to read:
45	456.048 Financial responsibility requirements for certain
46	health care practitioners.--
47	(1) As a prerequisite for licensure or license renewal,
48	the Board of Acupuncture, the Board of Chiropractic Medicine,
49	the Board of Podiatric Medicine, and the Board of Dentistry
50	shall, by rule, require that all health care practitioners
51	licensed under the respective board, and the Board of Medicine
52	and the Board of Osteopathic Medicine shall, by rule, require
53	that all anesthesiologist assistants licensed pursuant to s.
54	458.3475 or s. 459.023, and clinical perfusionists certified
55	pursuant to s. 468.901, and the Board of Nursing shall, by rule,
56	require that advanced registered nurse practitioners certified
57	under s. 464.012, and the department shall, by rule, require
58	that midwives maintain medical malpractice insurance or provide
59	proof of financial responsibility in an amount and in a manner
60	determined by the board or department to be sufficient to cover
61	claims arising out of the rendering of or failure to render
62	professional care and services in this state.
63	(2) The board or department may grant exemptions upon
64	application by practitioners meeting any of the following
65	criteria:
66	(a) Any person licensed under chapter 457, s. 458.3475, s.
67	459.023, chapter 460, chapter 461, s. 464.012, chapter 466, or
68	chapter 467, or certified under s. 468.901 who practices
69	exclusively as an officer, employee, or agent of the Federal
70	Government or of the state or its agencies or its subdivisions.
71	For the purposes of this subsection, an agent of the state, its
72	agencies, or its subdivisions is a person who is eligible for
73	coverage under any self-insurance or insurance program
74	authorized by the provisions of s. 768.28(16) or who is a
75	volunteer under s. 110.501(1).
76	(b) Any person whose license or certification has become
77	inactive under chapter 457, s. 458.3475, s. 459.023, chapter
78	460, chapter 461, part I of chapter 464, chapter 466, or chapter
79	467, or s. 468.901 and who is not practicing in this state. Any
80	person applying for reactivation of a license must show either
81	that such licensee maintained tail insurance coverage which
82	provided liability coverage for incidents that occurred on or
83	after October 1, 1993, or the initial date of licensure in this
84	state, whichever is later, and incidents that occurred before
85	the date on which the license became inactive; or such licensee
86	must submit an affidavit stating that such licensee has no
87	unsatisfied medical malpractice judgments or settlements at the
88	time of application for reactivation.
89	(c) Any person holding a limited license pursuant to s.
90	456.015, and practicing under the scope of such limited license.
91	(d) Any person licensed or certified under chapter 457, s.
92	458.3475, s. 459.023, chapter 460, chapter 461, s. 464.012,
93	chapter 466, or chapter 467, or s. 468.901 who practices only in
94	conjunction with his or her teaching duties at an accredited
95	school or in its main teaching hospitals. Such person may engage
96	in the practice of medicine to the extent that such practice is
97	incidental to and a necessary part of duties in connection with
98	the teaching position in the school.
99	(e) Any person holding an active license or certification
100	under chapter 457, s. 458.3475, s. 459.023, chapter 460, chapter
101	461, s. 464.012, chapter 466, or chapter 467, or s. 468.901 who
102	is not practicing in this state. If such person initiates or
103	resumes practice in this state, he or she must notify the
104	department of such activity.
105	(f) Any person who can demonstrate to the board or
106	department that he or she has no malpractice exposure in the
107	state.
108	(3) Notwithstanding the provisions of this section, the
109	financial responsibility requirements of ss. 458.320 and
110	459.0085 shall continue to apply to practitioners licensed under
111	those chapters, except for anesthesiologist assistants licensed
112	pursuant to s. 458.3475 or s. 459.023 who must meet the
113	requirements of this section.
114	Section 2. Section 468.901, Florida Statutes, is created
115	to 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
119	and training of clinical perfusion which is approved by the
120	boards as provided in subsection (5).
121	(b) "Boards" means the Board of Medicine and the Board of
122	Osteopathic Medicine.
123	(c) "Clinical perfusionist" means a person who has
124	graduated from an approved program, who is certified pursuant to
125	this section to perform medical services, and who is prescribed,
126	delegated, or supervised by a licensed physician.
127	(d) "Clinical perfusion" means the functions necessary for
128	the support, treatment, measurement, or supplementation of the
129	cardiovascular, circulatory, or respiratory systems or other
130	organs, or a combination of those activities, and the safe
131	management of physiologic functions by monitoring and analyzing
132	the parameters of the systems, under an order and the
133	supervision of a physician licensed under chapter 458 or chapter
134	459, through extracorporeal circulation, long-term clinical
135	support techniques, including extracorporeal carbon-dioxide
136	removal and extracorporeal membrane oxygenation, and associated
137	therapeutic and diagnostic technologies, such as counter
138	pulsation, ventricular assistance, auto transfusion, blood
139	conservation techniques, myocardial and organ preservation,
140	extracorporeal life support, isolated limb perfusion,
141	therapeutic aphaeresis, and platelet rich plasma sequestration.
142	(e) "Clinical perfusionists' certifying committee" means
143	the clinical perfusion certifying committee appointed by the
144	boards.
145	(f) "Continuing medical education" means courses
146	recognized and approved by the boards, the American Academy of
147	Physician Assistants, the American Medical Association, the
148	American Osteopathic Association, the American Board of
149	Cardiovascular Perfusion, or the Accreditation Council on
150	Continuing Medical Education.
151	(g) "Department" means the Department of Health.
152	(h) "Direct supervision" means the onsite, personal
153	supervision by a clinical perfusionist who is present when a
154	procedure is being performed and who is in all instances
155	immediately available to provide assistance and direction to the
156	clinical perfusionist while clinical perfusion services are
157	being performed.
158	(i) "Extracorporeal circulation" means the diversion of a
159	patient's blood through a heart-lung machine or a similar device
160	that assumes the functions of the patient's heart, lungs,
161	kidneys, liver, or other organs.
162	(j) "Perfusionist in training" means a student enrolled in
163	an approved program who has not yet passed the proficiency
164	examination and works under the direct supervision of a clinical
165	perfusionist.
166	(k) "Perfusion protocols" means perfusion-related policies
167	and protocols developed or approved by a licensed health
168	facility or a physician through collaboration with
169	administrators, clinical perfusionists, and other health care
170	professionals.
171	(l) "Proficiency examination" means an entry-level
172	examination administered by the American Board of Cardiovascular
173	Perfusion.
174	(m) "Provisional clinical perfusionist" means a person
175	provisionally certified under this section.
176	(n) "Supervising physician" means a physician licensed
177	under chapter 458 or chapter 459 who holds an active license.
178	(o) "Temporary clinical perfusionist" means a person
179	granted a temporary certificate under this section.
180	(2) PERFORMANCE OF A SUPERVISING PHYSICIAN.--A physician
181	who supervises a clinical perfusionist must be qualified in the
182	medical areas in which the clinical perfusionist performs.
183	(3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.--A clinical
184	perfusionist may perform duties established by rule by the
185	boards, including the following duties that are included in the
186	clinical perfusionist's protocol, if prescribed by a physician
187	or under the supervision of a physician:
188	1. Perform extracorporeal circulation and its clinical
189	support.
190	2. Perform or administer counter pulsation.
191	3. Perform circulatory support and ventricular assistance.
192	4. Perform extracorporeal membrane oxygenation and
193	extracorporeal life support.
194	5. Perform blood conservation techniques, autotransfusion,
195	and 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
201	reversal.
202	11. Perform hemodilution.
203	12. Perform hemofiltration.
204	13. Administer blood, blood products, supportive fluids,
205	and 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
212	fluids via the therapeutic apheresis circuit.
213	20. Perform pacemaker lead and battery analysis.
214	(b) A clinical perfusionist shall clearly convey to a
215	patient that he or she is a clinical perfusionist.
216	(c) A clinical perfusionist may perform medical tasks and
217	services within the framework of a written practice protocol
218	developed between the supervising physician and the clinical
219	perfusionist.
220	(d) A clinical perfusionist may not prescribe, order,
221	compound, or dispense any controlled substance, legend drug, or
222	medical device to any patient. This paragraph does not prohibit
223	a clinical perfusionist from administering legend drugs,
224	controlled substances, intravenous drugs, fluids, or blood
225	products that are ordered by the physician and administered to a
226	patient while under the orders of such physician.
227	(4) PERFORMANCE BY PERFUSIONISTS IN TRAINING.--The
228	practice of a perfusionist in training is exempt from the
229	requirements of this section while the perfusionist in training
230	is performing assigned tasks in conjunction with an approved
231	program. Before providing clinical perfusion in conjunction with
232	the requirements of an approved program, the perfusionist in
233	training shall clearly convey to the patient that he or she is a
234	perfusionist in training and is under direct supervision.
235	(5) PROGRAM APPROVAL.--The boards shall approve programs
236	for the education and training of clinical perfusionists which
237	hold full accreditation or provisional accreditation from the
238	Commission on Accreditation of Allied Health Education Programs
239	or a successor organization, as approved by the boards.
240	(6) CLINICAL PERFUSIONIST CERTIFICATION.--
241	(a) Any person seeking to be certified as a clinical
242	perfusionist must apply to the department. The department shall
243	issue 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
246	approved by the boards. The boards, on receipt of an application
247	and application fee, shall waive the examination requirement for
248	an applicant who at the time of application holds a current
249	certificate issued by a certifying agency approved by the
250	boards.
251	3. Be certified in basic cardiac life support.
252	4. Have completed the application form and remitted an
253	application fee, not to exceed $1,000, as set by the department.
254	An application must include:
255	a. A certificate of completion of an approved program or
256	its equivalent.
257	b. A sworn statement of any prior felony convictions.
258	c. A sworn statement of any prior discipline or denial of
259	certification or license in any state.
260	d. Two letters of recommendation, one from a physician and
261	one from a clinical perfusionist.
262	e. A set of fingerprints on a form and under procedures
263	specified by the department, along with payment in an amount
264	equal to the costs incurred by the department for a national
265	criminal history check of the applicant.
266
267	Before January 1, 2010, a person is eligible to apply to the
268	boards and receive a certification notwithstanding the
269	requirements of this subsection if the person was actively
270	engaged in the practice of perfusion consistent with applicable
271	law, the person was operating cardiopulmonary bypass systems
272	during cardiac surgical cases in a licensed health care facility
273	in this state as the person's primary function, and had been
274	operating the system for at least 9 of the 10 years preceding
275	the application for certification.
276	(b) Between October 1, 2009, and June 30, 2010, an
277	applicant who was not a graduate of an accredited program before
278	1981, but met the then-current eligibility requirements for
279	certification as a clinical perfusionist and subsequently was
280	certified, shall be certified as a clinical perfusionist if the
281	application otherwise complies with this section.
282	(c) A certificate must be renewed biennially. Each renewal
283	must include:
284	1. A renewal fee, not to exceed $1,000, as set by the
285	department.
286	2. A sworn statement of no felony convictions in the
287	immediately preceding 2 years.
288	(d) Each clinical perfusionist shall biennially complete
289	continuing medical education as required by the boards.
290	(e)1. A certificate as a provisional clinical perfusionist
291	may be issued by the boards to a person who has successfully
292	completed an approved perfusion education program, completed an
293	application and remitted an application fee, and submitted
294	evidence satisfactory to the boards of the successful completion
295	of the requisite education requirements.
296	2. A provisional certificate is valid for 2 years from the
297	date it is issued and may be extended subject to rule by the
298	boards. The application for extension must be signed by a
299	supervising clinical perfusionist. However, if a provisional
300	clinical perfusionist fails any portion of the certifying
301	examination during an extension of the 2-year validity period,
302	he or she must surrender the provisional certificate to the
303	boards.
304	(f) A certificate as a temporary clinical perfusionist may
305	be issued by the department to a person who has successfully
306	completed the perfusion certification application and met other
307	requirements established by the boards.
308	(g) At all times, a provisional clinical perfusionist,
309	temporary clinical perfusionist, or perfusionist in training may
310	only practice clinical perfusion under the supervision and
311	direction of a clinical perfusionist. The boards shall adopt
312	rules governing a clinical perfusionist's supervision of
313	provisional clinical perfusionists, temporary clinical
314	perfusionists, and perfusionists in training.
315	(h) The boards may impose upon a clinical perfusionist any
316	penalty specified in s. 456.072 or s. 458.331(2) if the clinical
317	perfusionist is found guilty of or is investigated for an act
318	that constitutes a violation of chapter 456, chapter 457, or
319	chapter 458.
320	(7) CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST TO
321	ADVISE THE BOARDS.--
322	(a) The chairs of the Board of Medicine and the Board of
323	Osteopathic Medicine may appoint a cardiovascular surgeon and a
324	clinical perfusionist to advise the boards as to the adoption of
325	rules for the certification of clinical perfusionists. The
326	boards may use a committee structure that is most practicable in
327	order to receive any recommendations regarding rules and all
328	matters relating to clinical perfusionists, including, but not
329	limited to, recommendations to improve safety in the practice of
330	clinical perfusion.
331	(b) In addition to its other duties and responsibilities
332	as prescribed by law, the boards shall:
333	1. Recommend to the department the certification of
334	clinical perfusionists.
335	2. Develop rules regulating the use of clinical
336	perfusionists under chapter 458 or chapter 459, except for rules
337	relating to the formulary developed under s. 458.347(4). The
338	boards shall also develop rules to ensure that the continuity of
339	supervision is maintained in each practice setting. The boards
340	shall consider adopting a proposed rule at the regularly
341	scheduled meeting immediately following the submission of the
342	proposed rule. A proposed rule may not be adopted by either
343	board unless both boards have accepted and approved the
344	identical language contained in the proposed rule. The
345	provisions of all the proposed rules must be approved by both
346	boards pursuant to each respective board's guidelines and
347	standards regarding the adoption of proposed rules.
348	3. Address concerns and problems of clinical perfusionists
349	to improve safety in the practice of clinical perfusion.
350	(c) When the boards find that an applicant for
351	certification has failed to meet, to the boards' satisfaction,
352	any of the requirements for certification set forth in this
353	section, the boards may enter an order to:
354	1. Refuse to certify the applicant;
355	2. Approve the applicant for certification with
356	restrictions on the scope of practice; or
357	3. Approve the applicant for provisional or temporary
358	certification. Such conditions may include placement of the
359	applicant on probation for a period of time and subject to such
360	conditions as the boards specify, including, but not limited to,
361	requiring the applicant to undergo treatment, to attend
362	continuing medical education courses, or to take corrective
363	action.
364	(8) DENIAL, SUSPENSION, OR REVOCATION OF
365	CERTIFICATION.--The boards may deny, suspend, or revoke the
366	certification of a clinical perfusionist whom the boards
367	determine has violated any provision of this section, chapter
368	456, chapter 458, or chapter 459 or any rule adopted pursuant
369	thereto.
370	(9) RULES.--The boards shall adopt rules to administer
371	this section.
372	(10) FEES.--The department shall allocate the fees
373	collected under this section to the boards for the sole purpose
374	of administering the provisions of this section.
375	(11) EXEMPTIONS.--
376	(a) This section does not limit the practice of a
377	physician licensed under chapter 458 or chapter 459 or a
378	respiratory therapist licensed under chapter 468, so long as
379	that person does not hold himself or herself out to the public
380	as possessing a certificate, provisional certificate, or
381	temporary certificate issued under this section or use a
382	professional title protected by this section.
383	(b) This section does not limit the practice of nursing or
384	prevent qualified members of other regulated health professions
385	from doing work of a nature consistent with the state laws and
386	rules that govern their respective health professions, so long
387	as those persons do not hold themselves out to the public as
388	possessing a certificate, provisional certificate, or temporary
389	certificate issued under this section or use a professional
390	title 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
393	territory who is employed by the United States Government or an
394	agency thereof while discharging his or her official duties.
395	2. Is a student providing services regulated under this
396	chapter who is:
397	a. Pursuing a course of study that leads to a degree in a
398	profession regulated by this chapter.
399	b. Providing services in a training setting, as long as
400	such services and associated activities constitute part of a
401	supervised course of study.
402	c. Designated by the title "perfusionist in training."
403	(d) The boards shall establish by rule the qualifications
404	necessary for a clinical perfusionist who is not a resident of
405	this state and is licensed or certified by any other state or
406	territory of the United States. Such clinical perfusionist may
407	not offer services in this state for more than 30 days in any
408	calendar year.
409	(e) Except as stipulated by the boards, the exemptions in
410	this subsection do not apply to any person certified under this
411	section whose certificate has been revoked or suspended by
412	either of the boards or whose license or certification in
413	another jurisdiction has been revoked or suspended by the
414	licensing or certifying authority in that jurisdiction.
415	(f) This subsection does not exempt a person from meeting
416	the minimum standards of performance in professional activities
417	when measured against generally prevailing peer performance,
418	including the undertaking of activities for which the person is
419	not qualified by training or experience.
420	(12) PAYMENTS AND REIMBURSEMENTS.--
421	(a) A hospital is not required to pay for, or reimburse
422	any person for, the costs of compliance with any requirement of
423	this section, including costs of continuing medical education.
424	(b) This section does not prevent third-party payors from
425	reimbursing employers of clinical perfusionists for covered
426	services rendered by such clinical perfusionists.
427	Section 3. This act shall take effect October 1, 2010.

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