Florida Senate - 2024 SENATOR AMENDMENT
Bill No. CS for HB 1561
Ì565294BÎ565294
LEGISLATIVE ACTION
Senate . House
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Floor: 1/AD/2R . Floor: C
03/04/2024 07:29 PM . 03/05/2024 06:41 PM
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Senator Garcia moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Paragraphs (a), (b), (c), and (h) of subsection
6 (1) and subsection (2) of section 458.328, Florida Statutes, are
7 amended to read:
8 458.328 Office surgeries.—
9 (1) REGISTRATION.—
10 (a)1. An office in which a physician performs a liposuction
11 procedure in which more than 1,000 cubic centimeters of
12 supernatant fat is temporarily or permanently removed, a Level
13 II office surgery, or a Level III office surgery must register
14 with the department. unless the office is licensed as A facility
15 licensed under chapter 390 or chapter 395 may not be registered
16 under this section.
17 2. The department must complete an inspection of any office
18 seeking registration under this section before the office may be
19 registered.
20 (b) By January 1, 2020, Each office registered under this
21 section or s. 459.0138 must designate a physician who is
22 responsible for the office’s compliance with the office health
23 and safety requirements of this section and rules adopted
24 hereunder. A designated physician must have a full, active, and
25 unencumbered license under this chapter or chapter 459 and shall
26 practice at the office for which he or she has assumed
27 responsibility. Within 10 calendar days after the termination of
28 a designated physician relationship, the office must notify the
29 department of the designation of another physician to serve as
30 the designated physician. The department may suspend the
31 registration of an office if the office fails to comply with the
32 requirements of this paragraph.
33 (c) As a condition of registration, each office must
34 establish financial responsibility by demonstrating that it has
35 met and continues to maintain, at a minimum, the same
36 requirements applicable to physicians in ss. 458.320 and
37 459.0085. An office in which a physician performs a gluteal fat
38 grafting procedure must also establish financial responsibility
39 by demonstrating that it has met and continues to maintain, at a
40 minimum, the same requirements applicable to physicians in ss.
41 458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable.
42 Each physician practicing at an office registered under this
43 section or s. 459.0138 must meet the financial responsibility
44 requirements under s. 458.320 or s. 459.0085, as applicable.
45 (h) A physician may only perform a procedure or surgery
46 identified in paragraph (a) in an office that is registered with
47 the department. The board shall impose a fine of $5,000 per day
48 on a physician who performs a procedure or surgery in an office
49 that is not registered with the department.
50 (2) STANDARDS OF PRACTICE.—
51 (a) A physician may not perform any surgery or procedure
52 identified in paragraph (1)(a) in a setting other than an office
53 surgery setting registered under this section or a facility
54 licensed under chapter 390 or chapter 395, as applicable. The
55 board shall impose a fine of $5,000 per incident on a physician
56 who violates this paragraph performing a gluteal fat grafting
57 procedure in an office surgery setting shall adhere to standards
58 of practice pursuant to this subsection and rules adopted by the
59 board.
60 (b) Office surgeries may not:
61 1. Be a type of surgery that generally results in blood
62 loss of more than 10 percent of estimated blood volume in a
63 patient with a normal hemoglobin level;
64 2. Require major or prolonged intracranial, intrathoracic,
65 abdominal, or joint replacement procedures, except for
66 laparoscopic procedures;
67 3. Involve major blood vessels and be performed with direct
68 visualization by open exposure of the major blood vessel, except
69 for percutaneous endovascular intervention; or
70 4. Be emergent or life threatening.
71 (c) A physician performing a gluteal fat grafting procedure
72 in an office surgery setting shall adhere to standards of
73 practice under this subsection and rules adopted by the board
74 which include, but are not limited to, all of the following:
75 1. A physician performing a gluteal fat grafting procedure
76 must conduct an in-person examination of the patient while
77 physically present in the same room as the patient no later than
78 the day before the procedure.
79 2. Before a physician may delegate any duties during a
80 gluteal fat grafting procedure, the patient must provide
81 written, informed consent for such delegation. Any duty
82 delegated by a physician during a gluteal fat grafting procedure
83 must be performed under the direct supervision of the physician
84 performing such procedure. Fat extraction and gluteal fat
85 injections must be performed by the physician and may not be
86 delegated.
87 3. Fat may only be injected into the subcutaneous space of
88 the patient and may not cross the fascia overlying the gluteal
89 muscle. Intramuscular or submuscular fat injections are
90 prohibited.
91 4. When the physician performing a gluteal fat grafting
92 procedure injects fat into the subcutaneous space of the
93 patient, the physician must use ultrasound guidance, or guidance
94 with other technology authorized under board rule which equals
95 or exceeds the quality of ultrasound, during the placement and
96 navigation of the cannula to ensure that the fat is injected
97 into the subcutaneous space of the patient above the fascia
98 overlying the gluteal muscle. Such guidance with the use of
99 ultrasound or other technology is not required for other
100 portions of such procedure.
101 5. An office in which a physician performs gluteal fat
102 grafting procedures must at all times maintain a ratio of one
103 physician to one patient during all phases of the procedure,
104 beginning with the administration of anesthesia to the patient
105 and concluding with the extubation of the patient. After a
106 physician has commenced, and while he or she is engaged in, a
107 gluteal fat grafting procedure, the physician may not commence
108 or engage in another gluteal fat grafting procedure or any other
109 procedure with another patient at the same time.
110 (d) If a procedure in an office surgery setting results in
111 hospitalization, the incident must be reported as an adverse
112 incident pursuant to s. 458.351.
113 (e) An office in which a physician performs gluteal fat
114 grafting procedures must at all times maintain a ratio of one
115 physician to one patient during all phases of the procedure,
116 beginning with the administration of anesthesia to the patient
117 and concluding with the extubation of the patient. After a
118 physician has commenced, and while he or she is engaged in, a
119 gluteal fat grafting procedure, the physician may not commence
120 or engage in another gluteal fat grafting procedure or any other
121 procedure with another patient at the same time.
122 Section 2. Paragraphs (a), (b), (c), and (h) of subsection
123 (1) and subsection (2) of section 459.0138, Florida Statutes,
124 are amended to read:
125 459.0138 Office surgeries.—
126 (1) REGISTRATION.—
127 (a)1. An office in which a physician performs a liposuction
128 procedure in which more than 1,000 cubic centimeters of
129 supernatant fat is temporarily or permanently removed, a Level
130 II office surgery, or a Level III office surgery must register
131 with the department. unless the office is licensed as A facility
132 licensed under chapter 390 or chapter 395 may not be registered
133 under this section.
134 2. The department must complete an inspection of any office
135 seeking registration under this section before the office may be
136 registered.
137 (b) By January 1, 2020, Each office registered under this
138 section or s. 458.328 must designate a physician who is
139 responsible for the office’s compliance with the office health
140 and safety requirements of this section and rules adopted
141 hereunder. A designated physician must have a full, active, and
142 unencumbered license under this chapter or chapter 458 and shall
143 practice at the office for which he or she has assumed
144 responsibility. Within 10 calendar days after the termination of
145 a designated physician relationship, the office must notify the
146 department of the designation of another physician to serve as
147 the designated physician. The department may suspend a
148 registration for an office if the office fails to comply with
149 the requirements of this paragraph.
150 (c) As a condition of registration, each office must
151 establish financial responsibility by demonstrating that it has
152 met and continues to maintain, at a minimum, the same
153 requirements applicable to physicians in ss. 458.320 and
154 459.0085. An office in which a physician performs a gluteal fat
155 grafting procedure must also establish financial responsibility
156 by demonstrating that it has met and continues to maintain, at a
157 minimum, the same requirements applicable to physicians in ss.
158 458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable.
159 Each physician practicing at an office registered under this
160 section or s. 458.328 must meet the financial responsibility
161 requirements under s. 458.320 or s. 459.0085, as applicable.
162 (h) A physician may only perform a procedure or surgery
163 identified in paragraph (a) in an office that is registered with
164 the department. The board shall impose a fine of $5,000 per day
165 on a physician who performs a procedure or surgery in an office
166 that is not registered with the department.
167 (2) STANDARDS OF PRACTICE.—
168 (a) A physician may not perform any surgery or procedure
169 identified in paragraph (1)(a) in a setting other than an office
170 surgery setting registered under this section or a facility
171 licensed under chapter 390 or chapter 395, as applicable. The
172 board shall impose a fine of $5,000 per incident on a physician
173 who violates this paragraph performing a gluteal fat grafting
174 procedure in an office surgery setting shall adhere to standards
175 of practice pursuant to this subsection and rules adopted by the
176 board.
177 (b) Office surgeries may not:
178 1. Be a type of surgery that generally results in blood
179 loss of more than 10 percent of estimated blood volume in a
180 patient with a normal hemoglobin level;
181 2. Require major or prolonged intracranial, intrathoracic,
182 abdominal, or joint replacement procedures, except for
183 laparoscopic procedures;
184 3. Involve major blood vessels and be performed with direct
185 visualization by open exposure of the major blood vessel, except
186 for percutaneous endovascular intervention; or
187 4. Be emergent or life threatening.
188 (c) A physician performing a gluteal fat grafting procedure
189 in an office surgery setting shall adhere to standards of
190 practice under this subsection and rules adopted by the board
191 which include, but are not limited to, all of the following:
192 1. A physician performing a gluteal fat grafting procedure
193 must conduct an in-person examination of the patient while
194 physically present in the same room as the patient no later than
195 the day before the procedure.
196 2. Before a physician may delegate any duties during a
197 gluteal fat grafting procedure, the patient must provide
198 written, informed consent for such delegation. Any duty
199 delegated by a physician during a gluteal fat grafting procedure
200 must be performed under the direct supervision of the physician
201 performing such procedure. Fat extraction and gluteal fat
202 injections must be performed by the physician and may not be
203 delegated.
204 3. Fat may only be injected into the subcutaneous space of
205 the patient and may not cross the fascia overlying the gluteal
206 muscle. Intramuscular or submuscular fat injections are
207 prohibited.
208 4. When the physician performing a gluteal fat grafting
209 procedure injects fat into the subcutaneous space of the
210 patient, the physician must use ultrasound guidance, or guidance
211 with other technology authorized under board rule which equals
212 or exceeds the quality of ultrasound, during the placement and
213 navigation of the cannula to ensure that the fat is injected
214 into the subcutaneous space of the patient above the fascia
215 overlying the gluteal muscle. Such guidance with the use of
216 ultrasound or other technology is not required for other
217 portions of such procedure.
218 5. An office in which a physician performs gluteal fat
219 grafting procedures must at all times maintain a ratio of one
220 physician to one patient during all phases of the procedure,
221 beginning with the administration of anesthesia to the patient
222 and concluding with the extubation of the patient. After a
223 physician has commenced, and while he or she is engaged in, a
224 gluteal fat grafting procedure, the physician may not commence
225 or engage in another gluteal fat grafting procedure or any other
226 procedure with another patient at the same time.
227 (d) If a procedure in an office surgery setting results in
228 hospitalization, the incident must be reported as an adverse
229 incident pursuant to s. 458.351.
230 (e) An office in which a physician performs gluteal fat
231 grafting procedures must at all times maintain a ratio of one
232 physician to one patient during all phases of the procedure,
233 beginning with the administration of anesthesia to the patient
234 and concluding with the extubation of the patient. After a
235 physician has commenced, and while he or she is engaged in, a
236 gluteal fat grafting procedure, the physician may not commence
237 or engage in another gluteal fat grafting procedure or any other
238 procedure with another patient at the same time.
239 Section 3. Subsection (6) of section 456.074, Florida
240 Statutes, is amended to read
241 456.074 Certain health care practitioners; immediate
242 suspension of license.—
243 (6) The department must issue an emergency order suspending
244 or restricting the registration of an office registered under s.
245 458.328 or s. 459.0138 s. 459.0139 upon a finding of probable
246 cause that the office or a physician practicing in the office is
247 not in compliance with the standards of practice for office
248 surgery adopted by the boards pursuant to s. 458.328 or s.
249 459.0138, as applicable, or is in violation of s. 458.331(1)(v)
250 or s. 459.015(1)(z), and that such noncompliance or violation
251 constitutes an immediate danger to the public.
252 Section 4. This act shall take effect upon becoming a law.
253
254 ================= T I T L E A M E N D M E N T ================
255 And the title is amended as follows:
256 Delete everything before the enacting clause
257 and insert:
258 A bill to be entitled
259 An act relating to office surgeries; amending ss.
260 458.328 and 459.0138, F.S.; revising the types of
261 procedures for which a medical office must register
262 with the Department of Health to perform office
263 surgeries; deleting obsolete language; making
264 technical and clarifying changes; requiring medical
265 offices performing specified office surgeries to
266 demonstrate to the department that they have
267 established financial responsibility in a specified
268 manner; revising standards of practice for office
269 surgeries; amending s. 456.074, F.S.; correcting a
270 cross-reference; providing an effective date.