Florida Senate - 2023 SENATOR AMENDMENT
Bill No. CS/CS/HB 1471, 1st Eng.
Ì324066*Î324066
LEGISLATIVE ACTION
Senate . House
.
.
.
Floor: WD .
05/01/2023 10:22 AM .
—————————————————————————————————————————————————————————————————
—————————————————————————————————————————————————————————————————
Senator Garcia moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 116 - 295
4 and insert:
5 Section 3. Present subsection (2) of section 458.328,
6 Florida Statutes, is redesignated as subsection (4), a new
7 subsection (2) and subsection (3) are added to that section, and
8 paragraph (e) of subsection (1) of that section is amended, to
9 read:
10 458.328 Office surgeries.—
11 (1) REGISTRATION.—
12 (e)1. An office seeking registration under this section
13 must be inspected by the department before the office may be
14 registered. The department may not register a facility until it
15 is inspected and shall not register a facility that must be
16 licensed under chapter 390 or chapter 395. Completion of an
17 inspection under this subparagraph does not guarantee a
18 registration.
19 2. If a registered office refuses any subsequent inspection
20 under subparagraph 3., the department must immediately suspend
21 the office′s registration and may not reinstate the registration
22 before the completion of an inspection by the department. Such
23 office must be closed during the entire period of suspension.
24 Completion of an inspection under this subparagraph does not
25 guarantee a registration, reinstatement of a registration, or
26 lifting of the suspension.
27 3. The department shall inspect a registered office at
28 least annually, including a review of patient records, to ensure
29 that the office is in compliance with this section and rules
30 adopted hereunder unless the office is accredited by a
31 nationally recognized accrediting agency approved by the board.
32 The inspection may be unannounced, except for the inspection of
33 an office that meets the description of a clinic specified in s.
34 458.3265(1)(a)3.h., and those wholly owned and operated
35 physician offices described in s. 458.3265(1)(a)3.g. which
36 perform procedures referenced in s. 458.3265(1)(a)3.h., which
37 must be announced.
38 (2) STANDARDS OF PRACTICE.—
39 (a) Surgeries performed in an office registered under this
40 section may not include surgeries that:
41 1. Are a type of surgery which generally results in blood
42 loss of more than 10 percent of estimated blood volume in a
43 patient with a normal hemoglobin level;
44 2. Require major or prolonged intracranial, intrathoracic,
45 abdominal, or joint replacement procedures, except for
46 laparoscopic procedures;
47 3. Involve major blood vessels and are performed with
48 direct visualization by open exposure of the major blood vessel,
49 except for percutaneous endovascular intervention; or
50 4. Are emergent or life threatening.
51 (b) If a procedure in an office surgery setting results in
52 hospitalization, the incident must be reported as an adverse
53 incident pursuant to s. 458.351.
54 (3) GLUTEAL FAT GRAFTING PROCEDURES.—
55 (a) Physicians performing gluteal fat grafting procedures
56 in an office surgery setting must adhere to standards of
57 practice prescribed under this subsection.
58 (b) A physician performing a gluteal fat grafting procedure
59 must conduct an in-person examination of the patient no later
60 than the day before the procedure.
61 (c) An office in which a physician performs gluteal fat
62 grafting procedures must at all times maintain a ratio of one
63 physician to one patient during all phases of the procedure,
64 beginning with the administration of anesthesia to the patient
65 and concluding with the extubation of the patient. However,
66 after a physician has commenced, and while he or she is engaged
67 in, a gluteal fat grafting procedure, the physician may not
68 commence or engage in another gluteal fat grafting procedure or
69 any other procedure with another patient at the same time.
70 (d) Before a physician may delegate any duties during a
71 gluteal fat grafting procedure, the patient must provide
72 written, informed consent to such delegation. Any duties
73 delegated during a gluteal fat grafting procedure must be
74 performed under the direct supervision of the physician
75 performing the procedure. Gluteal fat extractions and injections
76 must be performed by the physician performing the procedure and
77 may not be delegated.
78 (e) Only the physician performing the gluteal fat grafting
79 procedure may extract gluteal fat from, or inject gluteal fat
80 into, the patient. The gluteal fat may be injected only into the
81 subcutaneous space of the patient and may not cross the fascia
82 overlying the gluteal muscle. Intramuscular and submuscular fat
83 injections are prohibited.
84 (f) When the physician performing a gluteal fat grafting
85 procedure injects gluteal fat into the subcutaneous space of the
86 patient, the physician must use ultrasound guidance during the
87 placement and navigation of a cannula to ensure that the fat is
88 placed into the subcutaneous space of the patient above the
89 fascia overlying the gluteal muscle. Ultrasound guidance is not
90 required for other portions of the procedure.
91 Section 4. Present subsection (2) of section 459.0138,
92 Florida Statutes, is redesignated as subsection (4), a new
93 subsection (2) and subsection (3) are added to that section, and
94 paragraph (e) of subsection (1) of that section is amended, to
95 read:
96 459.0138 Office surgeries.—
97 (1) REGISTRATION.—
98 (e)1. An office seeking registration under this section
99 must be inspected by the department before the office may be
100 registered. The department may not register a facility until it
101 is inspected and shall not register a facility that must be
102 licensed under chapter 390 or chapter 395. Completion of an
103 inspection under this subparagraph does not guarantee a
104 registration.
105 2. If a registered office refuses any subsequent inspection
106 under subparagraph 3., the department must immediately suspend
107 the office′s registration and may not reinstate the registration
108 before the completion of an inspection by the department. Such
109 office must be closed during the entire period of suspension.
110 Completion of an inspection under this subparagraph does not
111 guarantee a registration, reinstatement of a registration, or
112 lifting of the suspension.
113 3. The department shall inspect a registered office at
114 least annually, including a review of patient records, to ensure
115 that the office is in compliance with this section and rules
116 adopted hereunder unless the office is accredited by a
117 nationally recognized accrediting agency approved by the board.
118 The inspection may be unannounced, except for the inspection of
119 an office that meets the description of clinic specified in s.
120 459.0137(1)(a)3.h., and those wholly owned and operated
121 physician offices described in s. 459.0137(1)(a)3.g. which
122 perform procedures referenced in s. 459.0137(1)(a)3.h., which
123 must be announced.
124 (2) STANDARDS OF PRACTICE.—
125 (a) Surgeries performed in an office registered under this
126 section may not:
127 1. Be a type of surgery that generally results in blood
128 loss of more than 10 percent of estimated blood volume in a
129 patient with a normal hemoglobin level;
130 2. Require major or prolonged intracranial, intrathoracic,
131 abdominal, or joint replacement procedures, except for
132 laparoscopic procedures;
133 3. Involve major blood vessels performed with direct
134 visualization by open exposure of the major blood vessel, except
135 for percutaneous endovascular intervention; or
136 4. Be emergent or life threatening.
137 (b) If a procedure in an office surgery setting results in
138 hospitalization, the incident must be reported as an adverse
139 incident pursuant to s. 459.026.
140 (3) GLUTEAL FAT GRAFTING PROCEDURES.—
141 (a) Physicians performing gluteal fat grafting procedures
142 in an office surgery setting must adhere to standards of
143 practice prescribed under this subsection.
144 (b) A physician performing a gluteal fat grafting procedure
145 must conduct an in-person examination of the patient no later
146 than the day before the procedure.
147 (c) An office in which a physician performs gluteal fat
148 grafting procedures must at all times maintain a ratio of one
149 physician to one patient during all phases of the procedure,
150 beginning with the administration of anesthesia to the patient
151 and concluding with the extubation of the patient. However,
152 after a physician has commenced, and while he or she is engaged
153 in, a gluteal fat grafting procedure, the physician may not
154 commence or engage in another gluteal fat grafting procedure or
155 any other procedure with another patient at the same time.
156 (d) Before a physician may delegate any duties during a
157 gluteal fat grafting procedure, the patient must provide
158 written, informed consent to such delegation. Any duties
159 delegated during a gluteal fat grafting procedure must be
160 performed under the direct supervision of the physician
161 performing the procedure. Gluteal fat extractions and injections
162 must be performed by the physician performing the procedure and
163 may not be delegated.
164 (e) Only the physician performing the gluteal fat grafting
165 procedure may extract gluteal fat from, or inject gluteal fat
166 into, the patient. The gluteal fat may be injected only into the
167 subcutaneous space of the patient and may not cross the fascia
168 overlying the gluteal muscle. Intramuscular and submuscular fat
169 injections are prohibited.
170 (f) When the physician performing a gluteal fat grafting
171 procedure injects gluteal fat into the subcutaneous space of the
172 patient, the physician must use ultrasound guidance during the
173 placement and navigation of a cannula to ensure that the fat is
174 placed into the subcutaneous space of the patient above the
175 fascia overlying the gluteal muscle. Ultrasound guidance is not
176 required for other portions of the procedure.
177
178 ================= T I T L E A M E N D M E N T ================
179 And the title is amended as follows:
180 Delete lines 13 - 23
181 and insert:
182 459.0138, F.S.; requiring that a physician′s office
183 seeking registration to perform office surgeries be
184 inspected by the Department of Health before it may be
185 registered; providing for immediate suspension of a
186 registration under specified circumstances; requiring
187 such offices to remain closed for the duration of any
188 suspensions; providing construction; specifying
189 surgeries that may not be performed in an office
190 surgery setting; requiring the reporting of specified
191 adverse incidents; requiring physicians performing
192 gluteal fat grafting procedures in an office surgery
193 setting to adhere to specified standards of practice;
194 providing an effective date.