Florida Senate - 2023 COMMITTEE AMENDMENT
Bill No. SB 1596
Ì584094;Î584094
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/28/2023 .
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The Committee on Health Policy (Garcia) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Between lines 374 and 375
4 insert:
5 Section 5. 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. If a registered office refuses any subsequent
15 inspection under subparagraph 2., the office′s registration must
16 be immediately suspended and may not be reinstated before
17 completion of an inspection by the department. Completion of an
18 inspection under this subparagraph does not guarantee a
19 registration or reinstatement of a registration.
20 2. The department shall inspect a registered office at
21 least annually, including a review of patient records, to ensure
22 that the office is in compliance with this section and rules
23 adopted hereunder unless the office is accredited by a
24 nationally recognized accrediting agency approved by the board.
25 The inspection may be unannounced, except for the inspection of
26 an office that meets the description of a clinic specified in s.
27 458.3265(1)(a)3.h., and those wholly owned and operated
28 physician offices described in s. 458.3265(1)(a)3.g. which
29 perform procedures referenced in s. 458.3265(1)(a)3.h., which
30 must be announced.
31 (2) GLUTEAL FAT GRAFTING PROCEDURES.—
32 (a) Physicians performing gluteal fat grafting procedures
33 in an office surgery setting must adhere to standards of
34 practice prescribed under this subsection. The board may adopt
35 rules to prescribe additional requirements for the safe
36 performance of gluteal fat grafting procedures, provided such
37 rules do not conflict with this subsection.
38 (b) An office in which a physician performs gluteal fat
39 grafting procedures must at all times maintain a ratio of one
40 physician to one patient during all phases of the procedure,
41 beginning with the administration of anesthesia to the patient
42 and concluding with the extubation of the patient. A physician
43 is not limited in the number of gluteal fat grafting procedures
44 that he or she may safely perform in accordance with the
45 applicable standard of care and as prescribed in this
46 subsection. However, after a physician has commenced, and while
47 he or she is engaged in, a gluteal fat grafting procedure, the
48 physician may not commence or engage in another gluteal fat
49 grafting procedure or any other procedure with another patient
50 at the same time.
51 (c) Before a physician may delegate any duties during a
52 gluteal fat grafting procedure, the patient must provide
53 written, informed consent to such delegation. Any duties
54 delegated during a gluteal fat grafting procedure must be
55 performed under the direct supervision of the physician
56 performing the procedure. Gluteal fat extractions and injections
57 must be performed by the physician performing the procedure and
58 may not be delegated.
59 (d) Only the physician performing the gluteal fat grafting
60 procedure may extract gluteal fat from, or inject gluteal fat
61 into, the patient. The gluteal fat may be injected only into the
62 subcutaneous space of the patient and may not cross the fascia
63 overlying the gluteal muscle. Intramuscular and submuscular fat
64 injections are prohibited.
65 (e) When the physician performing a gluteal fat grafting
66 procedure injects gluteal fat into the subcutaneous space of the
67 patient, the physician must use ultrasound guidance during the
68 placement and navigation of a cannula to ensure that the fat is
69 placed into the subcutaneous space of the patient above the
70 fascia overlying the gluteal muscle. Ultrasound guidance is not
71 required for other portions of the procedure.
72 (3) STANDARDS OF PRACTICE.—Surgeries performed in an office
73 registered under this section may not:
74 (a) Result in blood loss of more than 10 percent of
75 estimated blood volume in a patient with a normal hemoglobin
76 level;
77 (b) Require major or prolonged intracranial, intrathoracic,
78 abdominal, or joint replacement procedures, except for
79 laparoscopic procedures;
80 (c) Involve major blood vessels performed with direct
81 visualization by open exposure of the major blood vessel, except
82 for percutaneous endovascular intervention; or
83 (d) Be emergent or life threatening.
84 Section 6. Present subsection (2) of section 459.0138,
85 Florida Statutes, is redesignated as subsection (4), a new
86 subsection (2) and subsection (3) are added to that section, and
87 paragraph (e) of subsection (1) of that section is amended, to
88 read:
89 459.0138 Office surgeries.—
90 (1) REGISTRATION.—
91 (e)1. An office seeking registration under this section
92 must be inspected by the department before the office may be
93 registered. If a registered office refuses any subsequent
94 inspection under subparagraph 2., the office′s registration must
95 be immediately suspended and may not be reinstated before
96 completion of an inspection by the department. Completion of an
97 inspection under this subparagraph does not guarantee a
98 registration or reinstatement of a registration.
99 2. The department shall inspect a registered office at
100 least annually, including a review of patient records, to ensure
101 that the office is in compliance with this section and rules
102 adopted hereunder unless the office is accredited by a
103 nationally recognized accrediting agency approved by the board.
104 The inspection may be unannounced, except for the inspection of
105 an office that meets the description of clinic specified in s.
106 459.0137(1)(a)3.h., and those wholly owned and operated
107 physician offices described in s. 459.0137(1)(a)3.g. which
108 perform procedures referenced in s. 459.0137(1)(a)3.h., which
109 must be announced.
110 (2) GLUTEAL FAT GRAFTING PROCEDURES.—
111 (a) Physicians performing gluteal fat grafting procedures
112 in an office surgery setting must adhere to standards of
113 practice prescribed under this subsection. The board may adopt
114 rules to prescribe additional requirements for the safe
115 performance of gluteal fat grafting procedures, provided such
116 rules do not conflict with this subsection.
117 (b) An office in which a physician performs gluteal fat
118 grafting procedures must at all times maintain a ratio of one
119 physician to one patient during all phases of the procedure,
120 beginning with the administration of anesthesia to the patient
121 and concluding with the extubation of the patient. A physician
122 is not limited in the number of gluteal fat grafting procedures
123 that he or she may safely perform in accordance with the
124 applicable standard of care and as prescribed in this
125 subsection. However, after a physician has commenced, and while
126 he or she is engaged in, a gluteal fat grafting procedure, the
127 physician may not commence or engage in another gluteal fat
128 grafting procedure or any other procedure with another patient
129 at the same time.
130 (c) Before a physician may delegate any duties during a
131 gluteal fat grafting procedure, the patient must provide
132 written, informed consent to such delegation. Any duties
133 delegated during a gluteal fat grafting procedure must be
134 performed under the direct supervision of the physician
135 performing the procedure. Gluteal fat extractions and injections
136 must be performed by the physician performing the procedure and
137 may not be delegated.
138 (d) Only the physician performing the gluteal fat grafting
139 procedure may extract gluteal fat from, or inject gluteal fat
140 into, the patient. The gluteal fat may be injected only into the
141 subcutaneous space of the patient and may not cross the fascia
142 overlying the gluteal muscle. Intramuscular and submuscular fat
143 injections are prohibited.
144 (e) When the physician performing a gluteal fat grafting
145 procedure injects gluteal fat into the subcutaneous space of the
146 patient, the physician must use ultrasound guidance during the
147 placement and navigation of a cannula to ensure that the fat is
148 placed into the subcutaneous space of the patient above the
149 fascia overlying the gluteal muscle. Ultrasound guidance is not
150 required for other portions of the procedure.
151 (3) STANDARDS OF PRACTICE.—Surgeries performed in an office
152 registered under this section may not:
153 (a) Result in blood loss of more than 10 percent of
154 estimated blood volume in a patient with a normal hemoglobin
155 level;
156 (b) Require major or prolonged intracranial, intrathoracic,
157 abdominal, or joint replacement procedures, except for
158 laparoscopic procedures;
159 (c) Involve major blood vessels performed with direct
160 visualization by open exposure of the major blood vessel, except
161 for percutaneous endovascular intervention; or
162 (d) Be emergent or life threatening.
163
164 ================= T I T L E A M E N D M E N T ================
165 And the title is amended as follows:
166 Delete line 40
167 and insert:
168 screening requirements; amending ss. 458.328 and
169 459.0138, F.S.; requiring that a physician′s office
170 seeking registration to perform office surgeries must
171 be inspected by the Department of Health before it may
172 be registered; providing for immediate suspension of a
173 registration under specified circumstances; providing
174 construction; requiring physicians performing gluteal
175 fat grafting procedures in an office surgery setting
176 to adhere to specified standards of practice;
177 authorizing the Board of Medicine and the Board of
178 Osteopathic Medicine, respectively, to adopt certain
179 rules; providing an effective date.