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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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An act relating to office surgeries; amending ss. 2
458.328 and 459.0138, F.S.; revising the types of 3
procedures for which a medical office must register 4
with the Department of Health to perform office 5
surgeries; deleting obsolete language; making 6
technical and clarifying changes; requiring medical 7
offices performing specified office surgeries to 8
demonstrate to the department that they have 9
established financial responsibility in a specified 10
manner; revising standards of practice for office 11
surgeries; amending s. 456.074, F.S.; correcting a 12
cross-reference; providing an effective date. 13
14
Be It Enacted by the Legislature of the State of Florida: 15
16
Section 1. Paragraphs (a), (b), (c), and (h) of subsection 17
(1) and subsection (2) of section 458.328, Florida Statutes, are 18
amended to read: 19
458.328 Office surgeries. — 20
(1) REGISTRATION.— 21
(a)1. An office in which a physician performs a 22
liposuction procedur e in which more than 1,000 cubic centimeters 23
of supernatant fat is temporarily or permanently removed, a 24
Level II office surgery, or a Level III office surgery must 25
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
register with the department . unless the office is licensed as A 26
facility licensed under chapter 390 or chapter 395 may not be 27
registered under this section . 28
2. The department must complete an inspection of any 29
office seeking registration under this section before the office 30
may be registered. 31
(b) By January 1, 2020, Each office registered u nder this 32
section or s. 459.0138 must designate a physician who is 33
responsible for the office's compliance with the office health 34
and safety requirements of this section and rules adopted 35
hereunder. A designated physician must have a full, active, and 36
unencumbered license under this chapter or chapter 459 and shall 37
practice at the office for which he or she has assumed 38
responsibility. Within 10 calendar days after the termination of 39
a designated physician relationship, the office must notify the 40
department of the designation of another physician to serve as 41
the designated physician. The department may suspend the 42
registration of an office if the office fails to comply with the 43
requirements of this paragraph. 44
(c) As a condition of registration, each office must 45
establish financial responsibility by demonstrating that it has 46
met and continues to maintain, at a minimum, the same 47
requirements applicable to physicians in ss. 458.320 and 48
459.0085. An office in which a physician performs a gluteal fat 49
grafting procedure must also establish financial responsibility 50
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
by demonstrating that it has met and continues to maintain, at a 51
minimum, the same requirements applicable to physicians in ss. 52
458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable. 53
Each physician practicing at an office registered under this 54
section or s. 459.0138 must meet the financial responsibility 55
requirements under s. 458.320 or s. 459.0085, as applicable. 56
(h) A physician may only perform a procedure or surgery 57
identified in paragraph (a) in an office that is registered with 58
the department. The board shall impose a fine of $5,000 per day 59
on a physician who performs a procedure or surgery in an office 60
that is not registered with the department. 61
(2) STANDARDS OF PRACTICE. — 62
(a) A physician may not perform any surgery or procedure 63
identified in paragraph (1)(a) in a setting other than an office 64
surgery setting registered under this section or a facility 65
licensed under chapter 390 or chapter 395, as applicable. The 66
board shall impose a fine of $5,000 per incident on a physician 67
who violates this paragraph performing a gluteal fat grafting 68
procedure in an office surgery setting shall adhere to standards 69
of practice pursuant to this subsection and rules adopted by the 70
board. 71
(b) Office surgeries may not: 72
1. Be a type of surgery that generally results in blood 73
loss of more than 10 percent of estimated blood volume in a 74
patient with a normal hemoglobin level; 75
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
2. Require major or prolonged intracranial, intrathoracic, 76
abdominal, or joint replacement procedures, except for 77
laparoscopic procedures; 78
3. Involve major blood vessels and be performed with 79
direct visualization by open exposure of the major blood vessel, 80
except for percutaneous endovascular intervention; or 81
4. Be emergent or life threatening. 82
(c) A physician performing a gluteal fat grafting 83
procedure in an office surgery setting shall adhere to standards 84
of practice under this subsection and rules adopted by the board 85
which include, but are not limited to, all of the following: 86
1. A physician performing a gluteal fat grafting procedure 87
must conduct an in-person examination of the patient while 88
physically present in the same room as the patient no later than 89
the day before the procedure. 90
2. Before a physician may delegate any duties during a 91
gluteal fat grafting procedure, the patient must provide 92
written, informed consent for such delegation. Any duty 93
delegated by a physician during a gluteal fat grafting procedure 94
must be performed under the direct supe rvision of the physician 95
performing such procedure. Fat extraction and gluteal fat 96
injections must be performed by the physician and may not be 97
delegated. 98
3. Fat may only be injected into the subcutaneous space of 99
the patient and may not cross the fascia overlying the gluteal 100
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muscle. Intramuscular or submuscular fat injections are 101
prohibited. 102
4. When the physician performing a gluteal fat grafting 103
procedure injects fat into the subcutaneous space of the 104
patient, the physician must use ultrasound guidanc e, or guidance 105
with other technology authorized under board rule which equals 106
or exceeds the quality of ultrasound, during the placement and 107
navigation of the cannula to ensure that the fat is injected 108
into the subcutaneous space of the patient above the f ascia 109
overlying the gluteal muscle. Such guidance with the use of 110
ultrasound or other technology is not required for other 111
portions of such procedure. 112
5. An office in which a physician performs gluteal fat 113
grafting procedures must at all times maintain a ratio of one 114
physician to one patient during all phases of the procedure, 115
beginning with the administration of anesthesia to the patient 116
and concluding with the extubation of the patient. After a 117
physician has commenced, and while he or she is engaged in, a 118
gluteal fat grafting procedure, the physician may not commence 119
or engage in another gluteal fat grafting procedure or any other 120
procedure with another patient at the same time. 121
(d) If a procedure in an office surgery setting results in 122
hospitalization, the incident must be reported as an adverse 123
incident pursuant to s. 458.351. 124
(e) An office in which a physician performs gluteal fat 125
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grafting procedures must at all times maintain a ratio of one 126
physician to one patient during all phases of the procedu re, 127
beginning with the administration of anesthesia to the patient 128
and concluding with the extubation of the patient. After a 129
physician has commenced, and while he or she is engaged in, a 130
gluteal fat grafting procedure, the physician may not commence 131
or engage in another gluteal fat grafting procedure or any other 132
procedure with another patient at the same time. 133
Section 2. Paragraphs (a), (b), (c), and (h) of subsection 134
(1) and subsection (2) of section 459.0138, Florida Statutes, 135
are amended to read: 136
459.0138 Office surgeries. — 137
(1) REGISTRATION.— 138
(a)1. An office in which a physician performs a 139
liposuction procedure in which more than 1,000 cubic centimeters 140
of supernatant fat is temporarily or permanently removed, a 141
Level II office surgery, or a L evel III office surgery must 142
register with the department . unless the office is licensed as A 143
facility licensed under chapter 390 or chapter 395 may not be 144
registered under this section . 145
2. The department must complete an inspection of any 146
office seeking registration under this section before the office 147
may be registered. 148
(b) By January 1, 2020, Each office registered under this 149
section or s. 458.328 must designate a physician who is 150
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responsible for the office's compliance with the office health 151
and safety requirements of this section and rules adopted 152
hereunder. A designated physician must have a full, active, and 153
unencumbered license under this chapter or chapter 458 and shall 154
practice at the office for which he or she has assumed 155
responsibility. Withi n 10 calendar days after the termination of 156
a designated physician relationship, the office must notify the 157
department of the designation of another physician to serve as 158
the designated physician. The department may suspend a 159
registration for an office if the office fails to comply with 160
the requirements of this paragraph. 161
(c) As a condition of registration, each office must 162
establish financial responsibility by demonstrating that it has 163
met and continues to maintain, at a minimum, the same 164
requirements applicable to physicians in ss. 458.320 and 165
459.0085. An office in which a physician performs a gluteal fat 166
grafting procedure must also establish financial responsibility 167
by demonstrating that it has met and continues to maintain, at a 168
minimum, the same req uirements applicable to physicians in ss. 169
458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable. 170
Each physician practicing at an office registered under this 171
section or s. 458.328 must meet the financial responsibility 172
requirements under s. 458.320 or s. 459.0085, as applicable. 173
(h) A physician may only perform a procedure or surgery 174
identified in paragraph (a) in an office that is registered with 175
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the department. The board shall impose a fine of $5,000 per day 176
on a physician who performs a procedu re or surgery in an office 177
that is not registered with the department. 178
(2) STANDARDS OF PRACTICE. — 179
(a) A physician may not perform any surgery or procedure 180
identified in paragraph (1)(a) in a setting other than an office 181
surgery setting registered unde r this section or a facility 182
licensed under chapter 390 or chapter 395, as applicable. The 183
board shall impose a fine of $5,000 per incident on a physician 184
who violates this paragraph performing a gluteal fat grafting 185
procedure in an office surgery setting shall adhere to standards 186
of practice pursuant to this subsection and rules adopted by the 187
board. 188
(b) Office surgeries may not: 189
1. Be a type of surgery that generally results in blood 190
loss of more than 10 percent of estimated blood volume in a 191
patient with a normal hemoglobin level; 192
2. Require major or prolonged intracranial, intrathoracic, 193
abdominal, or joint replacement procedures, except for 194
laparoscopic procedures; 195
3. Involve major blood vessels and be performed with 196
direct visualization by open exposure of the major blood vessel, 197
except for percutaneous endovascular intervention; or 198
4. Be emergent or life threatening. 199
(c) A physician performing a gluteal fat grafting 200
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procedure in an office surgery setting shall adhere to standards 201
of practice under this subsection and rules adopted by the board 202
which include, but are not limited to, all of the following: 203
1. A physician performing a gluteal fat grafting procedure 204
must conduct an in-person examination of the patient while 205
physically present i n the same room as the patient no later than 206
the day before the procedure. 207
2. Before a physician may delegate any duties during a 208
gluteal fat grafting procedure, the patient must provide 209
written, informed consent for such delegation. Any duty 210
delegated by a physician during a gluteal fat grafting procedure 211
must be performed under the direct supervision of the physician 212
performing such procedure. Fat extraction and gluteal fat 213
injections must be performed by the physician and may not be 214
delegated. 215
3. Fat may only be injected into the subcutaneous space of 216
the patient and may not cross the fascia overlying the gluteal 217
muscle. Intramuscular or submuscular fat injections are 218
prohibited. 219
4. When the physician performing a gluteal fat grafting 220
procedure injects fat into the subcutaneous space of the 221
patient, the physician must use ultrasound guidance, or guidance 222
with other technology authorized under board rule which equals 223
or exceeds the quality of ultrasound, during the placement and 224
navigation of the cannula to ensure that the fat is injected 225
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into the subcutaneous space of the patient above the fascia 226
overlying the gluteal muscle. Such guidance with the use of 227
ultrasound or other technology is not required for other 228
portions of such procedure. 229
5. An office in which a physician performs gluteal fat 230
grafting procedures must at all times maintain a ratio of one 231
physician to one patient during all phases of the procedure, 232
beginning with the administration of anesthesia to the patient 233
and concluding with the extubation of the patient. After a 234
physician has commenced, and while he or she is engaged in, a 235
gluteal fat grafting procedure, the physician may not commence 236
or engage in another gluteal fat grafting procedure or any other 237
procedure with another pa tient at the same time. 238
(d) If a procedure in an office surgery setting results in 239
hospitalization, the incident must be reported as an adverse 240
incident pursuant to s. 458.351. 241
(e) An office in which a physician performs gluteal fat 242
grafting procedures must at all times maintain a ratio of one 243
physician to one patient during all phases of the procedure, 244
beginning with the administration of anesthesia to the patient 245
and concluding with the extubation of the patient. After a 246
physician has commenced, and w hile he or she is engaged in, a 247
gluteal fat grafting procedure, the physician may not commence 248
or engage in another gluteal fat grafting procedure or any other 249
procedure with another patient at the same time. 250
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Section 3. Subsection (6) of section 456.07 4, Florida 251
Statutes, is amended to read 252
456.074 Certain health care practitioners; immediate 253
suspension of license. — 254
(6) The department must issue an emergency order 255
suspending or restricting the registration of an office 256
registered under s. 458.328 or s. 459.0138 s. 459.0139 upon a 257
finding of probable cause that the office or a physician 258
practicing in the office is not in compliance with the standards 259
of practice for office surgery adopted by the boards pursuant to 260
s. 458.328 or s. 459.0138, as applica ble, or is in violation of 261
s. 458.331(1)(v) or s. 459.015(1)(z), and that such 262
noncompliance or violation constitutes an immediate danger to 263
the public. 264
Section 4. This act shall take effect upon becoming a law. 265