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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
1
An act relating to health care provider 2
accountability; amending s. 400.022, F.S.; revising 3
the rights of licensed nursing home facility 4
residents; providing definitions; amending s. 408.812, 5
F.S.; creating a cause of action for an ex parte 6
temporary injunction against continued unlicensed 7
activity; providing requirements for such injunction; 8
providing construction; authorizing the Agency f or 9
Health Care Administration to provide certain records 10
to local law enforcement and state attorneys' offices 11
under certain circumstances; amending ss. 458.328 and 12
459.0138, F.S.; requiring the Department of Health to 13
complete an inspection of any physici an′s office 14
seeking registration to perform office surgeries 15
before the office may be registered; requiring 16
immediate suspension of a registration under specified 17
circumstances; requiring such offices to remain closed 18
for the duration of any suspensions; r equiring a 19
suspension to remain in effect for a specified 20
timeframe; requiring physicians performing gluteal fat 21
grafting procedures in an office surgery setting to 22
adhere to specified standards of practice; specifying 23
surgeries that may not be performed i n an office 24
surgery setting; requiring physicians performing 25
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gluteal fat grafting procedures to conduct in -person 26
examinations of the patients; requiring the reporting 27
of specified adverse incidents; providing requirements 28
for the performance of gluteal fa t grafting 29
procedures; providing an effective date. 30
31
Be It Enacted by the Legislature of the State of Florida: 32
33
Section 1. Paragraph (o) of subsection (1) of section 34
400.022, Florida Statutes, is amended to read: 35
400.022 Residents' rights. — 36
(1) All licensees of nursing home facilities shall adopt 37
and make public a statement of the rights and responsibilities 38
of the residents of such facilities and shall treat such 39
residents in accordance with the provisions of that statement. 40
The statement shall assure each resident the following: 41
(o) The right to be free from mental and physical abuse, 42
sexual abuse, neglect, exploitation, corporal punishment, 43
extended involuntary seclusion, and from physical and chemical 44
restraints, except those restraints aut horized in writing by a 45
physician for a specified and limited period of time or as are 46
necessitated by an emergency. In case of an emergency, restraint 47
may be applied only by a qualified licensed nurse who shall set 48
forth in writing the circumstances requi ring the use of 49
restraint, and, in the case of use of a chemical restraint, a 50
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physician shall be consulted immediately thereafter. Restraints 51
may not be used in lieu of staff supervision or merely for staff 52
convenience, for punishment, or for reasons other than resident 53
protection or safety. For purposes of this paragraph, the terms 54
"sexual abuse," "neglect," and "exploitation" have the same 55
meanings as provided in 42 C.F.R. s. 483.5. 56
Section 2. Subsection (6) of section 408.812, Florida 57
Statutes, is amended to read: 58
408.812 Unlicensed activity. — 59
(6) In addition to granting injunctive relief pursuant to 60
subsection (2), if the agency determines that a person or entity 61
is operating or maintaining a provider without obtaining a 62
license and determines th at a condition exists that poses a 63
threat to the health, safety, or welfare of a client of the 64
provider, the person or entity is subject to the same actions 65
and fines imposed against a licensee as specified in this part, 66
authorizing statutes, and agency ru les. 67
(a) There is created a cause of action for an ex parte 68
temporary injunction against continued unlicensed activity by a 69
person or entity violating subsection (1), not to exceed 30 70
days. 71
(b) A sworn petition seeking the issuance of an ex parte 72
temporary injunction against continued unlicensed activity shall 73
allege all of the following: 74
1. The location of the unlicensed activity. 75
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2. The names of the owners and operators of the unlicensed 76
provider. 77
3. The type of services that require licensure. 78
4. The specific facts supporting the conclusion that the 79
unlicensed provider is engaged in unlicensed activity, including 80
the date, time, and location at which the unlicensed provider 81
was notified by the agency to discontinue such activity. 82
5. That agency personnel have verified, through an onsite 83
inspection, that the unlicensed provider is advertising, 84
offering, or providing services that require licensure. 85
6. Whether the unlicensed provider prohibited the agency 86
from conducting a subsequent investig ation to determine current 87
compliance with applicable laws and rules. 88
7. Any previous injunctive relief granted against the 89
unlicensed provider. 90
8. Any previous agency determination that the unlicensed 91
provider has been identified as engaging in unlice nsed activity. 92
(c) A bond may not be required by the court for entry of 93
an ex parte temporary injunction. 94
(d) Except as provided in s. 90.204, in a hearing to 95
obtain an ex parte temporary injunction, evidence other than 96
verified pleadings or affidavits by agency personnel or others 97
with firsthand knowledge of the alleged unlicensed activity may 98
not be used as evidence, unless the unlicensed provider appears 99
at the hearing. A denial of a petition for an ex parte temporary 100
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injunction shall specify the gro unds for denial in writing. 101
(e) If the court determines that the unlicensed provider 102
is engaged in continued unlicensed activity after agency 103
notification to cease such unlicensed activity, the court may 104
grant the ex parte temporary injunction restrainin g the 105
unlicensed provider from advertising, offering, or providing 106
services for which licensure is required. The court may also 107
order the unlicensed provider to provide to agency personnel 108
access to facility personnel, records, and clients for future 109
inspection of the unlicensed provider's premises. 110
(f) The agency must inspect the unlicensed provider's 111
premises within 20 days after entry of the ex parte temporary 112
injunction to verify compliance with such injunction. If the 113
unlicensed provider is in compli ance, the agency shall dismiss 114
the injunction. If unlicensed activity has continued, the agency 115
may file a petition for permanent injunction within 10 days 116
after identifying noncompliance. The agency may also petition to 117
extend the ex parte temporary injun ction until the permanent 118
injunction is decided. 119
(g) The agency may provide any inspection records to local 120
law enforcement or a state attorney's office upon request and 121
without redaction. 122
Section 3. Present subsection (2) of section 458.328, 123
Florida Statutes, is redesignated as subsection (3), a new 124
subsection (2) is added to that section, and paragraphs (a) and 125
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(e) of subsection (1) of that section are amended, to read: 126
458.328 Office surgeries. — 127
(1) REGISTRATION.— 128
(a)1. An office in which a p hysician performs a 129
liposuction procedure in which more than 1,000 cubic centimeters 130
of supernatant fat is removed, a Level II office surgery, or a 131
Level III office surgery must register with the department 132
unless the office is licensed as a facility under chapter 390 or 133
chapter 395. 134
2. The department must complete an inspection of any 135
office seeking registration under this section before the office 136
may be registered. 137
(e)1. The department shall inspect a registered office at 138
least annually, including a review of patient records, to ensure 139
that the office is in compliance with this section and rules 140
adopted hereunder unless the office is accredited by a 141
nationally recognized accrediting agency approved by the board. 142
The inspection may be unannounced, exce pt for the inspection of 143
an office that meets the description of a clinic specified in s. 144
458.3265(1)(a)3.h., and those wholly owned and operated 145
physician offices described in s. 458.3265(1)(a)3.g. which 146
perform procedures referenced in s. 458.3265(1)(a)3 .h., which 147
must be announced. 148
2. The department must immediately suspend the 149
registration of a registered office that refuses an inspection 150
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under subparagraph 1. The office must close during such 151
suspension. The suspension must remain in effect for at le ast 14 152
consecutive days and may not terminate until the department 153
issues a written declaration that the office may reopen 154
following the department′s completion of an inspection of the 155
office. 156
(2) STANDARDS OF PRACTICE. — 157
(a) A physician performing a gl uteal fat grafting 158
procedure in an office surgery setting shall adhere to standards 159
of practice pursuant to this subsection and rules adopted by the 160
board. 161
(b) Office surgeries may not: 162
1. Be a type of surgery that generally results in blood 163
loss of more than 10 percent of estimated blood volume in a 164
patient with a normal hemoglobin level; 165
2. Require major or prolonged intracranial, intrathoracic, 166
abdominal, or joint replacement procedures, except for 167
laparoscopic procedures; 168
3. Involve major blood vessels and be performed with 169
direct visualization by open exposure of the major blood vessel, 170
except for percutaneous endovascular intervention; or 171
4. Be emergent or life threatening. 172
(c)1. A physician performing a gluteal fat grafting 173
procedure must conduct an in-person examination of the patient 174
while physically present in the same room as the patient no 175
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later than the day before the procedure. 176
2. Before a physician may delegate any duties during a 177
gluteal fat grafting procedure, the patient must p rovide 178
written, informed consent for such delegation. Any duty 179
delegated by a physician during a gluteal fat grafting procedure 180
must be performed under the direct supervision of the physician 181
performing such procedure. Fat extraction and gluteal fat 182
injections must be performed by the physician and may not be 183
delegated. 184
3. Fat may only be injected into the subcutaneous space of 185
the patient and may not cross the fascia overlying the gluteal 186
muscle. Intramuscular or submuscular fat injections are 187
prohibited. 188
4. When the physician performing a gluteal fat grafting 189
procedure injects fat into the subcutaneous space of the 190
patient, the physician must use ultrasound guidance, or guidance 191
with other technology authorized under board rule which equals 192
or exceeds the quality of ultrasound, during the placement and 193
navigation of the cannula to ensure that the fat is injected 194
into the subcutaneous space of the patient above the fascia 195
overlying the gluteal muscle. Such guidance with the use of 196
ultrasound or other technology is not required for other 197
portions of such procedure. 198
(d) If a procedure in an office surgery setting results in 199
hospitalization, the incident must be reported as an adverse 200
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incident pursuant to s. 458.351. 201
(e) An office in which a physician performs gluteal fat 202
grafting procedures must at all times maintain a ratio of one 203
physician to one patient during all phases of the procedure, 204
beginning with the administration of anesthesia to the patient 205
and concluding with the extubation of the patient. After a 206
physician has commenced, and while he or she is engaged in, a 207
gluteal fat grafting procedure, the physician may not commence 208
or engage in another gluteal fat grafting procedure or any other 209
procedure with anoth er patient at the same time. 210
Section 4. Present subsection (2) of section 459.0138, 211
Florida Statutes, is redesignated as subsection (3), a new 212
subsection (2) is added to that section, and paragraphs (a) and 213
(e) of subsection (1) of that section are ame nded, to read: 214
459.0138 Office surgeries. — 215
(1) REGISTRATION.— 216
(a)1. An office in which a physician performs a 217
liposuction procedure in which more than 1,000 cubic centimeters 218
of supernatant fat is removed, a Level II office surgery, or a 219
Level III office surgery must register with the department 220
unless the office is licensed as a facility under chapter 390 or 221
chapter 395. 222
2. The department must complete an inspection of any 223
office seeking registration under this section before the office 224
may be registered. 225
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(e)1. The department shall inspect a registered office at 226
least annually, including a review of patient records, to ensure 227
that the office is in compliance with this section and rules 228
adopted hereunder unless the office is accredited by a 229
nationally recognized accrediting agency approved by the board. 230
The inspection may be unannounced, except for the inspection of 231
an office that meets the description of clinic specified in s. 232
459.0137(1)(a)3.h., and those wholly owned and operated 233
physician offices described in s. 459.0137(1)(a)3.g. which 234
perform procedures referenced in s. 459.0137(1)(a)3.h., which 235
must be announced. 236
2. The department must immediately suspend the 237
registration of a registered office that refuses an inspection 238
under subparagraph 1 . The office must close during such 239
suspension. The suspension must remain in effect for at least 14 240
consecutive days and may not terminate until the department 241
issues a written declaration that the office may reopen 242
following the department′s completion o f an inspection of the 243
office. 244
(2) STANDARDS OF PRACTICE. — 245
(a) A physician performing a gluteal fat grafting 246
procedure in an office surgery setting shall adhere to standards 247
of practice pursuant to this subsection and rules adopted by the 248
board. 249
(b) Office surgeries may not: 250
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1. Be a type of surgery that generally results in blood 251
loss of more than 10 percent of estimated blood volume in a 252
patient with a normal hemoglobin level; 253
2. Require major or prolonged intracranial, intrathoracic, 254
abdominal, or joint replacement procedures, except for 255
laparoscopic procedures; 256
3. Involve major blood vessels and be performed with 257
direct visualization by open exposure of the major blood vessel, 258
except for percutaneous endovascular intervention; or 259
4. Be emergent or life threatening. 260
(c)1. A physician performing a gluteal fat grafting 261
procedure must conduct an in -person examination of the patient 262
while physically present in the same room as the patient no 263
later than the day before the procedure. 264
2. Before a physician may delegate any duties during a 265
gluteal fat grafting procedure, the patient must provide 266
written, informed consent for such delegation. Any duty 267
delegated by a physician during a gluteal fat grafting procedure 268
must be performed under the direct supervision of the physician 269
performing such procedure. Fat extraction and gluteal fat 270
injections must be performed by the physician and may not be 271
delegated. 272
3. Fat may only be injected into the subcutaneous space of 273
the patient and may not cross the f ascia overlying the gluteal 274
muscle. Intramuscular or submuscular fat injections are 275
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prohibited. 276
4. When the physician performing a gluteal fat grafting 277
procedure injects fat into the subcutaneous space of the 278
patient, the physician must use ultrasound gu idance, or guidance 279
with other technology authorized under board rule which equals 280
or exceeds the quality of ultrasound, during the placement and 281
navigation of the cannula to ensure that the fat is injected 282
into the subcutaneous space of the patient above the fascia 283
overlying the gluteal muscle. Such guidance with the use of 284
ultrasound or other technology is not required for other 285
portions of such procedure. 286
(d) If a procedure in an office surgery setting results in 287
hospitalization, the incident must be r eported as an adverse 288
incident pursuant to s. 458.351. 289
(e) An office in which a physician performs gluteal fat 290
grafting procedures must at all times maintain a ratio of one 291
physician to one patient during all phases of the procedure, 292
beginning with the a dministration of anesthesia to the patient 293
and concluding with the extubation of the patient. After a 294
physician has commenced, and while he or she is engaged in, a 295
gluteal fat grafting procedure, the physician may not commence 296
or engage in another gluteal fat grafting procedure or any other 297
procedure with another patient at the same time. 298
Section 5. This act shall take effect July 1, 2023. 299