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A bill to be entitled 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
inspect specified offices before regi stration and 14
refuse to register a new office or immediately suspend 15
the registration of a registered office that refuses 16
an inspection for a specified timeframe; prohibiting 17
the department from registering specified facilities; 18
providing suspension require ments; providing standard 19
of practice requirements for office surgeries; 20
providing definitions; prohibiting certain office 21
surgeries; providing physician, office, and procedure 22
requirements; providing an effective date. 23
24
Be It Enacted by the Legislatur e of the State of Florida: 25
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Section 1. Paragraph (o) of subsection (1) of section 27
400.022, Florida Statutes, is amended to read: 28
400.022 Residents' rights. — 29
(1) All licensees of nursing home facilities shall adopt 30
and make public a statement of the rights and responsibilities 31
of the residents of such facilities and shall treat such 32
residents in accordance with the provisions of that statement. 33
The statement shall assure each resident the following: 34
(o) The right to be free from mental and physical abuse, 35
sexual abuse, neglect, exploitation, corporal punishment, 36
extended involuntary seclusion, and from physical and chemical 37
restraints, except those restraints authorized in writing by a 38
physician for a specified and limited period of time or as are 39
necessitated by an emergency. In case of an emergency, restraint 40
may be applied only by a qualified licensed nurse who shall set 41
forth in writing the circumstances requiring the use of 42
restraint, and, in the case of use of a chemical restraint, a 43
physician shall be consulted immediately thereafter. Restraints 44
may not be used in lieu of staff supervision or merely for staff 45
convenience, for punishment, or for reasons other than resident 46
protection or safety. For purposes of this paragraph, the terms 47
"sexual abuse," "neglect," and "exploitation" have the same 48
meanings as provided in 42 C.F.R. s. 483.5. 49
Section 2. Subsection (6) of section 408.812, Florida 50
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Statutes, is amended to read: 51
408.812 Unlicensed activity. — 52
(6) In addition to granting injunctive relief pursuant to 53
subsection (2), if the agency determines that a person or entity 54
is operating or maintaining a provider without obtaining a 55
license and determines that a condition exists that poses a 56
threat to the health, safety, or welfare of a client of the 57
provider, the person or entity is subject to the same actions 58
and fines imposed against a licensee as specified in this part, 59
authorizing statutes, and agency rules. 60
(a) There is created a cause of action for an ex parte 61
temporary injunction again st continued unlicensed activity by a 62
person or entity violating subsection (1), not to exceed 30 63
days. 64
(b) A sworn petition seeking the issuance of an ex parte 65
temporary injunction against continued unlicensed activity shall 66
allege all of the following: 67
1. The location of the unlicensed activity. 68
2. The names of the owners and operators of the unlicensed 69
provider. 70
3. The type of services that require licensure. 71
4. The specific facts supporting the conclusion that the 72
unlicensed provider is engaged in unlicensed activity, including 73
the date, time, and location at which the unlicensed provider 74
was notified by the agency to discontinue such activity. 75
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5. That agency personnel have verified, through an onsite 76
inspection, that the unlicensed provider is advertising, 77
offering, or providing services that require licensure. 78
6. Whether the unlicensed provider prohibited the agency 79
from conducting a subsequent investigation to determine current 80
compliance with applicable laws and rules. 81
7. Any previous injunctive relief granted against the 82
unlicensed provider. 83
8. Any previous agency determination that the unlicensed 84
provider has been identified as engaging in unlicensed activity. 85
(c) A bond may not be required by the cour t for entry of 86
an ex parte temporary injunction. 87
(d) Except as provided in s. 90.204, in a hearing to 88
obtain an ex parte temporary injunction, evidence other than 89
verified pleadings or affidavits by agency personnel or others 90
with firsthand knowledge of the alleged unlicensed activity may 91
not be used as evidence, unless the unlicensed provider appears 92
at the hearing. A denial of a petition for an ex parte temporary 93
injunction shall specify the grounds for denial in writing. 94
(e) If the court determines t hat the unlicensed provider 95
is engaged in continued unlicensed activity after agency 96
notification to cease such unlicensed activity, the court may 97
grant the ex parte temporary injunction restraining the 98
unlicensed provider from advertising, offering, or pr oviding 99
services for which licensure is required. The court may also 100
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order the unlicensed provider to provide to agency personnel 101
access to facility personnel, records, and clients for future 102
inspection of the unlicensed provider's premises. 103
(f) The agency must inspect the unlicensed provider's 104
premises within 20 days after entry of the ex parte temporary 105
injunction to verify compliance with such injunction. If the 106
unlicensed provider is in compliance, the agency shall dismiss 107
the injunction. If unlicense d activity has continued, the agency 108
may file a petition for permanent injunction within 10 days 109
after identifying noncompliance. The agency may also petition to 110
extend the ex parte temporary injunction until the permanent 111
injunction is decided. 112
(g) The agency may provide any inspection records to local 113
law enforcement or a state attorney's office upon request and 114
without redaction. 115
Section 3. Subsection (2) of section 458.328, Florida 116
Statutes, is renumbered as subsection (3), paragraphs (a) and 117
(e) of subsection (1) are amended, and a new subsection (2) is 118
added to that section, to read: 119
458.328 Office surgeries. — 120
(1) REGISTRATION.— 121
(a) An office in which a physician performs a liposuction 122
procedure in which more than 1,000 cubic centimeters of 123
supernatant fat is removed, a Level II office surgery, or a 124
Level III office surgery must register with the department 125
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unless the office is licensed as a facility under chapter 390 or 126
chapter 395. The department must inspect any such office before 127
registration. The department may not register a facility that 128
must be licensed under chapter 390 or chapter 395. 129
(e) The department shall inspect a registered office at 130
least annually, including a review of patient records, to ensure 131
that the office is in compl iance with this section and rules 132
adopted hereunder unless the office is accredited by a 133
nationally recognized accrediting agency approved by the board. 134
The inspection may be unannounced, except for the inspection of 135
an office that meets the description of a clinic specified in s. 136
458.3265(1)(a)3.h., and those wholly owned and operated 137
physician offices described in s. 458.3265(1)(a)3.g. which 138
perform procedures referenced in s. 458.3265(1)(a)3.h., which 139
must be announced. The department must refuse to regi ster a new 140
office or must immediately suspend the registration of a 141
registered office that refuses an inspection for 14 days. Such 142
office must be closed during the period of suspension. The 143
suspension must remain in effect until the department has 144
completed its inspection. 145
(2) STANDARD OF PRACTICE. — 146
(a) For purposes of this section, the term: 147
1. "Office surgery" means a surgery performed at an office 148
that primarily serves as a physician's office at which a 149
physician regularly performs consultations wi th surgical 150
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patients, presurgical examinations, and postoperative monitoring 151
and care related to office surgeries and at which patient 152
records are readily maintained and available. 153
2. "Physician" means a physician or surgeon licensed to 154
practice under this chapter. 155
(b) A physician performing a gluteal fat grafting 156
procedure in an office surgery setting shall adhere to standards 157
of practice pursuant to this subsection and rules adopted by the 158
board. 159
(c) Office surgeries may not: 160
1. Result in blood lo ss of more than 10 percent of 161
estimated blood volume in a patient with a normal hemoglobin 162
level; 163
2. Require major or prolonged intracranial, intrathoracic, 164
abdominal, or joint replacement procedures, except for 165
laparoscopic procedures; 166
3. Involve major blood vessels performed with direct 167
visualization by open exposure of the major blood vessel, except 168
for percutaneous endovascular intervention; or 169
4. Be emergent or life threatening. 170
(d)1. A physician performing a gluteal fat grafting 171
procedure must have sufficient training, as determined by the 172
board, to perform gluteal fat grafting procedures safely and 173
effectively. 174
2. A physician performing a gluteal fat grafting procedure 175
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must conduct an in-person examination of the patient no later 176
than the day before the procedure. 177
3. Any duty delegated by a physician, with a patient's 178
informed consent, to be performed during a gluteal fat grafting 179
procedure must be performed under the direct supervision of the 180
physician performing such procedure. Fat extraction and gluteal 181
fat injections must be performed by the physician and may not be 182
delegated. 183
4. Gluteal fat may only be injected into the subcutaneous 184
space of the patient and may not cross the fascia overlying the 185
gluteal muscle. Intramuscular or submuscular fat injections are 186
prohibited. 187
5. When the physician performing a gluteal fat grafting 188
procedure injects fat into the subcutaneous space of the 189
patient, the physician must use ultrasound guidance during the 190
placement and navigation of the canula to ensure that the fat is 191
injected into the subcutaneous space of the patient above the 192
fascia overlying the gluteal muscle. The board may establish 193
minimum technical standards for such ultrasound guidance. 194
Ultrasound guidance is not required for other portions of such 195
procedure. 196
(e) If a procedure in an office surgery setting results in 197
hospitalization, the type of procedure performed and the 198
location at which the procedure was performed, if known, must be 199
included in the hospital intake information for the purpose of 200
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adverse incident reporting. 201
(f) 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. However, 206
after a physician has commenced, and while he or she is engaged 207
in, a gluteal fat grafting procedure, the physician may not 208
commence or engage in another gluteal fat grafting procedure or 209
any other procedure with another patient at the same time. 210
Section 4. Subsection (2) of section 459.0138, Florida 211
Statutes, is renumbered as subsection (3), paragraphs (a) and 212
(e) of subsection (1) are amended, and a new subsection (2) is 213
added to that section, to read: 214
459.0138 Office surgeries. — 215
(1) REGISTRATION.— 216
(a) An office in which a physician performs a liposuction 217
procedure in which more than 1,000 cubic centimeters of 218
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. The department must inspect any such office before 222
registration. The department may not register a facility that 223
must be licensed under chapter 390 or chapter 395. 224
(e) The department shall inspect a registered office at 225
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least annually, including a review of p atient records, to ensure 226
that the office is in compliance with this section and rules 227
adopted hereunder unless the office is accredited by a 228
nationally recognized accrediting agency approved by the board. 229
The inspection may be unannounced, except for the inspection of 230
an office that meets the description of clinic specified in s. 231
459.0137(1)(a)3.h., and those wholly owned and operated 232
physician offices described in s. 459.0137(1)(a)3.g. which 233
perform procedures referenced in s. 459.0137(1)(a)3.h., which 234
must be announced. The department must refuse to register a new 235
office or immediately suspend the registration of a registered 236
office that refuses an inspection for 14 days. Such office must 237
be closed during the period of suspension. The suspension must 238
remain in effect until the department has completed its 239
inspection. 240
(2) STANDARD OF PRACTICE. — 241
(a) For purposes of this section, the term: 242
1. "Office surgery" means a surgery performed at an office 243
that primarily serves as a physician's office at which a 244
physician performs surgeries as permitted under this section. 245
The physician's office must be an office at which such physician 246
regularly performs consultations with surgical patients, 247
presurgical examinations, and postoperative monitoring and care 248
related to office surgeries and at which patient records are 249
readily maintained and available. 250
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2. "Physician" means a physician or surgeon licensed to 251
practice under this chapter. 252
(b) A physician performing a gluteal fat grafting 253
procedure in an office surger y setting shall adhere to standards 254
of practice pursuant to this subsection and rules adopted by the 255
board. 256
(c) Office surgeries may not: 257
1. Result in blood loss of more than 10 percent of 258
estimated blood volume in a patient with a normal hemoglobin 259
level; 260
2. Require major or prolonged intracranial, intrathoracic, 261
abdominal, or joint replacement procedures, except for 262
laparoscopic procedures; 263
3. Involve major blood vessels performed with direct 264
visualization by open exposure of the major blood vesse l, except 265
for percutaneous endovascular intervention; or 266
4. Be emergent or life threatening. 267
(d)1. A physician performing a gluteal fat grafting 268
procedure must have sufficient training, as determined by the 269
board, to perform gluteal fat grafting proced ures safely and 270
effectively. 271
2. Any duty delegated by a physician, with a patient's 272
informed consent, to be performed during a gluteal fat grafting 273
procedure must be performed under the direct supervision of the 274
physician performing such procedure. Fat e xtraction and gluteal 275
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fat injections must be performed by the physician and may not be 276
delegated. 277
4. Gluteal fat may only be injected into the subcutaneous 278
space of the patient and may not cross the fascia overlying the 279
gluteal muscle. Intramuscular or s ubmuscular fat injections are 280
prohibited. 281
5. When the physician performing a gluteal fat grafting 282
procedure injects fat into the subcutaneous space of the 283
patient, the physician must use ultrasound guidance during the 284
placement and navigation of the canu la to ensure that the fat is 285
injected into the subcutaneous space of the patient above the 286
fascia overlying the gluteal muscle. The board may establish 287
minimum technical standards for such ultrasound guidance. 288
Ultrasound guidance is not required for other portions of such 289
procedure. 290
(e) If a procedure in an office surgery setting results in 291
hospitalization, the type of procedure performed and the 292
location at which the procedure was performed, if known, must be 293
included in the hospital intake information f or the purpose of 294
adverse incident reporting. 295
Section 5. This act shall take effect July 1, 2023. 296