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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; amending s. 408.812, F.S.; creating a cause 5
of action for an ex parte temporary injunction against 6
continued unlicensed activity; providing requirements 7
for such injunction; providing construction; 8
authorizing the Agency for Health Care Administration 9
to provide certain records to local law enforcement 10
and state attorneys' offices under certain 11
circumstances; amending ss. 458.328 and 459.0138, 12
F.S.; requiring the Department of Health to inspect 13
specified offices before registration and refuse to 14
register a new office o r immediately suspend the 15
registration of a registered office that refuses an 16
inspection for a specified timeframe; prohibiting the 17
department from registering specified facilities; 18
providing suspension requirements; providing standard 19
of practice requirem ents 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 Legislature 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 eme rgency, 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. Res traints 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. 47
Section 2. Subsection (6) of section 408.812, Florida 48
Statutes, is amended to read: 49
408.812 Unlicensed activity. — 50
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(6) In addition to granting injunctive relief pursuant to 51
subsection (2), if the agency determines that a person or entity 52
is operating or maintaining a provider without obtaining a 53
license and determines that a condition exists th at poses a 54
threat to the health, safety, or welfare of a client of the 55
provider, the person or entity is subject to the same actions 56
and fines imposed against a licensee as specified in this part, 57
authorizing statutes, and agency rules. 58
(a) There is created a cause of action for an ex parte 59
temporary injunction against continued unlicensed activity by a 60
person or entity violating subsection (1), not to exceed 30 61
days. 62
(b) A sworn petition seeking the issuance of an ex parte 63
temporary injunction against continued unlicensed activity shall 64
allege all of the following: 65
1. The location of the unlicensed activity. 66
2. The names of the owners and operators of the unlicensed 67
provider. 68
3. The type of services that require licensure. 69
4. The specific facts supporting the conclusion that the 70
unlicensed provider is engaged in unlicensed activity, including 71
the date, time, and location at which the unlicensed provider 72
was notified by the agency to discontinue such activity. 73
5. That agency personnel have verif ied, through an onsite 74
inspection, that the unlicensed provider is advertising, 75
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offering, or providing services that require licensure. 76
6. Whether the unlicensed provider prohibited the agency 77
from conducting a subsequent investigation to determine curre nt 78
compliance with applicable laws and rules. 79
7. Any previous injunctive relief granted against the 80
unlicensed provider. 81
8. Any previous agency determination that the unlicensed 82
provider has been identified as engaging in unlicensed activity. 83
(c) A bond may not be required by the court for entry of 84
an ex parte temporary injunction. 85
(d) Except as provided in s. 90.204, in a hearing to 86
obtain an ex parte temporary injunction, evidence other than 87
verified pleadings or affidavits by agency personnel or others 88
with firsthand knowledge of the alleged unlicensed activity may 89
not be used as evidence, unless the unlicensed provider appears 90
at the hearing. A denial of a petition for an ex parte temporary 91
injunction shall specify the grounds for denial in writi ng. 92
(e) If the court determines that the unlicensed provider 93
is engaged in continued unlicensed activity after agency 94
notification to cease such unlicensed activity, the court may 95
grant the ex parte temporary injunction restraining the 96
unlicensed provider from advertising, offering, or providing 97
services for which licensure is required. The court may also 98
order the unlicensed provider to provide to agency personnel 99
access to facility personnel, records, and clients for future 100
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inspection of the unlicensed provider's premises. 101
(f) The agency must inspect the unlicensed provider's 102
premises within 20 days after entry of the ex parte temporary 103
injunction to verify compliance with such injunction. If the 104
unlicensed provider is in compliance, the agency shall d ismiss 105
the injunction. If unlicensed activity has continued, the agency 106
may file a petition for permanent injunction within 10 days 107
after identifying noncompliance. The agency may also petition to 108
extend the ex parte temporary injunction until the permanen t 109
injunction is decided. 110
(g) The agency may provide any inspection records to local 111
law enforcement or a state attorney's office upon request and 112
without redaction. 113
Section 3. Subsection (2) of section 458.328, Florida 114
Statutes, is renumbered as subs ection (3), paragraphs (a) and 115
(e) of subsection (1) are amended, and a new subsection (2) is 116
added to that section, to read: 117
458.328 Office surgeries. — 118
(1) REGISTRATION.— 119
(a) An office in which a physician performs a liposuction 120
procedure in which m ore than 1,000 cubic centimeters of 121
supernatant fat is removed, a Level II office surgery, or a 122
Level III office surgery must register with the department 123
unless the office is licensed as a facility under chapter 390 or 124
chapter 395. The department must ins pect any such office before 125
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registration. The department may not register a facility that 126
must be licensed under chapter 390 or chapter 395. 127
(e) The department shall inspect a registered office at 128
least annually, including a review of patient records, to ensure 129
that the office is in compliance with this section and rules 130
adopted hereunder unless the office is accredited by a 131
nationally recognized accrediting agency approved by the board. 132
The inspection may be unannounced, except for the inspection of 133
an office that meets the description of a clinic specified in s. 134
458.3265(1)(a)3.h., and those wholly owned and operated 135
physician offices described in s. 458.3265(1)(a)3.g. which 136
perform procedures referenced in s. 458.3265(1)(a)3.h., which 137
must be announced. The department must refuse to register a new 138
office or must immediately suspend the registration of a 139
registered office that refuses an inspection for 14 days. Such 140
office must be closed during the period of suspension. The 141
suspension must remain in effec t until the department has 142
completed its inspection. 143
(2) STANDARD OF PRACTICE. — 144
(a) For purposes of this section, the term: 145
1. "Office surgery" means a surgery performed at an office 146
that primarily serves as a physician's office at which a 147
physician regularly performs consultations with surgical 148
patients, presurgical examinations, and postoperative monitoring 149
and care related to office surgeries and at which patient 150
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records are readily maintained and available. 151
2. "Physician" means a physician or su rgeon licensed to 152
practice under this chapter. 153
(b) A physician performing a gluteal fat grafting 154
procedure in an office surgery setting shall adhere to standards 155
of practice pursuant to this subsection and rules adopted by the 156
board. 157
(c) Office surgeries may not: 158
1. Result in blood loss of more than 10 percent of 159
estimated blood volume in a patient with a normal hemoglobin 160
level; 161
2. Require major or prolonged intracranial, intrathoracic, 162
abdominal, or joint replacement procedures, except for 163
laparoscopic procedures; 164
3. Involve major blood vessels performed with direct 165
visualization by open exposure of the major blood vessel, except 166
for percutaneous endovascular intervention; or 167
4. Be emergent or life threatening. 168
(d)1. A physician performing a gluteal fat grafting 169
procedure must be a board -eligible or board-certified plastic 170
surgeon. 171
2. A physician performing a gluteal fat grafting procedure 172
must conduct an in-person examination of the patient no later 173
than 24 hours before the procedure. 174
3. Any duty delegated by a physician, with a patient's 175
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informed consent, to be performed during a gluteal fat grafting 176
procedure must be performed under the direct supervision of the 177
physician performing such procedure. Gluteal fat injections must 178
be performed by the physician and may not be delegated. 179
4. Gluteal fat may only be injected into the subcutaneous 180
space of the patient and may not cross the fascia overlying the 181
gluteal muscle. Intramuscular or submuscular fat injections are 182
prohibited. 183
5. When the physician performing a gluteal fat grafting 184
procedure injects fat into the subcutaneous space of the 185
patient, the physician must use ultrasound guidance during the 186
placement and navigation of the canula to ensure that the fat is 187
injected into the subcut aneous space of the patient above the 188
fascia overlying the gluteal muscle. The board may establish 189
minimum technical standards for such ultrasound guidance. 190
Ultrasound guidance is not required for other portions of such 191
procedure. 192
(e) If a procedure in a n office surgery setting results in 193
hospitalization, the type of procedure performed and the 194
location at which the procedure was performed, if known, must be 195
included in the hospital intake information for the purpose of 196
adverse incident reporting. 197
Section 4. Subsection (2) of section 459.0138, Florida 198
Statutes, is renumbered as subsection (3), paragraphs (a) and 199
(e) of subsection (1) are amended, and a new subsection (2) is 200
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added to that section, to read: 201
459.0138 Office surgeries. — 202
(1) REGISTRATION.— 203
(a) An office in which a physician performs a liposuction 204
procedure in which more than 1,000 cubic centimeters of 205
supernatant fat is removed, a Level II office surgery, or a 206
Level III office surgery must register with the department 207
unless the office is licensed as a facility under chapter 390 or 208
chapter 395. The department must inspect any such office before 209
registration. The department may not register a facility that 210
must be licensed under chapter 390 or chapter 395. 211
(e) The department shall inspect a registered office at 212
least annually, including a review of patient records, to ensure 213
that the office is in compliance with this section and rules 214
adopted hereunder unless the office is accredited by a 215
nationally recognized accrediting agency approved by the board. 216
The inspection may be unannounced, except for the inspection of 217
an office that meets the description of clinic specified in s. 218
459.0137(1)(a)3.h., and those wholly owned and operated 219
physician offices described in s. 459.0137(1)(a)3.g. which 220
perform procedures referenced in s. 459.0137(1)(a)3.h., which 221
must be announced. The department must refuse to register a new 222
office or immediately suspend the registration of a registered 223
office that refuses an inspection f or 14 days. Such office must 224
be closed during the period of suspension. The suspension must 225
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remain in effect until the department has completed its 226
inspection. 227
(2) STANDARD OF PRACTICE. — 228
(a) For purposes of this section, the term: 229
1. "Office surgery" means a surgery performed at an office 230
that primarily serves as a physician's office at which a 231
physician performs surgeries as permitted under this section. 232
The physician's office must be an office at which such physician 233
regularly performs consultations with surgical patients, 234
presurgical examinations, and postoperative monitoring and care 235
related to office surgeries and at which patient records are 236
readily maintained and available. 237
2. "Physician" means a physician or surgeon licensed to 238
practice under this chapter. 239
(b) A physician performing a gluteal fat grafting 240
procedure in an office surgery setting shall adhere to standards 241
of practice pursuant to this subsection and rules adopted by the 242
board. 243
(c) Office surgeries may not: 244
1. Result in blood loss of more than 10 percent of 245
estimated blood volume in a patient with a normal hemoglobin 246
level; 247
2. Require major or prolonged intracranial, intrathoracic, 248
abdominal, or joint replacement procedures, except for 249
laparoscopic procedures; 250
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3. Involve major blood vessels performed with direct 251
visualization by open exposure of the major blood vessel, except 252
for percutaneous endovascular intervention; or 253
4. Be emergent or life threatening. 254
(d)1. A physician performing a gluteal fat grafting 255
procedure must be a board-eligible or board-certified plastic 256
surgeon. 257
2. A physician performing a gluteal fat grafting procedure 258
must conduct an in-person examination of the patient no later 259
than 24 hours before the procedure. 260
3. Any duty delegated by a physicia n, with a patient's 261
informed consent, to be performed during a gluteal fat grafting 262
procedure must be performed under the direct supervision of the 263
physician performing such procedure. Gluteal fat injections must 264
be performed by the physician and may not b e delegated. 265
4. Gluteal fat may only be injected into the subcutaneous 266
space of the patient and may not cross the fascia overlying the 267
gluteal muscle. Intramuscular or submuscular fat injections are 268
prohibited. 269
5. When the physician performing a glutea l fat grafting 270
procedure injects fat into the subcutaneous space of the 271
patient, the physician must use ultrasound guidance during the 272
placement and navigation of the canula to ensure that the fat is 273
injected into the subcutaneous space of the patient abov e the 274
fascia overlying the gluteal muscle. The board may establish 275
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minimum technical standards for such ultrasound guidance. 276
Ultrasound guidance is not required for other portions of such 277
procedure. 278
(e) If a procedure in an office surgery setting results in 279
hospitalization, the type of procedure performed and the 280
location at which the procedure was performed, if known, must be 281
included in the hospital intake information for the purpose of 282
adverse incident reporting. 283
Section 5. This act shall take effect July 1, 2023. 284