Senate Bill 424 (2025) — Office surgery standards of practice

SB 424

Florida Bills

Florida Senate - 2025 SB 424 By Senator Gaetz 1-01021B-25 2025424__ Page 1 of 10 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to office surgery standards of 2 practice; providing a

short title; amending ss. 3 458.328 and 459.0138, F.S.; prohibiting physicians 4 from performing level II or level III surgeries on 5 immediate family members in an office surgery setting, 6 with exceptions; defining the term “immediate family 7 member”; prohibiting physicians from altering or 8 changing a consent form for a surgical procedure after 9 the patient has signed the form or after sedative 10 drugs have been administered to the patient; 11 specifying requirements for health care professionals 12 performing duties at a registered office which require 13 licensure or certification; specifying practice 14 standards for office surgeries; requiring office 15 surgeries to report adverse incidents to the 16 Department of Health within a specified timeframe; 17 specifying requirements if an adverse incident occurs 18 due to a local anesthetic; prohibiting office 19 surgeries from performing surgical procedures 20 concurrently with any construction or refurbishment 21 that interferes with the safe performance of such 22 procedures until it is safe to do so; requiring the 23 department to create an oversight committee for 24 specified purposes; requiring physicians performing 25 surgeries in office surgery settings to comply with 26 specified financial responsibility requirements; 27 providing an effective date. 28 29

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 2 of 10 CODING: Words stricken are deletions; words underlined are additions. Be It Enacted by the Legislature of the State of Florida: 30 31

Section 1. This act may be cited as “Hillary’s Law.” 32

Section 2. Present subsection (3) of

section 458.328, 33 Florida Statutes, is redesignated as subsection (4), a new 34 subsection (3) is added to that section, and subsection (2) is 35 amended, to read: 36 458.328 Office surgeries.— 37

(2) STANDARDS OF PRACTICE.— 38 (

a) A physician may not perform any surgery or procedure 39 identified in paragraph (1)(

a) in a setting other than an office 40 surgery setting registered under this

section or a facility 41 licensed under

chapter 390 or

chapter 395, as applicable. The 42 board shall impose a fine of $5,000 per incident on a physician 43 who violates this paragraph. 44 (

b) Office surgeries may not: 45 1. Be a type of surgery that generally results in blood 46 loss of more than 10 percent of estimated blood volume in a 47 patient with a normal hemoglobin level; 48 2. Require major or prolonged intracranial, intrathoracic, 49 abdominal, or joint replacement procedures, except for 50 laparoscopic procedures; 51 3. Involve major blood vessels and be performed with direct 52 visualization by open exposure of the major blood vessel, except 53 for percutaneous endovascular intervention; or 54 4. Be emergent or life threatening. 55 (

c) A physician performing a gluteal fat grafting procedure 56 in an office surgery setting shall adhere to standards of 57 practice under this subsection and rules adopted by the board 58

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 3 of 10 CODING: Words stricken are deletions; words underlined are additions. which include, but are not limited to, all of the following: 59 1. A physician performing a gluteal fat grafting procedure 60 must conduct an in-person examination of the patient while 61 physically present in the same room as the patient no later than 62 the day before the procedure. 63 2. Before a physician may delegate any duties during a 64 gluteal fat grafting procedure, the patient must provide 65 written, informed consent for such delegation.

Any duty 66 delegated by a physician during a gluteal fat grafting procedure 67 must be performed under the direct supervision of the physician 68 performing such procedure. Fat extraction and gluteal fat 69 injections must be performed by the physician and may not be 70 delegated. 71 3. Fat may only be injected into the subcutaneous space of 72 the patient and may not cross the fascia overlying the gluteal 73 muscle. Intramuscular or submuscular fat injections are 74 prohibited. 75 4.

When the physician performing a gluteal fat grafting 76 procedure injects fat into the subcutaneous space of the 77 patient, the physician must use ultrasound guidance, or guidance 78 with other technology authorized under board rule which equals 79 or exceeds the quality of ultrasound, during the placement and 80 navigation of the cannula to ensure that the fat is injected 81 into the subcutaneous space of the patient above the fascia 82 overlying the gluteal muscle. Such guidance with the use of 83 ultrasound or other technology is not required for other 84 portions of such procedure. 85 5.

An office in which a physician performs gluteal fat 86 grafting procedures must at all times maintain a ratio of one 87

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 4 of 10 CODING: Words stricken are deletions; words underlined are additions. physician to one patient during all phases of the procedure, 88 beginning with the administration of anesthesia to the patient 89 and concluding with the extubation of the patient. After a 90 physician has commenced, and while he or she is engaged in, a 91 gluteal fat grafting procedure, the physician may not commence 92 or engage in another gluteal fat grafting procedure or any other 93 procedure with another patient at the same time. 94 (

d) A physician may not: 95 1. Perform a level II or level III surgery on an immediate 96 family member unless the family member, due to cost or to 97 availability of alternate providers, cannot reasonably obtain 98 the surgical service from another physician. As used in this 99 subparagraph, the term “immediate family member” means a parent, 100 spouse, child, or sibling. 101 2. Alter or change an informed consent form for a procedure 102 after the consent has been signed, or after any sedative drugs 103 are administered to the patient. 104 (

e) All health care professionals performing duties at a 105 registered office which require licensure or certification must 106 be: 107 1. Licensed or certified, and may not perform surgeries or 108 procedures outside the scope of his or her license or 109 certification. 110 2. Certified in advanced cardiac life support and maintain 111 certification through continuing education every 2 years. 112 (

f) A registered office must have: 113 1. Appropriate staff on premises for procedures and 114 surgeries and administrative duties. 115 2. On the premises at all times a functioning automated 116

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 5 of 10 CODING: Words stricken are deletions; words underlined are additions. external defibrillator device as defined in s. 768.1325(2)(b) 117 and all necessary critical care equipment and medications. 118 3. Preoperative guidelines, intraoperative protocols, and 119 postoperative recovery guidelines in place for each surgery and 120 procedure, and any follow-up surgeries and procedures, for every 121 patient. 122 4.

Qualified anesthesia personnel present in the room 123 throughout the administration of all general and regional 124 anesthetics and provision of monitored anesthesia care. 125 5. Proper protocols in place for storing, accessing, 126 administering, and dispensing sedatives and drugs listed in 127

Schedule II,

Schedule III, or

Schedule IV of s. 893.03. 128 (g)(

d) If a procedure in an office surgery setting results 129 in hospitalization, the incident must be reported as an adverse 130 incident pursuant to s. 458.351 within 48 hours after its 131 occurrence. If an adverse incident occurs due to a local 132 anesthetic, all vials related to the local anesthetic and its 133 constitution that were administered must be saved as evidence 134 for the department and the sheriff’s office or municipal police 135 department. 136 (

h) A registered office having to undergo any type of 137 construction or refurbishment that materially interferes with 138 the safe performance of a surgical procedure in the office may 139 not perform any surgeries or procedures in the building until it 140 is safe to do so. 141 (

i) An oversight committee shall be created by the 142 department that oversees any violations of this

section and 143 reports such violations to the department. 144

(3) LIABILITY.—Any physician performing office surgeries in 145

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 6 of 10 CODING: Words stricken are deletions; words underlined are additions. an office registered under this

section must comply with the 146 financial responsibility requirements set forth in s. 458.320. 147

Section 3. Present subsection (3) of

section 459.0138, 148 Florida Statutes, is redesignated as subsection (4), a new 149 subsection (3) is added to that section, and subsection (2) is 150 amended, to read: 151 459.0138 Office surgeries.— 152

(2) STANDARDS OF PRACTICE.— 153 (

a) A physician may not perform any surgery or procedure 154 identified in paragraph (1)(

a) in a setting other than an office 155 surgery setting registered under this

section or a facility 156 licensed under

chapter 390 or

chapter 395, as applicable. The 157 board shall impose a fine of $5,000 per incident on a physician 158 who violates this paragraph. 159 (

b) Office surgeries may not: 160 1. Be a type of surgery that generally results in blood 161 loss of more than 10 percent of estimated blood volume in a 162 patient with a normal hemoglobin 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 and be 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 (

c) A physician performing a gluteal fat grafting procedure 171 in an office surgery setting shall adhere to standards of 172 practice under this subsection and rules adopted by the board 173 which include, but are not limited to, all of the following: 174

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 7 of 10 CODING: Words stricken are deletions; words underlined are additions. 1. A physician performing a gluteal fat grafting procedure 175 must conduct an in-person examination of the patient while 176 physically present in the same room as the patient no later than 177 the day before the procedure. 178 2. Before a physician may delegate any duties during a 179 gluteal fat grafting procedure, the patient must provide 180 written, informed consent for such delegation.

Any duty 181 delegated by a physician during a gluteal fat grafting procedure 182 must be performed under the direct supervision of the physician 183 performing such procedure. Fat extraction and gluteal fat 184 injections must be performed by the physician and may not be 185 delegated. 186 3. Fat may only be injected into the subcutaneous space of 187 the patient and may not cross the fascia overlying the gluteal 188 muscle. Intramuscular or submuscular fat injections are 189 prohibited. 190 4.

When the physician performing a gluteal fat grafting 191 procedure injects fat into the subcutaneous space of the 192 patient, the physician must use ultrasound guidance, or guidance 193 with other technology authorized under board rule which equals 194 or exceeds the quality of ultrasound, during the placement and 195 navigation of the cannula to ensure that the fat is injected 196 into the subcutaneous space of the patient above the fascia 197 overlying the gluteal muscle. Such guidance with the use of 198 ultrasound or other technology is not required for other 199 portions of such procedure. 200 5.

An office in which a physician performs gluteal fat 201 grafting procedures must at all times maintain a ratio of one 202 physician to one patient during all phases of the procedure, 203

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 8 of 10 CODING: Words stricken are deletions; words underlined are additions. beginning with the administration of anesthesia to the patient 204 and concluding with the extubation of the patient. After a 205 physician has commenced, and while he or she is engaged in, a 206 gluteal fat grafting procedure, the physician may not commence 207 or engage in another gluteal fat grafting procedure or any other 208 procedure with another patient at the same time. 209 (

d) A physician may not: 210 1. Perform a level II or level III surgery on an immediate 211 family member unless the family member, due to cost or to 212 availability of alternate providers, cannot reasonably obtain 213 the surgical service from another physician. As used in this 214 subparagraph, the term “immediate family member” means a parent, 215 spouse, child, or sibling. 216 2. Alter or change an informed consent form for a procedure 217 after the consent has been signed, or after any sedative drugs 218 are administered to the patient. 219 (

e) All health care professionals performing duties at a 220 registered office which require licensure or certification must 221 be: 222 1. Licensed or certified, and may not perform surgeries or 223 procedures outside the scope of his or her license or 224 certification. 225 2. Certified in advanced cardiac life support and maintain 226 certification through continuing education every 2 years. 227 (

f) A registered office must have: 228 1. Appropriate staff on premises for procedures and 229 surgeries and administrative duties. 230 2. On the premises at all times a functioning automated 231 external defibrillator device as defined in s. 768.1325(2)(b) 232

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 9 of 10 CODING: Words stricken are deletions; words underlined are additions. and all necessary critical care equipment and medications. 233 3. Preoperative guidelines, intraoperative protocols, and 234 postoperative recovery guidelines in place for each surgery and 235 procedure, and any follow-up surgeries and procedures, for every 236 patient. 237 4. Qualified anesthesia personnel present in the room 238 throughout the administration of all general and regional 239 anesthetics and provision of monitored anesthesia care. 240 5.

Proper protocols in place for storing, accessing, 241 administering, and dispensing sedatives and drugs listed in 242

Schedule II,

Schedule III, or

Schedule IV of s. 893.03. 243 (g)(

d) If a procedure in an office surgery setting results 244 in hospitalization, the incident must be reported as an adverse 245 incident pursuant to s. 458.351 within 48 hours after its 246 occurrence. If an adverse incident occurs due to a local 247 anesthetic, all vials related to the local anesthetic and its 248 constitution that were administered must be saved as evidence 249 for the department and the sheriff’s office or municipal police 250 department. 251 (

h) A registered office having to undergo any type of 252 construction or refurbishment that materially interferes with 253 the safe performance of a surgical procedure in the office may 254 not perform any surgeries or procedures in the building until it 255 is safe to do so. 256 (

i) An oversight committee shall be created by the 257 department that oversees any violations of this

section and 258 reports such violations to the department. 259

(3) LIABILITY.—Any physician performing office surgeries in 260 an office registered under this

section must comply with the 261

Florida Senate - 2025 SB 424 1-01021B-25 2025424__ Page 10 of 10 CODING: Words stricken are deletions; words underlined are additions. financial responsibility requirements set forth in s. 459.0085. 262

Section 4. This act shall take effect July 1, 2025. 263

Document details

Collection	Florida Bills
Citation	SB 424
Type	bill
Language	en
Format	pdf
Source	FL_SENATE
Identifier	0b0efb7a9789e3271e9cd514f828bdba2a7e9475

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