Florida Senate - 2024 SB 1188 By Senator Garcia 36-01129-24 20241188__ 1 A bill to be entitled 2 An act relating to office surgeries; amending ss. 3 458.328 and 459.0138, F.S.; revising the types of 4 procedures for which a medical office must register 5 with the Department of Health to perform office 6 surgeries; deleting obsolete language; making 7 technical and clarifying changes; revising standards 8 of practice for office surgeries; requiring medical 9 offices already registered with the department to 10 perform certain office surgeries as of a specified 11 date to reregister if such offices perform specified 12 procedures; specifying notification and inspection 13 procedures for the department and the Agency for 14 Health Care Administration in the event that, during 15 the reregistration process, the department determines 16 that the performance of specified procedures in an 17 office creates a risk of patient safety such that the 18 office should instead be regulated as an ambulatory 19 surgical center; requiring an office to cease 20 performing the specified procedures and relinquish its 21 office surgery registration and instead seek licensure 22 as an ambulatory surgical center under such 23 circumstances; requiring the department to develop a 24 schedule for reregistration of medical offices 25 affected by this act, to be completed by a specified 26 date; providing an effective date. 27 28 Be It Enacted by the Legislature of the State of Florida: 29 30 Section 1.Paragraphs (a), (b), and (h) of subsection (1) 31 and subsection (2) of section 458.328, Florida Statutes, are 32 amended, and subsection (4) is added to that section, to read: 33 458.328Office surgeries. 34 (1)REGISTRATION. 35 (a)1.An office in which a physician performs a liposuction 36 procedure in which more than 1,000 cubic centimeters of 37 supernatant fat is temporarily or permanently removed, a 38 liposuction procedure in which the patient is rotated 180 39 degrees or more during the procedure, a gluteal fat grafting 40 procedure, a Level II office surgery, or a Level III office 41 surgery must register with the department. unless the office is 42 licensed as A facility licensed under chapter 390 or chapter 395 43 may not be registered under this section. 44 2.The department must complete an inspection of any office 45 seeking registration under this section before the office may be 46 registered. 47 (b)By January 1, 2020, Each office registered under this 48 section or s. 459.0138 must designate a physician who is 49 responsible for the offices compliance with the office health 50 and safety requirements of this section and rules adopted 51 hereunder. A designated physician must have a full, active, and 52 unencumbered license under this chapter or chapter 459 and shall 53 practice at the office for which he or she has assumed 54 responsibility. Within 10 calendar days after the termination of 55 a designated physician relationship, the office must notify the 56 department of the designation of another physician to serve as 57 the designated physician. The department may suspend the 58 registration of an office if the office fails to comply with the 59 requirements of this paragraph. 60 (h)A physician may only perform a procedure or surgery 61 identified in paragraph (a) in an office that is registered with 62 the department. The board shall impose a fine of $5,000 per day 63 on a physician who performs a procedure or surgery in an office 64 that is not registered with the department. 65 (2)STANDARDS OF PRACTICE. 66 (a)A physician may not perform any surgery or procedure 67 identified in paragraph (1)(a) in a setting other than an office 68 registered under this section or a facility licensed under 69 chapter 390 or chapter 395, as applicable. The board shall 70 impose a fine of $5,000 per incident on a physician who violates 71 this paragraph performing a gluteal fat grafting procedure in an 72 office surgery setting shall adhere to standards of practice 73 pursuant to this subsection and rules adopted by the board. 74 (b)Office surgeries may not: 75 1.Be a type of surgery that generally results in blood 76 loss of more than 10 percent of estimated blood volume in a 77 patient with a normal hemoglobin level; 78 2.Require major or prolonged intracranial, intrathoracic, 79 abdominal, or joint replacement procedures, except for 80 laparoscopic procedures; 81 3.Involve major blood vessels and be performed with direct 82 visualization by open exposure of the major blood vessel, except 83 for percutaneous endovascular intervention; or 84 4.Be emergent or life threatening. 85 (c)A physician performing a gluteal fat grafting procedure 86 in an office surgery setting shall adhere to standards of 87 practice under this subsection and rules adopted by the board, 88 which include, but are not limited to, all of the following: 89 1.A physician performing a gluteal fat grafting procedure 90 must conduct an in-person examination of the patient while 91 physically present in the same room as the patient no later than 92 the day before the procedure. 93 2.Before a physician may delegate any duties during a 94 gluteal fat grafting procedure, the patient must provide 95 written, informed consent for such delegation. Any duty 96 delegated by a physician during a gluteal fat grafting procedure 97 must be performed under the direct supervision of the physician 98 performing such procedure. Fat extraction and gluteal fat 99 injections must be performed by the physician and may not be 100 delegated. 101 3.Fat may only be injected into the subcutaneous space of 102 the patient and may not cross the fascia overlying the gluteal 103 muscle. Intramuscular or submuscular fat injections are 104 prohibited. 105 4.When the physician performing a gluteal fat grafting 106 procedure injects fat into the subcutaneous space of the 107 patient, the physician must use ultrasound guidance, or guidance 108 with other technology authorized under board rule which equals 109 or exceeds the quality of ultrasound, during the placement and 110 navigation of the cannula to ensure that the fat is injected 111 into the subcutaneous space of the patient above the fascia 112 overlying the gluteal muscle. Such guidance with the use of 113 ultrasound or other technology is not required for other 114 portions of such procedure. 115 5.An office in which a physician performs gluteal fat 116 grafting procedures must at all times maintain a ratio of one 117 physician to one patient during all phases of the procedure, 118 beginning with the administration of anesthesia to the patient 119 and concluding with the extubation of the patient. After a 120 physician has commenced, and while he or she is engaged in, a 121 gluteal fat grafting procedure, the physician may not commence 122 or engage in another gluteal fat grafting procedure or any other 123 procedure with another patient at the same time. 124 (d)If a procedure in an office surgery setting results in 125 hospitalization, the incident must be reported as an adverse 126 incident pursuant to s. 458.351. 127 (e)An office in which a physician performs gluteal fat 128 grafting procedures must at all times maintain a ratio of one 129 physician to one patient during all phases of the procedure, 130 beginning with the administration of anesthesia to the patient 131 and concluding with the extubation of the patient. After a 132 physician has commenced, and while he or she is engaged in, a 133 gluteal fat grafting procedure, the physician may not commence 134 or engage in another gluteal fat grafting procedure or any other 135 procedure with another patient at the same time. 136 (4)REREGISTRATION.An office that registered under this 137 section before July 1, 2024, in which a physician performs 138 liposuction procedures that include a patient being rotated 180 139 degrees or more during the procedure or in which a physician 140 performs gluteal fat grafting procedures must seek 141 reregistration with the department consistent with the 142 parameters of initial registration under subsection (1) 143 according to a schedule developed by the department. During the 144 reregistration process, if the department determines that the 145 performance of such procedures in the office creates a 146 significant risk to patient safety and that the interests of 147 patient safety would be better served if such procedures were 148 instead regulated under the requirements of ambulatory surgical 149 center licensure under chapter 395: 150 (a)The department must notify the Agency for Health Care 151 Administration of its determination; 152 (b)The agency must inspect the office and determine, in 153 the interest of patient safety, whether the office is a 154 candidate for ambulatory surgical center licensure 155 notwithstanding the offices failure to meet all requirements 156 associated with such licensure at the time of inspection and 157 notwithstanding the exceptions provided under s. 395.002(3). 158 159 If the agency determines that an office is a candidate for 160 ambulatory surgical center licensure under paragraph (b), the 161 agency must notify the office and the department, and the office 162 must cease performing procedures described in this subsection. 163 The office may not recommence performing such procedures without 164 first relinquishing its registration under this section and 165 attaining ambulatory surgery center licensure under chapter 395. 166 Section 2.Paragraphs (a), (b), and (h) of subsection (1) 167 and subsection (2) of section 459.0138, Florida Statutes, are 168 amended, and subsection (4) is added to that section, to read: 169 459.0138Office surgeries. 170 (1)REGISTRATION. 171 (a)1.An office in which a physician performs a liposuction 172 procedure in which more than 1,000 cubic centimeters of 173 supernatant fat is temporarily or permanently removed, a 174 liposuction procedure in which the patient is rotated 180 175 degrees or more during the procedure, a gluteal fat grafting 176 procedure, a Level II office surgery, or a Level III office 177 surgery must register with the department. unless the office is 178 licensed as A facility licensed under chapter 390 or chapter 395 179 may not be registered under this section. 180 2.The department must complete an inspection of any office 181 seeking registration under this section before the office may be 182 registered. 183 (b)By January 1, 2020, Each office registered under this 184 section or s. 458.328 must designate a physician who is 185 responsible for the offices compliance with the office health 186 and safety requirements of this section and rules adopted 187 hereunder. A designated physician must have a full, active, and 188 unencumbered license under this chapter or chapter 458 and shall 189 practice at the office for which he or she has assumed 190 responsibility. Within 10 calendar days after the termination of 191 a designated physician relationship, the office must notify the 192 department of the designation of another physician to serve as 193 the designated physician. The department may suspend a 194 registration for an office if the office fails to comply with 195 the requirements of this paragraph. 196 (h)A physician may only perform a procedure or surgery 197 identified in paragraph (a) in an office that is registered with 198 the department. The board shall impose a fine of $5,000 per day 199 on a physician who performs a procedure or surgery in an office 200 that is not registered with the department. 201 (2)STANDARDS OF PRACTICE. 202 (a)A physician may not perform any surgery or procedure 203 identified in paragraph (1)(a) in a setting other than an office 204 registered under this section or a facility licensed under 205 chapter 390 or chapter 395, as applicable. The board shall 206 impose a fine of $5,000 per incident on a physician who violates 207 this paragraph performing a gluteal fat grafting procedure in an 208 office surgery setting shall adhere to standards of practice 209 pursuant to this subsection and rules adopted by the board. 210 (b)Office surgeries may not: 211 1.Be a type of surgery that generally results in blood 212 loss of more than 10 percent of estimated blood volume in a 213 patient with a normal hemoglobin level; 214 2.Require major or prolonged intracranial, intrathoracic, 215 abdominal, or joint replacement procedures, except for 216 laparoscopic procedures; 217 3.Involve major blood vessels and be performed with direct 218 visualization by open exposure of the major blood vessel, except 219 for percutaneous endovascular intervention; or 220 4.Be emergent or life threatening. 221 (c)A physician performing a gluteal fat grafting procedure 222 in an office surgery setting shall adhere to standards of 223 practice under this subsection and rules adopted by the board, 224 which include, but are not limited to, all of the following: 225 1.A physician performing a gluteal fat grafting procedure 226 must conduct an in-person examination of the patient while 227 physically present in the same room as the patient no later than 228 the day before the procedure. 229 2.Before a physician may delegate any duties during a 230 gluteal fat grafting procedure, the patient must provide 231 written, informed consent for such delegation. Any duty 232 delegated by a physician during a gluteal fat grafting procedure 233 must be performed under the direct supervision of the physician 234 performing such procedure. Fat extraction and gluteal fat 235 injections must be performed by the physician and may not be 236 delegated. 237 3.Fat may only be injected into the subcutaneous space of 238 the patient and may not cross the fascia overlying the gluteal 239 muscle. Intramuscular or submuscular fat injections are 240 prohibited. 241 4.When the physician performing a gluteal fat grafting 242 procedure injects fat into the subcutaneous space of the 243 patient, the physician must use ultrasound guidance, or guidance 244 with other technology authorized under board rule which equals 245 or exceeds the quality of ultrasound, during the placement and 246 navigation of the cannula to ensure that the fat is injected 247 into the subcutaneous space of the patient above the fascia 248 overlying the gluteal muscle. Such guidance with the use of 249 ultrasound or other technology is not required for other 250 portions of such procedure. 251 5.An office in which a physician performs gluteal fat 252 grafting procedures must at all times maintain a ratio of one 253 physician to one patient during all phases of the procedure, 254 beginning with the administration of anesthesia to the patient 255 and concluding with the extubation of the patient. After a 256 physician has commenced, and while he or she is engaged in, a 257 gluteal fat grafting procedure, the physician may not commence 258 or engage in another gluteal fat grafting procedure or any other 259 procedure with another patient at the same time. 260 (d)If a procedure in an office surgery setting results in 261 hospitalization, the incident must be reported as an adverse 262 incident pursuant to s. 458.351. 263 (e)An office in which a physician performs gluteal fat 264 grafting procedures must at all times maintain a ratio of one 265 physician to one patient during all phases of the procedure, 266 beginning with the administration of anesthesia to the patient 267 and concluding with the extubation of the patient. After a 268 physician has commenced, and while he or she is engaged in, a 269 gluteal fat grafting procedure, the physician may not commence 270 or engage in another gluteal fat grafting procedure or any other 271 procedure with another patient at the same time. 272 (4)REREGISTRATION.An office that registered under this 273 section before July 1, 2024, in which a physician performs 274 liposuction procedures that include a patient being rotated 180 275 degrees or more during the procedure or in which a physician 276 performs gluteal fat grafting procedures must seek 277 reregistration with the department consistent with the 278 parameters of initial registration under subsection (1) 279 according to a schedule developed by the department. During the 280 reregistration process, if the department determines that the 281 performance of such procedures in the office creates a 282 significant risk to patient safety and that the interests of 283 patient safety would be better served if such procedures were 284 instead regulated under the requirements of ambulatory surgical 285 center licensure under chapter 395: 286 (a)The department must notify the Agency for Health Care 287 Administration of its determination; 288 (b)The agency must inspect the office and determine, in 289 the interest of patient safety, whether the office is a 290 candidate for ambulatory surgical center licensure 291 notwithstanding the offices failure to meet all requirements 292 associated with such licensure at the time of inspection and 293 notwithstanding the exceptions provided under s. 395.002(3). 294 295 If the agency determines that an office is a candidate for 296 ambulatory surgical center licensure under paragraph (b), the 297 agency must notify the office and the department, and the office 298 must cease performing procedures described in this subsection. 299 The office may not recommence performing such procedures without 300 first relinquishing its registration under this section and 301 attaining ambulatory surgery center licensure under chapter 395. 302 Section 3.The Department of Health shall develop a 303 schedule for reregistration of offices affected by the 304 amendments made to s. 458.328(1) or s. 459.0138(1), Florida 305 Statutes, by this act. Registration of all such offices must be 306 completed by December 1, 2024. 307 Section 4.This act shall take effect upon becoming a law.