Florida Senate - 2024 CS for CS for SB 1188 By the Committees on Fiscal Policy; and Health Policy; and Senator Garcia 594-03650-24 20241188c2 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; specifying inspection procedures for such 7 offices seeking registration with the department; 8 requiring that certain offices seeking registration 9 provide proof to the department that they have met 10 specified requirements and rules; requiring the 11 department to inspect such offices to ensure that 12 certain equipment and procedures are present or in 13 place; requiring the department to notify the Agency 14 for Health Care Administration if an applicant is 15 unable to provide certain proof to the department and 16 to request that the agency inspect and consult with 17 the office; deleting obsolete language; providing that 18 the department may not register and must seek an 19 emergency suspension of an office under specified 20 circumstances; requiring that each office, as a 21 condition of registration, list certain medical 22 personnel and thereafter notify the department of the 23 addition or termination of such personnel within a 24 specified timeframe; providing for disciplinary action 25 for failure to comply; revising the materials that the 26 department must review when inspecting a registered 27 office; requiring offices already registered with the 28 department as of a specified date to provide a 29 registration update within a specified timeframe; 30 specifying requirements for such registration update 31 process; revising requirements for the standards of 32 practice for office surgeries; providing an 33 administrative penalty; revising rulemaking 34 requirements; creating ss. 458.3281 and 459.0139, 35 F.S.; providing construction; defining terms; 36 specifying general requirements for office surgeries; 37 specifying standards of practice for office surgeries, 38 delineated by the level of surgery being performed; 39 providing an exemption; authorizing the Board of 40 Medicine and the Board of Osteopathic Medicine, as 41 applicable, to adopt additional standards of practice 42 by rule; amending s. 456.074, F.S.; correcting a 43 cross-reference; providing an effective date. 44 45 Be It Enacted by the Legislature of the State of Florida: 46 47 Section 1.Section 458.328, Florida Statutes, is amended to 48 read: 49 458.328Office surgeries. 50 (1)REGISTRATION. 51 (a)1.An office in which a physician performs or intends to 52 perform a liposuction procedure in which more than 1,000 cubic 53 centimeters of supernatant fat is temporarily or permanently 54 removed, a liposuction procedure during which the patient is 55 rotated between the supine, lateral, and prone positions, a 56 Level II office surgery, or a Level III office surgery must 57 register with the department. unless the office is licensed as A 58 facility licensed under chapter 390 or chapter 395 may not be 59 registered under this section. 60 (b)2.The department must complete an inspection of any 61 office seeking registration under this section before the office 62 may be registered. 63 1.The inspection of the office seeking registration under 64 this section must include inspection for compliance with the 65 standards of practice set out in this section and s. 458.3281 66 and any applicable board rules for the levels of office surgery 67 and procedures listed on the application which any physician 68 practicing at the office performs or intends to perform. The 69 application must be updated within 10 calendar days before any 70 additional surgical procedures or levels of office surgery are 71 to be performed at the office. Failure to timely update the 72 application for any such additional surgical procedures or 73 levels of office surgery is a violation of this section and 74 subject to discipline under ss. 456.072 and 458.331. 75 2.The department must immediately suspend the registration 76 process of an office that refuses an inspection under 77 subparagraph 1., and the applicant must be required to reapply 78 for registration. 79 3.If the department determines that an office seeking 80 registration under this section is one in which a physician may 81 perform, or intends to perform, liposuction procedures that 82 include a patient being rotated between the supine, lateral, and 83 prone positions during the procedure, or in which a physician 84 may perform, or intends to perform, gluteal fat grafting 85 procedures, the office must provide proof to the department that 86 it has met the applicable requirements of s. 469 of the Florida 87 Building Code, relating to office surgery suites, and s. 88 458.3281 and the applicable rules adopted thereunder, and the 89 department must inspect the office to ensure that all of the 90 following are present or in place: 91 a.Equipment and a procedure for measuring and documenting 92 in a log the amount of supernatant fat removed, both temporarily 93 and permanently, from a particular patient, including tissue 94 disposal procedures. 95 b.A procedure for measuring and documenting the amount of 96 lidocaine injected for tumescent liposuction, if used. 97 c.Working ultrasound guidance equipment or other guidance 98 technology authorized under board rule which equals or exceeds 99 the quality of ultrasound guidance. 100 d.The office procedure for obtaining blood products. 101 e.Documentation on file at the office demonstrating that 102 any physician performing these procedures has privileges to 103 perform such procedures in a hospital no more than 30 minutes 104 away. 105 f.Procedures for emergency resuscitation and transport to 106 a hospital. 107 g.Procedures for anesthesia and surgical recordkeeping. 108 h.Any additional inspection requirements, as set by board 109 rule. 110 4.If an applicant is required under subparagraph 3. to 111 provide proof to the department that the office is in compliance 112 with the applicable requirements of s. 469 of the Florida 113 Building Code, relating to office surgery suites, or s. 458.3281 114 and the applicable rules adopted thereunder, but is unable to 115 provide such proof, the department must notify the Agency for 116 Health Care Administration and request the agency to inspect the 117 office and consult with the office about the process to apply 118 for ambulatory surgical center licensure under chapter 395 and 119 how the office may seek qualification for such licensure, 120 notwithstanding the offices failure to meet all requirements 121 associated with such licensure at the time of inspection and 122 notwithstanding any pertinent exceptions provided under s. 123 395.002(3). 124 (c)(b)To be By January 1, 2020, each office registered 125 under this section or s. 459.0138, an office must, at the time 126 of application, list a designated designate a physician who is 127 responsible for the offices compliance with the office health 128 and safety requirements of this section and rules adopted 129 hereunder. A designated physician must have a full, active, and 130 unencumbered license under this chapter or chapter 459 and shall 131 practice at the office for which he or she has assumed 132 responsibility. Within 10 calendar days after the termination of 133 a designated physician relationship, the office must notify the 134 department of the designation of another physician to serve as 135 the designated physician. The department may not register an 136 office if the office fails to comply with this requirement at 137 the time of application and must seek an emergency suspension of 138 suspend the registration of an office pursuant to s. 456.074(6) 139 if the office fails to timely notify the department of its new 140 designated physician within 10 calendar days after the 141 termination of the previous designated physician relationship 142 comply with the requirements of this paragraph. 143 (d)As a condition of registration, each office must, at 144 the time of application, list all medical personnel who will be 145 practicing at the office, including all of the following: 146 1.Physicians who intend to practice surgery or assist in 147 surgery at the office seeking registration, including their 148 respective license numbers and practice addresses. 149 2.Anesthesia providers, including their license numbers. 150 3.Nursing personnel licensed under chapter 464, including 151 their license numbers unless already provided under subparagraph 152 2. 153 4.Physician assistants, including their respective license 154 numbers and supervising physicians. 155 156 The office must notify the department of the addition or 157 termination of any of the types of medical personnel specified 158 under this paragraph within 10 calendar days before such 159 addition or after such termination. Failure to timely notify the 160 department of such addition or termination is a violation of 161 this section and subject to discipline under ss. 456.072 and 162 458.331. 163 (e)(c)As a condition of registration, each office must 164 establish financial responsibility by demonstrating that it has 165 met and continues to maintain, at a minimum, the same 166 requirements applicable to physicians in ss. 458.320 and 167 459.0085. Each physician practicing at an office registered 168 under this section or s. 459.0138 must meet the financial 169 responsibility requirements under s. 458.320 or s. 459.0085, as 170 applicable. 171 (f)(d)Each physician practicing or intending to practice 172 at an office registered under this section or s. 459.0138 must 173 shall advise the board, in writing, within 10 calendar days 174 before after beginning or after ending his or her practice at a 175 registered office, as applicable. 176 (g)(e)1.The department shall inspect a registered office 177 at least annually, including a review of patient records, 178 anesthesia logs, surgery logs, and liposuction logs, to ensure 179 that the office is in compliance with this section and rules 180 adopted hereunder unless the office is accredited in office 181 based surgery by the Joint Commission or other a nationally 182 recognized accrediting agency approved by the board. The 183 inspection may be unannounced, except for the inspection of an 184 office that meets the description of a clinic specified in s. 185 458.3265(1)(a)3.h., and those wholly owned and operated 186 physician offices described in s. 458.3265(1)(a)3.g. which 187 perform procedures referenced in s. 458.3265(1)(a)3.h., which 188 must be announced. 189 (h)2.The department must immediately suspend the 190 registration of a registered office that refuses an inspection 191 under paragraph (g) subparagraph 1. The office must close during 192 such suspension. The suspension must remain in effect for at 193 least 14 consecutive days and may not terminate until the 194 department issues a written declaration that the office may 195 reopen following the departments completion of an inspection of 196 the office. 197 (i)(f)The department may suspend or revoke the 198 registration of an office in which a procedure or surgery 199 identified in paragraph (a) is performed for failure of any of 200 its physicians, owners, or operators to comply with this section 201 and rules adopted hereunder or s. 459.0138 and rules adopted 202 thereunder. If an offices registration is revoked for any 203 reason, the department may deny any person named in the 204 registration documents of the office, including the persons who 205 own or operate the office, individually or as part of a group, 206 from registering an office to perform procedures or office 207 surgeries pursuant to this section or s. 459.0138 for 5 years 208 after the revocation date. 209 (j)(g)The department may impose any penalty set forth in 210 s. 456.072(2) against the designated physician for failure of 211 the office to operate in compliance with the office health and 212 safety requirements of this section and rules adopted hereunder 213 or s. 459.0138 and rules adopted thereunder. 214 (h)A physician may only perform a procedure or surgery 215 identified in paragraph (a) in an office that is registered with 216 the department. The board shall impose a fine of $5,000 per day 217 on a physician who performs a procedure or surgery in an office 218 that is not registered with the department. 219 (k)(i)The actual costs of registration and inspection or 220 accreditation must shall be paid by the person seeking to 221 register and operate the office in which a procedure or surgery 222 identified in paragraph (a) will be performed. 223 (2)REGISTRATION UPDATE. 224 (a)An office that registered under this section before 225 July 1, 2024, in which a physician performs liposuction 226 procedures that include a patient being rotated between the 227 supine, lateral, and prone positions during the procedure or in 228 which a physician performs gluteal fat grafting procedures must 229 provide a registration update to the department consistent with 230 the requirements of the initial registration under subsection 231 (1) no later than 30 days before the office surgerys next 232 annual inspection. 233 (b)Registration update inspections required under 234 subsection (1) must be performed by the department on the date 235 of the office surgerys next annual inspection. 236 (c)During the registration update process, the office 237 surgery may continue to operate under the original registration. 238 (d)In order to provide an office surgery time to update to 239 the requirements of subsection (1) and s. 458.3281, effective 240 July 1, 2024, and the applicable provisions of s. 469 of the 241 Florida Building Code, relating to office surgery suites, any 242 office surgery registered under this section before July 1, 243 2024, whose annual inspection is due in July or August 2024, may 244 request from the department, in writing, a 60-day postponement 245 of the required annual inspection, which postponement must be 246 granted. 247 (e)All other requests to the department for a postponement 248 of the registration update inspection required under this 249 registration update process must be in writing and be approved 250 by the chair of the Board of Medicine for good cause shown, and 251 such postponement may not exceed 30 days. 252 (3)STANDARDS OF PRACTICE. 253 (a)A physician performing a procedure or surgery in an 254 office registered under this section must comply with the 255 applicable provisions of s. 469 of the Florida Building Code, 256 relating to office surgery suites, and the standards of practice 257 for office surgery set forth in this section and s. 458.3281 and 258 any applicable rules adopted thereunder. 259 (b)A physician may not perform any surgery or procedure 260 identified in paragraph (1)(a) in a setting other than an office 261 registered under this section or a facility licensed under 262 chapter 390 or chapter 395, as applicable. The board shall 263 impose a fine of $5,000 per incident on a physician who violates 264 this paragraph performing a gluteal fat grafting procedure in an 265 office surgery setting shall adhere to standards of practice 266 pursuant to this subsection and rules adopted by the board. 267 (c)(b)Office surgeries may not: 268 1.Be a type of surgery that generally results in blood 269 loss of more than 10 percent of estimated blood volume in a 270 patient with a normal hemoglobin level; 271 2.Require major or prolonged intracranial, intrathoracic, 272 abdominal, or joint replacement procedures, except for 273 laparoscopic procedures; 274 3.Involve major blood vessels and be performed with direct 275 visualization by open exposure of the major blood vessel, except 276 for percutaneous endovascular intervention; or 277 4.Be emergent or life threatening. 278 (d)(c)A physician performing a gluteal fat grafting 279 procedure in an office surgery setting must comply with the 280 applicable provisions of s. 469 of the Florida Building Code, 281 relating to office surgery suites, and the standards of practice 282 under this subsection and s. 458.3281, and applicable rules 283 adopted thereunder, including, but not limited to, all of the 284 following standards of practice: 285 1.The A physician performing the a gluteal fat grafting 286 procedure must conduct an in-person examination of the patient 287 while physically present in the same room as the patient no 288 later than the day before the procedure. 289 2.Before a physician may delegate any duties during a 290 gluteal fat grafting procedure, the patient must provide 291 written, informed consent for such delegation. Any duty 292 delegated by a physician during a gluteal fat grafting procedure 293 must be performed under the direct supervision of the physician 294 performing such procedure. Fat extraction and gluteal fat 295 injections must be performed by the physician and may not be 296 delegated. 297 3.Fat may only be injected into the subcutaneous space of 298 the patient and may not cross the fascia overlying the gluteal 299 muscle. Intramuscular or submuscular fat injections are 300 prohibited. 301 4.When the physician performing a gluteal fat grafting 302 procedure injects fat into the subcutaneous space of the 303 patient, the physician must use ultrasound guidance, or guidance 304 with other technology authorized under board rule which equals 305 or exceeds the quality of ultrasound, during the placement and 306 navigation of the cannula to ensure that the fat is injected 307 into the subcutaneous space of the patient above the fascia 308 overlying the gluteal muscle. Such guidance with the use of 309 ultrasound or other technology is not required for other 310 portions of such procedure. 311 5.An office in which a physician performs gluteal fat 312 grafting procedures shall at all times maintain a ratio of one 313 physician to one patient during all phases of the procedure, 314 beginning with the administration of anesthesia to the patient 315 and concluding with the extubation of the patient. After a 316 physician has commenced, and while he or she is engaged in, a 317 gluteal fat grafting procedure, the physician may not commence 318 or engage in another gluteal fat grafting procedure or any other 319 procedure with another patient at the same time. 320 (e)(d)If a procedure in an office surgery setting results 321 in hospitalization, the incident must be reported as an adverse 322 incident pursuant to s. 458.351. 323 (e)An office in which a physician performs gluteal fat 324 grafting procedures must at all times maintain a ratio of one 325 physician to one patient during all phases of the procedure, 326 beginning with the administration of anesthesia to the patient 327 and concluding with the extubation of the patient. After a 328 physician has commenced, and while he or she is engaged in, a 329 gluteal fat grafting procedure, the physician may not commence 330 or engage in another gluteal fat grafting procedure or any other 331 procedure with another patient at the same time. 332 (4)(3)RULEMAKING. 333 (a)The board may shall adopt by rule additional standards 334 of practice for physicians who perform office procedures or 335 office surgeries under pursuant to this section, as warranted 336 for patient safety and by the evolution of technology and 337 medical practice. 338 (b)The board may adopt rules to administer the 339 registration, registration update, inspection, and safety of 340 offices in which a physician performs office procedures or 341 office surgeries under pursuant to this section. 342 Section 2.Section 458.3281, Florida Statutes, is created 343 to read: 344 458.3281Standard of practice for office surgery. 345 (1)CONSTRUCTION.This section does not relieve a physician 346 performing a procedure or surgery from the responsibility of 347 making the medical determination of whether an office is an 348 appropriate setting in which to perform that particular 349 procedure or surgery, taking into consideration the particular 350 patient on which the procedure or surgery is to be performed. 351 (2)DEFINITIONS.As used in this section, the term: 352 (a)Certified in advanced cardiac life support means a 353 person holds a current certification in an advanced cardiac life 354 support course with didactic and skills components, approved by 355 the American Heart Association, the American Safety and Health 356 Institute, the American Red Cross, Pacific Medical Training, or 357 the Advanced Cardiovascular Life Support (ACLS) Certification 358 Institute. 359 (b)Certified in basic life support means a person holds 360 a current certification in a basic life support course with 361 didactic and skills components, approved by the American Heart 362 Association, the American Safety and Health Institute, the 363 American Red Cross, Pacific Medical Training, or the ACLS 364 Certification Institute. 365 (c)Certified in pediatric advanced life support means a 366 person holds a current certification in a pediatric advanced 367 life support course with didactic and skills components approved 368 by the American Heart Association, the American Safety and 369 Health Institute, or Pacific Medical Training. 370 (d)Continual monitoring means monitoring that is 371 repeated regularly and frequently in steady, rapid succession. 372 (e)Continuous means monitoring that is prolonged without 373 any interruption at any time. 374 (f)Equipment means a medical device, instrument, or tool 375 used to perform specific actions or take certain measurements 376 during, or while a patient is recovering from, a procedure or 377 surgery which must meet current performance standards according 378 to its manufacturers guidelines for the specific device, 379 instrument, or tool, as applicable. 380 (g)Major blood vessels means a group of critical 381 arteries and veins, including the aorta, coronary arteries, 382 pulmonary arteries, superior and inferior vena cava, pulmonary 383 veins, and any intra-cerebral artery or vein. 384 (h)Office surgery means a physicians office in which 385 surgical procedures are performed by a physician for the 386 practice of medicine as authorized by this section and board 387 rule. The office must be an office at which a physician 388 regularly performs consultations with surgical patients, 389 preoperative examinations, and postoperative care, as 390 necessitated by the standard of care related to the surgeries 391 performed at the physicians office, and at which patient 392 records are readily maintained and available. The types of 393 procedures or surgeries performed in an office surgery are those 394 which need not be performed in a facility licensed under chapter 395 390 or chapter 395, and are not of the type that: 396 1.Generally result in blood loss of more than 10 percent 397 of estimated blood volume in a patient with a normal hemoglobin 398 count; 399 2.Require major or prolonged intracranial, intrathoracic, 400 abdominal, or major joint replacement procedures, except for 401 laparoscopic procedures; 402 3.Involve major blood vessels and are performed with 403 direct visualization by open exposure of the major vessel, 404 except for percutaneous endovascular intervention; or 405 4.Are generally emergent or life threatening in nature. 406 (i)Pediatric patient means a patient who is 13 years of 407 age or younger. 408 (j)Percutaneous endovascular intervention means a 409 procedure performed without open direct visualization of the 410 target vessel and which requires only needle puncture of an 411 artery or vein followed by insertion of catheters, wires, or 412 similar devices that are then advanced through the blood vessels 413 using imaging guidance. Once the catheter reaches the intended 414 location, various maneuvers to address the diseased area may be 415 performed, including, but not limited to, injection of contrast 416 medium for imaging; treatment of vessels with angioplasty; 417 atherectomy; covered or uncovered stenting; embolization or 418 intentionally occluding vessels or organs; and delivering 419 medications or radiation or other energy, such as laser, 420 radiofrequency, or cryo. 421 (k)Reasonable proximity means a distance that does not 422 exceed 30 minutes of transport time to the hospital. 423 (l)Surgery means any manual or operative procedure 424 performed upon the body of a living human being, including, but 425 not limited to, those performed with the use of lasers, for the 426 purposes of preserving health, diagnosing or curing disease, 427 repairing injury, correcting a deformity or defect, prolonging 428 life, or relieving suffering, or any elective procedure for 429 aesthetic, reconstructive, or cosmetic purposes. The term 430 includes, but is not limited to, incision or curettage of tissue 431 or an organ; suture or other repair of tissue or an organ, 432 including a closed as well as an open reduction of a fracture; 433 extraction of tissue, including premature extraction of the 434 products of conception from the uterus; insertion of natural or 435 artificial implants; or an endoscopic procedure with use of 436 local or general anesthetic. 437 (3)GENERAL REQUIREMENTS FOR OFFICE SURGERY. 438 (a)The physician performing the surgery must examine the 439 patient immediately before the surgery to evaluate the risk of 440 anesthesia and of the surgical procedure to be performed. The 441 physician performing the surgery may delegate the preoperative 442 heart and lung evaluation to a qualified anesthesia provider 443 within the scope of the providers practice and, if applicable, 444 protocol. 445 (b)The physician performing the surgery shall maintain 446 complete patient records of each surgical procedure performed, 447 which must include all of the following: 448 1.The patients name, patient number, preoperative 449 diagnosis, postoperative diagnosis, surgical procedure, 450 anesthetic, anesthesia records, recovery records, and 451 complications, if any. 452 2.The name of each member of the surgical team, including 453 the surgeon, first assistant, anesthesiologist, nurse 454 anesthetist, anesthesiologist assistant, circulating nurse, and 455 operating room technician, as applicable. 456 (c)Each office surgerys designated physician shall ensure 457 that the office surgery has procedures in place to verify that 458 all of the following have occurred before any surgery is 459 performed: 460 1.The patient has signed the informed consent form for the 461 procedure reflecting the patients knowledge of identified risks 462 of the procedure, consent to the procedure, the type of 463 anesthesia and anesthesia provider to be used during the 464 procedure, and the fact that the patient may choose the type of 465 anesthesia provider for the procedure, such as an 466 anesthesiologist, a certified registered nurse anesthetist, a 467 physician assistant, an anesthesiologist assistant, or another 468 appropriately trained physician as provided by board rule. 469 2.The patients identity has been verified. 470 3.The operative site has been verified. 471 4.The operative procedure to be performed has been 472 verified with the patient. 473 5.All of the information and actions required to be 474 verified under this paragraph are documented in the patients 475 medical record. 476 (d)With respect to the requirements set forth in paragraph 477 (c), written informed consent is not necessary for minor Level I 478 procedures limited to the skin and mucosa. 479 (e)The physician performing the surgery shall maintain a 480 log of all liposuction procedures performed at the office 481 surgery where more than 1,000 cubic centimeters of supernatant 482 fat is temporarily or permanently removed and where Level II and 483 Level III surgical procedures are performed. The log must, at a 484 minimum, include all of the following: 485 1.A confidential patient identifier. 486 2.Time of arrival in the operating suite. 487 3.The name of the physician performing the procedure. 488 4.The patients diagnosis, CPT codes used for the 489 procedure, the patients classification for risk with anesthesia 490 according to the American Society of Anesthesiologists physical 491 status classification system, and the type of procedure and 492 level of surgery performed. 493 5.Documentation of completion of the medical clearance 494 performed by the anesthesiologist or the physician performing 495 the surgery. 496 6.The name and provider type of the anesthesia provider 497 and the type of anesthesia used. 498 7.The duration of the procedure. 499 8.Any adverse incidents as identified in s. 458.351. 500 9.The type of postoperative care, duration of recovery, 501 disposition of the patient upon discharge, including the address 502 of where the patient is being discharged, discharge 503 instructions, and list of medications used during surgery and 504 recovery. 505 506 All surgical and anesthesia logs must be kept at the office 507 surgery and maintained for 6 years after the date of last 508 patient contact and must be provided to department investigators 509 upon request. 510 (f)For any liposuction procedure, the physician performing 511 the surgery is responsible for determining the appropriate 512 amount of supernatant fat to be removed from a particular 513 patient. A maximum of 4,000 cubic centimeters of supernatant fat 514 may be removed by liposuction in the office surgery setting. A 515 maximum of 50mg/kg of lidocaine may be injected for tumescent 516 liposuction in the office surgery setting. 517 (g)1.Liposuction may be performed in combination with 518 another separate surgical procedure during a single Level II or 519 Level III surgical procedure only in the following 520 circumstances: 521 a.When combined with an abdominoplasty, liposuction may 522 not exceed 1,000 cubic centimeters of supernatant fat. 523 b.When liposuction is associated and directly related to 524 another procedure, the liposuction may not exceed 1,000 cubic 525 centimeters of supernatant fat. 526 2.Major liposuction in excess of 1,000 cubic centimeters 527 of supernatant fat may not be performed on a patients body in a 528 location that is remote from the site of another procedure being 529 performed on that patient. 530 (h)For elective cosmetic and plastic surgery procedures 531 performed in a physicians office, the maximum planned duration 532 of all surgical procedures combined may not exceed 8 hours. 533 Except for elective cosmetic and plastic surgery, the physician 534 performing the surgery may not keep patients past midnight in a 535 physicians office. For elective cosmetic and plastic surgical 536 procedures, the patient must be discharged within 24 hours after 537 presenting to the office for surgery. However, an overnight stay 538 is allowed in the office if the total time the patient is at the 539 office does not exceed 23 hours and 59 minutes, including the 540 surgery time. An overnight stay in a physicians office for 541 elective cosmetic and plastic surgery must be strictly limited 542 to the physicians office. If the patient has not recovered 543 sufficiently to be safely discharged within the timeframes set 544 forth, the patient must be transferred to a hospital for 545 continued postoperative care. 546 (i)The American Society of Anesthesiologists Standards for 547 Basic Anesthetic Monitoring are hereby adopted and incorporated 548 by reference as the standards for anesthetic monitoring by any 549 qualified anesthesia provider under this section. 550 1.These standards apply to general anesthetics, regional 551 anesthetics, and monitored Level II and III anesthesia care. 552 However, in emergency circumstances, appropriate life support 553 measures take priority. These standards may be exceeded at any 554 time based on the judgment of the responsible supervising 555 physician or anesthesiologist. While these standards are 556 intended to encourage quality patient care, observing them does 557 not guarantee any specific patient outcome. This set of 558 standards addresses only the issue of basic anesthesia 559 monitoring, which is only one component of anesthesia care. 560 2.In certain rare or unusual circumstances, some of these 561 methods of monitoring may be clinically impractical, and 562 appropriate use of the described monitoring methods may fail to 563 detect adverse clinical developments. In such cases, a brief 564 interruption of continual monitoring may be unavoidable and does 565 not by itself constitute a violation of the standards of 566 practice of this section. 567 3.Under extenuating circumstances, the physician 568 performing the surgery or the anesthesiologist may waive the 569 following requirements: 570 a.The use of an oxygen analyzer with a low oxygen 571 concentration limit alarm, or other technology authorized under 572 board rule which equals or exceeds the quality of the oxygen 573 analyzer, during the administration of general anesthesia with 574 an anesthesia machine. 575 b.The use of pulse oximetry with a variable pitch pulse 576 tone and an audible low threshold alarm, or other technology 577 authorized under board rule which equals or exceeds the quality 578 of a pulse oximeter, and the use of adequate illumination and 579 exposure of the patient to assess color. 580 c.The use of capnography, capnometry, or mass 581 spectroscopy, or other technology authorized under board rule 582 which equals or exceeds the quality of capnography, capnometry, 583 or mass spectroscopy, as a quantitative method of analyzing the 584 end-tidal carbon dioxide for continual monitoring for the 585 presence of expired carbon dioxide during ventilation, from the 586 time of the endotracheal tube or supraglottic airway placement 587 until extubation or removal or initiating transfer of the 588 patient to a postoperative care location. 589 d.The use of continuous electrocardiogram display, or 590 other technology authorized under board rule which equals or 591 exceeds the quality of electrocardiogram display, from the 592 beginning of anesthesia until preparing to leave the 593 anesthetizing location. 594 e.The measuring of arterial blood pressure and heart rate 595 evaluated at least every 5 minutes during anesthesia. 596 597 When any of the monitoring is waived for extenuating 598 circumstances under this subparagraph, it must be documented in 599 a note in the patients medical record, including the reasons 600 for the need to waive the requirement. These standards are not 601 intended for the application to the care of an obstetrical 602 patient in labor or in the conduct of pain management. 603 (j)1.Because of the rapid changes in patient status during 604 anesthesia, qualified anesthesia personnel must be continuously 605 present in the room to provide anesthesia care for the entire 606 duration of all general anesthetics, regional anesthetics, and 607 monitored anesthesia care conducted on the patient. In the event 608 that there is a direct known hazard, such as radiation, to the 609 anesthesia personnel which might require intermittent remote 610 observation of the patient, some provision for monitoring the 611 patient must be made. In the event that an emergency requires 612 the temporary absence of the person primarily responsible for 613 the anesthesia, the best judgment of the supervising physician 614 or anesthesiologist shall be exercised in comparing the 615 emergency with the anesthetized patients condition and in the 616 selection of the person left responsible for the anesthesia 617 during the temporary absence. 618 2.During all anesthesia, the patients oxygenation, 619 ventilation, circulation, and temperature must be continually 620 evaluated to ensure adequate oxygen concentration in the 621 inspired gas and the blood. 622 a.During all general anesthesia using an anesthesia 623 machine, the concentration of oxygen in the patients breathing 624 system must be measured by an oxygen analyzer with a low oxygen 625 concentration limit alarm used to measure blood oxygenation. 626 b.During all anesthesia, a quantitative method of 627 assessing oxygenation, such as pulse oximetry, must be employed. 628 When a pulse oximeter is used, the variable pitch pulse tone and 629 the low threshold alarm must be audible to the qualified 630 anesthesia provider. Adequate illumination and exposure of the 631 patient are necessary to assess color. 632 c.During all anesthesia, every patient must have the 633 adequacy of his or her ventilation continually evaluated, 634 including, but not limited to, the evaluation of qualitative 635 clinical signs, such as chest excursion, observation of the 636 reservoir breathing bag, and auscultation of breath sounds. 637 Continual monitoring for the presence of expired carbon dioxide 638 must be performed unless invalidated by the nature of the 639 patients condition, the procedure, or the equipment. 640 Quantitative monitoring of the volume of expired gas must also 641 be performed. 642 d.When an endotracheal tube or supraglottic airway is 643 inserted, its correct positioning must be verified by clinical 644 assessment and by identification of carbon dioxide in the 645 expired gas. Continual end-tidal carbon dioxide analysis, in use 646 from the time of endotracheal tube or supraglottic airway 647 placement until extubation or removal or initiating transfer of 648 the patient to a postoperative care location, must be performed 649 using a quantitative method, such as capnography, capnometry, or 650 mass spectroscopy, or other technology authorized under board 651 rule which equals or exceeds the quality of capnography, 652 capnometry, or mass spectroscopy. When capnography or capnometry 653 is used, the end-tidal carbon dioxide alarm must be audible to 654 the qualified anesthesia provider. 655 e.When ventilation is controlled by a mechanical 656 ventilator, there must be in continuous use a device capable of 657 detecting disconnection of components of the breathing system. 658 The device must give an audible signal when its alarm threshold 659 is exceeded. 660 f.During regional anesthesia without sedation or local 661 anesthesia with no sedation, the adequacy of ventilation must be 662 evaluated by continual observation of qualitative clinical 663 signs. During moderate or deep sedation, the adequacy of 664 ventilation must be evaluated by continual observation of 665 qualitative clinical signs. Monitoring for the presence of 666 exhaled carbon dioxide is recommended. 667 g.Every patient receiving anesthesia must have the 668 electrocardiogram or other technology authorized under board 669 rule which equals or exceeds the quality of electrocardiogram 670 continuously displayed from the beginning of anesthesia until 671 preparing to leave the anesthetizing location. 672 h.Every patient receiving anesthesia must have arterial 673 blood pressure and heart rate determined and evaluated at least 674 every 5 minutes. 675 i.Every patient receiving general anesthesia must have 676 circulatory function continually evaluated by at least one of 677 the following methods: 678 (I)Palpation of a pulse. 679 (II)Auscultation of heart sounds. 680 (III)Monitoring of a tracing of intra-arterial pressure. 681 (IV)Ultrasound peripheral pulse monitoring. 682 (V)Pulse plethysmography or oximetry. 683 (VI)Other technology authorized under board rule which 684 equals or exceeds the quality of any of the methods listed in 685 sub-sub-subparagraphs (I)-(V). 686 j.Every patient receiving anesthesia must have his or her 687 temperature monitored when clinically significant changes in 688 body temperature are intended, anticipated, or suspected. 689 (k)1.The physician performing the surgery shall ensure 690 that the postoperative care arrangements made for the patient 691 are adequate for the procedure being performed, as required by 692 board rule. 693 2.Management of postoperative care is the responsibility 694 of the physician performing the surgery and may be delegated as 695 determined by board rule. If the physician performing the 696 surgery is unavailable to provide postoperative care, the 697 physician performing the surgery must notify the patient of his 698 or her unavailability for postoperative care before the 699 procedure. 700 3.If there is an overnight stay at the office in relation 701 to any surgical procedure: 702 a.The office must provide at least two persons to act as 703 monitors, one of whom must be certified in advanced cardiac life 704 support, and maintain a monitor-to-patient ratio of at least one 705 monitor to two patients. 706 b.Once the physician performing the surgery has signed a 707 timed and dated discharge order, the office may provide only one 708 monitor to monitor the patient. The monitor must be qualified by 709 licensure and training to administer all of the medications 710 required on the crash cart and must be certified in advanced 711 cardiac life support. 712 c.A complete and current crash cart must be present in the 713 office surgery and immediately accessible for the monitors. 714 4.The physician performing the surgery must be reachable 715 by telephone and readily available to return to the office if 716 needed. 717 5.A policy and procedures manual must be maintained in the 718 office at which Level II and Level III procedures are performed. 719 The manual must be updated and implemented annually. The policy 720 and procedures manual must provide for all of the following: 721 a.Duties and responsibilities of all personnel. 722 b.A quality assessment and improvement system designed to 723 objectively and systematically monitor and evaluate the quality 724 and appropriateness of patient care and opportunities to improve 725 performance. 726 c.Cleaning procedures and protocols. 727 d.Sterilization procedures. 728 e.Infection control procedures and personnel 729 responsibilities. 730 f.Emergency procedures. 731 6.The designated physician shall establish a risk 732 management program that includes all of the following 733 components: 734 a.The identification, investigation, and analysis of the 735 frequency and causes of adverse incidents. 736 b.The identification of trends or patterns of adverse 737 incidents. 738 c.The development of appropriate measures to correct, 739 reduce, minimize, or eliminate the risk of adverse incidents. 740 d.The documentation of such functions and periodic review 741 of such information at least quarterly by the designated 742 physician. 743 7.The designated physician shall report to the department 744 any adverse incidents that occur within the scope of office 745 surgeries. This report must be made within 15 days after the 746 occurrence of an incident as required by s. 458.351. 747 8.The designated physician is responsible for prominently 748 posting a sign in the office which states that the office is a 749 doctors office regulated under this section and ss. 458.328, 750 458.3281, and 459.0138 and the applicable rules of the Board of 751 Medicine and the Board of Osteopathic Medicine as set forth in 752 rules 64B8 and 64B15, Florida Administrative Code. This notice 753 must also appear prominently within the required patient 754 informed consent form. 755 9.All physicians performing surgery at the office surgery 756 must be qualified by education, training, and experience to 757 perform any procedure the physician performs in the office 758 surgery. 759 10.When Level II, Level II-A, or Level III procedures are 760 performed in an office surgery setting, the physician performing 761 the surgery is responsible for providing the patient, in 762 writing, before the procedure, with the name and location of the 763 hospital where the physician performing the surgery has 764 privileges to perform the same procedure as the one being 765 performed in the office surgery setting or the name and location 766 of the hospital with which the physician performing the surgery 767 has a transfer agreement in the event of an emergency. 768 (4)LEVEL I OFFICE SURGERY. 769 (a)Scope.Level I office surgery includes the following: 770 1.Minor procedures such as excision of skin lesions, 771 moles, warts, cysts, or lipomas and repair of lacerations or 772 surgery limited to the skin and subcutaneous tissue which are 773 performed under topical or local anesthesia not involving drug 774 induced alteration of consciousness other than minimal pre 775 operative tranquilization of the patient. 776 2.Liposuction involving the removal of less than 4,000 777 cubic centimeters of supernatant fat. 778 3.Incision and drainage of superficial abscesses; limited 779 endoscopies, such as proctoscopies, skin biopsies, 780 arthrocentesis, thoracentesis, paracentesis, dilation of the 781 urethra, cystoscopic procedures, and closed reduction of simple 782 fractures; or small joint dislocations, such as in the finger or 783 toe joints. 784 4.Procedures in which anesthesia is limited to minimal 785 sedation. The patients level of sedation must be that of 786 minimal sedation and anxiolysis, and the chances of 787 complications requiring hospitalization must be remote. As used 788 in this sub-subparagraph, the term minimal sedation and 789 anxiolysis means a drug-induced state during which patients 790 respond normally to verbal commands, and although cognitive 791 function and physical coordination may be impaired, airway 792 reflexes and ventilatory and cardiovascular functions remain 793 unaffected. Controlled substances, as defined in ss. 893.02 and 794 893.03, must be limited to oral administration in doses 795 appropriate for the unsupervised treatment of insomnia, anxiety, 796 or pain. 797 5.Procedures for which chances of complications requiring 798 hospitalization are remote as specified in board rule. 799 (b)Standards of practice.Standards of practice for Level 800 I office surgery include all of the following: 801 1.The medical education, training, and experience of the 802 physician performing the surgery must include training on proper 803 dosages and management of toxicity or hypersensitivity to 804 regional anesthetic drugs, and the physician must be certified 805 in advanced cardiac life support. 806 2.At least one operating assistant must be certified in 807 basic life support. 808 3.Intravenous access supplies, oxygen, oral airways, and a 809 positive pressure ventilation device must be available in the 810 office surgery, along with the following medications, stored per 811 the manufacturers recommendation: 812 a.Atropine, 3 mg. 813 b.Diphenhydramine, 50 mg. 814 c.Epinephrine, 1 mg in 10 ml. 815 d.Epinephrine, 1 mg in 1 ml vial, 3 vials total. 816 e.Hydrocortisone, 100 mg. 817 f.If a benzodiazepine is administered, flumazenil, 0.5 mg 818 in 5 ml vial, 2 vials total. 819 g.If an opiate is administered, naloxone, 0.4 mg in 1 ml 820 vial, 2 vials total. 821 4.When performing minor procedures, such as excision of 822 skin lesions, moles, warts, cysts, or lipomas and repair of 823 lacerations or surgery limited to the skin and subcutaneous 824 tissue performed under topical or local anesthesia in an office 825 surgery setting, physicians performing the procedure are exempt 826 from subparagraphs 1.-3. Current certification in basic life 827 support is recommended but not required. 828 5.A physician performing the surgery need not have an 829 assistant during the procedure unless the specific procedure 830 being performed requires an assistant. 831 (5)LEVEL II OFFICE SURGERY. 832 (a)Scope.Level II office surgery includes, but is not 833 limited to, all of the following procedures: 834 1.Hemorrhoidectomy. 835 2.Hernia repair. 836 3.Large joint dislocations. 837 4.Colonoscopy. 838 5.Liposuction involving the removal of up to 4,000 cubic 839 centimeters of supernatant fat. 840 6.Any other procedure the board designates by rule as a 841 Level II office surgery. 842 7.Surgeries in which the patients level of sedation is 843 that of moderate sedation and analgesia or conscious sedation. 844 As used in this subparagraph, the term moderate sedation and 845 analgesia or conscious sedation is a drug-induced depression of 846 consciousness during which patients respond purposefully to 847 verbal commands, either alone or accompanied by light tactile 848 stimulation; interventions are not required to maintain a patent 849 airway; spontaneous ventilation is adequate; and cardiovascular 850 function is maintained. For purposes of this term, reflex 851 withdrawal from a painful stimulus is not considered a 852 purposeful response. 853 (b)Standards of practice.Standards of practice for Level 854 II office surgery include, but are not limited to, the 855 following: 856 1.The physician performing the surgery, or the office 857 where the procedure is being performed, must have a transfer 858 agreement with a licensed hospital within reasonable proximity 859 if the physician performing the procedure does not have staff 860 privileges to perform the same procedure as that being performed 861 in the office surgery setting at a licensed hospital within 862 reasonable proximity. The transfer agreement required by this 863 section must be current and have been entered into no more than 864 5 years before the date of the offices most recent annual 865 inspection under s. 458.328. A transfer agreement must 866 affirmatively disclose an effective date and a termination date. 867 2.The physician performing the surgery must have staff 868 privileges at a licensed hospital to perform the same procedure 869 in that hospital as that being performed in the office surgery 870 setting or must be able to document satisfactory completion of 871 training, such as board certification or board eligibility by a 872 board approved by the American Board of Medical Specialties or 873 any other board approved by the Board of Medicine or Board of 874 Osteopathic Medicine, as applicable, or must be able to 875 establish comparable background, training, and experience. Such 876 board certification or comparable background, training, and 877 experience must also be directly related to and include the 878 procedures being performed by the physician in the office 879 surgery facility. 880 3.One assistant must be currently certified in basic life 881 support. 882 4.The physician performing the surgery must be currently 883 certified in advanced cardiac life support. 884 5.A complete and current crash cart must be available at 885 all times at the location where the anesthesia is being 886 administered. The designated physician of an office surgery is 887 responsible for ensuring that the crash cart is replenished 888 after each use, the expiration dates for the crash carts 889 medications are checked weekly, and crash cart events are 890 documented in the carts logs. Medicines must be stored per the 891 manufacturers recommendations, and multidose vials must be 892 dated once opened and checked daily for expiration. The crash 893 cart must, at a minimum, include the following intravenous or 894 inhaled medications: 895 a.Adenosine, 18 mg. 896 b.Albuterol, 2.5 mg with a small volume nebulizer. 897 c.Amiodarone, 300 mg. 898 d.Atropine, 3 mg. 899 e.Calcium chloride, 1 gram. 900 f.Dextrose, 50 percent; 50 ml. 901 g.Diphenhydramine, 50 mg. 902 h.Dopamine, 200 mg, minimum. 903 i.Epinephrine, 1 mg, in 10 ml. 904 j.Epinephrine, 1 mg in 1 ml vial, 3 vials total. 905 k.Flumazenil, 1 mg. 906 l.Furosemide, 40 mg. 907 m.Hydrocortisone, 100 mg. 908 n.Lidocaine appropriate for cardiac administration, 100 909 mg. 910 o.Magnesium sulfate, 2 grams. 911 p.Naloxone, 1.2 mg. 912 q.A beta blocker class drug. 913 r.Sodium bicarbonate, 50 mEq/50 ml. 914 s.Paralytic agent that is appropriate for use in rapid 915 sequence intubation. 916 t.A calcium channel blocker class drug. 917 u.If nonneuraxial regional blocks are performed, 918 Intralipid, 20 percent, 500 ml solution. 919 v.Any additional medication the board determines by rule 920 is warranted for patient safety and by the evolution of 921 technology and medical practice. 922 6.In the event of a drug shortage, the designated 923 physician is authorized to substitute a therapeutically 924 equivalent drug that meets the prevailing practice standards. 925 7.The designated physician is responsible for ensuring 926 that the office maintains documentation of its unsuccessful 927 efforts to obtain the required drug. 928 8.The designated physician is responsible for ensuring 929 that the following are present in the office surgery: 930 a.A benzodiazepine. 931 b.A positive pressure ventilation device, such as Ambu, 932 plus oxygen supply. 933 c.An end-tidal carbon dioxide detection device. 934 d.Monitors for blood pressure, electrocardiography, and 935 oxygen saturation. 936 e.Emergency intubation equipment that must, at a minimum, 937 include suction devices, endotracheal tubes, working 938 laryngoscopes, oropharyngeal airways, nasopharyngeal airways, 939 and bag valve mask apparatus that are sized appropriately for 940 the specific patient. 941 f.A working defibrillator with defibrillator pads or 942 defibrillator gel, or an automated external defibrillator unit. 943 g.Sufficient backup power to allow the physician 944 performing the surgery to safely terminate the procedure and to 945 allow the patient to emerge from the anesthetic, all without 946 compromising the sterility of the procedure or the environment 947 of care. 948 h.Working sterilization equipment cultured weekly. 949 i.Sufficient intravenous solutions and equipment for a 950 minimum of a weeks worth of surgical cases. 951 j.Any other equipment required by board rule, as warranted 952 by the evolution of technology and medical practice. 953 9.The physician performing the surgery must be assisted by 954 a qualified anesthesia provider, which may include any of the 955 following types of providers: 956 a.An anesthesiologist. 957 b.A certified registered nurse anesthetist. 958 c.A registered nurse, if the physician performing the 959 surgery is certified in advanced cardiac life support and the 960 registered nurse assists only with local anesthesia or conscious 961 sedation. 962 963 An anesthesiologist assistant may assist the anesthesiologist as 964 provided by board rule. An assisting anesthesia provider may not 965 function in any other capacity during the procedure. 966 10.If additional anesthesia assistance is required by the 967 specific procedure or patient circumstances, such assistance 968 must be provided by a physician, osteopathic physician, 969 registered nurse, licensed practical nurse, or operating room 970 technician. 971 11.The designated physician is responsible for ensuring 972 that each patient is monitored in the recovery room until the 973 patient is fully recovered from anesthesia. Such monitoring must 974 be provided by a licensed physician, physician assistant, 975 registered nurse with postanesthesia care unit experience, or 976 the equivalent who is currently certified in advanced cardiac 977 life support, or, in the case of pediatric patients, currently 978 certified in pediatric advanced life support. 979 (6)LEVEL II-A OFFICE SURGERY. 980 (a)Scope.Level II-A office surgeries are those Level II 981 office surgeries that have a maximum planned duration of 5 982 minutes or less and in which the chances of complications 983 requiring hospitalization are remote. 984 (b)Standards of practice. 985 1.All practice standards for Level II office surgery set 986 forth in paragraph (5)(b) must be met for Level II-A office 987 surgery except for the requirements set forth in subparagraph 988 (5)(b)9. regarding assistance by a qualified anesthesia 989 provider. 990 2.During the surgical procedure, the physician performing 991 the surgery must be assisted by a licensed physician, physician 992 assistant, registered nurse, or licensed practical nurse. 993 3.Additional assistance may be required by specific 994 procedure or patient circumstances. 995 4.Following the procedure, a licensed physician, physician 996 assistant, or registered nurse must be available to monitor the 997 patient in the recovery room until the patient is recovered from 998 anesthesia. The monitoring provider must be currently certified 999 in advanced cardiac life support, or, in the case of pediatric 1000 patients, currently certified in pediatric advanced life 1001 support. 1002 (7)LEVEL III OFFICE SURGERY. 1003 (a)Scope. 1004 1.Level III office surgery includes those types of surgery 1005 during which the patients level of sedation is that of deep 1006 sedation and analgesia or general anesthesia. As used in this 1007 subparagraph, the term: 1008 a.Deep sedation and analgesia means a drug-induced 1009 depression of consciousness during which: 1010 (I)Patients cannot be easily aroused but respond 1011 purposefully following repeated or painful stimulation; 1012 (II)The ability to independently maintain ventilatory 1013 function may be impaired; 1014 (III)Patients may require assistance in maintaining a 1015 patent airway and spontaneous ventilation may be inadequate; and 1016 (IV)Cardiovascular function is usually maintained. 1017 1018 For purposes of this sub-subparagraph, reflex withdrawal from a 1019 painful stimulus is not considered a purposeful response. 1020 b.General anesthesia means a drug-induced loss of 1021 consciousness during which: 1022 (I)Patients are not arousable, even by painful 1023 stimulation; 1024 (II)The ability to independently maintain ventilatory 1025 function is often impaired; 1026 (III)Patients often require assistance in maintaining a 1027 patent airway and positive pressure ventilation may be required 1028 because of depressed spontaneous ventilation or drug-induced 1029 depression of neuromuscular function; and 1030 (IV)Cardiovascular function may be impaired. 1031 2.The use of spinal or epidural anesthesia for a procedure 1032 requires that the procedure be considered a Level III office 1033 surgery. 1034 3.Only patients classified under the American Society of 1035 Anesthesiologists (ASA) risk classification criteria as Class I 1036 or Class II are appropriate candidates for a Level III office 1037 surgery. 1038 a.All Level III office surgeries on patients classified as 1039 ASA III or higher must be performed only in a hospital or 1040 ambulatory surgical center. 1041 b.For all ASA II patients above the age of 50, the 1042 physician performing the surgery must obtain a complete workup 1043 performed before the performance of a Level III office surgery 1044 in the office surgery setting. 1045 c.If the patient has a cardiac history or is deemed to be 1046 a complicated medical patient, the patient must have a 1047 preoperative electrocardiogram and be referred to an appropriate 1048 consultant for medical optimization. The referral to a 1049 consultant may be waived after evaluation by the patients 1050 anesthesiologist. 1051 (b)Standards of practice.Practice standards for Level III 1052 office surgery include all Level II office surgery standards and 1053 all of the following requirements: 1054 1.The physician performing the surgery must have staff 1055 privileges at a licensed hospital to perform the same procedure 1056 in that hospital as that being performed in the office surgery 1057 setting or must be able to document satisfactory completion of 1058 training, such as board certification or board qualification by 1059 a board approved by the American Board of Medical Specialties or 1060 any other board approved by the Board of Medicine or Board of 1061 Osteopathic Medicine, as applicable, or must be able to 1062 demonstrate to the accrediting organization or to the department 1063 comparable background, training, and experience. Such board 1064 certification or comparable background, training, and experience 1065 must also be directly related to and include the procedure being 1066 performed by the physician performing the surgery in the office 1067 surgery setting. In addition, the physician performing the 1068 surgery must have knowledge of the principles of general 1069 anesthesia. 1070 2.The physician performing the surgery must be currently 1071 certified in advanced cardiac life support. 1072 3.At least one operating assistant must be currently 1073 certified in basic life support. 1074 4.An emergency policy and procedures manual related to 1075 serious anesthesia complications must be available in the office 1076 surgery and reviewed biannually by the designated physician, 1077 practiced with staff, updated, and posted in a conspicuous 1078 location in the office. Topics to be covered in the manual must 1079 include all of the following: 1080 a.Airway blockage and foreign body obstruction. 1081 b.Allergic reactions. 1082 c.Bradycardia. 1083 d.Bronchospasm. 1084 e.Cardiac arrest. 1085 f.Chest pain. 1086 g.Hypoglycemia. 1087 h.Hypotension. 1088 i.Hypoventilation. 1089 j.Laryngospasm. 1090 k.Local anesthetic toxicity reaction. 1091 l.Malignant hyperthermia. 1092 m.Any other topics the board determines by rule are 1093 warranted for patient safety and by the evolution of technology 1094 and medical practice. 1095 5.An office surgery performing Level III office surgeries 1096 must maintain all of the equipment and medications required for 1097 Level II office surgeries and comply with all of the following 1098 additional requirements: 1099 a.Maintain at least 720 mg of dantrolene on site if 1100 halogenated anesthetics or succinylcholine are used. 1101 b.Equipment and medication for monitored postanesthesia 1102 recovery must be available in the office. 1103 6.Anesthetic safety regulations must be developed, posted 1104 in a conspicuous location in the office, and enforced by the 1105 designated physician. Such regulations must include all of the 1106 following requirements: 1107 a.All operating room electrical and anesthesia equipment 1108 must be inspected at least semiannually, and a written record of 1109 the results and corrective actions must be maintained. 1110 b.Flammable anesthetic agents may not be employed in 1111 office surgery facilities. 1112 c.Electrical equipment in anesthetizing areas must be on 1113 an audiovisual line isolation monitor, with the exception of 1114 radiologic equipment and fixed lighting more than 5 feet above 1115 the floor. 1116 d.Each anesthesia gas machine must have a pin index safety 1117 system or equivalent safety system and a minimum oxygen flow 1118 safety device. 1119 e.All reusable anesthesia equipment in direct contact with 1120 a patient must be cleaned or sterilized as appropriate after 1121 each use. 1122 f.The following monitors must be applied to all patients 1123 receiving conduction or general anesthesia: 1124 (I)Blood pressure cuff. 1125 (II)A continuous temperature device, readily available to 1126 measure the patients temperature. 1127 (III)Pulse oximeter. 1128 (IV)Electrocardiogram. 1129 (V)An inspired oxygen concentration monitor and a 1130 capnograph, for patients receiving general anesthesia. 1131 g.Emergency intubation equipment must be available in all 1132 office surgery suites. 1133 h.Surgical tables must be capable of Trendelenburg and 1134 other positions necessary to facilitate surgical procedures. 1135 i.An anesthesiologist, a certified registered nurse 1136 anesthetist, an anesthesiologist assistant, or a physician 1137 assistant qualified as set forth in board rule must administer 1138 the general or regional anesthesia. 1139 j.A physician, a registered nurse, a licensed practical 1140 nurse, a physician assistant, or an operating room technician 1141 must assist with the surgery. The anesthesia provider may not 1142 function in any other capacity during the procedure. 1143 k.The patient must be monitored in the recovery room until 1144 he or she has fully recovered from anesthesia. The monitoring 1145 must be provided by a physician, a physician assistant, a 1146 certified registered nurse anesthetist, an anesthesiologist 1147 assistant, or a registered nurse with postanesthesia care unit 1148 experience or the equivalent who is currently certified in 1149 advanced cardiac life support, or, in the case of pediatric 1150 patients, currently certified in pediatric advanced life 1151 support. 1152 (8)EXEMPTION.This section does not apply to a physician 1153 who is dually licensed as a dentist under chapter 466 when he or 1154 she is performing dental procedures that fall within the scope 1155 of practice of dentistry and are regulated under chapter 466. 1156 (9)RULEMAKING.The board may adopt by rule additional 1157 standards of practice for physicians who perform office 1158 surgeries or procedures under this section as warranted for 1159 patient safety and by the evolution of technology and medical 1160 practice. 1161 Section 3.Section 459.0138, Florida Statutes, is amended 1162 to read: 1163 459.0138Office surgeries. 1164 (1)REGISTRATION. 1165 (a)1.An office in which a physician performs or intends to 1166 perform a liposuction procedure in which more than 1,000 cubic 1167 centimeters of supernatant fat is temporarily or permanently 1168 removed, a liposuction procedure during which the patient is 1169 rotated between the supine, lateral, and prone positions, a 1170 Level II office surgery, or a Level III office surgery must 1171 register with the department. unless the office is licensed as A 1172 facility licensed under chapter 390 or chapter 395 may not be 1173 registered under this section. 1174 (b)2.The department must complete an inspection of any 1175 office seeking registration under this section before the office 1176 may be registered. 1177 1.The inspection of the office seeking registration under 1178 this section must include inspection for compliance with the 1179 standards of practice set out in this section and s. 458.3281 1180 and any applicable board rules for the levels of office surgery 1181 and procedures listed on the application which any physician 1182 practicing at the office performs or intends to perform. The 1183 application must be updated within 10 calendar days before any 1184 additional surgical procedures or levels of office surgery are 1185 to be performed at the office. Failure to timely update the 1186 application for any such additional surgical procedures or 1187 levels of office surgery is a violation of this section and 1188 subject to discipline under ss. 456.072 and 459.015. 1189 2.The department must immediately suspend the registration 1190 process of an office that refuses an inspection under 1191 subparagraph 1., and the applicant must be required to reapply 1192 for registration. 1193 3.If the department determines that an office seeking 1194 registration under this section is one in which a physician may 1195 perform, or intends to perform, liposuction procedures that 1196 include a patient being rotated between the supine, lateral, and 1197 prone positions during the procedure, or in which a physician 1198 may perform, or intends to perform, gluteal fat grafting 1199 procedures, the office must provide proof to the department that 1200 it has met the applicable requirements of s. 469 of the Florida 1201 Building Code, relating to office surgery suites, and s. 1202 458.3281 and the applicable rules adopted thereunder, and the 1203 department must inspect the office to ensure that all of the 1204 following are present or in place: 1205 a.Equipment and a procedure for measuring and documenting 1206 in a log the amount of supernatant fat removed, both temporarily 1207 and permanently, from a particular patient, including tissue 1208 disposal procedures. 1209 b.A procedure for measuring and documenting the amount of 1210 lidocaine injected for tumescent liposuction, if used. 1211 c.Working ultrasound guidance equipment or other guidance 1212 technology authorized under board rule which equals or exceeds 1213 the quality of ultrasound guidance. 1214 d.The office procedure for obtaining blood products. 1215 e.Documentation on file at the office demonstrating that 1216 any physician performing these procedures has privileges to 1217 perform such procedures in a hospital no more than 30 minutes 1218 away. 1219 f.Procedures for emergency resuscitation and transport to 1220 a hospital. 1221 g.Procedures for anesthesia and surgical recordkeeping. 1222 h.Any additional inspection requirements, as set by board 1223 rule. 1224 4.If an applicant is required under subparagraph 3. to 1225 provide proof to the department that the office is in compliance 1226 with the applicable requirements of s. 469 of the Florida 1227 Building Code, relating to office surgery suites, or s. 458.3281 1228 and the applicable rules adopted thereunder, but is unable to 1229 provide such proof, the department must notify the Agency for 1230 Health Care Administration and request the agency to inspect the 1231 office and consult with the office about the process to apply 1232 for ambulatory surgical center licensure under chapter 395 and 1233 how the office may seek qualification for such licensure, 1234 notwithstanding the offices failure to meet all requirements 1235 associated with such licensure at the time of inspection and 1236 notwithstanding any pertinent exceptions provided under s. 1237 395.002(3). 1238 (c)(b)To be By January 1, 2020, each office registered 1239 under this section or s. 458.328, an office must, at the time of 1240 application, list a designated designate a physician who is 1241 responsible for the offices compliance with the office health 1242 and safety requirements of this section and rules adopted 1243 hereunder. A designated physician must have a full, active, and 1244 unencumbered license under this chapter or chapter 458 and shall 1245 practice at the office for which he or she has assumed 1246 responsibility. Within 10 calendar days after the termination of 1247 a designated physician relationship, the office must notify the 1248 department of the designation of another physician to serve as 1249 the designated physician. The department may not register an 1250 office if the office fails to comply with this requirement at 1251 the time of application and must seek an emergency suspension of 1252 the suspend a registration of for an office pursuant to s. 1253 456.074(6) if the office fails to timely notify the department 1254 of its new designated physician within 10 calendar days after 1255 the termination of the previous designated physician 1256 relationship comply with the requirements of this paragraph. 1257 (d)As a condition of registration, each office must, at 1258 the time of application, list all medical personnel who will be 1259 practicing at the office, including all of the following: 1260 1.Physicians who intend to practice surgery or assist in 1261 surgery at the office seeking registration, including their 1262 respective license numbers and practice addresses. 1263 2.Anesthesia providers, including their license numbers. 1264 3.Nursing personnel licensed under chapter 464, including 1265 their license numbers unless already provided under subparagraph 1266 2. 1267 4.Physician assistants, including their respective license 1268 numbers and supervising physicians. 1269 1270 The office must notify the department of the addition or 1271 termination of any of the types of medical personnel specified 1272 under this paragraph within 10 calendar days before such 1273 addition or after such termination. Failure to timely notify the 1274 department of such addition or termination is a violation of 1275 this section and subject to discipline under ss. 456.072 and 1276 459.015. 1277 (e)(c)As a condition of registration, each office must 1278 establish financial responsibility by demonstrating that it has 1279 met and continues to maintain, at a minimum, the same 1280 requirements applicable to physicians in ss. 458.320 and 1281 459.0085. Each physician practicing at an office registered 1282 under this section or s. 458.328 must meet the financial 1283 responsibility requirements under s. 458.320 or s. 459.0085, as 1284 applicable. 1285 (f)(d)Each physician practicing or intending to practice 1286 at an office registered under this section or s. 458.328 must 1287 shall advise the board, in writing, within 10 calendar days 1288 before after beginning or after ending his or her practice at a 1289 the registered office, as applicable. 1290 (g)(e)1.The department shall inspect a registered office 1291 at least annually, including a review of patient records, 1292 anesthesia logs, surgery logs, and liposuction logs, to ensure 1293 that the office is in compliance with this section and rules 1294 adopted hereunder unless the office is accredited in office 1295 based surgery by the Joint Commission or other a nationally 1296 recognized accrediting agency approved by the board. The 1297 inspection may be unannounced, except for the inspection of an 1298 office that meets the description of a clinic specified in s. 1299 459.0137(1)(a)3.h., and those wholly owned and operated 1300 physician offices described in s. 459.0137(1)(a)3.g. which 1301 perform procedures referenced in s. 459.0137(1)(a)3.h., which 1302 must be announced. 1303 (h)2.The department must immediately suspend the 1304 registration of a registered office that refuses an inspection 1305 under paragraph (g) subparagraph 1. The office must close during 1306 such suspension. The suspension must remain in effect for at 1307 least 14 consecutive days and may not terminate until the 1308 department issues a written declaration that the office may 1309 reopen following the departments completion of an inspection of 1310 the office. 1311 (i)(f)The department may suspend or revoke the 1312 registration of an office in which a procedure or surgery 1313 identified in paragraph (a) is performed for failure of any of 1314 its physicians, owners, or operators to comply with this section 1315 and rules adopted hereunder or s. 458.328 and rules adopted 1316 thereunder. If an offices registration is revoked for any 1317 reason, the department may deny any person named in the 1318 registration documents of the office, including the persons who 1319 own or operate the office, individually or as part of a group, 1320 from registering an office to perform procedures or office 1321 surgeries pursuant to this section or s. 458.328 for 5 years 1322 after the revocation date. 1323 (j)(g)The department may impose any penalty set forth in 1324 s. 456.072(2) against the designated physician for failure of 1325 the office to operate in compliance with the office health and 1326 safety requirements of this section and rules adopted hereunder 1327 or s. 458.328 and rules adopted thereunder. 1328 (h)A physician may only perform a procedure or surgery 1329 identified in paragraph (a) in an office that is registered with 1330 the department. The board shall impose a fine of $5,000 per day 1331 on a physician who performs a procedure or surgery in an office 1332 that is not registered with the department. 1333 (k)(i)The actual costs of registration and inspection or 1334 accreditation must shall be paid by the person seeking to 1335 register and operate the office in which a procedure or surgery 1336 identified in paragraph (a) will be performed. 1337 (2)REGISTRATION UPDATE. 1338 (a)An office that registered under this section before 1339 July 1, 2024, in which a physician performs liposuction 1340 procedures that include a patient being rotated between the 1341 supine, lateral, and prone positions during the procedure or in 1342 which a physician performs gluteal fat grafting procedures must 1343 provide a registration update to the department consistent with 1344 the requirements of the initial registration under subsection 1345 (1) no later than 30 days before the office surgerys next 1346 annual inspection. 1347 (b)Registration update inspections required under 1348 subsection (1) must be performed by the department on the date 1349 of the office surgerys next annual inspection. 1350 (c) During the registration update process, the office 1351 surgery may continue to operate under the original registration. 1352 (d)In order to provide an office surgery time to update to 1353 the requirements of subsection (1) and s. 459.0139, effective 1354 July 1, 2024, and the applicable provisions of s. 469 of the 1355 Florida Building Code, relating to office surgery suites, any 1356 office surgery registered under this section before July 1, 1357 2024, whose annual inspection is due in July or August 2024, may 1358 request from the department, in writing, a 60-day postponement 1359 of the required annual inspection, which postponement must be 1360 granted. 1361 (e)All other requests to the department for a postponement 1362 of the registration update inspection required under this 1363 registration update process must be in writing and be approved 1364 by the chair of the Board of Medicine for good cause shown, and 1365 such postponement may not exceed 30 days. 1366 (3)STANDARDS OF PRACTICE. 1367 (a)A physician performing a procedure or surgery in an 1368 office registered under this section must comply with the 1369 applicable provisions of s. 469 of the Florida Building Code, 1370 relating to office surgery suites, and the standards of practice 1371 for office surgery set forth in this section and s. 459.0139 and 1372 any applicable rules adopted thereunder. 1373 (b)A physician may not perform any surgery or procedure 1374 identified in paragraph (1)(a) in a setting other than an office 1375 registered under this section or a facility licensed under 1376 chapter 390 or chapter 395, as applicable. The board shall 1377 impose a fine of $5,000 per incident on a physician who violates 1378 this paragraph performing a gluteal fat grafting procedure in an 1379 office surgery setting shall adhere to standards of practice 1380 pursuant to this subsection and rules adopted by the board. 1381 (c)(b)Office surgeries may not: 1382 1.Be a type of surgery that generally results in blood 1383 loss of more than 10 percent of estimated blood volume in a 1384 patient with a normal hemoglobin level; 1385 2.Require major or prolonged intracranial, intrathoracic, 1386 abdominal, or joint replacement procedures, except for 1387 laparoscopic procedures; 1388 3.Involve major blood vessels and be performed with direct 1389 visualization by open exposure of the major blood vessel, except 1390 for percutaneous endovascular intervention; or 1391 4.Be emergent or life threatening. 1392 (d)(c)A physician performing a gluteal fat grafting 1393 procedure in an office surgery setting must comply with the 1394 applicable provisions of s. 469 of the Florida Building Code, 1395 relating to office surgery suites, and the standards of practice 1396 under this subsection and s. 459.0139 and applicable rules 1397 adopted thereunder, including, but not limited to, all of the 1398 following standards of practice: 1399 1.The A physician performing the a gluteal fat grafting 1400 procedure must conduct an in-person examination of the patient 1401 while physically present in the same room as the patient no 1402 later than the day before the procedure. 1403 2.Before a physician may delegate any duties during a 1404 gluteal fat grafting procedure, the patient must provide 1405 written, informed consent for such delegation. Any duty 1406 delegated by a physician during a gluteal fat grafting procedure 1407 must be performed under the direct supervision of the physician 1408 performing such procedure. Fat extraction and gluteal fat 1409 injections must be performed by the physician and may not be 1410 delegated. 1411 3.Fat may only be injected into the subcutaneous space of 1412 the patient and may not cross the fascia overlying the gluteal 1413 muscle. Intramuscular or submuscular fat injections are 1414 prohibited. 1415 4.When the physician performing a gluteal fat grafting 1416 procedure injects fat into the subcutaneous space of the 1417 patient, the physician must use ultrasound guidance, or guidance 1418 with other technology authorized under board rule which equals 1419 or exceeds the quality of ultrasound, during the placement and 1420 navigation of the cannula to ensure that the fat is injected 1421 into the subcutaneous space of the patient above the fascia 1422 overlying the gluteal muscle. Such guidance with the use of 1423 ultrasound or other technology is not required for other 1424 portions of such procedure. 1425 5.An office in which a physician performs gluteal fat 1426 grafting procedures shall at all times maintain a ratio of one 1427 physician to one patient during all phases of the procedure, 1428 beginning with the administration of anesthesia to the patient 1429 and concluding with the extubation of the patient. After a 1430 physician has commenced, and while he or she is engaged in, a 1431 gluteal fat grafting procedure, the physician may not commence 1432 or engage in another gluteal fat grafting procedure or any other 1433 procedure with another patient at the same time. 1434 (e)(d)If a procedure in an office surgery setting results 1435 in hospitalization, the incident must be reported as an adverse 1436 incident pursuant to s. 458.351. 1437 (e)An office in which a physician performs gluteal fat 1438 grafting procedures must at all times maintain a ratio of one 1439 physician to one patient during all phases of the procedure, 1440 beginning with the administration of anesthesia to the patient 1441 and concluding with the extubation of the patient. After a 1442 physician has commenced, and while he or she is engaged in, a 1443 gluteal fat grafting procedure, the physician may not commence 1444 or engage in another gluteal fat grafting procedure or any other 1445 procedure with another patient at the same time. 1446 (4)(3)RULEMAKING. 1447 (a)The board may shall adopt by rule additional standards 1448 of practice for physicians who perform office procedures or 1449 office surgeries under pursuant to this section, as warranted 1450 for patient safety and by the evolution of technology and 1451 medical practice. 1452 (b)The board may adopt rules to administer the 1453 registration, registration update, inspection, and safety of 1454 offices in which a physician performs office procedures or 1455 office surgeries under pursuant to this section. 1456 Section 4.Section 459.0139, Florida Statutes, is created 1457 to read: 1458 459.0139Standard of practice for office surgery. 1459 (1)CONSTRUCTION.This section does not relieve a physician 1460 performing a procedure or surgery from the responsibility of 1461 making the medical determination of whether an office is an 1462 appropriate setting in which to perform that particular 1463 procedure or surgery, taking into consideration the particular 1464 patient on which the procedure or surgery is to be performed. 1465 (2)DEFINITIONS.As used in this section, the term: 1466 (a)Certified in advanced cardiac life support means a 1467 person holds a current certification in an advanced cardiac life 1468 support course with didactic and skills components, approved by 1469 the American Heart Association, the American Safety and Health 1470 Institute, the American Red Cross, Pacific Medical Training, or 1471 the Advanced Cardiovascular Life Support (ACLS) Certification 1472 Institute. 1473 (b)Certified in basic life support means a person holds 1474 a current certification in a basic life support course with 1475 didactic and skills components, approved by the American Heart 1476 Association, the American Safety and Health Institute, the 1477 American Red Cross, Pacific Medical Training, or the ACLS 1478 Certification Institute. 1479 (c)Certified in pediatric advanced life support means a 1480 person holds a current certification in a pediatric advanced 1481 life support course with didactic and skills components approved 1482 by the American Heart Association, the American Safety and 1483 Health Institute, or Pacific Medical Training. 1484 (d)Continual monitoring means monitoring that is 1485 repeated regularly and frequently in steady, rapid succession. 1486 (e)Continuous means monitoring that is prolonged without 1487 any interruption at any time. 1488 (f)Equipment means a medical device, instrument, or tool 1489 used to perform specific actions or take certain measurements 1490 during, or while a patient is recovering from, a procedure or 1491 surgery which must meet current performance standards according 1492 to its manufacturers guidelines for the specific device, 1493 instrument, or tool, as applicable. 1494 (g)Major blood vessels means a group of critical 1495 arteries and veins, including the aorta, coronary arteries, 1496 pulmonary arteries, superior and inferior vena cava, pulmonary 1497 veins, and any intra-cerebral artery or vein. 1498 (h)Office surgery means a physicians office in which 1499 surgical procedures are performed by a physician for the 1500 practice of medicine as authorized by this section and board 1501 rule. The office must be an office at which a physician 1502 regularly performs consultations with surgical patients, 1503 preoperative examinations, and postoperative care, as 1504 necessitated by the standard of care related to the surgeries 1505 performed at the physicians office, and at which patient 1506 records are readily maintained and available. The types of 1507 procedures or surgeries performed in an office surgery are those 1508 which need not be performed in a facility licensed under chapter 1509 390 or chapter 395, and are not of the type that: 1510 1.Generally result in blood loss of more than 10 percent 1511 of estimated blood volume in a patient with a normal hemoglobin 1512 count; 1513 2.Require major or prolonged intracranial, intrathoracic, 1514 abdominal, or major joint replacement procedures, except for 1515 laparoscopic procedures; 1516 3.Involve major blood vessels and are performed with 1517 direct visualization by open exposure of the major vessel, 1518 except for percutaneous endovascular intervention; or 1519 4.Are generally emergent or life threatening in nature. 1520 (i)Pediatric patient means a patient who is 13 years of 1521 age or younger. 1522 (j)Percutaneous endovascular intervention means a 1523 procedure performed without open direct visualization of the 1524 target vessel and which requires only needle puncture of an 1525 artery or vein followed by insertion of catheters, wires, or 1526 similar devices that are then advanced through the blood vessels 1527 using imaging guidance. Once the catheter reaches the intended 1528 location, various maneuvers to address the diseased area may be 1529 performed, including, but not limited to, injection of contrast 1530 medium for imaging; treatment of vessels with angioplasty; 1531 atherectomy; covered or uncovered stenting; embolization or 1532 intentionally occluding vessels or organs; and delivering 1533 medications or radiation or other energy, such as laser, 1534 radiofrequency, or cryo. 1535 (k)Reasonable proximity means a distance that does not 1536 exceed 30 minutes of transport time to the hospital. 1537 (l)Surgery means any manual or operative procedure 1538 performed upon the body of a living human being, including, but 1539 not limited to, those performed with the use of lasers, for the 1540 purposes of preserving health, diagnosing or curing disease, 1541 repairing injury, correcting a deformity or defect, prolonging 1542 life, or relieving suffering, or any elective procedure for 1543 aesthetic, reconstructive, or cosmetic purposes. The term 1544 includes, but is not limited to, incision or curettage of tissue 1545 or an organ; suture or other repair of tissue or an organ, 1546 including a closed as well as an open reduction of a fracture; 1547 extraction of tissue, including premature extraction of the 1548 products of conception from the uterus; insertion of natural or 1549 artificial implants; or an endoscopic procedure with use of 1550 local or general anesthetic. 1551 (3)GENERAL REQUIREMENTS FOR OFFICE SURGERY. 1552 (a)The physician performing the surgery must examine the 1553 patient immediately before the surgery to evaluate the risk of 1554 anesthesia and of the surgical procedure to be performed. The 1555 physician performing the surgery may delegate the preoperative 1556 heart and lung evaluation to a qualified anesthesia provider 1557 within the scope of the providers practice and, if applicable, 1558 protocol. 1559 (b)The physician performing the surgery shall maintain 1560 complete patient records of each surgical procedure performed, 1561 which must include all of the following: 1562 1.The patients name, patient number, preoperative 1563 diagnosis, postoperative diagnosis, surgical procedure, 1564 anesthetic, anesthesia records, recovery records, and 1565 complications, if any. 1566 2.The name of each member of the surgical team, including 1567 the surgeon, first assistant, anesthesiologist, nurse 1568 anesthetist, anesthesiologist assistant, circulating nurse, and 1569 operating room technician, as applicable. 1570 (c)Each office surgerys designated physician shall ensure 1571 that the office surgery has procedures in place to verify that 1572 all of the following have occurred before any surgery is 1573 performed: 1574 1.The patient has signed the informed consent form for the 1575 procedure reflecting the patients knowledge of identified risks 1576 of the procedure, consent to the procedure, the type of 1577 anesthesia and anesthesia provider to be used during the 1578 procedure, and the fact that the patient may choose the type of 1579 anesthesia provider for the procedure, such as an 1580 anesthesiologist, a certified registered nurse anesthetist, a 1581 physician assistant, an anesthesiologist assistant, or another 1582 appropriately trained physician as provided by board rule. 1583 2.The patients identity has been verified. 1584 3.The operative site has been verified. 1585 4.The operative procedure to be performed has been 1586 verified with the patient. 1587 5.All of the information and actions required to be 1588 verified under this paragraph are documented in the patients 1589 medical record. 1590 (d)With respect to the requirements set forth in paragraph 1591 (c), written informed consent is not necessary for minor Level I 1592 procedures limited to the skin and mucosa. 1593 (e)The physician performing the surgery shall maintain a 1594 log of all liposuction procedures performed at the office 1595 surgery where more than 1,000 cubic centimeters of supernatant 1596 fat is temporarily or permanently removed and where Level II and 1597 Level III surgical procedures are performed. The log must, at a 1598 minimum, include all of the following: 1599 1.A confidential patient identifier. 1600 2.Time of arrival in the operating suite. 1601 3.The name of the physician performing the procedure. 1602 4.The patients diagnosis, CPT codes used for the 1603 procedure, the patients classification for risk with anesthesia 1604 according to the American Society of Anesthesiologists physical 1605 status classification system, and the type of procedure and 1606 level of surgery performed. 1607 5.Documentation of completion of the medical clearance 1608 performed by the anesthesiologist or the physician performing 1609 the surgery. 1610 6.The name and provider type of the anesthesia provider 1611 and the type of anesthesia used. 1612 7.The duration of the procedure. 1613 8.Any adverse incidents as identified in s. 458.351. 1614 9.The type of postoperative care, duration of recovery, 1615 disposition of the patient upon discharge, including the address 1616 of where the patient is being discharged, discharge 1617 instructions, and list of medications used during surgery and 1618 recovery. 1619 1620 All surgical and anesthesia logs must be kept at the office 1621 surgery and maintained for 6 years after the date of last 1622 patient contact and must be provided to department investigators 1623 upon request. 1624 (f)For any liposuction procedure, the physician performing 1625 the surgery is responsible for determining the appropriate 1626 amount of supernatant fat to be removed from a particular 1627 patient. A maximum of 4,000 cubic centimeters of supernatant fat 1628 may be removed by liposuction in the office surgery setting. A 1629 maximum of 50mg/kg of lidocaine may be injected for tumescent 1630 liposuction in the office surgery setting. 1631 (g)1.Liposuction may be performed in combination with 1632 another separate surgical procedure during a single Level II or 1633 Level III surgical procedure only in the following 1634 circumstances: 1635 a.When combined with an abdominoplasty, liposuction may 1636 not exceed 1,000 cubic centimeters of supernatant fat. 1637 b.When liposuction is associated and directly related to 1638 another procedure, the liposuction may not exceed 1,000 cubic 1639 centimeters of supernatant fat. 1640 2.Major liposuction in excess of 1,000 cubic centimeters 1641 of supernatant fat may not be performed on a patients body in a 1642 location that is remote from the site of another procedure being 1643 performed on that patient. 1644 (h)For elective cosmetic and plastic surgery procedures 1645 performed in a physicians office, the maximum planned duration 1646 of all surgical procedures combined may not exceed 8 hours. 1647 Except for elective cosmetic and plastic surgery, the physician 1648 performing the surgery may not keep patients past midnight in a 1649 physicians office. For elective cosmetic and plastic surgical 1650 procedures, the patient must be discharged within 24 hours after 1651 presenting to the office for surgery. However, an overnight stay 1652 is allowed in the office if the total time the patient is at the 1653 office does not exceed 23 hours and 59 minutes, including the 1654 surgery time. An overnight stay in a physicians office for 1655 elective cosmetic and plastic surgery must be strictly limited 1656 to the physicians office. If the patient has not recovered 1657 sufficiently to be safely discharged within the timeframes set 1658 forth, the patient must be transferred to a hospital for 1659 continued postoperative care. 1660 (i)The American Society of Anesthesiologists Standards for 1661 Basic Anesthetic Monitoring are hereby adopted and incorporated 1662 by reference as the standards for anesthetic monitoring by any 1663 qualified anesthesia provider under this section. 1664 1.These standards apply to general anesthetics, regional 1665 anesthetics, and monitored Level II and III anesthesia care. 1666 However, in emergency circumstances, appropriate life support 1667 measures take priority. These standards may be exceeded at any 1668 time based on the judgment of the responsible supervising 1669 physician or anesthesiologist. While these standards are 1670 intended to encourage quality patient care, observing them does 1671 not guarantee any specific patient outcome. This set of 1672 standards addresses only the issue of basic anesthesia 1673 monitoring, which is only one component of anesthesia care. 1674 2.In certain rare or unusual circumstances, some of these 1675 methods of monitoring may be clinically impractical, and 1676 appropriate use of the described monitoring methods may fail to 1677 detect adverse clinical developments. In such cases, a brief 1678 interruption of continual monitoring may be unavoidable and does 1679 not by itself constitute a violation of the standards of 1680 practice of this section. 1681 3.Under extenuating circumstances, the physician 1682 performing the surgery or the anesthesiologist may waive the 1683 following requirements: 1684 a.The use of an oxygen analyzer with a low oxygen 1685 concentration limit alarm, or other technology authorized under 1686 board rule which equals or exceeds the quality of the oxygen 1687 analyzer, during the administration of general anesthesia with 1688 an anesthesia machine. 1689 b.The use of pulse oximetry with a variable pitch pulse 1690 tone and an audible low threshold alarm, or other technology 1691 authorized under board rule which equals or exceeds the quality 1692 of a pulse oximeter, and the use of adequate illumination and 1693 exposure of the patient to assess color. 1694 c.The use of capnography, capnometry, or mass 1695 spectroscopy, or other technology authorized under board rule 1696 which equals or exceeds the quality of capnography, capnometry, 1697 or mass spectroscopy, as a quantitative method of analyzing the 1698 end-tidal carbon dioxide for continual monitoring for the 1699 presence of expired carbon dioxide during ventilation, from the 1700 time of the endotracheal tube or supraglottic airway placement 1701 until extubation or removal or initiating transfer of the 1702 patient to a postoperative care location. 1703 d.The use of continuous electrocardiogram display, or 1704 other technology authorized under board rule which equals or 1705 exceeds the quality of electrocardiogram display, from the 1706 beginning of anesthesia until preparing to leave the 1707 anesthetizing location. 1708 e.The measuring of arterial blood pressure and heart rate 1709 evaluated at least every 5 minutes during anesthesia. 1710 1711 When any of the monitoring is waived for extenuating 1712 circumstances under this subparagraph, it must be documented in 1713 a note in the patients medical record, including the reasons 1714 for the need to waive the requirement. These standards are not 1715 intended for the application to the care of an obstetrical 1716 patient in labor or in the conduct of pain management. 1717 (j)1.Because of the rapid changes in patient status during 1718 anesthesia, qualified anesthesia personnel must be continuously 1719 present in the room to provide anesthesia care for the entire 1720 duration of all general anesthetics, regional anesthetics, and 1721 monitored anesthesia care conducted on the patient. In the event 1722 that there is a direct known hazard, such as radiation, to the 1723 anesthesia personnel which might require intermittent remote 1724 observation of the patient, some provision for monitoring the 1725 patient must be made. In the event that an emergency requires 1726 the temporary absence of the person primarily responsible for 1727 the anesthesia, the best judgment of the supervising physician 1728 or anesthesiologist shall be exercised in comparing the 1729 emergency with the anesthetized patients condition and in the 1730 selection of the person left responsible for the anesthesia 1731 during the temporary absence. 1732 2.During all anesthesia, the patients oxygenation, 1733 ventilation, circulation, and temperature must be continually 1734 evaluated to ensure adequate oxygen concentration in the 1735 inspired gas and the blood. 1736 a.During all general anesthesia using an anesthesia 1737 machine, the concentration of oxygen in the patients breathing 1738 system must be measured by an oxygen analyzer with a low oxygen 1739 concentration limit alarm used to measure blood oxygenation. 1740 b.During all anesthesia, a quantitative method of 1741 assessing oxygenation, such as pulse oximetry, must be employed. 1742 When a pulse oximeter is used, the variable pitch pulse tone and 1743 the low threshold alarm must be audible to the qualified 1744 anesthesia provider. Adequate illumination and exposure of the 1745 patient are necessary to assess color. 1746 c.During all anesthesia, every patient must have the 1747 adequacy of his or her ventilation continually evaluated, 1748 including, but not limited to, the evaluation of qualitative 1749 clinical signs, such as chest excursion, observation of the 1750 reservoir breathing bag, and auscultation of breath sounds. 1751 Continual monitoring for the presence of expired carbon dioxide 1752 must be performed unless invalidated by the nature of the 1753 patients condition, the procedure, or the equipment. 1754 Quantitative monitoring of the volume of expired gas must also 1755 be performed. 1756 d.When an endotracheal tube or supraglottic airway is 1757 inserted, its correct positioning must be verified by clinical 1758 assessment and by identification of carbon dioxide in the 1759 expired gas. Continual end-tidal carbon dioxide analysis, in use 1760 from the time of endotracheal tube or supraglottic airway 1761 placement until extubation or removal or initiating transfer of 1762 the patient to a postoperative care location, must be performed 1763 using a quantitative method, such as capnography, capnometry, or 1764 mass spectroscopy, or other technology authorized under board 1765 rule which equals or exceeds the quality of capnography, 1766 capnometry, or mass spectroscopy. When capnography or capnometry 1767 is used, the end-tidal carbon dioxide alarm must be audible to 1768 the qualified anesthesia provider. 1769 e.When ventilation is controlled by a mechanical 1770 ventilator, there must be in continuous use a device capable of 1771 detecting disconnection of components of the breathing system. 1772 The device must give an audible signal when its alarm threshold 1773 is exceeded. 1774 f.During regional anesthesia without sedation or local 1775 anesthesia with no sedation, the adequacy of ventilation must be 1776 evaluated by continual observation of qualitative clinical 1777 signs. During moderate or deep sedation, the adequacy of 1778 ventilation must be evaluated by continual observation of 1779 qualitative clinical signs. Monitoring for the presence of 1780 exhaled carbon dioxide is recommended. 1781 g.Every patient receiving anesthesia must have the 1782 electrocardiogram or other technology authorized under board 1783 rule which equals or exceeds the quality of electrocardiogram 1784 continuously displayed from the beginning of anesthesia until 1785 preparing to leave the anesthetizing location. 1786 h.Every patient receiving anesthesia must have arterial 1787 blood pressure and heart rate determined and evaluated at least 1788 every 5 minutes. 1789 i.Every patient receiving general anesthesia must have 1790 circulatory function continually evaluated by at least one of 1791 the following methods: 1792 (I)Palpation of a pulse. 1793 (II)Auscultation of heart sounds. 1794 (III)Monitoring of a tracing of intra-arterial pressure. 1795 (IV)Ultrasound peripheral pulse monitoring. 1796 (V)Pulse plethysmography or oximetry. 1797 (VI)Other technology authorized under board rule which 1798 equals or exceeds the quality of any of the methods listed in 1799 sub-sub-subparagraphs (I)-(V). 1800 j.Every patient receiving anesthesia must have his or her 1801 temperature monitored when clinically significant changes in 1802 body temperature are intended, anticipated, or suspected. 1803 (k)1.The physician performing the surgery shall ensure 1804 that the postoperative care arrangements made for the patient 1805 are adequate for the procedure being performed, as required by 1806 board rule. 1807 2.Management of postoperative care is the responsibility 1808 of the physician performing the surgery and may be delegated as 1809 determined by board rule. If the physician performing the 1810 surgery is unavailable to provide postoperative care, the 1811 physician performing the surgery must notify the patient of his 1812 or her unavailability for postoperative care before the 1813 procedure. 1814 3.If there is an overnight stay at the office in relation 1815 to any surgical procedure: 1816 a.The office must provide at least two persons to act as 1817 monitors, one of whom must be certified in advanced cardiac life 1818 support, and maintain a monitor-to-patient ratio of at least one 1819 monitor to two patients. 1820 b.Once the physician performing the surgery has signed a 1821 timed and dated discharge order, the office may provide only one 1822 monitor to monitor the patient. The monitor must be qualified by 1823 licensure and training to administer all of the medications 1824 required on the crash cart and must be certified in advanced 1825 cardiac life support. 1826 c.A complete and current crash cart must be present in the 1827 office surgery and immediately accessible for the monitors. 1828 4.The physician performing the surgery must be reachable 1829 by telephone and readily available to return to the office if 1830 needed. 1831 5.A policy and procedures manual must be maintained in the 1832 office at which Level II and Level III procedures are performed. 1833 The manual must be updated and implemented annually. The policy 1834 and procedures manual must provide for all of the following: 1835 a.Duties and responsibilities of all personnel. 1836 b.A quality assessment and improvement system designed to 1837 objectively and systematically monitor and evaluate the quality 1838 and appropriateness of patient care and opportunities to improve 1839 performance. 1840 c.Cleaning procedures and protocols. 1841 d.Sterilization procedures. 1842 e.Infection control procedures and personnel 1843 responsibilities. 1844 f.Emergency procedures. 1845 6.The designated physician shall establish a risk 1846 management program that includes all of the following 1847 components: 1848 a.The identification, investigation, and analysis of the 1849 frequency and causes of adverse incidents. 1850 b.The identification of trends or patterns of adverse 1851 incidents. 1852 c.The development of appropriate measures to correct, 1853 reduce, minimize, or eliminate the risk of adverse incidents. 1854 d.The documentation of such functions and periodic review 1855 of such information at least quarterly by the designated 1856 physician. 1857 7.The designated physician shall report to the department 1858 any adverse incidents that occur within the scope of office 1859 surgeries. This report must be made within 15 days after the 1860 occurrence of an incident as required by s. 458.351. 1861 8.The designated physician is responsible for prominently 1862 posting a sign in the office which states that the office is a 1863 doctors office regulated under this section and ss. 458.328, 1864 458.3281, and 459.0138 and the applicable rules of the Board of 1865 Medicine and the Board of Osteopathic Medicine as set forth in 1866 rules 64B8 and 64B15, Florida Administrative Code. This notice 1867 must also appear prominently within the required patient 1868 informed consent form. 1869 9.All physicians performing surgery at the office surgery 1870 must be qualified by education, training, and experience to 1871 perform any procedure the physician performs in the office 1872 surgery. 1873 10.When Level II, Level II-A, or Level III procedures are 1874 performed in an office surgery setting, the physician performing 1875 the surgery is responsible for providing the patient, in 1876 writing, before the procedure, with the name and location of the 1877 hospital where the physician performing the surgery has 1878 privileges to perform the same procedure as the one being 1879 performed in the office surgery setting or the name and location 1880 of the hospital with which the physician performing the surgery 1881 has a transfer agreement in the event of an emergency. 1882 (4)LEVEL I OFFICE SURGERY. 1883 (a)Scope.Level I office surgery includes the following: 1884 1.Minor procedures such as excision of skin lesions, 1885 moles, warts, cysts, or lipomas and repair of lacerations or 1886 surgery limited to the skin and subcutaneous tissue which are 1887 performed under topical or local anesthesia not involving drug 1888 induced alteration of consciousness other than minimal pre 1889 operative tranquilization of the patient. 1890 2.Liposuction involving the removal of less than 4,000 1891 cubic centimeters of supernatant fat. 1892 3.Incision and drainage of superficial abscesses; limited 1893 endoscopies, such as proctoscopies, skin biopsies, 1894 arthrocentesis, thoracentesis, paracentesis, dilation of the 1895 urethra, cystoscopic procedures, and closed reduction of simple 1896 fractures; or small joint dislocations, such as in the finger or 1897 toe joints. 1898 4.Procedures in which anesthesia is limited to minimal 1899 sedation. The patients level of sedation must be that of 1900 minimal sedation and anxiolysis, and the chances of 1901 complications requiring hospitalization must be remote. As used 1902 in this sub-subparagraph, the term minimal sedation and 1903 anxiolysis means a drug-induced state during which patients 1904 respond normally to verbal commands, and although cognitive 1905 function and physical coordination may be impaired, airway 1906 reflexes and ventilatory and cardiovascular functions remain 1907 unaffected. Controlled substances, as defined in ss. 893.02 and 1908 893.03, must be limited to oral administration in doses 1909 appropriate for the unsupervised treatment of insomnia, anxiety, 1910 or pain. 1911 5.Procedures for which chances of complications requiring 1912 hospitalization are remote as specified in board rule. 1913 (b)Standards of practice.Standards of practice for Level 1914 I office surgery include all of the following: 1915 1.The medical education, training, and experience of the 1916 physician performing the surgery must include training on proper 1917 dosages and management of toxicity or hypersensitivity to 1918 regional anesthetic drugs, and the physician must be certified 1919 in advanced cardiac life support. 1920 2.At least one operating assistant must be certified in 1921 basic life support. 1922 3.Intravenous access supplies, oxygen, oral airways, and a 1923 positive pressure ventilation device must be available in the 1924 office surgery, along with the following medications, stored per 1925 the manufacturers recommendation: 1926 a.Atropine, 3 mg. 1927 b.Diphenhydramine, 50 mg. 1928 c.Epinephrine, 1 mg in 10 ml. 1929 d.Epinephrine, 1 mg in 1 ml vial, 3 vials total. 1930 e.Hydrocortisone, 100 mg. 1931 f.If a benzodiazepine is administered, flumazenil, 0.5 mg 1932 in 5 ml vial, 2 vials total. 1933 g.If an opiate is administered, naloxone, 0.4 mg in 1 ml 1934 vial, 2 vials total. 1935 4.When performing minor procedures, such as excision of 1936 skin lesions, moles, warts, cysts, or lipomas and repair of 1937 lacerations or surgery limited to the skin and subcutaneous 1938 tissue performed under topical or local anesthesia in an office 1939 surgery setting, physicians performing the procedure are exempt 1940 from subparagraphs 1.-3. Current certification in basic life 1941 support is recommended but not required. 1942 5.A physician performing the surgery need not have an 1943 assistant during the procedure unless the specific procedure 1944 being performed requires an assistant. 1945 (5)LEVEL II OFFICE SURGERY. 1946 (a)Scope.Level II office surgery includes, but is not 1947 limited to, all of the following procedures: 1948 1.Hemorrhoidectomy. 1949 2.Hernia repair. 1950 3.Large joint dislocations. 1951 4.Colonoscopy. 1952 5.Liposuction involving the removal of up to 4,000 cubic 1953 centimeters of supernatant fat. 1954 6.Any other procedure the board designates by rule as a 1955 Level II office surgery. 1956 7.Surgeries in which the patients level of sedation is 1957 that of moderate sedation and analgesia or conscious sedation. 1958 As used in this subparagraph, the term moderate sedation and 1959 analgesia or conscious sedation is a drug-induced depression of 1960 consciousness during which patients respond purposefully to 1961 verbal commands, either alone or accompanied by light tactile 1962 stimulation; interventions are not required to maintain a patent 1963 airway; spontaneous ventilation is adequate; and cardiovascular 1964 function is maintained. For purposes of this term, reflex 1965 withdrawal from a painful stimulus is not considered a 1966 purposeful response. 1967 (b)Standards of practice.Standards of practice for Level 1968 II office surgery include, but are not limited to, the 1969 following: 1970 1.The physician performing the surgery, or the office 1971 where the procedure is being performed, must have a transfer 1972 agreement with a licensed hospital within reasonable proximity 1973 if the physician performing the procedure does not have staff 1974 privileges to perform the same procedure as that being performed 1975 in the office surgery setting at a licensed hospital within 1976 reasonable proximity. The transfer agreement required by this 1977 section must be current and have been entered into no more than 1978 5 years before the date of the offices most recent annual 1979 inspection under s. 459.0138. A transfer agreement must 1980 affirmatively disclose an effective date and a termination date. 1981 2.The physician performing the surgery must have staff 1982 privileges at a licensed hospital to perform the same procedure 1983 in that hospital as that being performed in the office surgery 1984 setting or must be able to document satisfactory completion of 1985 training, such as board certification or board eligibility by a 1986 board approved by the American Board of Medical Specialties or 1987 any other board approved by the Board of Medicine or Board of 1988 Osteopathic Medicine, as applicable, or must be able to 1989 establish comparable background, training, and experience. Such 1990 board certification or comparable background, training, and 1991 experience must also be directly related to and include the 1992 procedures being performed by the physician in the office 1993 surgery facility. 1994 3.One assistant must be currently certified in basic life 1995 support. 1996 4.The physician performing the surgery must be currently 1997 certified in advanced cardiac life support. 1998 5.A complete and current crash cart must be available at 1999 all times at the location where the anesthesia is being 2000 administered. The designated physician of an office surgery is 2001 responsible for ensuring that the crash cart is replenished 2002 after each use, the expiration dates for the crash carts 2003 medications are checked weekly, and crash cart events are 2004 documented in the carts logs. Medicines must be stored per the 2005 manufacturers recommendations, and multidose vials must be 2006 dated once opened and checked daily for expiration. The crash 2007 cart must, at a minimum, include the following intravenous or 2008 inhaled medications: 2009 a.Adenosine, 18 mg. 2010 b.Albuterol, 2.5 mg with a small volume nebulizer. 2011 c.Amiodarone, 300 mg. 2012 d.Atropine, 3 mg. 2013 e.Calcium chloride, 1 gram. 2014 f.Dextrose, 50 percent; 50 ml. 2015 g.Diphenhydramine, 50 mg. 2016 h.Dopamine, 200 mg, minimum. 2017 i.Epinephrine, 1 mg, in 10 ml. 2018 j.Epinephrine, 1 mg in 1 ml vial, 3 vials total. 2019 k.Flumazenil, 1 mg. 2020 l.Furosemide, 40 mg. 2021 m.Hydrocortisone, 100 mg. 2022 n.Lidocaine appropriate for cardiac administration, 100 2023 mg. 2024 o.Magnesium sulfate, 2 grams. 2025 p.Naloxone, 1.2 mg. 2026 q.A beta blocker class drug. 2027 r.Sodium bicarbonate, 50 mEq/50 ml. 2028 s.Paralytic agent that is appropriate for use in rapid 2029 sequence intubation. 2030 t.A calcium channel blocker class drug. 2031 u.If nonneuraxial regional blocks are performed, 2032 Intralipid, 20 percent, 500 ml solution. 2033 v.Any additional medication the board determines by rule 2034 is warranted for patient safety and by the evolution of 2035 technology and medical practice. 2036 6.In the event of a drug shortage, the designated 2037 physician is authorized to substitute a therapeutically 2038 equivalent drug that meets the prevailing practice standards. 2039 7.The designated physician is responsible for ensuring 2040 that the office maintains documentation of its unsuccessful 2041 efforts to obtain the required drug. 2042 8.The designated physician is responsible for ensuring 2043 that the following are present in the office surgery: 2044 a.A benzodiazepine. 2045 b.A positive pressure ventilation device, such as Ambu, 2046 plus oxygen supply. 2047 c.An end-tidal carbon dioxide detection device. 2048 d.Monitors for blood pressure, electrocardiography, and 2049 oxygen saturation. 2050 e.Emergency intubation equipment that must, at a minimum, 2051 include suction devices, endotracheal tubes, working 2052 laryngoscopes, oropharyngeal airways, nasopharyngeal airways, 2053 and bag valve mask apparatus that are sized appropriately for 2054 the specific patient. 2055 f.A working defibrillator with defibrillator pads or 2056 defibrillator gel, or an automated external defibrillator unit. 2057 g.Sufficient backup power to allow the physician 2058 performing the surgery to safely terminate the procedure and to 2059 allow the patient to emerge from the anesthetic, all without 2060 compromising the sterility of the procedure or the environment 2061 of care. 2062 h.Working sterilization equipment cultured weekly. 2063 i.Sufficient intravenous solutions and equipment for a 2064 minimum of a weeks worth of surgical cases. 2065 j.Any other equipment required by board rule, as warranted 2066 by the evolution of technology and medical practice. 2067 9.The physician performing the surgery must be assisted by 2068 a qualified anesthesia provider, which may include any of the 2069 following types of providers: 2070 a.An anesthesiologist. 2071 b.A certified registered nurse anesthetist. 2072 c.A registered nurse, if the physician performing the 2073 surgery is certified in advanced cardiac life support and the 2074 registered nurse assists only with local anesthesia or conscious 2075 sedation. 2076 2077 An anesthesiologist assistant may assist the anesthesiologist as 2078 provided by board rule. An assisting anesthesia provider may not 2079 function in any other capacity during the procedure. 2080 10.If additional anesthesia assistance is required by the 2081 specific procedure or patient circumstances, such assistance 2082 must be provided by a physician, osteopathic physician, 2083 registered nurse, licensed practical nurse, or operating room 2084 technician. 2085 11.The designated physician is responsible for ensuring 2086 that each patient is monitored in the recovery room until the 2087 patient is fully recovered from anesthesia. Such monitoring must 2088 be provided by a licensed physician, physician assistant, 2089 registered nurse with postanesthesia care unit experience, or 2090 the equivalent who is currently certified in advanced cardiac 2091 life support, or, in the case of pediatric patients, currently 2092 certified in pediatric advanced life support. 2093 (6)LEVEL II-A OFFICE SURGERY. 2094 (a)Scope.Level II-A office surgeries are those Level II 2095 office surgeries that have a maximum planned duration of 5 2096 minutes or less and in which the chances of complications 2097 requiring hospitalization are remote. 2098 (b)Standards of practice. 2099 1.All practice standards for Level II office surgery set 2100 forth in paragraph (5)(b) must be met for Level II-A office 2101 surgery except for the requirements set forth in subparagraph 2102 (5)(b)9. regarding assistance by a qualified anesthesia 2103 provider. 2104 2.During the surgical procedure, the physician performing 2105 the surgery must be assisted by a licensed physician, physician 2106 assistant, registered nurse, or licensed practical nurse. 2107 3.Additional assistance may be required by specific 2108 procedure or patient circumstances. 2109 4.Following the procedure, a licensed physician, physician 2110 assistant, or registered nurse must be available to monitor the 2111 patient in the recovery room until the patient is recovered from 2112 anesthesia. The monitoring provider must be currently certified 2113 in advanced cardiac life support, or, in the case of pediatric 2114 patients, currently certified in pediatric advanced life 2115 support. 2116 (7)LEVEL III OFFICE SURGERY. 2117 (a)Scope. 2118 1.Level III office surgery includes those types of surgery 2119 during which the patients level of sedation is that of deep 2120 sedation and analgesia or general anesthesia. As used in this 2121 subparagraph, the term: 2122 a.Deep sedation and analgesia means a drug-induced 2123 depression of consciousness during which: 2124 (I)Patients cannot be easily aroused but respond 2125 purposefully following repeated or painful stimulation; 2126 (II)The ability to independently maintain ventilatory 2127 function may be impaired; 2128 (III)Patients may require assistance in maintaining a 2129 patent airway and spontaneous ventilation may be inadequate; and 2130 (IV)Cardiovascular function is usually maintained. 2131 2132 For purposes of this sub-subparagraph, reflex withdrawal from a 2133 painful stimulus is not considered a purposeful response. 2134 b.General anesthesia means a drug-induced loss of 2135 consciousness during which: 2136 (I)Patients are not arousable, even by painful 2137 stimulation; 2138 (II)The ability to independently maintain ventilatory 2139 function is often impaired; 2140 (III)Patients often require assistance in maintaining a 2141 patent airway and positive pressure ventilation may be required 2142 because of depressed spontaneous ventilation or drug-induced 2143 depression of neuromuscular function; and 2144 (IV)Cardiovascular function may be impaired. 2145 2.The use of spinal or epidural anesthesia for a procedure 2146 requires that the procedure be considered a Level III office 2147 surgery. 2148 3.Only patients classified under the American Society of 2149 Anesthesiologists (ASA) risk classification criteria as Class I 2150 or Class II are appropriate candidates for a Level III office 2151 surgery. 2152 a.All Level III office surgeries on patients classified as 2153 ASA III or higher must be performed only in a hospital or 2154 ambulatory surgical center. 2155 b.For all ASA II patients above the age of 50, the 2156 physician performing the surgery must obtain a complete workup 2157 performed before the performance of a Level III office surgery 2158 in the office surgery setting. 2159 c.If the patient has a cardiac history or is deemed to be 2160 a complicated medical patient, the patient must have a 2161 preoperative electrocardiogram and be referred to an appropriate 2162 consultant for medical optimization. The referral to a 2163 consultant may be waived after evaluation by the patients 2164 anesthesiologist. 2165 (b)Standards of practice.Practice standards for Level III 2166 office surgery include all Level II office surgery standards and 2167 all of the following requirements: 2168 1.The physician performing the surgery must have staff 2169 privileges at a licensed hospital to perform the same procedure 2170 in that hospital as that being performed in the office surgery 2171 setting or must be able to document satisfactory completion of 2172 training, such as board certification or board qualification by 2173 a board approved by the American Board of Medical Specialties or 2174 any other board approved by the Board of Medicine or Board of 2175 Osteopathic Medicine, as applicable, or must be able to 2176 demonstrate to the accrediting organization or to the department 2177 comparable background, training, and experience. Such board 2178 certification or comparable background, training, and experience 2179 must also be directly related to and include the procedure being 2180 performed by the physician performing the surgery in the office 2181 surgery setting. In addition, the physician performing the 2182 surgery must have knowledge of the principles of general 2183 anesthesia. 2184 2.The physician performing the surgery must be currently 2185 certified in advanced cardiac life support. 2186 3.At least one operating assistant must be currently 2187 certified in basic life support. 2188 4.An emergency policy and procedures manual related to 2189 serious anesthesia complications must be available in the office 2190 surgery and reviewed biannually by the designated physician, 2191 practiced with staff, updated, and posted in a conspicuous 2192 location in the office. Topics to be covered in the manual must 2193 include all of the following: 2194 a.Airway blockage and foreign body obstruction. 2195 b.Allergic reactions. 2196 c.Bradycardia. 2197 d.Bronchospasm. 2198 e.Cardiac arrest. 2199 f.Chest pain. 2200 g.Hypoglycemia. 2201 h.Hypotension. 2202 i.Hypoventilation. 2203 j.Laryngospasm. 2204 k.Local anesthetic toxicity reaction. 2205 l.Malignant hyperthermia. 2206 m.Any other topics the board determines by rule are 2207 warranted for patient safety and by the evolution of technology 2208 and medical practice. 2209 5.An office surgery performing Level III office surgeries 2210 must maintain all of the equipment and medications required for 2211 Level II office surgeries and comply with all of the following 2212 additional requirements: 2213 a.Maintain at least 720 mg of dantrolene on site if 2214 halogenated anesthetics or succinylcholine are used. 2215 b.Equipment and medication for monitored postanesthesia 2216 recovery must be available in the office. 2217 6.Anesthetic safety regulations must be developed, posted 2218 in a conspicuous location in the office, and enforced by the 2219 designated physician. Such regulations must include all of the 2220 following requirements: 2221 a.All operating room electrical and anesthesia equipment 2222 must be inspected at least semiannually, and a written record of 2223 the results and corrective actions must be maintained. 2224 b.Flammable anesthetic agents may not be employed in 2225 office surgery facilities. 2226 c.Electrical equipment in anesthetizing areas must be on 2227 an audiovisual line isolation monitor, with the exception of 2228 radiologic equipment and fixed lighting more than 5 feet above 2229 the floor. 2230 d.Each anesthesia gas machine must have a pin index safety 2231 system or equivalent safety system and a minimum oxygen flow 2232 safety device. 2233 e.All reusable anesthesia equipment in direct contact with 2234 a patient must be cleaned or sterilized as appropriate after 2235 each use. 2236 f.The following monitors must be applied to all patients 2237 receiving conduction or general anesthesia: 2238 (I)Blood pressure cuff. 2239 (II)A continuous temperature device, readily available to 2240 measure the patients temperature. 2241 (III)Pulse oximeter. 2242 (IV)Electrocardiogram. 2243 (V)An inspired oxygen concentration monitor and a 2244 capnograph, for patients receiving general anesthesia. 2245 g.Emergency intubation equipment must be available in all 2246 office surgery suites. 2247 h.Surgical tables must be capable of Trendelenburg and 2248 other positions necessary to facilitate surgical procedures. 2249 i.An anesthesiologist, a certified registered nurse 2250 anesthetist, an anesthesiologist assistant, or a physician 2251 assistant qualified as set forth in board rule must administer 2252 the general or regional anesthesia. 2253 j.A physician, a registered nurse, a licensed practical 2254 nurse, a physician assistant, or an operating room technician 2255 must assist with the surgery. The anesthesia provider may not 2256 function in any other capacity during the procedure. 2257 k.The patient must be monitored in the recovery room until 2258 he or she has fully recovered from anesthesia. The monitoring 2259 must be provided by a physician, a physician assistant, a 2260 certified registered nurse anesthetist, an anesthesiologist 2261 assistant, or a registered nurse with postanesthesia care unit 2262 experience or the equivalent who is currently certified in 2263 advanced cardiac life support, or, in the case of pediatric 2264 patients, currently certified in pediatric advanced life 2265 support. 2266 (8)EXEMPTION.This section does not apply to a physician 2267 who is dually licensed as a dentist under chapter 466 when he or 2268 she is performing dental procedures that fall within the scope 2269 of practice of dentistry and are regulated under chapter 466. 2270 (9)RULEMAKING.The board may adopt by rule additional 2271 standards of practice for physicians who perform office 2272 surgeries or procedures under this section as warranted for 2273 patient safety and by the evolution of technology and medical 2274 practice. 2275 Section 5.Subsection (6) of section 456.074, Florida 2276 Statutes, is amended to read 2277 456.074Certain health care practitioners; immediate 2278 suspension of license. 2279 (6)The department must issue an emergency order suspending 2280 or restricting the registration of an office registered under s. 2281 458.328 or s. 459.0138 s. 459.0139 upon a finding of probable 2282 cause that the office or a physician practicing in the office is 2283 not in compliance with the standards of practice for office 2284 surgery adopted by the boards pursuant to s. 458.328 or s. 2285 459.0138, as applicable, or is in violation of s. 458.331(1)(v) 2286 or s. 459.015(1)(z), and that such noncompliance or violation 2287 constitutes an immediate danger to the public. 2288 Section 6.This act shall take effect upon becoming a law.