Bill Text: FL S0732 | 2019 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Office Surgery
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2019-06-26 - Chapter No. 2019-130 [S0732 Detail]
Download: Florida-2019-S0732-Introduced.html
Bill Title: Office Surgery
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2019-06-26 - Chapter No. 2019-130 [S0732 Detail]
Download: Florida-2019-S0732-Introduced.html
Florida Senate - 2019 SB 732 By Senator Flores 39-00277A-19 2019732__ 1 A bill to be entitled 2 An act relating to office surgery; amending s. 3 395.002, F.S.; revising the definition of the term 4 “ambulatory surgical center” to remove the exclusion 5 of physician offices; amending ss. 458.309 and 6 459.005, F.S.; deleting provisions related to the 7 registration and inspection of certain offices by the 8 Department of Health and the payment for such 9 registration and inspection, for the purpose of 10 relocating the requirements; creating ss. 458.3266 and 11 459.0138, F.S.; defining terms; relocating the 12 requirements that a person who seeks to operate an 13 office surgery center must register with the 14 department and pay registration costs; providing an 15 exception; requiring each office surgery center to 16 identify to the department a designated physician upon 17 registration or within a specified timeframe after the 18 resignation or termination of a designated physician; 19 authorizing the department to suspend a center’s 20 certificate of registration under certain 21 circumstances; requiring the department to issue a 22 certificate of registration to qualified applicants 23 and prohibiting the department from issuing a 24 certificate to certain centers; requiring the 25 department to revoke a certificate upon making a 26 certain determination; requiring a designated 27 physician of a center to perform certain actions upon 28 the revocation or suspension of the center’s 29 certificate and providing for the disposition of 30 medicinal drugs; authorizing the department to 31 prescribe a certain period of suspension when 32 suspending the certificate of an office surgery 33 center; prohibiting persons named in the registration 34 documents of a center whose certificate was revoked 35 from applying to operate a center for a specified 36 time; prohibiting a registration from being 37 transferred to a new owner and requiring a new owner 38 to register the center with the department before 39 beginning operation under the new ownership; 40 prohibiting a physician from practicing medicine in a 41 center that is not registered with the department; 42 prohibiting a physician from performing certain 43 procedures in a facility or office surgery center; 44 requiring a physician who practices in a center to 45 immediately notify the department of certain 46 noncompliance; requiring a physician to notify the 47 Board of Medicine or Board of Osteopathic Medicine, 48 respectively, within a specified timeframe after 49 beginning or ending his or her practice at a center; 50 providing for disciplinary action; providing 51 requirements for designated physicians; providing 52 facility and infection control requirements for 53 centers; specifying health and safety requirements; 54 prohibiting performance of a level III procedure in a 55 center unless an anesthesiologist is present and 56 available; specifying that level III procedures may be 57 performed only in a center on patients who meet 58 certain conditions; establishing requirements for a 59 surgeon to perform a level III procedure in a center; 60 relocating the requirement that the department inspect 61 each center for compliance annually unless the center 62 is accredited by certain organizations; relocating the 63 requirement that the person who registered and 64 operates the center pay costs of inspection; requiring 65 the Department of Health to attempt to resolve 66 violations during the inspection of a center; 67 requiring the owner or designated physician to 68 document actions taken to resolve violations; 69 requiring the department to verify correction of the 70 violation during a subsequent inspection; authorizing 71 the department to revoke a center’s certificate of 72 registration and prohibit associated physicians from 73 practicing at the center for failure to comply with 74 certain provisions; authorizing the department to 75 impose an administrative fine on a center for 76 violations of specified provisions; requiring the 77 department to consider specified factors in 78 determining whether to impose a penalty or determining 79 the amount of a fine to be imposed on a center; 80 providing that each day a violation continues after 81 the department orders its correction constitutes an 82 additional violation; requiring the department to 83 impose specified fines on an owner or a designated 84 physician for operating an unregistered center; 85 authorizing the department to adopt rules relating to 86 the registration, inspection, and safety of centers; 87 requiring the board to adopt rules specifying training 88 requirements for certain center practitioners; 89 republishing ss. 458.351 and 459.026, F.S., relating 90 to reports of adverse incidents in office practice 91 settings; providing an effective date. 92 93 Be It Enacted by the Legislature of the State of Florida: 94 95 Section 1. Subsection (3) of section 395.002, Florida 96 Statutes, is amended to read: 97 395.002 Definitions.—As used in this chapter: 98 (3) “Ambulatory surgical center” means a facility the 99 primary purpose of which is to provide elective surgical care, 100 in which the patient is admitted to and discharged from such 101 facility within the same working day and is not permitted to 102 stay overnight, and which is not part of a hospital. However, a 103 facility existing for the primary purpose of performing 104 terminations of pregnancy, an office maintained by a physician105for the practice of medicine,or an office maintained for the 106 practice of dentistry may not be construed to be an ambulatory 107 surgical center, provided that any facility or office which is 108 certified or seeks certification as a Medicare ambulatory 109 surgical center shall be licensed as an ambulatory surgical 110 center pursuant to s. 395.003. 111 Section 2. Subsection (3) of section 458.309, Florida 112 Statutes, is amended to read: 113 458.309 Rulemaking authority.— 114(3) A physician who performs liposuction procedures in115which more than 1,000 cubic centimeters of supernatant fat is116removed, level 2 procedures lasting more than 5 minutes, and all117level 3 surgical procedures in an office setting must register118the office with the department unless that office is licensed as119a facility under chapter 395. The department shall inspect the120physician’s office annually unless the office is accredited by a121nationally recognized accrediting agency or an accrediting122organization subsequently approved by the Board of Medicine. The123actual costs for registration and inspection or accreditation124shall be paid by the person seeking to register and operate the125office setting in which office surgery is performed.126 Section 3. Section 458.3266, Florida Statutes, is created 127 to read: 128 458.3266 Office surgery centers.— 129 (1) DEFINITIONS.—As used in this section, the term: 130 (a) “Deep sedation with analgesia” means a drug-induced 131 depression of consciousness during which all of the following 132 apply: 133 1. The patient cannot be easily aroused but responds 134 purposefully following repeated or painful stimulation. 135 2. The patient’s ability to independently maintain 136 ventilatory function may be impaired. 137 3. The patient may require assistance in maintaining a 138 patent airway, and spontaneous ventilation may be inadequate. 139 4. The patient’s cardiovascular function is usually 140 maintained. 141 5. The patient’s reflex withdrawal from painful stimulus is 142 not considered a purposeful response. 143 (b) “Designated physician” means a physician licensed under 144 this chapter or chapter 459 who practices at an office surgery 145 center and who has assumed responsibility for the center’s 146 compliance with this section and related board rules. 147 (c) “General anesthesia” means a drug-induced loss of 148 consciousness administered by an anesthesiologist or a certified 149 registered nurse anesthetist during which all of the following 150 apply: 151 1. The patient is not able to be aroused, even by painful 152 stimulation. 153 2. The patient’s ability to independently maintain 154 ventilatory function is often impaired. 155 3. The patient has a level of depressed neuromuscular 156 function. 157 4. The patient may require assistance in maintaining a 158 patent airway, and positive pressure ventilation is required. 159 5. The patient’s cardiovascular function may be impaired. 160 (d) “Level I procedure” includes procedures in which the 161 patient’s level of sedation is that of minimal sedation, and 162 controlled substances, as defined in ss. 893.02 and 893.03, are 163 limited to oral administration in doses appropriate for the 164 unsupervised treatment of insomnia, anxiety, or pain. The term 165 includes: 166 1. Minor procedures such as excision of skin lesions, 167 moles, warts, cysts, and lipomas; repair of lacerations; or 168 surgery limited to the skin and subcutaneous tissue performed 169 under topical or regional anesthesia not involving drug-induced 170 alteration of consciousness other than minimal preoperative 171 tranquilization of the patient. 172 2. The incision and drainage of superficial abscesses, 173 limited endoscopies such as proctoscopies, skin biopsies, 174 arthrocentesis, thoracentesis, paracentesis, dilation of 175 urethra, cystoscopic procedures, and closed reduction of simple 176 fractures or small joint dislocations, including, but not 177 limited to, finger and toe joints. 178 (e) “Level II procedure” includes any surgery in which the 179 patient’s level of sedation is that of moderate sedation and 180 analgesia or conscious sedation. The term includes, but is not 181 limited to: hemorrhoidectomy, hernia repair, large joint 182 dislocations, colonoscopy, and liposuction involving the removal 183 of up to 1,000 cubic centimeters of supernatant fat. 184 (f) “Level III procedure” includes any surgery in which the 185 patient’s level of sedation is that of deep sedation with 186 analgesia, general anesthesia, and spinal, regional, or epidural 187 anesthesia. 188 (g) “Minimal sedation” includes anxiolysis and means a 189 drug-induced state during which all of the following apply: 190 1. The patient may respond normally to verbal commands. 191 2. The patient’s cognitive function and physical 192 coordination may be impaired, while his or her airway reflexes, 193 ventilation, and cardiovascular functions are unaffected. 194 (h) “Moderate sedation with analgesia” or “conscious 195 sedation” are both drug-induced depressions of consciousness and 196 mean a state of consciousness during which all of the following 197 apply: 198 1. The patient responds purposefully to verbal commands, 199 either alone or accompanied by light tactile stimulation. 200 2. Interventions are not required to maintain a patent 201 airway, and spontaneous ventilation is adequate. 202 3. Cardiovascular function is maintained. 203 4. Reflex withdrawal from a painful stimulus is not 204 considered a purposeful response. 205 (i) “Office surgery” means any manual or operative 206 procedure, including by use of lasers, performed upon the body 207 of a living human being for the purposes of preserving health, 208 diagnosing or curing disease, repairing injury, correcting 209 deformity or defects, prolonging life, or relieving suffering or 210 any elective procedure for aesthetic, reconstructive, or 211 cosmetic purposes, to include, but not be limited to: incision 212 or curettage of tissue or an organ; suture or other repair of 213 tissue or an organ, including both a closed and open reduction 214 of a fracture; extraction of tissue, including premature 215 extraction of the products of conception from the uterus; 216 insertion of natural or artificial implants; or an endoscopic 217 procedure with use of local or general anesthetic. 218 (j) “Office surgery center” means any facility or office 219 surgery setting, other than a facility licensed under chapter 220 390 or chapter 395, where a physician performs any of the 221 following surgical procedures: 222 1. A level I procedure; 223 2. A level II procedure lasting more than 5 minutes; or 224 3. A level III procedure. 225 (k) “Regional anesthesia” is a drug-induced loss of 226 sensation in a circumscribed region of the body, produced by the 227 application of a regional anesthetic, usually by injection. The 228 term includes, but is not limited to, spinal, epidural, and 229 specific nerve blocks. 230 (l) “Surgery” or “surgical” means any manual or operative 231 procedure, including the use of lasers, performed upon the body 232 of a living human being for the purposes of preserving health, 233 diagnosing or curing disease, repairing injury, correcting 234 deformity or defects, prolonging life, or relieving suffering or 235 any elective procedure for aesthetic, reconstructive, or 236 cosmetic purposes. The term includes, but is not limited to, all 237 of the following: incision or curettage of tissue or an organ; 238 suture or other repair of tissue or an organ, including both a 239 closed and an open reduction of a fracture; extraction of 240 tissue, including premature extraction of the products of 241 conception from the uterus; insertion of natural or artificial 242 implants; or an endoscopic procedure with use of local, 243 regional, or general anesthetic. 244 (2) CERTIFICATE OF REGISTRATION.— 245 (a) A person who seeks to operate an office surgery center 246 must register the center with the department unless the center 247 is affiliated with an accredited medical school at which 248 training is provided for medical students, residents, or 249 fellows. 250 (b) Each office surgery center must be registered 251 separately, regardless of whether it is operated under the same 252 business name or management as another center. The actual costs 253 of registration, as determined by the department, must be paid 254 by the person seeking to register and operate the center. 255 (c) At the time of registration and thereafter, each office 256 surgery center shall identify to the department a designated 257 physician. Within 10 days after the resignation or termination 258 of its designated physician, a center shall identify to the 259 department the new designated physician. The department may 260 suspend a center’s certificate of registration for failure to 261 comply with this paragraph. 262 (d) The department shall issue a certificate of 263 registration to a qualified applicant who is required to 264 register under this section. The department may not issue a 265 certificate of registration to an office surgery center that is: 266 1. Not fully owned by a physician licensed under this 267 chapter or chapter 459 or a group of physicians licensed under 268 this chapter or chapter 459; 269 2. Not a health care center licensed under part X of 270 chapter 400; or 271 3. Owned by or in any contractual or employment 272 relationship with a physician licensed under this chapter or 273 chapter 459 who: 274 a. Has had his or her hospital privileges revoked in the 275 last 5 years; 276 b. Does not have a clear and active license with the 277 department; or 278 c. Has been the subject of disciplinary action in this 279 state or in another jurisdiction in the last 5 years for an 280 offense related to standard of care. 281 (e) If the department determines that an office surgery 282 center does not meet the requirements of paragraph (c) or is 283 owned, directly or indirectly, by a physician whose privileges, 284 license, or disciplinary status is identified in sub 285 subparagraph (d)3.a., sub-subparagraph (d)3.b., or sub 286 subparagraph (d)3.c., the department shall revoke the center’s 287 certificate of registration. 288 (f) If the center’s certificate of registration is revoked 289 or suspended, the designated physician of the center shall 290 ensure that, as appropriate, the owner or lessor of the center 291 property, the manager, or the proprietor, as of the effective 292 date of the suspension or revocation: 293 1. Ceases to operate the facility as an office surgery 294 center; and 295 2. Removes any signs and symbols identifying the premises 296 as an office surgery center. 297 (g) Upon the effective date of the suspension or 298 revocation, the designated physician of the office surgery 299 center shall advise the department of the disposition of the 300 medicinal drugs located on the premises. Such disposition is 301 subject to the supervision and approval of the department. 302 Medicinal drugs that are purchased or held by a center that is 303 not registered may be deemed adulterated for purposes of s. 304 499.006. 305 (h) When the department suspends the registration of an 306 office surgery center, it shall prescribe an appropriate period 307 of suspension, not to exceed 2 years. 308 (i) If the office surgery center’s registration is revoked, 309 any person named in the registration documents of the center, 310 including the persons who own or operate the center, may not 311 apply, individually or as part of a group, to operate an office 312 surgery center for a period of 5 years after the revocation 313 date. 314 (j) An office surgery center registration may not be 315 transferred to a new owner. If the ownership of a registered 316 office surgery center changes, the new owner must register the 317 center with the department before beginning operation under the 318 new ownership. 319 (3) OFFICE SURGERY CENTER PHYSICIANS; DESIGNATED 320 PHYSICIANS; PROHIBITION; REQUIREMENTS.— 321 (a)1. A physician may not practice medicine in an office 322 surgery center that is not registered with the department in 323 compliance with this section. 324 2. A physician may not perform surgical procedures in an 325 office surgery center which may: 326 a. Result in blood loss of more than 10 percent of 327 estimated blood volume in a patient having a normal hemoglobin 328 level; 329 b. Require major or prolonged intracranial, intrathoracic, 330 abdominal, or major joint replacement procedures, except for 331 laparoscopic procedures; or 332 c. Involve major blood vessels, when such procedure is 333 performed with direct visualization by open exposure of the 334 major vessel, except for percutaneous endovascular intervention; 335 or are generally emergent or life threatening in nature. 336 3. If a physician who practices in an office surgery center 337 determines that the center is not in compliance with subsection 338 (4), he or she must immediately notify the department of such 339 noncompliance. 340 4. A physician who practices in an office surgery center 341 shall notify the board in writing within 10 days after beginning 342 or ending his or her practice at the office surgery center. 343 344 A physician who violates this paragraph is subject to 345 disciplinary action by the board. 346 (b) The designated physician of an office surgery center 347 shall: 348 1. Ensure that the center maintains an ongoing quality 349 assurance program that objectively and systematically monitors 350 and evaluates the quality and appropriateness of patient care, 351 evaluates methods to improve patient care, identifies and 352 corrects deficiencies at the facility, alerts the designated 353 physician to identify and resolve recurring problems, and 354 provides opportunities for the center to improve its performance 355 and enhance and improve the quality of care provided to the 356 public. 357 2. Establish and document compliance with the quality 358 assurance program which includes at least the following 359 components: 360 a. Identification, investigation, and analysis of the 361 frequency and causes of incidents; 362 b. Identification of trends or patterns of adverse 363 incidents; and 364 c. Development of measures to correct, reduce, minimize, or 365 eliminate the risk of adverse incidents to patients. 366 3. Review, at least quarterly, the quality assurance 367 program. 368 4. Report all adverse incidents to the department as 369 provided in s. 458.351. 370 5. Notify the applicable board in writing of his or her 371 termination of employment within 10 days after such termination. 372 (4) OFFICE SURGERY CENTERS; REQUIREMENTS.—An office surgery 373 center must comply with the following requirements: 374 (a) Facility requirements.—The office surgery center must: 375 1. Be located and operated at a publicly accessible, fixed 376 location. 377 2. Display a sign that clearly identifies the name, hours 378 of operation, and street address of the center. The sign must be 379 prominently displayed in public view. 380 3. Maintain and publicly list a telephone number. 381 4. Provide emergency lighting and for emergency 382 communications. 383 5. Have a reception and waiting area. 384 6. Have a restroom. 385 7. Have an administrative area, including room for storage 386 of medical records, supplies, and equipment. 387 8. Have private patient examination rooms. 388 9. Have treatment rooms, if treatment is being provided to 389 the patients. 390 10. Publicly display a visible printed sign in a 391 conspicuous place in each waiting room which includes the name 392 and contact information of the center’s designated physician and 393 the names of all physicians practicing at the center. 394 11. Comply with ss. 499.0121 and 893.07, if the center 395 stores and dispenses prescription drugs. 396 (b) Infection control requirements.—The center must: 397 1. Maintain equipment and supplies to support infection 398 prevention and control. 399 2. Identify infection risks based on the following: 400 a. Geographic location, community, and population served. 401 b. The nature of the provided care, treatments, and 402 services. 403 c. An analysis of the center’s infection surveillance and 404 control data. 405 3. Maintain written infection prevention policies and 406 procedures that address prioritized risks and limit the 407 following: 408 a. Unprotected exposure to pathogens. 409 b. The transmission of infections associated with 410 procedures performed at the center. 411 c. The transmission of infections associated with the 412 center’s use of medical equipment, devices, and supplies. 413 (c) Health and safety requirements.—The center must: 414 1. Maintain its structurally sound buildings and keep its 415 grounds free from health and safety hazards. 416 2. Keep its furniture, appliances, and equipment clean, 417 safe, and in good repair. 418 3. Have evacuation procedures in the event of an emergency. 419 The procedures must provide for the evacuation of patients with 420 disabilities and center employees. 421 4. Have a written facility-specific disaster plan that 422 specifies actions to be taken in the event of the center closing 423 due to unforeseen disasters. The plan must provide for the 424 protection of medical records and any controlled substances. 425 5. Have at least one employee on the premises during 426 patient care hours who is certified in basic life support and 427 trained in reacting to accidents and medical emergencies. 428 6. Have written emergency policies and procedures related 429 to serious anesthesia complications which must be formulated, 430 reviewed annually, practiced, updated, and posted in a 431 conspicuous location. Such procedures must address all of the 432 following conditions: 433 a. Airway blockage and foreign body obstruction; 434 b. Allergic reactions; 435 c. Bradycardia; 436 d. Bronchospasm; 437 e. Cardiac arrest; 438 f. Chest pain; 439 g. Hypoglycemia; 440 h. Hypotension; 441 i. Hypoventilation; 442 j. Laryngospasm; 443 k. Local anesthetic toxicity reaction; and 444 l. Malignant hyperthermia. 445 (d) Equipment and supplies.—The center must: 446 1. Have the equipment and medications to properly manage 447 and treat a cardiac incident or arrest, including a full and 448 current crash cart with a defibrillator, and, at a minimum, the 449 intravenous or inhaled medications recommended by the American 450 Heart Association Guidelines for CPR & Emergency Cardiovascular 451 Care, as published November 2018, at the location where the 452 anesthetizing is being carried out. 453 2. Store medicines per the manufacturer’s recommendations 454 and note the date on multidose vials once they are opened. 455 3. Maintain dantrolene on site if halogenated anesthetics 456 or succinylcholine are used. 457 4. In terms of general preparation, equipment, and 458 supplies, be comparable to a freestanding ambulatory surgical 459 center, including, but not limited to, patient recovery 460 capability and provisions for proper recordkeeping. 461 5. Have blood pressure monitoring equipment, EKG, end-tidal 462 CO2 monitor, pulse oximeter, emergency intubation equipment, and 463 a temperature monitoring device. 464 6. Have at least one table capable of trendelenburg, 465 lithotomy, and other positions necessary to facilitate the 466 surgical procedure. 467 (e) Level III office surgery requirements.— 468 1. A level III procedure may not be performed in an office 469 surgery center unless an anesthesiologist, as defined in s. 470 458.3475 or s. 459.023, is physically present at the center and 471 available at the time of the procedure. 472 2. For a center in which level III procedures are 473 performed, either: 474 a. The center must have a written patient transfer 475 agreement with a hospital within reasonable proximity to the 476 center which includes the transfer of the patient’s medical 477 records held by the center and the treating physician to the 478 licensed hospital; or 479 b. The surgeon performing the level III procedure must have 480 admitting privileges at a hospital within reasonable proximity 481 to the center. 482 3. Level III procedures may be performed only on a patient 483 who is classified under the American Society of 484 Anesthesiologists’ (ASA) Physical Status Classification System, 485 as approved on October 15, 2014, as Class I or II. 486 4. All ASA Class II patients above the age of 50 undergoing 487 a level III office surgery procedure shall have a complete 488 medical workup performed by the surgeon before the performance 489 of level III surgery. If the patient has a cardiac history or 490 has other complicating health conditions, he or she must have a 491 preoperative EKG and be referred to an appropriate consultant 492 for medical optimization of the complicating conditions. The 493 referral to a consultant may be waived after evaluation by the 494 anesthesiologist to administer or supervise the patient’s 495 anesthesia. 496 5. To perform a level III procedure in an office surgery 497 center, the surgeon must have staff privileges at a licensed 498 hospital to perform the same level III procedure in the hospital 499 or must be able to document satisfactory completion of training, 500 such as board certification or board qualification by a board 501 approved by the American Board of Medical Specialties or any 502 other board approved by the Board of Medicine. 503 (5) INSPECTION.— 504 (a) The department shall inspect each office surgery center 505 annually, including a review of patient records, to ensure that 506 the center complies with this section and board rule, unless the 507 center is accredited by a nationally recognized accrediting 508 agency or an accrediting organization subsequently approved by 509 the board. The department also may inspect an office surgery 510 center as necessary to investigate a notification of 511 noncompliance made by a physician pursuant to subparagraph 512 (3)(a)3. 513 (b) The actual costs of inspection must be paid by the 514 person who registered and operates the office surgery center. 515 (c) During an onsite inspection, the department shall make 516 a reasonable attempt to resolve each violation with the owner or 517 designated physician of the office surgery center before issuing 518 a formal written notification. 519 (d) Any action taken to resolve a violation must be 520 documented in writing by the owner or designated physician of 521 the office surgery center and submitted to the department. The 522 department must verify any correction of the violation in a 523 subsequent inspection. 524 (6) ENFORCEMENT.— 525 (a) The department may revoke an office surgery center’s 526 certificate of registration and prohibit all physicians 527 associated with the center from practicing at the center for 528 failure to comply with this section and rules adopted hereunder. 529 (b) The department may impose an administrative fine of up 530 to $5,000 per violation on an office surgery center for 531 violations of this section; chapter 499, the Florida Drug and 532 Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and 533 Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug 534 Abuse Prevention and Control Act; chapter 893, the Florida 535 Comprehensive Drug Abuse Prevention and Control Act; or 536 department rule. 537 (c) In determining whether to impose a penalty on an office 538 surgery center, and in determining the amount of any fine, the 539 department shall consider all of the following factors: 540 1. The gravity of the violation, including the probability 541 that death or serious physical or emotional harm to a patient 542 has resulted, or could have resulted, from the center’s actions 543 or the actions of the physician; the gravity of the action or 544 potential harm; and the nature of the violations of applicable 545 laws or rules. 546 2. Any actions taken by the owner or designated physician 547 to correct the violation. 548 3. Whether any previous violations were committed at the 549 center. 550 4. Any financial benefits derived by the center from 551 committing or continuing to commit the violation. 552 (d) Each day a violation continues after the date on which 553 the department orders a correction of the violation constitutes 554 an additional, separate, and distinct violation. 555 (e) The department may impose a fine and, in the case of an 556 owner-operated office surgery center, revoke or deny a center’s 557 registration if the center’s designated physician knowingly and 558 intentionally misrepresents actions taken to correct a 559 violation. 560 (f) The department shall impose a fine of $5,000 per day on 561 an owner or designated physician of an office surgery center 562 registered under this section who concurrently operates an 563 unregistered center. 564 (g) The department shall impose a fine of $10,000 on a new 565 owner of an office surgery center that requires registration who 566 fails to register the center upon the change of ownership and 567 who operates the unregistered center. 568 (7) RULEMAKING.— 569 (a) The department may adopt rules to administer the 570 registration, inspection, and safety of office surgery centers. 571 (b) The board shall adopt rules specifying training 572 requirements for all licensed or certified office surgery center 573 health care practitioners and other health care practitioners 574 who are not regulated by any board. 575 Section 4. Section 458.351, Florida Statutes, is 576 republished to read: 577 458.351 Reports of adverse incidents in office practice 578 settings.— 579 (1) Any adverse incident that occurs on or after January 1, 580 2000, in any office maintained by a physician for the practice 581 of medicine which is not licensed under chapter 395 must be 582 reported to the department in accordance with the provisions of 583 this section. 584 (2) Any physician or other licensee under this chapter 585 practicing in this state must notify the department if the 586 physician or licensee was involved in an adverse incident that 587 occurred on or after January 1, 2000, in any office maintained 588 by a physician for the practice of medicine which is not 589 licensed under chapter 395. 590 (3) The required notification to the department must be 591 submitted in writing by certified mail and postmarked within 15 592 days after the occurrence of the adverse incident. 593 (4) For purposes of notification to the department pursuant 594 to this section, the term “adverse incident” means an event over 595 which the physician or licensee could exercise control and which 596 is associated in whole or in part with a medical intervention, 597 rather than the condition for which such intervention occurred, 598 and which results in the following patient injuries: 599 (a) The death of a patient. 600 (b) Brain or spinal damage to a patient. 601 (c) The performance of a surgical procedure on the wrong 602 patient. 603 (d)1. The performance of a wrong-site surgical procedure; 604 2. The performance of a wrong surgical procedure; or 605 3. The surgical repair of damage to a patient resulting 606 from a planned surgical procedure where the damage is not a 607 recognized specific risk as disclosed to the patient and 608 documented through the informed-consent process 609 610 if it results in: death; brain or spinal damage; permanent 611 disfigurement not to include the incision scar; fracture or 612 dislocation of bones or joints; a limitation of neurological, 613 physical, or sensory function; or any condition that required 614 the transfer of the patient. 615 (e) A procedure to remove unplanned foreign objects 616 remaining from a surgical procedure. 617 (f) Any condition that required the transfer of a patient 618 to a hospital licensed under chapter 395 from an ambulatory 619 surgical center licensed under chapter 395 or any facility or 620 any office maintained by a physician for the practice of 621 medicine which is not licensed under chapter 395. 622 (5) The department shall review each incident and determine 623 whether it potentially involved conduct by a health care 624 professional who is subject to disciplinary action, in which 625 case s. 456.073 applies. Disciplinary action, if any, shall be 626 taken by the board under which the health care professional is 627 licensed. 628 (6)(a) The board shall adopt rules establishing a standard 629 informed consent form that sets forth the recognized specific 630 risks related to cataract surgery. The board must propose such 631 rules within 90 days after the effective date of this 632 subsection. 633 (b) Before formally proposing the rule, the board must 634 consider information from physicians licensed under this chapter 635 or chapter 459 regarding recognized specific risks related to 636 cataract surgery and the standard informed consent forms adopted 637 for use in the medical field by other states. 638 (c) A patient’s informed consent is not executed until the 639 patient, or a person authorized by the patient to give consent, 640 and a competent witness sign the form adopted by the board. 641 (d) An incident resulting from recognized specific risks 642 described in the signed consent form is not considered an 643 adverse incident for purposes of s. 395.0197 and this section. 644 (e) In a civil action or administrative proceeding against 645 a physician based on his or her alleged failure to properly 646 disclose the risks of cataract surgery, a patient’s informed 647 consent executed as provided in paragraph (c) on the form 648 adopted by the board is admissible as evidence and creates a 649 rebuttable presumption that the physician properly disclosed the 650 risks. 651 (7) The board may adopt rules to administer this section. 652 Section 5. Section 459.005, Florida Statutes, is amended to 653 read: 654 459.005 Rulemaking authority.— 655(1)The board has authority to adopt rules pursuant to ss. 656 120.536(1) and 120.54 to implement the provisions of this 657 chapter conferring duties upon it. 658(2) A physician who performs liposuction procedures in659which more than 1,000 cubic centimeters of supernatant fat is660removed, level 2 procedures lasting more than 5 minutes, and all661level 3 surgical procedures in an office setting must register662the office with the department unless that office is licensed as663a facility under chapter 395. The department shall inspect the664physician’s office annually unless the office is accredited by a665nationally recognized accrediting agency or an accrediting666organization subsequently approved by the Board of Osteopathic667Medicine. The actual costs for registration and inspection or668accreditation shall be paid by the person seeking to register669and operate the office setting in which office surgery is670performed.671 Section 6. Section 459.0138, Florida Statutes, is created 672 to read: 673 459.0138 Office surgery centers.— 674 (1) DEFINITIONS.—As used in this section, the term: 675 (a) “Deep sedation with analgesia” means a drug-induced 676 depression of consciousness during which all of the following 677 apply: 678 1. The patient cannot be easily aroused but responds 679 purposefully following repeated or painful stimulation. 680 2. The patient’s ability to independently maintain 681 ventilatory function may be impaired. 682 3. The patient may require assistance in maintaining a 683 patent airway, and spontaneous ventilation may be inadequate. 684 4. The patient’s cardiovascular function is usually 685 maintained. 686 5. The patient’s reflex withdrawal from painful stimulus is 687 not considered a purposeful response. 688 (b) “Designated physician” means a physician licensed under 689 this chapter or chapter 458 who practices at an office surgery 690 center and who has assumed responsibility for the center’s 691 compliance with this section and related board rules. 692 (c) “General anesthesia” means a drug-induced loss of 693 consciousness administered by an anesthesiologist or a certified 694 registered nurse anesthetist during which all of the following 695 apply: 696 1. The patient is not able to be aroused, even by painful 697 stimulation. 698 2. The patient’s ability to independently maintain 699 ventilatory function is often impaired. 700 3. The patient has a level of depressed neuromuscular 701 function. 702 4. The patient may require assistance in maintaining a 703 patent airway, and positive pressure ventilation is required. 704 5. The patient’s cardiovascular function may be impaired. 705 (d) “Level I procedure” includes procedures in which the 706 patient’s level of sedation is that of minimal sedation, and 707 controlled substances, as defined in ss. 893.02 and 893.03, are 708 limited to oral administration in doses appropriate for the 709 unsupervised treatment of insomnia, anxiety, or pain. The term 710 includes: 711 1. Minor procedures such as excision of skin lesions, 712 moles, warts, cysts, and lipomas; repair of lacerations; or 713 surgery limited to the skin and subcutaneous tissue performed 714 under topical or regional anesthesia not involving drug-induced 715 alteration of consciousness other than minimal preoperative 716 tranquilization of the patient. 717 2. The incision and drainage of superficial abscesses, 718 limited endoscopies such as proctoscopies, skin biopsies, 719 arthrocentesis, thoracentesis, paracentesis, dilation of 720 urethra, cystoscopic procedures, and closed reduction of simple 721 fractures or small joint dislocations, including, but not 722 limited to, finger and toe joints. 723 (e) “Level II procedure” includes any surgery in which the 724 patient’s level of sedation is that of moderate sedation and 725 analgesia or conscious sedation. The term includes, but is not 726 limited to: hemorrhoidectomy, hernia repair, large joint 727 dislocations, colonoscopy, and liposuction involving the removal 728 of up to 1,000 cubic centimeters of supernatant fat. 729 (f) “Level III procedure” includes any surgery in which the 730 patient’s level of sedation is that of deep sedation with 731 analgesia, general anesthesia, and spinal, regional, or epidural 732 anesthesia. 733 (g) “Minimal sedation” includes anxiolysis and means a 734 drug-induced state during which all of the following apply: 735 1. The patient may respond normally to verbal commands. 736 2. The patient’s cognitive function and physical 737 coordination may be impaired, while his or her airway reflexes, 738 ventilation, and cardiovascular functions are unaffected. 739 (h) “Moderate sedation with analgesia” or “conscious 740 sedation” are both drug-induced depressions of consciousness and 741 mean a state of consciousness during which all of the following 742 apply: 743 1. The patient responds purposefully to verbal commands, 744 either alone or accompanied by light tactile stimulation. 745 2. Interventions are not required to maintain a patent 746 airway, and spontaneous ventilation is adequate. 747 3. Cardiovascular function is maintained. 748 4. Reflex withdrawal from a painful stimulus is not 749 considered a purposeful response. 750 (i) “Office surgery” means any manual or operative 751 procedure, including by use of lasers, performed upon the body 752 of a living human being for the purposes of preserving health, 753 diagnosing or curing disease, repairing injury, correcting 754 deformity or defects, prolonging life, or relieving suffering or 755 any elective procedure for aesthetic, reconstructive, or 756 cosmetic purposes, to include, but not be limited to: incision 757 or curettage of tissue or an organ; suture or other repair of 758 tissue or an organ, including both a closed and open reduction 759 of a fracture; extraction of tissue, including premature 760 extraction of the products of conception from the uterus; 761 insertion of natural or artificial implants; or an endoscopic 762 procedure with use of local or general anesthetic. 763 (j) “Office surgery center” means any facility or office 764 surgery setting, other than a facility licensed under chapter 765 390 or chapter 395, where a physician performs any of the 766 following surgical procedures: 767 1. A level I procedure; 768 2. A level II procedure lasting more than 5 minutes; or 769 3. A level III procedure. 770 (k) “Regional anesthesia” is a drug-induced loss of 771 sensation in a circumscribed region of the body, produced by the 772 application of a regional anesthetic, usually by injection. The 773 term includes, but is not limited to, spinal, epidural, and 774 specific nerve blocks. 775 (l) “Surgery” or “surgical” means any manual or operative 776 procedure, including the use of lasers, performed upon the body 777 of a living human being for the purposes of preserving health, 778 diagnosing or curing disease, repairing injury, correcting 779 deformity or defects, prolonging life, or relieving suffering or 780 any elective procedure for aesthetic, reconstructive, or 781 cosmetic purposes. The term includes, but is not limited to, all 782 of the following: incision or curettage of tissue or an organ; 783 suture or other repair of tissue or an organ, including both a 784 closed and an open reduction of a fracture; extraction of 785 tissue, including premature extraction of the products of 786 conception from the uterus; insertion of natural or artificial 787 implants; or an endoscopic procedure with use of local, 788 regional, or general anesthetic. 789 (2) CERTIFICATE OF REGISTRATION.— 790 (a) A person who seeks to operate an office surgery center 791 must register the center with the department unless the center 792 is affiliated with an accredited medical school at which 793 training is provided for medical students, residents, or 794 fellows. 795 (b) Each office surgery center must be registered 796 separately, regardless of whether it is operated under the same 797 business name or management as another center. The actual costs 798 of registration, as determined by the department, must be paid 799 by the person seeking to register and operate the center. 800 (c) At the time of registration and thereafter, each office 801 surgery center shall identify to the department a designated 802 physician. Within 10 days after the resignation or termination 803 of its designated physician, a center shall identify to the 804 department the new designated physician. The department may 805 suspend a center’s certificate of registration for failure to 806 comply with this paragraph. 807 (d) The department shall issue a certificate of 808 registration to a qualified applicant who is required to 809 register under this section. The department may not issue a 810 certificate of registration to an office surgery center that is: 811 1. Not fully owned by a physician licensed under this 812 chapter or chapter 458 or a group of physicians licensed under 813 this chapter or chapter 458; 814 2. Not a health care center licensed under part X of 815 chapter 400; or 816 3. Owned by or in any contractual or employment 817 relationship with a physician licensed under this chapter or 818 chapter 458 who: 819 a. Has had his or her hospital privileges revoked in the 820 last 5 years; 821 b. Does not have a clear and active license with the 822 department; or 823 c. Has been the subject of disciplinary action in this 824 state or in another jurisdiction in the last 5 years for an 825 offense related to standard of care. 826 (e) If the department determines that an office surgery 827 center does not meet the requirements of paragraph (c) or is 828 owned, directly or indirectly, by a physician whose privileges, 829 license, or disciplinary status is identified in sub 830 subparagraph (d)3.a., sub-subparagraph (d)3.b., or sub 831 subparagraph (d)3.c., the department shall revoke the center’s 832 certificate of registration. 833 (f) If the center’s certificate of registration is revoked 834 or suspended, the designated physician of the center shall 835 ensure that, as appropriate, the owner or lessor of the center 836 property, the manager, or the proprietor, as of the effective 837 date of the suspension or revocation: 838 1. Ceases to operate the facility as an office surgery 839 center; and 840 2. Removes any signs and symbols identifying the premises 841 as an office surgery center. 842 (g) Upon the effective date of the suspension or 843 revocation, the designated physician of the office surgery 844 center shall advise the department of the disposition of the 845 medicinal drugs located on the premises. Such disposition is 846 subject to the supervision and approval of the department. 847 Medicinal drugs that are purchased or held by a center that is 848 not registered may be deemed adulterated for purposes of s. 849 499.006. 850 (h) When the department suspends the registration of an 851 office surgery center, it shall prescribe an appropriate period 852 of suspension, not to exceed 2 years. 853 (i) If the office surgery center’s registration is revoked, 854 any person named in the registration documents of the center, 855 including the persons who own or operate the center, may not 856 apply, individually or as part of a group, to operate an office 857 surgery center for a period of 5 years after the revocation 858 date. 859 (j) An office surgery center registration may not be 860 transferred to a new owner. If the ownership of a registered 861 office surgery center changes, the new owner must register the 862 center with the department before beginning operation under the 863 new ownership. 864 (3) OFFICE SURGERY CENTER PHYSICIANS; DESIGNATED 865 PHYSICIANS; PROHIBITION; REQUIREMENTS.— 866 (a)1. A physician may not practice medicine in an office 867 surgery center that is not registered with the department in 868 compliance with this section. 869 2. A physician may not perform surgical procedures in an 870 office surgery center which may: 871 a. Result in blood loss of more than 10 percent of 872 estimated blood volume in a patient having a normal hemoglobin 873 level; 874 b. Require major or prolonged intracranial, intrathoracic, 875 abdominal, or major joint replacement procedures, except for 876 laparoscopic procedures; or 877 c. Involve major blood vessels, when such procedure is 878 performed with direct visualization by open exposure of the 879 major vessel, except for percutaneous endovascular intervention; 880 or are generally emergent or life threatening in nature. 881 3. If a physician who practices in an office surgery center 882 determines that the center is not in compliance with subsection 883 (4), he or she must immediately notify the department of such 884 noncompliance. 885 4. A physician who practices in an office surgery center 886 shall notify the board in writing within 10 days after beginning 887 or ending his or her practice at the office surgery center. 888 889 A physician who violates this paragraph is subject to 890 disciplinary action by the board. 891 (b) The designated physician of an office surgery center 892 shall: 893 1. Ensure that the center maintains an ongoing quality 894 assurance program that objectively and systematically monitors 895 and evaluates the quality and appropriateness of patient care, 896 evaluates methods to improve patient care, identifies and 897 corrects deficiencies at the facility, alerts the designated 898 physician to identify and resolve recurring problems, and 899 provides opportunities for the center to improve its performance 900 and enhance and improve the quality of care provided to the 901 public. 902 2. Establish and document compliance with the quality 903 assurance program which includes at least the following 904 components: 905 a. Identification, investigation, and analysis of the 906 frequency and causes of incidents; 907 b. Identification of trends or patterns of adverse 908 incidents; and 909 c. Development of measures to correct, reduce, minimize, or 910 eliminate the risk of adverse incidents to patients. 911 3. Review, at least quarterly, the quality assurance 912 program. 913 4. Report all adverse incidents to the department as 914 provided in s. 459.026. 915 5. Notify the applicable board in writing of his or her 916 termination of employment within 10 days after such termination. 917 (4) OFFICE SURGERY CENTERS; REQUIREMENTS.—An office surgery 918 center must comply with the following requirements: 919 (a) Facility requirements.—The office surgery center must: 920 1. Be located and operated at a publicly accessible, fixed 921 location. 922 2. Display a sign that clearly identifies the name, hours 923 of operation, and street address of the center. The sign must be 924 prominently displayed in public view. 925 3. Maintain and publicly list a telephone number. 926 4. Provide emergency lighting and for emergency 927 communications. 928 5. Have a reception and waiting area. 929 6. Have a restroom. 930 7. Have an administrative area, including room for storage 931 of medical records, supplies, and equipment. 932 8. Have private patient examination rooms. 933 9. Have treatment rooms, if treatment is being provided to 934 the patients. 935 10. Publicly display a visible printed sign in a 936 conspicuous place in each waiting room which includes the name 937 and contact information of the center’s designated physician and 938 the names of all physicians practicing at the center. 939 11. Comply with ss. 499.0121 and 893.07, if the center 940 stores and dispenses prescription drugs. 941 (b) Infection control requirements.—The center must: 942 1. Maintain equipment and supplies to support infection 943 prevention and control. 944 2. Identify infection risks based on the following: 945 a. Geographic location, community, and population served. 946 b. The nature of the provided care, treatments, and 947 services. 948 c. An analysis of the center’s infection surveillance and 949 control data. 950 3. Maintain written infection prevention policies and 951 procedures that address prioritized risks and limit the 952 following: 953 a. Unprotected exposure to pathogens. 954 b. The transmission of infections associated with 955 procedures performed at the center. 956 c. The transmission of infections associated with the 957 center’s use of medical equipment, devices, and supplies. 958 (c) Health and safety requirements.—The center must: 959 1. Maintain its structurally sound buildings and keep its 960 grounds free from health and safety hazards. 961 2. Keep its furniture, appliances, and equipment clean, 962 safe, and in good repair. 963 3. Have evacuation procedures in the event of an emergency. 964 The procedures must provide for the evacuation of patients with 965 disabilities and center employees. 966 4. Have a written facility-specific disaster plan that 967 specifies actions to be taken in the event of the center closing 968 due to unforeseen disasters. The plan must provide for the 969 protection of medical records and any controlled substances. 970 5. Have at least one employee on the premises during 971 patient care hours who is certified in basic life support and 972 trained in reacting to accidents and medical emergencies. 973 6. Have written emergency policies and procedures related 974 to serious anesthesia complications which must be formulated, 975 reviewed annually, practiced, updated, and posted in a 976 conspicuous location. Such procedures must address all of the 977 following conditions: 978 a. Airway blockage and foreign body obstruction; 979 b. Allergic reactions; 980 c. Bradycardia; 981 d. Bronchospasm; 982 e. Cardiac arrest; 983 f. Chest pain; 984 g. Hypoglycemia; 985 h. Hypotension; 986 i. Hypoventilation; 987 j. Laryngospasm; 988 k. Local anesthetic toxicity reaction; and 989 l. Malignant hyperthermia. 990 (d) Equipment and supplies.—The center must: 991 1. Have the equipment and medications to properly manage 992 and treat a cardiac incident or arrest, including a full and 993 current crash cart with a defibrillator, and, at a minimum, the 994 intravenous or inhaled medications recommended by the American 995 Heart Association Guidelines for CPR & Emergency Cardiovascular 996 Care, as published November 2018, at the location where the 997 anesthetizing is being carried out. 998 2. Store medicines per the manufacturer’s recommendations 999 and note the date on multidose vials once they are opened. 1000 3. Maintain dantrolene on site if halogenated anesthetics 1001 or succinylcholine are used. 1002 4. In terms of general preparation, equipment, and 1003 supplies, be comparable to a freestanding ambulatory surgical 1004 center, including, but not limited to, patient recovery 1005 capability and provisions for proper recordkeeping. 1006 5. Have blood pressure monitoring equipment, EKG, end-tidal 1007 CO2 monitor, pulse oximeter, emergency intubation equipment, and 1008 a temperature monitoring device. 1009 6. Have at least one table capable of trendelenburg, 1010 lithotomy, and other positions necessary to facilitate the 1011 surgical procedure. 1012 (e) Level III office surgery requirements.— 1013 1. A level III procedure may not be performed in an office 1014 surgery center unless an anesthesiologist, as defined in s. 1015 458.3475 or s. 459.023, is physically present at the center and 1016 available at the time of the procedure. 1017 2. For a center in which level III procedures are 1018 performed, either: 1019 a. The center must have a written patient transfer 1020 agreement with a hospital within reasonable proximity to the 1021 center which includes the transfer of the patient’s medical 1022 records held by the center and the treating physician to the 1023 licensed hospital; or 1024 b. The surgeon performing the level III procedure must have 1025 admitting privileges at a hospital within reasonable proximity 1026 to the center. 1027 3. Level III procedures may be performed only on a patient 1028 who is classified under the American Society of 1029 Anesthesiologists’ (ASA) Physical Status Classification System, 1030 as approved on October 15, 2014, as Class I or II. 1031 4. All ASA Class II patients above the age of 50 undergoing 1032 a level III office surgery procedure shall have a complete 1033 medical workup performed by the surgeon before the performance 1034 of level III surgery. If the patient has a cardiac history or 1035 has other complicating health conditions, he or she must have a 1036 preoperative EKG and be referred to an appropriate consultant 1037 for medical optimization of the complicating conditions. The 1038 referral to a consultant may be waived after evaluation by the 1039 anesthesiologist to administer or supervise the patient’s 1040 anesthesia. 1041 5. To perform a level III procedure in an office surgery 1042 center, the surgeon must have staff privileges at a licensed 1043 hospital to perform the same level III procedure in the hospital 1044 or must be able to document satisfactory completion of training, 1045 such as board certification or board qualification by a board 1046 approved by the American Board of Medical Specialties or any 1047 other board approved by the Board of Medicine. 1048 (5) INSPECTION.— 1049 (a) The department shall inspect each office surgery center 1050 annually, including a review of patient records, to ensure that 1051 the center complies with this section and board rule, unless the 1052 center is accredited by a nationally recognized accrediting 1053 agency or an accrediting organization subsequently approved by 1054 the board. The department also may inspect an office surgery 1055 center as necessary to investigate a notification of 1056 noncompliance made by a physician pursuant to subparagraph 1057 (3)(a)3. 1058 (b) The actual costs of inspection must be paid by the 1059 person who registered and operates the office surgery center. 1060 (c) During an onsite inspection, the department shall make 1061 a reasonable attempt to resolve each violation with the owner or 1062 designated physician of the office surgery center before issuing 1063 a formal written notification. 1064 (d) Any action taken to resolve a violation must be 1065 documented in writing by the owner or designated physician of 1066 the office surgery center and submitted to the department. The 1067 department must verify any correction of the violation in a 1068 subsequent inspection. 1069 (6) ENFORCEMENT.— 1070 (a) The department may revoke an office surgery center’s 1071 certificate of registration and prohibit all physicians 1072 associated with the center from practicing at the center for 1073 failure to comply with this section and rules adopted hereunder. 1074 (b) The department may impose an administrative fine of up 1075 to $5,000 per violation on an office surgery center for 1076 violations of this section; chapter 499, the Florida Drug and 1077 Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and 1078 Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug 1079 Abuse Prevention and Control Act; chapter 893, the Florida 1080 Comprehensive Drug Abuse Prevention and Control Act; or 1081 department rule. 1082 (c) In determining whether to impose a penalty on an office 1083 surgery center, and in determining the amount of any fine, the 1084 department shall consider all of the following factors: 1085 1. The gravity of the violation, including the probability 1086 that death or serious physical or emotional harm to a patient 1087 has resulted, or could have resulted, from the center’s actions 1088 or the actions of the physician; the gravity of the action or 1089 potential harm; and the nature of the violations of applicable 1090 laws or rules. 1091 2. Any actions taken by the owner or designated physician 1092 to correct the violation. 1093 3. Whether any previous violations were committed at the 1094 center. 1095 4. Any financial benefits derived by the center from 1096 committing or continuing to commit the violation. 1097 (d) Each day a violation continues after the date on which 1098 the department orders a correction of the violation constitutes 1099 an additional, separate, and distinct violation. 1100 (e) The department may impose a fine and, in the case of an 1101 owner-operated office surgery center, revoke or deny a center’s 1102 registration if the center’s designated physician knowingly and 1103 intentionally misrepresents actions taken to correct a 1104 violation. 1105 (f) The department shall impose a fine of $5,000 per day on 1106 an owner or designated physician of an office surgery center 1107 registered under this section who concurrently operates an 1108 unregistered center. 1109 (g) The department shall impose a fine of $10,000 on a new 1110 owner of an office surgery center that requires registration who 1111 fails to register the center upon the change of ownership and 1112 who operates the unregistered center. 1113 (7) RULEMAKING.— 1114 (a) The department may adopt rules to administer the 1115 registration, inspection, and safety of office surgery centers. 1116 (b) The board shall adopt rules specifying training 1117 requirements for all licensed or certified office surgery center 1118 health care practitioners and other health care practitioners 1119 who are not regulated by any board. 1120 Section 7. Section 459.026, Florida Statutes, is 1121 republished to read: 1122 459.026 Reports of adverse incidents in office practice 1123 settings.— 1124 (1) Any adverse incident that occurs on or after January 1, 1125 2000, in any office maintained by an osteopathic physician for 1126 the practice of osteopathic medicine which is not licensed under 1127 chapter 395 must be reported to the department in accordance 1128 with the provisions of this section. 1129 (2) Any osteopathic physician or other licensee under this 1130 chapter practicing in this state must notify the department if 1131 the osteopathic physician or licensee was involved in an adverse 1132 incident that occurred on or after January 1, 2000, in any 1133 office maintained by an osteopathic physician for the practice 1134 of osteopathic medicine which is not licensed under chapter 395. 1135 (3) The required notification to the department must be 1136 submitted in writing by certified mail and postmarked within 15 1137 days after the occurrence of the adverse incident. 1138 (4) For purposes of notification to the department pursuant 1139 to this section, the term “adverse incident” means an event over 1140 which the physician or licensee could exercise control and which 1141 is associated in whole or in part with a medical intervention, 1142 rather than the condition for which such intervention occurred, 1143 and which results in the following patient injuries: 1144 (a) The death of a patient. 1145 (b) Brain or spinal damage to a patient. 1146 (c) The performance of a surgical procedure on the wrong 1147 patient. 1148 (d)1. The performance of a wrong-site surgical procedure; 1149 2. The performance of a wrong surgical procedure; or 1150 3. The surgical repair of damage to a patient resulting 1151 from a planned surgical procedure where the damage is not a 1152 recognized specific risk as disclosed to the patient and 1153 documented through the informed-consent process 1154 1155 if it results in: death; brain or spinal damage; permanent 1156 disfigurement not to include the incision scar; fracture or 1157 dislocation of bones or joints; a limitation of neurological, 1158 physical, or sensory function; or any condition that required 1159 the transfer of the patient. 1160 (e) A procedure to remove unplanned foreign objects 1161 remaining from a surgical procedure. 1162 (f) Any condition that required the transfer of a patient 1163 to a hospital licensed under chapter 395 from an ambulatory 1164 surgical center licensed under chapter 395 or any facility or 1165 any office maintained by a physician for the practice of 1166 medicine which is not licensed under chapter 395. 1167 (5) The department shall review each incident and determine 1168 whether it potentially involved conduct by a health care 1169 professional who is subject to disciplinary action, in which 1170 case s. 456.073 applies. Disciplinary action, if any, shall be 1171 taken by the board under which the health care professional is 1172 licensed. 1173 (6)(a) The board shall adopt rules establishing a standard 1174 informed consent form that sets forth the recognized specific 1175 risks related to cataract surgery. The board must propose such 1176 rules within 90 days after the effective date of this 1177 subsection. 1178 (b) Before formally proposing the rule, the board must 1179 consider information from physicians licensed under chapter 458 1180 or this chapter regarding recognized specific risks related to 1181 cataract surgery and the standard informed consent forms adopted 1182 for use in the medical field by other states. 1183 (c) A patient’s informed consent is not executed until the 1184 patient, or a person authorized by the patient to give consent, 1185 and a competent witness sign the form adopted by the board. 1186 (d) An incident resulting from recognized specific risks 1187 described in the signed consent form is not considered an 1188 adverse incident for purposes of s. 395.0197 and this section. 1189 (e) In a civil action or administrative proceeding against 1190 a physician based on his or her alleged failure to properly 1191 disclose the risks of cataract surgery, a patient’s informed 1192 consent executed as provided in paragraph (c) on the form 1193 adopted by the board is admissible as evidence and creates a 1194 rebuttable presumption that the physician properly disclosed the 1195 risks. 1196 (7) The board may adopt rules to administer this section. 1197 Section 8. This act shall take effect July 1, 2019. 1198