Florida Senate - 2024                        COMMITTEE AMENDMENT
       Bill No. CS for SB 1188
       
       
       
       
       
       
                                Ì148378UÎ148378                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: WD            .                                
                  02/25/2024           .                                
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       The Committee on Fiscal Policy (Garcia) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 458.328, Florida Statutes, is amended to
    6  read:
    7         458.328 Office surgeries.—
    8         (1) REGISTRATION.—
    9         (a)1. An office in which a physician performs or intends to
   10  perform a liposuction procedure in which more than 1,000 cubic
   11  centimeters of supernatant fat is temporarily or permanently
   12  removed, a liposuction procedure during which the patient is
   13  rotated between the supine, lateral, and prone positions, a
   14  Level II office surgery, or a Level III office surgery must
   15  register with the department. unless the office is licensed as A
   16  facility licensed under chapter 390 or chapter 395 may not be
   17  registered under this section.
   18         (b)2. The department must complete an inspection of any
   19  office seeking registration under this section before the office
   20  may be registered.
   21         1. The inspection of the office seeking registration under
   22  this section must include inspection for compliance with the
   23  standards of practice set out in this section and s. 458.3281
   24  and any applicable board rules for the levels of office surgery
   25  and procedures listed on the application which any physician
   26  practicing at the office performs or intends to perform. The
   27  application must be updated within 10 calendar days before any
   28  additional surgical procedures or levels of office surgery are
   29  to be performed at the office. Failure to timely update the
   30  application for any such additional surgical procedures or
   31  levels of office surgery is a violation of this section and
   32  subject to discipline under ss. 456.072 and 458.331.
   33         2. The department must immediately suspend the registration
   34  process of an office that refuses an inspection under
   35  subparagraph 1., and the applicant must be required to reapply
   36  for registration.
   37         3. If the department determines that an office seeking
   38  registration under this section is one in which a physician may
   39  perform, or intends to perform, liposuction procedures that
   40  include a patient being rotated between the supine, lateral, and
   41  prone positions during the procedure, or in which a physician
   42  may perform, or intends to perform, gluteal fat grafting
   43  procedures, the office must provide proof to the department that
   44  it has met the applicable requirements of s. 469 of the Florida
   45  Building Code, relating to office surgery suites, and s.
   46  458.3281 and the applicable rules adopted thereunder, and the
   47  department must inspect the office to ensure that all of the
   48  following are present or in place:
   49         a. Equipment and a procedure for measuring and documenting
   50  in a log the amount of supernatant fat removed, both temporarily
   51  and permanently, from a particular patient, including tissue
   52  disposal procedures.
   53         b. A procedure for measuring and documenting the amount of
   54  lidocaine injected for tumescent liposuction, if used.
   55         c. Working ultrasound guidance equipment or other guidance
   56  technology authorized under board rule which equals or exceeds
   57  the quality of ultrasound guidance.
   58         d. The office procedure for obtaining blood products.
   59         e. Documentation on file at the office demonstrating that
   60  any physician performing these procedures has privileges to
   61  perform such procedures in a hospital no more than 20 minutes
   62  away.
   63         f. Procedures for emergency resuscitation and transport to
   64  a hospital.
   65         g. Procedures for anesthesia and surgical recordkeeping.
   66         h. Any additional inspection requirements, as set by board
   67  rule.
   68         4. If an applicant is unable to provide proof to the
   69  department that the office seeking registration is in compliance
   70  with the applicable requirements of s. 469 of the Florida
   71  Building Code, relating to office surgery suites, or s. 458.3281
   72  or the applicable rules adopted thereunder, in accordance with
   73  subparagraph 3., the department must notify the Agency for
   74  Health Care Administration and request the agency to inspect the
   75  office and consult with the office about the process to apply
   76  for ambulatory surgical center licensure under chapter 395 and
   77  how the office may seek qualification for such licensure,
   78  notwithstanding the office’s failure to meet all requirements
   79  associated with such licensure at the time of inspection and
   80  notwithstanding any pertinent exceptions provided under s.
   81  395.002(3).
   82         (c)(b) To be By January 1, 2020, each office registered
   83  under this section or s. 459.0138, an office must, at the time
   84  of application, list a designated designate a physician who is
   85  responsible for the office’s compliance with the office health
   86  and safety requirements of this section and rules adopted
   87  hereunder. A designated physician must have a full, active, and
   88  unencumbered license under this chapter or chapter 459 and shall
   89  practice at the office for which he or she has assumed
   90  responsibility. Within 10 calendar days after the termination of
   91  a designated physician relationship, the office must notify the
   92  department of the designation of another physician to serve as
   93  the designated physician. The department may not register an
   94  office if the office fails to comply with this requirement at
   95  the time of application and must seek an emergency suspension of
   96  suspend the registration of an office pursuant to s. 456.074(6)
   97  if the office fails to timely notify the department of its new
   98  designated physician within 10 calendar days after the
   99  termination of the previous designated physician relationship
  100  comply with the requirements of this paragraph.
  101         (d) As a condition of registration, each office must, at
  102  the time of application, list all medical personnel who will be
  103  practicing at the office, including all of the following:
  104         1. Physicians who intend to practice surgery or assist in
  105  surgery at the office seeking registration, including their
  106  respective license numbers and practice addresses.
  107         2. Anesthesia providers, including their license numbers.
  108         3. Nursing personnel licensed under chapter 464, including
  109  their license numbers unless already provided under subparagraph
  110  2.
  111         4. Physician assistants, including their respective license
  112  numbers and supervising physicians.
  113  
  114  The office must notify the department of the addition or
  115  termination of any of the types of medical personnel specified
  116  under this paragraph within 10 calendar days before such
  117  addition or after such termination. Failure to timely notify the
  118  department of such addition or termination is a violation of
  119  this section and subject to discipline under ss. 456.072 and
  120  458.331.
  121         (e)(c) As a condition of registration, each office must
  122  establish financial responsibility by demonstrating that it has
  123  met and continues to maintain, at a minimum, the same
  124  requirements applicable to physicians in ss. 458.320 and
  125  459.0085. Each physician practicing at an office registered
  126  under this section or s. 459.0138 must meet the financial
  127  responsibility requirements under s. 458.320 or s. 459.0085, as
  128  applicable.
  129         (f)(d) Each physician practicing or intending to practice
  130  at an office registered under this section or s. 459.0138 must
  131  shall advise the board, in writing, within 10 calendar days
  132  before after beginning or after ending his or her practice at a
  133  registered office, as applicable.
  134         (g)(e)1. The department shall inspect a registered office
  135  at least annually, including a review of patient records,
  136  anesthesia logs, surgery logs, and liposuction logs to ensure
  137  that the office is in compliance with this section and rules
  138  adopted hereunder unless the office is accredited in office
  139  based surgery by the Joint Commission or other a nationally
  140  recognized accrediting agency approved by the board. The
  141  inspection may be unannounced, except for the inspection of an
  142  office that meets the description of a clinic specified in s.
  143  458.3265(1)(a)3.h., and those wholly owned and operated
  144  physician offices described in s. 458.3265(1)(a)3.g. which
  145  perform procedures referenced in s. 458.3265(1)(a)3.h., which
  146  must be announced.
  147         (h)2. The department must immediately suspend the
  148  registration of a registered office that refuses an inspection
  149  under paragraph (g) subparagraph 1. The office must close during
  150  such suspension. The suspension must remain in effect for at
  151  least 14 consecutive days and may not terminate until the
  152  department issues a written declaration that the office may
  153  reopen following the department’s completion of an inspection of
  154  the office.
  155         (i)(f) The department may suspend or revoke the
  156  registration of an office in which a procedure or surgery
  157  identified in paragraph (a) is performed for failure of any of
  158  its physicians, owners, or operators to comply with this section
  159  and rules adopted hereunder or s. 459.0138 and rules adopted
  160  thereunder. If an office’s registration is revoked for any
  161  reason, the department may deny any person named in the
  162  registration documents of the office, including the persons who
  163  own or operate the office, individually or as part of a group,
  164  from registering an office to perform procedures or office
  165  surgeries pursuant to this section or s. 459.0138 for 5 years
  166  after the revocation date.
  167         (j)(g) The department may impose any penalty set forth in
  168  s. 456.072(2) against the designated physician for failure of
  169  the office to operate in compliance with the office health and
  170  safety requirements of this section and rules adopted hereunder
  171  or s. 459.0138 and rules adopted thereunder.
  172         (h) A physician may only perform a procedure or surgery
  173  identified in paragraph (a) in an office that is registered with
  174  the department. The board shall impose a fine of $5,000 per day
  175  on a physician who performs a procedure or surgery in an office
  176  that is not registered with the department.
  177         (k)(i) The actual costs of registration and inspection or
  178  accreditation must shall be paid by the person seeking to
  179  register and operate the office in which a procedure or surgery
  180  identified in paragraph (a) will be performed.
  181         (2) REGISTRATION UPDATE.—
  182         (a) An office that registered under this section before
  183  July 1, 2024, in which a physician performs liposuction
  184  procedures that include a patient being rotated between the
  185  supine, lateral, and prone positions during the procedure or in
  186  which a physician performs gluteal fat grafting procedures must
  187  provide a registration update to the department consistent with
  188  the requirements of the initial registration under subsection
  189  (1) no later than 30 days before the office surgery’s next
  190  annual inspection.
  191         (b) Registration update inspections required under
  192  subsection (1) must be performed by the department on the date
  193  of the office surgery’s next annual inspection.
  194         (c) During the registration update process, the office
  195  surgery may continue to operate under the original registration.
  196         (d) In order to provide an office surgery time to update to
  197  the requirements of subsection (1) and s. 458.3281, effective
  198  July 1, 2024, and the applicable provisions of s. 469 of the
  199  Florida Building Code, relating to office surgery suites, any
  200  office surgery registered under this section before July 1,
  201  2024, whose annual inspection is due in July or August 2024, may
  202  request from the department, in writing, a 60-day postponement
  203  of the required annual inspection, which postponement must be
  204  granted.
  205         (e) All other requests to the department for a postponement
  206  of the registration update inspection required under this
  207  registration update process must be in writing and be approved
  208  by the chair of the Board of Medicine for good cause shown, and
  209  such postponement may not exceed 30 days.
  210         (3) STANDARDS OF PRACTICE.—
  211         (a) A physician performing a procedure or surgery in an
  212  office registered under this section must comply with the
  213  applicable provisions of s. 469 of the Florida Building Code,
  214  relating to office surgery suites, and the standards of practice
  215  for office surgery set forth in this section and s. 458.3281, as
  216  applicable, and any applicable rules adopted thereunder.
  217         (b) A physician may not perform any surgery or procedure
  218  identified in paragraph (1)(a) in a setting other than an office
  219  registered under this section or a facility licensed under
  220  chapter 390 or chapter 395, as applicable. The board shall
  221  impose a fine of $5,000 per incident on a physician who violates
  222  this paragraph performing a gluteal fat grafting procedure in an
  223  office surgery setting shall adhere to standards of practice
  224  pursuant to this subsection and rules adopted by the board.
  225         (c)(b) Office surgeries may not:
  226         1. Be a type of surgery that generally results in blood
  227  loss of more than 10 percent of estimated blood volume in a
  228  patient with a normal hemoglobin level;
  229         2. Require major or prolonged intracranial, intrathoracic,
  230  abdominal, or joint replacement procedures, except for
  231  laparoscopic procedures;
  232         3. Involve major blood vessels and be performed with direct
  233  visualization by open exposure of the major blood vessel, except
  234  for percutaneous endovascular intervention; or
  235         4. Be emergent or life threatening.
  236         (d)(c) A physician performing a gluteal fat grafting
  237  procedure in an office surgery setting must comply with the
  238  applicable provisions of s. 469 of the Florida Building Code,
  239  relating to office surgery suites, and the standards of practice
  240  under this subsection and s. 458.3281, and applicable rules
  241  adopted thereunder, including, but not limited to, all of the
  242  following standards of practice:
  243         1. The A physician performing the a gluteal fat grafting
  244  procedure must conduct an in-person examination of the patient
  245  while physically present in the same room as the patient no
  246  later than the day before the procedure.
  247         2. Before a physician may delegate any duties during a
  248  gluteal fat grafting procedure, the patient must provide
  249  written, informed consent for such delegation. Any duty
  250  delegated by a physician during a gluteal fat grafting procedure
  251  must be performed under the direct supervision of the physician
  252  performing such procedure. Fat extraction and gluteal fat
  253  injections must be performed by the physician and may not be
  254  delegated.
  255         3. Fat may only be injected into the subcutaneous space of
  256  the patient and may not cross the fascia overlying the gluteal
  257  muscle. Intramuscular or submuscular fat injections are
  258  prohibited.
  259         4. When the physician performing a gluteal fat grafting
  260  procedure injects fat into the subcutaneous space of the
  261  patient, the physician must use ultrasound guidance, or guidance
  262  with other technology authorized under board rule which equals
  263  or exceeds the quality of ultrasound, during the placement and
  264  navigation of the cannula to ensure that the fat is injected
  265  into the subcutaneous space of the patient above the fascia
  266  overlying the gluteal muscle. Such guidance with the use of
  267  ultrasound or other technology is not required for other
  268  portions of such procedure.
  269         5. An office in which a physician performs gluteal fat
  270  grafting procedures shall at all times maintain a ratio of one
  271  physician to one patient during all phases of the procedure,
  272  beginning with the administration of anesthesia to the patient
  273  and concluding with the extubation of the patient. After a
  274  physician has commenced, and while he or she is engaged in, a
  275  gluteal fat grafting procedure, the physician may not commence
  276  or engage in another gluteal fat grafting procedure or any other
  277  procedure with another patient at the same time.
  278         (e)(d) If a procedure in an office surgery setting results
  279  in hospitalization, the incident must be reported as an adverse
  280  incident pursuant to s. 458.351.
  281         (e) An office in which a physician performs gluteal fat
  282  grafting procedures must at all times maintain a ratio of one
  283  physician to one patient during all phases of the procedure,
  284  beginning with the administration of anesthesia to the patient
  285  and concluding with the extubation of the patient. After a
  286  physician has commenced, and while he or she is engaged in, a
  287  gluteal fat grafting procedure, the physician may not commence
  288  or engage in another gluteal fat grafting procedure or any other
  289  procedure with another patient at the same time.
  290         (4)(3) RULEMAKING.—
  291         (a) The board may shall adopt by rule additional standards
  292  of practice for physicians who perform office procedures or
  293  office surgeries under pursuant to this section, as warranted
  294  for patient safety and by the evolution of technology and
  295  medical practice.
  296         (b) The board may adopt rules to administer the
  297  registration, registration update, inspection, and safety of
  298  offices in which a physician performs office procedures or
  299  office surgeries under pursuant to this section.
  300         Section 2. Section 458.3281, Florida Statutes, is created
  301  to read:
  302         458.3281 Standard of practice for office surgery.—
  303         (1) CONSTRUCTION.—This section does not relieve a physician
  304  performing a procedure or surgery from the responsibility of
  305  making the medical determination of whether an office is an
  306  appropriate setting in which to perform that particular
  307  procedure or surgery, taking into consideration the particular
  308  patient on which the procedure or surgery is to be performed.
  309         (2) DEFINITIONS.—As used in this section, the term:
  310         (a) “Certified in advanced cardiac life support” means a
  311  person holds a current certification in an advanced cardiac life
  312  support course with didactic and skills components, approved by
  313  the American Heart Association, the American Safety and Health
  314  Institute, the American Red Cross, Pacific Medical Training, or
  315  the Advanced Cardiovascular Life Support (ACLS) Certification
  316  Institute.
  317         (b) “Certified in basic life support” means a person holds
  318  a current certification in a basic life support course with
  319  didactic and skills components, approved by the American Heart
  320  Association, the American Safety and Health Institute, the
  321  American Red Cross, Pacific Medical Training, or the ACLS
  322  Certification Institute.
  323         (c) “Certified in pediatric advanced life support” means a
  324  person holds a current certification in a pediatric advanced
  325  life support course with didactic and skills components approved
  326  by the American Heart Association, the American Safety and
  327  Health Institute, or Pacific Medical Training.
  328         (d) “Continual monitoring” means monitoring that is
  329  repeated regularly and frequently in steady, rapid succession.
  330         (e) “Continuous monitoring” means monitoring that is
  331  prolonged without any interruption at any time.
  332         (f) “Equipment” means a medical device, instrument, or tool
  333  used to perform specific actions or take certain measurements
  334  during, or while a patient is recovering from, a procedure or
  335  surgery which must meet current performance standards according
  336  to its manufacturer’s guidelines for the specific device,
  337  instrument, or tool, as applicable.
  338         (g) “Major blood vessels” means a group of critical
  339  arteries and veins, including the aorta, coronary arteries,
  340  pulmonary arteries, superior and inferior vena cava, pulmonary
  341  veins, and any intra-cerebral artery or vein.
  342         (h) “Office surgery” means a physician’s office in which
  343  surgical procedures are performed by a physician for the
  344  practice of medicine as authorized by this section and board
  345  rule. The office must be an office at which a physician
  346  regularly performs consultations with surgical patients,
  347  preoperative examinations, and postoperative care, as
  348  necessitated by the standard of care related to the surgeries
  349  performed at the physician’s office, and at which patient
  350  records are readily maintained and available. The types of
  351  procedures or surgeries performed in an office surgery are those
  352  which need not be performed in a facility licensed under chapter
  353  390 or chapter 395, and are not of the type that:
  354         1. Generally result in blood loss of more than 10 percent
  355  of estimated blood volume in a patient with a normal hemoglobin
  356  count;
  357         2. Require major or prolonged intracranial, intrathoracic,
  358  abdominal, or major joint replacement procedures, except for
  359  laparoscopic procedures;
  360         3. Involve major blood vessels and are performed with
  361  direct visualization by open exposure of the major vessel,
  362  except for percutaneous endovascular intervention; or
  363         4. Are generally emergent or life threatening in nature.
  364         (i) “Pediatric patient” means a patient who is 13 years of
  365  age or younger.
  366         (j) “Percutaneous endovascular intervention” means a
  367  procedure performed without open direct visualization of the
  368  target vessel, and requires only needle puncture of an artery or
  369  vein followed by insertion of catheters, wires, or similar
  370  devices that are then advanced through the blood vessels using
  371  imaging guidance. Once the catheter reaches the intended
  372  location, various maneuvers to address the diseased area may be
  373  performed, including, but not limited to, injection of contrast
  374  medium for imaging; treatment of vessels with angioplasty;
  375  atherectomy; covered or uncovered stenting; embolization or
  376  intentionally occluding vessels or organs; and delivering
  377  medications or radiation or other energy, such as laser,
  378  radiofrequency, or cryo.
  379         (k) “Reasonable proximity” means a distance that does not
  380  exceed 30 minutes of transport time to the hospital.
  381         (l) “Surgery” means any manual or operative procedure
  382  performed upon the body of a living human being, including, but
  383  not limited to, those performed with the use of lasers, for the
  384  purposes of preserving health, diagnosing or curing disease,
  385  repairing injury, correcting a deformity or defect, prolonging
  386  life, relieving suffering, or any elective procedure for
  387  aesthetic, reconstructive, or cosmetic purposes. The term
  388  includes, but is not limited to, incision or curettage of tissue
  389  or an organ; suture or other repair of tissue or an organ,
  390  including a closed as well as an open reduction of a fracture;
  391  extraction of tissue, including premature extraction of the
  392  products of conception from the uterus; insertion of natural or
  393  artificial implants; or an endoscopic procedure with use of
  394  local or general anesthetic.
  395         (3) GENERAL REQUIREMENTS FOR OFFICE SURGERY.—
  396         (a) The physician performing the surgery must examine the
  397  patient immediately before the surgery to evaluate the risk of
  398  anesthesia and of the surgical procedure to be performed. The
  399  physician performing the surgery may delegate the preoperative
  400  heart and lung evaluation to a qualified anesthesia provider
  401  within the scope of the provider’s practice and, if applicable,
  402  protocol.
  403         (b) The physician performing the surgery shall maintain
  404  complete patient records of each surgical procedure performed,
  405  which must include all of the following:
  406         1. The patient’s name, patient number, preoperative
  407  diagnosis, postoperative diagnosis, surgical procedure,
  408  anesthetic, anesthesia records, recovery records, and
  409  complications, if any.
  410         2. The name of each member of the surgical team, including
  411  the surgeon, first assistant, anesthesiologist, nurse
  412  anesthetist, anesthesiologist assistant, circulating nurse, and
  413  operating room technician, as applicable.
  414         (c) Each office surgery’s designated physician shall ensure
  415  that the office surgery has procedures in place to verify that
  416  all of the following have occurred before any surgery is
  417  performed:
  418         1. The patient has signed the informed consent form for the
  419  procedure reflecting the patient’s knowledge of identified risks
  420  of the procedure, consent to the procedure, the type of
  421  anesthesia and anesthesia provider to be used during the
  422  procedure, and the fact that the patient may choose the type of
  423  anesthesia provider for the procedure, such as an
  424  anesthesiologist, a certified registered nurse anesthetist, a
  425  physician assistant, an anesthesiologist assistant, or another
  426  appropriately trained physician as provided by board rule.
  427         2. The patient’s identity has been verified.
  428         3. The operative site has been verified.
  429         4. The operative procedure to be performed has been
  430  verified with the patient.
  431         5. All of the information and actions required to be
  432  verified under this paragraph are documented in the patient’s
  433  medical record.
  434         (d) With respect to the requirements set forth in paragraph
  435  (c), written informed consent is not necessary for minor Level I
  436  procedures limited to the skin and mucosa.
  437         (e) The physician performing the surgery shall maintain a
  438  log of all liposuction procedures performed at the office
  439  surgery where more than 1,000 cubic centimeters of supernatant
  440  fat is temporarily or permanently removed and where Level II and
  441  Level III surgical procedures are performed. The log must, at a
  442  minimum, include all of the following:
  443         1. A confidential patient identifier.
  444         2. Time of arrival in the operating suite.
  445         3. The name of the physician performing the procedure.
  446         4. The patient’s diagnosis, CPT codes used for the
  447  procedure, the patient’s classification for risk with anesthesia
  448  according to the American Society of Anesthesiologists’ physical
  449  status classification system, and the type of procedure and
  450  level of surgery performed.
  451         5. Documentation of completion of the medical clearance
  452  performed by the anesthesiologist or the physician performing
  453  the surgery.
  454         6. The name and provider type of the anesthesia provider
  455  and the type of anesthesia used.
  456         7. The duration of the procedure.
  457         8. Any adverse incidents as identified in s. 458.351.
  458         9. The type of postoperative care, duration of recovery,
  459  disposition of the patient upon discharge, including the address
  460  of where the patient is being discharged, discharge
  461  instructions, and list of medications used during surgery and
  462  recovery.
  463  
  464  All surgical and anesthesia logs must be kept at the office
  465  surgery and maintained for 6 years after the date of last
  466  patient contact and must be provided to department investigators
  467  upon request.
  468         (f) For any liposuction procedure, the physician performing
  469  the surgery is responsible for determining the appropriate
  470  amount of supernatant fat to be removed from a particular
  471  patient. A maximum of 4,000 cubic centimeters of supernatant fat
  472  may be removed by liposuction in the office surgery setting. A
  473  maximum of 50mg/kg of lidocaine may be injected for tumescent
  474  liposuction in the office surgery setting.
  475         (g)1. Liposuction may be performed in combination with
  476  another separate surgical procedure during a single Level II or
  477  Level III operation, only in the following circumstances:
  478         a. When combined with an abdominoplasty, liposuction may
  479  not exceed 1,000 cubic centimeters of supernatant fat.
  480         b. When liposuction is associated and directly related to
  481  another procedure, the liposuction may not exceed 1,000 cubic
  482  centimeters of supernatant fat.
  483         2. Major liposuction in excess of 1,000 cubic centimeters
  484  of supernatant fat may not be performed on a patient’s body in a
  485  location that is remote from the site of another procedure being
  486  performed on that patient.
  487         (h) For elective cosmetic and plastic surgery procedures
  488  performed in a physician’s office, the maximum planned duration
  489  of all surgical procedures combined may not exceed 8 hours.
  490  Except for elective cosmetic and plastic surgery, the physician
  491  performing the surgery may not keep patients past midnight in a
  492  physician’s office. For elective cosmetic and plastic surgical
  493  procedures, the patient must be discharged within 24 hours after
  494  presenting to the office for surgery. However, an overnight stay
  495  is allowed in the office if the total time the patient is at the
  496  office does not exceed 23 hours and 59 minutes, including the
  497  surgery time. An overnight stay in a physician’s office for
  498  elective cosmetic and plastic surgery must be strictly limited
  499  to the physician’s office. If the patient has not recovered
  500  sufficiently to be safely discharged within the timeframes set
  501  forth, the patient must be transferred to a hospital for
  502  continued postoperative care.
  503         (i) The Standards of the American Society of
  504  Anesthesiologists for Basic Anesthetic Monitoring are hereby
  505  adopted and incorporated by reference as the standards for
  506  anesthetic monitoring by any qualified anesthesia provider under
  507  this section.
  508         1. These standards apply to general anesthetics, regional
  509  anesthetics, and monitored Level II and III anesthesia care.
  510  However, in emergency circumstances, appropriate life support
  511  measures take priority. These standards may be exceeded at any
  512  time based on the judgment of the responsible supervising
  513  physician or anesthesiologist. While these standards are
  514  intended to encourage quality patient care, observing them does
  515  not guarantee any specific patient outcome. This set of
  516  standards addresses only the issue of basic anesthesia
  517  monitoring, which is only one component of anesthesia care.
  518         2. In certain rare or unusual circumstances, some of these
  519  methods of monitoring may be clinically impractical, and
  520  appropriate use of the described monitoring methods may fail to
  521  detect adverse clinical developments. In such cases, a brief
  522  interruption of continual monitoring may be unavoidable and does
  523  not by itself constitute a violation of the standards of
  524  practice of this section.
  525         3. Under extenuating circumstances, the physician
  526  performing the surgery or the anesthesiologist may waive the
  527  following requirements:
  528         a. The use of an oxygen analyzer with a low oxygen
  529  concentration limit alarm, or other technology authorized under
  530  board rule which equals or exceeds the quality of the oxygen
  531  analyzer, during the administration of general anesthesia with
  532  an anesthesia machine.
  533         b. The use of pulse oximetry with a variable pitch pulse
  534  tone and an audible low threshold alarm, or other technology
  535  authorized under board rule which equals or exceeds the quality
  536  of a pulse oximeter, and the use of adequate illumination and
  537  exposure of the patient to assess color.
  538         c. The use of capnography, capnometry, or mass
  539  spectroscopy, or other technology authorized under board rule
  540  which equals or exceeds the quality of capnography, capnometry,
  541  or mass spectroscopy as a quantitative method of analyzing the
  542  end-tidal carbon dioxide for continual monitoring for the
  543  presence of expired carbon dioxide during ventilation, from the
  544  time of the endotracheal tube or supraglottic airway placement
  545  until extubation or removal or initiating transfer of the
  546  patient to a postoperative care location.
  547         d. The use of continuous electrocardiogram display, or
  548  other technology authorized under board rule which equals or
  549  exceeds the quality of electrocardiogram display, from the
  550  beginning of anesthesia until preparing to leave the
  551  anesthetizing location.
  552         e. The measuring of arterial blood pressure and heart rate
  553  evaluated at least every 5 minutes during anesthesia.
  554  
  555  When any of the monitoring is waived for extenuating
  556  circumstances under this subparagraph, it must be documented in
  557  a note in the patient’s medical record, including the reasons
  558  for the need to waive the requirement. These standards are not
  559  intended for the application to the care of an obstetrical
  560  patient in labor or in the conduct of pain management.
  561         (j)1. Because of the rapid changes in patient status during
  562  anesthesia, qualified anesthesia personnel must be continuously
  563  present in the room to provide anesthesia care for the entire
  564  duration of all general anesthetics, regional anesthetics, and
  565  monitored anesthesia care conducted on the patient. In the event
  566  that there is a direct known hazard, such as radiation, to the
  567  anesthesia personnel which might require intermittent remote
  568  observation of the patient, some provision for monitoring the
  569  patient must be made. In the event that an emergency requires
  570  the temporary absence of the person primarily responsible for
  571  the anesthesia, the best judgment of the supervising physician
  572  or anesthesiologist shall be exercised in comparing the
  573  emergency with the anesthetized patient’s condition and in the
  574  selection of the person left responsible for the anesthesia
  575  during the temporary absence.
  576         2. During all anesthesia, the patient’s oxygenation,
  577  ventilation, circulation, and temperature must be continually
  578  evaluated to ensure adequate oxygen concentration in the
  579  inspired gas and the blood.
  580         a. During all general anesthesia using an anesthesia
  581  machine, the concentration of oxygen in the patient’s breathing
  582  system must be measured by an oxygen analyzer with a low oxygen
  583  concentration limit alarm used to measure blood oxygenation.
  584         b. During all anesthesia, a quantitative method of
  585  assessing oxygenation, such as pulse oximetry, must be employed.
  586  When a pulse oximeter is used, the variable pitch pulse tone and
  587  the low threshold alarm must be audible to the qualified
  588  anesthesia provider. Adequate illumination and exposure of the
  589  patient are necessary to assess color.
  590         c. During all anesthesia, every patient must have the
  591  adequacy of his or her ventilation continually evaluated,
  592  including, but not limited to, the evaluation of qualitative
  593  clinical signs, such as chest excursion, observation of the
  594  reservoir breathing bag, and auscultation of breath sounds.
  595  Continual monitoring for the presence of expired carbon dioxide
  596  must be performed unless invalidated by the nature of the
  597  patient’s condition, the procedure, or the equipment.
  598  Quantitative monitoring of the volume of expired gas must also
  599  be performed.
  600         d. When an endotracheal tube or supraglottic airway is
  601  inserted, its correct positioning must be verified by clinical
  602  assessment and by identification of carbon dioxide in the
  603  expired gas. Continual end-tidal carbon dioxide analysis, in use
  604  from the time of endotracheal tube or supraglottic airway
  605  placement until extubation or removal or initiating transfer of
  606  the patient to a postoperative care location, must be performed
  607  using a quantitative method, such as capnography, capnometry, or
  608  mass spectroscopy, or other technology authorized under board
  609  rule which equals or exceeds the quality of capnography,
  610  capnometry, or mass spectroscopy. When capnography or capnometry
  611  is used, the end-tidal carbon dioxide alarm must be audible to
  612  the qualified anesthesia provider.
  613         e. When ventilation is controlled by a mechanical
  614  ventilator, there must be in continuous use a device capable of
  615  detecting disconnection of components of the breathing system.
  616  The device must give an audible signal when its alarm threshold
  617  is exceeded.
  618         f. During regional anesthesia without sedation or local
  619  anesthesia with no sedation, the adequacy of ventilation must be
  620  evaluated by continual observation of qualitative clinical
  621  signs. During moderate or deep sedation, the adequacy of
  622  ventilation must be evaluated by continual observation of
  623  qualitative clinical signs. Monitoring for the presence of
  624  exhaled carbon dioxide is recommended.
  625         g. Every patient receiving anesthesia must have the
  626  electrocardiogram or other technology authorized under board
  627  rule which equals or exceeds the quality of electrocardiogram
  628  continuously displayed from the beginning of anesthesia until
  629  preparing to leave the anesthetizing location.
  630         h. Every patient receiving anesthesia must have arterial
  631  blood pressure and heart rate determined and evaluated at least
  632  every 5 minutes.
  633         i. Every patient receiving general anesthesia must have
  634  circulatory function continually evaluated by at least one of
  635  the following methods:
  636         (I) Palpation of a pulse.
  637         (II) Auscultation of heart sounds.
  638         (III) Monitoring of a tracing of intra-arterial pressure.
  639         (IV) Ultrasound peripheral pulse monitoring.
  640         (V) Pulse plethysmography or oximetry.
  641         (VI) Other technology authorized under board rule which
  642  equals or exceeds the quality of any of the methods listed in
  643  sub-sub-subparagraphs (I)-(V).
  644         j. Every patient receiving anesthesia must have his or her
  645  temperature monitored when clinically significant changes in
  646  body temperature are intended, anticipated, or suspected.
  647         (k)1. The physician performing the surgery shall ensure
  648  that the postoperative care arrangements made for the patient
  649  are adequate for the procedure being performed, as required by
  650  board rule.
  651         2. Management of postoperative care is the responsibility
  652  of the physician performing the surgery and may be delegated as
  653  determined by board rule. If the physician performing the
  654  surgery is unavailable to provide postoperative care, the
  655  physician performing the surgery must notify the patient of his
  656  or her unavailability for postoperative care before the
  657  procedure.
  658         3. If there is an overnight stay at the office in relation
  659  to any surgical procedure:
  660         a. The office must provide at least two persons to act as
  661  monitors, one of whom must be certified in advanced cardiac life
  662  support, and maintain a monitor-to-patient ratio of at least one
  663  monitor to two patients.
  664         b. Once the physician performing the surgery has signed a
  665  timed and dated discharge order, the office may provide only one
  666  monitor to monitor the patient. The monitor must be qualified by
  667  licensure and training to administer all of the medications
  668  required on the crash cart and must be certified in advanced
  669  cardiac life support.
  670         c. A complete and current crash cart must be present in the
  671  office surgery and immediately accessible for the monitors.
  672         4. The physician performing the surgery must be reachable
  673  by telephone and readily available to return to the office if
  674  needed.
  675         5. A policy and procedures manual must be maintained in the
  676  office at which Level II and Level III procedures are performed.
  677  The manual must be updated and implemented annually. The policy
  678  and procedures manual must provide for all of the following:
  679         a. Duties and responsibilities of all personnel.
  680         b. A quality assessment and improvement system designed to
  681  objectively and systematically monitor and evaluate the quality
  682  and appropriateness of patient care and opportunities to improve
  683  performance.
  684         c. Cleaning procedures and protocols.
  685         d. Sterilization procedures.
  686         e. Infection control procedures and personnel
  687  responsibilities.
  688         f. Emergency procedures.
  689         6. The designated physician shall establish a risk
  690  management program that includes all of the following
  691  components:
  692         a. The identification, investigation, and analysis of the
  693  frequency and causes of adverse incidents.
  694         b. The identification of trends or patterns of adverse
  695  incidents.
  696         c. The development of appropriate measures to correct,
  697  reduce, minimize, or eliminate the risk of adverse incidents.
  698         d. The documentation of such functions and periodic review
  699  of such information at least quarterly by the designated
  700  physician.
  701         7. The designated physician shall report to the department
  702  any adverse incidents that occur within the scope of office
  703  surgeries. This report must be made within 15 days after the
  704  occurrence of an incident as required by s. 458.351.
  705         8. The designated physician is responsible for prominently
  706  posting a sign in the office which states that the office is a
  707  doctor’s office regulated under this section and ss. 458.328,
  708  458.3281, and 459.0138 and the applicable rules of the Board of
  709  Medicine and the Board of Osteopathic Medicine as set forth in
  710  rules 64B8 and 64B15, Florida Administrative Code. This notice
  711  must also appear prominently within the required patient
  712  informed consent form.
  713         9. All physicians performing surgery at the office surgery
  714  must be qualified by education, training, and experience to
  715  perform any procedure the physician performs in the office
  716  surgery.
  717         10. When Level II, Level II-A, or Level III procedures are
  718  performed in an office surgery setting, the physician performing
  719  the surgery is responsible for providing the patient, in
  720  writing, before the procedure, with the name and location of the
  721  hospital where the physician performing the surgery has
  722  privileges to perform the same procedure as the one being
  723  performed in the office surgery setting, and the name and
  724  location of the hospital with which the physician performing the
  725  surgery has a transfer agreement in the event of an emergency.
  726         (4) LEVEL I OFFICE SURGERY.—
  727         (a) Scope.—Level I office surgery includes the following:
  728         1. Minor procedures such as excision of skin lesions,
  729  moles, warts, cysts, or lipomas and repair of lacerations or
  730  surgery limited to the skin and subcutaneous tissue which are
  731  performed under topical or local anesthesia not involving drug
  732  induced alteration of consciousness other than minimal pre
  733  operative tranquilization of the patient.
  734         2. Liposuction involving the removal of less than 4,000
  735  cubic centimeters of supernatant fat.
  736         3. Incision and drainage of superficial abscesses; limited
  737  endoscopies, such as proctoscopies, skin biopsies,
  738  arthrocentesis, thoracentesis, paracentesis, dilation of the
  739  urethra, cystoscopic procedures, and closed reduction of simple
  740  fractures; or small joint dislocations, such as in the finger or
  741  toe joints.
  742         4. Procedures in which anesthesia is limited to minimal
  743  sedation. The patient’s level of sedation must be that of
  744  minimal sedation and anxiolysis, and the chances of
  745  complications requiring hospitalization must be remote. As used
  746  in this sub-subparagraph, the term “minimal sedation and
  747  anxiolysis” means a drug-induced state during which patients
  748  respond normally to verbal commands, and although cognitive
  749  function and physical coordination may be impaired, airway
  750  reflexes and ventilatory and cardiovascular functions remain
  751  unaffected. Controlled substances, as defined in ss. 893.02 and
  752  893.03, must be limited to oral administration in doses
  753  appropriate for the unsupervised treatment of insomnia, anxiety,
  754  or pain.
  755         5. Procedures for which chances of complications requiring
  756  hospitalization are remote as specified in board rule.
  757         (b) Standards of practice.—Standards of practice for Level
  758  I office surgery include all of the following:
  759         1. The medical education, training, and experience of the
  760  physician performing the surgery must include training on proper
  761  dosages and management of toxicity or hypersensitivity to
  762  regional anesthetic drugs, and the physician must be certified
  763  in advanced cardiac life support.
  764         2. At least one operating assistant must be certified in
  765  basic life support.
  766         3. Intravenous access supplies, oxygen, oral airways, and a
  767  positive pressure ventilation device must be available in the
  768  office surgery, along with the following medications, stored per
  769  the manufacturer’s recommendation:
  770         a. Atropine, 3 mg.
  771         b. Diphenhydramine, 50 mg.
  772         c. Epinephrine, 1 mg in 10 ml.
  773         d. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
  774         e. Hydrocortisone, 100 mg.
  775         f. If a benzodiazepine is administered, flumazenil, 0.5 mg
  776  in 5 ml vial, 2 vials total.
  777         g. If an opiate is administered, naloxone, 0.4 mg in 1 ml
  778  vial, 2 vials total.
  779         4. When performing minor procedures, such as excision of
  780  skin lesions, moles, warts, cysts, or lipomas and repair of
  781  lacerations or surgery limited to the skin and subcutaneous
  782  tissue performed under topical or local anesthesia in an office
  783  surgery setting, physicians performing the procedure are exempt
  784  from subparagraphs 1.-3. Current certification in basic life
  785  support is recommended but not required.
  786         5. A physician performing the surgery need not have an
  787  assistant during the procedure unless the specific procedure
  788  being performed requires an assistant.
  789         (5) LEVEL II OFFICE SURGERY.—
  790         (a) Scope.—Level II office surgery includes, but is not
  791  limited to, all of the following procedures:
  792         1. Hemorrhoidectomy.
  793         2. Hernia repair.
  794         3. Large joint dislocations.
  795         4. Colonoscopy.
  796         5. Liposuction involving the removal of up to 4,000 cubic
  797  centimeters of supernatant fat.
  798         6. Any other procedure the board designates by rule as a
  799  Level II office surgery.
  800         7. Surgeries in which the patient’s level of sedation is
  801  that of moderate sedation and analgesia or conscious sedation.
  802  As used in this subparagraph, the term “moderate sedation and
  803  analgesia or conscious sedation” is a drug-induced depression of
  804  consciousness during which patients respond purposefully to
  805  verbal commands, either alone or accompanied by light tactile
  806  stimulation; interventions are not required to maintain a patent
  807  airway; spontaneous ventilation is adequate; and cardiovascular
  808  function is maintained. For purposes of this term, a patient
  809  reflexively withdrawing from a painful stimulus is not
  810  considered a purposeful response.
  811         (b) Standards of practice.—Standards of practice for Level
  812  II office surgery include, but are not limited to, the
  813  following:
  814         1. The physician performing the surgery, or the office
  815  where the procedure is being performed, must have a transfer
  816  agreement with a licensed hospital within reasonable proximity
  817  if the physician performing the procedure does not have staff
  818  privileges to perform the same procedure as that being performed
  819  in the office surgery setting at a licensed hospital within
  820  reasonable proximity. The transfer agreement required by this
  821  section must be current and have been entered into no more than
  822  3 years before the date of the office’s most recent annual
  823  inspection under s. 458.328. A transfer agreement must
  824  affirmatively disclose an effective date and a termination date.
  825         2. The physician performing the surgery must have staff
  826  privileges at a licensed hospital to perform the same procedure
  827  in that hospital as that being performed in the office surgery
  828  setting or must be able to document satisfactory completion of
  829  training, such as board certification or board eligibility by a
  830  board approved by the American Board of Medical Specialties or
  831  any other board approved by the Board of Medicine, or must be
  832  able to establish comparable background, training, and
  833  experience. Such board certification or comparable background,
  834  training, and experience must also be directly related to and
  835  include the procedures being performed by the physician in the
  836  office surgery facility.
  837         3. One assistant must be currently certified in basic life
  838  support.
  839         4. The physician performing the surgery must be currently
  840  certified in advanced cardiac life support.
  841         5. A complete and current crash cart must be available at
  842  all times at the location where the anesthesia is being
  843  administered. The designated physician of an office surgery is
  844  responsible for ensuring that the crash cart is replenished
  845  after each use, the expiration dates for the crash cart’s
  846  medications are checked weekly, and crash cart events are
  847  documented in the cart’s logs. Medicines must be stored per the
  848  manufacturer’s recommendations, and multi-dose vials must be
  849  dated once opened and checked daily for expiration. The crash
  850  cart must, at a minimum, include the following intravenous or
  851  inhaled medications:
  852         a. Adenosine, 18 mg.
  853         b. Albuterol, 2.5 mg with a small volume nebulizer.
  854         c. Amiodarone, 300 mg.
  855         d. Atropine, 3 mg.
  856         e. Calcium chloride, 1 gram.
  857         f. Dextrose, 50 percent; 50 ml.
  858         g. Diphenhydramine, 50 mg.
  859         h. Dopamine, 200 mg, minimum.
  860         i. Epinephrine, 1 mg, in 10 ml.
  861         j. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
  862         k. Flumazenil, 1 mg.
  863         l. Furosemide, 40 mg.
  864         m. Hydrocortisone, 100 mg.
  865         n. Lidocaine appropriate for cardiac administration, 100
  866  mg.
  867         o. Magnesium sulfate, 2 grams.
  868         p. Naloxone, 1.2 mg.
  869         q. A beta blocker class drug.
  870         r. Sodium bicarbonate, 50 mEq/50 ml.
  871         s. Paralytic agent that is appropriate for use in rapid
  872  sequence intubation.
  873         t. A calcium channel blocker class drug.
  874         u. If nonneuraxial regional blocks are performed,
  875  Intralipid, 20 percent, 500 ml solution.
  876         v. Any additional medication the board determines by rule
  877  is warranted for patient safety and by the evolution of
  878  technology and medical practice.
  879         6. In the event of a drug shortage, the designated
  880  physician is authorized to substitute a therapeutically
  881  equivalent drug that meets the prevailing practice standards.
  882         7. The designated physician is responsible for ensuring
  883  that the office maintains documentation of its unsuccessful
  884  efforts to obtain the required drug.
  885         8. The designated physician is responsible for ensuring
  886  that the following are present in the office surgery:
  887         a. A benzodiazepine.
  888         b. A positive pressure ventilation device, such as Ambu,
  889  plus oxygen supply.
  890         c. An end-tidal carbon dioxide detection device.
  891         d. Monitors for blood pressure, electrocardiography, and
  892  oxygen saturation.
  893         e. Emergency intubation equipment that must, at a minimum,
  894  include suction devices, endotracheal tubes, working
  895  laryngoscopes, oropharyngeal airways, nasopharyngeal airways,
  896  and bag valve mask apparatus that are sized appropriately for
  897  the specific patient.
  898         f. A working defibrillator with defibrillator pads or
  899  defibrillator gel, or an automated external defibrillator unit.
  900         g. Sufficient backup power to allow the physician
  901  performing the surgery to safely terminate the procedure and to
  902  allow the patient to emerge from the anesthetic, all without
  903  compromising the sterility of the procedure or the environment
  904  of care.
  905         h. Working sterilization equipment cultured weekly.
  906         i. Sufficient intravenous solutions and equipment for a
  907  minimum of a week’s worth of surgical cases.
  908         j. Any other equipment required by board rule, as warranted
  909  by the evolution of technology and medical practice.
  910         9. The physician performing the surgery must be assisted by
  911  a qualified anesthesia provider, which may include any of the
  912  following types of providers:
  913         a. An anesthesiologist.
  914         b. A certified registered nurse anesthetist.
  915         c. A registered nurse, if the physician performing the
  916  surgery is certified in advanced cardiac life support and the
  917  registered nurse assists only with local anesthesia or conscious
  918  sedation.
  919  
  920  An anesthesiologist assistant may assist the anesthesiologist as
  921  provided by board rule. An assisting anesthesia provider may not
  922  function in any other capacity during the procedure.
  923         10. If additional anesthesia assistance is required by the
  924  specific procedure or patient circumstances, such assistance
  925  must be provided by a physician, osteopathic physician,
  926  registered nurse, licensed practical nurse, or operating room
  927  technician.
  928         11. The designated physician is responsible for ensuring
  929  that each patient is monitored in the recovery room until the
  930  patient is fully recovered from anesthesia. Such monitoring must
  931  be provided by a licensed physician, physician assistant,
  932  registered nurse with postanesthesia care unit experience, or
  933  the equivalent who is currently certified in advanced cardiac
  934  life support, or, in the case of pediatric patients, currently
  935  certified in pediatric advanced life support.
  936         (6) LEVEL II-A OFFICE SURGERY.—
  937         (a) Scope.—Level II-A office surgeries are those Level II
  938  office surgeries that have a maximum planned duration of 5
  939  minutes or less and in which the chances of complications
  940  requiring hospitalization are remote.
  941         (b) Standards of practice.—
  942         1. All practice standards for Level II office surgery set
  943  forth in paragraph (5)(b) must be met for Level II-A office
  944  surgery except for the requirements set forth in subparagraph
  945  (5)(b)9. regarding assistance by a qualified anesthesia
  946  provider.
  947         2. During the surgical procedure, the physician performing
  948  the surgery must be assisted by a licensed physician, physician
  949  assistant, registered nurse, or licensed practical nurse.
  950         3. Additional assistance may be required by specific
  951  procedure or patient circumstances.
  952         4. Following the procedure, a licensed physician, physician
  953  assistant, or registered nurse must be available to monitor the
  954  patient in the recovery room until the patient is recovered from
  955  anesthesia. The monitoring provider must be currently certified
  956  in advanced cardiac life support, or, in the case of pediatric
  957  patients, currently certified in pediatric advanced life
  958  support.
  959         (7) LEVEL III OFFICE SURGERY.—
  960         (a) Scope.—
  961         1. Level III office surgery includes those types of surgery
  962  during which the patient’s level of sedation is that of deep
  963  sedation and analgesia or general anesthesia. As used in this
  964  subparagraph, the term:
  965         a. “Deep sedation and analgesia” means a drug-induced
  966  depression of consciousness during which:
  967         (I) Patients cannot be easily aroused but respond
  968  purposefully following repeated or painful stimulation;
  969         (II) The ability to independently maintain ventilatory
  970  function may be impaired;
  971         (III) Patients may require assistance in maintaining a
  972  patent airway and spontaneous ventilation may be inadequate; and
  973         (IV) Cardiovascular function is usually maintained.
  974  
  975  For purposes of this sub-subparagraph, a reflexive withdrawal
  976  from a painful stimulus by a patient is not considered a
  977  purposeful response.
  978         b. “General anesthesia” means a drug-induced loss of
  979  consciousness during which:
  980         (I) Patients are not arousable, even by painful
  981  stimulation;
  982         (II) The ability to independently maintain ventilatory
  983  function is often impaired;
  984         (III) Patients often require assistance in maintaining a
  985  patent airway and positive pressure ventilation may be required
  986  because of depressed spontaneous ventilation or drug-induced
  987  depression of neuromuscular function; and
  988         (IV) Cardiovascular function may be impaired.
  989         2. The use of spinal or epidural anesthesia for a procedure
  990  requires that the procedure be considered a Level III office
  991  surgery.
  992         3. Only patients classified under the American Society of
  993  Anesthesiologists’ (ASA) risk classification criteria as Class I
  994  or Class II are appropriate candidates for a Level III office
  995  surgery.
  996         a. All Level III office surgeries on patients classified as
  997  ASA III or higher must be performed only in a hospital or
  998  ambulatory surgical center.
  999         b. For all ASA II patients above the age of 50, the
 1000  physician performing the surgery must obtain a complete workup
 1001  performed before the performance of a Level III office surgery
 1002  in the office surgery setting.
 1003         c. If the patient has a cardiac history or is deemed to be
 1004  a complicated medical patient, the patient must have a
 1005  preoperative electrocardiogram and be referred to an appropriate
 1006  consultant for medical optimization. The referral to a
 1007  consultant may be waived after evaluation by the patient’s
 1008  anesthesiologist.
 1009         (b) Standards of practice.—Practice standards for Level III
 1010  office surgery include all Level II office surgery standards and
 1011  all of the following requirements:
 1012         1. The physician performing the surgery must have staff
 1013  privileges at a licensed hospital to perform the same procedure
 1014  in that hospital as that being performed in the office surgery
 1015  setting or must be able to document satisfactory completion of
 1016  training, such as board certification or board qualification by
 1017  a board approved by the American Board of Medical Specialties or
 1018  any other board approved by the Board of Medicine, or must be
 1019  able to demonstrate to the accrediting organization or to the
 1020  department comparable background, training, and experience. Such
 1021  board certification or comparable background, training, and
 1022  experience must also be directly related to and include the
 1023  procedure being performed by the physician performing the
 1024  surgery in the office surgery setting. In addition, the
 1025  physician performing the surgery must have knowledge of the
 1026  principles of general anesthesia.
 1027         2. The physician performing the surgery must be currently
 1028  certified in advanced cardiac life support.
 1029         3. At least one operating assistant must be currently
 1030  certified in basic life support.
 1031         4. An emergency policy and procedures manual related to
 1032  serious anesthesia complications must be available in the office
 1033  surgery and reviewed biannually by the designated physician,
 1034  practiced with staff, updated, and posted in a conspicuous
 1035  location in the office. Topics to be covered in the manual must
 1036  include all of the following:
 1037         a. Airway blockage and foreign body obstruction.
 1038         b. Allergic reactions.
 1039         c. Bradycardia.
 1040         d. Bronchospasm.
 1041         e. Cardiac arrest.
 1042         f. Chest pain.
 1043         g. Hypoglycemia.
 1044         h. Hypotension.
 1045         i. Hypoventilation.
 1046         j. Laryngospasm.
 1047         k. Local anesthetic toxicity reaction.
 1048         l. Malignant hyperthermia.
 1049         m. Any other topics the board determines by rule are
 1050  warranted for patient safety and by the evolution of technology
 1051  and medical practice.
 1052         5. An office surgery performing Level III office surgeries
 1053  must maintain all of the equipment and medications required for
 1054  Level II office surgeries and comply with all of the following
 1055  additional requirements:
 1056         a. Maintain at least 720 mg of dantrolene on site if
 1057  halogenated anesthetics or succinylcholine are used.
 1058         b. Equipment and medication for monitored postanesthesia
 1059  recovery must be available in the office.
 1060         6. Anesthetic safety regulations must be developed, posted
 1061  in a conspicuous location in the office, and enforced by the
 1062  designated physician. Such regulations must include all of the
 1063  following requirements:
 1064         a. All operating room electrical and anesthesia equipment
 1065  must be inspected at least semiannually, and a written record of
 1066  the results and corrective actions must be maintained.
 1067         b. Flammable anesthetic agents may not be employed in
 1068  office surgery facilities.
 1069         c. Electrical equipment in anesthetizing areas must be on
 1070  an audiovisual line isolation monitor, with the exception of
 1071  radiologic equipment and fixed lighting more than 5 feet above
 1072  the floor.
 1073         d. Each anesthesia gas machine must have a pin-index system
 1074  or equivalent safety system and a minimum oxygen flow safety
 1075  device.
 1076         e. All reusable anesthesia equipment in direct contact with
 1077  a patient must be cleaned or sterilized as appropriate after
 1078  each use.
 1079         f. The following monitors must be applied to all patients
 1080  receiving conduction or general anesthesia:
 1081         (I) Blood pressure cuff.
 1082         (II) A continuous temperature device, readily available to
 1083  measure the patient’s temperature.
 1084         (III) Pulse oximeter.
 1085         (IV) Electrocardiogram.
 1086         (V) An inspired oxygen concentration monitor and a
 1087  capnograph, for patients receiving general anesthesia.
 1088         g. Emergency intubation equipment must be available in all
 1089  office surgery suites.
 1090         h. Surgical tables must be capable of Trendelenburg and
 1091  other positions necessary to facilitate surgical procedures.
 1092         i. An anesthesiologist, a certified registered nurse
 1093  anesthetist, an anesthesiologist assistant, or a physician
 1094  assistant qualified as set forth in board rule must administer
 1095  the general or regional anesthesia.
 1096         j. A physician, a registered nurse, a licensed practical
 1097  nurse, a physician assistant, or an operating room technician
 1098  must assist with the surgery. The anesthesia provider may not
 1099  function in any other capacity during the procedure.
 1100         k. The patient must be monitored in the recovery room until
 1101  he or she has fully recovered from anesthesia. The monitoring
 1102  must be provided by a physician, a physician assistant, a
 1103  certified registered nurse anesthetist, an anesthesiologist
 1104  assistant, or a registered nurse with postanesthesia care unit
 1105  experience or the equivalent who is currently certified in
 1106  advanced cardiac life support, or, in the case of pediatric
 1107  patients, currently certified in pediatric advanced life
 1108  support.
 1109         (8) RULEMAKING.—The board may adopt by rule additional
 1110  standards of practice for physicians who perform office
 1111  surgeries or procedures under this section as warranted for
 1112  patient safety and by the evolution of technology and medical
 1113  practice.
 1114         Section 3. Section 459.0138, Florida Statutes, is amended
 1115  to read:
 1116         459.0138 Office surgeries.—
 1117         (1) REGISTRATION.—
 1118         (a)1. An office in which a physician performs or intends to
 1119  perform a liposuction procedure in which more than 1,000 cubic
 1120  centimeters of supernatant fat is temporarily or permanently
 1121  removed, a liposuction procedure during which the patient is
 1122  rotated between the supine, lateral, and prone positions, a
 1123  Level II office surgery, or a Level III office surgery must
 1124  register with the department. unless the office is licensed as A
 1125  facility licensed under chapter 390 or chapter 395 may not be
 1126  registered under this section.
 1127         (b)2. The department must complete an inspection of any
 1128  office seeking registration under this section before the office
 1129  may be registered.
 1130         1. The inspection of the office seeking registration under
 1131  this section must include inspection for compliance with the
 1132  standards of practice set out in this section and s. 458.3281
 1133  and any applicable board rules for the levels of office surgery
 1134  and procedures listed on the application which any physician
 1135  practicing at the office performs or intends to perform. The
 1136  application must be updated within 10 calendar days before any
 1137  additional surgical procedures or levels of office surgery are
 1138  to be performed at the office. Failure to timely update the
 1139  application for any such additional surgical procedures or
 1140  levels of office surgery is a violation of this section and
 1141  subject to discipline under ss. 456.072 and 459.015.
 1142         2. The department must immediately suspend the registration
 1143  process of an office that refuses an inspection under
 1144  subparagraph 1., and the applicant must be required to reapply
 1145  for registration.
 1146         3. If the department determines that an office seeking
 1147  registration under this section is one in which a physician may
 1148  perform, or intends to perform, liposuction procedures that
 1149  include a patient being rotated between the supine, lateral, and
 1150  prone positions during the procedure, or in which a physician
 1151  may perform, or intends to perform, gluteal fat grafting
 1152  procedures, the office must provide proof to the department that
 1153  it has met the applicable requirements of s. 469 of the Florida
 1154  Building Code, relating to office surgery suites, and s.
 1155  458.3281 and the applicable rules adopted thereunder, and the
 1156  department must inspect the office to ensure that all of the
 1157  following are present or in place:
 1158         a. Equipment and a procedure for measuring and documenting
 1159  in a log the amount of supernatant fat removed, both temporarily
 1160  and permanently, from a particular patient, including tissue
 1161  disposal procedures.
 1162         b. A procedure for measuring and documenting the amount of
 1163  lidocaine injected for tumescent liposuction, if used.
 1164         c. Working ultrasound guidance equipment or other guidance
 1165  technology authorized under board rule which equals or exceeds
 1166  the quality of ultrasound guidance.
 1167         d. The office procedure for obtaining blood products.
 1168         e. Documentation on file at the office demonstrating that
 1169  any physician performing these procedures has privileges to
 1170  perform such procedures in a hospital no more than 20 minutes
 1171  away.
 1172         f. Procedures for emergency resuscitation and transport to
 1173  a hospital.
 1174         g. Procedures for anesthesia and surgical recordkeeping.
 1175         h. Any additional inspection requirements, as set by board
 1176  rule.
 1177         4. If an applicant is unable to provide proof to the
 1178  department that the office seeking registration is in compliance
 1179  with the applicable requirements of s. 469 of the Florida
 1180  Building Code, relating to office surgery suites, or s. 459.0139
 1181  or the applicable rules adopted thereunder, in accordance with
 1182  subparagraph 3., the department must notify the Agency for
 1183  Health Care Administration and request the agency to inspect the
 1184  office and consult with the office about the process to apply
 1185  for ambulatory surgical center licensure under chapter 395 and
 1186  how the office may seek qualification for such licensure,
 1187  notwithstanding the office’s failure to meet all requirements
 1188  associated with such licensure at the time of inspection and
 1189  notwithstanding any pertinent exceptions provided under s.
 1190  395.002(3).
 1191         (c)(b) To be By January 1, 2020, each office registered
 1192  under this section or s. 458.328, an office must, at the time of
 1193  application, list a designated designate a physician who is
 1194  responsible for the office’s compliance with the office health
 1195  and safety requirements of this section and rules adopted
 1196  hereunder. A designated physician must have a full, active, and
 1197  unencumbered license under this chapter or chapter 458 and shall
 1198  practice at the office for which he or she has assumed
 1199  responsibility. Within 10 calendar days after the termination of
 1200  a designated physician relationship, the office must notify the
 1201  department of the designation of another physician to serve as
 1202  the designated physician. The department may not register an
 1203  office if the office fails to comply with this requirement at
 1204  the time of application and must seek an emergency suspension of
 1205  the suspend a registration of for an office pursuant to s.
 1206  456.074(6) if the office fails to timely notify the department
 1207  of its new designated physician within 10 calendar days after
 1208  the termination of the previous designated physician
 1209  relationship comply with the requirements of this paragraph.
 1210         (d) As a condition of registration, each office must, at
 1211  the time of application, list all medical personnel who will be
 1212  practicing at the office, including all of the following:
 1213         1. Physicians who intend to practice surgery or assist in
 1214  surgery at the office seeking registration, including their
 1215  respective license numbers and practice addresses.
 1216         2. Anesthesia providers, including their license numbers.
 1217         3. Nursing personnel licensed under chapter 464, including
 1218  their license numbers unless already provided under subparagraph
 1219  2.
 1220         4. Physician assistants, including their respective license
 1221  numbers and supervising physicians.
 1222  
 1223  The office must notify the department of the addition or
 1224  termination of any of the types of medical personnel specified
 1225  under this paragraph within 10 calendar days before such
 1226  addition or after such termination. Failure to timely notify the
 1227  department of such addition or termination is a violation of
 1228  this section and subject to discipline under ss. 456.072 and
 1229  459.015.
 1230         (e)(c) As a condition of registration, each office must
 1231  establish financial responsibility by demonstrating that it has
 1232  met and continues to maintain, at a minimum, the same
 1233  requirements applicable to physicians in ss. 458.320 and
 1234  459.0085. Each physician practicing at an office registered
 1235  under this section or s. 458.328 must meet the financial
 1236  responsibility requirements under s. 458.320 or s. 459.0085, as
 1237  applicable.
 1238         (f)(d) Each physician practicing or intending to practice
 1239  at an office registered under this section or s. 458.328 must
 1240  shall advise the board, in writing, within 10 calendar days
 1241  before after beginning or after ending his or her practice at a
 1242  the registered office, as applicable.
 1243         (g)(e)1. The department shall inspect a registered office
 1244  at least annually, including a review of patient records, to
 1245  ensure that the office is in compliance with this section and
 1246  rules adopted hereunder unless the office is accredited in
 1247  office-based surgery by the Joint Commission or other a
 1248  nationally recognized accrediting agency approved by the board.
 1249  The inspection may be unannounced, except for the inspection of
 1250  an office that meets the description of a clinic specified in s.
 1251  459.0137(1)(a)3.h., and those wholly owned and operated
 1252  physician offices described in s. 459.0137(1)(a)3.g. which
 1253  perform procedures referenced in s. 459.0137(1)(a)3.h., which
 1254  must be announced.
 1255         (h)2. The department must immediately suspend the
 1256  registration of a registered office that refuses an inspection
 1257  under paragraph (g) subparagraph 1. The office must close during
 1258  such suspension. The suspension must remain in effect for at
 1259  least 14 consecutive days and may not terminate until the
 1260  department issues a written declaration that the office may
 1261  reopen following the department’s completion of an inspection of
 1262  the office.
 1263         (i)(f) The department may suspend or revoke the
 1264  registration of an office in which a procedure or surgery
 1265  identified in paragraph (a) is performed for failure of any of
 1266  its physicians, owners, or operators to comply with this section
 1267  and rules adopted hereunder or s. 458.328 and rules adopted
 1268  thereunder. If an office’s registration is revoked for any
 1269  reason, the department may deny any person named in the
 1270  registration documents of the office, including the persons who
 1271  own or operate the office, individually or as part of a group,
 1272  from registering an office to perform procedures or office
 1273  surgeries pursuant to this section or s. 458.328 for 5 years
 1274  after the revocation date.
 1275         (j)(g) The department may impose any penalty set forth in
 1276  s. 456.072(2) against the designated physician for failure of
 1277  the office to operate in compliance with the office health and
 1278  safety requirements of this section and rules adopted hereunder
 1279  or s. 458.328 and rules adopted thereunder.
 1280         (h) A physician may only perform a procedure or surgery
 1281  identified in paragraph (a) in an office that is registered with
 1282  the department. The board shall impose a fine of $5,000 per day
 1283  on a physician who performs a procedure or surgery in an office
 1284  that is not registered with the department.
 1285         (k)(i) The actual costs of registration and inspection or
 1286  accreditation must shall be paid by the person seeking to
 1287  register and operate the office in which a procedure or surgery
 1288  identified in paragraph (a) will be performed.
 1289         (2) REGISTRATION UPDATE.—
 1290         (a) An office that registered under this section before
 1291  July 1, 2024, in which a physician performs liposuction
 1292  procedures that include a patient being rotated between the
 1293  supine, lateral, and prone positions during the procedure or in
 1294  which a physician performs gluteal fat grafting procedures must
 1295  provide a registration update to the department consistent with
 1296  the requirements of the initial registration under subsection
 1297  (1) no later than 30 days before the office surgery’s next
 1298  annual inspection.
 1299         (b) Registration update inspections required under
 1300  subsection (1) must be performed by the department on the date
 1301  of the office surgery’s next annual inspection.
 1302         (c) During the registration update process, the office
 1303  surgery may continue to operate under the original registration.
 1304         (d) In order to provide an office surgery time to update to
 1305  the requirements of subsection (1) and s. 459.0139, effective
 1306  July 1, 2024, and the applicable provisions of s. 469 of the
 1307  Florida Building Code, relating to office surgery suites, any
 1308  office surgery registered under this section before July 1,
 1309  2024, whose annual inspection is due in July or August 2024, may
 1310  request from the department, in writing, a 60-day postponement
 1311  of the required annual inspection, which must be granted.
 1312         (e) All other requests to the department for a postponement
 1313  of the required registration update inspection under this
 1314  registration update process must be in writing and be approved
 1315  by the chair of the Board of Medicine for good cause shown, and
 1316  such postponement may not exceed 30 days.
 1317         (3) STANDARDS OF PRACTICE.—
 1318         (a) A physician performing a procedure or surgery in an
 1319  office registered under this section must comply with the
 1320  applicable provisions of s. 469 of the Florida Building Code,
 1321  relating to office surgery suites, and the standards of practice
 1322  for office surgery set forth in this section and s. 459.0139.
 1323         (b) A physician may not perform any surgery or procedure
 1324  identified in paragraph (1)(a) in a setting other than an office
 1325  registered under this section or a facility licensed under
 1326  chapter 390 or chapter 395, as applicable. The board shall
 1327  impose a fine of $5,000 per incident on a physician who violates
 1328  this paragraph performing a gluteal fat grafting procedure in an
 1329  office surgery setting shall adhere to standards of practice
 1330  pursuant to this subsection and rules adopted by the board.
 1331         (c)(b) Office surgeries may not:
 1332         1. Be a type of surgery that generally results in blood
 1333  loss of more than 10 percent of estimated blood volume in a
 1334  patient with a normal hemoglobin level;
 1335         2. Require major or prolonged intracranial, intrathoracic,
 1336  abdominal, or joint replacement procedures, except for
 1337  laparoscopic procedures;
 1338         3. Involve major blood vessels and be performed with direct
 1339  visualization by open exposure of the major blood vessel, except
 1340  for percutaneous endovascular intervention; or
 1341         4. Be emergent or life threatening.
 1342         (d)(c) A physician performing a gluteal fat grafting
 1343  procedure in an office surgery setting must comply with the
 1344  applicable provisions of s. 469 of the Florida Building Code,
 1345  relating to office surgery suites, and the standards of practice
 1346  under this subsection and s. 459.0139 and applicable rules
 1347  adopted thereunder, including, but not limited to, all of the
 1348  following standards of practice:
 1349         1. The A physician performing the a gluteal fat grafting
 1350  procedure must conduct an in-person examination of the patient
 1351  while physically present in the same room as the patient no
 1352  later than the day before the procedure.
 1353         2. Before a physician may delegate any duties during a
 1354  gluteal fat grafting procedure, the patient must provide
 1355  written, informed consent for such delegation. Any duty
 1356  delegated by a physician during a gluteal fat grafting procedure
 1357  must be performed under the direct supervision of the physician
 1358  performing such procedure. Fat extraction and gluteal fat
 1359  injections must be performed by the physician and may not be
 1360  delegated.
 1361         3. Fat may only be injected into the subcutaneous space of
 1362  the patient and may not cross the fascia overlying the gluteal
 1363  muscle. Intramuscular or submuscular fat injections are
 1364  prohibited.
 1365         4. When the physician performing a gluteal fat grafting
 1366  procedure injects fat into the subcutaneous space of the
 1367  patient, the physician must use ultrasound guidance, or guidance
 1368  with other technology authorized under board rule which equals
 1369  or exceeds the quality of ultrasound, during the placement and
 1370  navigation of the cannula to ensure that the fat is injected
 1371  into the subcutaneous space of the patient above the fascia
 1372  overlying the gluteal muscle. Such guidance with the use of
 1373  ultrasound or other technology is not required for other
 1374  portions of such procedure.
 1375         5. An office in which a physician performs gluteal fat
 1376  grafting procedures shall at all times maintain a ratio of one
 1377  physician to one patient during all phases of the procedure,
 1378  beginning with the administration of anesthesia to the patient
 1379  and concluding with the extubation of the patient. After a
 1380  physician has commenced, and while he or she is engaged in, a
 1381  gluteal fat grafting procedure, the physician may not commence
 1382  or engage in another gluteal fat grafting procedure or any other
 1383  procedure with another patient at the same time.
 1384         (e)(d) If a procedure in an office surgery setting results
 1385  in hospitalization, the incident must be reported as an adverse
 1386  incident pursuant to s. 458.351.
 1387         (e) An office in which a physician performs gluteal fat
 1388  grafting procedures must at all times maintain a ratio of one
 1389  physician to one patient during all phases of the procedure,
 1390  beginning with the administration of anesthesia to the patient
 1391  and concluding with the extubation of the patient. After a
 1392  physician has commenced, and while he or she is engaged in, a
 1393  gluteal fat grafting procedure, the physician may not commence
 1394  or engage in another gluteal fat grafting procedure or any other
 1395  procedure with another patient at the same time.
 1396         (4)(3) RULEMAKING.—
 1397         (a) The board may shall adopt by rule additional standards
 1398  of practice for physicians who perform office procedures or
 1399  office surgeries under pursuant to this section, as warranted
 1400  for patient safety and by the evolution of technology and
 1401  medical practice.
 1402         (b) The board may adopt rules to administer the
 1403  registration, registration update, inspection, and safety of
 1404  offices in which a physician performs office procedures or
 1405  office surgeries under pursuant to this section.
 1406         Section 4. Section 459.0139, Florida Statutes, is created
 1407  to read:
 1408         459.0139 Standard of practice for office surgery.—
 1409         (1) CONSTRUCTION.—This section does not relieve a physician
 1410  performing a procedure or surgery from the responsibility of
 1411  making the medical determination of whether an office is an
 1412  appropriate setting in which to perform that particular
 1413  procedure or surgery, taking into consideration the particular
 1414  patient on which the procedure or surgery is to be performed.
 1415         (2) DEFINITIONS.—As used in this section, the term:
 1416         (a) “Certified in advanced cardiac life support” means a
 1417  person holds a current certification in an advanced cardiac life
 1418  support course with didactic and skills components, approved by
 1419  the American Heart Association, the American Safety and Health
 1420  Institute, the American Red Cross, Pacific Medical Training, or
 1421  the Advanced Cardiovascular Life Support (ACLS) Certification
 1422  Institute.
 1423         (b) “Certified in basic life support” means a person holds
 1424  a current certification in a basic life support course with
 1425  didactic and skills components, approved by the American Heart
 1426  Association, the American Safety and Health Institute, the
 1427  American Red Cross, Pacific Medical Training, or the ACLS
 1428  Certification Institute.
 1429         (c) “Certified in pediatric advanced life support” means a
 1430  person holds a current certification in a pediatric advanced
 1431  life support course with didactic and skills components approved
 1432  by the American Heart Association, the American Safety and
 1433  Health Institute, or Pacific Medical Training.
 1434         (d) “Continual monitoring” means monitoring that is
 1435  repeated regularly and frequently in steady rapid succession.
 1436         (e) “Continuous monitoring” means monitoring that is
 1437  prolonged without any interruption at any time.
 1438         (f) “Equipment” means a medical device, instrument, or tool
 1439  used to perform specific actions, carry out desired effects, or
 1440  take certain measurements during, or while recovering from, a
 1441  procedure or surgery which must meet current performance
 1442  standards according to its manufacturer’s guidelines for the
 1443  specific device, instrument, or tool, as applicable.
 1444         (g) “Major blood vessels” means a group of critical
 1445  arteries and veins, including the aorta, coronary arteries,
 1446  pulmonary arteries, superior and inferior vena cava, pulmonary
 1447  veins, and any intra-cerebral artery or vein.
 1448         (h) “Office surgery” means a physician’s office in which
 1449  surgical procedures are performed by a physician for the
 1450  practice of medicine as authorized by this section and board
 1451  rule. The office must be an office at which a physician
 1452  regularly performs consultations with surgical patients,
 1453  preoperative examinations, and postoperative care, as
 1454  necessitated by the standard of care, related to the procedures
 1455  performed at the physician’s office, and at which patient
 1456  records are readily maintained and available. The types of
 1457  procedures or surgeries performed in an office surgery are those
 1458  which need not be performed in a facility licensed under chapter
 1459  390 or chapter 395, and are not of the type that:
 1460         1. Generally result in blood loss of more than 10 percent
 1461  of estimated blood volume in a patient with a normal hemoglobin
 1462  count;
 1463         2. Require major or prolonged intracranial, intrathoracic,
 1464  abdominal, or major joint replacement procedures, except for
 1465  laparoscopic procedures;
 1466         3. Involve major blood vessels and are performed with
 1467  direct visualization by open exposure of the major vessel,
 1468  except for percutaneous endovascular intervention; or
 1469         4. Are generally emergent or life threatening in nature.
 1470         (i) “Pediatric patient” means a patient who is 13 years of
 1471  age or younger.
 1472         (j) “Percutaneous endovascular intervention” means a
 1473  procedure performed without open direct visualization of the
 1474  target vessel and requiring only needle puncture of an artery or
 1475  vein followed by insertion of catheters, wires, or similar
 1476  devices which are then advanced through the blood vessels using
 1477  imaging guidance. Once the catheter reaches the intended
 1478  location, various maneuvers to address the diseased area may be
 1479  performed, which include, but are not limited to, injection of
 1480  contrast medium for imaging; treatment of vessels with
 1481  angioplasty; atherectomy; covered or uncovered stenting;
 1482  embolization or intentionally occluding vessels or organs; and
 1483  delivering medications, radiation, or other energy, such as
 1484  laser, radiofrequency, or cryo.
 1485         (k) “Reasonable proximity” means a distance that does not
 1486  exceed thirty 30 minutes of transport time to the hospital.
 1487         (l) “Surgery” means any manual or operative procedure
 1488  performed upon the body of a living human being, including, but
 1489  not limited to, those performed with the use of lasers, for the
 1490  purposes of preserving health, diagnosing or curing disease,
 1491  repairing injury, correcting a deformity or defect, prolonging
 1492  life, relieving suffering, or any elective procedure for
 1493  aesthetic, reconstructive, or cosmetic purposes. The term
 1494  includes, but is not limited to, incision or curettage of tissue
 1495  or an organ; suture or other repair of tissue or an organ,
 1496  including a closed as well as an open reduction of a fracture;
 1497  extraction of tissue, including premature extraction of the
 1498  products of conception from the uterus; insertion of natural or
 1499  artificial implants; or an endoscopic procedure with use of
 1500  local or general anesthetic.
 1501         (3) GENERAL REQUIREMENTS FOR OFFICE SURGERY.—
 1502         (a) The physician performing the operation must examine the
 1503  patient immediately before the surgery to evaluate the risk of
 1504  anesthesia and of the surgical procedure to be performed. The
 1505  physician performing the surgery may delegate the preoperative
 1506  heart-lung evaluation to a qualified anesthesia provider within
 1507  the scope of the provider’s practice and, if applicable,
 1508  protocol.
 1509         (b) The physician performing the surgery shall maintain
 1510  complete patient records of each surgical procedure performed,
 1511  which must include all of the following:
 1512         1. The patient’s name, patient number, preoperative
 1513  diagnosis, postoperative diagnosis, surgical procedure,
 1514  anesthetic, anesthesia records, recovery records, and
 1515  complications, if any.
 1516         2. The name of each member of the surgical team, including
 1517  the surgeon, first assistant, anesthesiologist, nurse
 1518  anesthetist, anesthesiologist assistant, circulating nurse, and
 1519  operating room technician.
 1520         (c) Each office surgery’s designated physician shall ensure
 1521  that the office surgery has procedures in place to verify that
 1522  all of the following have occurred before any surgery is
 1523  performed:
 1524         1. The patient has signed the informed consent form for the
 1525  procedure reflecting the patient’s knowledge of identified risks
 1526  of the procedure, consent to the procedure, the type of
 1527  anesthesia and anesthesia provider to be used during the
 1528  procedure, and the fact that the patient may choose the type of
 1529  anesthesia provider for the procedure, such as an
 1530  anesthesiologist, a certified registered nurse anesthetist, a
 1531  physician assistant, an anesthesiologist assistant, or another
 1532  appropriately trained physician as provided by board rule.
 1533         2. The patient’s identity has been verified.
 1534         3. The operative site has been verified.
 1535         4. The operative procedure to be performed has been
 1536  verified with the patient.
 1537         5. All of the information and actions required to be
 1538  verified under this paragraph are documented in the patient’s
 1539  medical record.
 1540         (d) With respect to the requirement set forth in paragraph
 1541  (c), written informed consent is not necessary for minor Level I
 1542  procedures limited to the skin and mucosa.
 1543         (e) The physician performing the surgery shall maintain a
 1544  log of all liposuction procedures performed at the office
 1545  surgery where more than 1,000 cubic centimeters of supernatant
 1546  fat is temporarily or permanently removed and where Level II and
 1547  Level III surgical procedures are performed. The log must, at a
 1548  minimum, include all of the following:
 1549         1. A confidential patient identifier.
 1550         2. Time of arrival in the operating suite.
 1551         3. The name of the physician performing the procedure.
 1552         4. The patient’s diagnosis, CPT codes used for the
 1553  procedure, the patient’s classification for risk with anesthesia
 1554  according to the American Society of Anesthesiologists’ physical
 1555  status classification system, and the type of procedure and
 1556  level of surgery performed.
 1557         5. Documentation of completion of the medical clearance
 1558  performed by the anesthesiologist or the physician performing
 1559  the surgery.
 1560         6. The name and provider type of the anesthesia provider
 1561  and the type of anesthesia used.
 1562         7. The duration of the procedure.
 1563         8. Any adverse incidents as identified in s. 458.351.
 1564         9. The type of postoperative care, duration of recovery,
 1565  disposition of the patient upon discharge, including the address
 1566  of where the patient is being discharged, discharge
 1567  instructions, and list of medications used during surgery and
 1568  recovery.
 1569  
 1570  All surgical and anesthesia logs must be kept at the office
 1571  surgery and maintained for 6 years after the date of last
 1572  patient contact and must be provided to department investigators
 1573  upon request.
 1574         (f) For any liposuction procedure, the physician performing
 1575  the surgery is responsible for determining the appropriate
 1576  amount of supernatant fat to be removed from a particular
 1577  patient. A maximum of 4,000 cubic centimeters of supernatant fat
 1578  may be removed by liposuction in the office surgery setting. A
 1579  maximum of 50mg/kg of lidocaine can be injected for tumescent
 1580  liposuction in the office surgery setting.
 1581         (g)1. Liposuction may be performed in combination with
 1582  another separate surgical procedure during a single Level II or
 1583  Level III operation only in the following circumstances:
 1584         a. When combined with an abdominoplasty, liposuction may
 1585  not exceed 1,000 cubic centimeters of supernatant fat.
 1586         b. When liposuction is associated and directly related to
 1587  another procedure, the liposuction may not exceed 1,000 cubic
 1588  centimeters of supernatant fat.
 1589         2. Major liposuction in excess of 1,000 cubic centimeters
 1590  of supernatant fat may not be performed on a patient’s body in a
 1591  location that is remote from the site of another procedure being
 1592  performed on that patient.
 1593         (h) For elective cosmetic and plastic surgery procedures
 1594  performed in a physician’s office, the maximum planned duration
 1595  of all surgical procedures combined may not exceed 8 hours.
 1596  Except for elective cosmetic and plastic surgery, the physician
 1597  performing the surgery may not keep patients past midnight in a
 1598  physician’s office. For elective cosmetic and plastic surgical
 1599  procedures, the patient must be discharged within 24 hours after
 1600  presenting to the office for surgery. However, an overnight stay
 1601  is allowed in the office if the total time the patient is at the
 1602  office does not exceed 23 hours and 59 minutes, including the
 1603  surgery time. An overnight stay in a physician’s office for
 1604  elective cosmetic and plastic surgery must be strictly limited
 1605  to the physician’s office. If the patient has not recovered
 1606  sufficiently to be safely discharged within the timeframes set
 1607  forth, the patient must be transferred to a hospital for
 1608  continued postoperative care.
 1609         (i) The Standards of the American Society of
 1610  Anesthesiologists for Basic Anesthetic Monitoring are hereby
 1611  adopted and incorporated by reference as the standards for
 1612  anesthetic monitoring by any qualified anesthesia provider under
 1613  this section.
 1614         1. These standards apply to general anesthetics, regional
 1615  anesthetics, and monitored Level II and III anesthesia care.
 1616  However, in emergency circumstances, appropriate life support
 1617  measures take priority. These standards may be exceeded at any
 1618  time based on the judgment of the responsible supervising
 1619  physician or anesthesiologist. While these standards are
 1620  intended to encourage quality patient care, observing them does
 1621  not guarantee any specific patient outcome. This set of
 1622  standards addresses only the issue of basic anesthesia
 1623  monitoring, which is only one component of anesthesia care.
 1624         2. In certain rare or unusual circumstances, some of these
 1625  methods of monitoring may be clinically impractical, and
 1626  appropriate use of the described monitoring methods may fail to
 1627  detect adverse clinical developments. In such cases, a brief
 1628  interruption of continual monitoring may be unavoidable and does
 1629  not by itself constitute a violation of the standards of
 1630  practice of this section.
 1631         3. Under extenuating circumstances, the responsible
 1632  supervising physician or anesthesiologist may waive the
 1633  following requirements:
 1634         a. The use of an oxygen analyzer with a low oxygen
 1635  concentration limit alarm, or other technology authorized under
 1636  board rule which equals or exceeds the quality of the oxygen
 1637  analyzer, during the administration of general anesthesia with
 1638  an anesthesia machine.
 1639         b. The use of pulse oximetry with a variable pitch pulse
 1640  tone and an audible low threshold alarm, or other technology
 1641  authorized under board rule which equals or exceeds the quality
 1642  of a pulse oximeter, and the use of adequate illumination and
 1643  exposure of the patient to assess color.
 1644         c. The use of capnography, capnometry, or mass
 1645  spectroscopy, or other technology authorized under board rule
 1646  which equals or exceeds the quality of capnography, capnometry,
 1647  or mass spectroscopy, as a quantitative method of analyzing the
 1648  end-tidal carbon dioxide for continual monitoring for the
 1649  presence of expired carbon dioxide during ventilation from the
 1650  time of the endotracheal tube or supraglottic airway placement,
 1651  until extubation or removal or initiating transfer of the
 1652  patient to a postoperative care location.
 1653         d. The use of continuous electrocardiogram display, or
 1654  other technology authorized under board rule which equals or
 1655  exceeds the quality of electrocardiogram display, from the
 1656  beginning of anesthesia until preparing to leave the
 1657  anesthetizing location.
 1658         e. The measuring of arterial blood pressure and heart rate
 1659  evaluated at least every 5 minutes during anesthesia.
 1660  
 1661  When any of the monitoring is waived for extenuating
 1662  circumstances under this subparagraph, it must be documented in
 1663  a note in the patient’s medical record, including the reasons
 1664  for the need to waive the requirement. These standards are not
 1665  intended for the application to the care of an obstetrical
 1666  patient in labor or in the conduct of pain management.
 1667         (j)1. Because of the rapid changes in patient status during
 1668  anesthesia, qualified anesthesia personnel must be continuously
 1669  present in the room to monitor the patient and provide
 1670  anesthesia care for the entire duration of all general
 1671  anesthetics, regional anesthetics, and monitored anesthesia care
 1672  conducted on the patient. In the event that there is a direct
 1673  known hazard, such as radiation, to the anesthesia personnel
 1674  which might require intermittent remote observation of the
 1675  patient, some provision for monitoring the patient must be made.
 1676  In the event that an emergency requires the temporary absence of
 1677  the person primarily responsible for the anesthetic, the best
 1678  judgment of the supervising physician or anesthesiologist shall
 1679  be exercised in comparing the emergency with the anesthetized
 1680  patient’s condition and in the selection of the person left
 1681  responsible for the anesthetic during the temporary absence.
 1682         2. During all anesthetics, the patient’s oxygenation,
 1683  ventilation, circulation, and temperature must be continually
 1684  evaluated to ensure adequate oxygen concentration in the
 1685  inspired gas and the blood during all anesthetics.
 1686         a. During all general anesthesia using an anesthesia
 1687  machine, the concentration of oxygen in the patient breathing
 1688  system must be measured by an oxygen analyzer with a low oxygen
 1689  concentration limit alarm used to measure blood oxygenation.
 1690         b. During all anesthetics, a quantitative method of
 1691  assessing oxygenation, such as pulse oximetry, must be employed.
 1692  When a pulse oximeter is used, the variable pitch pulse tone and
 1693  the low threshold alarm must be audible to the qualified
 1694  anesthesia provider. Adequate illumination and exposure of the
 1695  patient are necessary to assess color.
 1696         c. During all anesthetics, every patient must have the
 1697  adequacy of his or her ventilation continually evaluated,
 1698  including, but not limited to, the evaluation of qualitative
 1699  clinical signs, such as chest excursion, observation of the
 1700  reservoir breathing bag, and auscultation of breath sounds.
 1701  Continual monitoring for the presence of expired carbon dioxide
 1702  must be performed unless invalidated by the nature of the
 1703  patient’s condition, the procedure, or the equipment.
 1704  Quantitative monitoring of the volume of expired gas is strongly
 1705  encouraged.
 1706         d. When an endotracheal tube or supraglottic airway is
 1707  inserted, its correct positioning must be verified by clinical
 1708  assessment and by identification of carbon dioxide in the
 1709  expired gas. Continual end-tidal carbon dioxide analysis, in use
 1710  from the time of endotracheal tube or supraglottic airway
 1711  placement until extubation or removal or initiating transfer of
 1712  the patient to a postoperative care location, must be performed
 1713  using a quantitative method, such as capnography, capnometry, or
 1714  mass spectroscopy or other technology authorized under board
 1715  rule which equals or exceeds the quality of capnography,
 1716  capnometry, or mass spectroscopy. When capnography or capnometry
 1717  is used, the end-tidal carbon dioxide alarm must be audible to
 1718  the qualified anesthesia provider.
 1719         e. When ventilation is controlled by a mechanical
 1720  ventilator, there must be in continuous use a device that is
 1721  capable of detecting disconnection of components of the
 1722  breathing system. The device must give an audible signal when
 1723  its alarm threshold is exceeded.
 1724         f. During regional anesthesia without sedation or local
 1725  anesthesia with no sedation, the adequacy of ventilation must be
 1726  evaluated by continual observation of qualitative clinical
 1727  signs. During moderate or deep sedation, the adequacy of
 1728  ventilation must be evaluated by continual observation of
 1729  qualitative clinical signs. Monitoring for the presence of
 1730  exhaled carbon dioxide is recommended.
 1731         g. Every patient receiving anesthesia must have the
 1732  electrocardiogram or other technology authorized under board
 1733  rule which equals or exceeds the quality of electrocardiogram
 1734  continuously displayed from the beginning of anesthesia until
 1735  preparing to leave the anesthetizing location.
 1736         h. Every patient receiving anesthesia must have arterial
 1737  blood pressure and heart rate determined and evaluated at least
 1738  every 5 minutes.
 1739         i. Every patient receiving general anesthesia must have
 1740  circulatory function continually evaluated by at least one of
 1741  the following methods:
 1742         (I) Palpation of a pulse.
 1743         (II) Auscultation of heart sounds.
 1744         (III) Monitoring of a tracing of intra-arterial pressure.
 1745         (IV) Ultrasound peripheral pulse monitoring.
 1746         (V) Pulse plethysmography or oximetry.
 1747         (VI) Other technology authorized under board rule which
 1748  equals or exceeds the quality of any of the methods listed in
 1749  sub-sub-subparagraphs (I)-(V).
 1750         j. Every patient receiving anesthesia must have his or her
 1751  temperature monitored when clinically significant changes in
 1752  body temperature are intended, anticipated, or suspected.
 1753         (k)1. The physician performing the surgery shall ensure
 1754  that the postoperative care arrangements made for the patient
 1755  are adequate for the procedure being performed, as required by
 1756  board rule.
 1757         2. Management of postoperative care is the responsibility
 1758  of the physician performing the surgery and may be delegated as
 1759  determined by board rule. If the physician performing the
 1760  surgery is unavailable to provide postoperative care, the
 1761  physician performing the surgery must notify the patient of his
 1762  or her unavailability for postoperative care before the
 1763  procedure.
 1764         3. If there is an overnight stay at the office in relation
 1765  to any surgical procedure:
 1766         a. The office must provide at least two persons to act as
 1767  monitors, one of whom must be certified in advanced cardiac life
 1768  support, and maintain a monitor-to-patient ratio of at least one
 1769  monitor to two patients.
 1770         b. Once the physician performing the surgery has signed a
 1771  timed and dated discharge order, the office may provide only one
 1772  monitor to monitor the patient. The monitor must be qualified by
 1773  licensure and training to administer all of the medications
 1774  required on the crash cart and must be certified in advanced
 1775  cardiac life support.
 1776         c. A complete and current crash cart must be present in the
 1777  office surgery and immediately accessible for the monitors.
 1778         4. The physician performing the surgery must be reachable
 1779  by telephone and readily available to return to the office if
 1780  needed.
 1781         5. A policy and procedures manual must be maintained in the
 1782  office at which Level II and Level III procedures are performed.
 1783  The manual must be updated and implemented annually. The policy
 1784  and procedures manual must provide for all of the following:
 1785         a. Duties and responsibilities of all personnel.
 1786         b. A quality assessment and improvement system designed to
 1787  objectively and systematically monitor and evaluate the quality
 1788  and appropriateness of patient care and opportunities to improve
 1789  performance.
 1790         c. Cleaning procedures and protocols.
 1791         d. Sterilization procedures.
 1792         e. Infection control procedures and personnel
 1793  responsibilities.
 1794         f. Emergency procedures.
 1795         6. The designated physician shall establish a risk
 1796  management program that includes all of the following
 1797  components:
 1798         a. The identification, investigation, and analysis of the
 1799  frequency and causes of adverse incidents.
 1800         b. The identification of trends or patterns of adverse
 1801  incidents.
 1802         c. The development of appropriate measures to correct,
 1803  reduce, minimize, or eliminate the risk of adverse incidents.
 1804         d. The documentation of such functions and periodic review
 1805  of such information at least quarterly by the designated
 1806  physician.
 1807         7. The designated physician shall report to the department
 1808  any adverse incidents that occur within the scope of office
 1809  surgeries. This report must be made within 15 days after the
 1810  occurrence of an incident as required by s. 458.351.
 1811         8. The designated physician is responsible for prominently
 1812  posting a sign in the office which states that the office is a
 1813  doctor’s office regulated under this section and ss. 458.328,
 1814  458.3281, 459.0138 and the applicable rules of the Board of
 1815  Medicine and Osteopathic Medicine as set forth in rules 64B8 and
 1816  64B15, Florida Administrative Code. This notice must also appear
 1817  prominently within the required patient informed consent.
 1818         9. All physicians performing surgery at the office surgery
 1819  must be qualified by education, training, and experience to
 1820  perform any procedure the physician performs in the office
 1821  surgery.
 1822         10. When Level II, Level II-A, or Level III procedures are
 1823  performed in an office surgery, the physician performing the
 1824  surgery is responsible for providing the patient, in writing,
 1825  before the procedure, the name and location of the hospital
 1826  where the physician performing the surgery has privileges to
 1827  perform the same procedure as the one being performed in the
 1828  outpatient setting, or the name and location of the hospital
 1829  where the physician performing the surgery or the facility has a
 1830  transfer agreement.
 1831         (4) LEVEL I OFFICE SURGERY.—
 1832         (a) Scope.—Level I office surgery includes all of the
 1833  following:
 1834         1. Minor procedures such as excision of skin lesions,
 1835  moles, warts, cysts, or lipomas, and repair of lacerations or
 1836  surgery limited to the skin and subcutaneous tissue which are
 1837  performed under topical or local anesthesia not involving drug
 1838  induced alteration of consciousness other than minimal pre
 1839  operative tranquilization of the patient.
 1840         2. Liposuction involving the removal of less than 4,000
 1841  cubic centimeters of supernatant fat.
 1842         3. Incision and drainage of superficial abscesses; limited
 1843  endoscopies, such as proctoscopies, skin biopsies,
 1844  arthrocentesis, thoracentesis, paracentesis, dilation of
 1845  urethra, cystoscopic procedures, and closed reduction of simple
 1846  fractures; or small joint dislocations, such as in the finger or
 1847  toe joints.
 1848         4. Procedures in which anesthesia is limited to minimal
 1849  sedation. The patient’s level of sedation must be that of
 1850  minimal sedation and anxiolysis and the chances of complications
 1851  requiring hospitalization must be remote. As used in this sub
 1852  subparagraph, the term “minimal sedation and anxiolysis” means a
 1853  drug-induced state during which patients respond normally to
 1854  verbal commands, and although cognitive function and physical
 1855  coordination may be impaired, airway reflexes and ventilatory
 1856  and cardiovascular functions remain unaffected. Controlled
 1857  substances, as defined in ss. 893.02 and 893.03, must be limited
 1858  to oral administration in doses appropriate for the unsupervised
 1859  treatment of insomnia, anxiety, or pain.
 1860         5. Procedures for which chances of complications requiring
 1861  hospitalization are remote as specified in board rule.
 1862         (b) Standards of practice.—Standards of practice for Level
 1863  I office surgery include all of the following:
 1864         1. The medical education, training, and experience of the
 1865  physician performing the surgery must include training on proper
 1866  dosages and management of toxicity or hypersensitivity to
 1867  regional anesthetic drugs, and the physician must be certified
 1868  in advanced cardiac life support.
 1869         2. At least one operating assistant must be certified in
 1870  basic life support.
 1871         3. Intravenous access supplies, oxygen, oral airways, and a
 1872  positive pressure ventilation device must be available in the
 1873  office surgery, along with the following medications, stored per
 1874  the manufacturer’s recommendation:
 1875         a. Atropine, 3 mg.
 1876         b. Diphenhydramine, 50 mg.
 1877         c. Epinephrine, 1 mg in 10 ml.
 1878         d. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
 1879         e. Hydrocortisone, 100 mg.
 1880         f. If a benzodiazepine is administered, flumazenil, 0.5 mg
 1881  in 5 ml vial, 2 vials total.
 1882         g. If an opiate is administered, naloxone, 0.4 mg in 1 ml
 1883  vial, 2 vials total.
 1884         4. When performing minor procedures, such as excision of
 1885  skin lesions, moles, warts, cysts, or lipomas, and repair of
 1886  lacerations or surgery limited to the skin and subcutaneous
 1887  tissue performed under topical or local anesthesia, physicians
 1888  are exempt from subparagraphs 1.-3. Current certification in
 1889  basic life support is recommended but not required.
 1890         5. A physician performing the surgery need not have an
 1891  assistant during the procedure unless the specific procedure
 1892  being performed requires an assistant.
 1893         (5) LEVEL II OFFICE SURGERY.—
 1894         (a) Scope.—Level II office surgery includes, but is not
 1895  limited to, all of the following procedures:
 1896         1. Hemorrhoidectomy.
 1897         2. Hernia repair.
 1898         3. Large joint dislocations.
 1899         4. Colonoscopy.
 1900         5. Liposuction involving the removal of up to 4,000 cubic
 1901  centimeters of supernatant fat.
 1902         6. Any other procedure the board designates by rule as a
 1903  Level II office surgery.
 1904         7. Surgeries in which the patient’s level of sedation is
 1905  that of moderate sedation and analgesia or conscious sedation.
 1906  As used in this subparagraph, the term “moderate sedation and
 1907  analgesia or conscious sedation” is a drug-induced depression of
 1908  consciousness during which patients respond purposefully to
 1909  verbal commands, either alone or accompanied by light tactile
 1910  stimulation; interventions are not required to maintain a patent
 1911  airway; spontaneous ventilation is adequate; and cardiovascular
 1912  function is maintained. For purposes of the term, a patient
 1913  reflexively withdrawing from a painful stimulus is not
 1914  considered a purposeful response.
 1915         (b) Standards of practice.—Standards of practice for Level
 1916  II office surgery include, but are not limited to, the
 1917  following:
 1918         1. The physician performing the surgery, or the office
 1919  where the procedure is being performed, must have a transfer
 1920  agreement with a licensed hospital within reasonable proximity
 1921  if the physician performing the procedure does not have staff
 1922  privileges to perform the same procedure as that being performed
 1923  in the office surgery setting at a licensed hospital within
 1924  reasonable proximity. The transfer agreement required by this
 1925  section must be current and have been entered into no more than
 1926  3 years before the date of the office’s most recent annual
 1927  inspection under s. 459.0138. A transfer agreement must
 1928  affirmatively disclose an effective date and a termination date.
 1929         2. The physician performing the surgery must have staff
 1930  privileges at a licensed hospital to perform the same procedure
 1931  in that hospital as that being performed in the office surgery
 1932  setting or must be able to document satisfactory completion of
 1933  training, such as board certification or board eligibility by a
 1934  board approved by the American Board of Medical Specialties or
 1935  any other board approved by the Board of Medicine, or must be
 1936  able to establish comparable background, training, and
 1937  experience. Such board certification or comparable background,
 1938  training, and experience must also be directly related to and
 1939  include the procedures being performed by the physician in the
 1940  office surgery facility.
 1941         3. One assistant must be currently certified in basic life
 1942  support.
 1943         4. The physician performing the surgery must be currently
 1944  certified in advanced cardiac life support.
 1945         5. A complete and current crash cart must be available at
 1946  all times at the location where the anesthesia is being
 1947  administered. The designated physician of an office surgery is
 1948  responsible for ensuring that the crash cart is replenished
 1949  after each use, the expiration dates for the crash cart’s
 1950  medications are checked weekly, and crash cart events are
 1951  documented in the cart’s logs. Medicines must be stored per the
 1952  manufacturer’s recommendations, and multi-dose vials must be
 1953  dated once opened and checked daily for expiration. The crash
 1954  cart must, at a minimum, include the following intravenous or
 1955  inhaled medications:
 1956         a. Adenosine, 18 mg.
 1957         b. Albuterol, 2.5 mg with a small volume nebulizer.
 1958         c. Amiodarone, 300 mg.
 1959         d. Atropine, 3 mg.
 1960         e. Calcium chloride, 1 gram.
 1961         f. Dextrose, 50 percent; 50 ml.
 1962         g. Diphenhydramine, 50 mg.
 1963         h. Dopamine, 200 mg, minimum.
 1964         i. Epinephrine, 1 mg, in 10 ml.
 1965         j. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
 1966         k. Flumazenil, 1 mg.
 1967         l. Furosemide, 40 mg.
 1968         m. Hydrocortisone, 100 mg.
 1969         n. Lidocaine appropriate for cardiac administration, 100
 1970  mg.
 1971         o. Magnesium sulfate, 2 grams.
 1972         p. Naloxone, 1.2 mg.
 1973         q. A beta blocker class drug.
 1974         r. Sodium bicarbonate, 50 mEq/50 ml.
 1975         s. Paralytic agent that is appropriate for use in rapid
 1976  sequence intubation.
 1977         t. A calcium channel blocker class drug.
 1978         u. If nonneuraxial regional blocks are performed,
 1979  Intralipid, 20 percent, 500 ml solution.
 1980         v. Any additional medication the board determines by rule
 1981  is warranted for patient safety and by the evolution of
 1982  technology and medical practice.
 1983         6. In the event of a drug shortage, the designated
 1984  physician is authorized to substitute a therapeutically
 1985  equivalent drug that meets the prevailing practice standards.
 1986         7. The designated physician is responsible for ensuring
 1987  that the office maintains documentation of its unsuccessful
 1988  efforts to obtain the required drug.
 1989         8. The designated physician is responsible for ensuring
 1990  that the following are present in the office surgery:
 1991         a. A benzodiazepine.
 1992         b. A positive pressure ventilation device, such as Ambu,
 1993  plus oxygen supply.
 1994         c. An end-tidal carbon dioxide detection device.
 1995         d. Monitors for blood pressure, electrocardiography, and
 1996  oxygen saturation.
 1997         e. Emergency intubation equipment that must, at a minimum,
 1998  include suction devices, endotracheal tubes, working
 1999  laryngoscopes, oropharyngeal airways, nasopharyngeal airways,
 2000  and bag valve mask apparatus that are sized appropriately for
 2001  the specific patient.
 2002         f. A working defibrillator with defibrillator pads or
 2003  defibrillator gel, or an automated external defibrillator unit.
 2004         g. Sufficient backup power to allow the physician
 2005  performing the surgery to safely terminate the procedure and to
 2006  allow the patient to emerge from the anesthetic, all without
 2007  compromising the sterility of the procedure or the environment
 2008  of care.
 2009         h. Working sterilization equipment cultured weekly.
 2010         i. Sufficient intravenous solutions and equipment for a
 2011  minimum of a week’s worth of surgical cases.
 2012         j. Any other equipment required by board rule, as warranted
 2013  by the evolution of technology and medical practice.
 2014         9. The physician performing the surgery must be assisted by
 2015  a qualified anesthesia provider, which may include any of the
 2016  following types of providers:
 2017         a. An anesthesiologist.
 2018         b. A certified registered nurse anesthetist.
 2019         c. A registered nurse, if the physician performing the
 2020  surgery is certified in advanced cardiac life support and the
 2021  registered nurse assists only with local anesthesia or conscious
 2022  sedation.
 2023  
 2024  An anesthesiologist assistant may assist the anesthesiologist as
 2025  provided by board rule. An assisting anesthesia provider may not
 2026  function in any other capacity during the procedure.
 2027         10. If additional anesthesia assistance is required by the
 2028  specific procedure or patient circumstances, such assistance
 2029  must be provided by a physician, osteopathic physician,
 2030  registered nurse, licensed practical nurse, or operating room
 2031  technician.
 2032         11. The designated physician is responsible for ensuring
 2033  that each patient is monitored in the recovery room until fully
 2034  recovered from anesthesia. Such monitoring must be provided by a
 2035  licensed physician, physician assistant, registered nurse with
 2036  postanesthesia care unit experience, or the equivalent who is
 2037  currently certified in advanced cardiac life support, or, in the
 2038  case of pediatric patients, currently certified in pediatric
 2039  advanced life support.
 2040         (6) LEVEL II-A OFFICE SURGERY.—
 2041         (a) Scope.—Level II-A office surgeries are those Level II
 2042  office surgeries that have a maximum planned duration of 5
 2043  minutes or less and in which the chances of complications
 2044  requiring hospitalization are remote.
 2045         (b) Standards of practice.—
 2046         1. All practice standards for Level II office surgery set
 2047  forth in paragraph (5)(b) must be met for Level II-A office
 2048  surgery except for the requirements set forth in subparagraph
 2049  (5)(b)9. regarding assistance by a qualified anesthesia
 2050  provider.
 2051         2. During the surgical procedure, the physician performing
 2052  the surgery must be assisted by a licensed physician, physician
 2053  assistant, registered nurse, or licensed practical nurse.
 2054         3. Additional assistance may be required by specific
 2055  procedure or patient circumstances.
 2056         4. Following the procedure, a licensed physician, physician
 2057  assistant, or registered nurse must be available to monitor the
 2058  patient in the recovery room until the patient is recovered from
 2059  anesthesia. The monitoring provider must be currently certified
 2060  in advanced cardiac life support, or, in the case of pediatric
 2061  patients, currently certified in pediatric advanced life
 2062  support.
 2063         (7) LEVEL III OFFICE SURGERY.—
 2064         (a) Scope.—
 2065         1. Level III office surgery includes those types of surgery
 2066  during which the patient’s level of sedation is that of deep
 2067  sedation and analgesia or general anesthesia. As used in this
 2068  subparagraph, the term:
 2069         a. “Deep sedation and analgesia” means a drug-induced
 2070  depression of consciousness during which:
 2071         (I) Patients cannot be easily aroused but respond
 2072  purposefully following repeated or painful stimulation;
 2073         (II) The ability to independently maintain ventilatory
 2074  function may be impaired;
 2075         (III) Patients may require assistance in maintaining a
 2076  patent airway and spontaneous ventilation may be inadequate; and
 2077         (IV) Cardiovascular function is usually maintained.
 2078  
 2079  For purposes of this sub-subparagraph, a reflexive withdrawal
 2080  from a painful stimulus by a patient is not considered a
 2081  purposeful response.
 2082         b. “General anesthesia” means a drug-induced loss of
 2083  consciousness during which:
 2084         (I) Patients are not arousable, even by painful
 2085  stimulation;
 2086         (II) The ability to independently maintain ventilatory
 2087  function is often impaired;
 2088         (III) Patients often require assistance in maintaining a
 2089  patent airway and positive pressure ventilation may be required
 2090  because of depressed spontaneous ventilation or drug-induced
 2091  depression of neuromuscular function; and
 2092         (IV) Cardiovascular function may be impaired.
 2093         2. The use of spinal or epidural anesthesia for a procedure
 2094  requires that procedure to be considered a Level III office
 2095  surgery.
 2096         3. Only patients classified under the American Society of
 2097  Anesthesiologists’ (ASA) risk classification criteria as Class I
 2098  or Class II are appropriate candidates for a Level III office
 2099  surgery.
 2100         a. All Level III office surgeries on patients classified as
 2101  ASA III or higher are to be performed only in a hospital or
 2102  ambulatory surgical center.
 2103         b. For all ASA II patients above the age of 50, the
 2104  physician performing the surgery must obtain a complete workup
 2105  performed before the performance of a Level III office surgery
 2106  in the office surgery setting.
 2107         c. If the patient has a cardiac history or is deemed to be
 2108  a complicated medical patient, the patient must have a
 2109  preoperative electrocardiogram and be referred to an appropriate
 2110  consultant for medical optimization. The referral to a
 2111  consultant may be waived after evaluation by the patient’s
 2112  anesthesiologist.
 2113         (b) Standards of practice.—Practice standards for Level III
 2114  office surgery include all Level II office surgery standards and
 2115  all of the following requirements:
 2116         1. The physician performing the surgery must have staff
 2117  privileges at a licensed hospital to perform the same procedure
 2118  in that hospital as that being performed in the office surgery
 2119  setting or must be able to document satisfactory completion of
 2120  training, such as board certification or board qualification by
 2121  a board approved by the American Board of Medical Specialties or
 2122  any other board approved by the Board of Medicine, or must be
 2123  able to demonstrate to the accrediting organization or to the
 2124  department comparable background, training, and experience. Such
 2125  board certification or comparable background, training, and
 2126  experience must also be directly related to and include the
 2127  procedure being performed by the physician performing the
 2128  surgery in the office surgery setting. In addition, the
 2129  physician performing the surgery must have knowledge of the
 2130  principles of general anesthesia.
 2131         2. The physician performing the surgery must be currently
 2132  certified in advanced cardiac life support.
 2133         3. At least one operating assistant must be currently
 2134  certified in basic life support.
 2135         4. An emergency policy and procedures manual related to
 2136  serious anesthesia complications must be available in the office
 2137  surgery and reviewed biannually by the designated physician,
 2138  practiced with staff, updated, and posted in a conspicuous
 2139  location in the office. Topics to be covered in the manual must
 2140  include all of the following:
 2141         a. Airway blockage and foreign body obstruction.
 2142         b. Allergic reactions.
 2143         c. Bradycardia.
 2144         d. Bronchospasm.
 2145         e. Cardiac arrest.
 2146         f. Chest pain.
 2147         g. Hypoglycemia.
 2148         h. Hypotension.
 2149         i. Hypoventilation.
 2150         j. Laryngospasm.
 2151         k. Local anesthetic toxicity reaction.
 2152         l. Malignant hyperthermia.
 2153         m. Any other topics the board determines by rule are
 2154  warranted for patient safety and by the evolution of technology
 2155  and medical practice.
 2156         5. An office surgery performing Level III office surgeries
 2157  must maintain all of the equipment and medications required for
 2158  Level II office surgeries and comply with all of the following
 2159  additional requirements:
 2160         a. Maintain at least 720 mg of dantrolene on site if
 2161  halogenated anesthetics or succinylcholine are used.
 2162         b. Equipment and medication for monitored postanesthesia
 2163  recovery must be available in the office.
 2164         6. Anesthetic safety regulations must be developed, posted
 2165  in a conspicuous location in the office, and enforced by the
 2166  designated physician. Such regulations must include all of the
 2167  following requirements:
 2168         a. All operating room electrical and anesthesia equipment
 2169  must be inspected at least semiannually, and a written record of
 2170  the results and corrective actions must be maintained.
 2171         b. Flammable anesthetic agents may not be employed in
 2172  office surgery facilities.
 2173         c. Electrical equipment in anesthetizing areas must be on
 2174  an audiovisual line isolation monitor, with the exception of
 2175  radiologic equipment and fixed lighting more than 5 feet above
 2176  the floor.
 2177         d. Each anesthesia gas machine must have a pin-index system
 2178  or equivalent safety system and a minimum oxygen flow safety
 2179  device.
 2180         e. All reusable anesthesia equipment in direct contact with
 2181  a patient must be cleaned or sterilized as appropriate after
 2182  each use.
 2183         f. The following monitors must be applied to all patients
 2184  receiving conduction or general anesthesia:
 2185         (I) Blood pressure cuff.
 2186         (II) A continuous temperature device, readily available to
 2187  measure the patient’s temperature.
 2188         (III) Pulse oximeter.
 2189         (IV) Electrocardiogram.
 2190         (V) An inspired oxygen concentration monitor and a
 2191  capnograph, for patients receiving general anesthesia.
 2192         g. Emergency intubation equipment must be available in all
 2193  office surgery suites.
 2194         h. Surgical tables must be capable of Trendelenburg and
 2195  other positions necessary to facilitate surgical procedures.
 2196         i. An anesthesiologist, a certified registered nurse
 2197  anesthetist, an anesthesiologist assistant, or a physician
 2198  assistant qualified as set forth in board rule must administer
 2199  the general or regional anesthesia.
 2200         j. A physician, a registered nurse, a licensed practical
 2201  nurse, a physician assistant, or an operating room technician
 2202  must assist with the surgery. The anesthesia provider may not
 2203  function in any other capacity during the procedure.
 2204         k. The patient must be monitored in the recovery room until
 2205  he or she has fully recovered from anesthesia. The monitoring
 2206  must be provided by a physician, a physician assistant, a
 2207  certified registered nurse anesthetist, an anesthesiologist
 2208  assistant, or a registered nurse with postanesthesia care unit
 2209  experience or the equivalent who is currently certified in
 2210  advanced cardiac life support, or, in the case of pediatric
 2211  patients, currently certified in pediatric advanced life
 2212  support.
 2213         (8) RULEMAKING.—The board may adopt by rule additional
 2214  standards of practice for physicians who perform office
 2215  surgeries or procedures under this section as warranted for
 2216  patient safety and by the evolution of technology and medical
 2217  practice.
 2218         Section 5. This act shall take effect upon becoming a law.
 2219  
 2220  ================= T I T L E  A M E N D M E N T ================
 2221  And the title is amended as follows:
 2222         Delete everything before the enacting clause
 2223  and insert:
 2224                        A bill to be entitled                      
 2225         An act relating to office surgeries; amending ss.
 2226         458.328 and 459.0138, F.S.; revising the types of
 2227         procedures for which a medical office must register
 2228         with the Department of Health to perform office
 2229         surgeries; specifying inspection procedures for such
 2230         offices seeking registration with the department;
 2231         requiring that certain offices seeking registration
 2232         provide proof to the department that they have met
 2233         specified requirements and rules; requiring the
 2234         department to inspect such offices to ensure that
 2235         certain equipment and procedures are present or in
 2236         place; requiring the department to notify the Agency
 2237         for Health Care Administration if an applicant is
 2238         unable to provide certain proof to the department and
 2239         to request that the agency inspect and consult with
 2240         the office; deleting obsolete language; providing that
 2241         the department may not register and must seek an
 2242         emergency suspension of an office under specified
 2243         circumstances; requiring that each office, as a
 2244         condition of registration, list certain medical
 2245         personnel and thereafter notify the department of the
 2246         addition or termination of such personnel within a
 2247         specified timeframe; providing for disciplinary action
 2248         for failure to comply; revising the materials that the
 2249         department must review when inspecting a registered
 2250         office; requiring offices already registered with the
 2251         department as of a specified date to provide a
 2252         registration update within a specified timeframe;
 2253         specifying requirements for such registration update
 2254         process; revising requirements for the standards of
 2255         practice for office surgeries; providing an
 2256         administrative penalty; revising rulemaking
 2257         requirements; creating ss. 458.3281 and 459.0139,
 2258         F.S.; providing construction; defining terms;
 2259         specifying general requirements for office surgeries;
 2260         specifying standards of practice for office surgeries,
 2261         delineated by the level of surgery being performed;
 2262         authorizing the Board of Medicine and the Board of
 2263         Osteopathic Medicine, as applicable, to adopt
 2264         additional standards of practice by rule; providing an
 2265         effective date.