Florida Senate - 2024                        COMMITTEE AMENDMENT
       Bill No. CS for SB 1188
       
       
       
       
       
       
                                Ì589844QÎ589844                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  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 and
  216  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” means monitoring that is prolonged without
  331  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 which requires only needle puncture of an
  369  artery or vein followed by insertion of catheters, wires, or
  370  similar devices that are then advanced through the blood vessels
  371  using 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 20 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, or 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 surgical procedure only in the following
  478  circumstances:
  479         a. When combined with an abdominoplasty, liposuction may
  480  not exceed 1,000 cubic centimeters of supernatant fat.
  481         b. When liposuction is associated and directly related to
  482  another procedure, the liposuction may not exceed 1,000 cubic
  483  centimeters of supernatant fat.
  484         2. Major liposuction in excess of 1,000 cubic centimeters
  485  of supernatant fat may not be performed on a patient’s body in a
  486  location that is remote from the site of another procedure being
  487  performed on that patient.
  488         (h) For elective cosmetic and plastic surgery procedures
  489  performed in a physician’s office, the maximum planned duration
  490  of all surgical procedures combined may not exceed 8 hours.
  491  Except for elective cosmetic and plastic surgery, the physician
  492  performing the surgery may not keep patients past midnight in a
  493  physician’s office. For elective cosmetic and plastic surgical
  494  procedures, the patient must be discharged within 24 hours after
  495  presenting to the office for surgery. However, an overnight stay
  496  is allowed in the office if the total time the patient is at the
  497  office does not exceed 23 hours and 59 minutes, including the
  498  surgery time. An overnight stay in a physician’s office for
  499  elective cosmetic and plastic surgery must be strictly limited
  500  to the physician’s office. If the patient has not recovered
  501  sufficiently to be safely discharged within the timeframes set
  502  forth, the patient must be transferred to a hospital for
  503  continued postoperative care.
  504         (i) The American Society of Anesthesiologists Standards for
  505  Basic Anesthetic Monitoring are hereby adopted and incorporated
  506  by reference as the standards for anesthetic monitoring by any
  507  qualified anesthesia provider under 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 or the name and location
  724  of the hospital with which the physician performing the surgery
  725  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, reflex
  809  withdrawal from a painful stimulus is not considered a
  810  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 Board of
  832  Osteopathic Medicine, as applicable, or must be able to
  833  establish comparable background, training, and experience. Such
  834  board certification or comparable background, training, and
  835  experience must also be directly related to and include the
  836  procedures being performed by the physician in the office
  837  surgery facility.
  838         3. One assistant must be currently certified in basic life
  839  support.
  840         4. The physician performing the surgery must be currently
  841  certified in advanced cardiac life support.
  842         5. A complete and current crash cart must be available at
  843  all times at the location where the anesthesia is being
  844  administered. The designated physician of an office surgery is
  845  responsible for ensuring that the crash cart is replenished
  846  after each use, the expiration dates for the crash cart’s
  847  medications are checked weekly, and crash cart events are
  848  documented in the cart’s logs. Medicines must be stored per the
  849  manufacturer’s recommendations, and multidose vials must be
  850  dated once opened and checked daily for expiration. The crash
  851  cart must, at a minimum, include the following intravenous or
  852  inhaled medications:
  853         a. Adenosine, 18 mg.
  854         b. Albuterol, 2.5 mg with a small volume nebulizer.
  855         c. Amiodarone, 300 mg.
  856         d. Atropine, 3 mg.
  857         e. Calcium chloride, 1 gram.
  858         f. Dextrose, 50 percent; 50 ml.
  859         g. Diphenhydramine, 50 mg.
  860         h. Dopamine, 200 mg, minimum.
  861         i. Epinephrine, 1 mg, in 10 ml.
  862         j. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
  863         k. Flumazenil, 1 mg.
  864         l. Furosemide, 40 mg.
  865         m. Hydrocortisone, 100 mg.
  866         n. Lidocaine appropriate for cardiac administration, 100
  867  mg.
  868         o. Magnesium sulfate, 2 grams.
  869         p. Naloxone, 1.2 mg.
  870         q. A beta blocker class drug.
  871         r. Sodium bicarbonate, 50 mEq/50 ml.
  872         s. Paralytic agent that is appropriate for use in rapid
  873  sequence intubation.
  874         t. A calcium channel blocker class drug.
  875         u. If nonneuraxial regional blocks are performed,
  876  Intralipid, 20 percent, 500 ml solution.
  877         v. Any additional medication the board determines by rule
  878  is warranted for patient safety and by the evolution of
  879  technology and medical practice.
  880         6. In the event of a drug shortage, the designated
  881  physician is authorized to substitute a therapeutically
  882  equivalent drug that meets the prevailing practice standards.
  883         7. The designated physician is responsible for ensuring
  884  that the office maintains documentation of its unsuccessful
  885  efforts to obtain the required drug.
  886         8. The designated physician is responsible for ensuring
  887  that the following are present in the office surgery:
  888         a. A benzodiazepine.
  889         b. A positive pressure ventilation device, such as Ambu,
  890  plus oxygen supply.
  891         c. An end-tidal carbon dioxide detection device.
  892         d. Monitors for blood pressure, electrocardiography, and
  893  oxygen saturation.
  894         e. Emergency intubation equipment that must, at a minimum,
  895  include suction devices, endotracheal tubes, working
  896  laryngoscopes, oropharyngeal airways, nasopharyngeal airways,
  897  and bag valve mask apparatus that are sized appropriately for
  898  the specific patient.
  899         f. A working defibrillator with defibrillator pads or
  900  defibrillator gel, or an automated external defibrillator unit.
  901         g. Sufficient backup power to allow the physician
  902  performing the surgery to safely terminate the procedure and to
  903  allow the patient to emerge from the anesthetic, all without
  904  compromising the sterility of the procedure or the environment
  905  of care.
  906         h. Working sterilization equipment cultured weekly.
  907         i. Sufficient intravenous solutions and equipment for a
  908  minimum of a week’s worth of surgical cases.
  909         j. Any other equipment required by board rule, as warranted
  910  by the evolution of technology and medical practice.
  911         9. The physician performing the surgery must be assisted by
  912  a qualified anesthesia provider, which may include any of the
  913  following types of providers:
  914         a. An anesthesiologist.
  915         b. A certified registered nurse anesthetist.
  916         c. A registered nurse, if the physician performing the
  917  surgery is certified in advanced cardiac life support and the
  918  registered nurse assists only with local anesthesia or conscious
  919  sedation.
  920  
  921  An anesthesiologist assistant may assist the anesthesiologist as
  922  provided by board rule. An assisting anesthesia provider may not
  923  function in any other capacity during the procedure.
  924         10. If additional anesthesia assistance is required by the
  925  specific procedure or patient circumstances, such assistance
  926  must be provided by a physician, osteopathic physician,
  927  registered nurse, licensed practical nurse, or operating room
  928  technician.
  929         11. The designated physician is responsible for ensuring
  930  that each patient is monitored in the recovery room until the
  931  patient is fully recovered from anesthesia. Such monitoring must
  932  be provided by a licensed physician, physician assistant,
  933  registered nurse with postanesthesia care unit experience, or
  934  the equivalent who is currently certified in advanced cardiac
  935  life support, or, in the case of pediatric patients, currently
  936  certified in pediatric advanced life support.
  937         (6) LEVEL II-A OFFICE SURGERY.—
  938         (a) Scope.—Level II-A office surgeries are those Level II
  939  office surgeries that have a maximum planned duration of 5
  940  minutes or less and in which the chances of complications
  941  requiring hospitalization are remote.
  942         (b) Standards of practice.—
  943         1. All practice standards for Level II office surgery set
  944  forth in paragraph (5)(b) must be met for Level II-A office
  945  surgery except for the requirements set forth in subparagraph
  946  (5)(b)9. regarding assistance by a qualified anesthesia
  947  provider.
  948         2. During the surgical procedure, the physician performing
  949  the surgery must be assisted by a licensed physician, physician
  950  assistant, registered nurse, or licensed practical nurse.
  951         3. Additional assistance may be required by specific
  952  procedure or patient circumstances.
  953         4. Following the procedure, a licensed physician, physician
  954  assistant, or registered nurse must be available to monitor the
  955  patient in the recovery room until the patient is recovered from
  956  anesthesia. The monitoring provider must be currently certified
  957  in advanced cardiac life support, or, in the case of pediatric
  958  patients, currently certified in pediatric advanced life
  959  support.
  960         (7) LEVEL III OFFICE SURGERY.—
  961         (a) Scope.—
  962         1. Level III office surgery includes those types of surgery
  963  during which the patient’s level of sedation is that of deep
  964  sedation and analgesia or general anesthesia. As used in this
  965  subparagraph, the term:
  966         a. “Deep sedation and analgesia” means a drug-induced
  967  depression of consciousness during which:
  968         (I) Patients cannot be easily aroused but respond
  969  purposefully following repeated or painful stimulation;
  970         (II) The ability to independently maintain ventilatory
  971  function may be impaired;
  972         (III) Patients may require assistance in maintaining a
  973  patent airway and spontaneous ventilation may be inadequate; and
  974         (IV) Cardiovascular function is usually maintained.
  975  
  976  For purposes of this sub-subparagraph, reflex withdrawal from a
  977  painful stimulus is not considered a 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 Board of
 1019  Osteopathic Medicine, as applicable, or must be able to
 1020  demonstrate to the accrediting organization or to the department
 1021  comparable background, training, and experience. Such board
 1022  certification or comparable background, training, and experience
 1023  must also be directly related to and include the procedure being
 1024  performed by the physician performing the surgery in the office
 1025  surgery setting. In addition, the physician performing the
 1026  surgery must have knowledge of the principles of general
 1027  anesthesia.
 1028         2. The physician performing the surgery must be currently
 1029  certified in advanced cardiac life support.
 1030         3. At least one operating assistant must be currently
 1031  certified in basic life support.
 1032         4. An emergency policy and procedures manual related to
 1033  serious anesthesia complications must be available in the office
 1034  surgery and reviewed biannually by the designated physician,
 1035  practiced with staff, updated, and posted in a conspicuous
 1036  location in the office. Topics to be covered in the manual must
 1037  include all of the following:
 1038         a. Airway blockage and foreign body obstruction.
 1039         b. Allergic reactions.
 1040         c. Bradycardia.
 1041         d. Bronchospasm.
 1042         e. Cardiac arrest.
 1043         f. Chest pain.
 1044         g. Hypoglycemia.
 1045         h. Hypotension.
 1046         i. Hypoventilation.
 1047         j. Laryngospasm.
 1048         k. Local anesthetic toxicity reaction.
 1049         l. Malignant hyperthermia.
 1050         m. Any other topics the board determines by rule are
 1051  warranted for patient safety and by the evolution of technology
 1052  and medical practice.
 1053         5. An office surgery performing Level III office surgeries
 1054  must maintain all of the equipment and medications required for
 1055  Level II office surgeries and comply with all of the following
 1056  additional requirements:
 1057         a. Maintain at least 720 mg of dantrolene on site if
 1058  halogenated anesthetics or succinylcholine are used.
 1059         b. Equipment and medication for monitored postanesthesia
 1060  recovery must be available in the office.
 1061         6. Anesthetic safety regulations must be developed, posted
 1062  in a conspicuous location in the office, and enforced by the
 1063  designated physician. Such regulations must include all of the
 1064  following requirements:
 1065         a. All operating room electrical and anesthesia equipment
 1066  must be inspected at least semiannually, and a written record of
 1067  the results and corrective actions must be maintained.
 1068         b. Flammable anesthetic agents may not be employed in
 1069  office surgery facilities.
 1070         c. Electrical equipment in anesthetizing areas must be on
 1071  an audiovisual line isolation monitor, with the exception of
 1072  radiologic equipment and fixed lighting more than 5 feet above
 1073  the floor.
 1074         d. Each anesthesia gas machine must have a pin index safety
 1075  system or equivalent safety system and a minimum oxygen flow
 1076  safety device.
 1077         e. All reusable anesthesia equipment in direct contact with
 1078  a patient must be cleaned or sterilized as appropriate after
 1079  each use.
 1080         f. The following monitors must be applied to all patients
 1081  receiving conduction or general anesthesia:
 1082         (I) Blood pressure cuff.
 1083         (II) A continuous temperature device, readily available to
 1084  measure the patient’s temperature.
 1085         (III) Pulse oximeter.
 1086         (IV) Electrocardiogram.
 1087         (V) An inspired oxygen concentration monitor and a
 1088  capnograph, for patients receiving general anesthesia.
 1089         g. Emergency intubation equipment must be available in all
 1090  office surgery suites.
 1091         h. Surgical tables must be capable of Trendelenburg and
 1092  other positions necessary to facilitate surgical procedures.
 1093         i. An anesthesiologist, a certified registered nurse
 1094  anesthetist, an anesthesiologist assistant, or a physician
 1095  assistant qualified as set forth in board rule must administer
 1096  the general or regional anesthesia.
 1097         j. A physician, a registered nurse, a licensed practical
 1098  nurse, a physician assistant, or an operating room technician
 1099  must assist with the surgery. The anesthesia provider may not
 1100  function in any other capacity during the procedure.
 1101         k. The patient must be monitored in the recovery room until
 1102  he or she has fully recovered from anesthesia. The monitoring
 1103  must be provided by a physician, a physician assistant, a
 1104  certified registered nurse anesthetist, an anesthesiologist
 1105  assistant, or a registered nurse with postanesthesia care unit
 1106  experience or the equivalent who is currently certified in
 1107  advanced cardiac life support, or, in the case of pediatric
 1108  patients, currently certified in pediatric advanced life
 1109  support.
 1110         (8) EXEMPTION.—This section does not apply to a physician
 1111  who is dually licensed as a dentist under chapter 466 when he or
 1112  she is performing dental procedures that fall within the scope
 1113  of practice of dentistry and are regulated under chapter 466.
 1114         (9) RULEMAKING.—The board may adopt by rule additional
 1115  standards of practice for physicians who perform office
 1116  surgeries or procedures under this section as warranted for
 1117  patient safety and by the evolution of technology and medical
 1118  practice.
 1119         Section 3. Section 459.0138, Florida Statutes, is amended
 1120  to read:
 1121         459.0138 Office surgeries.—
 1122         (1) REGISTRATION.—
 1123         (a)1. An office in which a physician performs or intends to
 1124  perform a liposuction procedure in which more than 1,000 cubic
 1125  centimeters of supernatant fat is temporarily or permanently
 1126  removed, a liposuction procedure during which the patient is
 1127  rotated between the supine, lateral, and prone positions, a
 1128  Level II office surgery, or a Level III office surgery must
 1129  register with the department. unless the office is licensed as A
 1130  facility licensed under chapter 390 or chapter 395 may not be
 1131  registered under this section.
 1132         (b)2. The department must complete an inspection of any
 1133  office seeking registration under this section before the office
 1134  may be registered.
 1135         1. The inspection of the office seeking registration under
 1136  this section must include inspection for compliance with the
 1137  standards of practice set out in this section and s. 458.3281
 1138  and any applicable board rules for the levels of office surgery
 1139  and procedures listed on the application which any physician
 1140  practicing at the office performs or intends to perform. The
 1141  application must be updated within 10 calendar days before any
 1142  additional surgical procedures or levels of office surgery are
 1143  to be performed at the office. Failure to timely update the
 1144  application for any such additional surgical procedures or
 1145  levels of office surgery is a violation of this section and
 1146  subject to discipline under ss. 456.072 and 459.015.
 1147         2. The department must immediately suspend the registration
 1148  process of an office that refuses an inspection under
 1149  subparagraph 1., and the applicant must be required to reapply
 1150  for registration.
 1151         3. If the department determines that an office seeking
 1152  registration under this section is one in which a physician may
 1153  perform, or intends to perform, liposuction procedures that
 1154  include a patient being rotated between the supine, lateral, and
 1155  prone positions during the procedure, or in which a physician
 1156  may perform, or intends to perform, gluteal fat grafting
 1157  procedures, the office must provide proof to the department that
 1158  it has met the applicable requirements of s. 469 of the Florida
 1159  Building Code, relating to office surgery suites, and s.
 1160  458.3281 and the applicable rules adopted thereunder, and the
 1161  department must inspect the office to ensure that all of the
 1162  following are present or in place:
 1163         a. Equipment and a procedure for measuring and documenting
 1164  in a log the amount of supernatant fat removed, both temporarily
 1165  and permanently, from a particular patient, including tissue
 1166  disposal procedures.
 1167         b. A procedure for measuring and documenting the amount of
 1168  lidocaine injected for tumescent liposuction, if used.
 1169         c. Working ultrasound guidance equipment or other guidance
 1170  technology authorized under board rule which equals or exceeds
 1171  the quality of ultrasound guidance.
 1172         d. The office procedure for obtaining blood products.
 1173         e. Documentation on file at the office demonstrating that
 1174  any physician performing these procedures has privileges to
 1175  perform such procedures in a hospital no more than 20 minutes
 1176  away.
 1177         f. Procedures for emergency resuscitation and transport to
 1178  a hospital.
 1179         g. Procedures for anesthesia and surgical recordkeeping.
 1180         h. Any additional inspection requirements, as set by board
 1181  rule.
 1182         4. If an applicant is unable to provide proof to the
 1183  department that the office seeking registration is in compliance
 1184  with the applicable requirements of s. 469 of the Florida
 1185  Building Code, relating to office surgery suites, or s. 459.0139
 1186  or the applicable rules adopted thereunder, in accordance with
 1187  subparagraph 3., the department must notify the Agency for
 1188  Health Care Administration and request the agency to inspect the
 1189  office and consult with the office about the process to apply
 1190  for ambulatory surgical center licensure under chapter 395 and
 1191  how the office may seek qualification for such licensure,
 1192  notwithstanding the office’s failure to meet all requirements
 1193  associated with such licensure at the time of inspection and
 1194  notwithstanding any pertinent exceptions provided under s.
 1195  395.002(3).
 1196         (c)(b) To be By January 1, 2020, each office registered
 1197  under this section or s. 458.328, an office must, at the time of
 1198  application, list a designated designate a physician who is
 1199  responsible for the office’s compliance with the office health
 1200  and safety requirements of this section and rules adopted
 1201  hereunder. A designated physician must have a full, active, and
 1202  unencumbered license under this chapter or chapter 458 and shall
 1203  practice at the office for which he or she has assumed
 1204  responsibility. Within 10 calendar days after the termination of
 1205  a designated physician relationship, the office must notify the
 1206  department of the designation of another physician to serve as
 1207  the designated physician. The department may not register an
 1208  office if the office fails to comply with this requirement at
 1209  the time of application and must seek an emergency suspension of
 1210  the suspend a registration of for an office pursuant to s.
 1211  456.074(6) if the office fails to timely notify the department
 1212  of its new designated physician within 10 calendar days after
 1213  the termination of the previous designated physician
 1214  relationship comply with the requirements of this paragraph.
 1215         (d) As a condition of registration, each office must, at
 1216  the time of application, list all medical personnel who will be
 1217  practicing at the office, including all of the following:
 1218         1. Physicians who intend to practice surgery or assist in
 1219  surgery at the office seeking registration, including their
 1220  respective license numbers and practice addresses.
 1221         2. Anesthesia providers, including their license numbers.
 1222         3. Nursing personnel licensed under chapter 464, including
 1223  their license numbers unless already provided under subparagraph
 1224  2.
 1225         4. Physician assistants, including their respective license
 1226  numbers and supervising physicians.
 1227  
 1228  The office must notify the department of the addition or
 1229  termination of any of the types of medical personnel specified
 1230  under this paragraph within 10 calendar days before such
 1231  addition or after such termination. Failure to timely notify the
 1232  department of such addition or termination is a violation of
 1233  this section and subject to discipline under ss. 456.072 and
 1234  459.015.
 1235         (e)(c) As a condition of registration, each office must
 1236  establish financial responsibility by demonstrating that it has
 1237  met and continues to maintain, at a minimum, the same
 1238  requirements applicable to physicians in ss. 458.320 and
 1239  459.0085. Each physician practicing at an office registered
 1240  under this section or s. 458.328 must meet the financial
 1241  responsibility requirements under s. 458.320 or s. 459.0085, as
 1242  applicable.
 1243         (f)(d) Each physician practicing or intending to practice
 1244  at an office registered under this section or s. 458.328 must
 1245  shall advise the board, in writing, within 10 calendar days
 1246  before after beginning or after ending his or her practice at a
 1247  the registered office, as applicable.
 1248         (g)(e)1. The department shall inspect a registered office
 1249  at least annually, including a review of patient records,
 1250  anesthesia logs, surgery logs, and liposuction logs, to ensure
 1251  that the office is in compliance with this section and rules
 1252  adopted hereunder unless the office is accredited in office
 1253  based surgery by the Joint Commission or other a nationally
 1254  recognized accrediting agency approved by the board. The
 1255  inspection may be unannounced, except for the inspection of an
 1256  office that meets the description of a clinic specified in s.
 1257  459.0137(1)(a)3.h., and those wholly owned and operated
 1258  physician offices described in s. 459.0137(1)(a)3.g. which
 1259  perform procedures referenced in s. 459.0137(1)(a)3.h., which
 1260  must be announced.
 1261         (h)2. The department must immediately suspend the
 1262  registration of a registered office that refuses an inspection
 1263  under paragraph (g) subparagraph 1. The office must close during
 1264  such suspension. The suspension must remain in effect for at
 1265  least 14 consecutive days and may not terminate until the
 1266  department issues a written declaration that the office may
 1267  reopen following the department’s completion of an inspection of
 1268  the office.
 1269         (i)(f) The department may suspend or revoke the
 1270  registration of an office in which a procedure or surgery
 1271  identified in paragraph (a) is performed for failure of any of
 1272  its physicians, owners, or operators to comply with this section
 1273  and rules adopted hereunder or s. 458.328 and rules adopted
 1274  thereunder. If an office’s registration is revoked for any
 1275  reason, the department may deny any person named in the
 1276  registration documents of the office, including the persons who
 1277  own or operate the office, individually or as part of a group,
 1278  from registering an office to perform procedures or office
 1279  surgeries pursuant to this section or s. 458.328 for 5 years
 1280  after the revocation date.
 1281         (j)(g) The department may impose any penalty set forth in
 1282  s. 456.072(2) against the designated physician for failure of
 1283  the office to operate in compliance with the office health and
 1284  safety requirements of this section and rules adopted hereunder
 1285  or s. 458.328 and rules adopted thereunder.
 1286         (h) A physician may only perform a procedure or surgery
 1287  identified in paragraph (a) in an office that is registered with
 1288  the department. The board shall impose a fine of $5,000 per day
 1289  on a physician who performs a procedure or surgery in an office
 1290  that is not registered with the department.
 1291         (k)(i) The actual costs of registration and inspection or
 1292  accreditation must shall be paid by the person seeking to
 1293  register and operate the office in which a procedure or surgery
 1294  identified in paragraph (a) will be performed.
 1295         (2) REGISTRATION UPDATE.—
 1296         (a) An office that registered under this section before
 1297  July 1, 2024, in which a physician performs liposuction
 1298  procedures that include a patient being rotated between the
 1299  supine, lateral, and prone positions during the procedure or in
 1300  which a physician performs gluteal fat grafting procedures must
 1301  provide a registration update to the department consistent with
 1302  the requirements of the initial registration under subsection
 1303  (1) no later than 30 days before the office surgery’s next
 1304  annual inspection.
 1305         (b) Registration update inspections required under
 1306  subsection (1) must be performed by the department on the date
 1307  of the office surgery’s next annual inspection.
 1308         (c) During the registration update process, the office
 1309  surgery may continue to operate under the original registration.
 1310         (d) In order to provide an office surgery time to update to
 1311  the requirements of subsection (1) and s. 459.0139, effective
 1312  July 1, 2024, and the applicable provisions of s. 469 of the
 1313  Florida Building Code, relating to office surgery suites, any
 1314  office surgery registered under this section before July 1,
 1315  2024, whose annual inspection is due in July or August 2024, may
 1316  request from the department, in writing, a 60-day postponement
 1317  of the required annual inspection, which postponement must be
 1318  granted.
 1319         (e) All other requests to the department for a postponement
 1320  of the registration update inspection required under this
 1321  registration update process must be in writing and be approved
 1322  by the chair of the Board of Medicine for good cause shown, and
 1323  such postponement may not exceed 30 days.
 1324         (3) STANDARDS OF PRACTICE.—
 1325         (a) A physician performing a procedure or surgery in an
 1326  office registered under this section must comply with the
 1327  applicable provisions of s. 469 of the Florida Building Code,
 1328  relating to office surgery suites, and the standards of practice
 1329  for office surgery set forth in this section and s. 459.0139 and
 1330  any applicable rules adopted thereunder.
 1331         (b) A physician may not perform any surgery or procedure
 1332  identified in paragraph (1)(a) in a setting other than an office
 1333  registered under this section or a facility licensed under
 1334  chapter 390 or chapter 395, as applicable. The board shall
 1335  impose a fine of $5,000 per incident on a physician who violates
 1336  this paragraph performing a gluteal fat grafting procedure in an
 1337  office surgery setting shall adhere to standards of practice
 1338  pursuant to this subsection and rules adopted by the board.
 1339         (c)(b) Office surgeries may not:
 1340         1. Be a type of surgery that generally results in blood
 1341  loss of more than 10 percent of estimated blood volume in a
 1342  patient with a normal hemoglobin level;
 1343         2. Require major or prolonged intracranial, intrathoracic,
 1344  abdominal, or joint replacement procedures, except for
 1345  laparoscopic procedures;
 1346         3. Involve major blood vessels and be performed with direct
 1347  visualization by open exposure of the major blood vessel, except
 1348  for percutaneous endovascular intervention; or
 1349         4. Be emergent or life threatening.
 1350         (d)(c) A physician performing a gluteal fat grafting
 1351  procedure in an office surgery setting must comply with the
 1352  applicable provisions of s. 469 of the Florida Building Code,
 1353  relating to office surgery suites, and the standards of practice
 1354  under this subsection and s. 459.0139 and applicable rules
 1355  adopted thereunder, including, but not limited to, all of the
 1356  following standards of practice:
 1357         1. The A physician performing the a gluteal fat grafting
 1358  procedure must conduct an in-person examination of the patient
 1359  while physically present in the same room as the patient no
 1360  later than the day before the procedure.
 1361         2. Before a physician may delegate any duties during a
 1362  gluteal fat grafting procedure, the patient must provide
 1363  written, informed consent for such delegation. Any duty
 1364  delegated by a physician during a gluteal fat grafting procedure
 1365  must be performed under the direct supervision of the physician
 1366  performing such procedure. Fat extraction and gluteal fat
 1367  injections must be performed by the physician and may not be
 1368  delegated.
 1369         3. Fat may only be injected into the subcutaneous space of
 1370  the patient and may not cross the fascia overlying the gluteal
 1371  muscle. Intramuscular or submuscular fat injections are
 1372  prohibited.
 1373         4. When the physician performing a gluteal fat grafting
 1374  procedure injects fat into the subcutaneous space of the
 1375  patient, the physician must use ultrasound guidance, or guidance
 1376  with other technology authorized under board rule which equals
 1377  or exceeds the quality of ultrasound, during the placement and
 1378  navigation of the cannula to ensure that the fat is injected
 1379  into the subcutaneous space of the patient above the fascia
 1380  overlying the gluteal muscle. Such guidance with the use of
 1381  ultrasound or other technology is not required for other
 1382  portions of such procedure.
 1383         5. An office in which a physician performs gluteal fat
 1384  grafting procedures shall at all times maintain a ratio of one
 1385  physician to one patient during all phases of the procedure,
 1386  beginning with the administration of anesthesia to the patient
 1387  and concluding with the extubation of the patient. After a
 1388  physician has commenced, and while he or she is engaged in, a
 1389  gluteal fat grafting procedure, the physician may not commence
 1390  or engage in another gluteal fat grafting procedure or any other
 1391  procedure with another patient at the same time.
 1392         (e)(d) If a procedure in an office surgery setting results
 1393  in hospitalization, the incident must be reported as an adverse
 1394  incident pursuant to s. 458.351.
 1395         (e) An office in which a physician performs gluteal fat
 1396  grafting procedures must at all times maintain a ratio of one
 1397  physician to one patient during all phases of the procedure,
 1398  beginning with the administration of anesthesia to the patient
 1399  and concluding with the extubation of the patient. After a
 1400  physician has commenced, and while he or she is engaged in, a
 1401  gluteal fat grafting procedure, the physician may not commence
 1402  or engage in another gluteal fat grafting procedure or any other
 1403  procedure with another patient at the same time.
 1404         (4)(3) RULEMAKING.—
 1405         (a) The board may shall adopt by rule additional standards
 1406  of practice for physicians who perform office procedures or
 1407  office surgeries under pursuant to this section, as warranted
 1408  for patient safety and by the evolution of technology and
 1409  medical practice.
 1410         (b) The board may adopt rules to administer the
 1411  registration, registration update, inspection, and safety of
 1412  offices in which a physician performs office procedures or
 1413  office surgeries under pursuant to this section.
 1414         Section 4. Section 459.0139, Florida Statutes, is created
 1415  to read:
 1416         459.0139 Standard of practice for office surgery.—
 1417         (1) CONSTRUCTION.—This section does not relieve a physician
 1418  performing a procedure or surgery from the responsibility of
 1419  making the medical determination of whether an office is an
 1420  appropriate setting in which to perform that particular
 1421  procedure or surgery, taking into consideration the particular
 1422  patient on which the procedure or surgery is to be performed.
 1423         (2) DEFINITIONS.—As used in this section, the term:
 1424         (a) “Certified in advanced cardiac life support” means a
 1425  person holds a current certification in an advanced cardiac life
 1426  support course with didactic and skills components, approved by
 1427  the American Heart Association, the American Safety and Health
 1428  Institute, the American Red Cross, Pacific Medical Training, or
 1429  the Advanced Cardiovascular Life Support (ACLS) Certification
 1430  Institute.
 1431         (b) “Certified in basic life support” means a person holds
 1432  a current certification in a basic life support course with
 1433  didactic and skills components, approved by the American Heart
 1434  Association, the American Safety and Health Institute, the
 1435  American Red Cross, Pacific Medical Training, or the ACLS
 1436  Certification Institute.
 1437         (c) “Certified in pediatric advanced life support” means a
 1438  person holds a current certification in a pediatric advanced
 1439  life support course with didactic and skills components approved
 1440  by the American Heart Association, the American Safety and
 1441  Health Institute, or Pacific Medical Training.
 1442         (d) “Continual monitoring” means monitoring that is
 1443  repeated regularly and frequently in steady, rapid succession.
 1444         (e) “Continuous” means monitoring that is prolonged without
 1445  any interruption at any time.
 1446         (f) “Equipment” means a medical device, instrument, or tool
 1447  used to perform specific actions or take certain measurements
 1448  during, or while a patient is recovering from, a procedure or
 1449  surgery which must meet current performance standards according
 1450  to its manufacturer’s guidelines for the specific device,
 1451  instrument, or tool, as applicable.
 1452         (g) “Major blood vessels” means a group of critical
 1453  arteries and veins, including the aorta, coronary arteries,
 1454  pulmonary arteries, superior and inferior vena cava, pulmonary
 1455  veins, and any intra-cerebral artery or vein.
 1456         (h) “Office surgery” means a physician’s office in which
 1457  surgical procedures are performed by a physician for the
 1458  practice of medicine as authorized by this section and board
 1459  rule. The office must be an office at which a physician
 1460  regularly performs consultations with surgical patients,
 1461  preoperative examinations, and postoperative care, as
 1462  necessitated by the standard of care related to the surgeries
 1463  performed at the physician’s office, and at which patient
 1464  records are readily maintained and available. The types of
 1465  procedures or surgeries performed in an office surgery are those
 1466  which need not be performed in a facility licensed under chapter
 1467  390 or chapter 395, and are not of the type that:
 1468         1. Generally result in blood loss of more than 10 percent
 1469  of estimated blood volume in a patient with a normal hemoglobin
 1470  count;
 1471         2. Require major or prolonged intracranial, intrathoracic,
 1472  abdominal, or major joint replacement procedures, except for
 1473  laparoscopic procedures;
 1474         3. Involve major blood vessels and are performed with
 1475  direct visualization by open exposure of the major vessel,
 1476  except for percutaneous endovascular intervention; or
 1477         4. Are generally emergent or life threatening in nature.
 1478         (i) “Pediatric patient” means a patient who is 13 years of
 1479  age or younger.
 1480         (j) “Percutaneous endovascular intervention” means a
 1481  procedure performed without open direct visualization of the
 1482  target vessel and which requires only needle puncture of an
 1483  artery or vein followed by insertion of catheters, wires, or
 1484  similar devices that are then advanced through the blood vessels
 1485  using imaging guidance. Once the catheter reaches the intended
 1486  location, various maneuvers to address the diseased area may be
 1487  performed, including, but not limited to, injection of contrast
 1488  medium for imaging; treatment of vessels with angioplasty;
 1489  atherectomy; covered or uncovered stenting; embolization or
 1490  intentionally occluding vessels or organs; and delivering
 1491  medications or radiation or other energy, such as laser,
 1492  radiofrequency, or cryo.
 1493         (k) “Reasonable proximity” means a distance that does not
 1494  exceed 20 minutes of transport time to the hospital.
 1495         (l) “Surgery” means any manual or operative procedure
 1496  performed upon the body of a living human being, including, but
 1497  not limited to, those performed with the use of lasers, for the
 1498  purposes of preserving health, diagnosing or curing disease,
 1499  repairing injury, correcting a deformity or defect, prolonging
 1500  life, or relieving suffering, or any elective procedure for
 1501  aesthetic, reconstructive, or cosmetic purposes. The term
 1502  includes, but is not limited to, incision or curettage of tissue
 1503  or an organ; suture or other repair of tissue or an organ,
 1504  including a closed as well as an open reduction of a fracture;
 1505  extraction of tissue, including premature extraction of the
 1506  products of conception from the uterus; insertion of natural or
 1507  artificial implants; or an endoscopic procedure with use of
 1508  local or general anesthetic.
 1509         (3) GENERAL REQUIREMENTS FOR OFFICE SURGERY.—
 1510         (a) The physician performing the surgery must examine the
 1511  patient immediately before the surgery to evaluate the risk of
 1512  anesthesia and of the surgical procedure to be performed. The
 1513  physician performing the surgery may delegate the preoperative
 1514  heart and lung evaluation to a qualified anesthesia provider
 1515  within the scope of the provider’s practice and, if applicable,
 1516  protocol.
 1517         (b) The physician performing the surgery shall maintain
 1518  complete patient records of each surgical procedure performed,
 1519  which must include all of the following:
 1520         1. The patient’s name, patient number, preoperative
 1521  diagnosis, postoperative diagnosis, surgical procedure,
 1522  anesthetic, anesthesia records, recovery records, and
 1523  complications, if any.
 1524         2. The name of each member of the surgical team, including
 1525  the surgeon, first assistant, anesthesiologist, nurse
 1526  anesthetist, anesthesiologist assistant, circulating nurse, and
 1527  operating room technician, as applicable.
 1528         (c) Each office surgery’s designated physician shall ensure
 1529  that the office surgery has procedures in place to verify that
 1530  all of the following have occurred before any surgery is
 1531  performed:
 1532         1. The patient has signed the informed consent form for the
 1533  procedure reflecting the patient’s knowledge of identified risks
 1534  of the procedure, consent to the procedure, the type of
 1535  anesthesia and anesthesia provider to be used during the
 1536  procedure, and the fact that the patient may choose the type of
 1537  anesthesia provider for the procedure, such as an
 1538  anesthesiologist, a certified registered nurse anesthetist, a
 1539  physician assistant, an anesthesiologist assistant, or another
 1540  appropriately trained physician as provided by board rule.
 1541         2. The patient’s identity has been verified.
 1542         3. The operative site has been verified.
 1543         4. The operative procedure to be performed has been
 1544  verified with the patient.
 1545         5. All of the information and actions required to be
 1546  verified under this paragraph are documented in the patient’s
 1547  medical record.
 1548         (d) With respect to the requirements set forth in paragraph
 1549  (c), written informed consent is not necessary for minor Level I
 1550  procedures limited to the skin and mucosa.
 1551         (e) The physician performing the surgery shall maintain a
 1552  log of all liposuction procedures performed at the office
 1553  surgery where more than 1,000 cubic centimeters of supernatant
 1554  fat is temporarily or permanently removed and where Level II and
 1555  Level III surgical procedures are performed. The log must, at a
 1556  minimum, include all of the following:
 1557         1. A confidential patient identifier.
 1558         2. Time of arrival in the operating suite.
 1559         3. The name of the physician performing the procedure.
 1560         4. The patient’s diagnosis, CPT codes used for the
 1561  procedure, the patient’s classification for risk with anesthesia
 1562  according to the American Society of Anesthesiologists’ physical
 1563  status classification system, and the type of procedure and
 1564  level of surgery performed.
 1565         5. Documentation of completion of the medical clearance
 1566  performed by the anesthesiologist or the physician performing
 1567  the surgery.
 1568         6. The name and provider type of the anesthesia provider
 1569  and the type of anesthesia used.
 1570         7. The duration of the procedure.
 1571         8. Any adverse incidents as identified in s. 458.351.
 1572         9. The type of postoperative care, duration of recovery,
 1573  disposition of the patient upon discharge, including the address
 1574  of where the patient is being discharged, discharge
 1575  instructions, and list of medications used during surgery and
 1576  recovery.
 1577  
 1578  All surgical and anesthesia logs must be kept at the office
 1579  surgery and maintained for 6 years after the date of last
 1580  patient contact and must be provided to department investigators
 1581  upon request.
 1582         (f) For any liposuction procedure, the physician performing
 1583  the surgery is responsible for determining the appropriate
 1584  amount of supernatant fat to be removed from a particular
 1585  patient. A maximum of 4,000 cubic centimeters of supernatant fat
 1586  may be removed by liposuction in the office surgery setting. A
 1587  maximum of 50mg/kg of lidocaine may be injected for tumescent
 1588  liposuction in the office surgery setting.
 1589         (g)1. Liposuction may be performed in combination with
 1590  another separate surgical procedure during a single Level II or
 1591  Level III surgical procedure only in the following
 1592  circumstances:
 1593         a. When combined with an abdominoplasty, liposuction may
 1594  not exceed 1,000 cubic centimeters of supernatant fat.
 1595         b. When liposuction is associated and directly related to
 1596  another procedure, the liposuction may not exceed 1,000 cubic
 1597  centimeters of supernatant fat.
 1598         2. Major liposuction in excess of 1,000 cubic centimeters
 1599  of supernatant fat may not be performed on a patient’s body in a
 1600  location that is remote from the site of another procedure being
 1601  performed on that patient.
 1602         (h) For elective cosmetic and plastic surgery procedures
 1603  performed in a physician’s office, the maximum planned duration
 1604  of all surgical procedures combined may not exceed 8 hours.
 1605  Except for elective cosmetic and plastic surgery, the physician
 1606  performing the surgery may not keep patients past midnight in a
 1607  physician’s office. For elective cosmetic and plastic surgical
 1608  procedures, the patient must be discharged within 24 hours after
 1609  presenting to the office for surgery. However, an overnight stay
 1610  is allowed in the office if the total time the patient is at the
 1611  office does not exceed 23 hours and 59 minutes, including the
 1612  surgery time. An overnight stay in a physician’s office for
 1613  elective cosmetic and plastic surgery must be strictly limited
 1614  to the physician’s office. If the patient has not recovered
 1615  sufficiently to be safely discharged within the timeframes set
 1616  forth, the patient must be transferred to a hospital for
 1617  continued postoperative care.
 1618         (i) The American Society of Anesthesiologists Standards for
 1619  Basic Anesthetic Monitoring are hereby adopted and incorporated
 1620  by reference as the standards for anesthetic monitoring by any
 1621  qualified anesthesia provider under this section.
 1622         1. These standards apply to general anesthetics, regional
 1623  anesthetics, and monitored Level II and III anesthesia care.
 1624  However, in emergency circumstances, appropriate life support
 1625  measures take priority. These standards may be exceeded at any
 1626  time based on the judgment of the responsible supervising
 1627  physician or anesthesiologist. While these standards are
 1628  intended to encourage quality patient care, observing them does
 1629  not guarantee any specific patient outcome. This set of
 1630  standards addresses only the issue of basic anesthesia
 1631  monitoring, which is only one component of anesthesia care.
 1632         2. In certain rare or unusual circumstances, some of these
 1633  methods of monitoring may be clinically impractical, and
 1634  appropriate use of the described monitoring methods may fail to
 1635  detect adverse clinical developments. In such cases, a brief
 1636  interruption of continual monitoring may be unavoidable and does
 1637  not by itself constitute a violation of the standards of
 1638  practice of this section.
 1639         3. Under extenuating circumstances, the physician
 1640  performing the surgery or the anesthesiologist may waive the
 1641  following requirements:
 1642         a. The use of an oxygen analyzer with a low oxygen
 1643  concentration limit alarm, or other technology authorized under
 1644  board rule which equals or exceeds the quality of the oxygen
 1645  analyzer, during the administration of general anesthesia with
 1646  an anesthesia machine.
 1647         b. The use of pulse oximetry with a variable pitch pulse
 1648  tone and an audible low threshold alarm, or other technology
 1649  authorized under board rule which equals or exceeds the quality
 1650  of a pulse oximeter, and the use of adequate illumination and
 1651  exposure of the patient to assess color.
 1652         c. The use of capnography, capnometry, or mass
 1653  spectroscopy, or other technology authorized under board rule
 1654  which equals or exceeds the quality of capnography, capnometry,
 1655  or mass spectroscopy, as a quantitative method of analyzing the
 1656  end-tidal carbon dioxide for continual monitoring for the
 1657  presence of expired carbon dioxide during ventilation, from the
 1658  time of the endotracheal tube or supraglottic airway placement
 1659  until extubation or removal or initiating transfer of the
 1660  patient to a postoperative care location.
 1661         d. The use of continuous electrocardiogram display, or
 1662  other technology authorized under board rule which equals or
 1663  exceeds the quality of electrocardiogram display, from the
 1664  beginning of anesthesia until preparing to leave the
 1665  anesthetizing location.
 1666         e. The measuring of arterial blood pressure and heart rate
 1667  evaluated at least every 5 minutes during anesthesia.
 1668  
 1669  When any of the monitoring is waived for extenuating
 1670  circumstances under this subparagraph, it must be documented in
 1671  a note in the patient’s medical record, including the reasons
 1672  for the need to waive the requirement. These standards are not
 1673  intended for the application to the care of an obstetrical
 1674  patient in labor or in the conduct of pain management.
 1675         (j)1. Because of the rapid changes in patient status during
 1676  anesthesia, qualified anesthesia personnel must be continuously
 1677  present in the room to provide anesthesia care for the entire
 1678  duration of all general anesthetics, regional anesthetics, and
 1679  monitored anesthesia care conducted on the patient. In the event
 1680  that there is a direct known hazard, such as radiation, to the
 1681  anesthesia personnel which might require intermittent remote
 1682  observation of the patient, some provision for monitoring the
 1683  patient must be made. In the event that an emergency requires
 1684  the temporary absence of the person primarily responsible for
 1685  the anesthesia, the best judgment of the supervising physician
 1686  or anesthesiologist shall be exercised in comparing the
 1687  emergency with the anesthetized patient’s condition and in the
 1688  selection of the person left responsible for the anesthesia
 1689  during the temporary absence.
 1690         2. During all anesthesia, the patient’s oxygenation,
 1691  ventilation, circulation, and temperature must be continually
 1692  evaluated to ensure adequate oxygen concentration in the
 1693  inspired gas and the blood.
 1694         a. During all general anesthesia using an anesthesia
 1695  machine, the concentration of oxygen in the patient’s breathing
 1696  system must be measured by an oxygen analyzer with a low oxygen
 1697  concentration limit alarm used to measure blood oxygenation.
 1698         b. During all anesthesia, a quantitative method of
 1699  assessing oxygenation, such as pulse oximetry, must be employed.
 1700  When a pulse oximeter is used, the variable pitch pulse tone and
 1701  the low threshold alarm must be audible to the qualified
 1702  anesthesia provider. Adequate illumination and exposure of the
 1703  patient are necessary to assess color.
 1704         c. During all anesthesia, every patient must have the
 1705  adequacy of his or her ventilation continually evaluated,
 1706  including, but not limited to, the evaluation of qualitative
 1707  clinical signs, such as chest excursion, observation of the
 1708  reservoir breathing bag, and auscultation of breath sounds.
 1709  Continual monitoring for the presence of expired carbon dioxide
 1710  must be performed unless invalidated by the nature of the
 1711  patient’s condition, the procedure, or the equipment.
 1712  Quantitative monitoring of the volume of expired gas must also
 1713  be performed.
 1714         d. When an endotracheal tube or supraglottic airway is
 1715  inserted, its correct positioning must be verified by clinical
 1716  assessment and by identification of carbon dioxide in the
 1717  expired gas. Continual end-tidal carbon dioxide analysis, in use
 1718  from the time of endotracheal tube or supraglottic airway
 1719  placement until extubation or removal or initiating transfer of
 1720  the patient to a postoperative care location, must be performed
 1721  using a quantitative method, such as capnography, capnometry, or
 1722  mass spectroscopy, or other technology authorized under board
 1723  rule which equals or exceeds the quality of capnography,
 1724  capnometry, or mass spectroscopy. When capnography or capnometry
 1725  is used, the end-tidal carbon dioxide alarm must be audible to
 1726  the qualified anesthesia provider.
 1727         e. When ventilation is controlled by a mechanical
 1728  ventilator, there must be in continuous use a device capable of
 1729  detecting disconnection of components of the breathing system.
 1730  The device must give an audible signal when its alarm threshold
 1731  is exceeded.
 1732         f. During regional anesthesia without sedation or local
 1733  anesthesia with no sedation, the adequacy of ventilation must be
 1734  evaluated by continual observation of qualitative clinical
 1735  signs. During moderate or deep sedation, the adequacy of
 1736  ventilation must be evaluated by continual observation of
 1737  qualitative clinical signs. Monitoring for the presence of
 1738  exhaled carbon dioxide is recommended.
 1739         g. Every patient receiving anesthesia must have the
 1740  electrocardiogram or other technology authorized under board
 1741  rule which equals or exceeds the quality of electrocardiogram
 1742  continuously displayed from the beginning of anesthesia until
 1743  preparing to leave the anesthetizing location.
 1744         h. Every patient receiving anesthesia must have arterial
 1745  blood pressure and heart rate determined and evaluated at least
 1746  every 5 minutes.
 1747         i. Every patient receiving general anesthesia must have
 1748  circulatory function continually evaluated by at least one of
 1749  the following methods:
 1750         (I) Palpation of a pulse.
 1751         (II) Auscultation of heart sounds.
 1752         (III) Monitoring of a tracing of intra-arterial pressure.
 1753         (IV) Ultrasound peripheral pulse monitoring.
 1754         (V) Pulse plethysmography or oximetry.
 1755         (VI) Other technology authorized under board rule which
 1756  equals or exceeds the quality of any of the methods listed in
 1757  sub-sub-subparagraphs (I)-(V).
 1758         j. Every patient receiving anesthesia must have his or her
 1759  temperature monitored when clinically significant changes in
 1760  body temperature are intended, anticipated, or suspected.
 1761         (k)1. The physician performing the surgery shall ensure
 1762  that the postoperative care arrangements made for the patient
 1763  are adequate for the procedure being performed, as required by
 1764  board rule.
 1765         2. Management of postoperative care is the responsibility
 1766  of the physician performing the surgery and may be delegated as
 1767  determined by board rule. If the physician performing the
 1768  surgery is unavailable to provide postoperative care, the
 1769  physician performing the surgery must notify the patient of his
 1770  or her unavailability for postoperative care before the
 1771  procedure.
 1772         3. If there is an overnight stay at the office in relation
 1773  to any surgical procedure:
 1774         a. The office must provide at least two persons to act as
 1775  monitors, one of whom must be certified in advanced cardiac life
 1776  support, and maintain a monitor-to-patient ratio of at least one
 1777  monitor to two patients.
 1778         b. Once the physician performing the surgery has signed a
 1779  timed and dated discharge order, the office may provide only one
 1780  monitor to monitor the patient. The monitor must be qualified by
 1781  licensure and training to administer all of the medications
 1782  required on the crash cart and must be certified in advanced
 1783  cardiac life support.
 1784         c. A complete and current crash cart must be present in the
 1785  office surgery and immediately accessible for the monitors.
 1786         4. The physician performing the surgery must be reachable
 1787  by telephone and readily available to return to the office if
 1788  needed.
 1789         5. A policy and procedures manual must be maintained in the
 1790  office at which Level II and Level III procedures are performed.
 1791  The manual must be updated and implemented annually. The policy
 1792  and procedures manual must provide for all of the following:
 1793         a. Duties and responsibilities of all personnel.
 1794         b. A quality assessment and improvement system designed to
 1795  objectively and systematically monitor and evaluate the quality
 1796  and appropriateness of patient care and opportunities to improve
 1797  performance.
 1798         c. Cleaning procedures and protocols.
 1799         d. Sterilization procedures.
 1800         e. Infection control procedures and personnel
 1801  responsibilities.
 1802         f. Emergency procedures.
 1803         6. The designated physician shall establish a risk
 1804  management program that includes all of the following
 1805  components:
 1806         a. The identification, investigation, and analysis of the
 1807  frequency and causes of adverse incidents.
 1808         b. The identification of trends or patterns of adverse
 1809  incidents.
 1810         c. The development of appropriate measures to correct,
 1811  reduce, minimize, or eliminate the risk of adverse incidents.
 1812         d. The documentation of such functions and periodic review
 1813  of such information at least quarterly by the designated
 1814  physician.
 1815         7. The designated physician shall report to the department
 1816  any adverse incidents that occur within the scope of office
 1817  surgeries. This report must be made within 15 days after the
 1818  occurrence of an incident as required by s. 458.351.
 1819         8. The designated physician is responsible for prominently
 1820  posting a sign in the office which states that the office is a
 1821  doctor’s office regulated under this section and ss. 458.328,
 1822  458.3281, and 459.0138 and the applicable rules of the Board of
 1823  Medicine and the Board of Osteopathic Medicine as set forth in
 1824  rules 64B8 and 64B15, Florida Administrative Code. This notice
 1825  must also appear prominently within the required patient
 1826  informed consent form.
 1827         9. All physicians performing surgery at the office surgery
 1828  must be qualified by education, training, and experience to
 1829  perform any procedure the physician performs in the office
 1830  surgery.
 1831         10. When Level II, Level II-A, or Level III procedures are
 1832  performed in an office surgery setting, the physician performing
 1833  the surgery is responsible for providing the patient, in
 1834  writing, before the procedure, with the name and location of the
 1835  hospital where the physician performing the surgery has
 1836  privileges to perform the same procedure as the one being
 1837  performed in the office surgery setting or the name and location
 1838  of the hospital with which the physician performing the surgery
 1839  has a transfer agreement in the event of an emergency.
 1840         (4) LEVEL I OFFICE SURGERY.—
 1841         (a) Scope.—Level I office surgery includes the following:
 1842         1. Minor procedures such as excision of skin lesions,
 1843  moles, warts, cysts, or lipomas and repair of lacerations or
 1844  surgery limited to the skin and subcutaneous tissue which are
 1845  performed under topical or local anesthesia not involving drug
 1846  induced alteration of consciousness other than minimal pre
 1847  operative tranquilization of the patient.
 1848         2. Liposuction involving the removal of less than 4,000
 1849  cubic centimeters of supernatant fat.
 1850         3. Incision and drainage of superficial abscesses; limited
 1851  endoscopies, such as proctoscopies, skin biopsies,
 1852  arthrocentesis, thoracentesis, paracentesis, dilation of the
 1853  urethra, cystoscopic procedures, and closed reduction of simple
 1854  fractures; or small joint dislocations, such as in the finger or
 1855  toe joints.
 1856         4. Procedures in which anesthesia is limited to minimal
 1857  sedation. The patient’s level of sedation must be that of
 1858  minimal sedation and anxiolysis, and the chances of
 1859  complications requiring hospitalization must be remote. As used
 1860  in this sub-subparagraph, the term “minimal sedation and
 1861  anxiolysis” means a drug-induced state during which patients
 1862  respond normally to verbal commands, and although cognitive
 1863  function and physical coordination may be impaired, airway
 1864  reflexes and ventilatory and cardiovascular functions remain
 1865  unaffected. Controlled substances, as defined in ss. 893.02 and
 1866  893.03, must be limited to oral administration in doses
 1867  appropriate for the unsupervised treatment of insomnia, anxiety,
 1868  or pain.
 1869         5. Procedures for which chances of complications requiring
 1870  hospitalization are remote as specified in board rule.
 1871         (b) Standards of practice.—Standards of practice for Level
 1872  I office surgery include all of the following:
 1873         1. The medical education, training, and experience of the
 1874  physician performing the surgery must include training on proper
 1875  dosages and management of toxicity or hypersensitivity to
 1876  regional anesthetic drugs, and the physician must be certified
 1877  in advanced cardiac life support.
 1878         2. At least one operating assistant must be certified in
 1879  basic life support.
 1880         3. Intravenous access supplies, oxygen, oral airways, and a
 1881  positive pressure ventilation device must be available in the
 1882  office surgery, along with the following medications, stored per
 1883  the manufacturer’s recommendation:
 1884         a. Atropine, 3 mg.
 1885         b. Diphenhydramine, 50 mg.
 1886         c. Epinephrine, 1 mg in 10 ml.
 1887         d. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
 1888         e. Hydrocortisone, 100 mg.
 1889         f. If a benzodiazepine is administered, flumazenil, 0.5 mg
 1890  in 5 ml vial, 2 vials total.
 1891         g. If an opiate is administered, naloxone, 0.4 mg in 1 ml
 1892  vial, 2 vials total.
 1893         4. When performing minor procedures, such as excision of
 1894  skin lesions, moles, warts, cysts, or lipomas and repair of
 1895  lacerations or surgery limited to the skin and subcutaneous
 1896  tissue performed under topical or local anesthesia in an office
 1897  surgery setting, physicians performing the procedure are exempt
 1898  from subparagraphs 1.-3. Current certification in basic life
 1899  support is recommended but not required.
 1900         5. A physician performing the surgery need not have an
 1901  assistant during the procedure unless the specific procedure
 1902  being performed requires an assistant.
 1903         (5) LEVEL II OFFICE SURGERY.—
 1904         (a) Scope.—Level II office surgery includes, but is not
 1905  limited to, all of the following procedures:
 1906         1. Hemorrhoidectomy.
 1907         2. Hernia repair.
 1908         3. Large joint dislocations.
 1909         4. Colonoscopy.
 1910         5. Liposuction involving the removal of up to 4,000 cubic
 1911  centimeters of supernatant fat.
 1912         6. Any other procedure the board designates by rule as a
 1913  Level II office surgery.
 1914         7. Surgeries in which the patient’s level of sedation is
 1915  that of moderate sedation and analgesia or conscious sedation.
 1916  As used in this subparagraph, the term “moderate sedation and
 1917  analgesia or conscious sedation” is a drug-induced depression of
 1918  consciousness during which patients respond purposefully to
 1919  verbal commands, either alone or accompanied by light tactile
 1920  stimulation; interventions are not required to maintain a patent
 1921  airway; spontaneous ventilation is adequate; and cardiovascular
 1922  function is maintained. For purposes of this term, reflex
 1923  withdrawal from a painful stimulus is not considered a
 1924  purposeful response.
 1925         (b) Standards of practice.—Standards of practice for Level
 1926  II office surgery include, but are not limited to, the
 1927  following:
 1928         1. The physician performing the surgery, or the office
 1929  where the procedure is being performed, must have a transfer
 1930  agreement with a licensed hospital within reasonable proximity
 1931  if the physician performing the procedure does not have staff
 1932  privileges to perform the same procedure as that being performed
 1933  in the office surgery setting at a licensed hospital within
 1934  reasonable proximity. The transfer agreement required by this
 1935  section must be current and have been entered into no more than
 1936  3 years before the date of the office’s most recent annual
 1937  inspection under s. 459.0138. A transfer agreement must
 1938  affirmatively disclose an effective date and a termination date.
 1939         2. The physician performing the surgery must have staff
 1940  privileges at a licensed hospital to perform the same procedure
 1941  in that hospital as that being performed in the office surgery
 1942  setting or must be able to document satisfactory completion of
 1943  training, such as board certification or board eligibility by a
 1944  board approved by the American Board of Medical Specialties or
 1945  any other board approved by the Board of Medicine or Board of
 1946  Osteopathic Medicine, as applicable, or must be able to
 1947  establish comparable background, training, and experience. Such
 1948  board certification or comparable background, training, and
 1949  experience must also be directly related to and include the
 1950  procedures being performed by the physician in the office
 1951  surgery facility.
 1952         3. One assistant must be currently certified in basic life
 1953  support.
 1954         4. The physician performing the surgery must be currently
 1955  certified in advanced cardiac life support.
 1956         5. A complete and current crash cart must be available at
 1957  all times at the location where the anesthesia is being
 1958  administered. The designated physician of an office surgery is
 1959  responsible for ensuring that the crash cart is replenished
 1960  after each use, the expiration dates for the crash cart’s
 1961  medications are checked weekly, and crash cart events are
 1962  documented in the cart’s logs. Medicines must be stored per the
 1963  manufacturer’s recommendations, and multidose vials must be
 1964  dated once opened and checked daily for expiration. The crash
 1965  cart must, at a minimum, include the following intravenous or
 1966  inhaled medications:
 1967         a. Adenosine, 18 mg.
 1968         b. Albuterol, 2.5 mg with a small volume nebulizer.
 1969         c. Amiodarone, 300 mg.
 1970         d. Atropine, 3 mg.
 1971         e. Calcium chloride, 1 gram.
 1972         f. Dextrose, 50 percent; 50 ml.
 1973         g. Diphenhydramine, 50 mg.
 1974         h. Dopamine, 200 mg, minimum.
 1975         i. Epinephrine, 1 mg, in 10 ml.
 1976         j. Epinephrine, 1 mg in 1 ml vial, 3 vials total.
 1977         k. Flumazenil, 1 mg.
 1978         l. Furosemide, 40 mg.
 1979         m. Hydrocortisone, 100 mg.
 1980         n. Lidocaine appropriate for cardiac administration, 100
 1981  mg.
 1982         o. Magnesium sulfate, 2 grams.
 1983         p. Naloxone, 1.2 mg.
 1984         q. A beta blocker class drug.
 1985         r. Sodium bicarbonate, 50 mEq/50 ml.
 1986         s. Paralytic agent that is appropriate for use in rapid
 1987  sequence intubation.
 1988         t. A calcium channel blocker class drug.
 1989         u. If nonneuraxial regional blocks are performed,
 1990  Intralipid, 20 percent, 500 ml solution.
 1991         v. Any additional medication the board determines by rule
 1992  is warranted for patient safety and by the evolution of
 1993  technology and medical practice.
 1994         6. In the event of a drug shortage, the designated
 1995  physician is authorized to substitute a therapeutically
 1996  equivalent drug that meets the prevailing practice standards.
 1997         7. The designated physician is responsible for ensuring
 1998  that the office maintains documentation of its unsuccessful
 1999  efforts to obtain the required drug.
 2000         8. The designated physician is responsible for ensuring
 2001  that the following are present in the office surgery:
 2002         a. A benzodiazepine.
 2003         b. A positive pressure ventilation device, such as Ambu,
 2004  plus oxygen supply.
 2005         c. An end-tidal carbon dioxide detection device.
 2006         d. Monitors for blood pressure, electrocardiography, and
 2007  oxygen saturation.
 2008         e. Emergency intubation equipment that must, at a minimum,
 2009  include suction devices, endotracheal tubes, working
 2010  laryngoscopes, oropharyngeal airways, nasopharyngeal airways,
 2011  and bag valve mask apparatus that are sized appropriately for
 2012  the specific patient.
 2013         f. A working defibrillator with defibrillator pads or
 2014  defibrillator gel, or an automated external defibrillator unit.
 2015         g. Sufficient backup power to allow the physician
 2016  performing the surgery to safely terminate the procedure and to
 2017  allow the patient to emerge from the anesthetic, all without
 2018  compromising the sterility of the procedure or the environment
 2019  of care.
 2020         h. Working sterilization equipment cultured weekly.
 2021         i. Sufficient intravenous solutions and equipment for a
 2022  minimum of a week’s worth of surgical cases.
 2023         j. Any other equipment required by board rule, as warranted
 2024  by the evolution of technology and medical practice.
 2025         9. The physician performing the surgery must be assisted by
 2026  a qualified anesthesia provider, which may include any of the
 2027  following types of providers:
 2028         a. An anesthesiologist.
 2029         b. A certified registered nurse anesthetist.
 2030         c. A registered nurse, if the physician performing the
 2031  surgery is certified in advanced cardiac life support and the
 2032  registered nurse assists only with local anesthesia or conscious
 2033  sedation.
 2034  
 2035  An anesthesiologist assistant may assist the anesthesiologist as
 2036  provided by board rule. An assisting anesthesia provider may not
 2037  function in any other capacity during the procedure.
 2038         10. If additional anesthesia assistance is required by the
 2039  specific procedure or patient circumstances, such assistance
 2040  must be provided by a physician, osteopathic physician,
 2041  registered nurse, licensed practical nurse, or operating room
 2042  technician.
 2043         11. The designated physician is responsible for ensuring
 2044  that each patient is monitored in the recovery room until the
 2045  patient is fully recovered from anesthesia. Such monitoring must
 2046  be provided by a licensed physician, physician assistant,
 2047  registered nurse with postanesthesia care unit experience, or
 2048  the equivalent who is currently certified in advanced cardiac
 2049  life support, or, in the case of pediatric patients, currently
 2050  certified in pediatric advanced life support.
 2051         (6) LEVEL II-A OFFICE SURGERY.—
 2052         (a) Scope.—Level II-A office surgeries are those Level II
 2053  office surgeries that have a maximum planned duration of 5
 2054  minutes or less and in which the chances of complications
 2055  requiring hospitalization are remote.
 2056         (b) Standards of practice.—
 2057         1. All practice standards for Level II office surgery set
 2058  forth in paragraph (5)(b) must be met for Level II-A office
 2059  surgery except for the requirements set forth in subparagraph
 2060  (5)(b)9. regarding assistance by a qualified anesthesia
 2061  provider.
 2062         2. During the surgical procedure, the physician performing
 2063  the surgery must be assisted by a licensed physician, physician
 2064  assistant, registered nurse, or licensed practical nurse.
 2065         3. Additional assistance may be required by specific
 2066  procedure or patient circumstances.
 2067         4. Following the procedure, a licensed physician, physician
 2068  assistant, or registered nurse must be available to monitor the
 2069  patient in the recovery room until the patient is recovered from
 2070  anesthesia. The monitoring provider must be currently certified
 2071  in advanced cardiac life support, or, in the case of pediatric
 2072  patients, currently certified in pediatric advanced life
 2073  support.
 2074         (7) LEVEL III OFFICE SURGERY.—
 2075         (a) Scope.—
 2076         1. Level III office surgery includes those types of surgery
 2077  during which the patient’s level of sedation is that of deep
 2078  sedation and analgesia or general anesthesia. As used in this
 2079  subparagraph, the term:
 2080         a. “Deep sedation and analgesia” means a drug-induced
 2081  depression of consciousness during which:
 2082         (I) Patients cannot be easily aroused but respond
 2083  purposefully following repeated or painful stimulation;
 2084         (II) The ability to independently maintain ventilatory
 2085  function may be impaired;
 2086         (III) Patients may require assistance in maintaining a
 2087  patent airway and spontaneous ventilation may be inadequate; and
 2088         (IV) Cardiovascular function is usually maintained.
 2089  
 2090  For purposes of this sub-subparagraph, reflex withdrawal from a
 2091  painful stimulus is not considered a purposeful response.
 2092         b. “General anesthesia” means a drug-induced loss of
 2093  consciousness during which:
 2094         (I) Patients are not arousable, even by painful
 2095  stimulation;
 2096         (II) The ability to independently maintain ventilatory
 2097  function is often impaired;
 2098         (III) Patients often require assistance in maintaining a
 2099  patent airway and positive pressure ventilation may be required
 2100  because of depressed spontaneous ventilation or drug-induced
 2101  depression of neuromuscular function; and
 2102         (IV) Cardiovascular function may be impaired.
 2103         2. The use of spinal or epidural anesthesia for a procedure
 2104  requires that the procedure be considered a Level III office
 2105  surgery.
 2106         3. Only patients classified under the American Society of
 2107  Anesthesiologists’ (ASA) risk classification criteria as Class I
 2108  or Class II are appropriate candidates for a Level III office
 2109  surgery.
 2110         a. All Level III office surgeries on patients classified as
 2111  ASA III or higher must be performed only in a hospital or
 2112  ambulatory surgical center.
 2113         b. For all ASA II patients above the age of 50, the
 2114  physician performing the surgery must obtain a complete workup
 2115  performed before the performance of a Level III office surgery
 2116  in the office surgery setting.
 2117         c. If the patient has a cardiac history or is deemed to be
 2118  a complicated medical patient, the patient must have a
 2119  preoperative electrocardiogram and be referred to an appropriate
 2120  consultant for medical optimization. The referral to a
 2121  consultant may be waived after evaluation by the patient’s
 2122  anesthesiologist.
 2123         (b) Standards of practice.—Practice standards for Level III
 2124  office surgery include all Level II office surgery standards and
 2125  all of the following requirements:
 2126         1. The physician performing the surgery must have staff
 2127  privileges at a licensed hospital to perform the same procedure
 2128  in that hospital as that being performed in the office surgery
 2129  setting or must be able to document satisfactory completion of
 2130  training, such as board certification or board qualification by
 2131  a board approved by the American Board of Medical Specialties or
 2132  any other board approved by the Board of Medicine or Board of
 2133  Osteopathic Medicine, as applicable, or must be able to
 2134  demonstrate to the accrediting organization or to the department
 2135  comparable background, training, and experience. Such board
 2136  certification or comparable background, training, and experience
 2137  must also be directly related to and include the procedure being
 2138  performed by the physician performing the surgery in the office
 2139  surgery setting. In addition, the physician performing the
 2140  surgery must have knowledge of the principles of general
 2141  anesthesia.
 2142         2. The physician performing the surgery must be currently
 2143  certified in advanced cardiac life support.
 2144         3. At least one operating assistant must be currently
 2145  certified in basic life support.
 2146         4. An emergency policy and procedures manual related to
 2147  serious anesthesia complications must be available in the office
 2148  surgery and reviewed biannually by the designated physician,
 2149  practiced with staff, updated, and posted in a conspicuous
 2150  location in the office. Topics to be covered in the manual must
 2151  include all of the following:
 2152         a. Airway blockage and foreign body obstruction.
 2153         b. Allergic reactions.
 2154         c. Bradycardia.
 2155         d. Bronchospasm.
 2156         e. Cardiac arrest.
 2157         f. Chest pain.
 2158         g. Hypoglycemia.
 2159         h. Hypotension.
 2160         i. Hypoventilation.
 2161         j. Laryngospasm.
 2162         k. Local anesthetic toxicity reaction.
 2163         l. Malignant hyperthermia.
 2164         m. Any other topics the board determines by rule are
 2165  warranted for patient safety and by the evolution of technology
 2166  and medical practice.
 2167         5. An office surgery performing Level III office surgeries
 2168  must maintain all of the equipment and medications required for
 2169  Level II office surgeries and comply with all of the following
 2170  additional requirements:
 2171         a. Maintain at least 720 mg of dantrolene on site if
 2172  halogenated anesthetics or succinylcholine are used.
 2173         b. Equipment and medication for monitored postanesthesia
 2174  recovery must be available in the office.
 2175         6. Anesthetic safety regulations must be developed, posted
 2176  in a conspicuous location in the office, and enforced by the
 2177  designated physician. Such regulations must include all of the
 2178  following requirements:
 2179         a. All operating room electrical and anesthesia equipment
 2180  must be inspected at least semiannually, and a written record of
 2181  the results and corrective actions must be maintained.
 2182         b. Flammable anesthetic agents may not be employed in
 2183  office surgery facilities.
 2184         c. Electrical equipment in anesthetizing areas must be on
 2185  an audiovisual line isolation monitor, with the exception of
 2186  radiologic equipment and fixed lighting more than 5 feet above
 2187  the floor.
 2188         d. Each anesthesia gas machine must have a pin index safety
 2189  system or equivalent safety system and a minimum oxygen flow
 2190  safety device.
 2191         e. All reusable anesthesia equipment in direct contact with
 2192  a patient must be cleaned or sterilized as appropriate after
 2193  each use.
 2194         f. The following monitors must be applied to all patients
 2195  receiving conduction or general anesthesia:
 2196         (I) Blood pressure cuff.
 2197         (II) A continuous temperature device, readily available to
 2198  measure the patient’s temperature.
 2199         (III) Pulse oximeter.
 2200         (IV) Electrocardiogram.
 2201         (V) An inspired oxygen concentration monitor and a
 2202  capnograph, for patients receiving general anesthesia.
 2203         g. Emergency intubation equipment must be available in all
 2204  office surgery suites.
 2205         h. Surgical tables must be capable of Trendelenburg and
 2206  other positions necessary to facilitate surgical procedures.
 2207         i. An anesthesiologist, a certified registered nurse
 2208  anesthetist, an anesthesiologist assistant, or a physician
 2209  assistant qualified as set forth in board rule must administer
 2210  the general or regional anesthesia.
 2211         j. A physician, a registered nurse, a licensed practical
 2212  nurse, a physician assistant, or an operating room technician
 2213  must assist with the surgery. The anesthesia provider may not
 2214  function in any other capacity during the procedure.
 2215         k. The patient must be monitored in the recovery room until
 2216  he or she has fully recovered from anesthesia. The monitoring
 2217  must be provided by a physician, a physician assistant, a
 2218  certified registered nurse anesthetist, an anesthesiologist
 2219  assistant, or a registered nurse with postanesthesia care unit
 2220  experience or the equivalent who is currently certified in
 2221  advanced cardiac life support, or, in the case of pediatric
 2222  patients, currently certified in pediatric advanced life
 2223  support.
 2224         (8) EXEMPTION.—This section does not apply to a physician
 2225  who is dually licensed as a dentist under chapter 466 when he or
 2226  she is performing dental procedures that fall within the scope
 2227  of practice of dentistry and are regulated under chapter 466.
 2228         (9) RULEMAKING.—The board may adopt by rule additional
 2229  standards of practice for physicians who perform office
 2230  surgeries or procedures under this section as warranted for
 2231  patient safety and by the evolution of technology and medical
 2232  practice.
 2233         Section 5. Subsection (6) of section 456.074, Florida
 2234  Statutes, is amended to read
 2235         456.074 Certain health care practitioners; immediate
 2236  suspension of license.—
 2237         (6) The department must issue an emergency order suspending
 2238  or restricting the registration of an office registered under s.
 2239  458.328 or s. 459.0138 s. 459.0139 upon a finding of probable
 2240  cause that the office or a physician practicing in the office is
 2241  not in compliance with the standards of practice for office
 2242  surgery adopted by the boards pursuant to s. 458.328 or s.
 2243  459.0138, as applicable, or is in violation of s. 458.331(1)(v)
 2244  or s. 459.015(1)(z), and that such noncompliance or violation
 2245  constitutes an immediate danger to the public.
 2246         Section 6. This act shall take effect upon becoming a law.
 2247  
 2248  ================= T I T L E  A M E N D M E N T ================
 2249  And the title is amended as follows:
 2250         Delete everything before the enacting clause
 2251  and insert:
 2252                        A bill to be entitled                      
 2253         An act relating to office surgeries; amending ss.
 2254         458.328 and 459.0138, F.S.; revising the types of
 2255         procedures for which a medical office must register
 2256         with the Department of Health to perform office
 2257         surgeries; specifying inspection procedures for such
 2258         offices seeking registration with the department;
 2259         requiring that certain offices seeking registration
 2260         provide proof to the department that they have met
 2261         specified requirements and rules; requiring the
 2262         department to inspect such offices to ensure that
 2263         certain equipment and procedures are present or in
 2264         place; requiring the department to notify the Agency
 2265         for Health Care Administration if an applicant is
 2266         unable to provide certain proof to the department and
 2267         to request that the agency inspect and consult with
 2268         the office; deleting obsolete language; providing that
 2269         the department may not register and must seek an
 2270         emergency suspension of an office under specified
 2271         circumstances; requiring that each office, as a
 2272         condition of registration, list certain medical
 2273         personnel and thereafter notify the department of the
 2274         addition or termination of such personnel within a
 2275         specified timeframe; providing for disciplinary action
 2276         for failure to comply; revising the materials that the
 2277         department must review when inspecting a registered
 2278         office; requiring offices already registered with the
 2279         department as of a specified date to provide a
 2280         registration update within a specified timeframe;
 2281         specifying requirements for such registration update
 2282         process; revising requirements for the standards of
 2283         practice for office surgeries; providing an
 2284         administrative penalty; revising rulemaking
 2285         requirements; creating ss. 458.3281 and 459.0139,
 2286         F.S.; providing construction; defining terms;
 2287         specifying general requirements for office surgeries;
 2288         specifying standards of practice for office surgeries,
 2289         delineated by the level of surgery being performed;
 2290         providing an exemption; authorizing the Board of
 2291         Medicine and the Board of Osteopathic Medicine, as
 2292         applicable, to adopt additional standards of practice
 2293         by rule; amending s. 456.074, F.S.; correcting a
 2294         cross-reference; providing an effective date.