Nothing in this rule relieves the surgeon of the
responsibility for making the medical determination that the office is an
appropriate forum for the particular procedure(s) to be performed on the
(a) Surgery. For the purpose of this rule,
surgery is defined as any manual or operative procedure, including the use of
lasers, performed upon the body of a living human being for the purposes of
preserving health, diagnosing or curing disease, repairing injury, correcting
deformity or defects, prolonging life, relieving suffering or any elective
procedure for aesthetic, reconstructive or cosmetic purposes, to include, but
not be limited to: incision or curettage of tissue or an organ; suture or other
repair of tissue or organ, including a closed as well as an open reduction of a
fracture; extraction of tissue including premature extraction of the products
of conception from the uterus; insertion of natural or artificial implants; or
an endoscopic procedure with use of local or general anesthetic.
(b) Surgeon. For the purpose of this rule,
surgeon is defined as a licensed physician performing any procedure included
within the definition of surgery.
(c) Equipment. For the purpose of this rule,
implicit within the use of the term of equipment is the requirement that the
specific item named must meet current performance standards according to
Office surgery. For the purpose of this rule office surgery is defined as
surgery which is performed outside of any facility licensed under Chapter 390
or 395, F.S. Office surgical procedures shall not be of a type that generally
result in blood loss of more than ten percent of estimated blood volume in a
patient with a normal hemoglobin; require major or prolonged intracranial,
intrathoracic, abdominal, or major joint replacement procedures, except for
laparoscopic procedures; involve major blood vessels performed with direct
visualization by open exposure of the major vessel, except for percutaneous
endovascular intervention; or are generally emergent or life threatening in
endovascular intervention. For the purpose of this rule percutaneous
endovascular intervention is defined as a procedure performed without open
direct visualization of the target vessel, requires only needle puncture of an
artery or vein followed by insertion of catheters, wires, or similar devices
which are then advanced through the blood vessels using imaging guidance. Once
the catheter reaches the intended location various maneuvers to address the
diseased area may be performed which include, but are not limited to, injection
of contrast for imaging, treatment of vessels with angioplasty, atherectomy,
covered or uncovered stenting, intentionally occluding vessels or organs
(embolization), and delivering medications, radiation, or other energy such as
laser, radiofrequency, or cryo.
Major Blood Vessels. For the purpose of this rule major blood vessels are
defined as group of critical arteries and veins including the aorta, coronary
arteries, pulmonary arteries, superior and inferior vena cava, pulmonary veins,
and any intra-cerebral artery or vein.
(g) Pediatric patients are defined as those
patients who are 13 years of age or under.
General Requirements for Office Surgery.
(a) The surgeon must examine the patient
immediately before the surgery to evaluate the risk of anesthesia and of the
surgical procedure to be performed. The surgeon may delegate the preoperative
heart lung evaluation to a qualified anesthesia provider within the scope of
the provider's practice and, if applicable, protocol. The surgeon must maintain
complete records of each surgical procedure, as set forth in Rule
F.A.C., including anesthesia records, when applicable and the records shall
contain written informed consent from the patient reflecting the patient's
knowledge of identified risks, consent to the procedure, type of anesthesia and
anesthesia provider, and that a choice of anesthesia provider exists, i.e.,
anesthesiologist, anesthesiologist assistant, another appropriately trained
physician as provided in this rule, certified registered nurse anesthetist, or
requirement set forth in paragraph (2)(a), above, for written informed consent
is not necessary for minor Level I procedures limited to the skin and
(c) The surgeon must
maintain a log of all liposuction procedures where more than 1,000 cubic
centimeters of supernatant fat is removed, and Level II and Level III surgical
procedures performed, which must include a confidential patient identifier,
time of arrival in the operating suite, documentation of completion of the
medical clearance as performed by the anesthesiologist or the operating
physician, the surgeon's name, diagnosis, CPT Codes, patient ASA
classification, the type of procedure, the level of surgery, the anesthesia
provider, the type of anesthesia used, the duration of the procedure, and any
adverse incidents, as identified in Section
F.S. If not documented elsewhere in the patient record, the surgical log must
note the type of post-operative care, duration of recovery, disposition of the
patient upon discharge, and list of medications used during surgery and
recovery. The log and all surgical records shall be provided to investigators
of the Department of Health upon request and must be maintained for six (6)
years from the last patient contact.
(d) In any liposuction procedure, the surgeon
is responsible for determining the appropriate amount of supernatant fat to be
removed from a particular patient. A maximum of 4000cc supernatant fat may be
removed by liposuction in the office setting. A maximum of 50mg/kg of Lidocaine
can be injected for tumescent liposuction in the office setting.
Liposuction may be performed in
combination with another separate surgical procedure during a single Level II
or Level III operation, only in the following circumstances:
1. When combined with abdominoplasty,
liposuction may not exceed 1000cc of supernatant fat,
2. When liposuction is associated and
directly related to another procedure, the liposuction may not exceed 1000 cc
of supernatant fat,
liposuction in excess of 1000cc supernatant fat may not be performed in a
remote location from any other procedure.
(f) Standard of Care for Gluteal Fat
Grafting. When performing gluteal fat grafting procedures, fat may only be
injected into the subcutaneous space and must never cross the gluteal fascia.
Intramuscular or submuscular fat injections are prohibited.
(g) For elective cosmetic and plastic surgery
procedures performed in a physician's office, the maximum planned duration of
all surgical procedures combined must not exceed 8 hours. Except for elective
cosmetic and plastic surgery, the surgeon shall not keep patients past midnight
in a physician's office. For elective cosmetic and plastic surgical procedures,
the patient must be discharged within 24 hours of presenting to the office for
surgery; an overnight stay is permitted in the office provided the total time
the patient is at the office does not exceed 23 hours and 59 minutes including
the surgery time. An overnight stay in a physician's office for elective
cosmetic and plastic surgery shall be strictly limited to the physician's
office. If the patient has not recovered sufficiently to be safely discharged
within the timeframes set forth, the patient must be transferred to a hospital
for continued post-operative care.
The Board of Medicine adopts the
"Standards of the American Society of Anesthesiologists for Basic Anesthetic
Monitoring," approved by House Delegates on October 21, 1986, and last amended
on October 20, 2010, as the standards for anesthetic monitoring by any
qualified anesthesia provider.
standards apply to general anesthetics, regional anesthetics, and monitored
anesthesia care (Level II and III as defined by this rule) although, in
emergency circumstances, appropriate life support measures take precedence.
These standards may be exceeded at any time based on the judgment of the
responsible supervising physician or anesthesiologist. They are intended to
encourage quality patient care, but observing them cannot guarantee any
specific patient outcome. They are subject to revision from time to time, as
warranted by the evolution of technology and practice. This set of standards
addresses only the issue of basic anesthesia monitoring, which is one component
of anesthesia care.
2. In certain
rare or unusual circumstances some of these methods of monitoring may be
clinically impractical, and appropriate use of the described monitoring methods
may fail to detect untoward clinical developments. Brief interruptions of
continual monitoring may be unavoidable. For purpose of this rule, "continual"
is defined as "repeated regularly and frequently in steady rapid succession"
whereas "continuous" means "prolonged without any interruption at any
circumstances, the responsible supervising physician or anesthesiologist may
waive the requirements marked with an asterisk (*); it is recommended that when
this is done, it should be so stated (including the reasons) in a note in the
patient's medical record. These standards are not intended for the application
to the care of the obstetrical patient in labor or in the conduct of pain
(I) Qualified anesthesia personnel shall be
present in the room throughout the conduct of all general anesthetics, regional
anesthetics and monitored anesthesia care.
(II) Objective. Because of the rapid changes
in patient status during anesthesia, qualified anesthesia personnel shall be
continuously present to monitor the patient and provide anesthesia care. In the
event there is a direct known hazard, e.g., radiation, to the anesthesia
personnel which might require intermittent remote observation of the patient,
some provision for monitoring the patient must be made. In the event that an
emergency requires the temporary absence of the person primarily responsible
for the anesthetic, the best judgment of the supervising physician or
anesthesiologist will be exercised in comparing the emergency with the
anesthetized patient's condition and in the selection of the person left
responsible for the anesthetic during the temporary absence.
(I) During all anesthetics, the patient's
oxygenation, ventilation, circulation and temperature shall be continually
(A) Objective. To ensure adequate oxygen
concentration in the inspired gas and the blood during all
(I) Inspired gas: During every administration
of general anesthesia using an anesthesia machine, the concentration of oxygen
in the patient breathing system shall be measured by an oxygen analyzer with a
low oxygen concentration limit alarm in use.*
(II) Blood oxygenation: During all
anesthetics, a quantitative method of assessing oxygenation such as a pulse
oximetry shall be employed.* When the pulse oximeter is utilized, the variable
pitch pulse tone and the low theshold alarm shall be audible to the qualifed
anesthesia provider.* Adequate illumination and exposure of the patient are
necessary to assess color.*
(A) Objective. To ensure adequate ventilation
of the patient during all anesthetics.
(I) Every patient receiving general
anesthesia shall have the adequacy of ventilation continually evaluated.
Qualitative clinical signs such as chest excursion, observation of the
reservoir breathing bag and auscultation of breath sounds are useful. Continual
monitoring for the presence of expired carbon dioxide shall be performed unless
invalidated by the nature of the patient, procedure or equipment. Quantitative
monitoring of the volume of expired gas is strongly encouraged.*
(II) When an endotracheal tube or
supraglottic airway is inserted, its correct positioning must be verified by
clinical assessment and by identification of carbon dioxide in the expired gas.
Continual end-tidal carbon dioxide analysis, in use from the time of
endotracheal tube/supraglottic airway placement, until extubation/removal or
initiating transfer to a postoperative care location, shall be performed using
a quantitative method such as capnography, capnometry or mass spectroscopy.*
When capnography or capnometry is utilized, the end tidal carbon dioxide alarm
shall be audible to the qualifed anesthesia provider.*
(III) When ventilation is controlled by a
mechanical ventilator, there shall be in continuous use a device that is
capable of detecting disconnection of components of the breathing system. The
device must give an audible signal when its alarm threshold is
(IV) During regional
anesthesia (with no sedation) or local anesthesia (with no sedation), the
adequacy of ventilation shall be evaluated by continual observation of
qualitative clinical signs. During moderate or deep sedation the adequacy of
ventiliation shall be evaluated by continual observation of qualitative
clinical signs. Monitoring for the presence of exhaled carbon dioxide is
(A) Objective. To ensure the adequacy of the
patient's circulatory function during all anesthetics.
(I) Every patient receiving anesthesia shall
have the electrocardiogram continuously displayed from the beginning of
anesthesia until preparing to leave the anesthetizing location.*
(II) Every patient receiving anesthesia shall
have arterial blood pressure and heart rate determined and evaluated at least
every five minutes.*
patient receiving general anesthesia shall have, in addition to the above,
circulatory function continually evaluated by at least one of the following:
palpation of a pulse, auscultation of heart sounds, monitoring of a tracing of
intra-arterial pressure, ultrasound peripheral pulse monitoring, or pulse
plethysmography or oximetry.
(A) Objective. To aid in
the maintenance of appropriate body temperature during all
(B) Methods. Every
patient receiving anesthesia shall have temperature monitored when clinically
significant changes in body temperature are intended, anticipated or
(i) The surgeon must assure that
the post-operative care arrangements made for the patient are adequate to the
procedure being performed as set forth in Rule
F.A.C. Management of post surgical care is the responsibility of the operating
surgeon and may be delegated only as set forth in subsection
F.A.C. If the surgeon is unavailable to provide post-operative care, the
surgeon must notify the patient of his or her unavailability prior to the
If there is an
overnight stay at the office in relation to any surgical procedure:
1. The office must provide at least two (2)
monitors, one of these monitors must be certified in Advanced Cardiac Life
Support (ACLS), and maintain a monitor to patient ratio of at least 1 monitor
to 2 patients. Once the surgeon has signed a timed and dated discharge order,
the office may provide only one monitor to monitor the patient. The monitor
must be qualified by licensure and training to administer all of the
medications required on the crash cart and must be certified in Advanced
Cardiac Life Support. The full and current crash cart required below must be
present in the office and immediately accessible for the monitors.
2. The surgeon must be reachable by telephone
and readily available to return to the office if needed. For purposes of this
subsection, "readily available" means capable of returning to the office within
15 minutes of receiving a call.
A policy and procedure manual must be
maintained in the office, updated annually, and implemented. The policy and
procedure manual must contain the following: duties and responsibilities of all
personnel, quality assessment and improvement systems comparable to those
required by Rule
F.A.C.; cleaning, sterilization and infection control, and emergency
procedures. This applies only to physician offices at which Level II and Level
III procedures are performed.
The surgeon shall establish a risk management program that includes the
1. The identification,
investigation, and analysis of the frequency and causes of adverse incidents to
2. The identification of
trends or patterns of incidents,
The development of appropriate measures to correct, reduce, minimize, or
eliminate the risk of adverse incidents to patients; and,
4. The documentation of these functions and
periodic review no less than quarterly of such information by the
(m) The surgeon
shall report to the Department of Health any adverse incidents that occur
within the office surgical setting. This report shall be made within 15 days
after the occurrence of an incident as required by Section 458.351,
(n) A sign must be prominently
posted in the office which states that the office is a doctor's office
regulated pursuant to the rules of the Board of Medicine as set forth in rule
Division 64B8, F.A.C. This notice must also appear prominently within the
required patient informed consent.
(o) All physicians performing office surgery
must be qualified by education, training, and experience to perform any
procedure the physician performs in the office surgery setting.
(p) When Level II, IIA, or III procedures are
performed, the surgeon is responsible for providing the patient, in writing,
prior to the procedure, the name and location of the hospital where the surgeon
has privileges to perform the same procedure as that being performed in the
out-patient setting, or the name and location of the hospital where the surgeon
or the facility has a transfer agreement.
Level I Office Surgery.
Scope. Level I office surgery includes
1. Minor procedures such as
excision of skin lesions, moles, warts, cysts, lipomas and repair of
lacerations or surgery limited to the skin and subcutaneous tissue performed
under topical or local anesthesia not involving drug-induced alteration of
consciousness other than minimal pre-operative tranquilization of the
2. Liposuction involving
the removal of less than 4000cc supernatant fat is permitted.
3. Incision and drainage of superficial
abscesses, limited endoscopies such as proctoscopies, skin biopsies,
arthrocentesis, thoracentesis, paracentesis, dilation of urethra, cysto-scopic
procedures, and closed reduction of simple fractures or small joint
dislocations (i.e., finger and toe joints).
4. Anesthesia is limited to minimal sedation.
The patient's level of sedation is that of minimal sedation and anxiolysis and
the chances of complications requiring hospitalization are remote. Minimal
sedation and anxiolysis is a drug-induced state during which patients respond
normally to verbal commands. Although cognitive function and physical
coordination may be impaired, airway reflexes, and ventilatory and
cardiovascular functions are unaffected. Controlled substances, as defined in
F.S., are limited to oral administration in doses appropriate for the
unsupervised treatment of insomnia, anxiety or pain.
5. Chances of complication requiring
hospitalization are remote.
Standards for Level I Office Surgery.
1. Training Required. Surgeon's continuing
medical education should include: proper dosages; management of toxicity or
hypersensitivity to regional anesthetic drugs. One assistant must hold current
certification in an American Heart Association, American Safety and Health
Institute, American Red Cross, Pacific Medical Training approved Basic Life
Support course with didactic and skills components, or ACLS Certification
Institute Basic Life Support course with didactic and skills components, and
the surgeon must hold current certification in an American Heart Association,
American Safety and Health Institute, Pacific Medical Training approved
Advanced Cardiac Life Support course with didactic and skills components, or
ACLS Certification Institute Advanced Cardiac Life Support course with didactic
and skills components.
and Supplies Required. Intravenous access supplies, oxygen, oral airways, and a
positive pressure ventilation device shall be available in the office, along
with the following medications, stored per manufacturer's recommendation:
a. Atropine 3 mg,
b. Diphenhydramine 50 mg,
c. Epinephrine 1 mg in 10 ml,
d. Epinephrine 1 mg in 1 ml vial, 3 vials
e. Hydrocortisone 100
f. If a benzodiazepine is
administered, Flumazenil 0.5 mg in 5 ml vial, 2 vials total; and,
g. If an opiate is administered, Naloxone 0.4
mg in 1 ml vial, 2 vials total.
3. When performing minor procedures such as
excision of skin lesions, moles, warts, cysts, lipomas, and repair of
lacerations or surgery limited to the skin and subcutaneous tissue performed
under topical or local anesthesia, physicans are exempt from subparagraphs
(3)(b)1. and 2., above. Current Basic Life Support certification is recommended
but not required.
4. Assistance of
Other Personnel Required. No other assistance is required, unless the specific
surgical procedure being performed requires an assistant.