Fla. Admin. Code Ann. R. 64B8-9.009 - Standard of Care for Office Surgery
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 particular patient.
(1) Definitions.
(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
manufacturer's guidelines.
(d)
Office surgery.
1. For the purpose of this
rule office surgery is defined as surgery which is performed in an office
maintained by a physician for the practice of medicine where a surgeon performs
procedures as permitted by this rule and is governed pursuant to Rule
64B8-9.0091, F.A.C., and Section
458.328, F.S. The physician's
office must be an office at which the surgeon regularly performs consultations
with surgical patients, pre-surgical examinations, and post-surgical care
related to the surgeries performed at the physician's office, and where patient
records are readily maintained and available. 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 nature.
2. A
facility that meets the definition of an ambulatory surgical center as defined
in Section 395.002(3),
F.S., a hospital as defined in Section
395.002(12),
F.S., or an abortion clinic as defined in Section
390.011(2),
F.S., may not be registered as an office surgery facility under Rule
64B8-9.0091, F.A.C.
(e) Percutaneous 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.
(f)
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.
(2) 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
64B8-9.003, 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
physician assistant.
(b) The
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
mucosa.
(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
458.351, 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.
(e) 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,
3. Major
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.
(h) 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.
1. These
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
time."
3. Under extenuating
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
management.
a. Standard I.
(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.
b. Standard II.
(I) During all anesthetics, the patient's
oxygenation, ventilation, circulation and temperature shall be continually
evaluated.
(II) Oxygenation.
(A) Objective. To ensure adequate oxygen
concentration in the inspired gas and the blood during all
anesthetics.
(B) Methods.
(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.*
(III) Ventilation.
(A) Objective. To ensure adequate ventilation
of the patient during all anesthetics.
(B) Methods.
(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
exceeded.
(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
recommended.
(IV) Circulation.
(A) Objective. To ensure the adequacy of the
patient's circulatory function during all anesthetics.
(B) Methods.
(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.*
(III) Every
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.
(IV)
Body temperature.
(A) Objective. To aid in the
maintenance of appropriate body temperature during all anesthetics.
(B) Methods. Every patient receiving
anesthesia shall have temperature monitored when clinically significant changes
in body temperature are intended, anticipated or suspected.
(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
64B8-9.007, 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
64B8-9.007(4),
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
procedure.
(j) 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.
(k) 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 59A-5.019, 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.
(l) The surgeon shall
establish a risk management program that includes the following components:
1. The identification, investigation, and
analysis of the frequency and causes of adverse incidents to
patients,
2. The identification of
trends or patterns of incidents,
3.
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
surgeon.
(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, F.S.
(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.
(3) Level I Office Surgery.
(a) Scope. Level I office surgery includes
the following:
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
patient.
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
Sections 893.02 and
893.03, 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.
(b) 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.
2. Equipment 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
total; and,
e. Hydrocortisone 100
mg.
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.
(4) Level II Office Surgery.
(a) Scope.
1. Level II Office Surgery shall include, but
not be limited to: hemorrhoidectomy, hernia repair, large joint dislocations,
colonoscopy, and liposuction involving the removal of up to 4,000cc supernatant
fat.
2. Level II Office surgery
includes any surgery in which the patient's level of sedation is that of
moderate sedation and analgesia or conscious sedation. Moderate sedation and
analgesia or conscious sedation is a drug-induced depression of consciousness
during which patients respond purposefully to verbal commands, either alone or
accompanied by light tactile stimulation. No interventions are required to
maintain a patent airway, and spontaneous ventilation is adequate.
Cardiovascular function is maintained. Reflex withdrawal from a painful
stimulus is not considered a purposeful response.
(b) Standards for Level II Office Surgery.
1. Transfer Agreement Required. The
physician, or the facility where the procedure is being performed, must have a
transfer agreement with a licensed hospital within reasonable proximity if the
physician performing the procedure does not have staff privileges to perform
the same procedure as that being performed in the out-patient setting at a
licensed hospital within reasonable proximity. "Reasonable proximity" is
defined as not to exceed thirty (30) minutes transport time to the hospital.
The transfer agreement required by this rule must be current and have been
entered into no more than five (5) years prior to the date of the inspection. A
transfer agreement must affirmatively disclose an effective date.
2. Training Required.
a. The surgeon must have staff privileges at
a licensed hospital to perform the same procedure in that hospital as that
being performed in the office setting or must be able to document satisfactory
completion of training such as Board certification or Board eligibility by a
Board approved by the American Board of Medical Specialties or any other board
approved by the Board of Medicine or must be able to establish comparable
background, training, and experience. Such Board certification or comparable
background, training and experience must also be directly related to and
include the procedure(s) being performed by the physician in the office surgery
facility.
b. One (1) assistant must
be currently certified in and by an American Safety and Health Institute,
American Safety and Heart 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 be currently certified in
and by 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.
3. Equipment and Supplies
Required.
a. Full and current crash cart at
the location the anesthetizing is being carried out. Medicines shall be stored
per the manufacturer's recommendations and multi-dose vials shall be dated once
opened. The crash cart must include, at a minimum, the following intravenous or
inhaled medications:
(I) Adenosine 18
mg,
(II) Albuterol 2.5 mg with
small volume nebulizer,
(III)
Amiodarone 300 mg,
(IV) Atropine 3
mg,
(V) Calcium chloride 1
gram,
(VI) Dextrose 50%; 50
ml,
(VII) Diphenhydramine 50
mg,
(VIII) Dopamine 200 mg
minimum,
(IX) Epinephrine 1 mg in
10 ml,
(X) Epinephrine 1 mg in 1 ml
vial, 3 vials total,
(XI)
Flumazenil 1 mg,
(XII) Furosemide
40 mg,
(XIII) Hydrocortisone 100
mg,
(XIV) Lidocaine appropriate for
cardiac administration100 mg,
(XV)
Magnesium sulfate 2 grams,
(XVI)
Naloxone 1.2 mg,
(XVII) A beta
blocker class drug,
(XVIII) Sodium
bicarbonate 50 mEq/50 ml,
(XIX)
Paralytic agent that is appropriate for use in rapid sequence
intubation,
(XX) A calcium channel
blocker class drug; and,
(XXI)
Intralipid 20% 500 ml solution (only if non-neuraxial regional blocks are
performed).
In the event of a drug shortage, the physician is allowed to substitute a therapeutically equivalent drug that meets the prevailing standard of care. The office must maintain documentation of its unsuccessful efforts to obtain the required drug.
b. A Benzodiazepine must be present in the
office.
c. Positive pressure
ventilation device (e.g. Ambu) plus oxygen supply.
d. End tidal CO2 detection device.
e. Monitors for blood pressure/EKG/Oxygen
saturation.
f. Emergency intubation
equipment, which shall at a minimum include suction devices, endotracheal
tubes, laryngoscopes, oropharyngeal airways, nasopharyngeal airways and bag
valve mask apparatus that are patient-size specific.
g. Defibrillator with defibrillator pads or
defibrillator gel, or an Automated External Defibrillator unit (AED).
h. Sufficient back up power is required to
allow the physician to safely terminate the procedure and to allow the patient
to emerge from the anesthetic, all without compromising the sterility of the
procedure or the environment of care.
i. Sterilization equipment.
j. IV solution and IV equipment.
4. Assistance of Other Personnel
Required. The surgeon must be assisted by a qualified anesthesia provider as
follows: An Anesthesiologist, Certified Registered Nurse Anesthesist, or
Physician Assistant qualified as set forth in subparagraph
64B8-30.012(2)(b)
6., F.A.C., or a registered nurse may be utilized to assist with the
anesthesia, if the surgeon is ACLS certified. An anesthesiologist assistant may
assist the anesthesiologist as set forth in Rule
64B8-31.005, F.A.C. An assisting
anesthesia provider cannot function in any other capacity during the procedure.
If additional assistance is required by the specific procedure or patient
circumstances, such assistance must be provided by a physician, osteopathic
physician, registered nurse, licensed practical nurse, or operating room
technician. A physician licensed under Chapter 458 or 459, F.S., a licensed
physician assistant, a licensed registered nurse with post-anesthesia care unit
experience or the equivalent, credentialed by 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 Couse with didactic
and skills components or, in the case of pediatric patients, by an American
Heart Association, American Safety and Health Institute, or Pacific Medical
Training approved Pediatric Advanced Life Support course with didactic and
skills components must be available to monitor the patient in the recovery room
until the patient is recovered from anesthesia.
(5) Level IIA Office Surgery.
(a) Scope. Level IIA office surgeries are
those Level II office surgeries with a maximum planned duration of 5 minutes or
less and in which chances of complications requiring hospitalization are
remote.
(b) Standards for Level IIA
Office Surgery.
1. The standards set forth in
subsection 64B8-9.009(4),
F.A.C., must be met except for the requirements set forth in subparagraph
64B8-9.009(4)(b)
4., F.A.C., regarding assistance of other personnel.
2. Assistance of Other Personnel Required.
During the procedure, the surgeon must be assisted by a physician or physician
assistant who is licensed pursuant to Chapter 458 or 459, F.S., or by a
licensed registered nurse or a licensed practical nurse. Additional assistance
may be required by specific procedure or patient circumstances. Following the
procedure, a physician or physician assistant who is licensed pursuant to
Chapter 458 or 459, F.S., or a licensed registered nurse must be available to
monitor the patient in the recovery room until the patient is recovered from
anesthesia. The monitor must be certified by 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 or, in the case of pediatric patients, by an American
Heart Association, American Safety and Health Institute, or Pacific Medical
Training approved Pediatric Advanced Life Support course with didactic and
skills compenents.
(6) Level III Office Surgery.
(a) Scope.
1. Level III Office Surgery is that surgery
in which the patient's level of sedation is that of deep sedation and analgesia
or general anesthesia. Deep sedation and analgesia is a drug-induced depression
of consciousness during which patients cannot be easily aroused but respond
purposefully following repeated or painful stimulation. The ability to
independently maintain ventilatory function may be impaired. Patients may
require assistance in maintaining a patent airway, and spontaneous ventilation
may be inadequate. Cardiovascular function is usually maintained. Reflex
withdrawal from a painful stimulus is not considered a purposeful response.
General anesthesia is a drug-induced loss of consciousness during which
patients are not arousable, even by painful stimulation. The ability to
independently maintain ventilatory function is often impaired. Patients often
require assistance in maintaining a patent airway, and positive pressure
ventilation may be required because of depressed spontaneous ventilation or
drug-induced depression of neuromuscular function. Cardiovascular function may
be impaired. The use of spinal or epidural anesthesia shall be considered Level
III.
2. Only patients classified
under the American Society of Anesthesiologist's (ASA) risk classification
criteria as Class I or II are appropriate candidates for Level III office
surgery.
a. All Level III surgeries on
patients classified as ASA III and higher are to be performed only in a
hospital or ambulatory surgery center.
b. For all ASA II patients above the age of
50, the surgeon must obtain a complete workup performed prior to the
performance of Level III surgery in a physician office setting. If the patient
has a cardiac history or is deemed to be a complicated medical patient, the
patient must have a preoperative EKG and be referred to an appropriate
consultant for medical optimization. The referral to a consultant may be waived
after evaluation by the patient's anesthesiologist.
(b) Standards for Level III Office
Surgery. In addition to the standards for Level II Office Surgery, the surgeon
must comply with the following:
1. Training
Required.
a. The surgeon must have staff
privileges at a licensed hospital to perform the same procedure in that
hospital as that being performed in the office setting or must be able to
document satisfactory completion of training such as Board certification or
Board qualification by a Board approved by the American Board of Medical
Specialties or any other board approved by the Board of Medicine or must be
able to demonstrate to the accrediting organization or to the Department
comparable background, training and experience. Such Board certification or
comparable background, training and experience must also be directly related to
and include the procedure(s) being performed by the physician in the office
surgery facility. In addition, the surgeon must have knowledge of the
principles of general anesthesia.
b. One assistant must be currently certified
by 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 be
currently certified by 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.
2. Emergency
policies and procedures related to serious anesthesia complications shall be
formulated, periodically reviewed, practiced, updated, and posted in a
conspicuous location. Topics to be covered shall include the following:
a. Airway Blockage (foreign body
obstruction),
b. Allergic
Reactions,
c.
Bradycardia,
d.
Bronchospasm,
e. Cardiac
Arrest,
f. Chest Pain,
g. Hypoglycemia,
h. Hypotension,
i. Hypoventilation,
j. Laryngospasm,
k. Local Anesthetic Toxicity Reaction;
and,
l. Malignant
Hyperthermia.
3.
Equipment and Supplies Required.
a. Equipment
and medication, including at least 720 mg of dantrolene on site (if halogenated
anesthetics or succinylcholine are utilized), and monitored post-anesthesia
recovery must be available in the office.
b. The office, in terms of general
preparation, equipment, and supplies, must be comparable to a free standing
ambulatory surgical center, including, but not limited to, recovery capability,
and must have provisions for proper recordkeeping.
c. Blood pressure monitoring equipment; EKG;
end tidal CO2 monitor; pulse oximeter, emergency
intubation equipment and a temperature monitoring device.
d. Table capable of trendelenburg and other
positions necessary to facilitate the surgical procedure.
4. Assistance of Other Personnel Required. An
Anesthesiologist, Certified Registered Nurse Anesthetist, Anesthesiologist
Assistant, or Physician Assistant qualified as set forth in subparagraph
64B8-30.012(2)(c)
6., F.A.C., must administer the general or regional anesthesia and an M.D.,
D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or
Operating Room Technician must assist with the surgery. The anesthesia provider
cannot function in any other capacity during the procedure. A physician
licensed under Chapter 458 or 459, F.S., a licensed anesthesiologist assistant,
a licensed physician assistant, or a licensed registered nurse with
post-anesthesia care unit experience or the equivalent, and credentialed by 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, or in the case of pediatric
patients, by an American Heart Association, American Safety and Health
Institute, Pacific Medical Training approved Pediatric Advanced Life Support
course with didactic and skills components, must be available to monitor the
patient in the recovery room until the patient has recovered from
anesthesia.
(7)
This rule shall be reviewed, and if necessary, repealed, modified, or renewed
through the rulemaking process five years from the effective date.
Notes
Rulemaking Authority 458.309(1), 458.328(3), 458.331(1)(v) FS. Law Implemented 458.328, 458.331(1)(v), 458.351 FS.
New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-3-07, 3-25-10, 8-6-12, 11-22-12, 1-9-13, 3-3-13, 7-22-14, 4-6-15, 9-4-16, 5-22-17, 6-23-17, 9-4-17, 5-7-18, 7-2-18, 9-3-19, 3-2-20, 3-10-22.
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