Current through Reg. 50, No. 187; September 24, 2024
Moderate Sedation Permit applicants and permit holders shall
comply with the following requirements at each location where anesthesia
procedures are performed. The requirements shall be met and equipment
permanently maintained and available at each location.
(1) Operatory: The operatory where anesthesia
is to be administered must:
(a) Be of size and
design to accommodate the patient on a table or in an operating chair and
permit an operating team consisting of at least three individuals to freely
move about the patient. An operating table or chair which permits the patient
to be positioned so the operating team can maintain the airway, quickly alter
patient position in an emergency, and provide a firm platform for the
management of CPR;
(b) Be equipped
with a chair or table adequate for emergency treatment, including a chair or
cardiopulmonary resuscitation (CPR) board suitable for CPR;
(c) Be equipped with suction and backup
suction equipment, also including suction catheters and tonsil
suction.
(2) Recovery
Room: If a recovery room is present, it shall be equipped with suction and
backup suction equipment, positive pressure oxygen and sufficient light to
provide emergency treatment. The recovery room shall also be of adequate size
and design to allow emergency access and management. The recovery room shall be
situated to allow the patient to be observed by the dentist or an office team
member at all times.
(3) Standard
Equipment: The following standard equipment must be readily available to the
operatory and recovery room and must be maintained in good working order:
(a) A positive pressure oxygen delivery
system and backup system, including full face mask for adults and for pediatric
patients, if pediatric patients are treated;
(b) Oral and nasal airways of various
sizes;
(c) Blood pressure cuff and
stethoscope;
(d) A pulse oximeter
which provides continuous monitoring of pulse and rate of oxygen saturation of
the blood shall be used during each procedure;
(e) A Precordial stethoscope;
(f) Capnograph;
(g) Suction with backup suction, also
including suction catheters and tonsil suction;
(h) Thermometer;
(i) A backup lighting system; and,
(j) A scale to weigh
patients.
(4) Emergency
Equipment: The following emergency equipment must be present, readily available
and must be maintained in good working order:
(a) Appropriate I.V. set-up, including
appropriate supplies and fluids;
(b) Laryngoscope with spare batteries and
spare bulbs;
(c) McGill forceps,
endotracheal tubes, and stylet;
(d)
Appropriate syringes;
(e)
Tourniquet and tape;
(f) CPR board
or chair suitable for CPR;
(g)
Defibrillator equipment appropriate for the patient population being
treated;
(h) Cricothyrotomy
equipment; and,
(i) A Supraglottic
Airway Device (SAD) or a Lyryngeal Mask Airway (LMA).
(5) Medicinal Drugs: The following drugs or
type of drugs with a current shelf life must be maintained and easily
accessible from the operatory and recovery room and must be maintained in
sufficient amounts to address medical emergencies:
(a) Epinephrine;
(b) A narcotic (e.g., Naloxone) and
benzodiazepine (e.g., Flumazenil) antagonists, if these agents are
used;
(c) An antihistamine (e.g.,
Diphenhydramine);
(d) A
corticosteroid (e.g., Dexamethasone);
(e) Nitroglycerin;
(f) A bronchodilator (e.g., Albuterol
inhaler);
(g) An antihypoglycemic
agent (e.g., D50W IV solution);
(h)
Amiodarone;
(i) A vasopressor
(e.g., Ephedrine);
(j) An
anticonvulsant (e.g., Valium or Versed);
(k) Antihypertensive (e.g.,
Labetalol);
(l) Anticholinergic
(e.g, atropine);
(m)
Antiemetic;
(n) A paralytic agent
that is appropriate for the breakage of a laryngospasm or for the use of rapid
sequence intubation;
(o) An
appropriate antiarrhythmic medication (e.g., Lidocaine); and,
(p) Adenosine.
(6) Emergency Protocols: The applicant or
permit holder shall provide written emergency protocols, and shall annually
provide training to familiarize office personnel in the treatment of the
following clinical emergencies:
(a)
Laryngospasm;
(b)
Bronchospasm;
(c) Emesis and
aspiration;
(d) Airway blockage by
foreign body;
(e) Angina
pectoris;
(f) Myocardial
infarction;
(g)
Hypertension/Hypotension;
(h)
Hypertensive crisis;
(i) Allergic
and toxicity reactions;
(j)
Seizures;
(k) Syncope;
(l) Phlebitis;
(m) Intra-arterial injection;
(n)
Hyperventilation/Hypoventilation;
(o) Cardiac arrest; and,
(p) Cardiac arrhythmias.
The applicant or permit holder shall maintain for inspection
a permanent record, which reflects the date, time, duration, and type of
training provided to named personnel annually.
(7) Records: The following records are
required when moderate sedation is administered:
(a) The patient's current written medical
history, including known allergies and previous surgery;
(b) Physical examination including airway
evaluation and risk assessment (e.g., Mallampati Classification, Body Mass
Index, and ASA Classification);
(c)
Base line vital signs, including blood pressure, and pulse; and,
(d) A sedation or anesthesia record which
shall include:
1. Continuous monitoring of
vital signs, which are taken and recorded at a minimum of every 5 minute
intervals during the procedure;
2.
Drugs administered during the procedure, including route of administration,
dosage, time and sequence of administration;
3. Duration of the procedure including the
start and the finish times of the procedure;
4. Documentation of complications or
morbidity (See Rule 64B5-14.006, F.A.C., for Adverse
Incident Reporting requirements);
5. Status of patient upon discharge, and to
whom the patient is discharged; and,
6. Names of participating
personnel.
(8)
Continuous Monitoring: The patient who is administered a drug(s) for moderate
sedation must be continuously monitored intraoperatively by pulse oximetry, and
capnograph to provide pulse rate, oxygen saturation of the blood, and
ventilations (end-tidal carbon dioxide). A precordial/pretracheal stethoscope
must be available to assist in the monitoring of the heart rate and
ventilations.
Rulemaking Authority
466.004,
466.017 FS. Law Implemented
466.017
FS.
New 10-24-88, Amended 11-16-89, 4-24-91, Formerly
21G-14.009, 61F5-14.009, Amended 8-8-96, 10-1-96, Formerly 59Q-14.009, Amended
8-2-00, 11-4-03, 6-23-04, 3-23-06, 10-26-11, 3-9-14, 4-17-16, 11-13-17,
3-10-20.
