Current through Reg. 50, No. 187; September 24, 2024
Pediatric 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 the
sedated child patient is to be treated 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 cardiopulmonary resuscitation
(CPR) board of chair 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 so that the patient can be observed by the dentist or an office team
member at all times.
(3) Standard
Equipment: The following equipment must be readily available to the operatory
and recovery room and maintained in good working order:
(a) A positive pressure oxygen delivery
system and backup system, including full face mask for pediatric
patients;
(b) Oral and Nasal
Airways of appropriate size for the pediatric patient;
(c) Blood pressure cuff and stethoscope or
automated unit;
(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 for weighing pediatric
patients.
(4) Emergency
Equipment: The following emergency equipment must be present, readily available
and 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)
Suction with backup suction, also including suction catheters and tonsil
suction;
(e) Appropriate
syringes;
(f) Tourniquet and
tape;
(g) CPR board or chair
suitable for CPR;
(h) Defibrillator
equipment appropriate for the patient population being treated; and,
(i) Cricothyrotomy equipment.
(j) 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 HCl);
(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)
Antimetic;
(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., Lidcaine); 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 pediatric moderate sedation is administered:
(a) The patient's current written medical
history, including known allergies, history of previous surgery and anesthesia,
and the patient's age, weight, and calculation of maximum allowable local
anesthesia;
(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 pulse,
percent hemoglobin oxygen saturation, and when possible, blood pressure; and,
(d) An anesthesia or sedation
record which shall include:
1. Periodic vital
signs recorded a minimum of every 5 minute intervals during the
procedure;
2. Drugs, including
local anesthetics, administered during the procedure, including route of
administration, dosage, time and sequence of administration;
3. Duration of the procedure, including the
start and 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 pediatric
moderate sedation must be continuously monitored intra-operatively by pulse
oximetry and capnograph to provide pulse rate, oxygen saturation of the blood,
and ventilations (end-tidal carbon dioxide).
Rulemaking Authority
466.004,
466.017 FS. Law Implemented
466.017
FS.
New 8-8-96, Formerly 59Q-14.010, Amended 8-2-00, 5-20-01,
3-23-06, 10-26-11, 3-9-14, 4-17-16, 11-13-17,
3-10-20.
