64B5-14.010. Pediatric Conscious Sedation Requirements: Operatory, Recovery Room, Equipment, Medicinal Drugs, Emergency Protocols, Records, and Continuous Monitoring

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. History–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.