The board proposes the rule amendments to update the rule title and add language and clarification on the requirements for conscious sedation regarding operatory, recovery room, equipment, medicinal drugs, emergency protocols, records and continuous ...

 

DEPARTMENT OF HEALTH

Board of Dentistry

RULE NO.:RULE TITLE:

64B5-14.009Conscious Sedation

PURPOSE AND EFFECT: The board proposes the rule amendments to update the rule title and add language and clarification on the requirements for conscious sedation regarding operatory, recovery room, equipment, medicinal drugs, emergency protocols, records and continuous monitoring.

SUMMARY: The proposed rule amendments are necessary to update the rule title and the criteria for conscious sedation regarding operatory, recovery room, equipment, medicinal drugs, emergency protocols, records and continuous monitoring.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule.  A SERC has not been prepared by the agency.  The agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein:  During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature.  No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

Rulemaking Authority: 466.004, 466.017 FS.

Law Implemented: 466.017 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FLORIDA ADMINISTRATIVE WEEKLY.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan Foster, Executive Director, Board of Dentistry, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 64B5-14.009 follows. See Florida Administrative Code for present text.)

 

64B5-14.009 Conscious Sedation Requirements: Operatory, Recovery Room, Equipment, Medicinal Drugs, Emergency Protocols, Records, and Continuous Monitoring.

Conscious 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 adequate size and design to permit physical access of emergency equipment and personnel and to permit effective emergency management;

(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 or capnometer;

(f) Suction with backup suction, also including suction catheters and tonsil suction;

(g) Thermometer;

(h) A backup lighting system; and

(i) 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:

(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 muscle relaxant (e.g., Succinylcholine);

(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 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.

(7) Records: The following records are required when conscious 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;

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 conscious sedation must be continuously   monitored intraoperatively by pulse oximetry.  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. History–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,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Anesthesia Committee

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE:  Board of Dentistry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:  November 15, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 17, 2013