The Board proposes to update, add to and clarify personnel training, record keeping, facility and equipment requirements for use of general anesthesia or deep sedation, conscious sedation and pediatric sedation.  

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    DEPARTMENT OF HEALTH

    Board of Dentistry

    RULE NOS.: RULE TITLES:

    64B5-14.008 Requirements for General Anesthesia or Deep Sedation

    64B5-14.009 Conscious Sedation

    64B5-14.010 Pediatric Conscious Sedation

    PURPOSE AND EFFECT: The Board proposes to update, add to and clarify personnel training, record keeping, facility and equipment requirements for use of general anesthesia or deep sedation, conscious sedation and pediatric sedation.

    SUMMARY: The rules will clarify and add new personnel training, record keeping, facility and equipment requirements for use of general anesthesia or deep sedation, conscious sedation and pediatric sedation.

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.

    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.

    SPECIFIC AUTHORITY: 466.004 FS., 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 FAW.

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

     

    THE FULL TEXT OF THE PROPOSED RULES IS:

     

    64B5-14.008 Requirements for General Anesthesia or Deep Sedation.

    General Anesthesia 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) 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) 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) 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 adults and for pediatric patients, if pediatric patients are treated;

    (b) through (e) No change.

    (4) The following emergency equipment must be present:

    (a) through (b) No change.

    (c) McGill Intubation forceps and endotracheal tubes;

    (d) Suction Tonsillar suction with backup suction;

    (e) through (g) No change.

    (h) Stylet;

    (i) Spare bulbs and batteries;

    (j) Cricothyrotomy equipment;

    (k) Precordial stethoscope or capnometer; and

    (l)(h) Blood pressure cuff and stethoscope.

    (5) 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) through (m) No change.

    (n) An appropriate antiarrhythmic medication; and

    (o) Nytroglycerine;

    (p) Antiemetic;

    (q) Sodium bicarbonate; and

    (r)(p) Dantrolene, when used with volatile gases.

    (6) 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) through (i) No change.

    (j) Convulsions; and

    (k) Seizures;

    (l) Syncope

    (m) Phlebitis

    (n) Intra-arterial injection; and

    (o)(k) Hyperventilation/Hypoventilation.

    (7) The following records are required when general anesthesia is administered:

    (a) through(b) No change.

    (c) An anesthesia record which shall include:

    1. Continuous monitoring of Periodic vital signs taken at appropriate intervals during the procedure;

    2. through 3. No change.

    4. Documentation of complications or morbidity; and

    5. Status of patient upon discharge, and to whom the patient is discharged;.

    (d) Names of participating personnel.

    Specific Authority 466.004, 466.017 FS. Law Implemented 466.017 FS. HistoryNew 10-24-88, Amended 11-16-89, Formerly 21G-14.008, Amended 12-20-93, Formerly 61F5-14.008, Amended 8-8-96, Formerly 59Q-14.008, Amended 5-31-00, 6-23-04, 9-14-05, ________.

     

    64B5-14.009 Conscious Sedation.

    Conscious Sedation Permit applicants or 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) The operatory where sedation 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 CPR board or chair suitable for CPR;.

    (c) Be equipped with suction and backup suction equipment, also including tonsil suction and suction catheters.

    (2) 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) 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 adults and for pediatric patients, if pediatric patients are treated;

    (b) No change.

    (c) Blood pressure cuff and stethoscope; and

    (d) Suction and backup suction equipment, also including suction catheters and tonsil suction;

    (e)(d) A pulse oximeter which provides continuous monitoring of pulse and rate of oxygen saturation of the blood shall be used during each procedure;,

    (f) A backup lighting system;

    (g) A Precordial stethoscope or capnometer; and

    (h)(e) Ddefibrillator equipment appropriate for the patient population being treated. As of July 1, 2001 the facility must have

    (4)(a) through (c) No change.

    (5) 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) through (i) No change.

    (j) Amiodarone;.

    (k) Vasopressor;

    (l) Anticonvulsant;

    (m) Antihypertensive;

    (n) Anticholinergic; and

    (o) Antiemetic.

    (6) 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) though (i) No change.

    (j) Convulsions; and

    (k) Seizures;

    (l) Cardiac arrest;

    (m) Intra-arterial injection;

    (n) Syncope; and

    (o)(k) Hyperventilation/Hypoventilation.

    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) The following records are required when conscious sedation is administered:

    (a) through (c) No change.

    (d)1. through 4. No change.

    5. Status of patient upon discharge and to whom discharged.

    6. No change.

    (e) Names of participating personnel.

    Specific Authority 466.004, 466.017 FS. Law Implemented 466.017 FS. HistoryNew 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, ________.

     

    64B5-14.010 Pediatric Conscious Sedation.

    Pediatric Conscious Sedation Permit applicants or 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) The operatory where the sedated child patient is to be treated 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 CPR board or chair suitable for CPR;.

    (c) Be equipped with suction and backup suction equipment, also including tonsil suction and suction catheters.

    (2) 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) 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) through (c) No change.

    (d) Suction and backup suction equipment, also including tonsil suction and suction catheters.

    (e)(d) A pulse oximeter which provides continuous monitoring of pulse and rate of oxygen saturation of the blood shall be used during each procedure;

    (f)(e) A scale for weighing pediatric patients.; and

    (4) The following emergency equipment must be present:

    (a) through (b) No change.

    (c) Tourniquet and tape; and.

    (d) Defibrillator equipment appropriate for the patient population being treated.

    (5) 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) through (h) No change.

    (i) An antihypoglycemic (e.g., 50% glucose);.

    (j) A vasopressor;

    (k) An anticonvulsant;

    (l) An antihypertensive

    (m) Nitroglycerin;

    (n) An anticholinergic;

    (o) An antiemetic; and

    (p) Amiodarone.

    (6) 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) through (h) No change.

    (i) Convulsions; and

    (j) Hyperventilation/Hypoventilation;.

    (k) Syncope;

    (l) Seizures;

    (m) Cardiac arrest;

    (n) Intra-arterial injection;

    (o) Angina pectoris; and

    (p) Myocardial infarction.

    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) The following records are required when pediatric conscious sedation is administered:

    (a) through (c) No change.

    (d) A sedation record which shall include:

    1. through 4. No change.

    5. Status of patient upon discharge and to whom discharged.

    (e) Names of participating personnel.

    (8) Drugs for conscious sedation must be administered in a dental office and the patient must be observed by a qualified office staff member. Continuous monitoring with pulse oxymetry must be initiated with early signs of conscious sedation and continued until the patient is alert. A precordial, pretracheal stethoscope or capnometer must be available to assist interoperatively in the monitoring of heart and respiratory rates. A sphygmomanometer shall be immediately available.

    Specific Authority 466.004, 466.017 FS. Law Implemented 466.017 FS. HistoryNew 8-8-96, Formerly 59Q-14.010, Amended 8-2-00, 5-20-01, ________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Dentistry

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 4, 2005

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 16, 2005

Document Information

Comments Open:
2/3/2006
Summary:
The rules will clarify and add new personnel training, record keeping, facility and equipment requirements for use of general anesthesia or deep sedation, conscious sedation and pediatric sedation.
Purpose:
The Board proposes to update, add to and clarify personnel training, record keeping, facility and equipment requirements for use of general anesthesia or deep sedation, conscious sedation and pediatric sedation.
Rulemaking Authority:
466.004 FS., 466.017 FS.
Law:
466.017 FS.
Contact:
Sue Foster, Executive Director, Board of Dentistry/MQA, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258
Related Rules: (3)
64B5-14.008. Requirements for General Anesthesia or Deep Sedation
64B5-14.009. Conscious Sedation
64B5-14.010. Pediatric Conscious Sedation