The Board proposes the rule amendment to update terminology related to the use of sedation in the practice of dentistry.

 

DEPARTMENT OF HEALTH

Board of Dentistry

RULE NO.: RULE TITLE:

64B5-14.001 Definitions

64B5-14.002 Prohibitions

64B5-14.003 Training, Education, Certification, and Requirements for Issuance of Permits

64B5-14.0032 Itinerate/Mobile Anesthesia - Physician Anesthesiologist

64B5-14.0034 Itinerate/Mobile Anesthesia - General Anesthesia Permit Holders

64B5-14.004 Additional Requirements

64B5-14.005 Application for Permit

64B5-14.006 Reporting Adverse Occurrences

64B5-14.007 Inspection of Facilities and Demonstration of Sedation Technique

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

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

PURPOSE AND EFFECT: The Board proposes the rule amendment to update terminology related to the use of sedation in the practice of dentistry.

SUMMARY: Terminology related to the use of sedation used in the practice of dentistry will be updated.

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, 466.004(4), 466.017(3), (6), 466.017, 466.17(6 ) FS.

LAW IMPLEMENTED: 120.60(8), 466.002(3), 466.017(3), (4), (5), (6), 466.017 FS.

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

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

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B5-14.001 Definitions.

(1) through (3) No change.

(4) Moderate Conscious sedation – A depressed level of consciousness produced by the administration of pharmacologic substances, that retains the patient’s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal command. This modality includes administration of medications via all parenteral routes, that is, intravenous, intramuscular, subcutaneous, submucosal, or inhalation, as well as enteral routes, that is oral, rectal, or transmucosal. The drugs, and techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely.

(5) Pediatric Moderate Conscious Sedation – A depressed level of consciousness produced by the administration of pharmacologic substances, that retains a child patient’s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medication via all parenteral routes; that is intravenous, intramuscular, subcutaneous, submucosal, or inhalation, and all enteral routes; that is oral, rectal, or transmucosal. The drugs, doses, and techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. For the purposes of this chapter, a child is defined as an individual under 18 years of age, or any person who has special needs, which means having a physical or mental impairment that substantially limits one or more major life activities.

(6) through (8) No change.

(9) Office team approach – A methodology employed by a dentist in the administration of general anesthesia, deep sedation, moderate conscious sedation, and pediatric sedation whereby the dentist uses one or more qualified assistants/dental hygienists who, working under the direct supervision of the dentist, assist the dentist, and assist in emergency care of the patient.

(10) Minimal Sedation (anxiolysis) – The perioperative use of medication to relieve anxiety before or during a dental procedure which does not produce a depressed level of consciousness and maintains the patient’s ability to maintain an airway independently and to respond appropriately to physical and verbal stimulation. This minimal sedation shall include the administration of a single enteral sedative or a single narcotic analgesic medication administered in doses appropriate for the unsupervised treatment of anxiety and pain. If clinically indicated, an opiod analgesic may also be administered during or following a procedure if needed for the treatment of pain. Except in extremely unusual circumstances, the cumulative dose shall not exceed the maximum recommended dose (as per the manufacturers recommendation). It is understood that even at appropriate doses a patient may occasionally drift into a state that is deeper than minimal sedation. As long as the intent was minimal sedation and all of the above guidelines were observed, this shall not automatically constitute a violation. A permit shall not be required for the perioperative use of medication for the purpose of providing minimal sedation (anxiolysis).

(11) Titration of Oral Medication – The administration of small incremental doses of an orally administered medication until an intended level of moderate conscious sedation is observed.

(12) through (14) No change.

Rulemaking Authority 466.004(4), 466.017(3), 466.17(6) FS. Law Implemented 466.002(3), 466.017(3), 466.017(5) FS. History–New 1-31-80, Amended 4-7-86, Formerly 21G-14.01, Amended 12-31-86, 6-1-87, 9-1-87, 2-1-93, Formerly 21G-14.001, Amended 12-20-93, Formerly 61F5-14.001, Amended 8-8-96, Formerly 59Q-14.001, Amended 3-9-03, 11-4-03, 7-3-06, 6-11-07, 8-5-12,                              .

 

64B5-14.002 Prohibitions.

(1) No change.

(2) Moderate Conscious sedation. No dentists licensed in this State shall administer moderate conscious sedation in the practice of dentistry until they have obtained a permit as required by the provisions of this rule chapter.

(3) Pediatric Moderate Conscious Sedation: No dentist licensed in this State shall administer Pediatric Moderate Conscious Sedation in the practice of dentistry until such dentist has obtained a permit as required by the provisions of this rule chapter.

(4) through (6) No change.

(7) Titration of Oral Medication. The Board of Dentistry has determined that the perioperative titration of oral medication(s) with the intent to achieve a level of moderate conscious sedation poses a potential overdosing threat due to the unpredictability of enteral absorption and may result in an alteration of the state of consciousness of a patient beyond the intent of the practitioner. Such potentially adverse consequences may require immediate intervention and appropriate training and equipment. Beginning with the effective date of this rule, no dentist licensed in this state shall use any oral medication(s) to induce moderate conscious sedation until such dentist has obtained a permit as required by the provisions of this rule chapter. The use of enteral sedatives or narcotic analgesic medications for the purpose of providing minimal sedation (anxiolysis) as defined by and in accordance with subsection 64B5-14.001(10), F.A.C., shall not be deemed titration of oral medication and shall not be prohibited by this rule.

(8) No change.

(9) A hygienist certified by the board to administer local anesthesia shall not administer local anesthesia to a patient sedated by general anesthesia, deep sedation, moderate conscious sedation, or pediatric moderate conscious sedation. If a dentist has administered nitrous-oxide to the patient, the certified dental hygienist may administer local anesthesia under the direct supervision of the supervising dentist. A patient who has been prescribed a medical drug by their licensed health care provider for the purposes of life functions may be administered local anesthesia by the certified dental hygienist under the direct supervision of the supervising dentist. If, however, the medical drug is prescribed or administered for the purposes of a dental procedure which is intended to induce minimal sedation (anxiolysis), the hygienist may not administer local anesthesia to the patient.

Rulemaking Authority 466.004(4), 466.017(3), 466.017(6) FS. Law Implemented 466.017(3), 466.017(5) FS. History–New 1-31-80, Amended 4-20-81, 2-13-86, Formerly 21G-14.02, 21G-14.002, Amended 12-20-93, Formerly 61F5-14.002, Amended 8-8-96, Formerly 59Q-14.002, Amended 3-9-03, 11-4-03, 6-15-06, 12-25-06, 12-11-11, 8-5-12, 12-15-14, 7-14-16,                   .

 

64B5-14.003 Training, Education, Certification, and Requirements for Issuance of Permits.

(1) General Anesthesia Permit.

(a) through (c) No change.

(d) A dentist permitted to administer general anesthesia or deep sedation under this rule may administer moderate conscious sedation and nitrous-oxide inhalation moderate conscious sedation.

(e) No change.

(2) Moderate Conscious Sedation Permit.

(a) A permit shall be issued to a dentist authorizing the use of moderate conscious sedation at a specified practice location or locations on an outpatient basis for dental patients provided such dentist:

1. Has received formal training in the use of moderate conscious sedation; and

2. Is certified by the institution where the training was received to be competent in the administration of moderate conscious sedation; and

3. Is competent to handle all emergencies relating to moderate conscious sedation.

(b) No change.

(c) Personal Administration of Moderate Conscious Sedation: The board shall award credit towards the required 20 dental patients, if and only if, the applicant is responsible for and remains with the patient from pre-anesthetic evaluation through discharge. The evaluation and responsibilities include the following: pre-anesthetic evaluation, induction, maintenance, emergence, recovery, and approval for discharge. The board will not award credit for dental anesthetic procedures performed that are greater than or less than the administration of moderate conscious sedation.

(d) No change.

(e) A dentist utilizing moderate conscious sedation shall maintain a properly equipped facility for the administration of moderate conscious sedation, staffed with supervised assistant/dental hygienist personnel, capable of reasonably handling procedures, problems, and emergencies incident thereto. The facility must have the equipment capability of delivering positive pressure oxygen ventilation. Administration of moderate conscious sedation requires at least two individuals: a dentist, and an auxiliary trained in basic cardiac life support. It shall be incumbent upon the operating dentist to ensure insure that the patient is appropriately monitored.

(f) A dentist utilizing moderate conscious sedation and his assistant/dental hygienist personnel shall be certified in an American Heart Association or American Red Cross or equivalent agency sponsored cardiopulmonary resuscitation course at the basic life support level to include one person CPR, two person CPR, infant resuscitation, and obstructed airway with a periodic update not to exceed two years. Starting with the licensure biennium commencing on March of 2000, a dentist and all assistant/dental hygienist personnel shall also be trained in the use of either an Automated External Defibrillator or a defibrillator and electrocardiograph as part of their cardiopulmonary resuscitation course at the basic life support level. In addition to CPR certification, a dentist utilizing moderate conscious sedation must be currently trained in ACLS (Advanced Cardiac Life Support) or ATLS (Advanced Trauma Life Support).

(g) Dentists permitted to administer moderate conscious sedation may administer nitrous-oxide inhalation moderate conscious sedation.

(h) Dentists permitted to administer moderate conscious sedation may administer pediatric moderate conscious sedation in compliance with Rule 64B5-14.010, F.A.C.

(3) Pediatric Moderate Conscious Sedation Permit.

(a) A permit shall be issued to a dentist authorizing the use of pediatric moderate conscious sedation at a specified practice location or locations on an outpatient basis for dental patients provided such dentist:

1. Has received formal training in the use of pediatric moderate conscious sedation. This formal training program shall be offered through an accredited dental school or program; or through an accredited teaching program; and,

2. Is certified by the institution where the training was received to be competent in the administration of pediatric moderate conscious sedation. This certification shall specify the type, the number of hours, the number of patients treated and the length of training. The minimum number of didactic hours shall be sixty, which must include four (4) hours of airway management. Clinical training shall include personal administration for at least twenty patients including supervised training, management of sedation, clinical experience and demonstrated competence in airway management of the compromised airway. The program must certify that three (3) hours of clinical training was dedicated to hands-on simulated competence in airway management of the compromised airway; and

3. Personal Administration of Pediatric Moderate Conscious Sedation: The board shall award credit towards the required 20 dental patients, if and only if, the applicant is responsible for and remains with the patient from pre-anesthetic evaluation through discharge. The evaluation and responsibilities include the following: pre-anesthetic evaluation, induction, maintenance, emergency, recovery, and approval for discharge. The board will not award credit for dental anesthetic procedures performed that are greater than or less than the administration of pediatric moderate conscious sedation; or

4. No change.

5. Is competent to handle all emergencies relating to pediatric moderate conscious sedation. A dentist utilizing pediatric moderate conscious sedation shall maintain a properly equipped facility for the administration of pediatric moderate conscious sedation, staffed with supervised assistant/dental hygienist personnel, capable of reasonably handling procedures, problems, and emergencies incidental thereto. The facility must have the equipment capability of delivering positive pressure oxygen ventilation. Administration of pediatric moderate conscious sedation requires at least two individuals: a dentist, and an auxiliary trained in basic cardiac life support. It shall be incumbent upon the operating dentist to ensure insure that the patient is appropriately monitored.

(b) A dentist utilizing pediatric moderate conscious sedation and his assistant/dental hygienist personnel shall be certified in an American Heart Association or American Red Cross or equivalent agency sponsored cardiopulmonary resuscitation course at the basic life support level to include one person CPR, two person CPR, infant resuscitation, and obstructed airway with a periodic update not to exceed two years. Starting with the licensure biennium commencing on March of 2000, a dentist and all assistant/dental hygienist personnel shall also be trained in the use of either an Automated External Defibrillator or a defibrillator and electrocardiograph as part of their cardiopulmonary resuscitation course at the basic life support level. In addition to CPR certification, a dentist utilizing pediatric moderate conscious sedation must be currently trained in ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), or a course providing similar instruction which has been approved by the Board. An entity seeking approval of such a course shall appear before the Board and demonstrate that the content of such course and the hours of instruction are substantially equivalent to those in an ACLS or PALS course.

(c) Dentists permitted to administer pediatric moderate conscious sedation may administer nitrous-oxide inhalation moderate conscious sedation.

(d) Dentists permitted to administer moderate conscious sedation may administer pediatric moderate conscious sedation.

(4) Nitrous-Oxide Inhalation Analgesia.

(a) No change.

(b) A dentist utilizing nitrous-oxide inhalation analgesia and such dentist’s assistant/dental hygienist personnel shall be certified in an American Heart Association or American Red Cross or equivalent Agency sponsored cardiopulmonary resuscitation course at the basic life support level to include one man CPR, two man CPR, infant resuscitation and obstructed airway with a periodic update not to exceed two years. Starting with the licensure biennium commencing on March of 2000, a dentist and all assistant/dental hygienist personnel shall also be trained in the use of either an Automated External Defibrillator or a defibrillator and electrocardiograph as part of their cardiopulmonary resuscitation course at the basic life support level. In addition to CPR certification, a dentist utilizing pediatric moderate conscious sedation must be currently trained in ACLS (Advanced Cardiac Life Support), ATLS (Advanced Trauma Life Support), or PALS (Pediatric Advanced Life Support).

(c) No change.

(d) Nitrous oxide may be used in combination with a single dose enteral sedative or a single dose narcotic analgesic to achieve a minimally depressed level of consciousness so long as the manufacturer’s maximum recommended dosage of the enteral agent is not exceeded. Nitrous oxide may not be used in combination with more than one (1) enteral agent, or by dosing a single enteral agent in excess of the manufacturer’s maximum recommended dosage unless the administering dentist holds a moderate conscious sedation permit issued in accordance with subsection 64B5-14.003(2), F.A.C., or a pediatric moderate conscious sedation permit issued in accordance with Rule 64B5-14.010, F.A.C.

(5) No change.

Rulemaking Authority 466.004(4), 466.017(3), (6) FS. Law Implemented 466.017(3), (4), (5), (6) FS. History–New 1-31-80, Amended 4-20-81, 2-13-86, Formerly 21G-14.03, Amended 12-31-86, 11-8-90, 2-1-93, Formerly 21G-14.003, Amended 12-20-93, Formerly 61F5-14.003, Amended 8-8-96, 10-1-96, Formerly 59Q-14.003, Amended 2-17-98, 12-20-98, 5-31-00, 6-7-01, 11-4-03, 6-23-04, 6-11-07, 2-8-12, 8-16-12 (1)(a)-(f), 8-16-12 (5), 8-19-13, 12-16-13, 3-9-14, 7-14-16,                           .

 

64B5-14.0032 Itinerate/Mobile Anesthesia – Physician Anesthesiologist.

The provisions of this rule control the treatment of dental patients in an outpatient dental office setting where a physician anesthesiologist has performed the sedation services. This rule shall control notwithstanding any rule provision in this Chapter that prohibits such conduct. The level of sedation is not restricted to the level of the permit held by the treating dentist. The level of sedation may be any level necessary for the safe and effective treatment of the patient.

(1) No change.

(2) Pediatric Moderate Conscious Sedation Permit Holders:

A pediatric dentist, as recognized by the American Dental Association, who holds a pediatric moderate conscious sedation permit may treat their pediatric or special needs dental patients when a physician anesthesiologist performs the sedation services. The following conditions shall apply:

(a) through (d) No change.

A pediatric dentist who holds an active moderate conscious sedation permit and not a pediatric moderate conscious sedation permit shall meet the sedation permit requirement of this rule until the next biennial license renewal cycle that follows the effective date of this rule. At the next biennial license renewal cycle that follows the effective date of this rule, a pediatric dentist who hold a moderate conscious sedation permit may transfer the permit to a pediatric moderate conscious sedation permit without any additional cost besides the renewal fee.

(3) Moderate Conscious Sedation Permit Holders:

A dentist who holds a moderate conscious sedation permit may treat their adult or adult special needs dental patients when a physician anesthesiologist performs the sedation services.  The following conditions shall apply:

(a) through (d) No change.

(4) through (7) No change.

Rulemaking Authority 466.004(4), 466.017(3) FS. Law Implemented 466.017(3) FS. History–New 8-20-12, Amended 11-19-12, 2-21-13, 12-16-13,                                 .

 

64B5-14.0034 Itinerate/Mobile Anesthesia – General Anesthesia Permit Holders.

The provisions of this rule control the treatment of dental patients in an outpatient dental office where a dentist with a general anesthesia permit performs the sedation services for a treating dentist. The treating dentist must possess a general anesthesia permit, moderate conscious sedation permit, or pediatric moderate conscious sedation permit. The level of anesthesia administered shall be to any level necessary to safely and effectively treat the dental patient. This rule shall control notwithstanding any rule provision in this Chapter that prohibits such conduct.

(1) General Anesthesia Permit Holder’s Office:

A general anesthesia permit holder may perform sedation services for a dental patient of another general anesthesia permit holder or moderate conscious or pediatric moderate conscious sedation permit holder in his or her office or in another general anesthesia permit holder’s office. In this setting, the following shall apply:

(a) through (b) No change.

(2) Moderate Conscious and Pediatric moderate conscious Sedation Permit Holder’s Office:

A general anesthesia permit holder may perform sedation services for a dental patient of another dentist who holds a moderate conscious sedation permit or a pediatric moderate conscious sedation permit at the office of the treating dentist. In this setting, the following shall apply:

(a) The dental treatment may only be performed by the moderate conscious sedation or pediatric moderate conscious sedation permit holder;

(b) through (c) No change.

(3) Equipment:

When the general anesthesia permit holder performs the anesthesia services in a dental office of a moderate conscious or pediatric moderate conscious sedation permit holder’s office, the electrocardiograph and end tidal carbon dioxide monitor equipment mandates may be met as follows:

(a) through (c) No change.

(4) through (5) No change.

Rulemaking Authority 466.004(4), 466.017 FS. Law Implemented 466.017 FS. History–New 3-14-13, Amended                   .

64B5-14.004 Additional Requirements.

(1) Office Team – A dentist licensed by the Board and practicing dentistry in Florida and who is permitted by these rules to induce and administer general anesthesia, deep sedation, moderate conscious sedation, pediatric moderate conscious sedation or nitrous-oxide inhalation analgesia may employ the office team approach.

(2) Dental Assistants, Dental Hygienists – Dental assistants and dental hygienists may monitor nitrous-oxide inhalation analgesia under the direct supervision of a dentist who is permitted by rule to use general anesthesia, moderate conscious sedation, pediatric moderate conscious sedation, or nitrous-oxide inhalation analgesia, while rendering dental services allowed by Chapter 466, F.S., and under the following conditions:

(a) through (b) No change.

(3) through (4) No change.

(5) A dentist utilizing moderate conscious sedation in the dental office may induce only one patient at a time. A second patient shall not be induced until the first patient is awake, alert, conscious, spontaneously breathing, has stable vital signs, is ambulatory with assistance, is under the care of a responsible adult, and that portion of the procedure requiring the participation of the dentist is complete. In an office setting where two or more permit holders are present simultaneously, each may sedate one patient provided that the office has the necessary staff and equipment, as set forth in paragraph 64B5-14.003(2)(d), F.A.C., for each sedated patient.

(6) No change.

Rulemaking Authority 466.004(4), 466.017(3) FS. Law Implemented 466.017(3) FS. History–New 1-31-80, Amended 2-13-86, Formerly 21G-14.04, Amended 12-31-86, 12-28-92, Formerly 21G-14.004, Amended 12-20-93, Formerly 61F5-14.004, Amended 8-8-96, Formerly 59Q-14.004, Amended 11-4-03, 6-23-04, 5-24-05, 8-19-13,                               .

 

64B5-14.005 Application for Permit.

(1) No dentist shall administer, supervise or permit another health care practitioner, as defined in Section 456.001, F.S., to perform the administration of general anesthesia, deep sedation, moderate conscious sedation or pediatric moderate conscious sedation in a dental office for dental patients, unless such dentist possesses a permit issued by the Board. A permit is required even when another health care practitioner, as defined in Section 456.001, F.S., administers general anesthesia, deep sedation, moderate conscious sedation, or pediatric moderate conscious sedation in a dental office for a dental patient. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially. Each dentist in a practice who performs the administration of general anesthesia, deep sedation, moderate conscious sedation or pediatric moderate conscious sedation shall each possess an individual permit. Nothing in this paragraph shall be construed to prohibit administration of anesthetics as part of a program authorized by Rule 64B5-14.003, F.A.C., any other educational program authorized by Board rule, for training in the anesthetic being administered, or pursuant to a demonstration for inspectors pursuant to Rule 64B5-14.007, F.A.C.

(2) through (4) No change.

(5) An application for a moderate conscious sedation permit must include the application fee specified in Rule 64B5-15.017, F.A.C., which is non-refundable; the permit fee specified in Rule 64B5-15.018, F.A.C., which may be refunded if the application is denied without inspection of the applicant’s facilities; evidence indicating compliance with all the provisions of this chapter; and identification of the location or locations at which the licensee desires to be authorized to use or employ moderate conscious sedation.

(6) An application for a pediatric moderate conscious sedation permit must include the application fee specified in Rule 64B5-15.017, F.A.C., which is non-refundable; the permit fee specified in Rule 64B5-15.018, F.A.C., which may be refunded if the application is denied without inspection of the applicant’s facilities; evidence indicating compliance with all the provisions of this chapter; and identification of the location or locations at which the licensee desires to be authorized to use or employ pediatric moderate conscious sedation.

(7) No change.

(8) The holder of any general anesthesia, moderate conscious sedation, or pediatric moderate conscious sedation permit is authorized to practice pursuant to such permit only at the location or locations previously reported to the Board office.

Rulemaking Authority 466.004, 466.017(3), 466.017(6) FS. Law Implemented 466.017, 466.017(5) FS. History–New 4-7-86, Amended 1-29-89, 11-16-89, 11-8-90, 4-24-91, Formerly 21G-14.005, Amended 12-20-93, Formerly 61F5-14.005, Amended 8-8-96, Formerly 59Q-14.005, Amended 12-12-00, 11-4-03, 6-23-04, 2-22-06, 6-28-07, 7-5-10, 8-5-12,                      .

 

64B5-14.006 Reporting Adverse Occurrences.

(1) Definitions:

(a) Adverse occurrence – means any mortality that occurs during or as the result of a dental procedure, or an incident that results in the temporary or permanent physical or mental injury that requires hospitalization or emergency room treatment of a dental patient that occurred during or as a direct result of the use of general anesthesia, deep sedation, moderate conscious sedation, pediatric moderate conscious sedation, oral sedation, minimal sedation (anxiolysis), nitrous oxide, or local anesthesia.

(b) No change.

(2) through (7) No change.

Rulemaking Authority 466.004(4), 466.017(3), (6) FS. Law Implemented 466.017(3), (5) FS. History–New 2-12-86, Amended 3-27-90, Formerly 21G-14.006, Amended 12-20-93, Formerly 61F5-14.006, Amended 8-8-96, Formerly 59Q-14.006, Amended 11-4-03, 12-25-06, 8-5-12,                             .

 

64B5-14.007 Inspection of Facilities and Demonstration of Sedation Technique.

(1) The Chairman of the Board or the Board by majority vote shall appoint consultants who are Florida licensed dentists to inspect facilities where general anesthesia, deep sedation, moderate conscious sedation, or pediatric moderate conscious sedation is performed. Consultants shall receive instruction in inspection procedures from the Board prior to initiating an inspection.

(2) Prior to issuance of a general anesthesia permit, moderate conscious sedation permit, or pediatric moderate conscious sedation permit, the applicant must demonstrate that he or she has knowledge of the use of the required equipment and drugs as follows:

(a) No change.

(b) Demonstration of Moderate Conscious Sedation. A dental procedure utilizing moderate conscious sedation must be observed and evaluated. Any moderate conscious sedation technique that is routinely employed may be demonstrated. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation an appropriate response to the following emergencies:

1. through 13. No change.

(c) Demonstration of Pediatric Moderate Conscious Sedation. A dental procedure utilizing pediatric moderate conscious sedation must be observed and evaluated. Any pediatric moderate conscious sedation technique that is routinely employed may be demonstrated. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation an appropriate response to the following emergencies:

1. through 13. No change.

(3) Any dentist who has applied for or received a general anesthesia permit, moderate conscious sedation permit, or pediatric moderate conscious sedation permit shall be subject to announced or unannounced on-site inspection and evaluation by an inspection consultant. This inspection and evaluation shall be required prior to issuance of an anesthesia permit. However, if the Department cannot complete the required inspection prior to licensure, such inspection shall be waived until such time that it can be completed following licensure.

(4) No change.

(5) Any applicant who receives a failing grade as a result of the on-site inspection shall be denied a permit for general anesthesia anesthesia,  and  moderate conscious sedation and pediatric moderate sedation.

(6) Any permit holder who fails the inspection shall be so notified by the anesthesia inspection consultant and shall be given a written statement at the time of inspection which specifies the deficiencies which resulted in a failing grade. The inspection team shall give the permit holder 20 days from the date of inspection to correct any documented deficiencies. Upon notification by the permit holder to the inspection consultant that the deficiencies have been corrected, the inspector shall reinspect to ensure insure that the deficiencies have been corrected. If the deficiencies have been corrected, a passing grade shall be assigned. No permit holder who has received a failing grade shall be permitted 20 days to correct deficiencies unless he voluntarily agrees in writing that no general anesthesia or deep sedation or moderate conscious sedation will be performed until such deficiencies have been corrected and such corrections are verified by the anesthesia inspection consultant and a passing grade has been assigned.

(7) through (8) No change.

(9) The holder of any general anesthesia, moderate conscious sedation, or pediatric moderate conscious sedation permit shall inform the Board office in writing of any change in authorized locations for the use of such permits prior to accomplishing such changes. Written notice shall be required prior to the addition of any location or the closure of any previously identified location.

(10) No change.

Rulemaking Authority 466.017(3) FS. Law Implemented 120.60(8), 466.017(3) FS. History–New 10-24-88, Amended 3-27-90, 11-8-90, 4-24-91, 2-1-93, Formerly 21G-14.007, Amended 12-20-93, Formerly 61F5-14.007, Amended 8-8-96, Formerly 59Q-14.007, Amended 11-4-03, 6-11-07,                                  .

 

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

Moderate 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) through (6) No change.

(7) Records: The following records are required when moderate conscious sedation is administered:

(a) through (d) No change.

(8) Continuous Monitoring: The patient who is administered a drug(s) for moderate conscious 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. 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, 3-9-14, 4-17-16,                                       .

 

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

Pediatric Moderate 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) through (6) No change.

(7) Records: The following records are required when pediatric moderate conscious sedation is administered:

(a) through (d) No change.

(8) Continuous Monitoring: The patient who is administered a drug(s) for pediatric moderate conscious 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,                                   .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Dentistry

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Dentistry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 19, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 13, 2017