For Rule 64B5-14.001, F.A.C., the Board proposes the rule amendment to clarify language and definitions. For Rule 64B5-14.002, F.A.C., the Board proposes the rule amendment to update language regarding sedation. For Rule 64B5-14.0025, F.A.C., the ...

 

DEPARTMENT OF HEALTH

Board of Dentistry

RULE NOS.:RULE TITLES:

64B5-14.001Definitions

64B5-14.002Prohibitions

64B5-14.0025Application for Permit

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

64B5-14.0032Itinerate/Mobile Anesthesia - Physician Anesthesiologist

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

64B5-14.0036Treatment of Sedated Patients by Dentists Without an Anesthesia Permit

64B5-14.004Additional Requirements

64B5-14.006Reporting Adverse Occurrences

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

64B5-14.008Requirements for General Anesthesia or Deep Sedation: Operatory, Recovery Room, Equipment, Medicinal Drugs, Emergency Protocols, Records, and Continuous Monitoring

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: For Rule 64B5-14.001, F.A.C., the Board proposes the rule amendment to clarify language and definitions. For Rule 64B5-14.002, F.A.C., the Board proposes the rule amendment to update language regarding sedation. For Rule 64B5-14.0025, F.A.C., the Board proposes the rule promulgation to create a rule regarding the application for a permit for administering sedation. For Rule 64B5-14.003, F.A.C., the Board proposes the rule amendment to update the requirements for issuance of permits. For Rule 64B5-14.0032, F.A.C., the Board proposes the rule amendment for a comprehensive review for needed updates and to update language regarding itinerate/mobile anesthesia. For Rule 64B5-14.0034, F.A.C., the Board proposes the rule amendment to clarify language regarding Itinerate/Mobile Anesthesia – General Anesthesia Permit Holders. For Rule 64B5-14.0036, F.A.C., the Board proposes the rule amendment to clarify language regarding the treatment of sedated patients by dentists without an anesthesia permit. For Rule 64B5-14.004, F.A.C., the Board proposes the rule amendment to update requirements for continuing education and to remove unnecessary or outdated language. For Rule 64B5-14.006, F.A.C., the Board proposes the rule amendment to update language regarding reporting adverse occurrences. For Rule 64B5-14.007, F.A.C., the Board proposes the rule amendment to update language regarding inspection of facilities and demonstration of sedation technique. For Rule 64B5-14.008, F.A.C., the Board proposes the rule amendment to update requirements for general anesthesia or deep sedation: operatory, recovery room, equipment, medicinal drugs, emergency protocols, records, and continuous monitoring. For Rule 64B5-14.009, F.A.C., the Board proposes the rule amendment to update requirements for moderate sedation requirements for operatory, recovery room, equipment, medicinal drugs, emergency protocols, records, and continuous monitoring. For Rule 64B5-14.010, F.A.C., the Board proposes the rule amendment to update requirements for pediatric moderate sedation requirements for operatory, recovery room, equipment, medicinal drugs, emergency protocols, records, and continuous monitoring.

SUMMARY: For Rule 64B5-14.001, F.A.C., language and definitions will be clarified. For Rule 64B5-14.002, F.A.C., language regarding sedation will be updated. For Rule 64B5-14.0025, F.A.C., a rule will be created regarding the application for a permit for administering sedation. For Rule 64B5-14.003, F.A.C., the requirements for issuance of permits will be updated. For Rule 64B5-14.0032, F.A.C., language regarding itinerate/mobile anesthesia will be updated. For Rule 64B5-14.0034, F.A.C., language will be clarified regarding itinerate/mobile anesthesia for general anesthesia permit holders. For Rule 64B5-14.0036, F.A.C., language will be clarified regarding the treatment of sedated patients by dentists without an anesthesia permit. For Rule 64B5-14.004, F.A.C., requirements for continuing education will be updated and unnecessary or outdated language will be removed from the rule. For Rule 64B5-14.006, F.A.C., language regarding reporting adverse occurrences will be updated. For Rule 64B5-14.007, language regarding inspection of facilities and demonstration of sedation technique will be updated. For Rule 64B5-14.008, F.A.C., requirements for general anesthesia or deep sedation will be updated. For Rule 64B5-14.009, F.A.C., requirements for moderate sedation will be updated. For Rule 64B5-14.010, F.A.C., requirements for pediatric moderate sedation 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: 456.013(9), 456.0301, 456.031, 466.004(4), 466.0135, 466.014 FS.

LAW IMPLEMENTED: 456.013(9), 456.0301, 456.031, 456.033, 466.0135, 466.014, 466.017(4) 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 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 shall should carry a margin of safety wide enough to render unintended loss of consciousness unlikely.

(5) Pediatric Moderate 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 shall should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. For the purposes of this chapter, a pediatric patient 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 sedation, and pediatric sedation whereby the dentist uses two 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. A dentist who is permitted by these rules to administer and employ the use of general anesthesia, deep sedation, moderate sedation, or pediatric moderate sedation shall employ the office team approach.

(10) Minimal Sedation – 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 a single dose doses appropriate for the unsupervised treatment of anxiety and pain. If clinically indicated, an opioid 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.

(11) No change.

(12) Physician anesthesiologist – Any physician licensed pursuant to Chapter 458 or 459, F.S., who is currently board certified or board eligible by the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology, or is credentialed to administer anesthesia in a hospital or ambulatory surgical facility licensed pursuant to Chapter 395, F.S. by the Department of Health.

(13) Qualified Anesthetist: means an Advanced Practice Registered Nurse Practitioner who is licensed in this state to practice professional nursing and who is certified in the advanced or specialized nursing practice as a certified registered nurse anesthetist pursuant to Chapter 464, Part I, F.S.

(14) Certified Registered Dental Hygienist: means any Florida licensed dental hygienist who is certified by the Board and has received a certificate from the Department of Health that allows the administration of local anesthesia while the CRDH is directly appropriately supervised by a Florida licensed dentist.

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 4-7-86, 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, 11-13-17,                                .

 

64B5-14.002 Prohibitions.

(1) Levels of Anesthesia. No dentist licensed in this state shall administer or employ the use of general anesthesia, deep sedation, moderate sedation, and pediatric moderate sedation until they have obtained a permit as required by the provision of this chapter, unless specifically authorized otherwise by this chapter. The permit requirements of this chapter do not apply when treating patients at hospitals or ambulatory surgery centers licensed pursuant to Chapter 395, F.S. General anesthesia or deep sedation. No dentists licensed in this State shall administer moderate anesthesia or deep sedation in the practice of dentistry until they have obtained a permit as required by the provisions of this rule chapter.

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

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

(2)(4) Nitrous-oxide inhalation analgesia. No dentists licensed in this State shall administer nitrous-oxide inhalation analgesia in the practice of dentistry until they have complied with the provisions of this rule chapter. No agents other than nitrous-oxide and oxygen shall be  used for inhalation analgesia pursuant to Rule 64B5-14.003, F.A.C.

(3)(5) No change.

(6) The only agents that can be used for inhalation analgesia pursuant to Rule 64B5-14.003, F.A.C., below are nitrous-oxide and oxygen.

(4)(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 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, Nno dentist licensed in this state shall use any oral medication(s) to induce moderate 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 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.

(5)(8) The following general anesthetic drugs shall not be employed on or administered to a patient by a dentist unless the dentist possesses a valid general anesthesia permit issued by the Board pursuant to the requirements of this chapter: propofol, methohexital, thiopental, etomidate, ketamine, dexmedetomidine, or volatile gases (i.e., sevoflurane, isoflurane).

(6)(9) No change.

(7) Nothing in this chapter shall be construed to allow a dentist or dental hygienist or assistant to administer to herself or himself or to any person any drug or agent used for anesthesia, analgesia or sedation other than in the course of the practice of dentistry.

(8) A dentist utilizing general anesthesia, deep sedation, moderate sedation, or pediatric moderate sedation in the dental office may only have one patient at a time induced. A second patient shall not be induced until the first patient is awake, alert, conscious, spontaneously breathing, has stable vital signs, 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 for each sedated 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, 11-13-17,            .

 

64B5-14.0025 Application for Permit.

(1) Unless authorized by this chapter, no dentist shall administer, supervise or permit another health care practitioner, as defined in Section 456.001, F.S., or perform the administration of general anesthesia, deep sedation, moderate sedation or pediatric moderate 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 sedation, or pediatric moderate 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 sedation or pediatric moderate 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., for training in the anesthetic being administered, or pursuant to a demonstration for inspectors pursuant to Rule 64B5-14.007, F.A.C.

(2) An applicant for any type of anesthesia permit must submit proof of:

(a) Training in the particular type of anesthesia listed in Rule 64B5-14.003, F.A.C.; and,

(b) Documentation of actual clinical administration of anesthetics to 20 dental or oral and maxillofacial patients within two (2) years prior to application of the particular type of anesthetics for the permit applied for. However, if the applicant is applying for a pediatric moderate sedation permit and the actual clinical demonstration of anesthetics has been more than two years prior to the submission of the application, the applicant shall be entitled to licensure if the applicant has completed the American Academy of Pediatric Dentistry’s comprehensive course on the Safe & Effective Sedation for the Pediatric Dental Patient within six (6) months prior to the submission of the pediatric moderate sedation permit application.

(3) Prior to the issuance of such permit, an on-site inspection of the facility, equipment, drugs and personnel shall be conducted pursuant to Rule 64B5-14.007, F.A.C., to determine if the requirements of this chapter have been met.

(4) An application for a general anesthesia 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 general anesthesia or deep sedation.

(5) An application for a moderate 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 sedation.

(6) An application for a pediatric moderate 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 sedation.

(7) The Department shall renew the permit biennially upon application by the permit holder, proof of continuing education required by subsection 64B5-14.004, F.A.C., and payment of the renewal fee specified by Rule 64B5-15.019, F.A.C.

(8) The holder of any general anesthesia, moderate sedation, or pediatric moderate 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 FS. History–New            .

 

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

(1) General Anesthesia Permit.

(a) To be eligible for a A permit to authorize the use of general anesthesia or deep sedation  shall be issued to an actively licensed dentist authorizing the use of general anesthesia or deep sedation at a specified practice location or locations on an outpatient basis for dental patients, provided the dentist: shall comply with Rule 64B5-14.0025, F.A.C., and:

1. Complete Has completed a minimum of a two year residency program accredited by the Commission on Dental Accreditation in dental anesthesiology or complete has completed an oral and maxillofacial surgical residency program accredited by the Commission on Dental Accreditation beyond the undergraduate dental school level, or

2. No change.

3. Is eligible for examination by the American Board of Oral and Maxillofacial Surgery.; Or

4. Is a member of the American Association of Oral and Maxillofacial Surgeons.

(b)  A dentist employing or using general anesthesia or deep sedation shall maintain a properly equipped facility for the administration of general anesthesia, pursuant to Rule 64B5-14.008, F.A.C. 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 general anesthesia or deep sedation requires at least three individuals, each appropriately trained in accordance with this chapter: the operating dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist.

(c) A dentist employing or using general anesthesia or deep sedation and all 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 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 general anesthesia or deep sedation must be currently trained in ACLS (Advanced Cardiac Life Support) or ATLS (Advanced Trauma Life Support). Effective March 1, 2022, If treating a patient under the age of 7, a dentist utilizing any level of sedation must be currently trained in PALS (Pediatric Advanced Life Support).

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

(e) A dentist employing or using deep sedation shall maintain an active and current permit to perform general anesthesia.

(2) Moderate Sedation Permit.

(a) To be eligible for a A permit to authorize the shall be issued to a dentist authorizing the use of moderate sedation at a specified practice location or locations on an outpatient basis for dental patients, the dentist shall comply with Rule 64B5-14.0025, F.A.C., and provided such dentist:

1. Complete a Has received formal training course offered through a Commission on Dental Accreditation accredited dental school or program in the use of moderate sedation; or though an accredited teaching hospital. Clinical training must take place at the accredited dental school or accredited teaching hospital; and,

2. Is certified by the institution where the formal training was received to be competent in the administration of moderate sedation; and, 3. is Is competent to handle all emergencies relating to moderate sedation.

(b) The institution’s Such 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 (60), which must include four (4) hours of airway management. Airway management must include emergency airway management protocols. Clinical training shall include personal administration for at least twenty (20) patients including supervised training, clinical experience and demonstrated competence in airway management of the compromised airway. The program must certify that a total of three (3) hours of clinical training was dedicated to hands-on simulated training in emergency competence airway management of the compromised airway.

(c) Personal Administration of Moderate Sedation: The board shall award credit towards the required twenty (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 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 sedation.

(d) This formal training program shall be offered through an accredited dental school or program; or through an accredited, teaching hospital.

(d)(e) A dentist utilizing moderate sedation shall maintain a properly equipped facility for the administration of moderate sedation, pursuant to Rule 64B5-14.009, F.A.C.  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 sedation requires at least three two individuals,: each trained in accordance with this chapter: the operating a dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist. and an auxiliary trained in basic cardiac life support. It shall be incumbent upon the operating dentist to ensure that the patient is appropriately monitored.

(e)(f) A dentist utilizing moderate 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 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 sedation must be currently trained in ACLS (Advanced Cardiac Life Support) or ATLS (Advanced Trauma Life Support). Effective March 1, 2022, if treating a patient under the age of 7, a dentist utilizing moderate sedation must be currently trained in PALS (Pediatric Advanced Life Support).

(f)(g) No change.

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

(3) Pediatric Moderate Sedation Permit.

(a) To be eligible for a permit to authorize the use of pediatric moderate sedation at a specified practice location or locations on an outpatient basis for dental patients, the dentist shall comply with Rules 64B5-14.0025, F.A.C., and A permit shall be issued to a dentist authorizing the use of pediatric moderate sedation at a specified practice location or locations on an outpatient basis for dental patients provided such dentist:

1. Complete Has received formal training in the use of pediatric moderate sedation This formal training program shall be offered through an Commission on Dental Accreditation accredited dental school or program;, or through an accredited teaching hospital, or through an accredited pediatric residency program. Clinical training must take place at the accredited dental school or accredited teaching hospital program; and,

2. Is certified by the institution where the formal training was received to be competent in the administration of pediatric moderate sedation and is competent to handle all emergencies relating to pediatric moderate 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 (60), which must include four (4) hours of airway management. Clinical training shall include personal administration for at least twenty (20) 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 training competence in emergency airway management of the compromised airway; and,

3. Personal Administration of Pediatric Moderate Sedation: The board shall award credit towards the required twenty (20) pediatric 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 sedation, or

4. The applicant demonstrates that the applicant graduated, within 24 months prior to application for the permit, from an accredited post-doctoral pediatric residency. The pediatric residency anesthesia requirements must meet the minimum number of sedation cases as required in subsection (2).

4. 5. Is competent to handle all emergencies relating to pediatric moderate sedation. A dentist utilizing pediatric moderate sedation shall maintain a properly equipped facility for the administration of pediatric moderate sedation, pursuant to Rule 64B5-14.010, F.A.C. 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 sedation requires at least three two individuals, each trained in accordance with this chapter: the operating a dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist. and an auxiliary trained in basic cardiac life support. It shall be incumbent upon the operating dentist to ensure that the patient is appropriately monitored.

(b) A dentist utilizing pediatric moderate 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 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 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) No change.

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

(4) Nitrous-Oxide Inhalation Analgesia.

(a) A dentist may employ or use nitrous-oxide inhalation analgesia on an outpatient basis for dental patients provided such dentist:

1. Has completed no less than a two-day course of training as described in the American Dental Association’s “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students and Comprehensive Control of Pain and Anxiety in Dentistry” (eff. 10/16), which is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-_ or available at http://www.floridadentistry.gov, or its equivalent, or

2. No change.

3. Has a dental nitrous-oxide delivery system adequate equipment with fail-safe features and a 30 25% minimum oxygen flow.

(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 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 sedation must be currently trained in ACLS (Advanced Cardiac Life Support), or PALS (Pediatric Advanced Life Support).

(c) A dentist who regularly and routinely utilized nitrous-oxide inhalation analgesia on an outpatient basis in a competent and efficient manner for the three-year period preceding January 1, 1986, but has not had the benefit of formal training outlined in subparagraphs 1. and 2., of paragraph (4)(a), above, may continue such use provided the dentist fulfills the provisions set forth in subparagraph 3., of paragraph (4)(a), and the provisions of paragraph (b), above.

(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 more than a single dose, or by dosing a single enteral agent in excess of the manufacturer’s maximum recommended dosage unless the administering dentist holds a moderate sedation permit issued in accordance with subsection 64B5-14.003(2), F.A.C., or a pediatric moderate sedation permit issued in accordance with Rule 64B5-14.003(3) 14.010, F.A.C.

(e) Dental assistants and dental hygienists may monitor nitrous-oxide inhalation analgesia under the direct supervision of a dentist if the dental assistant or dental hygienist has complied with the training requirements in Rule 64B5-14.003(4)(b) and has completed, at a minimum, a two-day course of training as described in the American Dental Association’s “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” or its equivalent. After the dentist has induced a patient and established the maintenance level, the assistant or hygienist may monitor the administration of the nitrous-oxide oxygen making only diminishing adjustments during this administration and turning it off at the completion of the dental procedure.

(5) Local Anesthesia Certificate or Permit: A permit or certificate to administer local anesthesia under the direct supervision of a Florida licensed dentist to non-sedated patients eighteen (18) years of age or older shall be issued by the Department of Health to a Florida licensed dental hygienist who has completed the appropriate didactic and clinical education and experience as required by Section 466.017(5), F.S., and who has been certified by the Board as having met all the requirements of Section 466.017, F.S.

(a) A registered dental hygienist who is seeking a permit or certificate for administering local anesthesia must apply to the department on form DH-MQA 1261 (May 2012), Application for Dental Hygiene Certification Administration of Local Anesthesia, herein incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-01469, or available on the Florida Board of Dentistry website at http://www.floridasdentistry.gov http://www.doh.state.fl.us/mqa/dentistry.

(b) 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, 11-13-17,                              .

 

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) General Anesthesia Permit Holders:

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

(a) The physician anesthesiologist performs the administration of the anesthesia and the physician anesthesiologist is responsible for the anesthesia procedure;.

(b) The physician anesthesiologist shall have no other patient induced with anesthesia or begin the performance of any other anesthesia services until the patient is discharged;

(c)(b) The dental treatment takes place in the general anesthesia permit holder’s board-inspected and board-registered dental office that is on file with the board as an authorized location to perform sedation services and that has been inspected pursuant to Rule 64B5-14.007, F.A.C.

(2) Pediatric Moderate Sedation Permit Holders:

A pediatric dentist, as recognized by the American Dental Association, who holds a pediatric Moderate 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) No change.

(b)The physician anesthesiologist shall have no other patient induced with anesthesia or begin the performance of any other anesthesia services until the patient is discharged;

(c)(b) The treatment takes place in the permit holder’s dental office that is on file with the board as an authorized location to perform sedation services and that has been inspected pursuant to Rule 64B5-14.007, F.A.C. board-inspected and board-registered dental office;

(d)(c) No change.

(e)(d) A board-approved inspector performs an additional inspection of the dental office and the inspector reports the office to be in full compliance with the minimum supply, equipment, and facility requirements.

A pediatric dentist who holds an active Moderate sedation permit and not a pediatric moderate 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 sedation permit may transfer the permit to a pediatric moderate sedation permit without any additional cost besides the renewal fee.

(3) Moderate Sedation Permit Holders:

A dentist who holds a moderate 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) No change.

(b) The physician anesthesiologist shall have no other patient induced with anesthesia or begin the performance of any other anesthesia series until the patient is discharged;

(c)(b) The treatment takes place in the permit holder’s properly board-inspected and board-registered dental office; that is on file with the board as an authorized location to perform sedation services and that has been inspected pursuant to Rule 64B5-14.007, F.A.C.

(d)(c) No change.

(e)(d) A board-approved inspector performs an additional inspection of the dental office and the inspector reports the office to be in full compliance with the minimum supply, equipment, and facility requirements.

(4) No change.

(5) Staff or Assistants:

A dentist treating a patient pursuant to this rule must have at least three (3) properly credentialed individuals present as mandated in Rule 64B5-14.003, F.A.C. to fulfill the mandatory minimum required personnel requirements of Rule 64B5-14.003, F.A.C., a physician anesthesiologist assistant or a certified registered nurse anesthetist in addition to, or in lieu of a dental assistant or dental hygienist may be utilized. However, the dentist must have a dedicated member of the team to assist in the dental procedure or during dental emergencies.

(6) Equipment:

A dentist may comply with the electrocardiograph equipment requirements and end tidal carbon dioxide monitor equipment standards set by Rule 64B5-14.008, F.A.C., by utilizing the physician’s mobile or non-fixed equipment if the dentist meets the following conditions:

(a) During the required board inspection, the equipment is available for inspection, or the dentist supplies an inspection of the equipment which a licensed health care risk manager performed. A licensed health care risk manager inspection is valid for a period of twelve months; and,

(b) No change.

(c) As long as the permit holder’s dental office meets the supply, equipment, and facility requirements as mandated in Rule 64B5-14.008, F.A.C., nothing in this rule shall be interpreted to prevent a physician anesthesiologist from utilizing their non-fixed mobile equipment when providing anesthesia services in the permit holder’s dental office.

(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, 11-13-17,                                   .

 

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 sedation permit, or pediatric moderate 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) No change.

(2) Moderate and Pediatric Mmoderate 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 sedation permit or a pediatric moderate sedation permit at the office of the treating dentist. In this setting, the following shall apply:

(a) through (c) No change.

(3) Equipment:

When the general anesthesia permit holder performs the anesthesia services in a dental office of a moderate or pediatric moderate 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 11-13-17,         .

 

64B5-14.0036 Treatment of Sedated Patients by Dentists Without an Anesthesia Permit.

The provisions of this rule control the treatment of patients where an anesthesia permitted dentist sedates the dental patient in his or her board inspected and board registered dental office that is on file with the board as an authorized location to perform sedation services that has been inspected pursuant to 64B5-14.007, F.A.C., and a Florida licensed dentist without an anesthesia permit performs the dental treatment. This rule shall control notwithstanding any rule provision in this Chapter to the contrary, which prohibits such conduct.

(1) The permitted dentist shall perform the sedation in his or her out-patient dental office where the permitted dentist is authorized registered to perform the anesthesia services;

(2) through (4) No change.

Rulemaking Authority 466.004(4), 466.017 FS. Law Implemented 466.017 FS. History–New 3-14-13, Amended 8-19-13,           .

 

64B5-14.004 Continuing Education Additional Requirements.

(1) All dentists who hold an active sedation permit of any level must complete four (4) hours of continuing education in airway management and four (4) hours of continuing education in medical emergencies, every four (4) years from the last date the dentist took the continuing education course. The four (4) hours in airway management must include two hours didactic training in providing dentistry on sedated patients with compromised airways and two hours must include hands-on training in airway management of sedated patients. The continuing education must be taken through a board approved continuing education provider. The continuing education required by this subsection will take effect on March 1, 2014. The continuing education required by this subsection may be included in the thirty (30) hours required by Section 466.0135, F.S.

(2) During the licensure biennial renewal period that begins on March 1, 2020 and ever licensure biennial renewal period thereafter, all dentists who hold an active sedation permit of any level shall take the following continuing education instead of the continuing education required in subsection (1): A  four (4) hour board approved continuing education course in Medical Emergencies that shall include airway management as a component of the course.

(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 sedation, pediatric moderate 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 sedation, pediatric moderate sedation, or nitrous-oxide inhalation analgesia, while rendering dental services allowed by Chapter 466, F.S., and under the following conditions:

(a) Satisfactory completion of no less than a two-day course of training as described in the American Dental Association’s “Guidelines for Teaching and Comprehensive Control of Pain and Anxiety in Dentistry” or its equivalent; and,

(b) Maintenance of competency in cardiopulmonary resuscitation evidenced by certification 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.

(3) After the dentist has induced a patient and established the maintenance level, the assistant or hygienist may monitor the administration of the nitrous-oxide oxygen making only adjustments during this administration and turning it off at the completion of the dental procedure.

(4) Nothing in this rule shall be construed to allow a dentist or dental hygienist or assistant to administer to himself or to any person any drug or agent used for anesthesia, analgesia or sedation other than in the course of the practice of dentistry.

(5) A dentist utilizing moderate 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) All dentists who hold an active sedation permit of any level must complete four (4) hours of continuing education in airway management and four (4) hours of continuing education in medical emergencies, every four (4) years from the last date the dentist took the continuing education course. The four (4) hours in airway management must include two hours didactic training in providing dentistry on sedated patients with compromised airways and two hours must include hands-on training in airway management of sedated patients. The continuing education must be taken through a board approved continuing education provider. The continuing education required by this subsection will take effect on March 1, 2014. The continuing education required by this subsection may be included in the thirty (30) hours required by Section 466.0135, F.S.

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, 11-13-17,                                       .

 

64B5-14.006 Reporting Adverse Occurrences.

(1) No change.

(2) Dentists: Any dentist practicing in the State of Florida must notify the Board in writing by registered mail within forty-eight hours (48 hrs.) of any mortality or other adverse occurrence that occurs in the dentist’s outpatient facility. A complete written report shall be filed with the Board within thirty (30) days of the mortality or other adverse occurrence. The complete written report shall, at a minimum, include the following:

(a) through (e) No change.

(f) A detailed description of the adverse occurrence, to include 1) the onset and type of complications and the onset and type of symptoms experienced by the patient; 2) the onset and type of treatment rendered to the patient; and, 3) the onset and type of response of the patient to the treatment rendered, 4) final disposition of the patient; and,

(g) No change.

(3) through (7) No change.

(8) When a patient death or other adverse occurrence as described in subsection 64B5-14.006(1), F.A.C., is reported to the Department pursuant to Rule 64B5-14.006, F.A.C., the initial report shall be transmitted to the Chairman of the Board’s Probable Cause Panel or another designated member of the Probable Cause Panel to determine if there is legal sufficiency that there has been a violation of the practice act. If so, the Adverse Incident Report shall be referred to the Department of Health, Consumer Services Unit.

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, 11-13-17,                                     .

 

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

(1) The Department, in consult with the Anesthesia Chair Chairman of the Board or the Board by majority vote shall appoint consultants who are Florida licensed dentists who hold an active general anesthesia permit, moderate sedation permit, or a pediatric moderate sedation permit to inspect facilities where general anesthesia, deep sedation, moderate sedation, or pediatric moderate 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 sedation permit, or pediatric moderate sedation permit, the applicant shall pass an initial inspection. The initial inspection shall require the applicant to show compliance with Rule 64B5-14.008, 64B5-14.009 or 64B5-14.010, F.A.C., as applicable and must demonstrate that he or she has knowledge of the use of the required equipment and drugs as follows:

(a) Demonstration of General Anesthesia/Deep Sedation. A dental procedure utilizing general anesthesia/deep sedation must be observed and evaluated. Any general anesthesia/deep sedation technique that is routinely employed may be demonstrated. Demonstration must include placement of intravenous catheter. 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 that express full knowledge and treatment of the patient:

1. through 8. No change.

9. Allergic reaction/Anaphylactic reaction,

10. through 12. No change.

13. Respiratory depression/Apnea.

(b) Demonstration of Moderate Sedation. A dental procedure utilizing moderate sedation must be observed and evaluated. Any moderate sedation technique that is routinely employed may be demonstrated. Demonstration must include placement of intravenous catheter. 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 that express full knowledge and treatment of the patient:

1. through 8. No change.

9. Allergic reaction/Anaphylactic reaction,

10. through 12. No change.

13. Respiratory depression/Apnea.

(c) Demonstration of Pediatric Moderate Sedation. A dental procedure utilizing pediatric moderate sedation must be observed and evaluated. Any pediatric moderate 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 that express full knowledge and treatment of the patient:

1. through 8. No change.

9. Allergic reaction/Anaphylactic reaction,

10. through 12. No change.

13. Respiratory depression/Apnea.

(3) Any applicant who fails to comply with any of the above requirements as a result of the initial inspection shall receive a failing grade and shall be denied a permit for general anesthesia, moderate sedation or pediatric moderate sedation.

(4)(3) Any dentist who has applied for or received a general anesthesia permit, moderate sedation permit, or pediatric moderate sedation permit shall be subject to announced or unannounced  routine onsite inspection and evaluation by an inspection consultant. Routine inspections shall be conducted, at a minimum of, every three years. The routine inspection shall include: 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.

(a) Compliance with the requirements of Rule 64B5-14.008, 64B5-14.009 or 64B5-14.010, F.A.C., as applicable, by assigning a grade of pass or fail.

(4) The inspection consultant shall determine compliance with the requirements of Rules 64B5-14.008, 64B5-14.009 and 64B5-14.010, F.A.C., as applicable, by assigning a grade of pass or fail.

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

(b)(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 consultant 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 or accept a Corrective Action Plan (CAP) to ensure 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 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.

(c)(7) Upon a determination of the inspection consultant that a permit holder has received a failing grade and that the permit holder has not chosen to exercise his option by taking immediate remedial action within the 20 day time period and submitting to reinspection, or reinspection has established that remedial action has not been accomplished, the Inspection cConsultant shall refer the permit holder to the Department of Health, Consumer Services Unit determine whether the deficiencies constitute an imminent danger to the public. Should an imminent danger exist, the consultant shall report his findings to the Executive Director of the Board. The Executive Director shall immediately request an emergency meeting of the Probable Cause Panel. The Probable Cause Panel shall determine whether an imminent danger exists and upon this determination of imminent danger request the Secretary of the Department to enter an emergency suspension of the anesthesia permit. If no imminent danger exists, the consultant shall report his findings to the Probable Cause Panel for further action against the permit holder. Nothing herein is intended to affect the authority of the Secretary of the Department to exercise his emergency suspension authority independent of the Board or the Probable Cause Panel.

(8) When a patient death or other adverse occurrence as described in subsection 64B5-14.006(1), F.A.C., is reported to the Department pursuant to Rule 64B5-14.006, F.A.C., the initial report shall be faxed or otherwise telephonically transmitted to the Chairman of the Board’s Probable Cause Panel or another designated member of the Probable Cause Panel to determine if an emergency suspension order is necessary. If so, the Department shall be requested to promptly conduct an investigation which shall include an inspection of the office involved in the patient death.

(a) If the results of the investigation substantiate the previous determination, an emergency suspension order shall be drafted and presented to the Secretary of the Department for consideration and execution. Thereafter, a conference call meeting of the Probable Cause Panel shall be held to determine the necessity of further administrative action.

(b) If the determination is made that an emergency does not exist, the office involved with the patient death shall be inspected as soon as practicable following receipt of the notice required by Rule 64B5-14.006, F.A.C. However, in the event that the office has previously been inspected with a passing result, upon review of the inspection results, the Chairman of the Probable Cause Panel or other designated member of the Probable Cause Panel shall determine whether or not a reinspection is necessary. The complete written report of the adverse occurrence as required in Rule 64B5-14.006, F.A.C., shall be provided to the Probable Cause Panel of the Board to determine if further action is appropriate.

(c) If a routine inspection reveals a failure to comply with Rule 64B5-14.006, F.A.C., the Inspection Consultant shall obtain the information which was required to be reported and shall determine whether the failure to report the death or incident reveals that an imminent danger to the public exists and report to the Executive Director or Probable Cause Panel as set forth in subsection 64B5-14.007(7), F.A.C.

(5)(9) The holder of any general anesthesia, moderate sedation, or pediatric moderate 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. Any additional location shall be subject to a routine inspection no later than one year from the date of the added location.

(6)(10) Failure to provide access to an a inspection consultant team on two successive occasions shall be grounds for discipline for failure to comply with a legal obligation.  the issuance of an emergency suspension of the licensee’s permit pursuant to the provisions of Section 120.60(6), F.S.

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, 11-13-17,                                         .

 

64B5-14.008 Requirements for General Anesthesia or Deep Sedation: Operatory, Recovery Room, Equipment, Medicinal Drugs, Emergency Protocols, Records, and Continuous Monitoring.

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) Operatory: The operatory where anesthesia is to be administered must:

(a) Be of adequate 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 permit physical access of emergency equipment and personnel and to permit effective emergency management;

(b) through (c) No change.

(2) through (4) No change.

(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) through (m) No change.

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation A muscle relaxant (e.g., Succinylcholine);

(o) through (p) No change.

(q) Dantrolene or ryanodex, if volatile gases are used.

(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) through (p) No change.

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 general anesthesia or deep sedation is administered:

(a) through (c) No change.

(d) An anesthesia record which shall include:

1. through 2. No change.

3. Duration of the procedure, including the start and finish time of the procedure;

4. through 6. No change.

(8) No change.

Rulemaking Authority 466.004, 466.017 FS. Law Implemented 466.017 FS. History–New 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, 3-23-06, 10-24-11, 3-9-14,                                           .

 

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

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 anesthesia is to be administered 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 Be of adequate size and design to permit physical access of emergency equipment and personnel and to permit effective emergency management;

(b) through (c) No change.

(2) through (4) No change.

(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) through (m) No change.

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation A muscle relaxant (e.g., Succinylcholine);

(o) through (p) No change.

(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) through (p) No change.

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 moderate sedation is administered:

(a) through (c) No change.

(d) A sedation or anesthesia record which shall include:

1. through 2. No change.

3. Duration of the procedure including the start and the finish times of the procedure;

4. through 6. No change.

(8) No change.

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, 11-13-17,                                      .

 

64B5-14.010 Pediatric Moderate 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. Be of adequate size and design to permit physical access of emergency equipment and personnel and to permit effective emergency management;

(b) through (c) No change.

(2) through (4) No change.

(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) through (m) No change.

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation A muscle relaxant (e.g., Succinylcholine);

(o) through (p) No change.

(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) through (p) No change.

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) through (c) No change.

(d) An anesthesia or sedation record which shall include:

1. through 2. No change.

3. Duration of the procedure, including the start and finish times of the procedure;

4. through 6. No change.

(8) No change.

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,                                .

 

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: August 23, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 7, 2019