What are the Florida Rules for Anesthesia for Dentists?

as of 6/1/2023 the following rules were in place, please check for updates.

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CHAPTER 64B5-14

ANESTHESIA

64B5-14.001 Definitions

64B5-14.002 Prohibitions

64B5-14.0025 Application for Permit

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

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

64B5-14.0038 Use of a Qualified Anesthetist

64B5-14.004 Continuing Education Requirement

64B5-14.005 Application for Permit (Repealed)

64B5-14.006 Reporting Adverse Occurrences

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

64B5-14.008 Requirements for General Anesthesia or Deep Sedation: Operatory, Recovery Room, Equipment, Medicinal

Drugs, Emergency Protocols, Records, and Continuous Monitoring

64B5-14.009 Moderate Sedation Requirements: Operatory, Recovery Room, Equipment, Medicinal Drugs, Emergency

Protocols, Records, and Continuous Monitoring

64B5-14.010 Pediatric Moderate Sedation Requirements: Operatory; Recovery Room, Equipment, Medicinal Drugs,

Emergency Protocols, Records, and Continuous Monitoring

64B5-14.001 Definitions.

(1) Anesthesia – The loss of feeling or sensation, especially loss of the sensation of pain.

(2) General anesthesia – A controlled state of unconsciousness, produced by a pharmacologic agent, accompanied by a partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or verbal command. This modality includes administration of medications via parenteral routes; that is: intravenous, intramuscular, subcutaneous, submucosal, or inhalation, as well as enteral routes, that is oral, rectal, or transmucosal.

(3) Deep Sedation – A controlled state of depressed consciousness accompanied by partial loss of protective reflexes, including either or both the inability to continually maintain an airway independently or to respond appropriately to physical stimulation or verbal command, produced by pharmacologic or non-pharmacologic method or combination thereof. Deep sedation includes administration of medications via parenteral routes; that is intravenous, intra muscular, subcutaneous, submucosal, or inhalation, as well as enteral routes, that is oral, rectal, or transmucosal.

(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 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 carry a margin of safety wide enough to render unintended loss of consciousness unlikely. For the purposes of this chapter, a pediatric patient 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) Nitrous-oxide inhalation analgesia – The administration by inhalation of a combination of nitrous-oxide and oxygen producing an altered level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command.

(7) Local anesthesia – The loss of sensation of pain in a specific area of the body, generally produced by a topically applied agent or injected agent without causing the loss of consciousness.

(8) Analgesia – Absence of sensibility of pain, designating particularly the relief of pain without loss of consciousness.

(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 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. 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 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.

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

(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 currently holds anesthesia clinical privileges in a hospital or ambulatory surgical facility licensed pursuant to Chapter 395, F.S., and such privileges are commensurate with the anesthesia being provided in a dental office (e.g., pediatric anesthesia privileges is pediatric patients are being treated in the dental office).

(13) Qualified Anesthetist: means an Advanced Practice Registered Nurse 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 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, 3-10-20.

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.

(2) Nitrous-oxide inhalation analgesia. No dentist or dental hygienist licensed in this State shall assist the dentist in initiating nitrous-oxide inhalation analgesia in the practice of dentistry until they have complied with the provisions of this rule chapter, nor shall a hygienist assist the denist in initiating nitrous-oxide to a patient previouly sedated. No agents other than nitrous-oxide and oxygen shall be used for inhalation analgesia pursuant to Rule 64B5-14.003, F.A.C.

(3) Local anesthesia. Dentists licensed in this State may use local anesthetics to produce local anesthesia in the course of their practice of dentistry. Certified Registered Dental Hygienists are the only hygienists allowed to adminster local anesthesia.

(4) 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. No 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) 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: propofol, methohexital, thiopental, etomidate, ketamine, dexmedetomidine, or volatile gases (i.e., sevoflurane, isoflurane).

(6) 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 sedation, or pediatric moderate sedation. If a dentist or dental hygienist has assisted the dentist in initiating nitrous-oxide inhalation analgesia 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, the hygienist may not administer local anesthesia to the patient.

(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, 3-10-20, 9-12-22.

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. An applicant for a pediatric moderate sedation permit who completed the actual clinical demonstration of anesthetics more than two (2) years prior to the submission of the application, shall be entitled to a permit if the applicant also submits documentation of having completed the American Academy of Pediatric Dentistry's comprehensive course on the Safe & Effective Sedation for the Pediatric Dental Patient. This course shall be completed within six (6) months of the submission of the pediactric 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.

(a) Completed Application for General Anesthesia Permit, Form DH-MQA-1205 (08/2021), incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-13634, or available on the Board's website at http://www.floridasdentistry.gov;

(b) The application fee specified in Rule 64B5-15.017, F.A.C., which is non-refundable;

(c) 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; and

(d) 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:

(a) Completed Application for Moderate Sedation Permit, Form DH-MQA-1204 (08/2021), incorporated herein by reference and available at, https://www.flrules.org/Gateway/reference.asp?No=Ref-13635 or available on the Board's website at http://www.floridasdentistry.gov;

(b) The application fee specified in Rule 64B5-15.017, F.A.C., which is non-refundable;

(c) 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; and

(d) 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:

(a) Completed Application for Pediatric Moderate Sedation Permit, Form DH-MQA-1203 (08/2021), incorporated herein by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13636, or available on the Board's website at http://www.floridasdentistry.gov;

(b) The application fee specified in Rule 64B5-15.017, F.A.C., which is non-refundable;

(c) 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; and

(d) Identification of the location or locations at which the licensee desires to be authorized to use or employ moderate sedation.

(7) The Department shall renew the permit biennially upon application by the permit holder, proof of continuing education required by Rule 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 3-10-20, Amended 11-1-21.

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

(1) General Anesthesia Permit.

(a) To be eligible for a permit to authorize the use of general anesthesia or deep 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:

Complete a minimum of a two year residency program accredited by the Commission on Dental Accreditation in dental anesthesiology or complete an oral and maxillofacial surgical residency program accredited by the Commission on Dental Accreditation beyond the undergraduate dental school level, or
Is a diplomate of the American Board of Oral and Maxillofacial Surgery, or
Is eligible for examination by the American Board of Oral and Maxillofacial Surgery.

(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. Administration of general anesthesia or deep sedation requires at least three individuals, each 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. 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). Effective March 1, 2022, if treating a patient 7 years of age or under, 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.

(2) Moderate Sedation Permit.

(a) To be eligible for a permit to authorize 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:

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

(b) The institution's 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 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, 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) 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. Administration of moderate sedation requires at least three individuals, each trained in accordance with this chapter: the operating dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist.

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

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

(g) 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 Rule 64B5-14.0025, F.A.C., and:

Complete formal training in the use of pediatric moderate sedation through a 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; and,
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 in emergency airway management of the compromised airway.

(b) 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 in emergency airway management of the compromised airway; and,

(c) 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.

(d) 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. Administration of pediatric moderate sedation requires at least three individuals, each trained in accordance with this chapter: the operating dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist.

(e) 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. 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 PALS (Pediatric Advanced Life Support).

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

(4) Nitrous-Oxide Inhalation Analgesia.

(a) A dentist may use, or employ and authorize a dental hygienist to assist the dentist in initiating under indirect supervision, as specified by Rule 64B5-16.006, F.A.C., nitrous-oxide inhalation analgesia on an outpatient basis for dental patients provided such dentist and dental hygienist have:

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 (eff. 10/16), which is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11670 or available at http://www.floridadentistry.gov, or its equivalent, or
Training equivalent to that described above while a student in an accredited school of dentistry or dental hygiene; and,
A dental nitrous-oxide delivery system with fail-safe features and a 30% minimum oxygen flow.

(b) A dentist utilizing nitrous-oxide inhalation analgesia and such dentist's assistants and 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. 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 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 subsection 64B5-14.003(3), F.A.C.

(e) Dental assistants may monitor nitrous-oxide inhalation analgesia under the indirect supervision of a dentist if the dental assistant has complied with the training requirements in paragraph 64B5-14.003(4)(b), F.A.C., 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 or dental hygienist has induced a patient and established the maintenance level, the assistant 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 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 (08/2020), 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-13368, or available on the Florida Board of Dentistry website at http://www.floridasdentistry.gov.

(b) An applicant shall submit the following with the application:

A thirty-five dollar ($35) non refundable certificate or permit fee,
A certified copy of the applicant's transcripts that reflect the required didactic and clinical education and experience,
A certified copy of the diploma or certificate issued by the applicant's institution, program, or school; and,
Proof of acceptable certification in Cardiopulmonary Resuscitation for health professionals or Advanced Cardiac Life Support as defined in Section 466.017, F.S.

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, 3-10-20, 8-5-21, 9-12-22.

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) A physician anesthesiologist shall only have one patient at a time induced. A second patient shall not be induced until the first patient has been discharged out of the dental office or is arousable, spontaneously breathing, has stable vital signs and is under the care of a licensee or assistant that is trained in anesthesia recovery;

(c) The dental treatment takes place in the general anesthesia 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.

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

(c) 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.

(d) The dental office meets the supply, equipment, and facility requirements as mandated in Rule 64B5-14.008, F.A.C.;

(e) 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.

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

(d) The dental office meets the supply, equipment, and facility requirements as mandated in Rule 64B5-14.008, F.A.C.;

(4) Non-Sedation Permit Holders:

All provisions of this Chapter relating to the administration of any type of anesthesia or sedation and treatment to sedated patients shall remain in full force and effect. Nothing in this section supersedes, alters, or creates a variance to any prohibitions and mandates applicable to non-sedation permit holding dentists.

(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., an anesthesiologist assistant licensed pursuant to Section 458.3475, or 459.023, F.S., 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 emergencies.

(6) Equipment:

A dentist may comply with the electrocardiograph equipment requirements 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 health care risk manager performed. A health care risk manager inspection is valid for a period of twelve months; and,

(b) The dentist shall make the inspected equipment available during all required inspections, if specifically requested within 48 hours in advance of the inspection, and the equipment must be immediately available for an adverse incident inspection.

(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) Records:

The treating dentist shall maintain a complete copy of the anesthesia records in the patient's dental chart. The dentist shall make certain that name and license numbers identify the treating dentist, the physician anesthesiologist, and all personnel utilized during the procedure.

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, 3-10-20.

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) 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 or pediatric moderate 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) The dental treatment may only be performed by a treating dentist who holds a valid anesthesia permit of any level;

(b)The treating dentist and the anesthesia provider are both responsible for the adverse incident reporting under Rule 64B5-14.006, F.A.C.

(2) Moderate and Pediatric Moderate 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) The dental treatment may only be performed by the moderate sedation or pediatric moderate sedation permit holder;

(b) The general anesthesia permit holder may perform general anesthesia services once an additional board-inspection establishes that the office complies with the facility, equipment and supply requirements of Rule 64B5-14.008, F.A.C.;

(c) The treating dentist and the anesthesia provider are both responsible for the adverse incident reporting requirements under Rule 64B5-14.006, F.A.C.

(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 mandates may be met as follows:

(a) The general anesthesia permit holder provides the equipment which has already been inspected during the general anesthesia permit holder's required inspection;

(b) The equipment is available for inspection during the office's mandated inspection; and,

(4) Staff or Personnel:

An anesthesia provider and the treating dentist are both responsible for ensuring that a minimum number of three (3) personnel are present during the procedure. The personnel must meet the minimum credentialing requirements of Rule 64B5-14.003, F.A.C.

(5) Records: The treating dentist shall maintain a complete copy of the anesthesia records in the patient's dental chart. The dentist performing the anesthesia must maintain the original anesthesia records. The treating dentist must identify by name and license number all personnel utilized during the procedure.

Rulemaking Authority 466.004(4), 466.017 FS. Law Implemented 466.017 FS. History–New 3-14-13, Amended 11-13-17, 3-10-20.

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 dental office that is on file with the board as an authorized location to perform sedation services that has been inspected pursuant to Rule 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 to perform the anesthesia services;

(2) The permitted dentist shall remain with the patient from the onset of the performance of the anesthesia until discharge of the patient;

(3) The permitted dentist shall have no other patient induced with anesthesia or begin the performance of any other anesthesia services until the patient is discharged;

(4) The treating dentist shall have taken a minimum of four hours of continuing education in airway management prior to treating any sedated patient. Two hours must be in 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. After the initial airway management course, the treating dentist shall continue to repeat a minimum of four hours in airway management every four years from the date the course was last taken by the dentist. The continuing education courses taken may be credited toward the mandatory thirty hours of continuing education required for licensure renewal. The requirement that a dentist must first have taken an initial airway management course before treating a sedated patient shall not take effect until March 1, 2014.

Rulemaking Authority 466.004(4), 466.017 FS. Law Implemented 466.017 FS. History–New 3-14-13, Amended 8-19-13, 3-10-20.

64B5-14.0038 Use of a Qualified Anesthetist.

In an outpatient dental office, and pursuant to Section 466.002(2), F.S., a dentist may supervise a qualified anesthetist who is administering anesthetic for a dental procedure on a patient of the supervising dentist. The type of supervision required is direct supervision as defined in Section 466.003(8), F.S. In an outpatient dental office, the supervising dentist must have a valid permit for administering sedation to the level of sedation that the qualified anesthetist will be administering to the dental patient during the dental procedure. The dentist must maintain all office equipment and medical supplies required by this chapter to the level of the sedation that the qualified anesthetist will administer to the dental patient.

Rulemaking Authority 466.004(4), 466.017 FS. Law Implemented 466.002(2), 466.017, 466.003(8) FS. History‒New 11-11-13.

64B5-14.004 Continuing Education Requirement.

(1) Each Biennium, all dentists who hold an active sedation permit of any level must complete a four hour board-approved continuing education education course in Medical Emergencies. The continuing education required by this subsection may be included in the thirty (30) hours required by Section 466.0135, F.S.

(2) To be approved by the board, the Medical Emergencies continuing education course must include a hands-on airway management component.

(3) The Medical Emergencies continuing education course must be taken through a board approved continuing education provider.

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, 3-10-20, 6-2-22.

64B5-14.005 Application for Permit.

Rulemaking Authority 466.004, 466.017(3), 466.017(6) FS. Law Implemented 466.017 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, 11-13-17, Repealed 3-10-20.

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 sedation, pediatric moderate sedation, minimal sedation, nitrous oxide, or local anesthesia.

(b) Supervising Dentist – means the dentist that was directly responsible for supervising the Certified Registered Dental Hygienist (CRDH) who is authorized by proper credentials to administer local anesthesia.

(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) The name, address, and telephone number of the patient;

(b) A detailed description of the dental procedure;

(d) A detailed list of the drugs administered and the dosage administered;

(e) A detailed description of the techniques utilized in administering the drugs;

(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) A list of all witnesses and their contact information to include their address.

(3) A failure by the dentist to timely and completely comply with all the reporting requirements mandated by this rule is a basis for disciplinary action by the Board, pursuant to Section 466.028(1), F.S.

(4) Certified Registered Dental Hygienists: Any CRDH administering local anesthesia must notify the Board, in writing by registered mail within forty-eight hours (48 hrs.) of any adverse occurrence that was related to or the result of the administration of local anesthesia. 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) The name, address, and telephone number of the supervising dentist;

(b) The name, address, and telephone number of the patient;

(d) A detailed description of the preoperative physical condition of the patient;

(e) A detailed list of the local anesthesia administered and the dosage of the local anesthesia administered;

(f) A detailed description of the techniques utilized in administering the drugs;

(g) A detailed description of any other drugs the patient had taken or was administered;

(h) 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; and,

(i) A list of all witnesses and their contact information to include their address.

(5) A failure by the hygienist to timely and completely comply with all the reporting requirements mandated by this rule is a basis for disciplinary action by the Board pursuant to Section 466.028(1), F.S.

(6) Supervising Dentist:

If a Certified Registered Dental Hygienist is required to file a report under the provisions of this rule, the supervising dentist shall also file a contemporaneous report in accordance with subsection (2).

(7) The initial and complete reports required by this rule shall be mailed to: The Florida Board of Dentistry, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258.

(8) When a patient death or other adverse occurrence is reported to the Board pursuant to this rule, 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 as a complaint and the provision of Section 456.073, F.S. shall control.

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, 3-10-20.

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

(1) The Department, in consultation with the Anesthesia Chair 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 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 demonstrate compliance with Rule 64B5-14.008, 64B5-14.009 or 64B5-14.010, F.A.C., as applicable and 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 a response to the following emergencies that express full knowledge and treatment of the patient:

Airway obstruction,
Bronchospasm,
Aspiration of foreign object,
Angina pectoris,
Myocardial infarction,
Hypotension,
Hypertension,
Cardiac arrest,
Allergic reaction/Anaphylactic reaction,
Convulsions,
Hypoglycemia,
Syncope; and,
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 a response to the following emergencies that express full knowledge and treatment of the patient:

Airway obstruction,
Bronchospasm,
Aspiration of foreign object,
Angina pectoris,
Myocardial infarction,
Hypotension,
Hypertension,
Cardiac arrest,
Allergic reaction/Anaphylactic reaction,
Convulsions,
Hypoglycemia,
Syncope; and,
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 a response to the following emergencies that express full knowledge and treatment of the patient:

Airway obstruction,
Bronchospasm,
Aspiration of foreign object,
Angina pectoris,
Myocardial infarction,
Hypotension,
Hypertension,
Cardiac arrest,
Allergic reaction/Anaphylactic reaction,
Convulsions,
Hypoglycemia,
Syncope; and,
Respiratory depression/Apnea.

(d) Demonstrations of General Anesthesia/Deep Sedation, Moderate Sedation, and Pediatric Moderate Sedation as set forth above in paragraphs (2)(a)-(c) of this rule shall be conducted in accordance with the minimum standards of diagnosis and treatment when measured against generally prevailing peer performance. A demonstration that is not performed in accordance with such minimum standard shall be cause for a failing grade.

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

(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.

(b) A permit holder who fails an inspection conducted in accordance with subsection (4) of this rule 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 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) Upon a determination of the consultant that a permit holder has received a failing grade and that the permit holder has not chosen to exercise his option by taking remedial action within the 20 day time period and submitting to reinspection, or reinspection has established that remedial action has not been accomplished, the consultant shall refer the permit holder to the Department of Health, Consumer Services Unit, wherein the disciplinary provision of Section 456.073, F.S. shall control.

(5) 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) Failure to provide access to an inspection consultant on two successive occasions shall be grounds for discipline for failure to comply with a legal obligation.

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, 3-10-20, 11-28-22.

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 size and design to accommodate the patient on a table or in an operating chair and permit an operating team consisting of at least three individuals to freely move about the patient. An operating table or chair which permits the patient to be positioned so the operating team can maintain the airway, quickly alter patient position in an emergency, and provide a firm platform for the management of CPR;

(b) Be equipped with a chair or table adequate for emergency treatment, including a chair or cardiopulmonary resuscitation (CPR) board suitable for CPR;

(2) Recovery Room: If a recovery room is present, it shall be equipped with suction and back up suction equipment, positive pressure oxygen and sufficient light to provide emergency treatment. The recovery room shall also be of adequate size and design to allow emergency access and management. The recovery room shall be situated to allow the patient to be observed by the dentist or an office team member at all times.

(3) Standard Equipment: The following equipment must be readily available to the operatory and recovery room and maintained in good working order:

(a) A positive pressure oxygen delivery system and backup system, including full face mask for adults and for pediatric patients, if pediatric patients are treated;

(b) Oral and nasal airways of various sizes;

(d) Cardioscope – electrocardiograph (EKG) machine, pulse oximeter, and capnograph;

(e) Precordial stethoscope;

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

(g) Thermometer (Continuous temperature monitoring device, if volatile gases are used);

(h) A backup lighting system; and,

(i) A scale to weigh patients.

(4) Emergency Equipment: The following emergency equipment must be present, readily available and maintained in good working order:

(a) Appropriate I.V. set-up, including appropriate supplies and fluids;

(b) Laryngoscope with spare batteries and spare bulbs;

(d) Appropriate syringes;

(e) Tourniquet and tape;

(f) CPR board or chair suitable for CPR;

(g) Defibrillator equipment appropriate for the patient population being treated;

(h) Cricothyrotomy equipment; and,

(i) A Supraglottic Airway Device (SAD) or a Laryngeal Mask Airway (LMA).

(5) Medicinal Drugs: The following drugs or type of drugs with a current shelf life must be maintained and easily accessible from the operatory and recovery room and must be maintained in sufficient amounts to address medical emergencies:

(a) Epinephrine;

(b) A narcotic (e.g., Naloxone) and benzodiazepine (e.g., Flumazenil) antagonist, if these agents are used;

(d) A corticosteroid (e.g., Dexamethasone);

(e) Nitroglycerin;

(f) A bronchodilator (e.g., Albuterol inhaler);

(g) An antihypoglycemic agent (e.g., D50W IV solution);

(h) Amiodarone;

(i) A vasopressor (e.g., Ephedrine);

(j) An anticonvulsant (e.g., Valium or Versed);

(k) Antihypertensive (e.g., Labetalol);

(l) Anticholinergic (e.g., atropine);

(m) Antiemetic;

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation;

(o) An appropriate antiarrhythmic medication (e.g., Lidocaine);

(p) Adenosine; and,

(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) Laryngospasm;

(b) Bronchospasm;

(d) Airway blockage by foreign body;

(e) Angina pectoris;

(f) Myocardial infarction;

(g) Hypertension/Hypotension;

(h) Hypertensive crisis;

(i) Allergic and toxicity reactions;

(j) Seizures;

(k) Syncope;

(l) Phlebitis;

(m) Intra-arterial injection;

(n) Hyperventilation/Hypoventilation;

(o) Cardiac arrest; and,

(p) Cardiac arrhythmias.

The applicant or permit holder shall maintain for inspection a permanent record, which reflects the date, time, duration, and type of training provided to named personnel annually.

(7) Records: The following records are required when general anesthesia or deep sedation is administered:

(a) The patient's current written medical history, including known allergies and previous surgery;

(b) Physical examination including airway evaluation and risk assessment (e.g., Mallampati Classification, Body Mass Index, and ASA Classification);

(d) An anesthesia record which shall include:

Continuous monitoring of vital signs, which are taken and recorded at a minimum of every 5 minute intervals during the procedure;
Drugs administered during the procedure, including route of administration, dosage, time and sequence of administration;
Duration of the procedure, including the start and finish time of the procedure;
Documentation of complications or morbidity (See Rule 64B5-14.006, F.A.C., for Adverse Incident Reporting Requirements);
Status of patient upon discharge, and to whom the patient is discharged; and,
Names of participating personnel.

(8) Continuous Monitoring: The patient who is administered drug(s) for general anesthesia or deep sedation must be continuously monitored intra-operatively by electrocardiograph (EKG), pulse oximeter, and capnograph to provide heart rhythm and rate, oxygen saturation of the blood, and ventilations (end-tidal carbon dioxide). This equipment shall be used for each procedure.

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, 3-10-20.

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:

(b) Be equipped with a chair or table adequate for emergency treatment, including a chair or cardiopulmonary resuscitation (CPR) board suitable for CPR;

(2) Recovery Room: If a recovery room is present, it shall be equipped with suction and backup suction equipment, positive pressure oxygen and sufficient light to provide emergency treatment. The recovery room shall also be of adequate size and design to allow emergency access and management. The recovery room shall be situated to allow the patient to be observed by the dentist or an office team member at all times.

(3) Standard Equipment: The following standard equipment must be readily available to the operatory and recovery room and must be maintained in good working order:

(a) A positive pressure oxygen delivery system and backup system, including full face mask for adults and for pediatric patients, if pediatric patients are treated;

(b) Oral and nasal airways of various sizes;

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

(e) A Precordial stethoscope;

(f) Capnograph;

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

(h) Thermometer;

(i) A backup lighting system; and,

(j) A scale to weigh patients.

(4) Emergency Equipment: The following emergency equipment must be present, readily available and must be maintained in good working order:

(a) Appropriate I.V. set-up, including appropriate supplies and fluids;

(b) Laryngoscope with spare batteries and spare bulbs;

(d) Appropriate syringes;

(e) Tourniquet and tape;

(f) CPR board or chair suitable for CPR;

(g) Defibrillator equipment appropriate for the patient population being treated;

(h) Cricothyrotomy equipment; and,

(i) A Supraglottic Airway Device (SAD) or a Lyryngeal Mask Airway (LMA).

(a) Epinephrine;

(b) A narcotic (e.g., Naloxone) and benzodiazepine (e.g., Flumazenil) antagonists, if these agents are used;

(d) A corticosteroid (e.g., Dexamethasone);

(e) Nitroglycerin;

(f) A bronchodilator (e.g., Albuterol inhaler);

(g) An antihypoglycemic agent (e.g., D50W IV solution);

(h) Amiodarone;

(i) A vasopressor (e.g., Ephedrine);

(j) An anticonvulsant (e.g., Valium or Versed);

(k) Antihypertensive (e.g., Labetalol);

(l) Anticholinergic (e.g, atropine);

(m) Antiemetic;

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation;

(o) An appropriate antiarrhythmic medication (e.g., Lidocaine); and,

(p) Adenosine.

(a) Laryngospasm;

(b) Bronchospasm;

(d) Airway blockage by foreign body;

(e) Angina pectoris;

(f) Myocardial infarction;

(g) Hypertension/Hypotension;

(h) Hypertensive crisis;

(i) Allergic and toxicity reactions;

(j) Seizures;

(k) Syncope;

(l) Phlebitis;

(m) Intra-arterial injection;

(n) Hyperventilation/Hypoventilation;

(o) Cardiac arrest; and,

(p) Cardiac arrhythmias.

The applicant or permit holder shall maintain for inspection a permanent record, which reflects the date, time, duration, and type of training provided to named personnel annually.

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

(a) The patient's current written medical history, including known allergies and previous surgery;

(b) Physical examination including airway evaluation and risk assessment (e.g., Mallampati Classification, Body Mass Index, and ASA Classification);

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

Continuous monitoring of vital signs, which are taken and recorded at a minimum of every 5 minute intervals during the procedure;
Drugs administered during the procedure, including route of administration, dosage, time and sequence of administration;
Duration of the procedure including the start and the finish times of the procedure;
Documentation of complications or morbidity (See Rule 64B5-14.006, F.A.C., for Adverse Incident Reporting requirements);
Status of patient upon discharge, and to whom the patient is discharged; and,
Names of participating personnel.

(8) Continuous Monitoring: The patient who is administered a drug(s) for moderate 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, 11-13-17, 3-10-20.

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:

(b) Be equipped with a chair or table adequate for emergency treatment, including a cardiopulmonary resuscitation (CPR) board of chair suitable for CPR.

(2) Recovery Room: If a recovery room is present, it shall be equipped with suction and backup suction equipment, positive pressure oxygen and sufficient light to provide emergency treatment. The recovery room shall also be of adequate size and design to allow emergency access and management. The recovery room shall be situated so that the patient can be observed by the dentist or an office team member at all times.

(3) Standard Equipment: The following equipment must be readily available to the operatory and recovery room and maintained in good working order:

(a) A positive pressure oxygen delivery system and backup system, including full face mask for pediatric patients;

(b) Oral and Nasal Airways of appropriate size for the pediatric patient;

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

(e) A Precordial stethoscope;

(f) Capnograph;

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

(h) Thermometer;

(i) A backup lighting system; and,

(j) A scale for weighing pediatric patients.

(4) Emergency Equipment: The following emergency equipment must be present, readily available and maintained in good working order:

(a) Appropriate I.V. set-up, including appropriate supplies and fluids;

(b) Laryngoscope with spare batteries and spare bulbs;

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

(e) Appropriate syringes;

(f) Tourniquet and tape;

(g) CPR board or chair suitable for CPR;

(h) Defibrillator equipment appropriate for the patient population being treated; and,

(i) Cricothyrotomy equipment.

(j) A Supraglottic Airway Device (SAD) or a Lyryngeal Mask Airway (LMA).

(a) Epinephrine;

(b) A narcotic (e.g., Naloxone) and benzodiazepine (e.g., Flumazenil) antagonists, if these agents are used;

(d) A corticosteroid (e.g., Dexamethasone);

(e) Nitroglycerin;

(f) A bronchodilator (e.g., Albuterol inhaler);

(g) An antihypoglycemic agent (e.g., D50W IV solution);

(h) Amiodarone;

(i) A vasopressor (e.g., Ephedrine);

(j) An anticonvulsant (e.g., Valium or Versed);

(k) Antihypertensive (e.g., Labetalol);

(l) Anticholinergic (e.g., atropine);

(m) Antimetic;

(n) A paralytic agent that is appropriate for the breakage of a laryngospasm or for the use of rapid sequence intubation;

(o) An appropriate antiarrhythmic medication (e.g., Lidcaine); and,

(p) Adenosine.

(a) Laryngospasm;

(b) Bronchospasm;

(d) Airway blockage by foreign body;

(e) Angina pectoris;

(f) Myocardial infarction;

(g) Hypertension/Hypotension;

(h) Hypertensive crisis;

(i) Allergic and toxicity reactions;

(j) Seizures;

(k) Syncope;

(l) Phlebitis;

(m) Intra-arterial injection;

(n) Hyperventilation/Hypoventilation;

(o) Cardiac arrest; and,

(p) Cardiac arrhythmias.

The applicant or permit holder shall maintain for inspection a permanent record, which reflects the date, time, duration, and type of training provided to named personnel annually.

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

(a) The patient's current written medical history, including known allergies, history of previous surgery and anesthesia, and the patient's age, weight, and calculation of maximum allowable local anesthesia;

(b) Physical examination including airway evaluation and risk assessment (e.g., Mallampati Classification, Body Mass Index, and ASA Classification);

(c) Base line vital signs, including pulse, percent hemoglobin oxygen saturation, and when possible, blood pressure; and,

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

Periodic vital signs recorded a minimum of every 5 minute intervals during the procedure;
Drugs, including local anesthetics, administered during the procedure, including route of administration, dosage, time and sequence of administration;
Duration of the procedure, including the start and finish times of the procedure;
Documentation of complications or morbidity (See Rule 64B5-14.006, F.A.C., for Adverse Incident Reporting Requirements);
Status of patient upon discharge, and to whom the patient is discharged; and,
Names of participating personnel.

(8) Continuous Monitoring: The patient who is administered a drug(s) for pediatric moderate sedation must be continuously monitored intra-operatively by pulse oximetry and capnograph to provide pulse rate, oxygen saturation of the blood, and ventilations (end-tidal carbon dioxide).

Rulemaking Authority 466.004, 466.017 FS. Law Implemented 466.017 FS. History–New 8-8-96, Formerly 59Q-14.010, Amended 8-2-00, 5-20-01, 3-23-06, 10-26-11, 3-9-14, 4-17-16, 11-13-17, 3-10-20.

What are the Florida Rules for Anesthesia for Dentists

What are the Florida Rules for Anesthesia for Dentists?

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64B5-14.001 Definitions.

64B5-14.002 Prohibitions.

64B5-14.0025 Application for Permit.

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.

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

64B5-14.0038 Use of a Qualified Anesthetist.

64B5-14.004 Continuing Education Requirement.

64B5-14.005 Application for Permit.

64B5-14.006 Reporting Adverse Occurrences.

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

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

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

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

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