Definitions, Application for Permit, Training, Education, Certification, and Requirements for Issuance of Permits, Itinerate/Mobile Anesthesia - Physician Anesthesiologist, Reporting Adverse Occurrences, Inspection of Facilities and Demonstration of ...
RULE NOS.:RULE TITLES:
64B5-14.001Definitions
64B5-14.0025Application for Permit
64B5-14.003Training, Education, Certification, and Requirements for Issuance of Permits
64B5-14.0032Itinerate/Mobile Anesthesia - Physician Anesthesiologist
64B5-14.006Reporting Adverse Occurrences
64B5-14.007Inspection of Facilities and Demonstration of Sedation Technique
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 208, October 24, 2019 issue of the Florida Administrative Register.
The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and discussion and subsequent vote by the Board at the public meeting held November 22, 2019. The rules shall now read as follows:
64B5-14.001 Definitions.
(1) through (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 currently holds anesthesia clinical privileges in a hospital or ambulatory surgical facility licensed pursuant to Chapter 395 and such privileges are commensurate with the anesthesia being provided in a dental office (e.g., pediatric anesthesia privileges if pediatric patients are being treated in the dental office). is credentialed to administer anesthesia in a hospital or ambulatory surgical facility licensed pursuant to Chapter 395, F.S.
(13) through (14) No change.
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, .
64B5-14.0025 Application for Permit.
(1) No change.
(2) An applicant for any type of anesthesia permit must submit proof of:
(a) No change.
(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 An applicant is applying for a pediatric moderate sedation permit and who completed the actual clinical demonstration of anesthetics has been more than two (2) years prior to the submission of the application, the applicant shall be entitled to a permit licensure if the applicant also submits documentation of having has 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 prior to the submission of the pediactric moderate sedation permit application.
(3) through (8) No change.
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) through (b) No change.
(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 If treating a patient 7 years of age or under the age of 7, a dentist utilizing any level of sedation must be currently trained in PALS (Pediatric Advanced Life Support).
(d) No change.
(2) Moderate Sedation Permit.
(a) through (d) No change.
(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 the age of 7, a dentist utilizing moderate sedation must be currently trained in PALS (Pediatric Advanced Life Support).
(f) through (g) No change.
(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:
1. 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,
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.
(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)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
(d)4. 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 a dentist, a person responsible for monitoring the patient, and a person to assist the operating dentist.
(e)(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. 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)(c) No change.
(4) Nitrous-Oxide Inhalation Analgesia.
(a) through (d) No change.
(e) Dental assistants and dental hygienists may monitor nitrous-oxide inhalation analgesia under the indirect 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) 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) No change.
(b) A The physician anesthesiologist shall only have one no other patient at a time induced. A second patient shall not be induced with anesthesia or begin the performance of any other anesthesia services until the first patient has been is discharged out of the dental office or is arousable, spontaneously breathing, has stable vital signs and is under the care of the licensee or assistant that is trained in anesthesia recovery;
(c) No change.
(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) A The physician anesthesiologist shall only have one no other patient at a time induced. A second patient shall not be induced with anesthesia or begin the performance of any other anesthesia services until the first patient has been is 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) through (e) No change.
(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) A The physician anesthesiologist shall only have one no other patient at a time induced. A second patient shall not be induced with anesthesia or begin the performance of any other anesthesia series until the first patient has been is 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) through (e) No change.
(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., an a physician anesthesiologist assistant licensed pursuant to section 458.3475, F.S. or section 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) through (7) No change.
Rulemaking Authority 466.004(4), 466.017(3) FS. Law Implemented 466.017(3) FS. History–New 8-20-12, Amended 11-19-12, 2-21-13, 12-16-13, 11-13-17, .
64B5-14.006 Reporting Adverse Occurrences.
(1) No change.
(2) 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 Board Department pursuant to this rule 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 as a compliant 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, .
64B5-14.007 Inspection of Facilities and Demonstration of Sedation Technique.
(1) through (3) No change.
(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) through (b) No change.
(c) 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 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 disciplianry provision of section 456.073, F.S. shall control.
(5) through (6) No change.
Rulemaking Authority 466.017(3) FS. Law Implemented 120.60(8), 466.017(3) FS. History–New 10-24-88, Amended 3-27-90, 11-8-90, 4-24-91, 2-1-93, Formerly 21G-14.007, Amended 12-20-93, Formerly 61F5-14.007, Amended 8-8-96, Formerly 59Q-14.007, Amended 11-4-03, 6-11-07, 11-13-17, .
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.
