216-40-05 R.I. Code R. § 2.11

Current through June 20, 2024

Section 216-RICR-40-05-2.11 - Administration of Anesthesia in Dental Offices

2.11.1General Requirements

A. Any dentist licensed to practice dentistry in Rhode Island pursuant to R.I. Gen. Laws § 5-31.1-6, who holds an individual anesthesia permit, may administer anesthesia or sedation as authorized by his or her category of individual permit at any facility which has been issued a corresponding facility permit by the Board.

B. Notwithstanding the foregoing, any licensed dentist who intends to administer anesthesia services within a dental office in Rhode Island who has been issued an individual permit and has not been issued a facility permit shall only be permitted to do so by prior approval of the Board.

C. As a condition for approval for an Individual Anesthesia Permit or a Facility Anesthesia Permit, the Board, or its designee, shall conduct an onsite inspection with the applicant of all equipment, medications, and staff utilized for the purpose of administering deep sedation/general anesthesia and moderate sedation. Emergency scenario must be performed, with staff, as well as observation of actual surgical cases where appropriate. Said equipment shall meet all applicable requirements of this Part.

D. Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended.

E. For all levels of sedation, the qualified dentist must have the training, skill, drugs, and equipment to identify and manage such an occurrence until either assistance arrives (emergency medical service) or the patient returns to the intended level of sedation without airway or cardiovascular complications.

2.11.2Professional Permitting Requirements

A. The Board shall issue the following permits to qualified Dentists and Facilities:

1. Individual Anesthesia Permit:

a. Authorizes a Qualified Dentist, licensed by the State, to administer one or all of the following levels of sedation, which shall be delineated on the permit: minimal and nitrous oxide-oxygen alone, or in conjunction with a local anesthetic, moderate, deep sedation and/or general anesthesia, in a dental facility that has the required Facility Permit for the type of anesthesia or sedation being administered in compliance with this Part.

2. Portable Individual Anesthesia Permit:

a. Authorizes a trained Dentist Anesthesiologist to perform sedation services at any dental facility with the appropriate Facility Host Permit.

3. Pediatric Individual Anesthesia Permit: Authorizes a Qualified Dentist with additional training in pediatric sedation as set forth in this Part, licensed by the State of Rhode Island, to Administer moderate sedation to patients under the age of thirteen (13) in a dental facility that has the required Pediatric Facility Permit in compliance with this Part.

4. Facility Permit: Authorizes the administration of one or all of the following levels of sedation, which shall be delineated on the Permit: minimal and nitrous oxide-oxygen alone, or in conjunction with a local anesthetic, moderate, deep sedation and/or general anesthesia, by the onsite Qualified Dentist.

5. Facility Host Permit (H Permit): Authorizes the administration of moderate and deep sedation and/or general anesthesia at the specific site named on the Permit by the Qualified Providers.

6. Pediatric Facility Permit: Authorizes the administration of anesthesia to patients under the age of thirteen (13) by an onsite Qualified Dentist or Qualified Provider at the specific site named on the Permit.

2.11.3Qualifications for Individual Anesthesia Permit

A. All applicants for anesthesia individual permits must have been issued a Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6; and meet the individual qualifications for the permit they are seeking.

B. Applicants for a Nitrous Oxide Individual Anesthesia Permit must meet the following qualifications:

1. Have satisfactorily completed a minimum of fourteen (14) hours of nitrous oxide sedation training program from a CODA, PACE, or CERP approved advanced education program and whose training program is consistent with the provisions of the Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students (2016) incorporated by reference at § 2.2(J) of this Part, and which included experience in the administration of nitrous oxide sedation.

2.. Have fulfilled one of the following requirements set forth in §§ 2.11.3(C), (D), or (E) of this Part; and

C. Applicants for an Individual Anesthesia Permit in Minimal Sedation must demonstrate competency by having successfully completed:

1. Training in minimal sedation consistent with that prescribed in the ADA Guidelines for Teaching Pain Control and Sedation to Dentist and Dental Students (2016) incorporated by reference in § 2.2(D) of this Part; or

2. Comprehensive training in minimal sedation that satisfies the requirements described in the Minimal Sedation section of the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students at the time training was commenced; or

3. An advanced education program accredited by the Commission on Dental Accreditations that affords comprehensive and appropriate training necessary to administer and manage minimal sedation commensurate with these guidelines; and

4. A current certification in Basic Life Support (BLS) for Healthcare Providers; and

5. Successful completion of a respiratory rescue course employing high fidelity human manikins intended for dental professionals.

D. Applicants for an Individual Anesthesia Permit in Moderate Sedation must meet the following criteria:

1. Have successfully completed a minimum of sixty (60) hours of Moderate Sedation training to include a combination of enteral and parenteral sedation course in addition to management of at least twenty (20) adult case experiences as provided by the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students (2016) incorporated by reference in § 2.2(J) of this Part; and

2. Have completed a board approved simulation course that uses high fidelity human simulation.

3. Have a current certification in ACLS.

E. Applicants for Pediatric Individual Anesthesia Permit for Moderate Sedation must meet the following criteria:

1. To administer moderate sedation to all patients up to the age of twenty-one (21) as well as Special Health Care Needs (SHCN) patients of any age (as defined by the American Academy of Pediatric Dentistry Guidelines incorporated by reference in § 2.2(I) of this Part, applicants must have fulfilled one of the following education and training requirements:

a. Have completed a CODA-approved Pediatric Residency Program or are candidates or Diplomates of the American Board of Pediatric Dentistry (ABPD); or

b. Have completed a post-doctoral training program in Oral and Maxillofacial Surgery; or

c. Have completed a post-doctoral training program in Dental Anesthesiology.

2. Dentists who are Diplomates of the American Board of Pediatric Dentistry (ABPD), may administer moderate sedation to all patients up to age twenty-one (21) as well as Special Health Care Needs (SHCN) patients (as defined by the American Academy of Pediatric Dentistry Guidelines incorporated by reference in § 2.2(I) of this Part), of any age.

3. Dentists who hold a pediatric Moderate Sedation Permit and wish to treat children thirteen (13) years of age or over must also obtain an Adult Moderate Sedation Permit.

4. A separate Pediatric Individual Anesthesia Permit for Moderate Sedation Permit is not required for a dentist who holds a Deep Sedation/General Anesthesia Permit.

F. Applicants for Individual Anesthesia Permit in General Anesthesia/Deep Sedation must meet the following criteria:

1. Have completed a Board approved simulation course that uses high fidelity human simulation, and fulfilled one of the following education and training requirements:

a. Completion of an advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum; or

b. Completion of a post-doctoral training program (e.g. Oral and Maxillofacial Surgery (OMFS) or Dental Anesthesiology (DA)) which affords comprehensive appropriate training necessary to administer and manage general anesthesia/deep sedation.

2. Hold a current certification in ACLS.

G. Applicants for a Pediatric Individual Anesthesia Permit to administer or to authorize the administration of deep sedation/general anesthesia to pediatric patients must meet all the foregoing requirements and:

1. Maintain current American Heart Association (AHA) Advanced Cardiovascular Life Support (ACLS)/Pediatric Advanced Life Support (PALS) certification;

2. Be a candidate for or hold current board certification by the American Board of Oral and Maxillofacial Surgery (ABOMS), or

3. Be a candidate or diplomate of the American Dental Board of Anesthesiology (ADBA), or

4. Proof of education or training commensurate with the type of individual permit sought, as follows:

a. Completed an education program accredited by the ADA's Commission on Dental Accreditation (CODA) that provides comprehensive training necessary to administer and manage general anesthesia and deep sedation.

H. Applicants for a Portable Individual Anesthesia Permit:

1. A Qualified Provider who is transporting and utilizing equipment necessary to provide sedation and anesthesia services at a specific dental facility site holding the necessary Facility Host Permit must obtain both a Portable Individual Anesthesia Permit as well as hold an Individual Anesthesia Permit for the designated level of anesthesia that will be provided.

2. An applicant for a Portable Individual Anesthesia Permit must meet the following criteria:

a. Must hold a valid Rhode Island Dental License;

b. Must have current certification in ACLS and PALS; and

c. Must hold a valid Individual Anesthesia Permit for the level of sedation to be administered.

3. Successful completion of an on-site evaluation performed by a Board appointed office evaluation team, of all mobile equipment, including medications, and staff to be utilized in the administration of anesthesia services in a host facility. Evaluations and inspections shall be at the time of application, at renewal, or as requested by the Board.

2.11.4Qualifications for a Facility Permit

A. Qualifications for Nitrous Oxide Facility Permit:

1. An applicant for licensure shall submit to the Board written evidence on forms furnished by the Board that said applicant:

a. Has a Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;

b. Has a nitrous oxide sedation individual permit in accordance with the requirements set forth in § 2.11.3(B) of this Part; and

c. Has submitted a duly executed nitrous oxide sedation self-assessment form that complies with the standards established by the Board.

B. Qualifications for a Minimal Sedation Facility Permit:

1. Approval for a Minimal Sedation facility permit shall require the following prerequisites:

a. A Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6; and

b. A nitrous oxide sedation individual permit in accordance with the requirements set forth in § 2.11.3(B) of this Part; and

c. Submission of a duly executed minimal sedation self-assessment form that complies with the standards established by the Board.

C. Qualifications for a Moderate Sedation Facility Permit:

1. Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;

2. A moderate sedation individual permit in accordance with the requirements set forth in § 2.11.3(D) of this Part; and

3. Successful completion of an on-site office evaluation performed by an office evaluation team approved by the Board and the Director.

a. An office evaluation team shall consist of two or more persons chosen and approved by the Board and the Director. At least one of the evaluators must hold an Individual General Anesthesia Permit. At least one member of the team must have substantial experience in the administration of the method of delivery of anesthesia or sedation used by the dentist being evaluated.

b. The board may appoint a licensee member of the board to serve as a consultant at any evaluation.

4. An applicant for a Facility Permit to administer moderate sedation shall obtain a written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.

D. Qualifications for a General Anesthesia/Deep Sedation Facility Permit:

1. Rhode Island license to practice dentistry pursuant to R.I. Gen. Laws § 5-37.1-6;

2. A general anesthesia/deep sedation individual permit in accordance with the requirements set forth in § 2.11.3(E) of this Part; and

3. Successful completion of an on-site office evaluation performed by an office evaluation team appointed by the Board and the Director.

4. An applicant for a Facility Permit to administer deep sedation or general anesthesia shall obtain written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.

E. Qualifications for a Facility Host Permit (H Permit):

1. An applicant pursuing a Facility Host Permit (H Permit) authorizing the administration of moderate or deep anesthesia and/or general anesthesia at the specific site named on the permit by a Qualified provider who is not the Operating Dentist must submit an attestation to the safety of all equipment used in connection with the administration of anesthesia.

2. An applicant for a Facility Host Permit to administer moderate sedation, deep sedation, or general anesthesia shall obtain written agreement from a hospital to accept emergency patients, or show evidence of membership on a hospital staff.

3. Successful completion of an on-site office evaluation performed by an office evaluation team appointed by the Board and the Director.

2.11.5Application

A. Application for a permit shall be made on forms provided by the Board which shall be completed and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by the following documents (non-returnable and non-refundable):

1. Supporting official transcripts of verification of the qualification requirements as set forth in §§ 2.11.2, 2.11.3, and 2.11.4 of this Part;

2. A statement attesting that he or she has not been involved in any morbidity or mortality secondary to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation; and

3. The permit fee, where applicable, as determined annually by the Director of Health in consultation with the Board and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title); and

4. Such other information as may be deemed necessary and as may be requested by the Board.

2.11.6Issuance and Renewal of Permit

A. Upon receipt of an application for a permit to administer or to permit the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, the Board with the advice of the advisory consultant(s), may issue a permit to an applicant found to meet all the prescribed requirements of this Part. Said permit unless sooner suspended or revoked shall expire on June 30 of each even numbered year.

B. Every person issued a permit who desires to renew his or her permit shall file with the Board one (1) month before the date of expiration of permit, a renewal application duly executed together with the renewal fee, where applicable, as determined biennially by the Director in consultation with the Board and as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). Upon receipt of such renewal application and payment of any fee, a renewal shall be issued effective for two (2) years from the date of renewal, unless sooner suspended or revoked.

C. Any person who allows his or her permit to lapse through accident, mistake or unforeseen cause by failing to renew the permit on or before the expiration date, may be reinstated upon filing an application with payment of the current renewal fee, where applicable, in accordance with § 2.11.6(B) of this Part.

2.11.7Inspections

A. The Board may, through appointed advisory consultants, conduct such inspections and investigations as deemed necessary by the Board to ensure compliance with the requirements of this Part.

B. Refusal to permit an inspection shall constitute a valid ground for permit denial, suspension or revocation.

C. Every applicant shall be given notice by the Board of all deficiencies reported as a result of an inspection or investigation.

2.11.8Inactive Status

A. A dentist who holds a permit for the administration of or to permit the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation in his or her dental office and who desires to withdraw from the practice of dental anesthesia in his or her office, may request from the Board that his or her permit be withdrawn and placed on an inactive status.

B. A dentist whose permit has been inactive for more than one (1) year may be reactivated upon application to the Board and submission of any current application fee, as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). The Board shall determine, at its discretion, whether or not to reactivate the permit or require renewed proof of competency or need for additional educational requirements.

2.11.9Personnel Requirements for Nitrous Oxide Sedation, Minimal Sedation, Moderate Sedation, and General Anesthesia/Deep Sedation

A. Personnel

1. A dentist administering or permitting the administration of nitrous oxide sedation, minimal sedation, moderate sedation, and general anesthesia/deep sedation must ensure that there is a sufficient number of members on the team of auxiliary personnel to assist in handling procedures and emergencies.

B. Minimal Sedation:

1. At least one additional person trained in Basic Life Support (BLS) for providers must be present in addition to the dentist.

C. Moderate Sedation:

1. During the administration of moderate sedation, the dentist must ensure that there are a minimum of three (3) trained individuals present and on the team of auxiliary personnel:

a. At least one staff member shall be designated as the patient monitor. The patient monitor may assist in the delivery of anesthesia under the personal supervision of the operating dentist. The provider must be trained in Advanced Cardiac Life Support (ACLS) and if they are treating a patient less than thirteen (13) years old they must be trained in Pediatric Advanced Life Support (PALS).

b. The second staff member must have ACLS and PALS training.

c. The third member of the team must be trained in BLS for providers and must be present in the facility. This staff member must be immediately available in case of emergency or if the staff member in charge of monitoring is involved in interruptible patient related tasks of short duration.

2. A dentist administering or permitting the administration of moderate sedation to pediatric patients must meet the requirements set forth in § 2.11.3(F) of this Part.

3. A Qualified Provider administering anesthesia in a host facility must attest to the adequacy and competency of the host facility and staff.

D. General Anesthesia/Deep Sedation:

1. The dentist administering General Anesthesia/Deep Sedation shall hold a current certificate in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS), as described in the ADA Guidelines for the Use of Sedation and General Anesthesia by Dentist incorporated by reference in § 2.2(C) of this Part.

2. An Oral and Maxillofacial Surgeon holding a Permit issued by the Board for the administration of general anesthesia/deep sedation may employ and utilize the services of a DAANCE-certified maxillofacial surgery assistant in accordance with the following criteria:

a. Satisfactory evidence of completion of a Dental Anesthesia Assistants National Certification Examination (DAANCE)-certified surgical assistant training course prepared and administrated by the American Association of Oral and Maxillofacial Surgeons and recertification in the DAANCE training program every five (5) years; and

b. Completion of a board of examiners in dentistry-approved Advanced Cardiac Life Support (ACLS) course and/or Pediatric Advanced Life Support (PALS) and recertification in advanced cardiac Life Support (ACLS) and/or Pediatric Advanced Life Support (PALS) every two (2) years; and

c. The valid Deep Sedation/ General Anesthesia Individual Permit by the Oral and Maxillofacial Surgeon where the DAANCE assistant will be performing his or her services; and

d. Direct supervision by an Oral and Maxillofacial Surgeon holding a valid General Anesthesia/Deep Sedation Permit; and

e. Direct visual supervision by an Oral and Maxillofacial Surgeon holding a valid General Anesthesia/Deep Sedation Permit where the DAANCE- certified maxillofacial assistant is performing the following tasks:

(1) Following instructions to prepare and assist in the administration of medications:

(2) Adjusting the rate of intravenous fluid infusion beyond a keep-open rate;

(3) Adjusting an electronic device to provide medications, such as an infusion pump; or

(4) Assisting with preparation/delivery/infusion/administration of emergency medications in order to assist the Oral and Maxillofacial Surgeon in an emergency.

f. The Oral and Maxillofacial Surgeon shall remain immediately available in the facility for the patient, and the DAANCE-certified maxillofacial surgery assistant for evaluation and treatment until the patient meets discharge criteria; and

g. The DAANCE-certified maxillofacial surgery assistant who is assigned to monitoring the patient may not have any other responsibilities while monitoring the patient under general anesthesia/Deep Sedation; and

h. The licensed provider will be responsible for the patient's recovery; and

i. Peri-operative monitoring consisting of at least continuous electrocardiogram, monitoring of blood pressure, pulse oximetry, and end-tidal carbon dioxide consistent with published national standards adopted by the American Association of Oral and Maxillofacial Surgeons in conjunction with the American Society of Anesthesiologists; and

j. The conclusion of the peri-operative monitoring period shall be at the discretion of the licensed provider, using the modified Aldrete scale/scoring system. The patient may then be transferred to a discharge area and shall no longer require continuous monitoring.

3. Supervision. A DAANCE-certified maxillofacial surgery assistant shall perform the functions authorized by the Act and this Part only by delegation or authority from the Oral and Maxillofacial Surgeon and under the appropriate level of direct or direct visual supervision, and provided the Oral and Maxillofacial Surgeon is acting within the scope of his or her license. The responsibility for monitoring a patient and determining the selection of the drug, dosage, and timing of all anesthetic mediations rests solely with the Oral and Maxillofacial surgeon.

4. A dentist administering or permitting the administration of deep sedation/general anesthesia to pediatric patients must ensure that at least three (3) trained individuals are present, one of whom may be the dentist operator:

a. An individual, trained in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS), other than the dentist operator, to continually observe vital signs, airway patency, and adequacy of ventilation;

b. An individual who is trained in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS) and is skilled in airway management; and

c. An individual, trained in Basic Life Support (BLS), who must remain in attendance in the discharge area until the patient is approved for discharge by a Qualified Provider.

5. A Qualified Provider administering anesthesia in a host facility must attest to the adequacy and competency of the host facility and staff.

6. The dentist administering or permitting the administration of general anesthesia/ deep sedation shall hold a current certificate in Advanced Cardiac Life Support, as described in the Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.

7. The dentist administering or permitting the administration of moderate sedation shall hold a current certificate in Advanced Cardiac Life Support, as described in the most current version of the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.

8. The dentist administering or permitting the administration of minimal sedation shall hold a current certificate in Basic Cardiac Life Support, as described in the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) incorporated by reference in § 2.2(C) of this Part.

9. The dentist administering or permitting the administration of nitrous oxide sedation shall hold a current certificate in Basic Life Support (BLS).

10. Each member of the team of auxiliary personnel shall hold a current certificate in Basic Life Support (BLS).

E. Management of Services:

1. Written policies and procedures shall be established regarding:

a. the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation;

b. maintenance of safety controls;

c. qualifications and supervision of the team of auxiliary personnel involved in the general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation service.

2. In addition, the policies shall include provisions for no less than the following:

a. Pre-anesthesia evaluation;

b. Safety of the patient during the anesthesia period;

c. Review of patient's condition prior to induction of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and post-anesthetic evaluation;

d. Signed informed consent obtained prior to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation. In the case of a minor, consent from a parent or legal guardian shall be obtained; in case of emergency, an oral permit will be acceptable;

e. Recording of all events related to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation;

f. Written report(s) of any morbidity requiring hospitalization or mortality occurring in the dental office as a result of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and/or Board certified or Board eligible anesthesiologists, employed by or practicing in conjunction with a dentist shall remain on the premises of the dental office until the patient has been discharged from the dentist's (or anesthesiologist's) care.

F. Monitoring and Documentation

1. A dentist administering or permitting the administration of general anesthesia/deep sedation, moderate sedation or minimal sedation shall ensure that the following monitoring and documentation requirements are met:

a. Monitoring: direct clinical observation of the patient during administration shall occur.

b. Oxygenation: the color of mucosa, skin or blood should be continually evaluated. Oxygen saturation shall be evaluated continuously by pulse oximetry.

c. Ventilation: chest excursion shall be observed. For minimal sedation the dentist shall continuously auscultate breath sounds or monitor end-tidal CO². For deeper levels of sedation, continuous monitoring of end-tidal CO² is required.

d. Circulation: The dentist shall continually evaluate blood pressure and heart rate (unless the patient is unable to tolerate such monitoring).

e. Documentation: An appropriate time-oriented anesthetic record shall be maintained. The dentist shall document individuals present during the administration of anesthesia.

f. Recovery and Discharge: Oxygen and suction equipment shall be immediately available in the recovery area and operatory. There shall be continual monitoring of oxygenation, ventilation, and circulation when the anesthetic is no longer being administered. The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility. The dentist shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge. The dentist shall provide explanation and documentation of postoperative instructions to the patient and/or a responsible adult at the time of discharge. The dentist shall determine that the patient has met discharge criteria prior to leaving the office.

2. The anesthesia permit holder shall be responsible for the anesthetic management, adequacy of the facility/office, and treatment of emergencies associated with the administration of anesthesia, including immediate access to pharmacologic antagonists, if any, and age and size appropriate equipment for establishing a patent airway and providing positive pressure ventilation with oxygen.

216 R.I. Code R. § 216-RICR-40-05-2.11

Amended effective 4/4/2019