Statutes, codes, and regulations
Rhode Island Administrative Code
Title 216 - Department of healthChapter 40 - Professional licensing and facility regulationSubchapter 05 - Professional Licensing
Part 2 - Dentists, Dental Hygienists, and Dental Assistants
Section 216-RICR-40-05-2.13 - Physical Facility, Equipment and Safety

216-40-05 R.I. Code R. § 2.13

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Current through June 20, 2024
Section 216-RICR-40-05-2.13 - Physical Facility, Equipment and Safety
2.13.1 Equipment Requirements for Nitrous Oxide Sedation, Minimal Sedation, Moderate Sedation, or General Anesthesia/Deep Sedation Services
A. In order to ensure the protection and safety of patients receiving general anesthesia/deep sedation, moderate sedation, minimal sedation, or nitrous oxide sedation in a dental office, the following standards shall be applied in determining the adequacy and safety of the physical facility and equipment.
1. The current standards of the American Dental Association, Guidelines for the Use of Sedation and General Anesthesia by Dentists (2016) incorporated by reference in § 2.2(C) of this Part including but not limited to the following equipment requirements:
a. Equipment shall have a fail-safe system that is appropriately checked and calibrated;
b. Equipment shall have an appropriate scavenging system; and
c. If nitrous oxide and oxygen delivery equipment capable of delivering less than 25% oxygen is used, an in-line oxygen analyzer shall be used;
2. The standards for "Occupational Exposure to Waste Anesthetic Gases and Vapors" of the National Institute for Occupational Safety and Health (NIOSH) incorporated by reference in § 2.2(F) of this Part; and
3. The Rhode Island Fire Safety Code where flammable anesthetics are present.
B. The licensed dentist administering or permitting the administration of nitrous oxide sedation shall meet the following equipment requirements:
1. Automated external defibrillator (AED);
2. Gas delivery machines checked and calibrated periodically as required by manufacturer;
3. Equipment capable of delivering positive pressure ventilation;
4. Gas delivery system must have the following:
a. An oxygen fail-safe system;
b. Safety keyed hose attachment;
c. Capability to administer one hundred percent (100%) oxygen in all rooms in which nitrous oxide is administered;
d. Storage signage for nitrous oxide/oxygen tanks in compliance with applicable safety codes;
e. Adequate waste gas scavenging system;
f. Autoclavable or disposable hoods.
C. Minimal Sedation:
1. The dentist administering or permitting the administration of minimal sedation shall have the following age and size appropriate equipment:
a. Sphygmomanometer;
b. Automatic External Defibrillator (AED); and
c. Appropriate emergency drugs as determined by the Board.
D. Moderate Sedation:
1. A dentist administering or permitting the administration of moderate sedation shall have the following age and size appropriate equipment:
a. Sphygmomanometer and stethoscope;
b. Pulse Oximeter;
c. Capnograph;
d. AED; and
e. Appropriate emergency drugs as determined by the Board.
2. The equipment necessary for monitoring end-tidal CO2 and auscultation of breath sounds must be immediately available.
3. The equipment necessary to administer positive pressure ventilation.
4. An appropriate scavenging system must be available if gases other than oxygen or air are used.
5. The equipment necessary to establish intravascular or intraosseous access must be available until the patient meets discharge criteria.
6. When inhalation equipment is used, it must be a fail-safe system that is appropriately checked and calibrated. The equipment must also have a functioning device that prohibits the delivery of less than thirty percent (30%) oxygen.
E. General Anesthesia/Deep Sedation:
1. The dentist administrating or permitting the administration of general anesthesia/general anesthesia shall have the following equipment:
a. A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
b. When inhalation equipment is used, it must be a fail-safe system that is appropriately checked and calibrated in accordance with manufacturer's recommendations. The equipment must also have a functioning device that prohibits the delivery of less than thirty percent (30%) oxygen.
c. An appropriate scavenging system must be available if gases other than oxygen or air are used.
d. The equipment necessary to establish intravenous access must be available.
e. Equipment and drugs necessary to provide advanced airway management.
f. Resuscitation medications and a defibrillator must be immediately available.
g. The dentist administering or permitting the administration of general anesthesia/deep sedation shall have equipment as referenced in the Office Inspection Form approved by the Board.
2.13.2Clinical Guidelines
A. General Anesthesia/Deep Sedation
1. Patient History and Evaluation: Patients considered for deep sedation or general anesthesia must undergo an evaluation prior to the administration of any sedative. This must consist of their medical history and medication use and NPO (nothing by mouth) status. In addition, patients with considerable medical considerations (e.g., ASA Ill, IV of the ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference above in § 2.2(H) of this Part), may also require consultation with their primary care physician or consulting medical specialist Assessment of Body Mass Index (BMI) should be considered part of a pre-procedural workup.
2. Preoperative Evaluation and Preparation
a. The patient, parent (if a minor), legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agent and informed consent for the proposed sedative/anesthesia must be obtained.
b. A focused physical evaluation must be performed as deemed appropriate.
c. Baseline vital signs including body weight, height, blood pressure, pulse rate, respiration rate, and blood oxygen saturation by pulse oximetry must be obtained unless invalidated by the patient, procedure or equipment. In addition, body temperature should be measured when clinically appropriate.
d. Pre-operative verbal and written instructions must be given to the patient, escort, legal guardian or care-giver, including pre-operative fasting instructions based on the ASA Summary of Fasting and Pharmacological Recommendations.
e. An intravenous line, which is secured throughout the procedure, must be established except as provided in part IVC.6 "Special Needs Patients" of the American Dental Association Guidelines for the Use of Sedation and General Anesthesia by Dentists (2016) incorporated by reference in § 2.2(C) of this Part.
3. Monitoring and Documentation
a. Monitoring. A Qualified Dentist or Qualified Provider administering deep sedation/general anesthesia/deep sedation must remain in the operatory room until the patient meets the criteria for recovery. The Qualified Dentist or Qualified Provider must not leave the facility until he or she has personally observed that the patient meets the criteria for discharge and has signed off on the patient's release. Monitoring must include:
(1) Oxygenation: the color of mucosa, skin, or blood should be continuously evaluated, Oxygen saturation must be evaluated continuously by pulse oximetry.
(2) Ventilation: Intubated patient: End-tidal CO2 must be continuously monitored and evaluated. Non-intubated patients: End-tidal CO2 must be continuously monitored and evaluated unless precluded or invalidated by the nature of the patient, procedure, or equipment. In addition, ventilation should be monitored and evaluated by continuous observation of qualitative signs, including auscultation of breath sounds with a precordial or pretracheal stethoscope.
(3) Respiratory rate must be continuously monitored and evaluated.
(4) Circulation: The dentist shall continually evaluate heart rate and rhythm via ECG throughout the procedure, as well as pulse rate via pulse oximetry.
(5) The Qualified Dentist or Qualified Provider must continually evaluate blood pressure.
(6) Temperature: A device capable of measuring body temperature must be readily available during the administration of deep sedation or general anesthesia. The equipment to continuously monitor body temperature should be available and must be performed whenever triggering agents associated with malignant hypothermia are administered.
b. Documentation
(1) Documentation of compliance with manufacturers' recommended maintenance of monitors, anesthesia delivery systems, and other anesthesia-related equipment should be maintained. A pre-procedural check of equipment for each administration must be performed.
(2) Appropriate time-oriented anesthetic record must be maintained, including the names of all the drugs, dosages and their administration times, including local anesthetics and monitored physiological parameters.
(3) Pulse oximetry and end-tidal CO2 measurements, heart rate, and respiratory rate must be continuously monitored. Blood pressure must be continually monitored. If continuous monitoring is not possible in pediatric or special needs patients, the reason why must be documented.
4. Recovery and Discharge
a. Oxygen and suction equipment must be immediately available in the discharge area and operatory.
b. The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility.
c. The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and level of consciousness.
d. The Qualified Dentist or Qualified Provider shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge.
e. The Qualified Dentist or Qualified Provider or his or her designee shall provide explanation and documentation of postoperative instructions to the patient and/or responsible adult at the time of discharge.
f. If a pharmacological reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer period than usual before discharge, since re-sedation may occur once the effect of the reversal agent has waned.
5. Emergency Management
a. The Qualified Dentist or Qualified Provider is responsible for sedative/anesthetic management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of deep sedation or general anesthesia and providing the equipment, drugs and protocols for patient rescue except as required for the Facility Host Permit.
b. The Board certified or Board eligible anesthesiologist, employed by or practicing in conjunction with a dentist must remain on the premise of the dental office until the patient has been discharged from the dentist's (or anesthesiologist's) care.
c. Proper documentation must include the following:
(1) Maintenance of an appropriate time-oriented anesthetic record including monitoring of blood pressure every five (5) minutes.
(2) Record of the individuals present during the administration of the anesthetic prepared by the dentist.
(3) Recording of all events relative to the administration of nitrous oxide, minimal sedation, moderate sedation, or deep sedation/general anesthesia.
(4) Written report(s) of any morbidity requiring hospitalization or mortality occurring in the dental office as a result of minimal sedation or nitrous oxide sedation, moderate sedation, or deep sedation/general anesthesia.
B. Moderate Sedation
1. Patient History and Evaluation:
a. Patients considered for moderate sedation must be suitably evaluated prior to the start of any sedation procedure. In healthy or medically stable individuals (ASA I, II of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) this may consist of a review of their current medical history and medication use.
b. In addition, patients with multiple medical comorbidities (ASA III, IV of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) may require consultation with his or her primary care provider or consulting medical specialist.
2. Pre-operative Evaluation and Preparation is pursuant to the requirements of § 2.13.2(A)(2) of this Part.
3. Monitoring and Documentation
a. Monitoring
(1) A Qualified Dentist or Qualified Provider administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concluded and the patient recovers to a minimally sedated level a qualified auxiliary may be directed by the dentist to remain with the patient and continue to monitor them as explained in the guidelines until they are discharged from the facility. The dentist must not leave the facility until he or she has personally observed that the patient meets the criteria for discharge and has signed off on the patient's release. Monitoring must include:
(AA) Consciousness: Level of sedation (e.g., responsiveness to verbal command) must be continually assessed.
(BB) Oxygenation: Oxygen saturation must be evaluated by pulse oximetry continuously.
(CC) Ventilation: The dentist must observe chest excursions continually. The dentist must monitor ventilation and/or breathing by monitoring end-tidal CO2 unless precluded or invalidated by the nature of the patient, procedure or equipment Ventilation should be monitored by continuous observation of qualitative signs, including auscultation of breath sounds with precordial or pretracheal stethoscope or as needed if CO2 capnograph is used.
(DD) Vital signs including blood pressure must be obtained and recorded continually.
(EE) Circulation: The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continually monitor the patient's blood pressure and level of consciousness. Oxygenation and heart rate must be continuously monitored.
b. Documentation
(1) Appropriate time-oriented anesthesia record must be maintained, including the names of all drugs, dosages and their administration times, including local anesthetics, dosages and monitored physiological parameters.
(2) Pulse oximetry, heart rate, respiratory rate, blood pressure and level of consciousness must be recorded continually.
4. Recovery and Discharge
a. Oxygen and suction equipment must be immediately available if a separate discharge area is utilized.
b. The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must continuously oxygenation and continually monitor the patient's blood pressure, heart rate, and level of consciousness.
c. Post-operative written instructions must be signed by the Qualified Dentist or Qualified Provider. The written and verbal instructions must be given to the patient, parent, escort, legal guardian or care-giver.
d. If a pharmacological reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer period than usual before discharge, since re-sedation may occur once the effect of the reversal agent has waned.
5. Emergency Management
a. If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient is returned to the intended level of sedation.
b. The Qualified Dentist or Qualified Provider is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation and providing the equipment, drugs, and protocol for patient rescue.
C. Minimal Sedation
1. Patient History and Evaluation
a. Patients considered for minimal sedation must be suitably evaluated prior to the start of any sedation procedure. In healthy or medically stable individuals (ASA I, II of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) this may consist of a review of their current medical history and medication use.
b. In addition, patients with multiple medical comorbidities (ASA III, IV of ASA Physical Status Classification System for Dental Patient Care 2017, incorporated by reference in § 2.2(H) of this Part) may require consultation with his or her primary care provider or consulting medical specialist.
2. Pre-Operative Preparation
a. Informed consent must be obtained from the patient, person designated as the patient's power of attorney for healthcare, or parent if the patient is a minor.
b. Patient evaluation must be obtained unless invalidated by the nature of the patient, procedure, or equipment. Body temperature must be measured when clinically indicated.
c. An appropriate focused physical evaluation must be performed.
e. Pre-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.
3. Monitoring and Documentation
a. Monitoring. A dentist, or at the dentist's direction, an appropriately trained individual, must remain in the operatory during active sedation to monitor the patient on a continual basis until the patient meets the criteria for discharge. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:
(1) Consciousness: Level of sedation (e.g., responsiveness to verbal command) must be continually assessed.
(2) Oxygenation: Oxygen saturation by pulse oximetry may be clinically useful and should be considered.
(3) Ventilation: The dentist and/or appropriately trained individual must observe chest excursions. The dentist and/or appropriately trained individual must verify respirations.
(4) Circulation: Blood pressure and heart rate must be evaluated pre-operatively, post-operatively and intraoperatively as necessary (unless patient is unable to tolerate such monitoring).
b. When administering nitrous oxide, the gas must be turned off when the dentist or dental hygienist administering the drug leaves the room. A dental assistant must stay in the room to monitor the patient if the dentist or dental hygienist is not physically present.
c. Documentation: An appropriate sedation record must be maintained, including names of all drugs administered, time administered and route of administration including local anesthetics, dosages, and monitored physiological parameters.
4. Recovery and Discharge
a. Oxygen and suction equipment must be immediately available if a separate discharge area is utilized.
b. The Qualified Dentist or Qualified Provider or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist.
c. The Qualified Dentist or Qualified Provider must determine and document that level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge, using an Aldrete score, or a similar set of standards approved by the board.
d. Post-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian, or caregiver.
D. Nitrous Oxide Sedation. When administering nitrous oxide, the gas must be turned off when the dentist or dental hygienist administering the drug leaves the room. A dental assistant must stay in the room to monitor the patient if the dentist or dental hygienist is not physically present.
E. Dental Pediatric Anesthesia.
1. A Pediatric Individual Anesthesia Permit for Moderate Sedation is required for:
a. The administration of Nitrous Oxide-Oxygen sedation in a concentration higher than fifty percent (50%) or the administration of a lower concentration of Nitrous Oxide-Oxygen Analgesia via face mask, which may produce general anesthesia.
b. The administration of Nitrous Oxide-Oxygen while the child is under the influence of any other sedative agent.
c. Treatment of children younger than eighteen (18) months old, with moderate sedation, may only be administered by a Deep Sedation/General Anesthesia permit holder.
2. Patient History and Evaluation as well as Pre-Operative Evaluation and Preparation are pursuant to the requirements of §§ 2.13.2(B)(1) and (2) of this Part.
3. Monitoring Equipment
a. Ventilation, oxygenation circulation and level of consciousness must be monitored continuously.
b. Continuous monitoring of oxygen saturation, heart rate, respiratory rate and end tidal carbon dioxide must be provided via the following monitors:
(1) Pulse oximeter
(2) Capnograph
(3) Continual monitoring (every 5-10 minutes) of blood pressure with size appropriate cuff is mandatory.
(4) Continuous monitoring with pulse oximetry, and capnography and continual intermediate monitoring of blood pressure with size appropriate cuff must be employed, unless precluded or invalidated by the nature of the patient, procedure or equipment, which should be specifically noted in the patient record.
c. Heart rate, respiratory rate, blood pressure, oxygen saturation, and expired carbon dioxide values should be recorded, at minimum every ten (10) minutes in a time-based record.
d. Continuous monitoring of heart rate and oxygen saturation must be maintained in the recovery area with presence of at least one trained individual. Vital signs should be recorded at specific intervals (every 10-15) minutes, until discharge criteria are met. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility.
e. In addition the equipment requirements noted in AAP and American Academy of Pediatric Dentistry guidelines, oxygen and suction equipment must be immediately available in the discharge area and operatory.
(1) Stethoscope or precordial stethoscope/amplified, audible pretracheal stethoscope.
(2) Electrocardiographic monitor (ECG) with a minimum of 3-leads.
(3) Defibrillator with size-appropriate patches/paddles for use in pediatric patients.
(4) A device capable of measuring body temperature.
4. Personnel
a. In addition to the dentist, at least one other person trained in PALS, and capable of providing advanced airway skills must be present in the operatory at all times. It is required that at least one of the practitioners present in the room be skilled at obtaining vascular access in children. The individual assigned for monitoring may be responsible for assisting with interruptible patient-related tasks of short duration, such as holding an instrument or troubleshooting equipment for the monitoring of appropriate physiologic parameters.
b. A third individual trained in BLS Basic Life Support for Providers must be present in the facility. This staff member should be immediately available in case of emergency or if the staff member-in-charge of monitoring is involved in the dental treatment rendered, beyond interruptible patient-related tasks of short duration.
5. Discharge
a. Oxygen and suction equipment must be immediately available immediately available in the discharge area and operatory.
b. The patient shall have continuous supervision until oxygenation, ventilation, and circulation are stable and the patient is appropriately responsive for discharge from the facility.
c. The dentist or clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and. level of consciousness.
d. The Qualified Dentist or Qualified Provider shall determine and document that oxygenation, ventilation, and circulation are stable prior to discharge.
e. The dentist or his or her designee shall provide explanation and documentation of postoperative instructions to the patient and/or responsible adult at the time of discharge.
6. Emergency Management
a. The Qualified Dentist or Qualified Provider shall be responsible for the anesthetic management, and treatment of emergencies associated with the administration of anesthesia, including immediate access to pharmacological antagonists, if any, and appropriately sized equipment for establishing a patent airway and providing positive pressure ventilation with oxygen.
b. The Facility Host Permit holder is responsible for the adequacy of the facility.
2.13.3Facility Permit
A. Prior to the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation in a dental office by a qualified dentist as described in § 2.11.2 of this Part and/or a Board certified or Board eligible anesthesiologist employed by or practicing in conjunction with a dentist, each office site shall obtain a facility permit to allow the administration of these anesthesia services on the premises.
1. A facility permit is issued for one office site, and is non-transferable.
a. Those dental office sites in which all anesthesia services are administered by a licensed dentist approved by the Board to administer anesthesia services as described in § 2.11.1(B) of this Part are exempt from the requirements of § 2.13.3 of this Part.
2. Application for a permit shall be made on forms provided by the Board. These forms shall be completed, notarized and submitted to the Board thirty (30) days prior to the scheduled date of the Board meeting. Such application shall be accompanied by:
a. The permit fee (non-refundable and non-returnable) 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
b. Such other information as may be deemed necessary and as may be requested by the Board.
3. Upon receipt of an application for a facility permit as described above, 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 will expire five (5) years from the date of issuance.
a. To renew such permit, the applicant will file with the Board a renewal application at least one (1) month before the date of expiration of the permit, duly executed together with the renewal fee 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). Upon receipt of such renewal application and payment of any fee, a renewal shall be issued effective for five (5) years from the date of renewal, unless sooner suspended or revoked.
b. Any applicant allowing this 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 in accordance with § 2.13.3(A)(3) of this Part.
4. Those dental offices holding facility permits as described above may be subject to inspections as described in § 2.11.5 of this Part.
2.13.4Violations && Sanctions
A. Failure to comply with any of the provisions of § 2.11 of this Part shall be cause for denial, revocation or suspension of permit for the administration of general anesthesia/deep sedation, moderate sedation, minimal sedation or nitrous oxide sedation, and of disciplinary action in accordance with § 2.15.1 of this Part.
B. Furthermore, all hearings and reviews pertaining to the requirements as set forth in this Part, will be subject to the provisions of § 2.15.2 of this Part.

216 R.I. Code R. § 216-RICR-40-05-2.13

Amended effective 4/4/2019