Title of Regulation: 18VAC60-21. Regulations Governing the Practice of Dentistry (amending 18VAC60-21-291, 18VAC60-21-301).

Statutory Authority: §§ 54.1-2400 and 54.1-2709.5 of the Code of Virginia.

Public Hearing Information:

September 16, 2016 - 9:05 a.m. - Perimeter Building, 9960 Mayland Drive, 2nd Floor, Board Room 4, Richmond, VA 23233

Public Comment Deadline: October 21, 2016.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4437, FAX (804) 527-4428, or email sandra.reen@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Dentistry the authority to promulgate regulations to administer the regulatory system. Section 54.1-2709.5 of the Code of Virginia stipulates a permit for administering sedation and anesthesia is required.

Purpose: The purpose of the amendments is to include the use of capnography as a requirement for dentists who administer moderate sedation, deep sedation, or general anesthesia in their offices. Capnography is the monitoring of the concentration or partial pressure of carbon dioxide in the respiratory gases. Capnography has been shown to be effective in the early detection of adverse respiratory events such as hypoventilation, esophageal intubation, and circuit disconnection thus being a means of preventing patient injury. During procedures done under sedation, capnography provides information on the frequency and regularity of ventilation. Capnography provides a method to detect life-threatening conditions, such as malposition of tracheal tubes, unsuspected ventilatory failure, circulatory failure, and defective breathing circuits. Capnography and pulse oximetry together could help prevent anesthesia mishaps. Since such equipment is the national standard for monitoring patients, it should be incorporated into Virginia regulation to ensure that the health and safety of dental patients is adequately protected.

Substance: 18VAC60-21-291 sets out the requirements for administration of conscious/moderate sedation; subsection B is amended to include an end-tidal carbon dioxide monitor (capnograph) as required equipment.

Currently, 18VAC60-21-301 C currently requires an end-tidal carbon dioxide monitor as equipment for use for intubated patients; the amendment requires an end-tidal carbon dioxide monitor (capnograph) for all patients receiving deep sedation or general anesthesia.

Issues: The primary advantage to the public is the greater protection for the citizens of the Commonwealth who receive moderate sedation, deep sedation, or general anesthesia in dental offices. The use of capnography coupled with pulse oximetry can prevent anesthesia/sedation problems that may be avoidable if a patient is adequately monitored. There are no disadvantages. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Dentistry proposes to require that a dentist who administers conscious/moderate sedation or deep sedation/general anesthesia maintain a capnograph/end tidal CO₂ monitor in working order and immediately available to areas where patients will be sedated and recover from sedation.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. In order to administer conscious/moderate sedation dentists must: 1) hold a conscious/moderate sedation permit, 2) hold a deep sedation/general anesthesia permit, or 3) be an oral and maxillofacial surgeon who maintains membership in the American Association of Oral and Maxillofacial Surgeons (AAOMS). In order to administer deep sedation/general anesthesia dentists must either hold a deep sedation/general anesthesia permit or be an oral and maxillofacial surgeon who maintains AAOMS membership.

The Board proposes to require that dentists who administer conscious/moderate sedation or deep sedation/general anesthesia maintain a capnograph/end tidal CO₂ monitor in working order and immediately available to areas where patients will be sedated and recover from sedation. The National Institutes of Health, National Library of Medicine Medical Dictionary defines capnograph as a monitoring device that measures the concentration of carbon dioxide in exhaled air and displays a numerical readout and waveform tracing. Some but likely not all dentists who administer conscious/moderate sedation or deep sedation/general anesthesia already have and use a capnograph.

According to the Department of Health Professions, capnographs cost approximately $2,200 to $4,500, depending on the technology and functionality of the equipment. The proposed amendment will require those dentists who administer conscious/moderate sedation or deep sedation/general anesthesia and do not already have a capnograph to obtain one.

A 2011 meta-analysis article in the Journal of Clinical Anesthesia found that cases of respiratory complications were 17.6 times more likely to be detected if monitored by capnography compared to standard monitoring alone.¹ Given this very large increase in the likelihood of detecting potentially life threatening complications, the benefits of the proposed amendment likely exceed the costs.

Businesses and Entities Affected. The proposed amendment pertains to the 51 dentists who have a permit for deep sedation/general anesthesia, the 194 dentists who have a permit for moderate/conscious sedation, and any dentists who are considering administering conscious/moderate sedation or deep sedation/general anesthesia in the future. Of the 258 licensed oral/maxillofacial surgeons, the majority would hold AAOMS membership that includes periodic inspections by AAOMS, and therefore, are not required to obtain an anesthesia/sedation permit from the Board. Most dentists work for dental practices, virtually all of which would qualify as small businesses.²

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendment may have a small positive impact on employment at firms that sell or manufacture capnographs.

Effects on the Use and Value of Private Property. The proposed amendment may moderately increase the value of firms that sell or manufacture capnographs.

Real Estate Development Costs. The proposed amendment does not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Most dentists work for dental practices, virtually all of which would qualify as small businesses. The proposal increases costs for those practices that offer conscious/moderate sedation or deep sedation/general anesthesia and do not already have a capnograph.

Alternative Method that Minimizes Adverse Impact. There is no apparent alternative that will reduce the adverse impact while still meeting the intended policy goal of a large reduction in potential health risk.  

Adverse Impacts:

Businesses. The proposed amendment increases cost for those practices that offer conscious/moderate sedation or deep sedation/general anesthesia and do not already have a capnograph.

Localities. The proposed amendment does not adversely affect localities.

Other Entities. The proposed amendment does not adversely affect other entities.

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¹Waugh JB, Epps CA, and Khodneva YA. "Capnography enhances surveillance of respiratory events during procedural sedation: a meta-analysis." Journal of Clinical Anesthesia, 2011 May; 23(3):189-96.

²Data source: Department of Health Professions.

Agency's Response to Economic Impact Analysis: The Board of Dentistry concurs with the analysis of the Department of Planning and Budget.

Summary:

Amendments require that a dentist who administers conscious/moderate sedation or deep sedation or general anesthesia maintain an end-tidal carbon dioxide monitor (capnograph) in working order and immediately available to areas where patients will be sedated and recover from sedation.

18VAC60-21-291. Requirements for administration of conscious/moderate sedation.

A. Delegation of administration.

1. A dentist who does not hold a permit to administer conscious/moderate sedation shall only use the services of a qualified dentist or an anesthesiologist to administer such sedation in a dental office. In a licensed outpatient surgery center, a dentist who does not hold a permit to administer conscious/moderate sedation shall use either a qualified dentist, an anesthesiologist, or a certified registered nurse anesthetist to administer such sedation.

2. A dentist who holds a permit may administer or use the services of the following personnel to administer conscious/moderate sedation:

a. A dentist with the training required by 18VAC60-21-290 D 2 to administer by an enteral method;

b. A dentist with the training required by 18VAC60-21-290 D 1 to administer by any method;

c. An anesthesiologist;

d. A certified registered nurse anesthetist under the medical direction and indirect supervision of a dentist who meets the training requirements of 18VAC60-21-290 D 1; or

e. A registered nurse upon his direct instruction and under the immediate supervision of a dentist who meets the training requirements of 18VAC60-21-290 D 1.

3. If minimal sedation is self-administered by or to a patient 13 years of age or older before arrival at the dental office, the dentist may only use the personnel listed in subdivision 2 of this subsection to administer local anesthesia. No sedating medication shall be prescribed for or administered to a patient 12 years of age or younger prior to his arrival at the dentist office or treatment facility.

4. Preceding the administration of conscious/moderate sedation, a permitted dentist may use the services of the following personnel under indirect supervision to administer local anesthesia to anesthetize the injection or treatment site:

a. A dental hygienist with the training required by 18VAC60-25-100 C to parenterally administer Schedule VI local anesthesia to persons 18 years of age or older; or

b. A dental hygienist, dental assistant, registered nurse, or licensed practical nurse to administer Schedule VI topical oral anesthetics.

5. A dentist who delegates administration of conscious/moderate sedation shall ensure that:

a. All equipment required in subsection B of this section is present, in good working order, and immediately available to the areas where patients will be sedated and treated and will recover; and

b. Qualified staff is on site to monitor patients in accordance with requirements of subsection D of this section.

B. Equipment requirements. A dentist who administers conscious/moderate sedation shall have available the following equipment in sizes for adults or children as appropriate for the patient being treated and shall maintain it in working order and immediately available to the areas where patients will be sedated and treated and will recover:

1. Full face mask or masks;

2. Oral and nasopharyngeal airway management adjuncts;

3. Endotracheal tubes with appropriate connectors or other appropriate airway management adjunct such as a laryngeal mask airway;

4. A laryngoscope with reserve batteries and bulbs and appropri­ately sized laryngoscope blades;

5. Pulse oximetry;

6. Blood pressure monitoring equipment;

7. Pharmacologic antagonist agents;

8. Source of delivery of oxygen under controlled positive pressure;

9. Mechanical (hand) respiratory bag;

10. Appropriate emergency drugs for patient resuscitation;

11. Electrocardiographic monitor if a patient is receiving parenteral administration of sedation or if the dentist is using titration;

12. Defibrillator;

13. Suction apparatus;

14. Temperature measuring device;

15. Throat pack; and

16. Precordial or pretracheal stethoscope; and

17. A end-tidal carbon dioxide monitor (capnograph).

C. Required staffing. At a minimum, there shall be a two person treatment team for conscious/moderate sedation. The team shall include the operating dentist and a second person to monitor the patient as provided in 18VAC60-21-260 K and assist the operating dentist as provided in 18VAC60-21-260 J, both of whom shall be in the operatory with the patient throughout the dental procedure. If the second person is a dentist, an anesthesiologist, or a certified registered nurse anesthetist who administers the drugs as permitted in 18VAC60-21-291 A, such person may monitor the patient.

D. Monitoring requirements.

1. Baseline vital signs shall be taken and recorded prior to administration of any controlled drug at the facility and prior to discharge.

2. Blood pressure, oxygen saturation, and pulse shall be monitored continually during the administration and recorded every five minutes.

3. Monitoring of the patient under conscious/moderate sedation is to begin prior to administration of sedation or, if pre-medication is self-administered by the patient, immediately upon the patient's arrival at the dental facility and shall take place continuously during the dental procedure and recovery from sedation. The person who administers the sedation or another licensed practitioner qualified to administer the same level of sedation must remain on the premises of the dental facility until the patient is evaluated and is discharged.

E. Discharge requirements.

1. The patient shall not be discharged until the responsible licensed practitioner determines that the patient's level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge and vital signs have been taken and recorded.

2. Post-operative instructions shall be given verbally and in writing. The written instructions shall include a 24-hour emergency telephone number.

3. The patient shall be discharged with a responsible individual who has been instructed with regard to the patient's care.

F. Emergency management. The dentist shall be proficient in handling emergencies and complications related to pain control procedures, including the maintenance of respiration and circulation, immediate estab­lishment of an airway, and cardiopulmonary resuscitation.

18VAC60-21-301. Requirements for administration of deep sedation or general anesthesia.

A. Preoperative requirements. Prior to the appointment for treatment under deep sedation or general anesthesia the patient shall:

1. Be informed about the personnel and procedures used to deliver the sedative or anesthetic drugs to assure informed consent as required by 18VAC60-21-260 F.

2. Have a physical evaluation as required by 18VAC60-21-260 C.

3. Be given preoperative verbal and written instructions including any dietary or medication restrictions.

B. Delegation of administration.

1. A dentist who does not meet the requirements of 18VAC60-21-300 shall only use the services of a dentist who does meet those requirements or an anesthesiologist to administer deep sedation or general anesthesia in a dental office. In a licensed outpatient surgery center, a dentist shall use either a dentist who meets the requirements of 18VAC60-20-300 18VAC60-21-300, an anesthesiologist, or a certified registered nurse anesthetist to administer deep sedation or general anesthesia.

2. A dentist who meets the requirements of 18VAC60-20-300 18VAC60-21-300 may administer or use the services of the following personnel to administer deep sedation or general anesthesia:

a. A dentist with the training required by 18VAC60-21-300 C;

b. An anesthesiologist; or

c. A certified registered nurse anesthetist under the medical direction and indirect supervision of a dentist who meets the training requirements of 18VAC60-21-300 C.

3. Preceding the administration of deep sedation or general anesthesia, a dentist who meets the requirements of 18VAC60-20-300 18VAC60-21-300 may use the services of the following personnel under indirect supervision to administer local anesthesia to anesthetize the injection or treatment site:

a. A dental hygienist with the training required by 18VAC60-25-100 C to parenterally administer Schedule VI local anesthesia to persons 18 years of age or older; or

b. A dental hygienist, dental assistant, registered nurse, or licensed practical nurse to administer Schedule VI topical oral anesthetics.

C. Equipment requirements. A dentist who administers deep sedation or general anesthesia shall have available the following equipment in sizes appropriate for the patient being treated and shall maintain it in working order and immediately available to the areas where patients will be sedated and treated and will recover:

1. Full face mask or masks;

2. Oral and nasopharyngeal airway management adjuncts;

3. Endotracheal tubes with appropriate connectors or other appropriate airway management adjunct such as a laryngeal mask airway;

4. A laryngoscope with reserve batteries and bulbs and appropriately sized laryngoscope blades;

5. Source of delivery of oxygen under controlled positive pressure;

6. Mechanical (hand) respiratory bag;

7. Pulse oximetry and blood pressure monitoring equipment available and used in the treatment room;

8. Appropriate emergency drugs for patient resuscitation;

9. EKG monitoring equipment;

10. Temperature measuring devices;

11. Pharmacologic antagonist agents;

12. External defibrillator (manual or automatic);

13. For intubated patients, an End-Tidal CO² monitor An end-tidal carbon dioxide monitor (capnograph);

14. Suction apparatus;

15. Throat pack; and

16. Precordial or pretracheal stethoscope.

D. Required staffing. At a minimum, there shall be a three-person treatment team for deep sedation or general anesthesia. The team shall include the operating dentist, a second person to monitor the patient as provided in 18VAC60-21-260 K, and a third person to assist the operating dentist as provided in 18VAC60-21-260 J, all of whom shall be in the operatory with the patient during the dental procedure. If a second dentist, an anesthesiologist, or a certified registered nurse anesthetist administers the drugs as permitted in 18VAC60-21-301 B, such person may serve as the second person to monitor the patient.

E. Monitoring requirements.

1. Baseline vital signs shall be taken and recorded prior to administration of any controlled drug at the facility to include: temperature, blood pressure, pulse, oxygen saturation, and respiration.

2. The patient's vital signs and EKG readings shall be monitored, recorded every five minutes, and reported to the treating dentist throughout the administration of controlled drugs and recovery. When depolarizing medications are administered, temperature shall be monitored constantly.

3. Monitoring of the patient undergoing deep sedation or general anesthesia is to begin prior to the administration of any drugs and shall take place continuously during administration, the dental procedure, and recovery from anesthesia. The person who administers the anesthesia or another licensed practitioner qualified to administer the same level of anesthesia must remain on the premises of the dental facility until the patient has regained consciousness and is discharged.

F. Emergency management.

1. A secured intravenous line must be established and maintained throughout the procedure.

2. The dentist shall be proficient in handling emergencies and complications related to pain control procedures, including the maintenance of respiration and circulation, immediate establishment of an airway, and cardiopulmonary resuscitation.

G. Discharge requirements.

1. The patient shall not be discharged until the responsible licensed practitioner determines that the patient's level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge and vital signs have been taken and recorded.

2. Post-operative instructions shall be given verbally and in writing. The written instructions shall include a 24-hour emergency telephone number for the dental practice.

3. The patient shall be discharged with a responsible individual who has been instructed with regard to the patient's care.