Title of Regulation: 18VAC60-20. Regulations Governing Dental Practice (amending 18VAC60-20-10, 18VAC60-20-30, 18VAC60-20-107, 18VAC60-20-108, 18VAC60-20-110, 18VAC60-20-120, 18VAC60-20-135; repealing 18VAC60-20-140).

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

Public Hearing Information:

December 6, 2013 - 9 a.m. - Perimeter Building Conference Center, 9960 Mayland Drive, Henrico, VA

Public Comment Deadline: December 6, 2013.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4538, 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 requires permits for sedation and anesthesia for any dentist who administers or prescribes medication or administers nitrous oxide/oxygen or a combination of a medication and nitrous oxide/oxygen for the purpose of inducing anxiolysis or minimal sedation in a dental office.

Purpose: The intent of the regulatory action is compliance with the statutory mandate of Chapter 526 of the 2011 Acts of the Assembly to require any dentist who provides or administers sedation or anesthesia in a dental office to obtain either a conscious/moderate sedation permit or a deep sedation/general anesthesia permit issued by the board and to establish reasonable education, training, and equipment standards for safe administration and monitoring of sedation and anesthesia to patients in a dental office.

Dentists who meet current qualifications of education and training are qualified for permits under the proposed regulations. The intent is to have some accountability for such qualifications to ensure that patients are being treated by dentists who are appropriately trained and experienced in sedation or anesthesia. Dentists who were self-certified (no formal education or training required) prior to January 1989 will be allowed to hold a temporary permit until September 14, 2014, to allow adequate time to obtain the appropriate qualifications for administration of conscious/moderate sedation.

Additionally, regulatory provisions relating to sedation and anesthesia previously adopted by the board during the periodic review of 18VAC60-20 are included in this action to set standards for safe administration and monitoring of sedation and anesthesia in a dental office. Those standards include essential emergency equipment, recordkeeping, emergency management, and monitoring and sedation of pediatric patients. The goal of the amended regulation is to allow persons currently qualified to administer sedation and anesthesia in dental offices to continue to do so, provided they administer or delegate administration in a safe environment with appropriate personnel and equipment to monitor and to handle emergency situations. Once dentists have obtained sedation or anesthesia permits, the board will be able to periodically inspect dental offices to ensure there are qualified personnel and essential equipment and practices in place as necessary for patient health and safety.

To protect the health and safety of patients who receive conscious/moderate sedation or deep sedation/general anesthesia, the Board of Dentistry and the Department of Health Professions sought legislative action in the 2011 General Assembly to authorize the issuance of permits for provision or administration of sedation or anesthesia in dental offices.

In recent years, the use of sedation and anesthesia in dental practices has increased significantly and the offer of sedation dentistry is frequently used in advertising to attract patients. Sedation and anesthesia are provided by dentists to reduce patient anxiety about undergoing dental treatment and to eliminate pain during the procedure. The use of such controlled substances brings with it the risks of adverse reactions and even death. Current regulations require dentists to have appropriate training, trained auxiliary personnel, and patient monitoring equipment in order to administer sedation and anesthesia. Dentists are also required to report adverse patient reactions to such administration. Based on the current legal authority of the Board of Dentistry, compliance with these requirements to ensure patient safety is only checked by the board after a complaint or an adverse reaction report is received.

Authorizing the board to require dentists in the Commonwealth to obtain a permit to administer conscious/moderate sedation and deep sedation/general anesthesia in a dental practice advances patient safety by enabling proactive oversight by the board through periodic inspections. The permits enable the board to implement a periodic inspection program of the practices where sedation and anesthesia are administered to verify that (i) the treating dentist has the necessary education and training to safely administer controlled substances and to perform lifesaving interventions when adverse reactions occur; (ii) required patient monitoring and safety equipment is present and maintained in working order, and that personnel are properly trained in its use; and (iii) auxiliary personnel have the required training and are assigned duties within the parameters established in the regulations.

Based on data collected by the American Association of Dental Boards (AADB) and reported in the 2010 edition of the AADB Composite, Virginia is currently one of only four states that do not require dentists to obtain permits to administer conscious/moderate sedation and deep sedation/general anesthesia in a dental practice. The board has determined that the proposed regulations, which replace emergency regulations, are necessary to accord patients in Virginia the level of protection provided by the vast majority of other states.

Substance: The substantive provisions of the regulations are: (i) establishment of definitions for words and terms used in sedation and anesthesia regulations; (ii) general provisions for administration, including recordkeeping and requirements for emergency management; (iii) requirements for deep sedation/general anesthesia permits, including training, delegation of administration, emergency equipment, and monitoring and discharge of patients; and (iv) requirements for conscious/moderate sedation permits, including training, delegation of administration, emergency equipment, and monitoring and discharge of patients.

Issues: The primary advantage to the public is greater patient safety and accountability in the provision of sedation and anesthesia in dental offices. There are no disadvantages; persons who are currently qualified will be able to obtain permits or will have adequate time to obtain the required coursework and equipment for monitoring and emergency management. There are no advantages or disadvantages to the Commonwealth; the board set the application and renewal fee with the goal of covering expenditures related to sedation and anesthesia permits.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 526 (Senate Bill 1146) of the 2011 Acts of the Assembly, the Board of Dentistry proposes to establish a permit program for dentists who provide or administer conscious/moderate sedation or deep sedation/general anesthesia in a dental office.

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

Estimated Economic Impact. Sedation and anesthesia are provided by dentists to reduce patient anxiety about undergoing dental treatment and to eliminate pain during the procedure. According to the Department of Health Professions (DHP), the use of sedation and anesthesia in dental practices has increased significantly and the offer of "sedation dentistry" is frequently used in advertising to attract patients in recent years. The use of controlled substances in dentistry brings with it the risks of adverse reactions and even death.

Since 2007, the Board has received 10 reports of patients needing emergency or follow-up care after receiving dental treatment under sedation or anesthesia. While seven of these incidents were minor in nature, three were highly publicized critical incidents involving children. Each of those three incidents resulted in the death of a child. Through its investigation, the Board has learned that children under the age of 12 are particularly susceptible to having extreme adverse reactions to sedation and anesthesia. The Board also found that the treating dentists failed to properly monitor and record vital signs and pulse oximetry readings. In at least one of these cases, excessive medication was administered, the sedatives were administered by unlicensed personnel and the parents were left alone with their unmonitored children following administration of the pre-operative medications. Additionally, the Board found that Virginia is currently one of only four states that do not require dentists to obtain permits to administer sedation and anesthesia in a dental practice.

Also, the Board has received three petitions for rulemaking advocating for regulatory changes in the area of sedation and anesthesia (one in 2008 and two in 2009) and numerous public comments made at Board meetings asking the Board to update and strengthen its regulations for administration. Two of the petitions for rulemaking specifically advocate that dentists be required to prove they have the training required to administer sedation and anesthesia through a registration or permit process and further encourage periodic inspection of dental practices using sedation and anesthesia. When these petitions were considered, the Board was advised by legal counsel that legislative authority was needed before permits could be required.

Current regulations have required dentists to have appropriate training, trained auxiliary personnel and patient monitoring equipment in order to administer sedation and anesthesia. Dentists have been also required to report adverse patient reactions to such administration. However, based on the pre-emergency legal authority of the Board, compliance with these requirements to ensure patient safety was only checked by the Board after a complaint or an adverse reaction report is received.

As a result, in 2011, legislation was introduced at the request of DHP and the Board to establish a permit program for administration of sedation and anesthesia in dentistry. The legislation required that the Board promulgate emergency regulations which became effective September 14, 2012.

The proposed regulations will permanently replace emergency regulations currently in effect. The proposed regulations do not introduce any new education or training requirements for administration of sedation and anesthesia in a dental practice. They, however, require a dentist to obtain a permit to practice sedation or anesthesia dentistry. The Board proposes to establish a $100 annual permit fee for both types of permits. A $35 late fee is also proposed, which is consistent with fee structures of other regulated professions. It is not known at this time whether these fees will be sufficient to cover the Board's administrative expenses associated with issuance of permits, inspections, and taking corrective actions.

The emergency regulations require all dentists who administer moderate sedation/conscious sedation or deep sedation/general anesthesia in dental offices to obtain a permit by March, 2013. Dentists who were "self-certified" (no formal education or training required) prior to January 1989 will be allowed to hold a temporary permit until September 14, 2014, to allow adequate time to obtain the appropriate qualifications for administration of conscious/moderate sedation. As of March 18, 2013, there were 132 moderate/conscious and 18 deep sedation/general anesthesia permits issued. Many additional permit applications are expected to be received by DHP before the deadline. However, the Board has no estimate of the number of permits that will be issued before the end of March, 2013.

In addition, the proposed regulations require certain equipment to be able to administer sedation or anesthesia. The additional emergency equipment that must be available in the areas where patients are sedated and recover from sedation or anesthesia include a defibrillator, an electrocardiographic monitor (EKG)¹, a suction apparatus, a temperature measuring device, a throat pack, and a precordial or pretracheal stethoscope. The cost of this equipment represents additional compliance costs to the dentists wishing to administer sedation and anesthesia in their office. According to DHP, an EKG machine and a stethoscope are the most expensive equipment costing approximately $2,000 and $700, respectively.

The emergency regulations required an EKG machine for any type of moderate sedation while these permanent proposed regulations do not require an EKG machine for moderate sedation administered in a single dose by an enteral method. Thus, a number of dentists may have already acquired an EKG machine due to the equipment requirements set out in the emergency regulations that may not be required to have it under the proposed permanent regulations. While these dentists have already incurred the additional compliance costs, some of them may choose to sell their EKG machines to recover some of their original purchase costs.

The main expected benefit of the proposed permit program is to strengthen compliance with the existing requirements. Sedation and anesthesia permits are expected to advance patient safety by enabling proactive oversight by the Board through periodic inspections. The permits will enable the Board to implement a periodic inspection program of the practices where sedation and anesthesia are administered to verify that 1) the treating dentist has the necessary education and training to safely administer controlled substances and to perform life saving interventions when adverse reactions occur; 2) required patient monitoring and safety equipment is present, is maintained in working order, and that personnel are properly trained in its use; and 3) auxiliary personnel have the required training and are assigned duties within the parameters established in the regulations.

Given the significant risk of death due to errors in administration of sedation and anesthesia and follow up care, to the extent that the permit program will reduce this risk, the proposed amendments should create a net benefit.

Businesses and Entities Affected. The proposed regulations will specifically affect dentists who wish to administer sedation and anesthesia in their offices. As of March 18, 2013, there are 132 moderate/conscious and 18 deep sedation/general anesthesia permits issued. Many additional permit applications are expected to be received by DHP before the deadline. However, the Board has no estimate of the number of permits that will be issued before the end of March, 2013.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposed regulations will require dentists wishing to administer sedation and anesthesia in their offices to pay for the permit fee and purchase necessary equipment if they do not currently have it. Added compliance costs may discourage sedation and anesthesia dentistry by a small margin and reduce supply of sedation and anesthesia dentistry services. However, this possible change in supply is not likely to cause a significant reduction in employment.

Effects on the Use and Value of Private Property. Added compliance costs due to the permit fees and the required equipment would negatively affect profitability of dentists administering sedation and anesthesia in their offices and consequently their asset values.

Small Businesses: Costs and Other Effects. There are 3,049 dental offices are in Virginia. All of these dental practices are small businesses. The proposed changes will add to their compliance costs in terms of the permit fees and cost of the required equipment if they wish to use sedation and anesthesia in their practice.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There is no known alternative method that minimizes the adverse impact on small businesses while accomplishing the same goals.

Real Estate Development Costs. No impact on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ EKG is not required for moderate sedation administered in a single dose by an enteral method.

Agency's Response to Economic Impact Analysis: The Board of Dentistry concurs with the analysis of the Department of Planning and Budget for the proposed regulation, 18VAC60-20 (Regulations Governing Dental Practice), relating to permits for sedation and anesthesia.

Summary:

Pursuant to Chapter 526 of the 2011 Acts of the Assembly, the proposed amendments regulate provision of permits for dentists who provide or administer conscious/moderate sedation or deep sedation/general anesthesia in a dental office. The proposed amendments (i) define words and terms used in sedation and anesthesia regulations; (ii) establish general provisions pertaining to administration of sedation and anesthesia, including recordkeeping, reporting, emergency management, and continuing education requirements; (iii) require dentists who administer deep sedation/general anesthesia and conscious/moderate sedation to obtain permits from the Board of Dentistry; (iv) set out requirements pertaining to the delegation of administration of deep sedation, general anesthesia, and conscious/moderate sedation; (v) set forth the equipment that must be maintained in working order and immediately available to areas where patients will be sedated and treated and where patients will recover; and (vi) establish requirements for the monitoring and discharge of patients.

Part I
General Provisions

18VAC60-20-10. Definitions.

A. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"ADA" means the American Dental Association.

"Advertising" means a representation or other notice given to the public or members thereof, directly or indirectly, by a dentist on behalf of himself, his facility, his partner or associate, or any dentist affiliated with the dentist or his facility by any means or method for the purpose of inducing purchase, sale or use of dental methods, services, treatments, operations, procedures or products, or to promote continued or increased use of such dental methods, treatments, operations, procedures or products.

"Analgesia" means the diminution or elimination of pain in the conscious patient.

"Anxiolysis" means the diminution or elimination of anxiety through the use of pharmacological agents in a dosage that does not cause depression of consciousness.

"CODA" means the Commission on Dental Accreditation of American Dental Association.

"Conscious sedation" means a minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal commands, produced by pharmacological or nonpharmacological methods, including inhalation, parenteral, transdermal or enteral, or a combination thereof.

"Deep sedation/general anesthesia" means an induced state of depressed consciousness or unconsciousness accompanied by a complete or partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or respond purposefully to physical stimulation or verbal command and is produced by a pharmacological or nonpharmacological method or a combination thereof.

"Dental assistant I" means any unlicensed person under the direction of a dentist who renders assistance for services provided to the patient as authorized under this chapter but shall not include an individual serving in purely a secretarial or clerical capacity.

"Dental assistant II" means a person under the direction and direct supervision of a dentist who is registered to perform reversible, intraoral procedures as specified in this chapter.

"Mobile dental facility" means a self-contained unit in which dentistry is practiced that is not confined to a single building and can be transported from one location to another.

"Portable dental operation" means a nonfacility in which dental equipment used in the practice of dentistry is transported to and utilized on a temporary basis at an out-of-office location, including patients' homes, schools, nursing homes, or other institutions.

"Radiographs" means intraoral and extraoral x-rays of hard and soft tissues to be used for purposes of diagnosis.

B. The following words and terms relating to supervision as used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Direct supervision" means that the dentist examines the patient and records diagnostic findings prior to delegating restorative or prosthetic treatment and related services to a dental assistant II for completion the same day or at a later date. The dentist prepares the tooth or teeth to be restored and remains immediately available to the dental assistant II for guidance or assistance during the delivery of treatment and related services.The dentist examines the patient to evaluate the treatment and services before the patient is dismissed.

"Direction" means the level of supervision that a dentist is required to exercise with a dental hygienist, a dental assistant I, or a dental assistant II or that a dental hygienist is required to exercise with a dental assistant to direct and oversee the delivery of treatment and related services.

"Enteral" means any technique of administration in which the agent is absorbed through the gastrointestinal tract or oral mucosa (i.e., oral, rectal, sublingual).

"General supervision" means that a dentist completes a periodic comprehensive examination of the patient and issues a written order for hygiene treatment that states the specific services to be provided by a dental hygienist during one or more subsequent appointments when the dentist may or may not be present. The order may authorize the dental hygienist to supervise a dental assistant performing duties delegable to dental assistants I.

"Immediate supervision" means the dentist is in the operatory to supervise the administration of sedation or provision of treatment.

"Indirect supervision" means the dentist examines the patient at some point during the appointment, and is continuously present in the office to advise and assist a dental hygienist or a dental assistant who is (i) delivering hygiene treatment, (ii) preparing the patient for examination or treatment by the dentist or dental hygienist, or (iii) preparing the patient for dismissal following treatment.

C. The following words and terms relating to sedation or anesthesia as used in the chapter shall have the following meanings unless the context clearly indicates otherwise:

"Conscious/moderate sedation" or "moderate sedation" means a drug-induced depression of consciousness, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from a painful stimulus is not considered a purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

"Deep sedation" means a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. Reflex withdrawal from a painful stimulus is not considered a purposeful response. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

"Enteral" means any technique of administration in which the agent is absorbed through the gastrointestinal tract or oral mucosa (i.e., oral, rectal, sublingual).

"General anesthesia" means a drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilator function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

"Inhalation" means a technique of administration in which a gaseous or volatile agent, including nitrous oxide, is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed.

"Inhalation analgesia" means the inhalation of nitrous oxide and oxygen to produce a state of reduced sensibility to pain without the loss of consciousness.

"Local anesthesia" means the loss of sensation or pain in the oral cavity or the maxillofacial or adjacent and associated structures generally produced by a topically applied or injected agent without depressing the level of consciousness.

"Minimal sedation" means a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilator and cardiovascular functions are unaffected. Minimal sedation includes "anxiolysis" (the diminution or elimination of anxiety through the use of pharmacological agents in a dosage that does not cause depression of consciousness) and includes "inhalation analgesia" (the inhalation of nitrous oxide and oxygen to produce a state of reduced sensibility to pain without the loss of consciousness).

"Mobile dental facility" means a self-contained unit in which dentistry is practiced that is not confined to a single building and can be transported from one location to another.

"Moderate sedation" (see meaning of conscious/moderate sedation).

"Monitoring" means to observe, interpret, assess, and record appropriate physiologic functions of the body during sedative procedures and general anesthesia appropriate to the level of sedation as provided in Part IV (18VAC60-20-107 et seq.).

"Parenteral" means a technique of administration in which the drug bypasses the gastrointestinal tract (i.e., intramuscular, intravenous, intranasal, submucosal, subcutaneous, or intraocular).

"Portable dental operation" means a nonfacility in which dental equipment used in the practice of dentistry is transported to and utilized on a temporary basis at an out-of-office location, including patients' homes, schools, nursing homes, or other institutions.

"Radiographs" means intraoral and extraoral x-rays of hard and soft tissues to be used for purposes of diagnosis.

"Titration" means the incremental increase in drug dosage to a level that provides the optimal therapeutic effect of sedation.

18VAC60-20-30. Other fees.

A. Dental licensure application fees. The application fee for a dental license by examination, a faculty license, or a temporary permit as a dentist shall be $400. The application fee for dental license by credentials shall be $500.

B. Dental hygiene licensure application fees. The application fee for a dental hygiene license by examination, a faculty license to teach dental hygiene, or a temporary permit as a dental hygienist shall be $175. The application fee for dental hygienist license by endorsement shall be $275.

C. Dental assistant II registration application fee. The application fee for registration as a dental assistant II shall be $100.

D. Wall certificate. Licensees desiring a duplicate wall certificate or a dental assistant II desiring a wall certificate shall submit a request in writing stating the necessity for a wall certificate, accompanied by a fee of $60.

E. Duplicate license or registration. Licensees or registrants desiring a duplicate license or registration shall submit a request in writing stating the necessity for such duplicate, accompanied by a fee of $20. If a licensee or registrant maintains more than one office, a notarized photocopy of a license or registration may be used.

F. Licensure or registration certification. Licensees or registrants requesting endorsement or certification by this board shall pay a fee of $35 for each endorsement or certification.

G. Restricted license. Restricted license issued in accordance with § 54.1-2714 of the Code of Virginia shall be at a fee of $285.

H. Restricted volunteer license. The application fee for licensure as a restricted volunteer dentist or dental hygienist issued in accordance with § 54.1-2712.1 or § 54.1-2726.1 of the Code of Virginia shall be $25.

I. Returned check. The fee for a returned check shall be $35.

J. Inspection fee. The fee for an inspection of a dental office shall be $350 with the exception of a routine inspection of an office in which the dentist has a conscious/moderate sedation permit or a deep sedation/general anesthesia permit.

K. Mobile dental clinic or portable dental operation. The application fee for registration of a mobile dental clinic or portable dental operation shall be $250. The annual renewal fee shall be $150 and shall be due by December 31. A late fee of $50 shall be charged for renewal received after that date.

L. Conscious/moderate sedation permit. The application fee for a permit to administer conscious/moderate sedation shall be $100. The annual renewal fee shall be $100 and shall be due by March 31. A late fee of $35 shall be charged for renewal received after that date.

M. Deep sedation/general anesthesia permit. The application fee for a permit to administer deep sedation/general anesthesia shall be $100. The annual renewal fee shall be $100 and shall be due by March 31. A late fee of $35 shall be charged for renewal received after that date.

Part IV
Anesthesia, Sedation and Analgesia

18VAC60-20-107. General provisions.

A. This part (18VAC60-20-107 et seq.) shall not apply to:

1. The administration of local anesthesia in dental offices; or

2. The administration of anesthesia in (i) a licensed hospital as defined in § 32.1-123 of the Code of Virginia or state-operated hospitals or (ii) a facility directly maintained or operated by the federal government.

B. Appropriateness of administration of general anesthesia or sedation in a dental office.

1. Anesthesia and sedation may be provided in a dental office for patients who are Class I and II as classified by the American Society of Anesthesiologists (ASA).

2. Conscious sedation, deep sedation or general anesthesia shall not be provided in a dental office for patients in ASA risk categories of Class IV and V.

3. Patients in ASA risk category Class III shall only be provided general anesthesia or any level of sedation by:

a. A dentist after he has documented a consultation with their primary care physician or other medical specialist regarding potential risk and special monitoring requirements that may be necessary; or

b. An oral and maxillofacial surgeon after performing an evaluation and documenting the ASA risk assessment category of the patient and any special monitoring requirements that may be necessary.

C. Prior to administration of any level of sedation or general anesthesia, the dentist shall discuss the nature and objectives of the anesthesia or sedation planned along with the risks, benefits and alternatives and shall obtain informed, written consent from the patient or other responsible party. The written consent shall be maintained in the patient record.

D. The determinant for the application of these rules shall be the degree of sedation or consciousness level of a patient that should reasonably be expected to result from the type and dosage of medication, the method of administration and the individual characteristics of the patient as documented in the patient's record. The drugs and techniques used must carry a margin of safety wide enough to render unlikely an unintended reduction of or loss of consciousness when factoring in titration and the patient's age, weight, and ability to metabolize drugs.

E. A dentist who is administering anesthesia or sedation to patients prior to June 29, 2005, shall have one year from that date to comply with the educational requirements set forth in this chapter for the administration of anesthesia or sedation. When conscious/moderate sedation, deep sedation, or general anesthesia is administered, the patient record shall also include:

1. Notation of the patient's American Society of Anesthesiologists classification;

2. Review of medical history and current conditions;

3. Written informed consent for administration of sedation and anesthesia and for the dental treatment to be performed;

4. Preoperative vital signs;

5. A record of the name, dose, strength of drugs, and route of administration including the administration of local anesthetics with notations of the time sedation and anesthesia were administered;

6. Monitoring records of all required vital signs and physiological measures recorded every five minutes; and

7. A list of staff participating in the administration, treatment, and monitoring including name, position, and assigned duties.

F. Pediatric patients. No sedating medication shall be prescribed for or administered to a child age 12 years and under prior to his arrival at the dentist office or treatment facility.

G. Emergency management.

1. If a patient enters a deeper level of sedation than the dentist intended and was prepared to provide, the dentist shall stop the dental treatment until the patient returns to and is stable at the intended level of sedation.

2. A dentist in whose office sedation or anesthesia is administered shall have written basic emergency procedures established and staff trained to carry out such procedures.

H. Reporting of adverse reactions. A written report shall be submitted to the board by the treating dentist within 30 days following any mortality or morbidity that directly results from the administration of any level of sedation or anesthesia and that occurs in the facility or during the first 24 hours immediately following the patient's departure from the facility.

I. Continuing education. A dentist who administers or a dental hygienist who monitors patients under general anesthesia, deep sedation, or conscious sedation shall complete four hours every two years of approved continuing education directly related to administration or monitoring of such anesthesia or sedation as part of the hours required for licensure renewal as specified in 18VAC60-20-50.

18VAC60-20-108. Administration of minimal sedation (anxiolysis or inhalation analgesia).

A. Education and training requirements. A dentist who utilizes anxiolysis or inhalation analgesia shall have training in and knowledge of:

1. Medications used, the appropriate dosages and the potential complications of administration.

2. Physiological effects of nitrous oxide and potential complications of administration.

B. Equipment requirements. A dentist who utilizes anxiolysis or inhalation analgesia or who directs the administration of inhalation analgesia by a dental hygienist shall maintain the following equipment in his office and be trained in its use:

1. Blood pressure monitoring equipment.

2. Positive pressure oxygen.

3. Mechanical (hand) respiratory bag.

C. Monitoring requirements.

1. The treatment team for anxiolysis shall consist of the dentist and a second person in the operatory with the patient to assist, monitor and observe the patient. Once the administration of anxiolysis has begun, the dentist shall ensure that a person qualified in accordance with 18VAC60-20-135 is present with the patient at all times to determine the level of consciousness by continuous visual monitoring of the patient.

2. A dentist or a dental hygienist who utilizes inhalation analgesia shall ensure that there is continuous visual monitoring of the patient to determine the level of consciousness.

3. If inhalation analgesia is used, monitoring shall include making the proper adjustments of nitrous oxide machines at the request of or by the dentist or a dental hygienist qualified in accordance with requirements of 18VAC60-20-81 to administer nitrous oxide during administration of the sedation and observing the patient's vital signs.

4. If any other pharmacological agent is used in addition to nitrous oxide/oxygen and a local anesthetic, requirements for the induced level of sedation must be met.

D. Discharge requirement. The dentist shall ensure that the patient is not discharged to his own care until he exhibits normal responses.

18VAC60-20-110. Requirements to administer for the administration of deep sedation/general anesthesia.

A. Educational requirements. After March 31, 2013, no dentist may administer deep sedation/general anesthesia in a dental office unless he has been issued a permit by the board. The requirement for a permit shall not apply to an oral and maxillofacial surgeon who maintains membership in the American Association of Oral and Maxillofacial Surgeons (AAOMS) and who provides the board with reports that result from the periodic office examinations required by AAOMS. Such an oral and maxillofacial surgeon shall be required to post a certificate issued by AAOMS.

B. To determine eligibility for a deep sedation/general anesthesia permit, a dentist shall submit the following:

1. A completed application form;

2. The application fee as specified in 18VAC60-20-30;

3. A copy of the certificate of completion of a CODA accredited program or other documentation of training content that meets the educational and training qualifications specified in subsection C of this section; and

4. A copy of current certification in ACLS or PALS as required in subsection C of this section.

C. Educational and training qualifications for a deep sedation/general anesthesia permit.

1. A dentist may employ or be issued a permit to use deep sedation/general anesthesia on an outpatient basis in a dental office by meeting one of the following educational criteria and by posting the educational certificate, in plain view of the patient, which verifies completion of the advanced training as required in subdivision 1 or 2 of this subsection. These requirements shall not apply nor or interfere with requirements for obtaining hospital staff privileges.

1. Has completed a. Completion of a minimum of one calendar year of advanced training in anesthesiology and related academic subjects beyond the undergraduate dental school level in a training program in conformity with published guidelines by the American Dental Association (Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry) in effect at the time the training occurred; or

2. b. Completion of an American Dental Association approved a CODA accredited residency in any dental specialty which incorporates into its curriculum a minimum of one calendar year of full-time training in clinical anesthesia and related clinical medical subjects (i.e., medical evaluation and management of patients), comparable to those set forth in published guidelines by the American Dental Association for Graduate and Postgraduate Training in Anesthesia in effect at the time the training occurred.

After June 29, 2006, dentists 2. Dentists who administer deep sedation/general anesthesia shall hold current certification in advanced resuscitative techniques with hands-on simulated airway and megacode training for healthcare providers, including basic electrocardiographic interpretation, such as courses in Advanced Cardiac Life Support (ACLS) for Health Professionals or Pediatric Advanced Life Support (PALS) for Health Professionals and current Drug Enforcement Administration registration.

B. Exceptions.

1. A dentist who has not met the requirements specified in subsection A of this section may treat patients under deep sedation/general anesthesia in his practice if a qualified anesthesiologist, or a dentist who fulfills the requirements specified in subsection A of this section, is present and is responsible for the administration of the anesthetic.

2. If a dentist fulfills the requirements specified in subsection A of this section, he may employ the services of a certified nurse anesthetist.

C. D. Posting. Any dentist who utilizes deep sedation/general anesthesia shall post The deep sedation/general anesthesia permit or AAOMS certificate required under subsection A of this section shall be posted along with the dental license and current registration with the Drug Enforcement Administration, the certificate of education required under subsection A of this section. All licenses and permits must be current.

E. Delegation of administration.

1. A dentist who does not hold a permit to administer deep sedation and general anesthesia shall only use the services of a dentist with a current deep sedation/general anesthesia permit or an anesthesiologist to administer deep sedation or general anesthesia in a dental office. In a licensed outpatient surgery center, a dentist not qualified who does not hold a permit to administer deep sedation or general anesthesia shall use either a permitted dentist, an anesthesiologist, or a certified registered nurse anesthetist to administer deep sedation or general anesthesia.

2. A dentist who does hold a permit may administer or use the services of the following personnel to administer deep sedation or general anesthesia:

a. A dentist with a current deep sedation/anesthesia permit;

b. An anesthesiologist; or

c. A certified registered nurse anesthetist under the medical direction and indirect supervision of a dentist who meets the educational requirements of subsection C of this section.

3. Preceding the administration of deep sedation or general anesthesia, 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 in 18VAC60-20-81 to parenterally administer Schedule VI local anesthesia to persons age 18 years or older; or

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

4. A dentist who delegates administration of deep sedation/general anesthesia shall ensure that:

a. All equipment required in subsection F 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 G of this section.

D. F. Emergency Required equipment and techniques. A dentist who administers deep sedation/general anesthesia shall be proficient in handling emergencies and complications related to pain control procedures, including the maintenance of respiration and circulation, and immediate establishment of an airway and cardiopulmonary resuscitation, and. He shall maintain have available the following emergency equipment in the dental facility 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 for children or adults, as appropriate for the patient being treated masks;

2. Oral and nasopharyngeal airways airway management adjuncts;

3. Endotracheal tubes for children or adults, or both, 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 for children or adults, or both;

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 and temperature measuring devices;

10. Pharmacologic antagonist agents;

11. External defibrillator (manual or automatic); and

12. For intubated patients, an End-Tidal CO² monitor;

13. Suction apparatus;

14. Throat pack; and

15. Precordial or pretracheal stethoscope.

E. G. Monitoring requirements.

1. The treatment team for deep sedation/general anesthesia shall at least consist of the operating dentist, a second person to monitor and observe the patient and a third person to assist the operating dentist, all of whom shall be in the operatory with the patient during the dental procedure treatment. The second person may be the health professional delegated to administer sedation or anesthesia.

2. Monitoring of the patient under undergoing deep sedation/general anesthesia, including direct, visual observation of the patient by a one member of the treatment team, is to begin prior to induction of anesthesia and shall take place continuously following induction, during the dental procedure, and during recovery from anesthesia. The person who administered 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.

3. Monitoring deep sedation/general anesthesia shall include the following: recording and reporting of blood pressure, pulse, respiration and other vital signs to the attending dentist.

a. EKG readings and 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, respiration, and heart rate. The EKG readings and patient's vital signs 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.

b. A secured intravenous line must be established during induction and maintained through recovery.

H. 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. Postoperative 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.

18VAC60-20-120. Requirements to administer for administration of conscious/moderate sedation.

A. After March 31, 2013, no dentist may administer conscious/moderate sedation in a dental office unless he has been issued a permit by the board. The requirement for a permit shall not apply to an oral and maxillofacial surgeon who maintains membership in the American Association of Oral and Maxillofacial Surgeons (AAOMS) and who provides the board with reports that result from the periodic office examinations required by AAOMS. Such an oral and maxillofacial surgeon shall be required to post a certificate issued by AAOMS.

B. Automatic qualification. Dentists qualified who hold a current permit to administer deep sedation/general anesthesia may administer conscious/moderate sedation.

C. To determine eligibility for a conscious/moderate sedation permit, a dentist shall submit the following:

1. A completed application form indicating one of the following permits for which the applicant is qualified:

a. Conscious/moderate sedation by any method;

b. Conscious/moderate sedation by enteral administration only; or

c. Temporary conscious/moderate sedation permit (may be renewed one time);

2. The application fee as specified in 18VAC60-20-30;

3. A copy of a transcript, certification, or other documentation of training content that meets the educational and training qualifications as specified in subsection D or E of this section, as applicable; and

4. A copy of current certification in ACLS or PALS as required in subsection F of this section.

B. D. Educational requirements for administration of a permit to administer conscious/moderate sedation by any method.

1. A dentist may be issued a conscious/moderate sedation permit to employ or use any method of conscious sedation by meeting one of the following criteria:

a. Completion of training for this treatment modality according to guidelines published by the American Dental Association (Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry) in effect at the time the training occurred, while enrolled at an accredited dental program or while enrolled in a post-doctoral university or teaching hospital program; or

b. Completion of an approved a continuing education course offered by a provider approved in 18VAC60-20-50 and consisting of 60 hours of didactic instruction plus the management of at least 20 patients per participant, demonstrating competency and clinical experience in parenteral conscious sedation and management of a compromised airway. The course content shall be consistent with guidelines published by the American Dental Association (Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry) in effect at the time the training occurred.

2. A dentist who was self-certified in anesthesia and conscious sedation prior to January 1989 may be issued a temporary conscious/moderate sedation permit to continue to administer only conscious sedation until September 14, 2014. After September 14, 2014, a dentist shall meet the requirements for and obtain a conscious/moderate sedation permit by any method or by enteral administration only.

C. E. Educational requirement for enteral administration of conscious sedation only. A dentist may be issued a conscious/moderate sedation permit to only administer conscious sedation by an enteral method if he has completed an approved a continuing education program, offered by a provider approved in 18VAC60-20-50, of not less than 18 hours of didactic instruction plus 20 clinically-oriented experiences in enteral and/or combination inhalation-enteral conscious sedation techniques. The course content shall be consistent with the guidelines published by the American Dental Association (Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry) in effect at the time the training occurred. The certificate of completion and a detailed description of the course content must be maintained.

D. F. Additional training required. After June 29, 2006, dentists Dentists who administer conscious sedation shall hold current certification in advanced resuscitation techniques with hands-on simulated airway and megacode training for health care providers, including basic electrocardiographic interpretation, such as Advanced Cardiac Life Support as evidenced by a certificate of completion posted with the dental license (ACLS) for Health Professionals or Pediatric Advanced Life Support (PALS) for Health Professionals, and current registration with the Drug Enforcement Administration.

G. Posting. The conscious/moderate sedation permit required under subsection A of this section and issued in accordance with subsection C of this section or the AAOMS certificate issued to an oral and maxillofacial surgeon shall be posted along with the dental license and registration with the Drug Enforcement Administration. All licenses and permits must be current.

H. Delegation of administration.

1. A dentist who does not hold a permit to administer conscious/moderate sedation shall only use the services of a permitted 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 permitted 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 subsection E of this section to administer by an enteral method;

b. A dentist with the training required by subsection D of this section 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 education and training requirements of subsection D or E of this section; or

e. A registered nurse upon his direct instruction and under the immediate supervision of a dentist who meets the education and training requirements of subsection D of this section.

3. If minimal sedation is self-administered by or to a patient age 13 years 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 child age 12 years and 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 18VAC60-20-81 to parenterally administer Schedule VI local anesthesia to persons age 18 years 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 I 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 J of this section.

E. Emergency Required equipment and techniques. A dentist who administers conscious sedation 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, and shall maintain have available the following emergency airway equipment in the dental facility 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 for children or adults, as appropriate for the patient being treated masks;

2. Oral and nasopharyngeal airways airway management adjuncts;

3. Endotracheal tubes for children or adults, or both, with appropriate connectors or other appropriate airway management adjunct such as a laryngeal mask airway and a laryngoscope with reserve batteries and bulbs and appropriately sized laryngoscope blades for children or adults, or both. In lieu of a laryngoscope and endotracheal tubes, a dentist may maintain airway adjuncts designed for the maintenance of a patent airway and the direct delivery of positive pressure oxygen;

4. Pulse oximetry;

5. Blood pressure monitoring equipment;

6. Pharmacologic antagonist agents;

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

8. Mechanical (hand) respiratory bag; and

9. Appropriate emergency drugs for patient resuscitation;

10. Defibrillator;

11. Suction apparatus;

12. Temperature measuring device;

13. Throat pack;

14. Precordial and pretracheal stethoscope; and

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

F. J. Monitoring requirements.

1. The administration treatment team for conscious sedation shall at least consist of the operating dentist and a second person to assist, monitor, and observe the patient. Both shall be in the operatory with the patient throughout the dental treatment. The second person may be the health professional delegated to administer sedation.

2. Monitoring of the patient under conscious undergoing conscious/moderate sedation, including direct, visual observation of the patient by a one member of the treatment team, is to begin prior to administration of sedation, or if medication is self-administered by the patient, when the patient arrives immediately upon the patient's arrival at the dental office and shall take place continuously during the dental procedure treatment and during 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 responsive evaluated and is discharged.

3. Monitoring conscious/moderate sedation shall include the following:

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

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

K. 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. Postoperative instructions shall be given verbally and in writing. The written instructions shall include a 24-hour emergency telephone number of the dental practice.

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

18VAC60-20-135. Ancillary personnel Personnel assisting in sedation or anesthesia.

After June 29, 2006, dentists Dentists who employ ancillary personnel to assist in the administration and monitoring of any form of conscious/moderate sedation or deep sedation/general anesthesia shall maintain documentation that such personnel have:

1. Minimal training resulting in current certification in basic resuscitation techniques with hands-on airway training for health care providers, such as Basic Cardiac Life Support for Health Professionals or an approved, a clinically oriented course devoted primarily to responding to clinical emergencies offered by an approved provider of continuing education as set forth in 18VAC60-20-50 C; or

2. Current certification as a certified anesthesia assistant (CAA) by the American Association of Oral and Maxillofacial Surgeons or the American Dental Society of Anesthesiology (ADSA).

18VAC60-20-140. Report of adverse reactions. (Repealed.)

A written report shall be submitted to the board by the treating dentist within 30 days following any mortality or morbidity which directly results from the administration of local anesthesia, general anesthesia, conscious sedation, or nitrous oxide oxygen inhalation analgesia and which occurs in the facility or during the first 24 hours immediately following the patient's departure from the facility.

FORMS (18VAC60-20)

Application Requirements for Dentists and Application for License to Practice Dentistry (rev. 11/10)

Application Requirements and Application for Restricted Dental Volunteer License/Restricted Dental Hygiene License (rev. 11/10)

Requirements and Instructions for a Temporary Resident's License to Persons Enrolled in Advanced Dental Education Programs and Application for Temporary Resident's License (rev. 2/10)

Application Requirements and Application for Teacher's License or Full-Time Faculty License (rev. 11/10)

Application Requirements for Dental Hygienists and Application for Licensure to Practice Dental Hygiene (rev. 11/10)

Application Requirements for Registration as a Dental Assistant II (rev. 3/11)

Application for Registration to Practice as a Dental Assistant II (eff. 3/11)

Form A, Certification of Dental Assisting Education (eff. 3/11)

Form B, Certification of Employment (eff. 3/11)

Form C, Certification of Authorization to Perform Expanded Duties as a Dental Assistant II (eff. 3/11)

Instructions for Reinstatement of License and Reinstatement Application for Dental/Dental Hygiene Licensure (rev. 2/10)

Instructions for Application for Reactivation of License and Application for Reactivation of License (rev. 2/10)

Application for Certification to Perform Cosmetic Procedures (rev. 2/10)

Oral and Maxillofacial Surgeon Registration of Practice (rev. 2/10)

Oral and Maxillofacial Surgeon Reinstatement of Registration of Practice (rev. 2/10)

Application for Registration for Volunteer Practice (rev. 8/08)

Sponsor Certification for Volunteer Registration (rev. 8/08)

Application for Registration of a Mobile Dental Facility or Portable Dental Operation (eff. 6/10)

Application for a Permit to Administer Conscious/Moderate Sedation (rev. 10/12)

Application for a Permit to Administer Deep Sedation/General Anesthesia (rev. 10/12)