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Bulletin

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Bulletin

    Bulletin

    Maryland State Board of Dental Examiners

    Anesthesia and Sedation

    New Regulations Become Effective on January 4, 2010

    Please Read Carefully

    (Authority: Annotated Code of Maryland, Health Occupations Article, ? 4-205 (a)(1), and the Code of

    Maryland Regulations, (COMAR) Title 10, Subtitle 44, Chapter 12, Anesthesia and Sedation)

    The Maryland Legislature has mandated that the Maryland State Board of Dental Examiners ("the Board”) promulgate regulations governing anesthesia and sedation. In accordance with the legislation the Board formed an eight member Anesthesia and Sedation Committee composed of oral and maxillofacial surgeons, pediatric dentists, a periodontist and prosthodontist, and general dentists. During the course of its deliberations the Committee held two public hearings and invited the public to attend a third public Board meeting in which comments were solicited. In addition, the regulation draft appeared in the Maryland Register, the State’s legal periodical, where public

    comment was again requested.

The Board’s concerns for the welfare of the State’s citizens when anesthesia and sedation

    are administered is reflected in Regulation .08A which states in its entirety:

    Because sedation is a continuum, it is not always possible to predict how an

    individual patient will respond. Therefore, practitioners intending to produce a

    given level of sedation shall be able to recover patients whose level of sedation

    becomes deeper than initially intended. Individuals administering moderate

    enteral sedation or moderate parenteral sedation shall be able to recover patients

    who enter a state of deep sedation or general anesthesia, while those

    administering deep sedation shall be able to recover patients who enter a state of

    general anesthesia. Therefore training and evaluation guidelines shall reflect this

    concern.

A copy of the regulations may be obtained at the Board’s website at

    www.dhmh.state.md.us/dental/. Click the link titled “Final Copy of Anesthesia and

    Sedation Regulations.”

    It is the intent of this Bulletin to apprise each Maryland licensed dentist of the most significant points of the regulations. This Bulletin provides a thumbnail sketch and a general summary of the attached regulations but is not intended to be exhaustive. Each Maryland dentist and their staff are responsible for following the provisions of the actual regulations. Failure to do so may result in disciplinary action. Therefore the Board strongly urges each dentist to carefully read the regulations and become

    familiar with their provisions. The regulations will become effective on January 4, 2010.

    Please keep in mind that the Board’s laws and regulations change over time. Remain apprised of all changes.

    Thumbnail Sketch of the New Anesthesia and Sedation Regulations

    (The References are to the specific regulations in the chapter)

Note: Dentists who are advertising “Sleep” or “Sedation” dentistry and

    administering an agent that produces a state beyond anxiolysis as defined by these regulations will be required to obtain at least a Class I Permit.

1. The administration of “Anxiolysis” will not require a permit. See .04

    2. The Board will no longer issue “Administration” or “Facility” permits. (The University of Maryland Dental School is an exception for facility permits.) The Board will instead issue either a Class I, Class II, or Class III permit allowing dentists to administer either general anesthesia or sedation at a particular practice location in which the dentist has been tested or in which the dentist qualifies for an exception to examination. See .05 3. Dentists who hold either a general anesthesia administration permit or a parenteral sedation administration permit in existence on the effective date of the new regulations will be permitted to continue to administer in accordance with the permit until the expiration date on the permit only in a facility in which they also hold a facility permit. When the permit expires the dentist may, after satisfying certain conditions, convert the permit to a Class I, Class II, or Class III permit. See .14 and .16

    4. A dentist with a general anesthesia administration permit or a parenteral sedation administration permit who wishes to administer at a location in which he or she does not hold a facility permit, must apply to the Board for a permit under the terms of the new regulations. See .14

    5. A general anesthesia facility permit issued to a dentist who does not hold a general anesthesia administration permit shall expire on the effective date of the new regulations. See .15

    6. A parenteral sedation facility permit issued to a dentist who does not hold a parenteral sedation administration permit shall expire on the effective date of the new regulations. See .15

    7. Dentists may apply for a:

     Class I Permit: authorizes a dentist to use a non-parenteral anesthetic technique to attain a level of moderate sedation;

     Class II Permit: authorizes a dentist to use a parenteral anesthetic to attain a level of moderate sedation as well as any procedure allowed with a Class I permit; or

    Class III permit: authorizes a dentist to use an anesthetic technique to attain the level of deep sedation or general anesthesia as well as any procedure allowed under either a Class I or Class II permit. See .05

    8. Class I, Class II, and Class III permits will be issued for a specific practice location. See .07

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    9. A dentist seeking a permit must be tested at each location in which he or she desires a permit. Exception: A dentist who has passed an administration and facility evaluation for a permit may receive a like permit at another facility at which at least one dentist has passed an administration and facility evaluation for a like permit at that facility within 2 years of the date of application for the additional permit. Alternatively,

    a dentist who has passed an administration and facility evaluation for a permit may receive a like permit for another facility if the dentist seeking the additional permit is present during a facility evaluation at which the dentist and the dentist’s staff pass a facility evaluation, and the dentist seeking the additional permit passes an evaluation, appropriate for the permit level that includes simulated management of emergencies with the participation of the clinical office staff trained to handle emergencies. See Regulations .07 through .12

    10. Renewal of Class I and Class II Permits. Amongst other requirements, an applicant shall submit written verification of inspection of anesthesia and monitoring equipment; written verification that since issuance of the permit or the previous renewal of the permit the applicant and individuals on the staff have completed training in basic life support and the handling of medical emergencies, and that appropriate non-expired drugs are maintained; provide an affidavit to the Board indicating whether the applicant has treated a patient under deep sedation or general anesthesia with an “incident”; and provide proof of compliance with continuing education requirements. See .19

    11. Renewal of Class III Permits. Amongst other requirements, an applicant shall pass a renewal evaluation in each facility for which the applicant wishes to renew a permit; provide an affidavit to the Board indicating whether the applicant has treated a patient under deep sedation or general anesthesia with an “incident”; and provide proof of

    compliance with continuing education requirements. See .20

    12. All facilities shall maintain for 5 years for inspection by the Board the name and license number of each dentist who has administered anesthesia or sedation. See .25 13. The Board may conduct unannounced inspection visits during reasonable business hours. See .26

    14. Continuing Education. See .28

    15. Permits may not be transferred to another person or location. See .29 16. Treating dentists who wish to bring a physician or another dentist into their office to administer anesthesia or sedation to their (treating dentist’s) patients must first obtain a certificate from the Board which is specific to the treating dentist’s practice location. The

    treating dentist must complete a Board-approved training program and maintain a Class I, Class II, or Class III permit for the administration site. The dentist who administers the anesthesia or sedation must maintain the appropriate permit for the administration site. See .30

    17. A treating dentist who travels to the office of a physician or another dentist where anesthesia or sedation is administered to the treating dentist’s patient by the physician or another dentist must first obtain a certificate from the Board. The certificate is not specific to a particular practice location. The treating dentist must complete a Board-approved training program and maintain either a Class I, Class II, or Class III permit for an administration site in the State. The dentist who administers the anesthesia or sedation must maintain the appropriate permit for the administration site. See .31

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    18. A treating dentist who allows a certified registered nurse anesthetist to administer anesthesia or sedation to the treating dentist’s patients must first obtain a certificate. In

    addition, the dentist must maintain a permit, appropriate for the level of sedation or anesthesia being administered by the certified registered nurse anesthetist. See .32 19. Display and Location of Permits. See .33

    20. Morbidity and Mortality Reports. A dentist shall report to the Board in writing, any death caused by or resulting from the dentist’s administration of anxiolysis, moderate sedation, deep sedation, or general anesthesia within 7 days after its occurrence. A dentist shall report to the Board, in writing, any substantially disabling incident caused by or resulting from the dentist’s administration of anxiolysis, moderate sedation, deep sedation, or general anesthesia within 15 days after its occurrence. See .34

    21. Violations for Individuals with Class I, Class II, or Class III Permits. See .35 22. Violations for Individuals with General Anesthesia and Parenteral Sedation Permits in Existence on the Effective Date of the Anesthesia and Sedation Regulations. See .36 23. Summary Suspension of a Permit. See .37

    Summary of the Regulations:

    (The references are to the specific regulations in the Chapter.)

Definitions: Significant terms are defined. See .03

    Anxiolysis: A permit is not required for a dentist to administer anxiolysis. See .04

    Hospitals: The administration of anesthesia and sedation by dentists in hospitals is not covered by these regulations. See .01

Permits Required. See .06

    A dentist may not administer an anesthetic technique in order to attain a level beyond anxiolysis unless the dentist holds an appropriate Class I, Class II, or Class III permit.

Permit Types. See .05

    Class I: Authorizes a dentist to use a non-parenteral anesthetic technique to attain the level of moderate sedation.

    Class II: Authorizes a dentist to use a parenteral anesthetic technique to attain the level of moderate sedation and any procedure allowed with a Class I permit.

    Class III: Authorizes a dentist to use an anesthetic technique to attain the level of deep sedation or general anesthesia and any procedure allowed under either a Class I or Class II permit.

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Expiration of Permits. See .18

     th year following the effective date of the permit. A permit expires on April 1 of the 5

Permits are Location Specific. See .07

    The Board will no longer issue a Parenteral Sedation Administration Permit, a Parenteral Sedation Facility Permit, a General Anesthesia Administration Permit, or a General Anesthesia Facility Permit. Instead, the appropriate Class I, Class II, or Class III permit must be obtained for each location at which the dentist wishes to administer. Qualifications for Obtaining a Permit. See .08

Class I:

    1) Meet the requirements outlined in regulations .09 through .11 as appropriate for a Class I Permit, dealing with the administration evaluation and the facility evaluation. 2) Successfully complete a Board approved course of instruction of at least 24 hours of didactic education plus 20 clinically oriented experiences that provide competency in oral and combination inhalation-oral moderate sedation, or a postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords the appropriate training.

    3) Hold current certification in either ACLS, PALS, or a Board-approved course in medical emergencies and airway management.

    ) Receive a successful evaluation by the Board. 4

    5) Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident.

Class II:

    1) Meet the requirements outlined in regulations .09 through .11 as appropriate for a Class II permit, dealing with the administration evaluation and the facility evaluation. 2) Successfully complete a Board approved course of instruction of at least 60 hours of didactic education plus management of at least 20 patients per participant in moderate parenteral sedation techniques, or a postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords the appropriate training.

    3) Hold current certification in either ACLS or PALS.

    4) Receive a successful evaluation by the Board.

    5) Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident.

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Class III:

    1) Meet the requirements outlined in regulations .09 through .11 as appropriate for a Class III permit, dealing with the administration evaluation and the facility evaluation. 2) Successfully complete an advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum that is approved by the Board, or a postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords the appropriate training.

    3) Hold current certification in either ACLS or PALS.

    4) Receive a successful evaluation by the Board.

    5) Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident.

Exceptions to Standard Administration and Facility Evaluation. See .12

    1) A dentist who has passed an administration and facility evaluation for a Class I, Class II, or Class III permit may receive a like permit for another facility or facilities if the dentist holds an active Class I, Class II, or Class III permit for which the dentist has passed an administration and facility evaluation and each facility for which the dentist seeks another permit has at least one dentist who has passed an administration and facility evaluation for a like permit at that location within 2 years of the date of application for the additional permit. Alternatively:

    2) A dentist who has passed an administration and facility evaluation for a Class I, Class II, or Class III permit may receive a like permit for another facility or facilities if the dentist holds an active Class I, Class II, or Class III permit for which the dentist has passed an administration and facility evaluation, and the dentist seeking the additional permit is present during a facility evaluation at which the dentist and the dentist’s staff pass a facility evaluation, and the dentist seeking the additional permit passes an evaluation, appropriate for the permit level that includes simulated management of emergencies with the participation of the clinical office staff trained to handle emergencies.

Appropriately Trained Individuals. See .13

    Administration of moderate enteral sedation, moderate parenteral sedation, deep sedation, or general anesthesia to a patient requires at least the following appropriately trained individuals: the treating dentist, an individual trained and competent in basic life support or its equivalent, and another individual trained and competent in basic life support or its equivalent in close proximity to assist if needed.

     Presence and Inducing a Second Patient. See .13

    A dentist administering moderate enteral sedation, moderate parenteral sedation, deep sedation, or general anesthesia to a patient may not leave the site and may not induce a second patient until the first patient is conscious, is spontaneously breathing, has stable vital signs, is ambulatory with assistance, and is under the care of a responsible adult.

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    For those treating dentists using the services of a physician, another dentist, or certified registered nurse anesthetist, See .13 with respect to leaving the site and inducing a second patient.

    General Anesthesia and Parenteral Sedation Administration Permits in Existence on the Effective Date of the new Regulations. See .14

    A dentist who held a current general anesthesia administration permit on the effective date of the new regulations may continue to administer anesthesia and sedation under the existing general anesthesia administration permit, consistent with a Class III permit, only in a facility or facilities in which the dentist holds a current general anesthesia facility permit. In such cases, the permit is valid until it expires. Prior to expiration it should be converted to a Class III permit in accordance with Regulation .16

     A dentist who held a current parenteral sedation administration permit on the effective date of the new regulations may continue to administer parenteral sedation under the existing parenteral sedation administration permit, consistent with a Class II permit, only in a facility or facilities in which the dentist holds a current parenteral sedation facility permit. In such cases the permit is valid until it expires. Prior to expiration it should be converted to a Class II permit in accordance with Regulation .16

    A dentist who held a current general anesthesia administration permit or a parenteral sedation administration permit on the effective date of the new regulations, and who wishes to administer general anesthesia or parenteral sedation in a facility in which he or she does not hold a current general anesthesia or parenteral sedation facility permit, must apply for a new permit in accordance with the new regulations for each facility in which he or she wishes to administer general anesthesia or parenteral sedation.

    General Anesthesia and Parenteral Sedation Facility Permits in Existence on the Effective Date of the New Regulations. See .15

    A general anesthesia facility permit issued to a dentist who does not hold a general anesthesia administration permit, and a parenteral sedation facility permit issued to a dentist who does not hold a parenteral sedation administration permit, shall expire on the effective date of the new regulations.

    Conversion of General Anesthesia and Parenteral Sedation Administration Permits in Existence on the effective date of the new regulations. (This regulation is for those

    dentists who held permits before the effective date of the new regulations). See .16

General anesthesia administration permit:

    Before the expiration of a general anesthesia administration permit, the Board shall mail an application to the permit holder to convert the general anesthesia administration permit to a Class III permit.

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    A dentist who held a general anesthesia administration permit, and a general anesthesia facility permit on the effective date of the new regulations, may receive a Class III permit for the location(s) in which the dentist held a general anesthesia facility permit, if the dentist:

    (1) Passes a renewal evaluation in each facility;

    (2) Submits an affidavit indicating whether the dentist has treated a patient under deep sedation or general anesthesia with an “incident”;

    (3) Provides proof of compliance with continuing education requirements; and (4) Submits an application form and pays the appropriate fee.

    Parenteral sedation administration permit:

    A dentist who held a parenteral sedation administration permit, and a parenteral sedation facility permit on the effective date of the new regulations, may receive a Class II permit for the location(s) in which the dentist held a parenteral sedation facility permit, if the dentist:

    (1) Submits written verification of inspection of the dentist’s anesthesia and monitoring equipment from a recognized service company for each location;

    (2) Submits written verification that the dentist and staff have completed training in basic life support and the handling of medical emergencies before the submission of the application;

    (3) Submits written verification that appropriate non-expired drugs are maintained; (4) Submits an affidavit indicating whether the dentist has treated a patient under deep sedation or general anesthesia with an “incident”;

    (5) Provides proof of compliance with continuing education requirements; and (6) Submits an application form and pays the appropriate fee.

Compliance for Dentists with General Anesthesia and Parenteral Sedation

    Administration Permits in Existence on the Effective Date of the Regulations. See .17.

    A dentist with a general anesthesia administration permit or a parenteral sedation administration permit in existence on the effective date of the regulations shall comply with Regulations .13, .25, .26, .29, .30, .31, and .33 of the regulations.

Renewal of Class I and Class II Permits. See .19 (This concerns the renewal of the

    permits that are issued on and after the effective date of the new regulations. A Class I or Class II permit would be renewed shortly before it expired. For example, a Class I or Class II permit issued by the Board in 2009 would be renewed shortly before it expired in 2014).

    Before the expiration of a Class I or Class II permit, the Board shall mail a renewal application to the permit holder to renew the permit. Before the permit expires the permit may be renewed for an additional 5 year term if the applicant:

    (1) Submits written verification of inspection of the applicant’s anesthesia and

    monitoring equipment from a recognized service company;

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    (2) Since the issuance of the permit or the previous renewal of the permit, the applicant and staff have completed training in basic life support and the handling of emergencies before the submission of the application;

    (3) Submits written verification that appropriate non-expired drugs are maintained; (4) Provides an affidavit indicating whether the dentist has treated a patient under deep sedation or general anesthesia with an “incident”;

    (5) Provides proof of compliance with continuing education requirements; and (6) Submits an application form and pays the appropriate fee.

Renewal of Class III Permits. See .20 (This concerns the renewal of the permits that are

    issued on and after the effective date of the new regulations. A Class III permit would be renewed shortly before it expired. For example, a Class III permit issued by the Board in 2009 would be renewed shortly before it expired in 2014).

    Before the expiration of a Class III permit, the Board shall mail a renewal application to the permit holder to renew the permit. Before the permit expires the permit may be renewed for an additional 5 year term if the applicant:

    (1) Passes a renewal evaluation in each facility in which the applicant wishes to renew a permit (The renewal evaluation shall consist of an evaluation of anesthesia and monitoring equipment and verification that appropriate non-expired drugs are maintained);

    (2) Provides an affidavit indicating whether the dentist has treated a patient under deep sedation or general anesthesia with an “incident”;

    (3) Provides proof of compliance with continuing education requirements; and (4) Submits an application form and pays the appropriate fee.

Dental School Permits. See .21 through .24

Records. See .25

    All facilities including dental schools shall maintain for 5 years for inspection by the Board the name and license number of each dentist who has administered anesthesia or sedation.

Unannounced Inspection Visits. See .26

    The board or its designee may conduct, during reasonable business hours, unannounced inspection visits of any dental office or facility for which a dentist holds a Class I permit, Class II permit, Class III permit, general anesthesia administration permit, general anesthesia facility permit, parenteral sedation administration permit, and parenteral sedation facility permit.

Facility Owner or Operator. See .27

    The owner or operator of a facility may not permit an individual to administer anesthesia or sedation unless the individual is qualified to do so under the Board’s regulations. The

    owner must insure that the facility is properly equipped, remains properly staffed, and has appropriate non-expired drugs.

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Continuing Education Requirements for Renewal of a Permit. See .28

Class I, Class II, and Class III Permits:

    (A) An applicant who seeks renewal of a Class I, Class II, or Class III permit shall: (1) Complete not less than 10 hours of clinical continuing education related to sedation or anesthesia in a classroom setting during the 5-year term of the permit; and (2) Maintain CPR certification from one of the programs identified in the regulation. (B) Class I permit:

    In addition to the requirements in paragraph (A), an applicant for the renewal of a Class I permit shall do one of the following:

    (1) Maintain Advanced Cardiac Life Support (ACLS) certification;

    (2) Maintain Pediatric Advanced Life Support certification (PALS); or

    (3) Complete a Board-approved course that provides instruction on medical emergencies and airway management.

(C) Class II and Class III permits:

    In addition to the requirements in paragraph (A), an applicant for the renewal of a Class II or Class III permit shall either:

    (1) Maintain Advanced Cardiac Life Support (ACLS) certification; or

    (2) Maintain Pediatric Advanced Life Support (PALS) certification.

Transfer of Permits. See .29

A permit may not be transferred to another individual or location.

Administration by Physicians or Dentists at the Site of a Treating Dentist. See. 30

    This regulation is directed to those dentists (treating dentists) who wish to bring a physician or another dentist into their office to administer anesthesia or sedation to their (treating dentist’s) patients.

    The treating dentist is required to first apply to the Board and obtain a certificate. In addition to other requirements the treating dentist must complete a Board-approved training program and maintain either a Class I, Class II, or Class III permit for the administration site. The dentist who administers the anesthesia or sedation must maintain the appropriate permit for the administration site.

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