<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.44.12.08" title_num="10" subtitle_num="44" chapter_num="12" heading="Qualifications for Obtaining a Permit.">
  <paragraph num="A.">
    <text>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. Training and evaluation guidelines shall reflect this concern.</text>
  </paragraph>
  <paragraph num="B.">
    <text>In addition to the requirements outlined in this regulation, in order to obtain a permit, a dentist shall also meet the requirements outlined in Regulations .09—.11 of this chapter.</text>
  </paragraph>
  <paragraph num="C.">
    <text>A permit may be issued to a dentist authorizing the use of moderate sedation, deep sedation, or general anesthesia at a specific practice location.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Class I: Moderate Enteral Sedation Permit. To qualify for a Class I permit, an applicant shall successfully complete:</text>
    <paragraph num="(1)">
      <text>A Board-approved course of instruction that documents training 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</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage moderate enteral sedation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Clinically oriented experiences referred to in §D(1) of this regulation may include:</text>
    <paragraph num="(1)">
      <text>Supervised administration;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Observations of videotaped patients undergoing oral or combination inhalation-oral moderate sedation; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Human simulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>In addition to the requirements outlined in §D of this regulation, an applicant for a Class I permit shall:</text>
    <paragraph num="(1)">
      <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire, or successfully complete a course approved by the Board that provides instruction on medical emergencies and airway management;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Receive a successful evaluation by the Board or the Board's designee;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Submit any other pertinent documents or information requested by the Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>An affidavit provided to the Board under §F(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include at least the following:</text>
    <paragraph num="(1)">
      <text>The date of the incident;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The name, age, and address of the patient;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The patient's original complete dental records;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The name and license number of the licensee and the name and address of all other persons present during the incident;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The address where the incident took place;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The preoperative physical condition of the patient;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The type of anesthesia and dosages of drugs administered to the patient;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The techniques used in administering the drugs;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Any adverse occurrence including:</text>
      <paragraph num="(a)">
        <text>The patient's signs and symptoms;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The treatments instituted in response to adverse occurrences;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The patient's response to the treatment; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The patient's condition on termination of any procedures undertaken; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(10)">
      <text>A narrative description of the incident including approximate times and evolution of symptoms.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>Class II: Moderate Parenteral Sedation Permit. To qualify for a Class II permit, an applicant shall successfully complete:</text>
    <paragraph num="(1)">
      <text>A Board-approved course of instruction that documents training of at least 60 hours of didactic instruction plus management of at least 20 dental patients, who may be simulated, per participant in moderate parenteral sedation techniques; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage moderate parenteral sedation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="I.">
    <text>In addition to the requirements outlined in §§H and I of this regulation, an applicant for a Class II permit shall:</text>
    <paragraph num="(1)">
      <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Receive a successful evaluation by the Board or the Board's designee;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Submit any other pertinent documents or information requested by the Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="J.">
    <text>An affidavit provided to the Board under §I(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in §G of this regulation.</text>
  </paragraph>
  <paragraph num="K.">
    <text>Class III: Deep Sedation and General Anesthesia Permit. To qualify for a Class III permit, an applicant shall have successfully completed:</text>
    <paragraph num="(1)">
      <text>An advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum that is approved by the Board; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A postdoctoral training program accredited by the Commission on Dental Accreditation or its successor organization that affords comprehensive and appropriate training necessary to administer and manage deep sedation and general anesthesia.</text>
    </paragraph>
  </paragraph>
  <paragraph num="L.">
    <text>In addition to the requirements outlined in §I of this regulation, an applicant for a Class III permit shall:</text>
    <paragraph num="(1)">
      <text>Hold current certification in either ACLS or PALS, which the permit holder may not allow to expire;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Receive a successful evaluation by the Board or its designee;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Provide an affidavit to the Board indicating whether the applicant has ever treated a patient under deep sedation or general anesthesia with an incident; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Submit any other pertinent documents or information requested by the Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>An affidavit provided to the Board under §L(3) of this regulation, which indicates that the applicant has treated a patient under deep sedation or general anesthesia with an incident, shall include the information contained in §G of this regulation.</text>
  </paragraph>
</regulation>