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<regulation prefix="Regulation" num=".14" citation="COMAR 10.22.02.14" title_num="10" subtitle_num="22" chapter_num="02" heading="Quality Assurance.">
  <paragraph num="A.">
    <text>The licensee shall submit a quality assurance plan and any subsequent substantive changes to the plan to the Administration for approval.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The licensee shall develop and implement a system of internal quality assurance which at a minimum:</text>
    <paragraph num="(1)">
      <text>Is focused on the individual's choices, preferences, and satisfaction, and includes personal contact with the individuals being served;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Has outcomes and results that are measurable and may be incorporated into future IPs for the individuals being served;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Has outcomes and results that are measurable and may be incorporated into systemic changes in a licensee's operation;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Collects and evaluates data and analyzes trends identified through quality assurance activities including:</text>
      <paragraph num="(a)">
        <text>The name of the individual with a behavior plan,</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The medication or other restrictive technique used,</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The date and time the restrictive technique was used,</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Whether the medication or other restrictive technique was used as an emergency or as part of a behavior plan, and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Whether the medication or other restrictive technique used is meeting the goals and objectives established in the behavior plan;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Provides for prompt and appropriate response when an individual's health or safety is at risk; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Includes proactive strategies to improve the quality of services, including health and safety.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The licensee shall:</text>
    <paragraph num="(1)">
      <text>Establish goals and standards to measure the quality of services being delivered and define how the standards are measured;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain records to demonstrate the effectiveness of its quality assurance activities;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Implement changes based on the results of the evaluated data; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Be held accountable by the Administration for accomplishing the goals and standards that are established as part of the licensee's system of quality assurance.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The Administration may request documentation from a licensee to verify that the licensee is accomplishing the goals and standards set forth in the licensee's quality assurance plan.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Standing Committees.</text>
    <paragraph num="(1)">
      <text>The licensee shall establish a committee or committees to perform the following functions:</text>
      <paragraph num="(a)">
        <text>Perform the quality assurance functions set forth in this regulation;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Review the licensee's protocol for identifying, reporting, documenting, investigating, and reviewing of incidents to ensure compliance with Administration procedures;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Monitor whether the licensee's protocol identified in §E(2) of this regulation is being properly implemented by reviewing all incidents in an effort to identify deficient practices and recommend necessary corrective action;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Approve all behavior plans which use restrictive techniques to ensure that the behavior plan complies with the requirements of COMAR 10.22.04.03A and 10.22.10;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Review, approve, and establish the time frame for the restriction of a right if it is not related to a challenging behavior, in accordance with COMAR 10.22.04.03A; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Review the licensee's policies and procedures, and implementation of them, to ensure that they adequately protect the legal and human rights of each individual served by the licensee.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The committee or committees may be organized to perform the functions set forth in §A of this regulation for one or more licensees.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The committee or committees shall include an equal number of licensee staff, and individuals, proponents, or members of the community who are not employed by the licensee. For a committee member who is remunerated only to serve as a member of the committee, that member is not counted as staff or as a member of the community.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The committee or committees may consult with a licensed health professional such as a psychologist, physician, physician's assistant, nurse practitioner, or board-certified clinical pharmacist, as needed.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A committee member may not participate in the decision making process of any:</text>
      <paragraph num="(a)">
        <text>Incident in which the committee member was involved; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Behavior plan the committee member has developed.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>The committee or committees shall meet as needed to perform the functions identified in §E(1) of this regulation, with, at least, a majority of members present.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>The committee or committees shall ensure confidentiality for the individual in accordance with Health-General Article, §7-1010, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
</regulation>