<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.34.28.10" title_num="10" subtitle_num="34" chapter_num="28" heading="Quality Assurance Program.">
  <paragraph num="A.">
    <text>The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the automated medication system that addresses, at minimum:</text>
    <paragraph num="(1)">
      <text>A testing program which includes daily accuracy sampling that verifies the integrity of the system;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Investigation of medication errors related to the automated medication system, and remedial actions taken;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Review of discrepancies and transaction reports to identify patterns of inappropriate use and access;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Review of the overall functioning of the system2;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Security and access:</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Preventative maintenance;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Sanitation;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Storage conditions;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Inventory of drugs;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Drug procurement, delivery, and receipt;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Record keeping;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Proper labeling procedures; and</text>
    </paragraph>
    <paragraph num="(13)">
      <text>Protocols in the event of a power outage or other situation in which the services of the system are interrupted, that include:</text>
      <paragraph num="(a)">
        <text>A plan for insuring continuity of pharmacy services to patients; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A plan for system recovery.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the remote or decentralized automated medication system that addresses, at a minimum, system override management to include:</text>
    <paragraph num="(1)">
      <text>A list of medications that can be overridden which is limited to starter doses; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Review of system overrides to ensure appropriate utilization.</text>
    </paragraph>
  </paragraph>
</regulation>