<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".11" citation="COMAR 10.34.28.11" title_num="10" subtitle_num="34" chapter_num="28" heading="Record Keeping.">
  <paragraph num="A.">
    <text>The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The records referred to in §A of this regulation shall include:</text>
    <paragraph num="(1)">
      <text>Maintenance records and service logs;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>System failure reports;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Documentation of patient outcomes resulting from system failures;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Accuracy audits and system performance audits;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Copies of reports and analyses generated as part of the quality assurance program, including daily accuracy sampling;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Reports or databases related to level of access and changes in the level of access to the system;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Training records including:</text>
      <paragraph num="(a)">
        <text>Contents of the training program;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Dates of training completion; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The identity of those attending the training program;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>Records of destruction of medication waste removed from the system, to include an independent witness signature; and</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Transaction information as follows:</text>
      <paragraph num="(a)">
        <text>Transactions involving medications stored in or removed, dispensed, or distributed from the system;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Medications dispensed or distributed for a patient, which shall be recorded to include the:</text>
        <paragraph num="(i)">
          <text>Identity of the particular automated medication system accessed;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Identification of the individual accessing the system;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Date of transaction;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Name, strength, dosage form, and quantity of drug accessed; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Name of the patient for whom the drug was accessed; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Records of stocking or removal of medications from an automated medication system, which shall include the:</text>
        <paragraph num="(i)">
          <text>Date;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Name, strength, dosage form, and quantity of drug stocked or removed; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Name, initials, or identification code of the individual stocking or removing drugs from the system.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>