<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.07.06.06" title_num="10" subtitle_num="07" chapter_num="06" heading="Root Cause Analysis.">
  <paragraph num="A.">
    <text>The hospital shall appoint an interdisciplinary root cause analysis team that shall include:</text>
    <paragraph num="(1)">
      <text>Individuals who have knowledge of the event or near-miss;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Representatives of hospital leadership; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Individuals with expertise in the subject matter of the event.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to participate in the root cause analysis as appropriate.</text>
  </paragraph>
  <paragraph num="C.">
    <text>The root cause analysis shall examine the cause and effect of the event through an impartial process by:</text>
    <paragraph num="(1)">
      <text>Analysis of human and other factors;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Analysis of related processes and systems;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Analysis of underlying cause and effect systems through a series of “why” questions;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Identification of risks and possible contributing factors; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Determination of improvement in processes or systems.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>A root cause analysis shall:</text>
    <paragraph num="(1)">
      <text>Be internally consistent; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Include consideration of relevant literature and best practices.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The hospital shall provide feedback including changes to hospital policy or procedure resulting from the root cause analysis to hospital employees and staff who were involved in the event or near-miss and to other employees or staff who would benefit from the feedback.</text>
  </paragraph>
</regulation>