<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".01" citation="COMAR 10.07.06.01" title_num="10" subtitle_num="07" chapter_num="06" heading="Purpose.">
  <text>The purpose of this chapter is to provide a safe environment for patients by requiring hospitals to:</text>
  <paragraph num="A.">
    <text>Identify adverse events;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Encourage reporting of near-misses;</text>
  </paragraph>
  <paragraph num="C.">
    <text>Assess and prioritize near-misses and adverse events based on level of disability or potential disability to patients;</text>
  </paragraph>
  <paragraph num="D.">
    <text>Determine the appropriate hospital response based on level of disability or potential disability;</text>
  </paragraph>
  <paragraph num="E.">
    <text>Conduct a root cause analysis of:</text>
    <paragraph num="(1)">
      <text>All level 1 events;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>All level 2 events; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>If warranted, any near-miss or other adverse event;</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Conduct an appropriate investigation of adverse events and near-misses that do not require or warrant a root cause analysis;</text>
  </paragraph>
  <paragraph num="G.">
    <text>Provide a process by which the concerns of patients can be addressed; and</text>
  </paragraph>
  <paragraph num="H.">
    <text>Provide a process to notify a patient or, if appropriate, a patient's family, whenever an outcome of care differs significantly from an anticipated outcome.</text>
  </paragraph>
</regulation>