<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.07.06.04" title_num="10" subtitle_num="07" chapter_num="06" heading="Near-Miss and Adverse Event Reporting and Determination of Appropriate Response.">
  <paragraph num="A.">
    <text>The hospital shall develop and encourage a supportive environment that permits spontaneous identification, open discussion, and timely and accurate reporting of near-misses and adverse events.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The hospital shall establish a clear and well-defined near-miss and adverse event identification and reporting process that shall:</text>
    <paragraph num="(1)">
      <text>Encourage reporting of near-misses and require reporting of adverse events;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>List and describe examples of adverse events that shall be reported;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Designate a hospital representative to whom a near-miss is encouraged to be reported or to whom an adverse event shall be reported;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Provide a time frame within which the near-miss is encouraged to be reported or within which an adverse event shall be reported;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Require that an individual employed by the hospital or appointed to the medical staff and who is aware of an adverse event shall report the adverse event in accordance with this chapter;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Develop a procedure to coordinate receipt of all adverse events and near-misses and to prioritize adverse events and near-misses based on level of disability or potential disability; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Develop a procedure to assign an appropriate response to level 1 and level 2 adverse events, other adverse events, and near-misses.</text>
    </paragraph>
  </paragraph>
</regulation>