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<regulation prefix="Regulation" num=".02" citation="COMAR 10.07.06.02" title_num="10" subtitle_num="07" chapter_num="06" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Action plan” means a written document that includes:</text>
      <paragraph num="(a)">
        <text>Specific measures to correct problems or areas of concerns;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Specific measures to address areas of system improvement;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Time frames for implementation of any specific measures; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Title of responsible individual to monitor implementation and effectiveness.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>“Adverse event” means an unexpected occurrence related to an individual's medical treatment and not related to the natural course of the patient's illness or underlying disease condition.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Department” means the Maryland Department of Health.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Level 1 adverse event” means an adverse event that results in death or serious disability.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>“Level 2 adverse event” means an adverse event that requires a medical intervention to prevent death or serious disability.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Level 3 adverse event” means an adverse event that does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>“Medical review committee” has the meaning stated in Health Occupations Article, §1-401, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>“Near-miss” means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Patient safety program” means an ongoing, proactive program for identifying risks to patient safety and reducing medical errors which is one component of the hospital-wide risk management program.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Root cause analysis” means a medical review committee process as defined under Health Occupations Article, §1-401, Annotated Code of Maryland, for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or near-misses.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still is present at the time of discharge.</text>
    </paragraph>
  </paragraph>
</regulation>