<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".12" citation="COMAR 10.51.05.12" title_num="10" subtitle_num="51" chapter_num="05" heading="Case Records.">
  <paragraph num="A.">
    <text>A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by:</text>
    <paragraph num="(1)">
      <text>Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Using electronic signatures only if a security protocol is in place;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Having a tracking policy and system for electronic record changes, when the electronic document is complete; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>In regard to examination documents, a licensee shall ensure that:</text>
    <paragraph num="(1)">
      <text>If information is recorded on both sides, each side of a page is considered a separate page;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>If examination documents consist of multiple pages, a page numbering system that includes either the total number of pages or a mark signifying the end of the document is used;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>An examination document:</text>
      <paragraph num="(a)">
        <text>Includes details to support the conclusions and opinions reported by each examiner or analyst;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is free of erasures or obliterations;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is marked with a unique identifier and the examiner’s or analyst’s handwritten initials or electronic signature; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Includes each date casework or an analysis was performed;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>If an individual in addition to the examiner or analyst interprets or reports the results, both individuals initial or electronically sign each page of the examination documents;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Abbreviations and symbols are defined in the SOPM;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Erroneous results, corrections, and amendments:</text>
      <paragraph num="(a)">
        <text>Are crossed out with a single line, not erased, and not deleted or made illegible; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Have corrections entered beside the erroneous result;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>All corrections and amendments are initialed and dated;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>If electronically signed, measures are taken to ensure the signature is secure; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>There is no loss or change of the original documents.</text>
    </paragraph>
  </paragraph>
</regulation>