<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.52.12.10" title_num="10" subtitle_num="52" chapter_num="12" heading="Results.">
  <paragraph num="A.">
    <text>Normal Screening Results.</text>
    <paragraph num="(1)">
      <text>The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen within 3 business days after receipt of the blood-spot specimen.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:</text>
      <paragraph num="(a)">
        <text>Enter the results in the newborn infant's medical record; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Make the results available to the parent, guardian, or primary care providers upon request.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Abnormal Screening Results.</text>
    <paragraph num="(1)">
      <text>The Department’s public health laboratory shall immediately report abnormal newborn screening test results to the Follow-Up Unit.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The Department’s public health laboratory shall report to the Follow-Up Unit all known demographic and clinical data on the newborn infant in an electronic format compatible with the Department’s information system databases operated by the Department’s public health laboratory, as set forth at COMAR 10.10.13.25.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The Follow-Up Unit shall enter results in the Department’s database and initiate follow-up procedures as specified in Regulation .12 of this chapter.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The submitter of the blood-spot specimen shall:</text>
      <paragraph num="(a)">
        <text>Enter the results in the newborn infant's medical record; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Make the abnormal results available immediately to the newborn's parent, guardian, or primary care providers.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>