<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.52.12.04" title_num="10" subtitle_num="52" chapter_num="12" heading="Responsibilities of the Department.">
  <paragraph num="A.">
    <text>Program Maintenance. The Department shall operate a Newborn Screening Program to identify congenital and hereditary disorders and provide follow-up services to newborn infants.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Laboratory Oversight. The Department shall ensure that a laboratory holding a permit to offer or perform first-tier, supplemental, or second-tier tests to identify congenital and hereditary disorders in newborn infants is subjected to regulatory oversight that includes surveys and proficiency testing as set forth in:</text>
    <paragraph num="(1)">
      <text>COMAR 10.10.02; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>COMAR 10.10.05.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Notification. The Department shall notify the parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory may perform post screening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.</text>
  </paragraph>
</regulation>