<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".13" citation="COMAR 10.52.12.13" title_num="10" subtitle_num="52" chapter_num="12" heading="Records.">
  <paragraph num="A.">
    <text>The screening of newborn infants pursuant to this chapter is a population based public health surveillance program.</text>
  </paragraph>
  <paragraph num="B.">
    <text>On request, a laboratory or health care provider shall make available to the Follow-Up Unit medical records, records of laboratory tests, and any other medical information the Follow-Up Unit considers necessary to:</text>
    <paragraph num="(1)">
      <text>Screen a newborn infant for hereditary and congenital disorders set forth in Regulation .05 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Carry out the State's Newborn Screening Program, including:</text>
      <paragraph num="(a)">
        <text>Contacting the families and primary health care providers of newborn infants with newborn screening test results indicating a high risk of having a hereditary or congenital disorder;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Providing recommendations regarding the appropriate follow-up and diagnostic evaluation of the newborn infant;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Determining what follow-up evaluations and diagnostic tests were performed and on what date the evaluations and tests were performed;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Determining if and on what date a diagnosis of a specific hereditary or congenital disorder in a newborn infant was made; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Determining if and on what date treatment and follow-up care have been initiated; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Ensure compliance with the pertinent regulations set forth in this chapter and in COMAR 10.10.13.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Information that the Department receives under this chapter is confidential and may only be used or disclosed:</text>
    <paragraph num="(1)">
      <text>To provide services to the newborn infant and the infant's family;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To study the relationships of the various factors determining the frequency and distribution of the disorders set forth in Regulation .05 of this chapter;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>For State or federally mandated statistical reports; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>To ensure that the information received by the Department is accurate and reliable.</text>
    </paragraph>
  </paragraph>
</regulation>