<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".12" citation="COMAR 10.52.12.12" title_num="10" subtitle_num="52" chapter_num="12" heading="Follow-Up Procedures.">
  <paragraph num="A.">
    <text>Department's Responsibilities.</text>
    <paragraph num="(1)">
      <text>The Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly regarding:</text>
      <paragraph num="(a)">
        <text>Results of first-tier, supplemental, and second-tier tests;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The importance of identifying and locating a newborn infant with test results indicative of increased risk for an hereditary or congenital disorder;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The urgent need for follow-up; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The need to share newborn screening information between hospitals, healthcare providers, treatment centers, and laboratory personnel.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>If the parent or guardian fails to respond to the birthing facility, health care provider, or other responsible individual acting as set forth in §B(1) of this regulation, the individual in charge of the birthing facility or the individual’s designated representative, health care provider, or other responsible individual shall notify the Follow-Up Unit, which shall then try to notify the parent or guardian of the need for follow-up by using at least one of the following means, in the indicated order of priority:</text>
      <paragraph num="(a)">
        <text>Telephone;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Certified mail, if medically appropriate;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Public health nurse visit; or</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Law enforcement contact.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The Follow-Up Unit shall provide recommendations to the responsible birthing facility, health care provider, and the parent or guardian, as appropriate, regarding the appropriate follow-up and diagnostic evaluation of the newborn infant.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The Follow-Up Unit shall recommend:</text>
      <paragraph num="(a)">
        <text>Sources of diagnostic evaluation, specialty care, and treatment; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>That no treatment be administered to the newborn infant until the results of the follow-up evaluation have established that the infant has a hereditary or congenital disorder.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>The Follow-Up Unit shall inform health care personnel and parents or guardians of:</text>
      <paragraph num="(a)">
        <text>The nature, cost, benefits, and risks of any therapy; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The availability of any programs to assist individuals affected by a hereditary or congenital disorder.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Responsibilities of the Birthing Facility or Health Care Provider. The individual in charge of the birthing facility or individual’s designated representative or health care provider shall:</text>
    <paragraph num="(1)">
      <text>Evaluate the infant for signs, symptoms, and biochemical evidence of a hereditary or congenital disorder;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Refer the newborn infant for further evaluation:</text>
      <paragraph num="(a)">
        <text>To the appropriate specialists; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For the appropriate diagnostic tests;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Collect and submit any required blood-spot specimens for repeat screening or diagnostic testing; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Report the results of diagnostic testing to the Follow-Up Unit.</text>
    </paragraph>
  </paragraph>
</regulation>