<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.11.01.04" title_num="10" subtitle_num="11" chapter_num="01" heading="Identification of Newborn Infants — Additional Procedures Permitted.">
  <paragraph num="A.">
    <text>An institution may perform additional identification procedures on an infant before the infant leaves the delivery room. These methods do not link mother and infant, but may be useful in establishing the identity of an infant, and include:</text>
    <paragraph num="(1)">
      <text>Cord blood sampling;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Footprinting;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Taking a color photograph of the infant;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Physically assessing the infant and documenting of any distinguishing features; or</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Another procedure proposed by the institution to the Secretary for approval that provides at least equivalent identification.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An institution proposing to the Secretary another procedure to identify newborn infants shall include in the proposal at least the following information:</text>
    <paragraph num="(1)">
      <text>Method of collection;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Methods of storage;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Specimen labeling;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Specimen security and chain of custody;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Testing method, or methods to be used;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Circumstances for testing;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Quality assurance of tests;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Confidentiality issues;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Protection against unauthorized access; and</text>
    </paragraph>
    <paragraph num="(10)">
      <text>Record and documentation system.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Identification of Policies and Procedures. An institution shall:</text>
    <paragraph num="(1)">
      <text>Develop policies and methods for conducting each additional infant identification procedure under this regulation, and each procedure shall be documented with at least the following information:</text>
      <paragraph num="(a)">
        <text>Mother's name;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Mother's patient identification number;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Date of birth;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Gender of the newborn infant;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Birth order if a multiple birth; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Designate and train personnel responsible for performing newborn infant identification procedures.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Verification.</text>
    <paragraph num="(1)">
      <text>An institution shall verify that the identification procedure was performed by completing a form supplied by the institution or related facility. Information on the form shall include, but need not be limited to the:</text>
      <paragraph num="(a)">
        <text>Type of identification procedures performed;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Date and time the identification procedure was performed; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Name of personnel performing the identification procedure.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>An institution shall enter this form, which lists at least the information required in §D(1)(a), (b), and (c), of this regulation, into the infant's institutional medical record and maintain it as part of the infant's overall institutional record.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Retention. An institution shall retain any identifying material (blood sample or footprint) for at least 10 days or until the newborn is discharged, whichever comes later.</text>
  </paragraph>
</regulation>