<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.09.09.02" title_num="10" subtitle_num="09" chapter_num="09" heading="License Requirements.">
  <paragraph num="A.">
    <text>The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed.</text>
  </paragraph>
  <paragraph num="C.">
    <text>Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Out-of-State Laboratories.</text>
    <paragraph num="(1)">
      <text>Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed.</text>
    </paragraph>
  </paragraph>
</regulation>