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<section article="ghg" article_name="Health - General" number="17-205" title_number="17" title_name="Laboratories" subtitle_number="2" subtitle_name="Medical Laboratories">
  <level label="a">
    <text>Except as provided in §§ 10–14A–03 and 10–14B–03 of the State Government Article, a person shall hold a license issued by the Secretary before the person may:</text>
    <level label="1">
      <text>Offer or perform medical laboratory tests or examinations in this State;</text>
    </level>
    <level label="2">
      <text>Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or</text>
    </level>
    <level label="3">
      <text>Represent or service in this State a medical laboratory regardless of the laboratory’s location.</text>
    </level>
  </level>
  <level label="b">
    <text>The Secretary shall issue a letter of exception to a laboratory that:</text>
    <level label="1">
      <text>Performs only limited medical laboratory tests or examinations; and</text>
    </level>
    <level label="2">
      <text>Meets the exception requirements in regulations adopted by the Secretary pursuant to this subtitle.</text>
    </level>
  </level>
  <level label="c">
    <text>For the purposes of this section, “limited medical laboratory tests or examinations” means medical laboratory procedures as defined in regulations adopted by the Secretary pursuant to this subtitle.</text>
  </level>
  <level label="d">
    <text>If preliminary screening procedures are performed by an operator who is trained under § 17–214(k) of this subtitle, an employer:</text>
    <level label="1">
      <text>Is not required to obtain a permit or to obtain a letter of exception from the Secretary under this section to perform testing; but</text>
    </level>
    <level label="2">
      <text>Is required before performing preliminary screening procedures, as defined under § 17–214(a) of this subtitle, to register with the Secretary in accordance with requirements adopted in regulations by the Maryland Department of Health.</text>
    </level>
  </level>
</section>
