<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".15" citation="COMAR 10.51.05.15" title_num="10" subtitle_num="51" chapter_num="05" heading="Facilities.">
  <paragraph num="A.">
    <text>Facility Administration. A licensee shall ensure that a laboratory:</text>
    <paragraph num="(1)">
      <text>Is adequate for the testing services offered;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Has the required safety equipment as defined by the laboratory SOPM.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Security. A licensee shall:</text>
    <paragraph num="(1)">
      <text>Control and limit access to areas of the laboratory to those persons who regularly work in an area or are designated by the laboratory director as having access to an area; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Ensure that:</text>
      <paragraph num="(a)">
        <text>Entrances and exits have adequate security measures;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Internal areas that are required to have controlled or limited access are protected by a locked system;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The distribution of all keys, magnetic cards, and entry devices is documented and authorized by the director;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>The facility is secure; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>All short-term and long-term storage areas have controlled or limited access and have a lock system in place.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Safety. A licensee shall:</text>
    <paragraph num="(1)">
      <text>Have a safety policy and procedure, that is reviewed annually;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Designate an employee as the safety officer with responsibilities defined by the licensee;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Have appropriate safety policies and procedures;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Demonstrate appropriate safety policies and procedures;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Have appropriate safety devices and equipment available and in close proximity to the appropriate areas; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Be in compliance with all federal, State, and local regulations regarding the handling and disposal of infectious materials, chemicals, radioactive materials, sharps, and glassware.</text>
    </paragraph>
  </paragraph>
</regulation>