<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.30.01.08" title_num="10" subtitle_num="30" chapter_num="01" heading="Affiliation Guidelines.">
  <paragraph num="A.">
    <text>To assure quality and continuity of patient care, formal affiliation agreements shall be negotiated as required in the standards and guidelines of the Commission. The affiliation agreement shall be constructed so no entity benefits financially.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Affiliation agreements shall include, but not necessarily be limited to, the:</text>
    <paragraph num="(1)">
      <text>Means by which patients may be transferred between the affiliated institutions for the purpose of providing dialysis, transplantation services, or other medical care;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Conditions under which dialysis facilities, hospitals, and transplant centers agree to provide medical backup facility to assure optimal patient care;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Mechanisms for assuring quality of care including provisions for consultative help and review of patient progress;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Provisions of or referral to a certified home dialysis training program with specific mechanisms for ensuring adequate supervision and assistance for patients on home dialysis; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Specific provisions by hospitals to end-stage kidney disease patients for dialysis services as well as adequate:</text>
      <paragraph num="(a)">
        <text>Laboratory services;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Social services; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Dietetic services;</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The dialysis facility shall review and revise the affiliation agreements periodically and if a change in ownership or other details of operation changes during the period while the affiliation agreement is in force.</text>
  </paragraph>
</regulation>