<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.05.04.04" title_num="10" subtitle_num="05" chapter_num="04" heading="Administration.">
  <paragraph num="A.">
    <text>Governing Body. The governing body shall:</text>
    <paragraph num="(1)">
      <text>Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Develop a written organizational plan.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Administrator.</text>
    <paragraph num="(1)">
      <text>Qualifications.</text>
      <paragraph num="(a)">
        <text>The kidney dialysis center administrator, if not the chief executive officer, shall at a minimum:</text>
        <paragraph num="(i)">
          <text>Be 21 years old or older;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Have at least 1 year of dialysis experience; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The administrator, if not the chief executive officer, shall have knowledge in:</text>
        <paragraph num="(i)">
          <text>Infection control;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Principles of dialysis;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Water treatment;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Reuse;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Data collection and quality assurance;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Emergency procedures;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Fiscal operations, including business management and personnel;</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Regulations; and</text>
        </paragraph>
        <paragraph num="(ix)">
          <text>Policies and procedures.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Duties.</text>
      <paragraph num="(a)">
        <text>The administrator shall be on site or available on call.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The administrator shall have overall responsibility for:</text>
        <paragraph num="(i)">
          <text>Implementing the facility's policies and coordinating the provision of services that the facility provides;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Organizing and coordinating the administrative functions of the facility;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Establishing procedures for the accountability of those personnel involved in patient care;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Participating in the development of organizational and fiscal planning for the facility;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Informing patients of the availability of emergency services.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Waiver of Requirements for Administrator.</text>
      <paragraph num="(a)">
        <text>The Department may grant a kidney dialysis center a waiver, with or without conditions, for a center that operates an administrator-in-training program.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A center with an administrator-in-training program shall submit to the Department the:</text>
        <paragraph num="(i)">
          <text>Administrator-in-training curriculum, including course outline and supporting materials;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Center's requirements for individuals who are selected to participate in the administrator-in-training program; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may:</text>
        <paragraph num="(i)">
          <text>Inspect the kidney dialysis center; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Confer with the governing body.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Grant or Denial of Waiver. The Department may grant a waiver request if it determines that:</text>
        <paragraph num="(i)">
          <text>The administrator-in-training program sufficiently meets the requirements of this regulation; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A waiver will not adversely affect patients.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>If the Department determines that the conditions of §B(3)(d) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Written Decision.</text>
        <paragraph num="(i)">
          <text>The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request.</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(g)">
        <text>If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed.</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Policies and Procedures.</text>
    <paragraph num="(1)">
      <text>The administrator, in consultation with the governing body, shall develop and implement policies and procedures governing the operation of the facility, which includes at a minimum those items in COMAR 10.05.01.06D and the following:</text>
      <paragraph num="(a)">
        <text>The provision of dialysis and other end-stage renal disease services;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The reuse of dialysis supplies including hemodialyzers and blood tubing, if reuse of supplies is practiced by the facility;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Implementing and evaluating the patient care plan and the long-term care program for each patient; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Informing patients of the availability of emergency services.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The administrator shall ensure that all:</text>
      <paragraph num="(a)">
        <text>Policies and procedures are:</text>
        <paragraph num="(i)">
          <text>Reviewed by staff at least annually and are revised as necessary; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Available at all times for staff inspection and use; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Appropriate personnel implement all policies and procedures adopted.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>