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<regulation prefix="Regulation" num=".05" citation="COMAR 10.30.02.05" title_num="10" subtitle_num="30" chapter_num="02" heading="Nocturnal Hemodialysis Programs.">
  <paragraph num="A.">
    <text>Nephrologist.</text>
    <paragraph num="(1)">
      <text>The director of a freestanding dialysis facility shall be a nephrologist with at least 1 year of experience in chronic hemodialysis.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A freestanding dialysis facility shall have at least one additional nephrologist trained in dialysis techniques to provide adequate continuous coverage.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Medical Director.</text>
    <paragraph num="(1)">
      <text>A freestanding dialysis facility shall appoint a medical director.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The medical director shall:</text>
      <paragraph num="(a)">
        <text>Assure that the facility has documented eligibility criteria for the nocturnal dialysis patient;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Determine the patient’s appropriateness and suitability for nocturnal hemodialysis by considering and documenting the patient’s:</text>
        <paragraph num="(i)">
          <text>Overall medical condition, including whether the patient is hemodynamically stable;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Expectations for care;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Response to in-center, daytime hemodialysis; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Availability of transportation;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Assure that an order from a nephrologist, nurse practitioner, or physician assistant for nocturnal hemodialysis is written;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Coordinate the comprehensive kidney health care team to assure quality of care;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Assure there are written policies which address plans to select the appropriate end-stage kidney disease modality;</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility;</text>
      </paragraph>
      <paragraph num="(k)">
        <text>Assure that the end-stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;</text>
      </paragraph>
      <paragraph num="(l)">
        <text>Assure the appropriate execution of the dialysis orders and day-to-day patient care policy by the nursing and technical staff;</text>
      </paragraph>
      <paragraph num="(m)">
        <text>Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;</text>
      </paragraph>
      <paragraph num="(n)">
        <text>Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;</text>
      </paragraph>
      <paragraph num="(o)">
        <text>Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;</text>
      </paragraph>
      <paragraph num="(p)">
        <text>Supervise the development of a dialysis water standards policy, including implementation, monitoring, and enforcement;</text>
      </paragraph>
      <paragraph num="(q)">
        <text>Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;</text>
      </paragraph>
      <paragraph num="(r)">
        <text>Supervise the development of freestanding dialysis policies on the administration of intradialytic medications;</text>
      </paragraph>
      <paragraph num="(s)">
        <text>Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;</text>
      </paragraph>
      <paragraph num="(t)">
        <text>Assure that there are written policies regarding patient care and facility personnel organization;</text>
      </paragraph>
      <paragraph num="(u)">
        <text>Assure that there are written policies regarding patient education;</text>
      </paragraph>
      <paragraph num="(v)">
        <text>Assure that there are written policies regarding medical staff bylaws and licensed and certified staff credentialing;</text>
      </paragraph>
      <paragraph num="(w)">
        <text>Assure that there are written freestanding dialysis policies for:</text>
        <paragraph num="(i)">
          <text>Anemia management;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Adequacy of dialysis measures;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Dialysis water standards;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Immunization guidelines for Hepatitis B, influenza, pneumococcal, and any other applicable vaccines;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Use of Vitamin D analogues; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Monitoring parameters associated with the development of kidney osteodystrophy;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(x)">
        <text>Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program;</text>
      </paragraph>
      <paragraph num="(y)">
        <text>Assure attending physicians and any other licensed or certified personnel comply with State and federal mandates applicable to the freestanding dialysis facility;</text>
      </paragraph>
      <paragraph num="(z)">
        <text>Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and</text>
      </paragraph>
      <paragraph num="(aa)">
        <text>Establish documented practice goals within the freestanding dialysis facility, which should assure optimal patient care.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Nursing Services.</text>
    <paragraph num="(1)">
      <text>Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who:</text>
      <paragraph num="(a)">
        <text>Is a full-time employee of the facility;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is a registered nurse;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Has at least:</text>
        <paragraph num="(i)">
          <text>12 months of experience in clinical nursing; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>An additional 6 months of experience in providing nursing care to patients on maintenance dialysis; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Participates in the facility's Quality Assessment and Performance Improvement Program.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Charge Nurse. The charge nurse responsible for each shift shall:</text>
      <paragraph num="(a)">
        <text>Be a registered nurse;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Be on duty in the treatment area at all times when patients are being treated, except for while on breaks when the charge nurse shall be readily available; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Have at least 12 months of experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Direct Patient Care Providers.</text>
    <paragraph num="(1)">
      <text>Staffing Ratio.</text>
      <paragraph num="(a)">
        <text>Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis:</text>
        <paragraph num="(i)">
          <text>Shall be a minimum of one staff member to five participants; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>May be sufficient to meet the needs of the patients.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A monitoring individual shall:</text>
      <paragraph num="(a)">
        <text>Be trained in dialysis procedures and may be a:</text>
        <paragraph num="(i)">
          <text>Physician;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Physician assistant;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Nurse practitioner;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Registered nurse;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Licensed practical nurse; or</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Certified nursing assistant—dialysis technician; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Provide direct patient care during treatment, which shall include, at a minimum:</text>
        <paragraph num="(i)">
          <text>Initiation of treatment;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Termination of treatment; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Monitoring vital signs.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.</text>
  </paragraph>
  <paragraph num="F.">
    <text>The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.</text>
  </paragraph>
  <paragraph num="G.">
    <text>Psychiatric services may be obtained by referral to a licensed psychiatrist.</text>
  </paragraph>
  <paragraph num="H.">
    <text>Social Worker.</text>
    <paragraph num="(1)">
      <text>The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Annual Psychosocial Update.</text>
      <paragraph num="(a)">
        <text>A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The annual psychosocial update shall include, at a minimum, the following issues:</text>
        <paragraph num="(i)">
          <text>Review of treatment options;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Vocational rehabilitation;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Adjustment to illness issues;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Patient behaviors that may warrant discharge; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Any changes in the patient's relationships, living situation, and living wills.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The annual psychosocial update may be included with the mandatory quarterly documentation for psychosocially stable patients.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The social worker shall document progress notes:</text>
      <paragraph num="(a)">
        <text>At least quarterly for stable patients; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>At least monthly or more frequently for unstable patients, including but not limited to, patients experiencing:</text>
        <paragraph num="(i)">
          <text>Adult Protective Services or Child Protective Services involvement;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Housing crisis or change;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Change in support system if patient is a vulnerable adult or child;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Violent or abusive behaviors or events;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Emotional or psychological crisis including suicidal tendencies or emotional distress;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Death or major illness in the family;</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Financial crisis interfering with the patient's ability to secure food, transportation, or medication;</text>
        </paragraph>
        <paragraph num="(viii)">
          <text>Extended or frequent hospitalizations;</text>
        </paragraph>
        <paragraph num="(ix)">
          <text>Marked deterioration in health status or in functional status; or</text>
        </paragraph>
        <paragraph num="(x)">
          <text>Situations that would warrant social work intervention.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The social worker's progress notes shall contain, at a minimum:</text>
      <paragraph num="(a)">
        <text>Documentation of the patient's adjustment to dialysis;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Patient behaviors that may warrant discharge;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Any referrals made to outside agencies; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>The social worker shall:</text>
      <paragraph num="(a)">
        <text>Recommend changes in treatment based on the patient's psychosocial needs;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Provide case work and group work services to patients and their families in dealing with the special problems associated with end-stage kidney disease;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Participate in continuous quality improvement activities and patient care planning.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>