Sec. 10.30.02.05. Nocturnal Hemodialysis Programs

A. Nephrologist or Physician.

(1) The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis.

(2) A freestanding dialysis facility shall have at least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage.

B. Medical Director.

(1) A freestanding dialysis facility shall appoint a medical director.

(2) 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.

(3) The medical director shall:

(a) Assure that the facility has documented selection criteria for the nocturnal dialysis patient;

(b) Determine the patient’s appropriateness for nocturnal hemodialysis by considering and documenting the patient’s:

(i) Overall medical condition, including whether the patient is hemodynamically stable;

(ii) Expectations for care;

(iii) Response to in-center, daytime hemodialysis; and

(iv) Availability of transportation;

(c) Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care;

(d) Assure that an order from a physician, nurse practitioner, or physician assistant for nocturnal hemodialysis is written;

(e) Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift;

(f) Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;

(g) 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;

(h) Coordinate the comprehensive renal health care team to assure quality of care;

(i) Assure there are written policies which address a long term patient care plan to select the appropriate end-stage renal disease modality;

(j) 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;

(k) Assure that the end-stage renal disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;

(l) Assure the appropriate execution of the dialysis orders and day-to-day patient care policy by the nursing and technical staff;

(m) Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;

(n) Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;

(o) Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;

(p) Supervise the development of a dialysis water standards policy, including implementation, monitoring, and enforcement;

(q) Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;

(r) Supervise the development of a freestanding dialysis facility-specific policy on the administration of epogen and intradialytically administered medications;

(s) Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;

(t) Assure that there are written policies regarding patient care and facility personnel organization;

(u) Assure that there are written policies regarding patient education;

(v) Assure that there are written policies regarding medical staff bylaws and physician credentialing;

(w) Assure that there are written freestanding dialysis facility-specific policies for:

(i) Dialyzer reuse or reprocessing;

(ii) Anemia management;

(iii) Adequacy of dialysis measures;

(iv) Dialysis water standards;

(v) Immunization guidelines for Hepatitis B, influenza, and pneumococcal vaccines;

(vi) Use of I.V. Vitamin D analogues; and

(vii) Monitoring parameters associated with the development of renal osteodystropy;

(x) Assure quality improvement programs to monitor the policies listed in §B(3)(o)-(s) of this regulation and actively participate in the facility's quality improvement program;

(y) Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility;

(z) Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and

(aa) Establish documented practice goals within the freestanding dialysis facility, which should exceed minimal requirements to assure optimal patient care.

C. Nursing Services.

(1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who:

(a) Is a full-time employee of the facility;

(b) Is a registered nurse;

(c) Has at least:

(i) 12 months of experience in clinical nursing; and

(ii) An additional 6 months of experience in providing nursing care to patients on maintenance dialysis; and

(d) Participates in the facility's Quality Assessment and Performance Improvement Program.

(2) Charge Nurse. The charge nurse responsible for each shift shall:

(a) Be a registered nurse;

(b) 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

(c) 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.

D. Direct Patient Care Providers.

(1) Staffing Ratio.

(a) Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis:

(i) Shall be a minimum of one staff member to five participants; and

(ii) May be sufficient to meet the needs of the patients.

(b) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.

(c) The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients.

(2) A monitoring individual shall:

(a) Be trained in dialysis procedures and may be a:

(i) Physician;

(ii) Physician assistant;

(iii) Nurse practitioner;

(iv) Registered nurse;

(v) Licensed practical nurse; or

(vi) Certified nursing assistant—dialysis technician; and

(b) Provide direct patient care during treatment, which shall include, at a minimum:

(i) Initiation of treatment;

(ii) Termination of treatment; and

(iii) Monitoring vital signs.

(3) The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.

E. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.

F. 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.

G. Psychiatric services may be obtained by referral to a licensed psychiatrist.

H. Social Worker.

(1) The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.

(2) Annual Psychosocial Update.

(a) A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.

(b) The annual psychosocial update shall include, at a minimum, the following issues:

(i) Review of treatment options;

(ii) Vocational rehabilitation;

(iii) Adjustment to illness issues;

(iv) Patient behaviors that may warrant discharge; and

(v) Any changes in the patient's relationships, living situation, and living wills.

(c) The annual psychosocial update may be included as quarterly documentation for psychosocially stable patients.

(3) The social worker shall document progress notes:

(a) At least quarterly for stable patients; and

(b) At least monthly or more frequently for unstable patients, including but not limited to, patients experiencing:

(i) Adult Protective Services or Child Protective Services involvement;

(ii) Housing crisis or change;

(iii) Change in support system if patient is a vulnerable adult or child;

(iv) Violent or abusive behaviors or events;

(v) Emotional or psychological crisis including suicidal tendencies or emotional distress;

(vi) Death or major illness in the family;

(vii) Financial crisis interfering with the patient's ability to secure food, transportation, or medication;

(viii) Extended or frequent hospitalizations;

(ix) Marked deterioration in health status or in functional status; or

(x) Situations that would warrant social work intervention.

(4) The social worker's progress notes shall contain, at a minimum:

(a) Documentation of the patient's adjustment to dialysis;

(b) Patient behaviors that may warrant discharge;

(c) Any referrals made to outside agencies; and

(d) Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.

(5) The social worker shall:

(a) Recommend changes in treatment based on the patient's psychosocial needs;

(b) Provide case work and group work services to patients and their families in dealing with the special problems associated with end-stage renal disease;

(c) Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and

(d) Participate in continuous quality improvement activities and patient care planning.