Nephrologist or Physician. The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis. Each freestanding dialysis facility shall have: At least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage; or A licensed professional trained in dialysis. Medical Director. Each freestanding dialysis facility shall appoint a medical director. 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 and: Has at least 12 months of experience or training in the care of patients at end-stage kidney disease facilities; or Has served at least 12 months as a director of a dialysis or transplantation program before 1976. The medical director shall: Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility; 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; Coordinate the comprehensive kidney health care team to assure quality of care; Assure there are written policies which address patient care plans to select the appropriate end stage kidney disease modality; 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; Assure that the end stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed; Assure the appropriate execution of the dialysis orders and day to day patient care policy by the nursing and technical staff; Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects; Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians; Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques; Supervise the development of a dialysis water standards policy including implementation, monitoring, and enforcement; Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines; Supervise the development of freestanding dialysis policies on the administration of intradialytic medications; Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility; Assure that there are written policies regarding patient care and facility personnel organization; Assure that there are written policies regarding patient education; Assure that there are written policies regarding medical staff bylaws and physician credentialing; Assure that there are written policies regarding freestanding dialysis policies for anemia management, adequacy of dialysis measures, infection control, dialysis water standards, immunization guidelines for Hepatitis B, influenza, pneumococcal vaccines, and any other applicable vaccines, and use of Vitamin D analogues and monitoring parameters associated with the development of kidney osteodystrophy; Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program; Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility; Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and Establish documented practice goals within the freestanding dialysis facility to assure optimal patient care. Nursing Services. Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that: Is a full time employee of the facility; Is a registered nurse; Has at least: 12 months of experience in clinical nursing; and An additional 6 months experience in providing nursing care to patients on maintenance dialysis; and Participates in the facility's Quality Assessment and Performance Improvement Program. Charge Nurse. The charge nurse responsible for each shift: Shall be a registered nurse; Shall 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; Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and May not be included in the staffing ratio except: When there are nine or fewer patients; or In the event of an emergency. Staffing Exception Reporting. The freestanding dialysis facility shall have a staffing exception reporting protocol in a format approved by the Commission for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include: The date and shift of the exception; A description of the emergency staffing situation; Actions taken in response; and Any measures taken to ensure the center's future compliance. The exception reporting protocol shall be included in the center's quality assurance process. The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation. Direct Patient Care Providers. Staffing Ratio. The monitoring individual-to-patient ratio at each facility shall be: A minimum of one staff member to three participants; and Sufficient to meet the needs of patients. The facility shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. A monitoring individual shall: Be trained in dialysis procedures and may be a: Physician; Physician assistant; Nurse practitioner; Registered nurse; Licensed practical nurse; or Certified nursing assistant—dialysis technician; and Provide direct patient care during treatment, which shall include at a minimum: Initiation of treatment; Termination of treatment; and Monitoring vital signs. The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment. 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. Psychiatric services may be obtained by referral to a licensed psychiatrist. Social Worker. The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility. Annual Psychosocial Update. A comprehensive annual psychosocial update shall be conducted annually or more often if indicated. The annual psychosocial update shall include, at a minimum, the issues below: Review of treatment options; Vocational rehabilitation; Adjustment to illness issues; Patient behaviors that may warrant discharge; and Any changes in the patient's relationships, living situation, and living wills. The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation. The social worker shall document progress notes: At least quarterly for stable patients; and At least monthly or more frequently for unstable patients including, but not limited to, patients experiencing: Adult Protective Services or Child Protective Services involvement; Housing crisis or change; Change in support system if patient is a vulnerable adult or child; Violent or abusive behaviors or events; Emotional or psychological crisis including suicidal tendencies or emotional distress; Death or major illness in the family; Financial crisis interfering with the patient's ability to secure food, transportation, or medication; Extended or frequent hospitalizations; Marked deterioration in health status or in functional status; or Situations that would warrant social work intervention. The social worker's progress notes shall contain, at a minimum: Documentation of the patient's adjustment to dialysis; Patient behaviors that may warrant discharge; Any referrals made to outside agencies; and Follow-up of psychosocial issues identified in previous social work notes or the assessment or update. The social worker shall: Recommend changes in treatment based on the patient's psychosocial needs; Provide case work and group work services to patients and their families in dealing with the special problems associated with end stage kidney disease; Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and Participate in continuous quality improvement activities and patient care planning.