Location and Program Affiliation. Home hemodialysis or peritoneal dialysis programs, or both, may be situated in either a dialysis facility or hospital, as long as the appropriate standards are satisfied. To assure quality and continuity of patient care, the home dialysis program shall negotiate a formal affiliation agreement compliant with this subtitle. The home dialysis program shall be affiliated with a certified transplantation center. Home dialysis programs shall provide sufficient backup dialysis stations through specific affiliation agreements with certified dialysis facilities. Home dialysis training performed by dialysis centers or facilities shall also meet the standards established in this regulation. Home dialysis programs shall make arrangements for appropriate medical records, patient care policies, dietetic services, social services, sanitation standards, and fire and safety standards. Patients dialyzing at home shall keep records of dialysis treatments and supplies used. Physical and Medical Standards. Home dialysis programs shall: Contain a dialysis station for training with either beds or chairs; Contain floor space that assures usable space of at least 80 square feet of floor space per patient station that may include bed or chair space, nursing space, and work area, but excludes storage space; Contain space to be sufficiently flexible to provide access to any of the four extremities; Provide appropriate provisions to assure patient privacy; Provide refrigerated and nonrefrigerated storage space; Provide sufficient area and space for: Maintenance of equipment; Storage of the equipment and supplies; and Preparing and testing dialyzers; Utilize water of sufficient purity to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements; and Provide adequate backup center dialysis. Training. The home dialysis program shall maintain a written training manual and program that shall be available and approved by the Commission. The home dialysis program shall have patient training manuals available for patient utilization at times other than the dialysis procedure. The home dialysis program shall provide visual aids to complement instructional programs. It is generally accepted that training periods will vary depending on the needs of the patient and on the intensity and planning of the program. The training program shall also test the availability and purity of the water supply in the patient's home before home hemodialysis is instituted. The Commission shall review the training manual and program to determine if the length of training time is sufficient. Staffing. Nephrologist and Additional Licensed Staff. The director of the home dialysis program shall be a nephrologist with at least 1 year of experience in chronic dialysis including experience in home dialysis training. One additional nephrologist, physician’s assistant, or certified registered nurse practitioner trained in dialysis shall be available to provide adequate continuous coverage. Medical Director. A home dialysis program shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter. Additional Home Dialysis Program Requirements. Home dialysis programs shall maintain a minimum nursing staff requirement of one nurse per two training stations. The nurse in charge of training shall have at least 12 months experience in providing nursing care including 6 months of experience in dialysis and 3 months of experience in the specific modality for which the nurse will provide self-care training. Technical assistance by qualified personnel shall be available for the repair and maintenance of dialysis equipment in the home dialysis program and homes. Home dialysis programs shall assure that adequate personnel are available to provide periodic follow-up home visits to patients on home dialysis programs. The training programs shall have adequate social services and dietetic staffing by licensed and trained professionals. Psychiatric services may be obtained by referral to a licensed psychiatrist. In dialysis programs providing home dialysis training, dialysis personnel responsible for staffing the dialysis programs may participate in home dialysis training as long as the staffing ratio standards are met. Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04H of this chapter. Administration. The administration of the home dialysis program shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. The home dialysis program shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost. Compliance. Home dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission.