Location and Program Affiliation. Centers seeking certification as transplant centers, under Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall be located in hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations and participate in a patient registry program with a certified organ procurement organization. An agreement shall exist with an established functioning tissue typing laboratory providing 24-hour-a-day service. The hospital shall provide an active nephrology service to provide for continuity of care. The transplantation program shall conform to generally accepted medical standards for tissue typing and for transplantation. For the purpose of protecting patient safety and welfare, a transplant center may not discontinue or phase out patient services until: The transplant center has notified the Commission of the transplant center's intention; Patients being treated by that transplant center have been transferred to another transplant center; Patients' continuing care has been assured to the satisfaction of the patient and the Commission; The transplant center submits to the Commission evidence that the transfer of patients to another transplant center has been satisfactorily accomplished; and Patients being treated in a transplant center that is withdrawing from the Kidney Disease Program are provided continued access to the same reimbursement principles of the Kidney Disease Program. Physical Standards. The transplant center shall be located in a hospital that is participating as a provider of services in the Medicare program and is approved by Centers for Medicare and Medicaid Services as a kidney transplantation center. Staffing. Director of Transplantation Center. The kidney transplantation center shall be under the general supervision of: A UNOS qualified transplantation surgeon (42 CFR §405.2102) and a qualified transplant nephrology physician director; or Another physician meeting UNOS criteria as a physician director for kidney transplantation (42 CFR §405.2102). The director shall be responsible for planning, organizing, conducting and directing the transplant center and devoting sufficient time to carry out these responsibilities, which include but are not limited to: Coordinating with the hospital in which the transplant center is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors; Ensuring that tissue typing and organ procurement services are available through a UNOS associated OPO and an ASHI certified laboratory; Ensuring that transplantation surgery is performed by, or under the direct supervision of, a UNOS qualified transplant surgeon; and Ensuring that the transplant center shall have an adequate number of clinical transplant coordinators to ensure the continuity of care of patients and living donors during the: Pre-transplant, transplant, and discharge phases of transplant; and Donor evaluation, donation, and discharge phases of donation. The clinical transplant coordinator shall: Be a registered nurse or clinician licensed by the state in which the clinical transplant coordinator practices; and Have experience and knowledge of transplantation and living donation issues. The clinical transplant coordinator's responsibilities include, but are not limited to: Ensuring the coordination of the clinical aspects of transplant patient and living donor care; and Acting as a liaison between kidney transplant centers and dialysis facilities. The transplant center that performs living donor transplantation shall identify either an independent living donor advocate or an independent living donor advocate team to ensure the protection of the rights of living donors and prospective living donors. The living donor advocate or living donor advocate team may not be involved in transplantation activities on a routine basis. The kidney transplant center shall: Directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients; and Have written policies and procedures for ongoing communications with the dialysis patients' local dialysis facilities. Additional Transplant Program Requirements. Sufficient skilled personnel shall be available to provide 24-hour-a-day coverage for the transplantation service. A transplantation team shall exist in a certified transplant center consisting of: The transplant center director; The director's assistant; and A UNOS certified transplant surgeon, if not the transplant center director, and a UNOS certified physician director (a transplant nephrologist or physician meeting UNOS criteria to be a physician director for a kidney transplant program). Physical and Medical Standards. The transplant center shall: Provide support services in clinical immunology, infectious diseases, and immunopathology; and Be an administratively separate and distinct division or unit. Transplant Activity. For optimum performance and success of the transplant procedure, transplant centers shall perform a minimum of 10 transplants per year. The Commission recognizes that the number of transplants performed depends on many variables and the standard specified in §F(1) of this regulation serves only as a guideline. The guideline specified in §F(1) of this regulation is established to indicate that transplant centers shall remain active in order to improve the success rate and to lower costs. The transplant center shall make arrangements for medical records, patient care policies, dietetic services, sanitation standards, and fire and life safety standards as referenced in this subtitle. Patient Treatment Eligibility. In general, the patient eligibility standards as established for the dialysis program shall apply to the transplantation program, recognizing that constant improvements in the immunology and treatment of the rejection process are increasing the number of disease processes in which transplantation is applicable. Written recommendations about the mode of therapy shall be kept on file for the review of the Commission. Since transplantation is at present the best means of treating most patients with irreversible kidney failure, transplantation shall be considered for all patients accepted into this program when reasonable benefit and success are anticipated. However, candidacy for transplantation may not be a basic criteria for eligibility into the overall Kidney Disease Program. A patient rejecting a transplanted kidney shall automatically receive assistance to gain entry into a dialysis program. Administration. The transplant center shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the transplant patients. Before placement on the center's waiting list, a prospective transplant candidate shall: Receive a psychosocial evaluation; and Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined. When a patient is placed on a center's waiting list or is selected to receive a transplant, the center shall document in the patient's medical record the patient's eligibility criteria used. The transplant center shall provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or dialysis facility. The transplant center shall have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also shall have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation. The transplant center's patient and donor management policies shall ensure that: Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician through the donor evaluation, donation, and discharge phases of donation. A transplant center shall keep their waiting lists up to date on an ongoing basis including: Updating of waiting list patients' clinical information; Removing patients from the center's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a center's waiting list; Notifying the Organ Procurement and Transplant Network not later than 24 hours after a patient's removal from the center's waiting list; and Notifying the patient and dialysis facility if applicable if the patient is removed from the center's waiting list. The transplant center shall develop guidelines to ensure adequate patient and freestanding dialysis facility notification of change in patient transplant status. The transplant center shall maintain up-to-date patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation. The transplant center shall make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families. The transplant center shall develop, implement, and maintain a written comprehensive data driven Quality Assessment and Performance Improvement (QAPI) program designed to monitor and evaluate performance of all transplantation services. The QAPI program shall include, but not be limited to: Patient and donor eligibility criteria; Accuracy of the waiting list; Assurance of donor and recipient matching; Patient and donor management; Consent practices; Patient education; Patient satisfaction; and Patient rights. The transplant center shall take actions that result in performance improvements and track performance to ensure that improvements are sustained. The transplant center shall establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case. The hospital shall provide designated administrative personnel to keep the necessary records as well as other information needed for accurate determination of cost. The hospital or transplant center administration shall assure that patients are informed of the center's internal and external grievance mechanisms. Compliance. Transplant centers shall comply with the provisions set forth in this subtitle. Location and Program Affiliation. Freestanding dialysis facilities seeking a certification as a freestanding dialysis facility, under the terms of Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall have, for the diagnosis and treatment of irreversible kidney failure and its complications, arrangements with: A laboratory that meets the needs of end-stage kidney disease patients; A hospital that can provide acute care services to meet the needs of end-stage kidney disease patients; A backup dialysis facility; and Transplant services. A freestanding dialysis facility desiring to phase out or discontinue dialysis services shall notify the Commission as soon as the decision to withdraw the facility from the Kidney Disease Program has been made by the administration of the facility. A freestanding dialysis facility withdrawal from the Kidney Disease Program may not be accomplished until: Patients being treated by that freestanding dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patient and the Commission; The freestanding dialysis facility has submitted to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and Patients previously certified and being treated in a freestanding dialysis facility that is being withdrawn from the Kidney Disease Program have continued access to the same reimbursement principle of the Kidney Disease Program. Physical Standards. The freestanding dialysis facility shall: Have usable floor space of at least 80 square feet per patient station that may include bed or chair space, nursing space, and work area but excludes storage space; Have at least 20 square feet of the patient station floor space available on the side of the patient to be occupied by the dialysis assembly; Arrange the space to be sufficiently flexible to provide access to any of the four extremities; Contain a nursing station and be designed for patient privacy, surveillance, and isolation when indicated; 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, according to current Association for the Advancement of Medical Instrumentation's recommendations which are incorporated by reference in this subtitle to prevent bacterial or endotoxin contamination or toxic accumulation of trace elements in patients undergoing long-term dialysis; Comply with medical records, patient care policies, sanitation standards, and fire and life safety standards as set forth in this subtitle; and Comply with the quality assurance program as identified in Regulation .04B(3)(s) of this chapter and provide: Summarized format documentation, upon request, of the facility’s quality assurance program; and Written documentation of the facility’s meeting attendance, goals, outcomes, and action plans, including evaluation and revision of the plans, as appropriate. Administration. The freestanding dialysis facility shall be under the supervision of the governing body. The governing body shall: Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and Develop a written organizational plan. The freestanding dialysis facility administration shall: Be under the supervision of the governing body; and Provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. The freestanding dialysis facility shall provide designated administrative personnel to keep necessary records as well as other information for accurate determination of costs. The freestanding dialysis facility administration shall assure that patients are informed of the facility's internal and external grievance mechanisms. Compliance. Freestanding dialysis facilities shall comply with: The provisions set forth in this subtitle; Regulation .04 of this chapter; and The requirements of this subtitle for certification purposes with the Commission. Governing Body. The governing body shall: Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and Develop a written organizational plan. Administrator. Qualifications. The kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum: Be 21 years old or older; 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; Have at least 1 year of dialysis experience; and Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through a criminal history records check completed within 1 month before employment. The administrator, if not the chief executive officer, shall have knowledge in: Infection control; Principles of dialysis; Water treatment; Reuse; Data collection and quality assurance; Emergency procedures; Fiscal operations, including business management and personnel; Regulations; and Policies and procedures. Duties. The administrator shall be on site or available on call. The administrator shall have overall responsibility for: Implementing the facility's policies and coordinating the provision of services that the facility provides; Organizing and coordinating the administrative functions of the facility; Establishing procedures for the accountability of those personnel involved in patient care; Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations; Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; Participating in the development of organizational and fiscal planning for the facility; Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and Informing patients of the availability of emergency services. Waiver of Requirements for Administrator. The Commission may grant a kidney dialysis facility a waiver, with or without conditions, for a facility that operates an administrator-in-training program. A facility with an administrator-in-training program shall submit to the Commission the: Administrator-in-training curriculum, including course outline and supporting materials; Facility requirements for individuals who are eligible to participate in the administrator-in-training program; and Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients. In evaluating a waiver request submitted under this regulation, the Commission shall review the statements in the application and may: Inspect the kidney dialysis center; or Confer with the governing body. Grant or Denial of Waiver. The Commission may grant a waiver request if it determines that: The administrator-in-training program sufficiently meets the requirements of this regulation; and A waiver will not adversely affect patients. If the Commission determines that the conditions of §F(1) and (2) of this regulation are not met, the Commission shall deny the request for a waiver. The denial of a waiver may not be appealed. Written Decision. The Commission 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. If the Commission grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department. 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. Any substantive changes to the administrator-in-training program shall be submitted to the Commission for prior approval. Policies and Procedures. The administrator shall: In consultation with the governing body, develop and implement policies and procedures governing the operation of the facility, which include at a minimum those items in §F(1) and (2) of this regulation; and Ensure that all policies and procedures are: Reviewed by the governing body at least annually and are revised as necessary; Available at all times for staff inspection and use; and Appropriate personnel implement all policies and procedures adopted. 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. Nephrologist. The director of a freestanding dialysis facility shall be a nephrologist with at least 1 year of experience in chronic hemodialysis. A freestanding dialysis facility shall have at least one additional nephrologist trained in dialysis techniques to provide adequate continuous coverage. Medical Director. A 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. The medical director shall: Assure that the facility has documented eligibility criteria for the nocturnal dialysis patient; Determine the patient’s appropriateness and suitability for nocturnal hemodialysis by considering and documenting the patient’s: Overall medical condition, including whether the patient is hemodynamically stable; Expectations for care; Response to in-center, daytime hemodialysis; and Availability of transportation; Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care; Assure that an order from a nephrologist, nurse practitioner, or physician assistant for nocturnal hemodialysis is written; Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift; 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 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 licensed and certified staff credentialing; Assure that there are written freestanding dialysis policies for: Anemia management; Adequacy of dialysis measures; Dialysis water standards; Immunization guidelines for Hepatitis B, influenza, pneumococcal, and any other applicable vaccines; 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 and any other licensed or certified personnel 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, which should assure optimal patient care. Nursing Services. Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who: 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 of 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; 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 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. Direct Patient Care Providers. Staffing Ratio. Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis: Shall be a minimum of one staff member to five participants; and May be sufficient to meet the needs of the patients. The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients. 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 following issues: 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 annual psychosocial update may be included with the mandatory quarterly documentation for psychosocially stable patients. 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. 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. Location and Program Affiliation. Self-care dialysis facilities may be situated in free-standing dialysis facilities as long as appropriate standards are satisfied. To assure quality and continuity of patient care, including backup dialysis, the self-care dialysis facility or a hospital shall negotiate a formal affiliation agreement compliant with this subtitle. Self-care dialysis facilities shall make arrangements for appropriate medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in federal regulations for Medicare Programs and those of the Commission. Self-care dialysis facilities shall keep records of dialysis frequency and other factors relating to cost determination. For the purpose of protecting patient safety and welfare, a self-care dialysis facility may not withdraw or phase out services until: The self-care dialysis facility has notified the Commission as soon as possible of the self-care dialysis facility's intention to discontinue services; Patients being treated by that self-care dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patients and the Commission; The self-care dialysis facility submits to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and Patients previously certified and being treated in a self-care dialysis facility that is being withdrawn from the Kidney Disease Program continue to have access to the same reimbursement principles of the Kidney Disease Program. Physical Standards. A self-care dialysis facility shall: Make available adequate floor space that may include bed or chair space, nursing space, and work area, but excludes storage space; Arrange the space to be sufficiently flexible to provide access to any of the four extremities; Provide patient privacy and comfort; Provide refrigerated and nonrefrigerated storage space; Provide sufficient work area and space for: Maintenance of equipment; Storage of equipment and supplies; and Preparing and testing dialyzers; and Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation recommendations which are incorporated by reference in this subtitle to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements in patients undergoing long-term dialysis. Training. Self-care dialysis facilities shall provide training that includes: Visual aids to complement the instructional program; and Training periods that vary depending on the various needs of the patient and training program of the self-care dialysis facility. Staffing. Nephrologist and Additional Licensed Staff. The director of the self-care dialysis facility shall be a nephrologist with at least 1 year of experience in chronic dialysis. At least 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 self-care dialysis facility shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter. Additional Self-Care Dialysis Facilities Requirements. Direct patient care providers shall be trained in dialysis procedures and may be a: Registered nurse; Licensed practical nurse; or Certified nursing assistant—dialysis technician. A charge nurse: Shall be a registered nurse; Shall be on duty in the treatment area, except for while on breaks, when the charge nurse shall be readily available, at all times when patients are being treated; 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 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, at a minimum: The date and shift of the exception; and A description of the emergency staffing situation. Additional staffing may be achieved with the use of licensed practical nurses or certified nursing assistant—dialysis technicians. Supervisory nursing personnel, which includes the charge nurse, may not be included in the calculation of staff/patient ratio if the supervisory nursing personnel do not participate in the monitoring of dialysis. Technical assistance by qualified technicians shall be available for the repair and maintenance of equipment. In addition, the self-care dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients. The self-care dialysis facility shall have psychiatric services available to patients by referral. 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 self-care dialysis facility shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. The self-care dialysis facility shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost. Compliance. Self-care dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission. Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland Effective date: December 22, 2003 (30:25 Md. R. 1846) Regulation .01 repealed effective April 5, 2010 (37:7 Md. R. 571) Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .04C amended effective April 24, 2006 (33:8 Md. R. 733) Regulation .04G adopted effective April 24, 2006 (33:8 Md. R. 733) Regulation .05C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571) Regulation .06C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571) Chapter revised effective March 16, 2015 (42:5 Md. R. 486) Regulation .02 amended effective August 18, 2025 (52:16 Md. R 846) Regulation .03 amended effective August 18, 2025 (52:16 Md. R 846) Regulation .04 amended effective August 18, 2025 (52:16 Md. R 846) Regulation .05A, B, H amended effective August 18, 2025 (52:16 Md. R 846) Regulation .06A, C, E amended effective August 18, 2025 (52:16 Md. R 846) Regulation .07 amended effective August 18, 2025 (52:16 Md. R 846)