Chapter 02. Physical and Medical Standards

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.

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).

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:

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.

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.

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.

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).

Receive a psychosocial evaluation; and

Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined.

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.

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.

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.

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.

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.

Maintenance of equipment;

Storage of the equipment and supplies; and

Preparing and testing dialyzers;

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.

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.

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 kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum:

The administrator, if not the chief executive officer, shall have knowledge in:

The administrator shall be on site or available on call.

The administrator shall have overall responsibility for:

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:

In evaluating a waiver request submitted under this regulation, the Commission shall review the statements in the application and may:

Grant or Denial of Waiver. The Commission may grant a waiver request if it determines that:

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.

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.

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:

At least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage; or

A licensed professional trained in dialysis.

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.

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.

Is a full time employee of the facility;

Is a registered nurse;

Has at least:

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

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:

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 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.

The monitoring individual-to-patient ratio at each facility shall be:

The facility shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.

Be trained in dialysis procedures and may be a:

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

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:

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.

At least quarterly for stable patients; and

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

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.

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.

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:

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:

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.

Is a full-time employee of the facility;

Is a registered nurse;

Has at least:

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

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.

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

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.

Be trained in dialysis procedures and may be a:

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

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:

The annual psychosocial update may be included with the mandatory quarterly documentation for psychosocially stable patients.

At least quarterly for stable patients; and

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

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.

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.

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:

Utilize water of sufficient purity to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements; and

Provide adequate backup center dialysis.

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.

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.

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.

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.

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:

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.

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.

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.

Direct patient care providers shall be trained in dialysis procedures and may be a:

A charge nurse:

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:

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.