Criteria and Standard to Evaluate the Appropriateness of ESRD Care

INTRODUCTION

The Renal Network, Inc., is an organization of nephrology professionals and patients representing dialysis centers and facilities, transplantation centers and organ procurement organizations in Illinois, Indiana, Kentucky, and Ohio. The goals of the Network are to ensure the provision of accessible, quality care to the ESRD patient in the most cost effective manner possible and to maximize patient rehabilitation through home dialysis and transplantation.

To achieve and maintain these goals, standards must be set by and for these professionals and their respective organizations.

SERVICES

The survival and well being of ESRD patients are mainly dependent upon precise clinical management by a team of trained and experienced physicians and allied health personnel functioning in a coordinated manner. These professionals must employ the integrated facilities of an adequately staffed and equipped hospital or outpatient facility.

The following five services must be available in the treatment of ESRD patients:

Inpatient dialysis service: provides dialysis to an ESRD patient, because of medical necessity, on a temporary inpatient basis in the hospital.
Outpatient dialysis service: provides dialysis on an outpatient basis at a renal dialysis center or facility and includes staff-assisted dialysis.
Home dialysis training: training includes continuous ambulatory peritoneal dialysis (CAPD), continuous cycling peritoneal dialysis (CCPD), and home hemodialysis training.
Home dialysis: dialysis performed by an appropriately trained patient at home.
Renal transplantation service: provides for the excision of a kidney from a living-related, living non-related, or cadaveric donor, the surgical implantation of that kidney into an ESRD patient, and appropriate medical and surgical transplantation care to the living donor and to the recipient beFebruary 29, 2008These services are provided by ESRD facilities which are approved to provide at least one of the ESRD services specified above. The types of ESRD facilities are as follows:

A RENAL DIALYSIS CENTER is a hospital unit which furnishes the full spectrum of diagnostic, therapeutic and rehabilitative services required for the care of ESRD dialysis patients (including inpatient dialysis furnished directly or by arrangement). The center is located in a hospital that is licensed in its state, is JCAHO approved and certified under the Medicare Program. The center provides the five ESRD treatment services listed, directly or by arrangement.

A RENAL DIALYSIS FACILITY is a unit which furnishes dialysis service or services to ESRD patients. If the facility is located in a hospital, the hospital is licensed in Illinois, Indiana, Kentucky, or Ohio, is JCAHO approved and certified by the Medicare Program. The facility will have a written affiliation agreement to provide inpatient care and other hospital services. Of the five listed ESRD services, the facility provides at least one directly and the others by arrangement.
AVAILABILITY & ACCESSIBILITY

Dialysis, transplantation and related services must be made available in communities throughout the four-state area; planning to meet the need of ESRD patients must consider cost effective utilization rates to bring together accessibility for the patient and efficiency for the dialysis provider.

Appropriate referral to home dialysis and/or transplantation programs is critical in meeting the Network's goals. These therapies better enable the ESRD patient to maintain employment or to participate in vocational rehabilitation efforts as well as to maintain a lifestyle more similar to that before developing ESRD.

Evaluation for home dialysis and transplantation should be completed prior to the initiation of dialysis or as soon as possible after the patient begins dialysis. The timely completion of these evaluations will allow them to be incorporated into the patient's long-term care plan.

Evaluation of the need for expansion to staff assisted dialysis must consider the goals of home dialysis and transplantation, as well.

Care should be accessible to all patients regardless of their ability to pay, method of payment, sex, race creed and/or age. Documentation should be maintained to demonstrate the use of this policy in providing for the needs of the dialysis population.

HOME CARE AND TRANSPLANTATION

Each facility and center must offer home dialysis training to its patients, either directly or through a written agreement with another provider. Federal regulations on these requirements are outlined in Appendix VIII, under "Clinical and Support Services."

To stress the importance of appropriate referral, The Renal Network has established as an annual goal the examination of the rates of home dialysis and transplantation. The Network rates will be compared to national rates, to ensure that the Network is maintaining these referrals consistently with national trends.

Home dialysis training programs must strive to make their patients as self-sufficient as possible. An assessment must be made of the patient's ability to learn to perform dialysis. Certain factors must be considered, such as the patient's home and family conditions. Another consideration is the patient's ability to determine if he or she can perform dialysis in the home, with minimal professional supervision and assistance. Also, support services must be provided for patients who perform home dialysis.

It is mandatory that all dialysis facilities maintain active referral relationships with transplantation centers to ensure that patients who are candidates for this treatment have ready access to it.

The renal transplantation center is a unit within a hospital that is licensed in Illinois, Indiana, Kentucky, or Ohio, JCAHO approved and certified under the Medicare Program and provides the following:

Renal transplantation: furnishes directly.
Inpatient dialysis: furnishes directly.
Organ procurement: furnishes directly or by arrangement.
Histocompatibility testing: furnishes directly or by arrangement.
Support services following successful renal transplantation: furnishes directly.

Specific minimal guidelines are found in Appendix I.

PERSONNEL

Health care personnel employed by the dialysis centers and facilities must be adequately educated and trained to ensure their ability to provide quality patient care.

Professionals representing many aspects of treatment are necessary to treat the full range of problems associated with ESRD. Needed are nephrologists, surgeons, consulting physician specialists, nurses, social workers and dietitians. This multi-disciplinary approach is essential. Each patient must have access to these team members who work together on the patient's short and long-term planning. Services of these professionals must be available through the provider either directly or through arrangement.

Minimum guidelines as specified by federal regulation are outlined in Appendix II for physician director, dialysis access surgeon, nurse in charge, administrative officer, dietitian and social worker. Recommended dietitian functions are detailed in Appendix III; social worker functions are contained in Appendix IV.

LONG-TERM PLANNING

The chronic nature of ESRD requires careful long-term planning on the part of the health care team. Understanding of this plan by the patient and/or family members is critical to the success of the plan and to the health of the patient.

Each patient's long-term care plan shall comply with all applicable local, state, and federal requirements. Additionally, each facility/center shall define and maintain written criteria to identify and evaluate candidates for the various modalities of home dialysis and for transplantation (See Appendix X, Long-Term Planning).

The ESRD patients shall be allowed to participate in the decision-making process concerning his/her illness. The health care team shall promote the ESRD patient's understanding of the causes, nature, and implication of his/her illness and the options for treatment.

Patient educational materials should be developed as needed and distributed to the patient to aid in this understanding of the illness and treatments.

FACILITY DESIGN AND CLINICAL SERVICES

The design of the facility or center is critical in providing for the physical and emotional well-being of the ESRD patient. Space should be well-lighted, well-ventilated and assure patient privacy when appropriate. Minimum specifications, as required by federal regulation, are outlined in Appendix V. Air borne, blood, and body fluid precautions, in accordance with guidelines of the Occupational Safety and Health Administration, Centers for Disease Control, and state government of the dialysis center, are required as the standard of care for the safety of patients and staff. Use of these precautions preclude the need for isolation stations for the general population.

Isolation of patients with hepatitis should be accomplished in accordance with recommendations of the Centers for Disease Control.

The Renal Network endorses the hepatitis B serologic screening guidelines of the Centers for Disease Control in the dialysis setting; modifications may be made as necessitated by a particular population within a dialysis unit. The rationale for such modification must be documented and included as a part of the unit's policy.

Recommended standards to ensure water quality are outlined in Appendix VI. Recommendations for procedures for the reuse of hemodialyzers are outlined in Appendix VII. Guidelines given in both Appendices VI and VII are in accordance with those adopted and promoted by the Association for Advanced Medical Instrumentation (AAMI).

The complexity of ESRD care requires the provider to maintain many differing clinical and support services to assure total care for the ESRD patient from the provider, either through direct provision of the service or by arrangement. Specific guidelines for clinical and support services are outlined in Appendix VIII.

ACCOUNTABILITY

Due to the many aspects of care required to treat the ESRD patient, the provider must be involved with other health care and health planning organizations and be accountable to these audiences as well as to the patients it serves.

The center shall provide for all patients an adequate follow-up system designed and implemented to identify and follow-up on the needs of discharged patients, and designed to evaluate the impact of the facility services.
Providers shall maintain an ongoing quality improvement program.
A formal complaint process should be available for use by the patient, as well.
The renal dialysis facility must maintain written affiliation agreements or arrangements to assure that ESRD patients are provided inpatient hospital care and other hospital services, when needed, in a renal dialysis center. This includes acceptance and treatment in emergencies, (isolation if not available at the facility), and the transfer or referral of patients, with timely acceptance and admission, when determined medically appropriate by the attending physician.
Centers shall not discriminate based on age, race, sex, or handicap (in accordance with Section 504 of the Rehabilitation Act of 1973), against referral of patients.
The center or facility shall be a member of the The Renal Network Coordinating Council.
Providers of dialysis services shall maintain organizations in compliance with the current edition of the state health plan.

PREFACE

The guidelines presented in these appendices have been developed to ensure basic levels of quality in dialysis facilities, dialysis centers and transplantation centers in Illinois, Indiana, Kentucky and Ohio.

The guidelines may be used to aid in the review of new or expanded ESRD programs; these guidelines are not to be considered as licensure requirements. The guidelines are intended to be consistent with current federal and state regulations.

Section 2991 of Public Law 92-603 amended Section 226 of the Social Security Act by extending Medicare coverage to any eligible individual who has chronic renal disease and who requires hemodialysis, peritoneal dialysis, or renal transplantation.

To obtain a copy of the federal regulations governing chronic renal dialysis, contact: Superintendent of Documents, U.S. Government Printing Office, (www.access.gpo.gov) Washington, D.C., (202)512-1800 (Order Desk). Request the Code of Federal Regulations, Vol. 42, Subpart U, ESRD REGS. 400-429 (Stock #869-013-00159-1).

The federal regulations which implement this coverage specify that the objectives of the Medicare End-Stage Renal Disease Program are to:

Assist beneficiaries who have been diagnosed as having end-stage renal disease (ESRD) to receive the care they need;
Encourage proper distribution and effective utilization of ESRD treatment resources while maintaining or improving the quality of care;
Provide the flexibility necessary for the efficient delivery of appropriate care by physicians and facilities; and,
Encourage home dialysis or transplantation for the maximum practical number of patients who are medically, socially, and psychologically suitable candidates for such treatment.

APPENDIX I

RENAL TRANSPLANTATION CENTER

Transplant centers and organ procurement organizations within Networks 9 and 10 shall be administered and operated in accordance with federal regulation and state law, as well as the guidelines developed by the United Network of Organ Sharing (UNOS). These guidelines are stated in the by-laws for that organization More information may be obtained by visiting the UNOS web site at http://www.unos.org

APPENDIX II

RENAL DIALYSIS CENTER/FACILITY PERSONNEL

The following specific minimal guidelines, as well as the general policies in this appendix, apply to an existing, proposed, or the expansion/modernization of a renal dialysis facility and/or center.

General.
1. Professional and health care personnel shall be licensed or certified as required by the state code.
2. Whenever patients are undergoing dialysis:
3. Equal employment opportunities shall be provided to all eligible applicants regardless of race, nationality, handicap, religion, sex, or age. Reasonable accommodations shall be made for qualified handicapped individuals to be employed and to fulfill requirements of their position.
4. A formal system of staff evaluation and monitoring shall be established with performance evaluations taking place at least annually.
5. High standards in staff performance and continued updating of staff skills should be promoted through continuing education and staff development, either directly or by arrangement with some other sources.
Medical.

Physician in Charge. There shall be a licensed physician designated with the overall responsibilities for the Renal Dialysis Center or Renal Dialysis Facility. This physician shall be:

Board certified in internal medicine or pediatrics by a professional board and have at least 12 months of experience or training in the management of patients at ESRD facilities,

During the five-year period preceding September 1, 1976, have served for at least 12 months as the director of a renal dialysis or transplantation program.

Dialysis Access Surgeon. A licensed physician experienced in dialysis access surgery shall be available to patients dialyzed at the facility.

Nursing.

Nurse in Charge. The nurse in charge is a person who is licensed as a registered nurse by the state of Indiana, Kentucky or Ohio, and

Has at least 12 months of experience in clinical nursing and an additional six months of experience in nursing care of the patient with permanent kidney failure or undergoing kidney transplantation, including training in and experience with the dialysis process;

OR

Has 18 months of experience in nursing care of the patient on maintenance dialysis, or in nursing care of the patient with a kidney transplant, including training in and experience with the dialysis process

OR

If the nurse responsible for nursing service (qualified) is in charge of self-care dialysis training, at least three months of the total required ESRD experience must be in training patients in self-care.
This registered nurse is responsible for the planning, implementation, and evaluation, of the clinical component of the nursing program of the center or facility.
Home Dialysis Training Nurse. If home dialysis training is provided, a licensed registered nurse who has at least three months of the total required ESRD experience in training patients in home dialysis is required.

Administrative Officer.

An administrative officer/chief executive officer may be designated. This person must:

Hold at least a baccalaureate degree, or its equivalent, and have at least one year of experience in an ESRD unit;

Be the physician in charge or the nurse in charge;

Have demonstrated capability by acting for at least two years as an administrative (chief executive) officer in a dialysis unit or transplantation program.

This person is responsible for the:

1. Overall management of the facility;
2. Enforcement of the rules and regulations relative to the level of patient care and safety of patients;
3. Protection of the personal and property rights of the ESRD patients;
4. Planning, organizing, and directing of those responsibilities delegated to that person by the governing body of the facility;
5. Maintenance of an ongoing liaison among the governing body, medical and nursing personnel, and other professional and supervisory staff of the facility through meetings and periodic reports; and,
6. Maintenance of current knowledge of the local, state, and federal rules and regulations, and laws as they pertain to ESRD.

Allied Health.

Dietitian. A dietitian is a person who:

Is licensed by the state where practicing and is eligible for registration by the American Dietetic Association under its requirements in effect on publication of this document, and has at least one year of experience in clinical nutrition;

Has a baccalaureate or advanced degree with major studies in food and nutrition or dietetics, and has at least one year of experience in clinical nutrition.

Social Worker. A social worker is a person who:

Is licensed as a social worker by the state where practicing and has completed a course of study with specialization in clinical practice at, and holds a master's degree from, a graduate school of social work accredited by the Council of Social Work Education;

Holds a bachelor's degree of social work and has served for at least two years as a social worker prior to September 1, 1976, one year of which was in dialysis unit or transplantation program, and has established a consultative relationship with a social worker who is qualified under the previous paragraph. There shall be monthly documentation of consultation with a qualified MSW

APPENDIX III

NUTRITIONAL CARE FUNCTIONS

The following specific minimal guidelines apply to an existing, proposed or the expansion/modernization of a renal dialysis facility and/or center.

Development of a nutritional care plan.

Gather information on the nutrition history, including medical record review, patient interview, and anthropometics.
Prepare a nutrition assessment based upon information obtained from nutrition history, including a statement of the patient's current nutrition history, a statement of the patient's current nutritional needs and a suggestion of appropriate diet prescription.
Develop a nutrition care plan outlining appropriate goals of management, patient instruction and follow-up.

Documentation: Regular documentation in the patient's medical record at least summarizing the nutrition history, assessment and plan; this would include a summary of the instruction of the patient and follow-up recommended; ensure that required applications, forms and letters are completed and forwarded to appropriate programs as necessary.
Team care planning and collaboration.

Participation in routine bedside rounds with medical/surgical/renal service(s).
Participation in a structured team care planning meeting, providing specific information regarding patients' nutritional status (progress/problems) and contributing to the development of total care plans.

Information and referral.

Investigation of home services and/or community resources appropriate for the patients' nutritional needs (e.g., location of low sodium food products, nutritional supplements, Meals-on-Wheels programs).
Communication to the patient/family regarding available home services and/or community resources.

Education.

Instruction of the patient/family regarding dietary recommendations during the hospital/facility stay and upon discharge home.
Development of education materials relating to nutrition, used in hospital/facility.
Initial education of extended care programs (e.g., schools, nursing homes, VNA) regarding a particular patient's nutritional needs and diet prescription.
Performance of in-service education of hospital and or facility staff.
Routine education of students not directly responsible for patient care regarding the nutritional needs of ESRD (e.g., dietetic interns, medical students).

Transfer/pre-admission planning.

Communication with the transfer facility (e.g., other hospital, dialysis unit, nursing home) regarding a specific patient's nutritional needs and care plan.
Ongoing consultation with the transfer facility regarding a specific patient's nutritional status and progress with nutrition care plan.

Hospital/facility planning activities.

Participation with menu planning, product development, meeting with vendors, purchasing, etc.
Participation in the administrative activities and mechanisms of the hospital/facility which relate to short and long term planning and program development (e.g., committee work).

Community health planning activities.

Working with the community and its agencies to develop necessary programs and uncovering community resources to meet patient and family needs.
Responsibility for representing the hospital/facility or discipline to community groups in carrying out appropriate programs (e.g., Networks, Kidney Foundation affiliates).

On-going nutrition assessment: Regular performance of calorie counts, dietary recalls, review of laboratory data, review of medical records, phone follow-up with home/chronic care facilities/schools.
Research: Routine studying of the nutritional aspects of ESRD patients, their care and needs.
Medical review/utilization review audit activities: Regular participation in the formal concurrent review process of the hospital/facility related to the JCAHO, medical review boards, and/or Network requirements.
Supervisory activities: Responsibility on a regular and ongoing basis for the supervision of at least one full time nutritional care provider involved in direct patient care activities, and/or responsibility for coordinating the renal nutritional services program within the hospital/facility.
Other: Any additional responsibilities (not included in these guidelines for instance, continuing education) performed on a regular and ongoing basis that are significant to the mission/function of the overall renal care program.

APPENDIX IV

SOCIAL WORK FUNCTIONS

The following is a list of social work functions which may be appropriate to the provision of nephrology social work services to patient/family, staff, family and community. The first six functions are currently required by ESRD Medicare regulations. In addition to these six basic social work activities, other listed functions may be necessary and/or complementary to the overall mission of the facility and its provision of social work service.

Psychosocial Evaluations: The gathering of information about the patient's social, psychological, cultural, environmental, and financial situation and utilizing this information for a psychosocial assessment and treatment plan or formal report/presentation.
Casework counseling of patients and families: Counseling directed toward helping patients and their families adjust to illness/treatment/lifestyle changes and to deal with the adjustment effectively.
Groupwork: Counseling directed toward helping groups of patients and their families deal with specifically identified problems/goals, e.g., role reversal, sexual function.
Information and referral: Information provided to the patient and family about the types of community resources available; connection made with the resources so identified.
Facilitating community agency referral: Assistance beyond information is provided to ensure patient access to appropriate resources, e.g., applications are completed on behalf of patients and processed; conferences and visits are carried out to agencies on behalf of or with patients; representation of patient and patient interest is directly made to community social agencies; escort; transportation and child care are provided/arranged.
Team care planning and collaboration: A structured meeting which provides specialized knowledge to other health care personnel regarding patient psychosocial problems, procedures, or services and participation in development of total care plan.
Transfer planning: Collaboration between staff in patient transfer of treatment modality, and/or preparation and facilitation of patient transfer in/out of treatment facility.
Pre-admission planning: Counseling on patient and family problems directly related to planning and arranging for hospital admission.
Discharge planning: Counseling on patient problems directly related to planning and arranging for post hospital care in order to provide continuity of care and consolidate gains made during hospitalization.
Facilitating use of hospital and/or facility services: Advocacy role is assumed within hospital and/or facility on behalf of patient and family with all facility staff, departments, and hospital personnel.
Patient and family education: The enhancement of patient and family knowledge through a structured program geared to provide knowledge to patients and/or families with regard to treatment modalities, psychosocial adjustment to treatment, etc.
Financial assistance: Financial or other concrete aid is provided directly by the hospital or facility social work department; transportation assistance, medications, prosthetic devices, etc.
Case consultation to community agencies: A structured meeting which provides specialized knowledge to health care personnel of an outside agency regarding the psychosocial problems of a patient/family active with the outside agency.
Program consultation to hospital staff and/or facility staff: Assesses patient population to determine unmet needs, investigates and channels information about patient care problems to appropriate departments, identifies and makes recommendations for changes in hospital, or facility policies and procedures as related to patient/family needs and rights.
Program consultation to community agencies: A structured meeting which provides specialized knowledge to community institutions.
Hospital/facility planning activities: Significant involvement in the administrative activities and mechanisms of the hospital/facility which relate to short-term and long-term planning and program development; or that relate to community services.
Community health planning activities: Working with the community and its agencies to develop necessary programs and uncovering community resources to meet patient and family needs.
Community service activities: Responsibility to represent the hospital, facility, or discipline to the community groups in carrying out appropriate programs, e.g., organ banks, Networks, kidney foundations.
Teaching: Routine and systematic teaching of medical, nursing, social work, and other appropriate students.
Research: A structured system of study of the psychosocial factors of ESRD patients, their care, and needs.
Medical review/utilization review audit activities: Participates in the formal concurrent review process of the hospital/facility related to the JCAHO, medical review board, and/or Network requirements.
Supervisory activities: Responsibility on a regular and ongoing basis for supervision of from two to four full-time professional social work staff involved in direct patient care activities, and/or responsibility for coordinating the renal social work program within the hospital/facility.
Other: Additional responsibilities (not included in Items 1-22 above) performed on a regular and ongoing basis that are significant to the mission/function of the overall renal care program, e.g., a large home care program, home helper program.

APPENDIX V

FACILITY DESIGN

The following specific minimal guidelines, as well as the general policies in this appendix, apply to an existing, proposed or expansion/modernization of a renal dialysis facility and/or center.

Patient Care Unit. If inpatient dialysis is provided, an area will be designated that:

Is separated from other areas of the hospital,
Has dialysis equipment available for all stations,
Has adequate stations to meet the inpatient dialysis requirements of the center or facility.

Building and Equipment.

The physical structure in which the ESRD services are furnished shall be constructed, equipped, and maintained in accordance with JCAHO and state guidelines to ensure the safety of patients, staff, and the public.
Buildings shall meet or exceed architectural standards set forth in American National Standards for Making Building and Facilities Accessible to and Usable by the Physically Handicapped (ANSI Standards).

Environment.

The facility shall be maintained and equipped to provide a functional, sanitary, and comfortable environment with an adequate amount of well-lighted space for the services provided.
Air borne, blood, and body fluid precautions are the standard practice. Sterilization and maintenance of equipment shall be provided to facilitate the prevention and control of hepatitis and other infections.
Isolation of patients with hepatitis should be accomplished in accordance with recommendations of the Centers for Disease Control. Additionally, hepatitis B serologic screening guidelines of the Centers for Disease Control in the dialysis setting will be followed; modifications may be made as necessitated by a particular population within a dialysis unit. The rationale for such modification must be documented and included as a part of the unit's policy.
Treatment areas shall be designed and equipped to provide adequate and safe dialysis therapy, as well as privacy and comfort for patients. The space for treating each patient shall be sufficient to accommodate medically needed equipment and staff, and to ensure that such equipment and staff can reach the patient in an emergency.
Heating and ventilation systems shall be capable of maintaining adequate and comfortable temperatures.

Nursing/Monitoring. A nursing/monitoring station shall be provided from which adequate surveillance of patients receiving hemodialysis services can be made.

APPENDIX VI

WATER QUALITY STANDARDS

The Renal Network, Inc. endorses the current Recommended Practice for Water Quality Standards as developed Association for the Advancement of Medical Instrumentation (AAMI) as they apply to all renal dialysis facilities and/or centers, whether they are existing, proposed or to be expanded and modernized.

Recommended practices may be obtained by contacting AAMI, 3330 Washington Blvd., Arlington, VA 22201; telephone (703)525-4890; fax (703)276-0793. Email addressed can be accessed through the AAMI web site: www.aami.org.

APPENDIX VII

REUSE OF DIALYZERS

The Renal Network, Inc., endorses the current Recommended Practice for the Reuse of Dialyzers as developed by the Association for the Advancement of Medical Instrumentation (AAMI) for those facilities which employ reuse of dialyzers.

APPENDIX VIII

CLINICAL AND SUPPORT SERVICES

The following specific minimal guidelines apply to all renal dialysis facilities and/or centers, whether they are existing, proposed or to be expanded and modernized.

Physician Supervision. The following are minimum guidelines for adequate physician supervision. More frequent physician-patient contact may be warranted or required by the patient's condition or the policy of the facility.

Every physician is responsible for ensuring that his/her patients have immediate coverage by an internist (or pediatrician for patients 16 and under) with 24-hour consultation and back-up by a nephrologist.
All in-center patients should be seen by a physician at least monthly. Home dialysis patients may be seen less frequently.
A progress note regarding patient status and evaluation should be entered in the patient record by the physician monthly.
Physical examinations should be made available to all patients at least twice annually, in a private setting while the patient is not dialyzing.
Physicians should attend a multi-disciplinary patient review meeting monthly.
The medical director or his/her designee should participate in the continuing in-service education with other members of the dialysis team twice annually.

Specialty Evaluation and Consultation Services. Timely specialty evaluation and consultation shall be furnished directly by the center or facility, by agreement or by arrangement, in the following clinical specialties:

Cardiology
Endocrinology
Hematology
Infectious diseases
Neurology
Orthopaedic surgery
Pathology
Pediatrics (if children are cared for)
Psychiatry
Urology
Vascular surgery
General surgery
Radiology

Support and Diagnostic. The following services shall be furnished by the center or facility directly, by agreement, or by arrangement:

Angiography
Inhalation therapy
Nuclear medicine
Rehabilitation
Computerized tomography
Ultrasonography

Laboratory Services.

The center or facility shall make available laboratory services (other than the specialty of tissue pathology and histocompatibility testing) to meet the needs of the ESRD patient.
Laboratory services are to be performed either by a Medicare-approved hospital or by a qualified Medicare-approved independent laboratory.
Routine Procedures. The center or facility may furnish routine procedures such as hematocrit or hemoglobin, clotting time and blood glucose tests in accordance with requirements of the Clinical Laboratory Improvement Act.
Emergency Procedures. If the renal dialysis center or a renal dialysis facility is a hospital unit and provides inpatient dialysis, the following laboratory services will be furnished directly on a 24-hour basis:

CBC
Platelet count
Coagulant screening, prothrombin time, PTT
Fibrinogen
Urine microscopic
Urine glucose
Cerebrospinal fluid studies (smear, culture, cell count, protein, glucose)
Blood gases
Blood glucose
Blood pH
Serum urea nitrogen
Serum sodium
Serum chloride
Serum creatinine
Serum potassium
Serum bilirubin
Serum amylase
Blood typing--crossmatching

Non-emergency Procedures. In addition to the routine and emergency procedures listed, all of the following procedures should be furnished directly by the center or facility or by arrangement:

Serum proteins
Serum immunoglobulins
CPK
SGPT
LDH isogram
Serum calcium]
Serum phosphorus
Urine sodium, potassium, pH, osmolality, and protein
Serum osmolality
LDH
SGOT
Drug assays for therapeutic agents (i.e., Digoxin, Phenytoin, Phenobarbital)

Microbiology and Pathology. If a renal dialysis center or a renal dialysis facility is a hospital unit and provides inpatient dialysis, the following will be furnished directly, or by agreement:

Immunofluorescence and electron microscopy
Unusual pathogen cultures (i.e., fungal cultures, tissue cultures, and TB cultures)
Unusual pathogen smears (i.e., fungal smears and TB smears).

Renal Transplantation Services. The center or facility shall furnish by agreement:

Evaluation of its ESRD patients for renal transplantation;
Histocompatibility testing; and,
Renal transplantation for ESRD patients where appropriate.

Recipient Registry. The center or facility shall participate in a patient registry program for patients who are awaiting cadaveric renal transplantation.
Outpatient Dialysis Services.

Staff-Assisted Dialysis Services. The center or facility must provide all necessary dialysis services and staff required in performing the dialysis.
Home Dialysis Services. The center or facility shall furnish home dialysis training directly or by agreement. If home dialysis training is furnished by the center or facility, the following home dialysis support services shall be furnished, where appropriate:

Surveillance of the patient's home adaptation and partner's ability to assist with treatment, including provisions for visits to the home or the facility;
Consultation for the patient with a qualified social worker and a qualified dietitian;
A record-keeping system which assures continuity of care;
Installation and maintenance of dialysis equipment;
Testing and appropriate treatment of the water;
Ordering of supplies on an ongoing basis; and,
Cannula and fistula care.

Patient Follow-up. The center or facility shall furnish outpatient services for the evaluation, care, and follow up, including cannula and fistula care of ESRD patients on dialysis.
Dietetic Services. Dietetic services, to include assessing the nutritional and dietetic needs of each patient, recommending therapeutic diets, counseling patients and their families on prescribed diets, and monitoring adherence and response to diets, shall be furnished directly, by agreement, or by arrangement, by a qualified dietitian, in consultation with the attending physician.

The medical record must contain a statement by the renal dietitian indicating the prescribed diet that includes protein, sodium, potassium and fluid intake, within two weeks of the first outpatient maintenance dialysis.
The medical record must contain a statement by the renal dietitian within one month of the first outpatient maintenance dialysis in the facility which includes all of the following:

Diet history to include at least height, ideal weight taken from actuarial tables; prescribed dry weight; previous diet restrictions and or instructions and the patient's concept of same.
A statement that the initial dietary instructions were explained to the patient and/or significant other.

The renal dietitian must document in the patient record that the following have been assessed every three months (note: all elements are pre-dialysis): serum albumin; serum urea nitrogen; serum phosphorus; serum potassium; average interdialytic weight change; change in dry weight in the preceding three months.
Every three months, based on these assessments (Item C above), documentation should be maintained on corrective actions plans if any of the following conditions exist:

Serum albumin at or below the lower limit of normal as determined by the laboratory which processes the tests.
Serum K > 6.5 meq/l in the two most current measurements.
BUN < 50 mg% or over 120 mg% after largest interdialytic interval.
Serum inorganic phosphorus >7.0 or < 2.5 mg% in the two most current measurements.
Interdialytic weight change of > 4 kg. or 8% of the patient's target weight.
Unintentional target weight increase of over 10% or unintentional decrease of 5% in the previous three month period.

If registered dietitian staffing is inadequate to meet these guidelines, the staffing formula developed by the Council on Renal Nutrition of the National Kidney Foundation (web site www.kidney.org) is recommended to determine the appropriate number of registered dietitians necessary for the case-mix of the patient population of the facility.

Social Services.

Social services shall be provided to patients and their families and are directed at supporting and maximizing the social functioning and adjustment of the patient. These services should promote the maintenance of interpersonal relationships among family members and should promote the ability of the patient to deal with stress related to ESRD when appropriate.
These services include conducting psychosocial evaluations, participating in team review of patient progress and recommending changes in treatment based on the patient's current psychosocial needs, including the ability to recommend psychological evaluation, providing casework and groupwork services to patients and their families in dealing with the special problems associated with ESRD, and identifying community social agencies and other resources and assisting patients and their families to utilize them. These services are furnished directly, by agreement, or by arrangement, by a qualified social worker. The social worker shall meet the qualifications listed in Appendix II.

The medical record will show that a psychosocial assessment was completed within three months of the first maintenance dialysis.
The medical record will show the patient has contact with the qualified social worker within six months of the date of the first psychosocial assessment, and within six-month intervals thereafter.

Social services shall integrate each patient into the existing network of rehabilitation services so that each patient may reach his/her highest potential for complete self-sufficiency within the physical, personal, interpersonal, and vocational domains.
Social services shall work closely with the state vocational rehabilitation programs, and other rehabilitation programs, to strengthen the process of referral and to enhance each individual patient's ability to the maximum level of self-sufficiency appropriate to the patient's needs, abilities, and desires.
Patients shall be made aware through counseling, literature, and referral of available rehabilitation resources and services.
The social worker shall have a working knowledge of the Medicare system and offer assistance in filing claims with Medicare as well as with third party payors.
If social worker staffing is inadequate to meet these guidelines, the staffing formula developed by the Council of Nephrology Social Workers of the National Kidney Foundation (web site www.kidney.org) is recommended to determine the appropriate number of social workers necessary for the case-mix of the patient population of the facility.

Pediatric ESRD Support is outlined in Appendix IX, Pediatric Scope of Care.

APPENDIX IX

PEDIATRIC SCOPE OF CARE

PLEASE NOTE: These guidelines are contained in a separate file. Click above on Pediatic Scope of Care to access this information.

APPENDIX X

LONG-TERM PLANNING

The medical record must contain a statement signed by the patient and/or significant other that confirms he/she has been presented the options and expectations of the ESRD therapy by the physician responsible for the care of the patient to include hemodialysis, peritoneal dialysis, home dialysis and transplantation.

This shall be accomplished within three months of the first chronic maintenance dialysis in the facility. If the patient transfers, a copy of this signed statement must be included with the transferring medical documents.

The long-term program will be developed by the patient care team in consultation with the patient and/or significant other. This program shall be completed, along with the signature of the patient and/or significant other, within three months of the first chronic maintenance dialysis in the facility. If the patient transfers, a copy of the signed program will be included with transferred medical documents. The long-term program will be transferred within one working day, in accordance with federal regulation.

This long-term program will be reviewed at least annually, more often if necessary, and signed by the patient and/or significant other.

Each patient's long term care plan shall comply with all applicable local, state, and federal requirements. Additionally, each facility/center shall define and maintain written criteria to identify and evaluate candidates for the various modalities of home dialysis and for transplantation.

Patient educational materials should be developed as needed and distributed to the patient to aid in this understanding of the illness and treatments.

Facilitates the achievement of optimal wellness for renal disease patients.

Criteria and Standard to Evaluate the Appropriateness of ESRD Care