1997ANNUAL REPORT 

FOR

END-STAGE RENAL DISEASE

NETWORKS 9 & 10

THE RENAL NETWORK, INC.

Submitted By: Sponsored By:

The Renal Network, Inc. Health Care Financing Administration

911 East 86th Street, Suite 202 Contract Numbers: 500-94-0027

Indianapolis, IN 46240 & 500-96-E028

317-257-8265

Date: May 21, 1998

THE RENAL NETWORK, INC.

1997 ANNUAL REPORT

TABLE OF CONTENTS

I. Introduction

A. Network Description

B. Incidence Rates 1988-1997

C. Prevalence Rates 1988-1997

D. Network Structure

II. Network Activities

A. Network Goals and Objectives

B. Patient Interaction in Network Activities

C. Cooperative Network & ESRD Medicare Survey and Certification

D. 1996 Quality Assurance/Improvement Activities

1. The Core Indicator Project

D.1 4th Quarter Hemodialysis patients 1996, 1997

D.2 Nov96 – April 97 Peritoneal Dialysis Patients

2. Core Indicator Results

D.3 Distribution of HCT Values by State 1996, 1997 (HD)

Fig D.1 % HD Patients w/HCT ³ 31 vol%

Fig D.2 Distribution of HD HCT Values

D.4 Anemia Management Average Values (HD)

D.5 Average HCT & Standard Deviation by State (PD)

Fig D.3 % HD Pts with TSAT Values

Fig D.4 % HD Pts with Ferritin Values

Fig D.5 Distribution of PD HCT Values

D.6 HD Adequacy Average Values by State & Network

Fig D.6 % HD Pts URR ³ 65%

Fig D.7 % HD Pts Kt/V ³ 1.2

Fig D.8 % PD Pts w/reported CrCl

Fig D.9 % PD Pts w/reported Kt/V

Fig D.10 % CAPD Pts w/reported CrCl ³ 60 liters/wk

Fig D.11 % CAPD Pts w/reported Kt/V ³ 2.0

D.7 PD Adequacy Average Values by State & Network

Fig D.12 % CCPD Pts w/reported CrCl ³ 63 liters/wk

Fig D.13 % CCPD Pts w/reported Kt/V ³ 2.1

D.8 Albumin Average Values by State & Network

Fig D.14 % HD Pts/Albumin ³ 3.5 gm/dl

Fig D.15 %PD Pts Albumin ³ 3.5 gm/dl 24

D.9 PD Blood Pressure Values by State & Network

Fig D.16 % PD Pts w/Systolic BP > 150 mmHg

Fig D.17 % PD Pts w/Diastolic BP > 90 mmHG

3. Core Indicator Interventions

4. National Core Indicator Project

E. Network Special Projects/Studies

1. Peritonitis Rate Benchmarks

2. Quality Improvement Projects

3. Barriers To Adequacy Study

4. 1991 – 1992 Peritonitis & Catheter Survival Study

5. Focused Quality Assurance Activities

6. Other Network Quality Assurance Activities

F. Community Outreach

G. Grievances

H. Vocational Rehabilitation

III. Network Administration

A. Facility Compliance

B. Need for Additional/Alternative Services

C. Sanctions

IV. Data Management

A. System Description

B. Compliance Tracking

C. Patient Tracking System

V. Data Tables

1. Kentucky 1

2. Kentucky 2

3. Ohio 1

4. Ohio 2

5. Ohio 3

6. Ohio 4

7. Ohio 5

8. Ohio 6

9. Ohio 7

10. Ohio 8

11. Ohio 9

12. Ohio 10

13. Indiana 1

14. Indiana 2

15. Indiana 3

16. Illinois 1

17. Illinois 2

18. Illinois 3

19. Illinois 4

20. Illinois 5

21. Illinois 6

22. Illinois 7

23. Illinois 8

24. Illinois 9

25. Illinois 10

26. Illinois 11

27. Pediatric Facilities

 

VI. Dialysis Patient Information

1. ESRD Incidence (Demographic) - 1997

2. ESRD Prevalence (Demographic) - 1997

3. Patient Population at Year End

4 Patient Modality Breakdown

5. Patient Population by Facility

6. Patient Population by Age, Race, and Sex

7. In-Center Patients by State and Year

8. Patient Population, Incenter Patients

9. Home Dialysis Rates

10. Home Patients by State and Year

11. Patient Population, Home Patients

12. Patients Completing Home Training

13. New Starts by State and Year

14. Additions

15. Deaths by State and Year

16. Losses

VII. Transplant Patient Information

1. Transplant Status 12/31/97

2. Transplant Rates 1988 - 1997

3. Transplants 1997

4. Comparative Performance of Facilities

5. Transplants Performed by Type

May 21, 1998

Enclosed please find the work of the Network Coordinating Council and Staff of The Renal Network entitled 1997 Annual Report. This report represents a significant coordinated effort among health care providers, patient, and Network administrative staff outlining the year's activities.

The Renal Network, Inc. (ESRD Networks 9 & 10) is an agency which monitors the treatment of End- Stage Renal Disease patients in the states of Illinois, Indiana, Kentucky, and Ohio. In total, 18 ESRD Networks throughout the country monitor dialysis and transplant centers. The goal of the ESRD Networks is to assure appropriateness of dialytic care while fostering patient independence and well-being. ESRD Networks are funded through the Health Care Financing Administration.

The Renal Network is particularly proud of patient participation at all levels of its function from the Board of Trustees through the Medical Review Board and Network Coordinating Council to each individual local dialysis unit. Further patient involvement in state organizations will help bring to light patient needs, requirements, and expectations and help serve as a focus for education.

Network Council and Committee Members are volunteers who have given of their own time to assure the quality of delivered care to patients on End-Stage Renal Disease support systems. These same individuals have participated in the development of various goals and outcome surveys. Our appreciation goes to facility staff, members of the Medical Review Board, Executive Committee, the Network Coordinating Council, and the Patient Advisory Councils. These committees have addressed the requirements of our contract and have gone well beyond to assure a progressive pro-active network.

I am particularly proud to be a member of The Renal Network. I am extremely thankful to all the dedicated professionals, particularly in each of the dialysis facilities, as well as, the Network administrative office without whose dedication and perseverance the Network accomplishments would not have been possible.

Sincerely,

Emil P. Paganini, M.D.

President

THE RENAL NETWORK, INC.

1997 ANNUAL REPORT

I. INTRODUCTION

A. Network Description

The Renal Network encompasses the states of Illinois, Indiana, Kentucky, and Ohio. The total population in the four-state area is estimated at 33,033,515. ESRD incidence and prevalence rates continued to increase during 1997 as shown in the following tables.

Incidence Rates

1988 - 1997

Prevalence Rates

1988 - 1997

Illinois, "The Prairie State", ranks 6^th among all states in population. Figures from the U.S. Department of Commerce, Bureau of the Census Update 1990 show the population divided by race as:

About 8% of the population is defined as Hispanic in ethnicity. Divided by age groups, approximately 25.8% of the population was under the age of 18; 61.7% were between the ages of 18 and 64; and 12.6% were aged 65 or greater. Currently, the female population is approximately 51.5% and the male population is 48.5%.

One-half of the population of the state live in the metropolitan Chicago area. In total, 83 percent of the population live in urban areas and 17 percent of the population live in rural areas. Other urban areas in Illinois (with a population of greater than 100,000) are Springfield (the state capital), Rockford, and Peoria.

Indiana, "The Hoosier State," ranks 12th among all states in population. Figures from the U.S. Department of Commerce, Bureau of the Census Update 1990 show the population divided by race as:

Divided by age groups, approximately 26.3% of the population was at age 18 or under; 61.3% were between the ages of 18 and 65; and 12.1% were over the age of 65. Currently, the female population is approximately 51.5% and the male population is 48.5%.

About two-thirds of Indiana's population live in urban areas. Indianapolis, the state capital, is the largest city in the Network area, as well as Indiana, with a population of over 1,000,000. Other urban areas in Indiana (with population greater than 100,000) are Fort Wayne, Gary, Evansville and South Bend.

Kentucky, "The Bluegrass State," ranks 23rd among all states in population. Figures from the U.S. Department of Commerce, Bureau of the Census Update 1990 show the population divided by race as:

Divided by age groups, approximately 26.7% of the population was at age 18 or under; 61% were between the ages of 18 and 65; and 12.3% were over the age of 65. The female population is approximately 52% and the male population is 48%.

The Kentucky population is about evenly divided between rural and urban dwellers. Urban centers (with population greater than 100,000) are Louisville, Lexington, Owensboro, Covington, Bowling Green, Paducah, Hopkinsville, and Ashland. Kentucky's state capital is Frankfort.

Ohio, "The Buckeye State," ranks sixth among all states in population. Figures from the U.S. Department of Commerce, Bureau of the Census Update 1990 show the population divided by race as:

Divided by age groups, approximately 26.3% of the population was at age 18 or under; 61.2% were between the ages of 18 and 65; and 12.5% were over the age of 65. Currently, the female population is approximately 52.1% of total population and the male population is 47.9%.

About three-quarters of the population of Ohio live in urban areas. Urban centers (with population greater than 100,000) include Cleveland, Columbus (the state capital), Cincinnati, Toledo, Akron, Dayton, and Youngstown.

B. Network Structure

1. Staffing

The Renal Network employs thirteen full and part-time employees. Those employees include:

2. Committees

Network Coordinating Council: The Network Coordinating Council is composed of representatives of dialysis providers from hospitals and other facilities located in the states of Illinois, Indiana, Kentucky, and Ohio. The hospitals and facilities are certified by the Secretary of Health and Human Services to furnish at least one specific end-stage renal disease service. The Network Coordinating Council includes a representative of each of the current Medicare approved end-stage renal disease facilities. Each facility has a single representative, designated by its chief executive officer or medical director, who is approved by the governing board of the facility. The Council is responsible for the election of members to the Board of Trustees and the Medical Review Board. Elections are held by mail-in ballot. The Council meets once annually. During 1997, the Council met on May 15.

During 1997, the following occurred:

• Financial statements for year-end 1996 and year-to-date were disclosed.

• The 1997 slates for membership on the Board of Trustees and Medical Review Board were presented and approved. Nominations were accepted from the floor and at the annual meeting in May. Members were elected to both committees by mail-in ballot in the fall. Terms of office were to begin on January 1, 1998 and end on December 31, 2000.

• 1996 data were presented and the 1996 Annual Report was approved.

• The Network Coordinating Council was updated on the proposed changes to the HCFA 2728 form, activities of the Forum of Renal Networks, and contract issues.

• A bylaws change was approved to transfer governing ability from the Network Coordinating Council to the Board of Trustees.

• The 1997 Nephrology Conference was held at the Radisson Plaza Hotel in Indianapolis, IN on May 14, 15, and 16th. The Conference held educational programs for administrators, physicians, nurses, social workers, dietitians, and technicians.

• Dialysis facilities within Networks 9 & 10 were informed of and participated in the HCFA Core Indicators Project and the Anemia Study.

• Reports were given on the Adequacy of Dialysis Project, the Quality of Life Project, the Barriers To Adequate Dialysis Project, and the Peritonitis Rate Project.

Board of Trustees (formerly Executive Committee): The Board of Trustees is the chief governing body of ESRD Networks 9 & 10. The Board of Trustees holds the Network contracts for ESRD Networks 9 & 10 with the Health Care Financing Administration, and is responsible for meeting contract deliverables and oversight of the administration of the Network budget.

During 1997, governance duties were delegated to the Board of Trustees from the Network Coordinating Council by a bylaws change. The purpose of the change in governance was to accommodate the increase in dialysis programs with the addition of Network 10, without slowing the process of government by adding extensive numbers to the Council. In this method, each dialysis facility within Networks 9 & 10 is represented on the Network Coordinating Council which elects members to the Board of Trustees and also the Medical Review Board. The day-to-day governing of the contract is left to the Board of Trustees, which reports its activities to the Council. The officers of the Board of Trustees serve as the Executive Committee.

The Board of Trustees is composed of 20 members, elected for three year terms of office including:

8 Renal Physicians	4 ESRD Patients
Chairperson of the Medical Review Board	1 Nurse
1 Social Worker	1 Administrator
1 Dietitian	1 Technician
1 Public Member	1 Non-Categorical Position
The Past President

The Board of Trustees met in person on January 22, March 12 and September 12, 1997. They also met twice by conference call.

Members of the Board of Trustees for 1997 were:

During 1997, the following occurred:

• Network financial records were reviewed and expenditure reports approved.

• The Board of Trustees heard updates from the Medical Review Board, the Patient Advisory Councils, the Nominating Committee, and the Program Committee. These updates included committee activities and action items.

• The Board of Trustees was updated on the proposed changes to the HCFA 2728 form, activities of the Forum of ESRD Networks, and contract issues.

Medical Review Board: With the addition of Network 10, the Medical Review Board expanded its membership via a bylaws amendment to allow representation from the State of Illinois. The Medical Review Board (MRB) is composed of 35 members, elected for three year terms of office including:

16 Physicians	3 ESRD Nurses
3 ESRD Social Workers	3 ESRD Dietitians
3 ESRD Facility Administrators	4 ESRD Patients
3 ESRD Technicians

The Medical Review Board functions with the concurrence and subject to the review and control of the Network Coordinating Council through the Board of Trustees. It performs functions prescribed by the regulations issued by the Secretary of Health and Human Services, as well as other duties related to quality assurance, vocational rehabilitation, and patient concerns as requested by the Network Coordinating Council. The MRB met on March 12, May 14, September 10, and November 19, 1997. Additional meetings were held for the Data Analysis Subcommittee on September 9 and November 18, and via telephone conference call.

Members of the Medical Review Board for 1997 were:

During 1997, the Medical Review Board:

• Oversaw the development of The Physician Activity Report. This report, when finalized, will show Network nephrologists their patients’ core indicator data as reported via the unique physician identification number (UPIN). The project was near completion at year-end, with an implementation date set for the first quarter of 1998.

• Developed the first Quality Improvement Project (QIP) of the new HCFA-Network contract. The QIP looks at physician practices in prescription and adequacy measurements in the area of peritoneal dialysis. A study protocol and data collection instruments were developed. The project had received preliminary approval from HCFA at year-end. Discussions were also begun for a second QIP on hemodialysis access.

• Continued work on a joint project with the Peer Review Organization for Ohio, Peer Review Systems (PRS). The project was entitled "Barriers to Adequacy of Dialysis." Under the direction of MRB Member Dr. Ash Sehgal, the project looked at barriers which would cause a patient to received inadequate dialysis. The barriers chosen where barriers which could be positively impacted through intervention. The study was ongoing at year-end.

• Began a project to encourage the use of quality of life measurements for dialysis patients by their dialysis programs. A task force of volunteers from the MRB was recruited to oversee this process. The task force agreed to use the KDQOL from the Rand Corporation as it is an accepted quality of life measurement tool, and one which has been in use for several years. Volunteer facilities were recruited to participate in the project. The facilities were provided with the instrument. They gave their data to the Network, which performed the data entry. The project was ongoing at year-end.

• Oversaw the dissemination of a Facility Profile, which displays descriptive data from each facility, with comparisons of regional, state, Network and national statistics for those same areas, include demographic and diagnosis data. Included also are SMR and gross mortality. These profiles are distributed annually to each facility to help them in their continuous quality improvement efforts.

• Oversaw the activities of the Pediatric Renal Group, a subcommittee of the Medical Review Board. The goal of the group is to act as a resource to the Network on the care and treatment of pediatric dialysis and transplant patients.

• Received continuous updates on the activities of the Health Care Financing Administration and the new Scope of Work, the United State Renal Data System (USRDS), The Forum of ESRD Networks, and the Quality Assurance Committee of The Forum.

• Reviewed data from the Facility Compliance Report on an ongoing basis.

• In January conducted a site visit to a facility; this intervention was prompted by grievances filed against the facility. The members of the site visit team of the MRB identified opportunities for improvement. The site visit team and representatives worked for corrective actions throughout the year. A follow-up site visit was conducted in December. Members of the site visit team agreed that the facility had made the improvements requested after the first visit. The matter was considered closed and final by year-end.

• Reviewed data profiles, including rates for mortality, home therapy, and transplantation.

• Reviewed grievances filed with the Network.

• Oversaw the continued implementation of the HCFA core indicators project.

• Oversaw and participated in the development and implementation of the Core Interventions Project.

Patient Advisory Councils: The Patient Advisory Councils (PAC) operate as four distinct councils in the states of Illinois, Indiana, Kentucky and Ohio. Membership is composed of an appointed representative and an alternate from dialysis and transplant facilities who choose to participate on the Council. There are 165 PAC Reps throughout the Network.

• Information about the PAC was sent to each facility to recruit PAC Representatives and Alternates.

• The PACs promoted the Client Communication System (CCS) which increases communication among patients and staff. An increasing number of facilities are using the CCS format and have recruited shift representatives for various dialysis shifts and have regular meetings to discuss the needs and concerns of their patients.

• Patient Services staff had an exhibit and booth at the Patient Education Day, sponsored by the National Kidney Foundation of IL, on April 26 in Peoria, IL, to inform renal patients of Network resources for patients and to recruit PAC members for Illinois.

• The Illinois Patient Advisory Council met on June 22 for its first PAC meeting and workshop which was held in Downers Grove, IL. Over 50 PAC Representatives, Alternates, and family members attended this meeting. The keynote speaker was John Newmann, Ph.D. and he discussed patient advocacy, adequacy of dialysis, and rehabilitation issues. Additional topics included an overview of the Network, the PAC Role, the Client Communication System, and educational material from Amgen.

• On November 7 the Kentucky PAC Chairperson gave a presentation at the Ohio Renal Administrators meeting on the Client Communication System.

Patient Leadership Committee: The Patient Leadership Committee's (PLC) purpose is to identify and address ESRD patient needs and concerns through the development of educational projects and activities. It focuses on the overall needs of renal patients in the Network. Its membership includes the state PAC Chairpersons and Vice-Chairpersons, patients from the four state area who represent the four modalities of treatment, and staff members from each state.

The first PLC completed its term in 1996. Thus, this year was the first year of a new three-year term with new subcommittees and several new members. There are now four subcommittees which address different patient issues:

The Quality of Life Subcommittee is addressing patient quality of life by writing articles on positive attitude, exercise, social issues, and rehabilitation for the patient newsletter, Renal Outreach. The first article was published in the Fall 1997 issue. It also is developing corresponding material for workshops in the form of Facilitator Guide and Instructor and Student Manuals.

The Patient Empowerment Subcommittee is revising a list of Patient Rights and Responsibilities to reflect a 4^th to 5^th grade reading level after having reviewed 15 versions of Patient Rights and Responsibilities, all of which were at a higher reading level. It also is developing poster ideas to stimulate interest in knowing one’s rights and responsibilities.

The Quality of Care/Staff Relations Subcommittee is developing a set of workshop materials for patient/staff relationship improvement and will include the topics of communication, cooperation, sensitivity, mutual respect, and trust.

The Pediatric Subcommittee is developing a game for children entitled Kidney Kapers for pediatric patients and their families. The game will be piloted in early 1998.

The PLC met on March 21, June 6, September 12, and November 21, 1997. The overall committee addressed a variety of issues including rehabilitation, PAC involvement and activities, and updating the Client Communication System booklet.

The following were members of the Patient Leadership Committee during 1997:

Evenard Davis	George Drummer III
Lorraine Edmond	Robert Felter
Joanne Gabria	Barbara Hasbargen RN
Jackie Herran	Carol Jackson MSW
Donald McTigue	Janet Nevitt MSW
Robin Pruett	Sally Rice MSSW
Elaine Spaulding	Martinlow Spaulding
Sharon Stockwell	Monroe Walker Jr.
Nancy Ware, L.I.S.W.

II. NETWORK ACTIVITIES

A. Network Goals and Objectives

The Network organizations are responsible for:

1. Encouraging, consistent with sound medical practice, the use of those treatment settings most compatible with the successful rehabilitation of the patient and the participation of patients, providers of services, and renal disease facilities in vocational rehabilitation programs.
2. Developing criteria and standards relating to the quality and appropriateness of patient care by working with patients, facilities, and providers; encouraging participation in vocational rehabilitation programs; and by establishing Network goals with respect to the placement of patients in self-care settings and undergoing or preparing for transplantation.
3. Evaluating the procedure by which facilities and providers in the Network assess the appropriateness of patients for proposed treatment modalities.
4. Implementing a procedure for evaluating and resolving patient grievances.
5. Conducting on-site reviews of facilities and providers as necessary, utilizing standards of care established by the Network organization to assure proper medical care.
6. Collecting, validating, and analyzing data necessary to prepare reports and to assure the maintenance of the ESRD patient registry.
7. Collecting, validating, and submitting to the Secretary data for inclusion in the national ESRD medical information system.
8. Identifying facilities and providers that are not cooperating toward meeting Network goals and assisting such facilities and providers in developing appropriate plans for correction. Reporting to the Secretary facilities and providers that are not providing appropriate medical care.
9. Submitting an annual report to the Secretary that includes a full statement of Network goals, data on the Network's performance in meeting its goals and encouraging participation in vocational rehabilitation programs.
10. Identifying those facilities that have consistently failed to cooperate with Network goals and recommendations with respect to the need for additional or alternative services or facilities in the Network in order to meet the Network goals, including self-dialysis training, transplantation, and organ procurement facilities.

The following is a listing of goals for The Renal Network, Inc.:

• To assist each ESRD patient to reach maximum capacity in achieving independence in employment through increased use of vocational rehabilitation services.

The Renal Network believes this goal area is best met through development and dissemination of education and information to patients and to renal providers, to encourage them to use the vocational rehabilitation services available through established agencies. To meet this goal in 1997, the Network began distributing a finance resources brochure; included vocational rehabilitation topics in newsletters and workshops; and made contacts with outside resources to provide additional assistance in the vocational rehabilitation area. This goal area is detailed in section H. Vocational Rehabilitation. Vocational rehabilitation referrals are monitored, by facility, annually.

• To increase patient involvement in his/her medical care program and in the decision making operations of the Network.

This goal is continuously maintained through the governing structure of the Network, as defined in the bylaws. Eight patient members serve on the governing and policy-making bodies: four on the Executive Committee and four on the Medical Review Board. Four Patient Advisory Committees (PAC) and a Patient Leadership Committee (PLC) assess the needs of patients, and develop projects based on these needs. Their activities are detailed in Section B. Patient Interaction in Network Activities. The Network philosophy is to increase each patient's awareness of his or her renal disease and treatment, so he or she will be an informed patient, and able to make the most appropriate treatment choices.

• To assure patient access to a high quality care including appropriate treatment settings.

All Network activities share the common goal of promoting high quality care within the member dialysis facilities. Implementation of special studies to make practice recommendations and implementation of HCFA initiatives such as core indicators support the goal of assuring access to high quality care. Specific quality improvement activities are outlined in Section D, 1996 Quality Assurance/Improvement Activities.

• To maintain a patient specific medical information system, based upon the 1983 HCFA-adopted minimal common data set that permits continual and consistent assessment of the ESRD population and provides data to support quality assurance activities and the Medical Review Board.

The existence of a patient-specific data system has created baseline data which support quality improvement. Through the system, the statistics contained in this report are made possible. The data is used as supportive material to establish benchmarks and to identify facilities with outcomes showing special cause variation. Data collection has enabled Network 9 & 10 to monitor facilities and identify trends which may necessitate intervention. The data system is also instrumental in implementing special studies.

• To stress the importance of appropriate referral, the The Renal Network has established the annual goals to monitor the rates of home dialysis and transplantation, to ensure these rates meet or surpass national trends.

The Network annually examines the areas of home therapy and transplantation by reviewing facility specific rates. Network 9 & 10 facilities are maintaining rates in these areas which currently meet or exceed the national norm. Additionally, the Network examines the availability of home therapy services, and the transplant waiting list statistics to ensure appropriate referrals are possible in these areas. These areas are explained on this page.

1. Self Care.

Network 9 developed and adopted a document entitled "Criteria and Standards to Evaluate the Appropriateness of ESRD Care" during 1989. This document contains goals for Network facilities in various aspects of dialysis treatment. (This document was adopted by ESRD Network 10 when it joined Network 9 on August 1, 1996.)

The introductory philosophy statement of the "Criteria and Standards" establishes Network goals for the treatment modalities of self-care and transplantation (listed above in "Network Goals and Objectives"). The Patient Relations Subcommittee of the MRB monitors the rate of home therapy within the Network using the most current data available. In 1997, the subcommittee examined data from 1996. The 1996 data showed the Network rate of home therapy to be 18%, compared to the national average of 15%. The Subcommittee agreed that this was satisfactory. Overall, the percentage of home therapy achieved the Network goal of ensuring that rates of home dialysis and transplantation meet or surpass national trends.

2. Transplantation.

The Network achieved a transplantation rate of approximately 4% in 1996, compared to the national average of 4%. The Board reviewed this data and concluded that in light of the current shortage of available donor kidneys, 4% is an acceptable rate. The Board monitors transplantation data on an ongoing basis and will continue to oversee developments in this area. Overall, the percentage of transplantation achieved the Network goal of ensuring that rates of home dialysis and transplantation meet or surpass national trends.

B. Patient Interaction in Network Activities.

The Renal Network maintains an active relationship with the renal community. Through regular communications with the Health Care Financing Administration and the Forum of ESRD Networks, and other professional organizations, the Network provides information of national interest to the local ESRD community, through various and continuous means of communication. To promote patient input and participation in the Network, the following activities were conducted during 1997.

• Postcards introducing the Network to new patients were sent to 8,635 individuals; new patient packets were sent to 1,078 people who responded to the postcard.

• PAC information packets were updated for new PAC representatives and new PAC alternates. These packets include information about the PAC, the Client Communication System, the Patient Leadership Committee, the Network, and Network resources.

• Resource material in Spanish was made available to those who requested it and translation assistance was available upon request.

• New social worker folders were updated; the material acquaints them with the function of the PAC and the PLC, provides information about other patient service activities, and provides them with a list of Network resources.

• PAC members, PLC members and other patients contributed articles to issues of Renal Outreach. The patient newsletters included articles about patient resources, educational information, dates of future meetings, and personal stories from patients.

• The booklet "Getting a Good Night’s Sleep" was published.

• An updated version of the "Write Now!" booklet was published.

• A session was held for Dialysis Centers of America-Chicago area social workers on June 24 to discuss patient services, the PAC, and the Client Communication System.

• PAC members were sent resources to share with patients at their facilities as well as suggestions on how to be an active PAC Representative.

• A meeting providing an overview of the Patient-to-Patient Training Program for volunteers who want to offer peer support was held on June 23 in Chicago for social workers of Neomedia, Inc.

• Throughout the year, information about the PAC, PLC, and Patient-to-Patient Program and patient resources were sent to patients and staff who expressed an interest in becoming involved with any of the programs.

• Patients in Indianapolis and surrounding areas were invited to participate in four sessions of a Rehabilitation Workshop which was a pilot project of the National Kidney Foundation.

• The Resource Information Guide was updated and distributed to all PAC Reps and social workers in the Network.

• A presentation on patient services and resources was given to the Indiana Nephrology Social Workers at their meeting on February 21 in Indianapolis.

C. Cooperative Network and ESRD Medicare Survey and Certification Activities.

During 1997, the Network maintained ongoing cooperative relationships with a wide variety of organizations within the renal and Medicare communities.

The Network maintains and ongoing relationship with Health Care Excel, the organization which administers the peer review organizations (PRO) for both Kentucky and Ohio. The Network is represented on cooperative committees organized by Health Care Excel. The Network has joined in a cooperative project with Peer Review Systems, the PRO for the State of Ohio.

The Network is represented on the Medicare Partners, a group representing organizations with the common goal of assisting Medicare beneficiaries within the states of Indiana and Kentucky. Discussions were being held with organizations within Ohio.

The Network acts as a resource to the departments of health in the Illinois, Indiana, Kentucky, and Ohio. Interactions between the Network and the state health agencies are ongoing. The Network continuously acts as an expert adviser for the technical aspects of dialysis, and provides Network developed resources when requested.

The Network also provides resources and contacts with other dialysis agencies, such as the American Association for Medical Instrumentation, the National Kidney Foundation and its affiliates, the United States Renal Data Service, and the United Network for Organ Sharing. The relationship between state health agencies and Network 9 & 10 continues to develop in a collaborative manner.

The Network participated in the HCFA/Medicare Flu campaign for 1997, distributing information on flu shots to dialysis patients and dialysis facilities.

D. 1997 Quality Assurance/Improvement Activities

1. The Core Indicator Project.

This project is designed to develop a consistent clinical database to assess patient outcomes and support improvement activities at the Network and facility levels. The elements of the database represent clinical measures indicating key components of ESRD patient care. In 1997, more that 85% of facilities participated in the Network-wide improvement projects. The goals of the project are to (1) increase the knowledge of the core indicator project to the Network 9 & 10 ESRD providers, (2) analyze the applicability of the core indicator on the facility and network levels, (3) implement improvement intervention programs on a Network-wide level and (4) improve patient outcomes.

Continuous quality improvement methods and clinical guidelines are integrated in the interventions programs. The Renal Network, Inc. established a process to collect, analyze, and provide data feedback core indicator reports to facilities.

Hemodialysis Outcomes:

• 71% patients with average URR >=65%, a 5% increase from 4Q96
• Average URR increased from 67% to 68%
• 77% patients with average Kt/V >=1.2, a 7% increase from 4Q96
• Average Kt/V increased from 1.34 to 1.42
• 72% patients with average hematocrit >=31 vol%, a 3% increase from 4Q96
• 37% patients with average hematocrit between 33-36 vol%
• Average hematocrit increased from 32.6 to 32.8 vol%
• 81% of patients with average albumin >=3.5 gm/dl, a 2% increase from 4Q96
• Average albumin increased from 3.7 to 3.8 gm/dl

• Peritoneal Dialysis Outcomes:
• 66% patients with measurement of weekly Creatinine Clearance
• 68% patients with measurement of weekly Kt/V
• 54% patients met weekly Kt/V target by modality
• 52% patient met weekly CrCl target by modality
• 77% patients with hematocrits >=31 vol%, average hematocrit 33.8 vol%
• 52% patients with albumins >=3.5 gm/dl, average albumin 3.4 gm/dl
• 26% patients with Systolic BP > 150 mmHg, average SBP 137 mmHg
• 16% patients with Diastolic BP > 90 mmHg, Average DBP 79 mmHg

In the Network–wide core indicator project, facilities collected data on 100% of prevalent patients in the fourth quarter of the year. The data was analyzed and feedback reports were distributed. The hemodialysis fourth quarter 1996 and 1997 samples and facility participation rates by state are described in D.1.

87% of the peritoneal dialysis programs collected 100% of patients’ core indicator data between November 1996 and April 1997. This time frame coincides with the national core indicator sample that is a random sample of peritoneal dialysis patient in the nation. Facility specific feedback reports were distributed. These reports showed patient outcome comparisons by health service region, state and network. Table D.2. describes the peritoneal dialysis core indicator patient sample by state, Networks and nation.

TABLE D.1 4th Quarter 1997 and 1996 Hemodialysis (HD) Patients Network-wide Core Indicators Project

Subgroup totals may not add to 100% due to rounding or missing data elements.

TABLE D.2 Nov96-Apr97 Peritoneal Dialysis (PD) Patients Network-wide Core Indicators Project

Subgroup totals may not add to 100% due to rounding or missing data elements.

2. Core Indicator Results.

Three clinical areas are addressed in the hemodialysis core indicator project. The treatment of anemia includes the first monthly pre-dialysis hematocrit (HCT), transferrin saturation rate (TSAT), ferritin level and weekly Epogen (Epo) dosage. Adequacy of dialysis contains the first monthly-paired pre-post serum urea nitrogen for a urea reduction ratio (URR) and a calculation of Kt/V using the Daugirdis II methodology. The nutritional status is measured by the serum albumin; bromocresol purple assay measurements are adjusted by 0.3 for comparison to the bromocresol green measurements.

TABLE D.3

2.a.Treatment of Anemia - Hemodialysis. Figure D.1. shows the percent of patients with average pre-dialysis HCT of greater than or equal to 31 vol% improved between the 4th quarter of 1996 and 1997. Confidence intervals show statistical differences between the two year samples and states. Average HCT increased from 32.6 to 32.8. Figure D.2. shows the distribution of HCT values for the US and Networks and Table D.3. outlines the distribution by state. There was a decrease in the percent of patients with values less then 27 vol%. Table D.4. compares average and standard deviation values by state for HCT, TSAT, ferritin and Epo dose. The average TSAT was 29% and the average ferritin was 469 ng/ml. The more frequent route of Epo administration was reported as intravenous (77%), average dose of 223 units/kilogram/ week with a standard deviation of 570. Figures D.3. & D.4.compares TSAT and ferritin values between states and Network.

Treatment of Anemia – Peritoneal Dialysis. 77% of the PD patients had an average HCT >=31 vol% between November 1996 – April 1997. The average HCT was 33.76 (sd4.52). Figure D.5. compares PD patient HCT outcomes by state, networks and nation. Table D.5. compares the average and standard deviations by state and networks.

2.b. Adequacy of Hemodialysis

Figure D.6. shows the percent of patients with an average URR of 65% or greater by state and by year. There are statistical differences in the states and years. In the Networks, there was a 5% increase in patients meeting this URR level. Figure D.7. shows the percent of patients with an average Kt/V of 1.2 or greater. All states showed a statistical difference between years. The average URR was 68% with a sd of 8.5. Average Kt/V using the Daugirdas II method was 1.42 with a sd of 0.36. The average time on dialysis increased 5 minutes, from 209 to 214. Table D.6. shows the states and networks average and sd for URR, Kt/V and time.

2.c. Adequacy of Peritoneal Dialysis. Figure D.8. shows the percent of patients with a facility reported measurement of total weekly creatinine clearance (CrCl) between November 1996 – April 1997. Figure D.9. shows the percent of patients with a reported measurement of Kt/V between November 1996 – April 1997. 34% of the Network PD patients had no adequacy measurement of CrCl reported in the sample, n=1183. Final DOQI guidelines for PD adequacy were published in September 1997.

55% of the CAPD patients met a CrCl of >=60 liter/week and 54% met a Kt/V of >=2.0. 47% of the CCPD patients met a CrCl of >=63 liter/week and 54% met a Kt/V of >=2.1.

Figures D.10.,11.,12. 13.and Table D.7.outline adequacy values by PD modality, state and networks.

Table D.7. PD Adequacy average (avg) & standard deviation(sd) by modality, state & networks Nov96-Apr97 CrCl reported as liters/week.

2.d. Nutritional Status. The serum albumin was measured as a nutritional outcome. More than 90% of the patients had an albumin measured with a bromocresol green (BCG) assay. An adjustment of 0.3 was made to serum albumins measured using the bromocresol purple (BCP) assay for comparisons.

Hemodialysis - Albumin. The average albumin increased from 3.69 to 3.78 gm/dl, 4Q96-4Q97. 81% of patients had an average albumin of >= 3.5 gm/dl, an increase of 2%. Figure D.14. compares the percent patients with average albumin >=3.5 gm/dl by state and year. Table D.8. outlines the average and standard deviation values.

Peritoneal Dialysis - Albumin. In the sample period of Nov96 – Apr 97 , the average albumin was 3.44 and 52% of patients had an average albumin of >= 3.5 gm/dl. Figure D.15. compares the percent patients with albumins >=3.5 gm/dl by state and year. Table D.8. outlines the average and standard deviation values.

TABLE D.8 Albumin (gm/dl) average (avg) and standard deviation (sd) by HD, PD, State, and Network

2.e. Blood Pressure Control - PD. The average upright systolic and diastolic blood pressures were 137/79 mmHg for the time frame. There were slight differences between states and the networks. Figure D.16. shows the percent of patients with average systolic BP > 150 mmHg. Figure D.17. shows the percent of patients with diastolic BP >90mmHg. Table D.9. outlines the average and standard deviation values.

3. Network 9 & 10 Core Indicator Interventions.

The goals of the core indicator interventions are (1) to increase the knowledge of the core indicator project to the Network ESRD providers; (2) analyze the applicability of the core indicator on the facility and network levels; and (3) implement pilot programs that can be repeated on a Network-wide level.

Participation in data collection intervention activities improved from 86% to greater than 95%. Attendance at education workshops held constant at 95%. The workshops were held regionally, focused on the areas of anemia management and hemodialysis adequacy, and outlined the "Dialysis Outcomes Quality Initiative (DOQI) guidelines.

The following describes the percent of hemodialysis Network patients in the 4Q97 sample meeting the recommended DOQI Guidelines for care:

• Hematocrit between 33-36 vol% 37%
• Epo dose between 120-180 u/kg/wk 20%
• TSAT between 20-50% 68%
• Ferritin between 100-800 ng/ml 68%
• HD Albumin >= 3.5 mg/dl 81%
• URR >= 65% 71%
• Kt/V Daugirdas II >=1.2 77%

The following describes the percent of PD Network patients in the Nov96–Apr97 sample meeting the recommended DOQI Guidelines for care:

• Hematocrit between 33-36 vol% 31%
• PD Albumin >= 3.5 mg/dl 48%
• CAPD CrCl >= 60 L/wk 58%
• CCPD CrCl >= 63 L/wk 50%
• CAPD Kt/V >= 2.0 53%
• CCPD Kt/V >= 2.1 54%

The Network made three main changes in 1997. The first two were directed at facilities with changes in the facility feedback reports and the Electronic Patient Tracking (E.P.T.) program. These revisions enhanced the comparison of facility outcomes with the congruent health service area, state and network outcomes. The third major change was the design and implementation of the "Physician Activity Sheet." The purpose of the "Physician Activity Sheet" focused on the professional-patient-facility link to improve patient outcomes.

Under the direction of the MRB, a pilot project began in January and concluded in May. MRB and BOT physicians (n=24) were tagged with their specific 4^th quarter hemodialysis patient outcome data via the unique physician identifier number, (UPIN). Patient outcomes and UPINs were collected at the facility and sent to the Network office.

Patient lists and outcome data were then sent to each physician for validation. The next step in the process was the correction of the UPINs and patients. Physicians then communicated to the facilities any errors. Corrected facility information and physician feedback reports were regenerated and reports were distributed.

Two key process elements were identified in the pilot project:

1. A close link was needed between the patient’s monthly core indicator data and physician.
2. The UPIN data needed to match the appropriate physician.

The core indicator section of the E.P.T. program was revised to link the monthly core indicator data to the physicians. More than 650 physicians received a "Physician Activity Sheet" reporting the 1997 fourth quarter hemodialysis core indicator data. Each report compared the physician’s total patients core indicator outcomes with the outcomes of patients in the specific facility, the facility, health service area region, state, network and nation. Additional comparisons were done between all physicians in the state for average hematocrit, transferrin saturation rate, ferritin level, weekly Epo dose/kilogram, urea reduction ratio, Kt/V and albumin.

1998 Interventions. 1998 interventions will include data collection and feedback reports and regional education workshops. The focus will be on DOQI guidelines, physician-patient outcome data and facility plans for improvement.

4. National Core Indicator Project.

All 18 Networks participated in this national quality improvement initiative. Random samples of hemodialysis and peritoneal dialysis patients were drawn, only the hemodialysis sample is representative of the network. The PD sample is used for a national rate only. Table D.10. outlines the comparison of the Networks to other Networks in the nation.

* HCFA 1997 Annual Report ESRD Core Indicators Project, December 1997.

E. Network Special Projects/Studies.

1. Peritonitis Rate Benchmarks.

The peritonitis rate of the Network was assessed in December 1996 with 100% of the Network peritoneal dialysis programs reporting on the prevalent patient population. The overall peritonitis rate was one episode in every 13.5 months. There was no statistical difference between CAPD and CCPD.

Gram positive organisms were the main cause of peritonitis: 21%S.aureus, 17%S. epi. The reported cases of VRE were rare at 0.7%.

Dr. Richard Hamburger and the Data Analysis Subcommittee presented a poster on the peritonitis data for the 1997 meetings of the American Society of Nephrology. The abstract, entitled "A Prospective Study To Determine The Current Peritonitis Rate In Peritoneal Dialysis Patients," was accepted for a poster and a four minute discussion. The following table highlights peritonitis rates from the data.

2. Quality Improvement Projects.

The development of Quality Improvement Projects (QIP) is mandated in the Network contract with HCFA. During 1997, the Data Analysis Subcommittee began development of the first QIP of the new contract. The QIP focuses on the area of peritoneal dialysis prescription. The QIP process involved the identification of a problem planning and implementing intervention, followed by data collection to assess the improvement made. The problem was identified through the core indicator collection for November 1996 – April 1997. These data showed that 70% of the patients had one Kt/V measurement and 60% of the peritoneal patients had a total creatinine clearance measured.

The QIP will address measurement and prescription adequacy through three collections of data. The first collection was completed during 1997. The second data collection will occur with the collection of the 1997 core indicator data for peritoneal dialysis. The third data collection will fill in data missing for the core indicators, specifically on aspects of the dialysis prescription, and if changes were made to the prescriptions based on adequacy measurements. Interventions will come in the form of a distribution of the data feedback to the facilities, and workshops. Data will again be collected a year after the QIP is completed to reassess any improvements which have been made.

The Data Subcommittee also decided on vascular access as the focus of a second QIP. Vascular access data was collected on the prevalent hemodialysis patients from 100% of facilities for the period December 25-31, 1997. This data was used to establish baseline rates for the network quality improvement project. Preliminary data showed variation between states, health service areas and facilities. A Catheter Use Ratio methodology was designed and presented for review by Dr. Ashwini Sehgal to the Data Analysis Subcommittee.

Vascular Access QIP- Preliminary Data

3. Barriers to Adequacy Study.

The Network and Peer Review Systems (PRS) continued the Barriers to Adequacy Study in Ohio. The study first identified three aspects of care as the most critical barriers to adequacy of dialysis: low prescriptions, non-compliance, and use of catheters. This study consisted of a data collection for 1,200 patients in 20 dialysis units in Ohio. The data feedback meeting and education workshop for participants was held on December 3 in Dayton, Ohio. At year-end, participants were developing strategies for intervention. These issues will be revisited in 1998 to measure improvements, which have been made.

4. 1991-1992 Peritonitis and Catheter Survival Study.

A journal article based on the 1991 Peritonitis and Catheter Survival Study was published during 1997. The article, entitled "Outcomes of Single Organism Peritonitis in Peritoneal Dialysis: Gram Negatives Versus Gram Positives in the Network 9 Peritonitis Study," was published in Kidney International, Vol. 52, 1997) with C. Martin Bunke, M.D., Michael E. Brier, Ph.D., and Thomas A. Golper, M.D., as authors.

5. Focused Quality Assurance Activities.

The Network conducted one site visit during 1997. A site visit team of 11 members visited the facility in January. The reason for the site visit was based on poor response to two separate grievances which had been filed with The Renal Network. The team wrote a report identifying opportunities for improvement and requesting a correction action plan. During the year, the MRB continued to work with the facility in a cooperative manner, working toward improvement. A follow-up site visit was conducted in December. All team members agreed that the facility had made improvements as requested. The intervention was considered final and closed by year-end.

6. Other Network Quality Assurance Activities

1. Facility-Based Quality Assurance Activities. Facilities are required to have a quality assurance program in place, per the Network Criteria and Standards to Evaluate the Appropriateness of ESRD Care. This document is distributed to all new facilities.
   
2. Educational Materials and Guidelines. In 1997, the Network provided educational materials and guidelines that addressed medical case review information and continuous quality improvement. All of the educational materials and guideline information affects patient care. This information addressed aspects of direct patient care, product care, and facility care. Educational material and guidelines are developed and distributed in an ongoing manner.
   
3. Statistical Analysis. The Network, through the MRB, conducted statistical analysis of data throughout the year. In prior years, the Network selected aspects of data to study, mainly in the area of gross mortality and standard mortality ratios.
   
4. Facility Profiles. To foster concepts of continuing quality improvement, in 1996 the MRB decided to provide comparison data to each facility which would allow them to look at their own data and design improvement plans as they considered necessary. To do this, a facility profile was designed. The profile is drawn from the Network data and contains data specific to each facility, along with a comparison of regional, state, Network, and national data. Data elements included are incidence, demographic and diagnosis information, mortality and SMR. The profiles were distributed during the 1996 spring meeting of the Network Coordinating Council, and as requested by individuals facilities during the year. These facility profiles continued in 1997.
   
5. United States Renal Data System, U.S.R.D.S. The Network provided logistical and quality assurance support for the Dialysis Morbidity & Mortality Study (DMMS). All patient and facility forms were processed at the network office and then sent to the U.S.R.S. Coordinating Center. DMMS Wave activities closed in December. The following outlines the number of facilities and patients in each Wave of the study.