The End Stage Renal Disease Network of Texas (#14) is under contract #HHSM NW014C with the Centers for Medicare & Medicaid Services

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1 The End Stage Renal Disease Network of Texas (#14) is under contract #HHSM NW014C with the Centers for Medicare & Medicaid Services Baltimore, Maryland

2 E S R D Network Mission Statement: We support quality dialysis and kidney transplant healthcare through patient services, education, quality improvement, and information management. Definition of Quality: Quality of care is the degree to which health services to individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Institute of Medicine 1 P age ESRD Network of Texas, Inc. (#14) 14 We will: The management, staff, and Boards of the ESRD Network of Texas, Inc. will work to assure the health care security for ESRD patients in Texas. This includes access to appropriate and quality health care that achieves desired outcomes, protection of rights of dignity and consumer satisfaction, and dissemination of clear and useful information to assist with health care decisions. Vision We will foster a commitment to continued treatment of ESRD patients while preserving a safe environment, provide web-based resources, and find ways to decrease facility workload yet still get the information we need. Values We strive to understand and act upon the needs of customers, employees, Boards, and partners. Our success is dependent on collaboration with providers, patients, and the volunteer Network Boards and committees. We act with integrity in all we do.

3 ~ ~ 1 PREFACE Statement of the Chairman June 2012 It is my pleasure to endorse and submit the 2011 Annual Report of ESRDNetwork #14. This report provides data and narrative to chronicle the activities of the Network for the period from January 1, 2011 through December 31, On behalf of the members of the Executive Committee, I extend sincere appreciation to all individuals serving on the various committees for their active participation in developing and carrying out the projects and programs of Network #14. The staff and volunteers of the Network are to be commended for their continuing efforts to improve the care and quality of life of the ESRDpatients in Texas. Our appreciation also goes to all the providers and patients for their cooperation in working toward the successful accomplishment of the Network Goals. Vascular Access Quality Improvement Projects conducted in 2011 successfully increased use of AVF in Network #14 that will improve the lives of our patients. Additionally, as this significant progress was achieved, the catheter rate has remained the lowest among the ESRDNetworks. While the improvements have been realized, substantial barriers to achieving the CMSgoal of 66% of patients with AVF remain. The Texas ESRDEmergency Coalition, the statewide disaster coalition, remained active and ready to provide disaster assistance to patients and providers. The Network has met its goal to function in a highly efficient and productive manner, as evidenced by its fulfillment of contractual obligations while responding to the needs and concerns of the large number of both dialysis and transplant providers (547) and patients (50,292) that comprise Network #14. This was accomplished with a limited number of staff and with the lowest contract reimbursement per Medicare funded dialysis treatment of any Network. In 2011, 5,119,800 dialysis treatments were delivered to Texas patients, 91.2 percent of which were currently enrolled in Medicare. "'It is by continuing to work together with providers that the Network assures that ESRD patients receive care that is safe, consistent with current professional knowledge, and that improves patient outcomes. We look forward to the coming year and the challenges it will bring. ~~ :yavlw~ Chairman, ESRDNetwork of Texas, Ine. 21Page ESRD Network of Texas, Inc. (#14)

4 TABLE OF CONTENTS 1. PREFACE 2 Statement of Chairman Table of Contents 2. INTRODUCTION 4 Network Description Network Structure Committee Function and Activity 3. CMS NATIONAL GOALS & NETWORK ACTIVITIES 20 Improve the Quality and Safety of Dialysis Related Services Provided for Individuals with ESRD in Texas 20 Improve Independence, Quality of Life and Rehabilitation of Individuals Through Support for Transplantation, Use of Self-Care Modalities and In-Center Self Care, as Appropriate, Through the End of Life..77 Improve Patient Perception of Care and Experience of Care and Resolve Patient s Complaints and Grievances...82 Improve Collaboration With Providers to Ensure Achievement of Goals 92 Improve the Collection, Reliability, Timeliness, and Use of Data to Measure Processes of Care and Outcomes, to Maintain a Patient Registry, and to Support Goals of the ESRD Network Program SANCTION RECOMMENDATIONS RECOMMENDATIONS FOR ADDITIONAL FACILITIES & SERVICES DATA TABLES P age ESRD Network of Texas, Inc. (#14)

5 INTRODUCTION This annual report is submitted as a contract deliverable by the ESRD Network of Texas, Inc., which serves as the contractor for ESRD Network #14. The report format follows the guidelines set forth by CMS in the ESRD Network Organization Manual. The report covers the contract period between January 1, 2011 and December 31, NETWORK DESCRIPTION Network #14 encompasses the state of Texas, which is the second largest state in land area behind Alaska, with 267 thousand square miles of land. Texas is also the second most populous state in the nation behind California, with an estimated population of 25.7 million residents in 2011, increasing 529,120 from Calculated from the 2010 census, Texas experienced the highest estimated numeric increase among states in 2011 (2.1%); though California has the largest population, it only saw an estimated increase of 437,956 (1.2%) in Eight percent of the nation s population resided in Texas in The metropolitan areas of Austin, Dallas-Fort Worth, Houston, San Antonio, and the Rio Grande Valley continued to grow in 2011, accounting for 55 percent of growth between 2010 and The most growth occurred in the Dallas-Fort Worth area, closely followed by the Houston Metroplex. ESRD Network #14 is the largest Network in number of total patients (50,273), followed by Network #6 (49,178), and the third largest Network in number of dialysis Providers (524) behind Network #6 (591) and Network #9 (525) at year end Population estimates predict that minority groups will make up increasing percentages of the Texas population in the next three decades, and the 2010 census demonstrates this change. Since 2004, Texas has been a majority-minority state, with minority being defined as all people except single-race, non-hispanic whites. While Hispanics in the U.S. numbered 52 million in 2011, in Texas, the number of Hispanics increased from 9.5 million in 2010 to 9.8 million in 2011 and comprises 38.1 percent of the state's population. Nineteen percent of the total U.S. Hispanic population resided in Texas in As in recent years, the state Hispanic growth is fueled in nearly equal measure by immigration and natural increase. The immigration increase is of concern in the ESRD community due to predictable problems for immigrants in obtaining health care, particularly in a population that is predisposed to diabetes, and thus ESRD. 4 Page ESRD Network of Texas, Inc. (#14)

6 Additionally, Texas continues to rank the highest among states in uninsured population, with 27.2 percent of the population uninsured at the beginning of The age of the general population is also expected to change. Ten percent of Texans were 65 years of age and over in 2010; by 2030 this age group is estimated to increase to 17 percent. African-Americans, expected to make up only 9 percent of the Texas population by the year 2010, increased from 11.1 percent in 2009 to 11.8 percent in 2010 and are estimated to have made up 12.2 percent of Texas population in Chart 1 Gender (%) Prevalent Texas ESRD Patients Male Female The percent of females in the Texas ESRD prevalent population has decreased 2.6% since 2000, with a 0.4% decrease from 2010, while the percent of males in the prevalent population has increased 2.2% since 2000 with a 0.4% increase from 2010 (Chart 1). Hispanics are the most highly represented ethnic group in the Texas ESRD population, with approximately 42 percent comprising newly diagnosed (incident) patients in 2011 and 45 percent comprising all (prevalent) Texas ESRD patients (Chart 2), compared to 38.1 percent Hispanic in the total 2011 Texas estimated population. African- Americans make up 30 percent of the ESRD patients in Texas, nearly triple the Texas estimated population percentage. Hispanic, 17,600, 45% Chart 2 Ethnicity Prevalent Texas ESRD Patients Non Hispanic, 21,578, 55% 5 P age ESRD Network of Texas, Inc. (#14)

7 Chart 3 Age Comparison Texas ESRD 2011 & General Population ESRD General Population Persons age 45 years and over account for 85% of all ESRD patients in 2011, up from 84% in This age group comprised only 34.4% of the general Texas population. The percent of Texas ESRD patients 65 and over, at 37.6%, is nearly four times that of the general population at 10.4%. In contrast, less than 1% of all Texas ESRD patients are children aged 0-19, which is significantly below the general population (30%) in this age range (Chart 3). The age range has the greatest proportion of ESRD patients, followed by those aged 50-59, and (Chart 4). The percentage of very elderly dialysis patients, >80 years, has increased from 6.6% in 2000 to 8% in Chart 4 Percentage ESRD Patients by Age % % % 80+ 8% % % % % % 6 P age ESRD Network of Texas, Inc. (#14)

8 Incidence and Prevalence of End Stage Renal Disease (ESRD) in Texas The incidence of ESRD in Texas is above the national average and trended upward annually for many years with the exception of The rate increased to 387 per million in 2010, but decreased to 376 per million in The prevalence of ESRD in Texas, however, continues to rise. In 1990, 524 out of each million Texans had a diagnosis of ESRD; in 2011 the unadjusted prevalence rate for the Texas population had climbed to 1,524 per million, up from 1,489 in 2010 (Chart 5). 2,000 1,500 1, Chart 5 Texas ESRD Patient Incidence and Prevalence 764 Rates per million Texas population per yer 994 1,073 1,154 1,246 1,315 1,402 1,437 1,489 1, Texas Population 25.7 Million Incidence Prevalence At the end of 2011, 50,273 persons were receiving renal replacement therapy (dialysis and transplant combined) in Texas. Of these, 39,177 were receiving dialysis and 11,114 had functioning transplants. In 2011, 9,654 newly diagnosed persons with ESRD began receiving dialysis, a 1.1 percent decrease from 2010 (Chart 6); however, the prevalent population at 39,177 increased 4.7 percent over ,000 20,000 0 Chart 6 Texas ESRD Patient Growth Trend 29,371 30,899 32,383 33,933 35,623 37,420 39,177 15,221 22,447 5,794 9,232 2,398 3,297 5,001 7,018 8,355 8,910 8,840 9,125 9,441 9,763 9, Incident Prevalent 7 P age ESRD Network of Texas, Inc. (#14)

9 ESRD Facilities At the end of 2011, Texas had a total of 494 Medicare approved dialysis facilities located in 119 of the 254 Texas counties. These facilities are located in 46.8 percent of Texas counties, the same as Harris County (Houston area) has the most facilities (n=90), Bexar County (San Antonio area) the second highest number (n=45), and Dallas County (Dallas area) the third highest number (n=42). When Fort Worth (n= 32) is combined with Dallas to encompass the DFW Metroplex with 74 facilities, the area does not exceed Harris County in Twenty-three transplant centers and one special renal children s camp were also in operation. In 2011, 9,971 dialysis stations were available for use in dialysis facilities as reported in SIMS, a 2.3 percent increase over Dialysis facilities are concentrated in highly populated urban areas and in some border counties, in accordance with the population centers of the state. There are two Veterans Affairs (VA), three military, and two criminal justice non-medicare certified dialysis facilities operating in Texas. While improvement has been seen, as was observed in 2009 and again in 2010, new facilities are awaiting initial Medicare Certification for long periods. At year end, 23 dialysis facilities were waiting, some for over a year, as compared with 20 dialysis centers at year end 2010 and 44 dialysis centers at year end As has been true for a number of years, the majority of facilities are owned by National Corporations, with the percent increasing in 2011 (Chart 7). Chart Texas Facility Ownership by Percent Nat'l Chain 83% Regional 5% Hospital 1% Prison 0% Military 1% Independent 9% Pediatric 1% 8 P age ESRD Network of Texas, Inc. (#14)

10 NETWORK STRUCTURE The Network organizational structure is capable of supporting all activities of the Network, especially the comprehensive Quality Management Program. In addition to the Network employees, contract staff and volunteers are utilized. There are three primary volunteer committees: the Network Council, Board of Directors (Executive Committee), and the Medical Review Board (MRB). Staffing Glenda Harbert, RN, CNN, CPHQ Executive Director The Executive Director (ED) provides advice to the Board of Directors and Council on goals, objectives, work plans, policies and procedures; identifies and assists in the establishment of relationships with ESRD providers and other health related organizations; administers the operational and financial aspects of the corporation and contract requirements; makes reports to the Council and committees and is responsible for their activities; manages the staff and daily office operations; and performs other duties assigned by the Board of Directors or contracting officer. The ED serves as the project director and, as such, is responsible for adherence to all contract provisions and is the primary source of information between the Network organization and Centers for Medicare & Medicaid Services. Nathan Muzos, BS, MCSE, MCSD, MCDBA, CompTIA A+ Information Management Director The Information Management Director (IMD) collaborates with CMS, providers, and other ESRD Networks to successfully transition to and maintain a dynamic web-based database that accurately stores current status of all ESRD patients receiving Renal Replacement Therapies in Texas; to produce comprehensive provider specific comparative profiles; to perform functions to support special studies and quality improvement activities as directed, and to support the users of the system. Under the direction of the Network s ED, the IMD is responsible for overseeing and managing the daily operations, maintenance, and integrity of the Network #14 database and systems to ensure timely completion of specified deliverables, creation of designated reports, and other special projects as directed. 9 P age ESRD Network of Texas, Inc. (#14)

11 Kelly Shipley, BS, RHIA Quality Improvement Director The Quality Improvement Director (QID) serves as staff for the MRB to coordinate MRB activities; develops the quality improvement approach to include evaluating the quality of patient care, conducting quality improvement projects, conducting necessary training for completion of quality improvement projects and trend analysis; writes reports for the MRB and Council; directs data collection, display, and analysis for the MRB; serves as a resource for providers and facility quality improvement personnel; collaborates with the MRB to develop the Quality Improvement Work Plan (QIWP), and performs other duties assigned by the ED. Treneva Butler, LCSW, NSW-C Patient Services Coordinator The Patient Services Coordinator (PSC) manages concerns, complaints and grievances and coordinates the development of a rehabilitation approach that includes identifying rehabilitation resources and encouraging patient rehabilitation; develops educational materials to increase awareness of treatment options; and conducts training in Advanced Care Planning and Decreasing Conflict. The PSC maintains liaison with unit social workers, proposes special studies as appropriate, and performs other duties assigned by the ED. Debbie O Daniel Office Manager The Office Manager (OM) provides administrative support to the ED, QID, IMD, and PSC; serves as office manager; assists with meeting arrangements; assists in specials studies; assists the Executive Director with financial responsibilities; types correspondence and reports; maintains a filing system; maintains the computerized mailing labels; participates in the Community Information Resources team; and performs other duties assigned by the ED or staff. Angeline Wieler, BSN, RN, CNN, CPHQ Quality Improvement Coordinator The Quality Improvement Coordinator (QIC) functions with the QID and assists in the development and implementation of an overall quality improvement approach. Under the direction of the QID, the QIC is responsible for facility liaison with QI contacts. This individual also assists in the development of educational strategies and materials to increase awareness of all treatment options, new technologies and professional 10 P age ESRD Network of Texas, Inc. (#14)

12 practices, manages Network and MRB technical assistance to the Department of State Health Services (DSHS), and performs other duties assigned by the ED or the QID. Christi Cosby, BS, MPH Quality Improvement Analyst The Quality Improvement Analyst (QIA) works with the QID and QIC to implement and monitor quality improvement projects and special studies. This includes shared responsibility for organizing, collecting, validating, compiling, analyzing, and reporting results of these projects and studies. The QIA provides technical assistance to facilities during data collection projects and assists with the QI workplans and QI improvement plans. The QIA also assists with other projects as assigned by the ED or QID. Carolyn Atkins, BSN, RN, CCTC Quality Improvement Nurse The Quality Improvement Nurse (QIN), under the direction of the QID, assists with facility QI contacts and in the development of educational strategies and dissemination of materials that support the work of the QIWP. This individual provides technical assistance to the MRB and performs other duties assigned by the ED or the QID. Beverly Sneed, BSN, RN Quality/Patient Services Nurse The Quality/Patient Services Nurse (QPN) assists the QID and QIC with the development and implementation of an overall quality improvement approach. Under the direction of the QID, the QPN is responsible for facility liaison with QI contacts. This individual also assists in the development of educational strategies and materials to increase awareness of all treatment options, new technologies and professional practices, manages Network and MRB technical assistance to DSHS, and performs other duties assigned by the ED or the QID. Grant Kingsley, BSW through September 2011 Sylvia Dominguez, BSW commencing November 2011 Patient Services Social Worker The Patient Services Social Worker (PSSW) assists the PSC with managing the concerns, complaints, and grievances within the renal community, provides technical assistance, and performs other duties as assigned by the ED or PSC. 11 P age ESRD Network of Texas, Inc. (#14)

13 Casey Contreras, BS Information Management Coordinator The Information Management Coordinator (IMC) assists the IMD in the maintenance and update of the patient and facility specific database; assists in meeting the data related contract deliverables, including oversight of the annual facility survey process; provides facility training on completion of data forms; responds to and assists in the processing of data requests; manages the monthly Patient Activity Report process; serves as a resource to providers and Network staff; assists with VISION and CROWNWeb activities; and performs other duties assigned by the ED or the IMD. Jennie Conley Administrative Assistant The Administrative Assistant (AA) functions in a cross departmental role. This includes performing data specialist activities in the maintenance and update of the patient and facility specific database and facility training and assisting in the management of the monthly patient activity report process. Responsibilities in the QI Department include oversight of quality improvement data collection, verification, and validation initiatives, including Vascular Access. The AA also performs other duties assigned by the ED or the OM. Doris Wilson Information Management Clerk The Information Management Clerk (IM Clerk) manages the data entry process for the CMS forms and obtains missing information. This individual also assists with phone duty, accepts incoming deliveries, assists with mail duties, and performs other duties assigned by the ED, IMD, IMC, or OM. Kathleen Prewitt, BA Information Management Clerk The Information Management Clerk (IM Clerk) manages the data entry process for the CMS forms and obtains missing information. This individual also assists with phone duty, accepts incoming deliveries, assists with mail duties, and performs other duties assigned by the ED, IMD, IMC, or OM. 12 P age ESRD Network of Texas, Inc. (#14)

14 Ashley Wright, BA Information Management Clerk The Information Management Clerk (IM Clerk) manages the data entry process for the CMS forms and obtains missing information. This individual also assists with phone duty, accepts incoming deliveries, assists with mail duties, and performs other duties assigned by the ED, IMD, IMC, or OM. Magdalena Sanchez, BS Information Management Clerk The Information Management Clerk (IM Clerk) manages the data entry process for the CMS forms and obtains missing information. This individual also assists with phone duty, accepts incoming deliveries, assists with mail duties, and performs other duties assigned by the ED, IMD, IMC, or OM. Leigh Husni, BS Project Assistant The Project Assistant supports the design of Quality Improvement Projects and the annual Quality of Care data, assists in data collection and analysis, writes reports and papers for distribution, generates profile reports, performs functions of website maintenance, and performs other duties assigned by the ED or the QID. Andrea Fichtner, MPH through September 2011 Anna Koenig, BS, MPH commencing September 2011 Outreach Coordinator The Outreach Coordinator (OC), under the direction of the ED, coordinates the activities of the Network with its many partners, provides educational information and training to ESRD professionals, patients and their family members, and other members of the renal community. The OC is the liaison to the statewide coalition and is responsible for directing the activities of the Patient Advisory Committee and Network Patient Representatives in each facility, as well as directs and facilitates coalition activities. 13 P age ESRD Network of Texas, Inc. (#14)

15 COMMITTEE FUNCTION AND ACTIVITY Network Council The Network Council provides the mechanism for coordinated information exchange between the providers of ESRD services and the Network organization. The facilities in the Network are responsible for carrying out the Network goals and objectives and adhering to the standards and criteria developed by the Medical Review Board. Each Medicare certified ESRD facility in Network #14 has been invited to join the Network Council and has appointed a representative to the Council. The Patient Advisory Committee has also appointed a representative to the council to ensure that patient concerns are addressed. In order to ensure that all disciplines are represented on the Council, the Network can appoint individuals to represent any discipline that is not represented by the various facility appointments. In 2011, an environmental scan of the Council Representatives was utilized to gain insight and direction to guide Network activities. The Network Council met once in Special Accomplishments: In 2011, the Council approved revision of the organizational Bylaws. Board of Directors (Executive Committee) The Network organization activities are under the direction of an elected nine member voluntary Board of Directors. The Board manages the business affairs of the corporation, establishes policy for Network Council consideration, establishes goals for Network Council consideration, and is responsible for the accomplishment of the contract through the Network organization. The Board receives reports from the Executive Director, as well as the coordinators of the Information Management, Quality Improvement, and Patient Services departments. The Board met three times in person and once by conference call in Special Accomplishments: In 2011, the Board of Directors completed an organizational assessment in collaboration with the Center for Non-Profit Management, drafted revised Bylaws and worked with the Council for approval. 14 P age ESRD Network of Texas, Inc. (#14)

16 Medical Review Board The Medical Review Board (MRB) is a 21 member voluntary, multi-disciplinary advisory body appointed by the Board of Directors of Network #14 that represents the diverse geographic areas and the various ESRD related disciplines. These appointments are based upon recommendations from the appropriate professional organizations and renal community. The Omnibus Budget Reconciliation Act of 1986 (OBRA) (Public Law ) required the establishment of the MRB and directed that ESRD facilities and providers follow the recommendations of the MRB (Section 9335 {g}). The MRB met four times in person and conducted numerous conference calls in The purpose of the MRB is to assure, through the application of suitable procedures of health care review, that the care provided to ESRD patients within Network #14 is maintained at an optimal achievable level of quality. The MRB operates in accordance with established procedures and observes strict conflict of interest guidelines as defined in Section 1126 (a) (1) of the Social Security Act. The Medical Review Board objectives are: To assesses facility progress in meeting the Network goals To evaluate professional performance and patient outcomes for consistency with expected and desirable standards and results that define quality care To identify and evaluate patterns of care exhibited in the Network's facilities and compare such patterns, when possible, to local, regional, and national findings in an attempt to identify problems, inefficiencies, and/or areas of performance where improvements could be realized On the basis of its review, to recommend or carry out actions indicated for improvements in the ESRD care of individual patients or groups of patients Special Accomplishments of the MRB: During 2011, the MRB focused on the following: Provision of professional expertise and opinions for 7 new and 11 continuing Texas DSHS referrals Participation in active quarterly review of all open DSHS referrals Continued collaboration with DSHS regarding the DSHS referral process to the MRB Provided direction and guidance for development of the Quality Improvement Work Plan and identified, participated in, and assisted with implementation of the Network-wide quality improvement projects (QIPs), including review of aggregated focus facility results 15 P age ESRD Network of Texas, Inc. (#14)

17 Patient Advisory Committee The Patient Advisory Committee (PAC) is comprised of ESRD patients and/or caregivers to ESRD patients that represent the ethnic diversity, geographic distribution and treatment modalities of the ESRD population in Texas. When position vacancies arise, all dialysis facilities and transplant centers in Texas are contacted with a request for nominations for the PAC. The primary requirement is that the patient is highly recommended by his/her own physician, nurse, social worker, and dietitian as a positive role model to other patients. The PAC met two times face to face and had nine conference calls in The PAC collaborates with the Network Patient Representatives (NPR) that each facility is asked to appoint. PAC members were requested to assist on many occasions by facility staff with new patients and/or family members who were struggling with their new lives as ESRD patients/family members. During 2011, the PAC focused on the following: Worked as a liaison between the ESRD patient population and the Network staff, Boards, and Committees Scheduled and participated in two regional Network Patient Representative (NPR) meetings in the Dallas/Fort Worth area Reviewed and made revision suggestions for the letter to New ESRD Patients Suggested the creation of a Ten Suggestions and Tips poster for dialysis patients to be distributed to all facilities statewide with instructions to post for viewing by all patients and family members Reviewed and made suggestions on patient educational materials developed by the Network for distribution in facility mail-outs, patient and/or professional newsletters, and posting to the Network website Continued use of the PAC Seal of Approval that is affixed to educational items reviewed by the PAC Provided feedback to the Texas ESRD Emergency Coalition (TEEC) through a patient s perspective when dealing with a disaster situation Provided patient education articles for the monthly NetLink newsletter that is distributed to all facilities Provided patient education articles for the semi-annual Lone Star Newsletter 16 P age ESRD Network of Texas, Inc. (#14)

18 Developed a patient education project focusing on the effects of fluid overload on a patient s heart, which consisted of the development of a brochure and poster to be disseminated in 2012 Other Committees In addition to the three primary committees, there are other committees and subcommittees, such as the Nominating Committee and discipline and project specific committees, that are utilized for Network operations and are activated or appointed as required. 17 P age ESRD Network of Texas, Inc. (#14)

19 Committee Membership Executive Committee Chairman Melvin Laski, MD Nephrologist Lubbock, Texas Vice Chairman Manny Alvarez, MD Nephrologist El Paso, Texas Secretary Charles Orji, MD Nephrologist Tyler, Texas Treasurer Larry McGowan, BA Administrator College Station, Texas Member at Large LeighAnne Tanzberger Patient Houston, Texas Member at Large Laura Yates, RN Nephrology Nurse Harlingen, Texas Member at Large JD Bell, MD Nephrologist Bedford, Texas Past Chair Richard Gibney, MD Nephrologist Waco, Texas MRB Chairman Ruben Velez, MD Nephrologist Dallas, Texas Medical Review Board Nephrologists Ruben Velez, MD, Chairman Robert Hootkins, MD, Past-Chairman Donald Molony, MD, Chair Elect Clyde Rutherford, MD Navid Saigal, MD Mohanram Narayanan, MD Dallas, Texas Austin, Texas Houston, Texas Corpus Christi, Texas Live Oak, Texas Temple, Texas Pediatric Nephrologists Mazen Arar, MD Samhar Al-Akash, MD San Antonio, Texas Corpus Christi, Texas Transplant Surgeons Osama Gaber, MD Greg Jaffers, MD Houston, Texas Temple, Texas Nurses Debbie Heinrich, RN, CDN Patricia White, RN, CNN KayLynne Duran, RN, CNN Social Workers Mary Beth Callahan, LCSW Martha Donaho, LCSW Austin, Texas Greenville, Texas Laredo, Texas Dallas, Texas Houston, Texas 18 P age ESRD Network of Texas, Inc. (#14)

20 Dietitians Jane Louis, RD Jana Zimmer, RD Houston, Texas Rancho Viejo, Texas Patients Diane Morgan Anna Gonzales Dallas, Texas San Antonio, Texas Technologist John Dahlin, CHT Dallas, Texas 19 P age ESRD Network of Texas, Inc. (#14)

21 CMS National Goals & Network Activities During calendar year 2011 the End Stage Renal Disease Network of Texas, Inc. (Network #14) continued efforts to meet the national goals of CMS Health Care Quality Improvement Program (HCQIP). In support of HCQIP, the Network developed and conducted multiple activities to improve the quality of care, health services, and quality of life for End Stage Renal Disease (ESRD) beneficiaries. The Network performed quality activities described in this section in GOAL: IMPROVE THE QUALITY AND SAFETY OF DIALYSIS RELATED SERVICES PROVIDED FOR INDIVIDUALS WITH ESRD Quality Improvement Work Plan (QIWP) Activities Network #14 developed a Quality Improvement Work Plan (QIWP) in conjunction with the Medical Review Board to meet the HCQIP goal of improving the quality and safety of dialysis related services provided for individuals with ESRD. The QIWP implemented one or more Quality Improvement Projects in each of the following four categories to address the complex, quality-related health and safety needs of ESRD patients: 487 facilities & 35,348 patients were impacted by the VA QIP interventions Vascular Access (2 projects completed, 1 new project implemented) Clinical Performance Measures (2 projects initiated) Network Specific (1 project initiated) Facility Specific (2 projects completed) VASCULAR ACCESS QUALITY IMPROVEMENT PROJECTS The 2011 AVF QIWP interventions impacted 487 facilities and 35,348 patients After several years of stagnation in AVF rate, Network #14 started with the lowest AVF rate nationally in 2005, and a steady increase followed. At year end 2011, the rate was 60.3 percent, equal to the national percent, and Network #14 ranked seventh (7th) among the 18 ESRD Networks (Charts 8 & 9). 20 Page ESRD Network of Texas, Inc. (#14)

22 At year end 2011, Network #14 had the highest rate of increase in AVF among all Networks. Since the inception of the Fistula First Project, a 34.6% increase from baseline has occurred, compared to the national increase of 27.9% (Chart 8). Percent Increase in AVF Chart 8 Percent Increase in AVF from Baseline All Networks December US ESRD Networks and US Percent of Patients with AVF Chart 9 Network Rank by AVF December US ESRD Networks and US The number of patients with AVF in use increased by 1,645 in P age ESRD Network of Texas, Inc. (#14)

23 Number of Facilities Chart 10 Network 14 Distribution of Percent AVF Rate Percent AVF Rate 12/ / / / / / / /2011 The number of facilities with over 40% AVFs increased from 46 (14.6%) in October 2003 to 470 (95.3%) in December 2011 (Chart 10), depicting a classic Quality Improvement shift over time and closing of a quality gap. The number of patients with AVF in use in Network #14 increased by 1,645 in In December 2010, 19,813 prevalent patients had an AVF in use out of 34,696 total HD patients (57.1%), compared to December 2011 when 21,638 prevalent patients had an AVF in use out of 35,934 total HD patients (60.3%). VASCULAR ACCESS QUALITY IMPROVEMENT PROJECTS CONTINUING FROM 2010 FUNCTIONING FISTULA During 2011, Network #14 continued with the Vascular Access Quality Improvement Project (QIP) initiated in 2010 designed to achieve optimal vascular access outcomes in dialysis facilities reporting prevalent AVF rates less than or equal to 55% and who had 8 or more maturing fistulas by focusing on functioning fistulas. A group of seventytwo focus facilities were identified that met the QIP criteria. The QIP is described in Table P age ESRD Network of Texas, Inc. (#14)

24 Table 1. Functioning Fistula Vascular Access Quality Improvement Project Components Objectives I. Education: Three Webinars To provide up-to-date information on vascular access processes and outcomes monitoring II. Information: Patient- Specific Data Profiles To disperse actionable patient-level information to facilities for improvement prioritization III. Collaborative Site Visits To assess and address facility VA processes; facility, physician and patient VA barriers on-site; offer solutions and resources IV. Vascular Access Coordinator To determine the extent to which facilities utilize VA Coordinators in their VA program & support use of and development of VA Coordinators V. Resources and Tools To provide technical assistance and guidance in the use of best-practice tools, such as the AVF Tracking Tool The Network held eleven vascular access collaborative site visits during 2011, nine of which were for the Functioning Fistula QIP and two were for the Close the Gap QIP, in a variety of locations including the Corpus Christi-Kingsville area, the Dallas/Fort-Worth area, and the Houston Metroplex to better assist selected focus facilities with their vascular access processes and outcomes. Objectives of the visits included: Promote awareness of the Network #14 QIP related to vascular access Review and analyze facility specific vascular access data with leadership and staff on-site and to provide strategies for improvement Evaluate facility processes that support the vascular access program Interact with personnel who have a key role at the facility regarding vascular access processes and outcomes Interact with patients regarding their understanding of their vascular access and the education and information provided to them on vascular access options, if applicable Provide evidence-based clinical practices and resources to support the facility s vascular access patient care processes Evaluation forms with eleven questions were given to leaders at the participating facilities at the exit conferences or mailed to the facilities after the visits. The questions focused on 1) satisfaction with the Network staff conducting the visit, 100% of respondents said they would recommend a collaborative site visit to a peer. 23 P age ESRD Network of Texas, Inc. (#14)

25 2) aspects of the visit such as duration in time and variety of evaluation activities, 3) resources and information provided at the visit, and 4) whether the facility participants learned something new in particular areas as a result of the visit. During the Functioning Fistula QIP, interventions were implemented from September 2010 through February 2011, with continuous attention through June 2011 for some of the focus facilities. Sixty-two of seventy-two focus facilities improved their AVF rates in the project timeframe (Chart 11). The remaining 10 facilities that had not shown improvement were required to continue submitting data until September Analysis of results in December 2011 showed this subset of facilities had an improvement in AVF rate as well. These results are illustrated in Chart 12. Chart 11 Percent Prevalent AVF of Functioning Fistula Focus Facilities from the Project Mid-Point (January 2011) to Project End (June 2011) and Beyond 70.0% 60.0% Percent Prevalent AVF 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Jan 2011 June 2011 Dec focus facilities 47.1% 52.5% 54.6% Network % 59.4% 60.3% The 72 focus facilities in the Functioning Fistula project showed continued improvement through the end of the project with sustained and continued improvement through the end of 2011 (Chart 12). 24 P age ESRD Network of Texas, Inc. (#14)

26 70.0% Chart 12 Percent Prevalent AVF of Functioning Fistula Continued Focus Facilities from Project Mid Point (January 2011) to Project End (June 2011) and Continued Focus Period (June Dec 2011) Percent Prevalent AVF 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% Jan 2011 June 2011 Dec % Functioning Fistula Continued Focus Facilities NEW VASCULAR ACCESS QUALITY IMPROVEMENT PROJECTS IN 2011 During the and contract years, Network #14 implemented two focused Quality Improvement Projects (QIPs) designed to increase the Network prevalent arteriovenous fistula (AVF) rate to greater than or equal to 60.4 percent and decrease the catheter greater than or equal to 90 day rate. QI Project #1: The Catheter Operation Reduction and Elimination (CORE) project targeted facilities that had 15 percent or more of their prevalent hemodialysis patients with catheters only greater than or equal to 90 days. QI Project #2: The Close the Gap project targeted facilities in the top ten counties of Texas with the largest hemodialysis patient populations (high volume counties), facilities with a patient census of greater than or equal to 50 in urban areas, and facilities that had an adult prevalent AVF rate of less than or equal to 50 percent. VASCULAR ACCESS QUALITY IMPROVEMENT PROJECT #1 CATHETER OPERATION REDUCTION AND ELIMINATION (CORE) Goal: To reduce the percent of adult hemodialysis patients with catheter > 90 days in 70% of focus facilities 25 P age ESRD Network of Texas, Inc. (#14)

27 In March 2011, the Network s prevalent AVF rate for adult hemodialysis patients was 57.9 percent, compared to 58 percent nationally, which exceeded the Network contract goal of 56.4 percent by 1.5 percentage points. Since the Network successfully met and exceeded its contract AVF goal, Network #14 developed and implemented a QIP (CORE) targeting the high rate of patients with catheters greater than or equal to 90 days in 25 facilities in Texas. The QIP focused on these facilities because 15 percent or greater of their prevalent hemodialysis patients had catheters only greater than or equal to 90 days in the fourth quarter of 2010, which was higher than both the K/DOQI guidelines and MRB recommendation of 10 percent of patients, as well as the overall Texas rate of 6.2 percent of patients. The CORE QIP was based on several components, outlined below. CATHETER OPERATION REDUCTION & ELIMINATION Physician Group Profiles A physician group practice profile including payer source was developed (Chart 13) based on patients seen by a nephrologist prior to the initiation of dialysis, who started dialysis with a catheter only for vascular access. This profile is one of many strategies which the ESRD Network of Texas, Inc. has developed to bring awareness to this segment of CKD patients and to the need for reducing the utilization of catheters for dialysis access in order to improve the health and care for this population of patients and reduce costs, morbidity, and mortality associated with catheters, such as healthcare-associated infections, hospital readmissions, and repetitive procedures. Lack of a payer for surgical treatment is one of the primary barriers cited to permanent vascular access placement prior to initiation of dialysis; however, many patients (88.7% Network-wide) do indeed have a payer prior to start of dialysis, and yet, they have only a catheter at initiation. The profile highlights this fact and encourages groups to examine their practices regarding early vascular access placement and to re-double their efforts to identify CKD patients with coverage and aggressively educate patients about the need for early placement and follow them actively to obtain placement prior to initiation of dialysis. The MRB defined a large physician group as one with 8 or more physicians belonging to the practice. Twenty large physician groups were identified in Texas. The profile is generated from data listed on the 2728 CMS form, classified by the timeframe that the 26 P age ESRD Network of Texas, Inc. (#14)

28 patient was seen by the nephrologist prior to dialysis (less than 6 months, 6 to 12 months, and greater than 12 months), and includes payer source. Strategies used by the Network included collaboration with the Texas Medical Foundation (TMF) Quality Improvement Organization (QIO), the distribution of group profiles to the medical directors of the large physician groups with comparative group data, a variety of educational resources regarding arteriovenous fistulas, and ultimately, a request for action plans from groups that fell in the bottom performer category, defined as groups with the highest incident catheter group rates in the state for patients seen by a nephrologist prior to the initiation of dialysis. Round I, February 2011 Distributed group profiles to medical directors and provided education Partnered with TMF and had joint meeting with medical director from a group with the highest incident catheter rate in the state; assisted director with identification of internal (group) and external barriers to placing AVFs in pre-esrd patients Evaluated feedback results from medical directors regarding the group profile report In Round I, an evaluation of the profile was distributed to the medical directors. Favorable responses pointed to a need to continue to produce and distribute the group profiles to the medical directors of large groups in Texas at six month intervals going forward. Forty-five percent (9 out of 20) of group leaders completed and returned a profile evaluation 77 percent responded they will use the profile to make changes in group practice or processes 100 percent were interested in receiving physician specific profiles on group members 100 percent responded they will use the profile to influence group members to make timely referrals to surgeons 88 percent stated they will use the profile to inform group members on patterns of care related to catheters prior to dialysis 77 percent indicated that the profiles provided new information on catheter utilization at dialysis initiation for incident patients 27 P age ESRD Network of Texas, Inc. (#14)

29 Round II, July 2011 Distributed group profiles to medical directors with comparative group information including group ranking Identified top performers 10 percent of groups who achieved the lowest incident catheter rate; Medical Review Board acknowledged groups with top performance Identified bottom performers 25 percent of groups who had the highest incident catheter rate; Medical Review Board requested action plans Developed and distributed a Nephrology Group Leader Action Checklist with five key action steps, target dates, and completion status The majority of the bottom performer groups returned requested action plans. Two of the medical directors opted to use the Nephrology Group Leader Action Checklist for their action plan and requested and were given additional educational resources. One of the medical directors from a large group responded that the group profile had received much attention and review of their own data confirmed that of the Network s. As a result, this group strengthened their access placement process and implemented additional improvement strategies. Overall, the responses to the group profile report from the group medical directors were positive. Various interactions, such as a meeting at the group practice office and one-on-one calls, confirmed that the sharing of practice patterns and comparative data with nephrologists provided insights for some of the nephrologists. In conclusion, use of physician specific profiles is being explored in tandem for the physician groups who have the largest percentage of incident catheter only at the start of dialysis. In addition, plans are underway for the third round of the group profile reports which will reflect data from the first six months of 2011 and will incorporate a focus on early transplant evaluation in CKD patients. Finally, an analysis of change over the year will be conducted. 28 P age ESRD Network of Texas, Inc. (#14)

30 Chart 13 Large Physician Group Profile Facility Collaboration In March 2011, the Network sent the 25 focus facilities a letter describing facility selection for participation in the CORE project and provided a catheter reduction toolkit with CD developed by the Forum of ESRD Networks Medical Advisory Council (MAC). The Toolkit provided quality improvement approaches that a facility could use to ensure care coordination for patients. The facilities were asked to fax the Network an acknowledgement to verify receipt of the toolkit. In April 2011, the Network hosted two introductory webinars for the Large Dialysis Organizations (LDOs) and non-ldo focus facilities, with the goals and objectives of 29 P age ESRD Network of Texas, Inc. (#14)

31 implementing the MAC toolkit and providing technical assistance and resources for the individualized needs of each facility, as well as the project goal of reducing the percent of adult hemodialysis patients with catheter greater than or equal to 90 days in 70 percent of focus facilities. The Network had further goals and objectives for LDO facilities of identifying high-risk catheter patients by using the vascular access patient specific data profiles and implementing patient specific vascular access action plans. Patient Engagement In April 2011, the MRB composed a letter to hemodialysis catheter patients warning of the risks involved with receiving treatments through their current access (catheter) and encouraging them to discuss a permanent vascular access with their physicians. It was translated into Spanish, and the Network posted both English and Spanish letters on the ESRD Network #14 website under patient education. Focus facilities were directed to utilize the letter in educating patients about the dangers of catheters. Vascular Access Coordinators In May 2011, the Network held a Vascular Access Coordinator workshop for a medium dialysis organization that had several focus facilities either enrolled in the Functioning Fistula QIP or the CORE QIP. The workshop was designed with the following objectives: Discuss the current vascular access projects conducted by Network #14 Discuss the critical role of the Vascular Access Coordinator in assessment of accesses, follow up for identified issues, and mentoring the cannulation process of difficult vascular accesses Describe various tools and resources discussed and implementation of those resources to achieve success. Data Driven Outcome Mapping In July 2011, the Network distributed patient specific data (PSD) profile reports to the 13 LDO facilities participating in the CORE QIP. The PSD profiles were designed to inform the LDO facilities of their vascular access results, providing patient information to assist in the identification and prioritization of potential opportunities for improvement, and to assist with the implementation of a patient specific vascular access plan for each patient (Tables 2 and 3). Di care Services, CMS requested a Perfoe 30 P age ESRD Network of Texas, Inc. (#14)

32 Table 2. Vascular Access Facility Profile using PSD Tier I II III Description Overview Analysis Priorities Content Facility ranking within the Network Facility VA results Comparison with national (CMS & KDOQI) goals, Network average, top 10% Network facilities Facility level vascular access patterns in 90-day timeframes VA patterns color coded in a stoplight fashion for user-friendly data interpretation Listing of patients who are not moving in an optimal VA pattern over the 90-day period Trigger questions to be used for evaluation of VA improvement opportunities Table 3. Vascular Access performance levels published in the PSD profiles Performance Level VA month one VA three months later *AVF...AVF Good/Improving *Cath only < 90 days Cath + AVF *Cath + AVF AVG only Caution Improving/Caution Neutral * Cath only < 90 days Cath only < 90 days *AVF Cath +AVF *Cath + AVF Cath only < or > 90 days Caution Worse/Worse *AVF Other *AVG only Cath only < or > 90 days aces on 7/2 Results From baseline December 2010 to August 2011, 21 out of 25 (84%) focus facilities improved their catheter greater than or equal to 90 day rate (Chart 14), 12 out of 20 (60%) large physician groups lowered their number of catheter only greater than or equal to 90 days rate in their incident populations (Chart 15), and Network #14 s percentage of incident population with AVFs increased from 19.8 percent in 2010 to 22.9 percent in 2011 (Chart 16). Network #14 exceeded its CORE goal of 70% or more of focus facilities improving their catheter >90 day rate, with 21 out of 25 (84%) facilities showing improvement. 31 P age ESRD Network of Texas, Inc. (#14)

33 Chart 14 Change in Percent of Patients with Catheter > 90 days for 25 focus facilities from December August % % % Percent of Patients 10.0% 15.0% 20.0% 25.0% % 35.0% 25 Focus Facilities 33.3 Percent Incident Pts who start Dialysis with a Catheter 40% 30% 20% 10% 0% -10% -20% Chart 15 Change in Percentage Points from 2010 to overall 20 Large Physician Groups -2.7% all 20 groups combined Data source: cumulative 2728 data January to December 2010/ P age ESRD Network of Texas, Inc. (#14)

34 Chart 16 Percentage of Incident Patients with AVF Percent of Patients % (n=617 pts) 22.9% (n=644 pts) Texas Data source: FFBI Dashboard January 2010 and December 2011 VASCULAR ACCESS QUALITY IMPROVEMENT PROJECT #2 CLOSE THE GAP Goals: The goals of this VA QIP were threefold. For the Network to achieve a prevalent AVF rate for adult hemodialysis patients of at least 60.4% by March 2012 and to achieve +0.2 percentage points on a monthly basis For non-focus facilities with a prevalent AVF rate <50% that did not meet the project selection criteria to submit to the Network 100% of gap charts signed by the medical director on a quarterly basis For focus facilities to submit to the Network 100% of gap charts signed by the medical director on a monthly basis for 3 months, to complete the gap chart worksheets and project implementation plan, and to meet or exceed individual facility gap chart goals by project end 33 P age ESRD Network of Texas, Inc. (#14)

35 In September 2011, the Network s prevalent AVF rate for adult hemodialysis patients was 59.9 percent, compared to 59.8 percent nationally, which exceeded the Network contract goal of 59.6 percent by 0.3 percentage points. Although Network #14 exceeded its contract goal, the MRB determined that the prevalent AVF goal should be the midpoint between the CMS contract goal of 59.6 percent and the Network s stretch goal of 61.2 percent, establishing a new goal of 60.4 percent. The Network initiated the Close the Gap QIP to meet or exceed this new goal. The Medical Review Board selected 28 focus facilities (Chart 17) for the Close the Gap project by identifying the top ten counties in Texas with high patient populations, determining which of those facilities had a patient census greater than or equal to 50 in an urban setting, and identifying those facilities with an AVF rate less than or equal to 50 percent. Chart 17 Close the Gap Focus Facility Locations and Counties The Close the Gap vascular access QIP consisted of 6 components, as follows: 34 P age ESRD Network of Texas, Inc. (#14)

36 1) At the end of August 2011, the Network notified the 28 focus facilities by letter that they had been selected based on meeting project criteria to participate in the Close the Gap QIP. The letter was addressed to the Medical Director, the Facility Administrator, and the Head Nurse and stated the particular components of the QIP that each facility would need to complete in order to be released from the project, as well as the projected timeline. The Network also suggested that each facility appoint a Vascular Access Coordinator if it did not already have one in place. 2) At the end of September 2011, the Network hosted a mandatory webinar for the focus facilities introducing the project with the following goals and objectives: To identify the Close the Gap QIP components To understand how focus facilities were selected To identify effective vascular access data tools/resources to assist facilities in achieving optimal permanent VA placement To establish a project timeline The facilities downloaded an evaluation sheet for the webinar from the Network #14 website, and the results from 34 facilities responding are shown in Chart 18. One hundred percent of respondents felt the webinar met its goals and objectives in a clear manner. Chart 18 Evaluation Results from the Close the Gap Webinar The webinar successfully met those goals and objectives The goals and objectives of the webinar were clearly defined % Yes VAC Resources CSV VA PSD Profile Gap Chart % Very Clear and Somewhat Clear Fcous facility selection Goal of the CTG QI Project Percent of Responses 35 P age ESRD Network of Texas, Inc. (#14)

37 3) In September 2011, the Network mailed out the quarterly Fistula First data to all facilities, including the addition of a gap chart worksheet for the 28 focus facilities to complete and fax back to the Network. The gap chart worksheet asked the focus facilities to complete three steps: 1) analyze the facility gap chart to determine the number of new AVF placements needed by March 2012, 2) assess the facility s current vascular access profile to identify areas for improvement, and 3) review recommendations for next steps to be discussed with the facilities QAPI vascular access team. With this mail-out, the facilities whose prevalent AVF rate was less than or equal to 50 percent were required to return their gap charts signed by the facility Medical Director to the Network, which included the 28 focus facilities. 4) In the last quarter of 2011, the 28 focus facilities received monthly (October, November, December) Fistula First information that included various Close the Gap project information, as well as vascular access patient specific data profiles for the 21 LDO facilities participating. The facilities were again required to have their Medical Directors sign the gap charts and return them to the Network. 5) In November 2011, the Network mailed the 28 focus facilities a Vascular Access Coordinator Resource Manual, which was developed by Network #14 QI staff to enhance or supplement the facilities current vascular access program. The Vascular Access Coordinator Resource Manual was designed for the person who performs the various functions of the Vascular Access Coordinator at a dialysis facility to provide a readily available resource guide with QAPI tools and templates, resources, educational material for staff and patients, checklists, algorithms, monitoring and evaluation forms, tracking logs, and several other helpful items. The resources are indexed according to the thirteen Fistula First Change Package Concepts for easy identification and linkage to the specific facility vascular access quality improvement goals, such as reduction of catheters, increasing arteriovenous fistulas, and collaborating with the surgical community for timely referral and placement of permanent vascular accesses. The Network directed the focus facilities to select at least one new process that they planned to implement to improve their AVF rates, complete the Process Implementation Plan included in the mail-out, and submit it to back the Network. 6) Lastly, during the Close the Gap QIP, Network #14 planned and implemented regional sweeps, comprised of a bundle of specific intensive activities that have been effective in previous QIPS and which were used in conjunction with the Close the Gap focus facilities to improve vascular access outcomes. The regional sweeps consisted of collaborative site visits, Vascular Access Coordinator workshops, and Metro-Mentoring 36 Page ESRD Network of Texas, Inc. (#14)

38 meetings. In 2011, two collaborative site visits were held for the CTG QIP, one VA Coordinator workshop occurred in December, and one Metro-Mentoring meeting was held in November. The regional sweeps continued into the first quarter of Results Goal #1: While the Network showed increasing improvement in its overall AVF rate during the project timeframe, it had not yet reached its stretch goal of 60.4 percent prevalent AVF by project s end in January 2012 (Chart 19). Goal #2: One hundred percent of the non-focus facilities with AVF rates less than or equal to 50 percent returned their signed gap charts to the Network each quarter encompassing the Close the Gap QIP (104/104 in September 2011 and 97/97 in December 2011). Goal #3: One hundred percent of focus facilities (28 of 28) successfully completed the Close the Gap project requirements (Table 4). Fifteen out of 28 focus facilities (53.6%) met their individual AVF rate goals during the project timeframe, while the remaining 13 focus facilities (46.4%) did not (Charts 20 and 21). Overall, 24 out of 28 focus facilities (85.7%) improved their AVF rates, while the remaining 4 focus facilities (14.3%) had worse AVF rates by project s end January 2012 (Chart 22). Chart 19 Close the Gap Goal #1 Network: > 60.4% prevalent AVF rate by March % Baseline = 60.3% 60.0% 59.0% 58.0% CTG QIP Goal > 60.4% NW AVF = 60.3% Dec, Jan, Feb 57.0% 56.0% 55.0% 54.0% NW14 AVF Rate Contract Goal 37 P age ESRD Network of Texas, Inc. (#14)

39 Table 4. Close the Gap Goal #3 Focus Facilities: Complete QIP project requirements Project Requirements All Focus Facilities Completion Rate a. CTG Webinar Attendance x 1 100% b. Gap Chart Worksheet x 1 100% c. Submission of Signed Gap 100% Charts Monthly x 3 mos. d. Process Implementation Plan x1 100% Project Requirements Subset Focus Facilities # Focus Facilities Attendance Rate e. VA Coordinator Workshop x 1 17/18 94% f. Metro Mentoring Mtg. x 1 18/18 100% g. VA Collaborative Site Visit 6/6 100% Chart 20 Close the Gap Goal #3 Focus Facilities: Meet or Exceed Facility Gap AVF Goals by March 2012 * 46.40% 53.6% Met n=15 Not Met * Based on January 2012 FF data released March 15, P age ESRD Network of Texas, Inc. (#14)

40 Chart 21 Close the Gap Goal #3 Focus Facilities: Meet or Exceed Facility Gap AVF Goals by March 2012 % Change in AVF Actual vs Goal Focus Facility AVF Gap Goals Met/Exceed vs Not Met Chart 22 Overall Close the Gap QIP Results Percentage of Focus Facilities with Improved/Worse AVF rates baseline (June 2011) to January % n=4 85.7% n=24 Percent Change from baseline (June 2011) to January 2012 AVF rate + 4.3% AVG rate 2.2% All catheter rate 2.2% Catheter > 90 days 0.5% Improved Worse 39 P age ESRD Network of Texas, Inc. (#14)

41 ADDITIONAL VASCULAR ACCESS PROJECT ACTIVITIES DURING 2011 Fistula First Reports A total of 1,984 Fistula First facility specific vascular access reports were distributed during April, June, September, October, November, and December 2011 to all outpatient dialysis facilities with hemodialysis patients. The quarterly facility Fistula First mail-out was redesigned in 2010 by streamlining information that the facility received with one Fistula First Progress Report cover letter with bulleted short descriptions and directions for attached material. Enclosures with the Fistula First reports included project information, Network #14 comparative data, FFBI change package strategies, K/DOQI Vascular Access Guidelines, cannulation procedures, professional educational opportunities such as vascular webinars and workshops, and patient educational material. The quarterly facility Fistula First mail-outs for 2011 followed the 2010 redesign, adding patient specific data profiles and regional comparative data in December. With the Fistula First mail-out in September 2011, an evaluation was distributed to facilities on the usability of the information provided. Two hundred fifty-four out of four hundred eighty facilities responded for a 52.9 percent response rate. Evaluation of the results validated the need for continuing the quarterly Fistula First information updates to facilities (Chart 23), as well as prompted the addition of new materials to the mail-out. Two hundred thirty-four of the two hundred fifty-four facilities responding affirmed they would utilize regional comparative data if included in the mail-out, while 99 of 108 LDO facilities responding affirmed they would utilize patient specific data profiles if included in the mail-out. Chart 23 FF Mail-out Assessment I would use a facility ranking in my community/region I would use patient specific data (LDOs only) approx. 345 LDOs in Network yes 6 no yes 9 no 40 P age ESRD Network of Texas, Inc. (#14)

42 Gap Analysis Goals and Charts Annually, the MRB determines Gap Analysis Goals for each facility based on their current prevalent AVF rate in comparison to the CMS target goal of 66% and patient census. Improvement goals for 2011 had no ceiling; however, progress toward monthly goals was established and assessed for each facility (Chart 24). Chart 24 Facility Fistula First Gap Chart The Gap Analysis Charts display the percent of AVFs currently in use at the facility compared to the percent of functional AVFs the facility needs to reach the projected goal set for each facility by Network #14. The facility AVF percent goal indicated on the facility-specific Gap Analysis Chart is based on CMS calculated rate of improvement for Network #14. A tool was distributed with the facility gap charts to assist facilities in utilizing the data on the Gap Chart for Quality Assessment and Performance Improvement (QAPI) vascular access review. 41 P age ESRD Network of Texas, Inc. (#14)

43 To ensure that the Medical Directors of the low performing facilities were aware of the current situation and engaged in improvement actions, during the first half of 2011 Network #14 requested that all facilities with a prevalent AVF rate of less than or equal to 40 percent obtain the Medical Director s signature on the gap chart and submit it back to the Network. Due to new MRB directives and a successful track record with this intervention in the past, in September 2011 Network #14 requested that all facilities with a prevalent AVF rate of less than or equal to 50 percent obtain the Medical Director s signature on the gap chart and submit it back to the Network. One hundred percent of facilities returned gap charts that were signed by the Medical Director. A 25 percent decrease in the number of facilities required to submit signed gap charts (cut point less than or equal to 40 percent AVF) is noted when comparing March to June 2011 results, while a 6.7 percent decrease in the number of facilities required to submit signed gap charts (cut point less than or equal to 50 percent AVF) is noted when comparing September to December 2011 (Chart 25). Chart 25 Number of Facilities Required to Return Gap Charts Signed by Medical Director During Fistula First Mail-Out Number of Facilities <=40% prevalent AVF <=50% prevalent AVF First mail out which MRB recommendations required <=50% AVF to return signed gap charts Mar 2011 Jun 2011 Sept 2011 Dec 2011 Month of Fistula First Quarterly Mail Out Recognition To recognize those facilities with superior performance in meeting the goals of the Fistula First project, 115 facilities received benchmark certificates in September 2011 in recognition of attaining at least 66 percent of their patients meeting the benchmark standard for prevalent AVF utilization. Public acknowledgement forms were made available to facilities. For those facilities who gave the Network permission to publish their facility name associated with a high AVF rate, the facility names were published in the Network s monthly newsletter NetLink, which highlighted their achievement status. 42 Page ESRD Network of Texas, Inc. (#14)

44 Cannulation Training In 2011, several different venues were used for cannulation training, including two special sessions at the Network #14 Annual Conference, during vascular access collaborative site visits with facilities, and through quarterly Fistula First mail-outs that included the use of algorithms and information for both patients and professionals on the buttonhole technique. Table 5 displays a comprehensive list of additional vascular access activities that were completed in Table 5. Additional Vascular Access Project Activities During 2011 Data Reports Texas Gap Charts and Progress Charts Facility Fistula First AVF Goal Projection Charts Mailed to Facilities Instructions How to Use Gap Charts & Fistula First Data to Develop Vascular Access Goals and Strategies Stakeholders All Facilities; Vascular Access Patient Specific Data Profiles Patients; Providers Large Physician Group Incident Catheter Profiles Tools MRB Standard for Vascular Access QAPI and specific QAPI tracking and actions provided to Department of State Health Services with a request that surveyors Mailed and posted on website determine if facilities are meeting the standards and encourage their use to comply with the Conditions for Coverage for QAPI Stakeholders MRB Algorithm for Vascular Access Management was provided to assist All Providers; DSHS; patients facilities in identifying next actions in various situations related to vascular access Texas Kidney Health Care VA placement reimbursement policies to encourage VA placement prior to discharge, for newly diagnosed ESRD patients requiring permanent VA Patient Educational tool in English and Spanish FFBI AVF Maturation Algorithm Buttonhole Technique professional and patient resources Vascular Access Coordinator Resource Manual Educational Sessions Presentation at the Metro-Mentoring meetings in the DFW area in November 2011 Vascular Access Coordinator workshops in the DFW area in May and December 2011 A surgeon from Texas attended the FFBI Surgeon training workshop in Atlanta, GA in December 2011 QI Staff Technical & QI Staff provided vascular access technical and educational assistance to 1,740 Professional Assistance Network #14 facilities and practitioners via phone and . Examples of technical and educational assistance: Developing physician strategies to change surgical practice patterns to improve AVF placement and patency rates Utilization of comparative FF data and FFBI resources in QI meetings to drive changes to improve vascular access outcomes Coaching nurse managers and vascular access coordinators to correctly download and use the Fistula First reporting tools Locating vascular access patient education tools 43 P age ESRD Network of Texas, Inc. (#14)

45 Table 5. Additional Vascular Access Project Activities During 2011 Explanation of Staff Cannulation Skills Assessment Tool and how to incorporate into staff training, skills assessment and re-training Stenosis monitoring and acceptable methods to perform monthly testing and review in QAPI Implementing barriers assessment tools to identify primary barrier in order to begin strategic improvement processes Cannulation Workshops Network #14 sponsored two cannulation workshops in 2011 and incorporated cannulation training during the Annual Conference Cannulation training included in Vascular Access Coordinator workshop curriculum Results of the Fistula First Project to Date Since the inception of the Fistula First project in 2003 through December 2011, the Network #14 prevalent AVF rate has improved 34.6 percent from baseline, compared to the U.S. prevalent AVF rate improvement of 27.9 percent for the same time period (Chart 26). Chart 26 Ne twork #1 4 Percent Pre vale n t AVFs Octobe r 2003 to December Network 14 U.S. Percent of Patients /03 12/04 12/05 12/06 12/07 12/08 12/09 12/10 12/11 During 2011, the Network #14 prevalent AVF rate improved an average of 0.25 percent per month (range percent) (Chart 27). The December 2011 Fistula First Dashboard reflected a 60.3 percent prevalent AVF rate for Network #14, as was the prevalent AVF rate for the U.S. 44 P age ESRD Network of Texas, Inc. (#14)

46 Chart 27 Percent of Improvement in AVF Rates All Networks October 2003 to December 2011 Network 1 Network 2 Network 3 Network 4 Network 5 Network 6 Network 7 40 Network 8 Network 9 Network 10 Network 11 Network 12 Network 13 Network 14 Percent of Improvement from Baseline Network 15 Network 16 Network 17 Network 18 US Network /03 12/04 12/05 12/06 12/07 12/08 12/09 12/10 12/11 Furthermore, in September 2011 the Network met the AVF target of 59.6 percent established by CMS and has demonstrated consistent monthly improvement in the last quarter of 2011 since exceeding the CMS goal (Chart 28). 61.0% C hart 28 Network #14 Prevalent AVF Rate A chievement of CMS C ontract Goal 60.0% 59.0% 58.0% 57.0% 56.0% 55.0% 54.0% Sep Oct Nov Dec Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec AVF Rate Contract Goal P age ESRD Network of Texas, Inc. (#14)

47 Although Network #14 facilities have made great strides in improving vascular access outcomes during the last five years, significant system barriers continue to negatively impact Texas facilities ability, and therefore Network #14 s ability, to improve prevalent AVF rates to the 66 percent prevalent AVF rate goal set by CMS. These barriers include: Lack of identification and/or treatment of Stage 3-4 CKD patients, resulting in urgent initiation of chronic dialysis via hemodialysis catheter in the hospital setting Failure to achieve permanent vascular access placement in Stage 4 CKD patients under the care of a nephrologist Discharge of hospitalized incident CKD patients with catheter only and no permanent access placement, due to lack of financial reimbursement for incident vascular access placement and/or lack of vascular access planning Lack of Medicare reimbursement during initial 90-day Medicare eligibility period for VA placement in incident ESRD patients dialyzing in chronic outpatient hemodialysis clinics High rate of uninsured population in Texas that limits vascular access placement Lack of qualified access surgeons in select geographic areas Arteriovenous graft placement in incident patients that are suitable AVF candidates Failure to utilize recommended vessel mapping and physical assessments to optimize AVF creation and maturation, including failure to assess: o Suitability of patients for AVF placement o Selection of most appropriate vessels, anatomical location and surgical procedure for AVF creation Reluctance of prevalent patients with a prior failed AVF to consider further AVF placement surgery Inability to track and trend surgeon specific AVF maturation rates due to lack of patient specific vascular access data tied to surgeon data Strategic planning with Texas Medical Foundation (TMF) resulted in development of collaborative initiatives for meeting the goals and objectives of Network #14 s Vascular Access Improvement Projects and TMF s Chronic Kidney Disease (CKD) sub-national CKD Contract. 46 P age ESRD Network of Texas, Inc. (#14)

48 CLINICAL INDICATOR PERFORMANCE IN TEXAS CMS and Network data from the Elab project are included in educational materials provided to each facility. Network #14 achieved the following standing among the 18 Networks for the 2012 Quality of Care Project (fourth quarter 2011 data): Sixth highest ranking among Networks for percent of Hemodialysis patients with Kt/V > 1.2 (97.5%) Sixth lowest ranking among Networks for percent of Hemodialysis patients with Hgb < 10.0 g/dl (12.6%) Eighth highest ranking among Networks for percent of Peritoneal Dialysis patients with TSAT > 20% (90.5%) Second highest ranking among Networks for percent of Hemodialysis patients with TSAT > 20% (90.3%) 2011 QUALITY OF CARE INDICATORS PROJECT The Quality of Care (QOC) Indicators Project was implemented sixteen years ago to increase the percent of Texas patients achieving quality goals for adequacy, anemia and iron management, albumin, and bone and mineral metabolism clinical indicators. The goals of this multi-pronged collaborative initiative between Network #14 and Texas dialysis facilities, also described in the Clinical Indicators section include: Collection of fourth quarter hemodialysis and peritoneal dialysis clinical indicator data from 100 percent of Network #14 s Large Dialysis Organization (LDO) and non-large Dialysis Organization (non-ldo) facilities Utilization of facility data to generate comparative facility-specific data charts for distribution to Texas facilities Provision of objective measures for comparison of facility outcomes to both peers and practice guideline recommendations for facility specific quality improvement purposes Provision of threshold for measurement as a potential catalyst to drive improvement activities Identification of facilities with outlier clinical indicator outcomes requiring Network assistance and/or quality improvement interventions Network #14 employs processes for accurate and timely completion of the QOC Indicators Project that include facility data collection through the Elab Data Collection 47 P age ESRD Network of Texas, Inc. (#14)

49 Project, a multi-network data collection process funded by CMS. In this initiative Large Dialysis Organizations (LDOs) submit Lab Collection data to Network #11 via electronic data transfer protocols, and independent facilities and facilities affiliated with regional dialysis organizations submit data directly to Network #14 according to the Lab Data Collection protocols established by Network #11. Data collection forms for independent and regionally owned dialysis organizations were mailed via certified mail to HD, Frequent HD, and PD providers. Network #14 submits non-ldo data to Network #11 via MyQualityNet for merging with LDO facility data and subsequent analysis and development of facility-specific reports. The reports highlight the percent of patients meeting clinical indicator goals, means and medians, facility demographics, and Network #14 comparative data for clinical indicators. Data tables were received from Network #11 during second quarter The MRB reviewed the Quality of Care data in April and June 2011 and determined HD and PD clinical outcome cut-points based on recommended standards of care for dialysis adequacy, anemia management, iron management, and bone and mineral metabolism management. Facility specific charts and a one page summary of Texas Quality of Care outcomes were distributed to all facilities during August A cover letter instructed all facilities to review facility-specific and comparative outcome data in the Quality Assessment and Performance Improvement (QAPI) meeting and to perform a selfassessment to identify if any quality gaps exist between actual and desired core indicator outcomes (clinical performance measures or CPM) for adequacy outcomes, anemia and iron management, albumin, and bone and mineral metabolism management. Facilities were directed to identify opportunities for improvement in clinical practices and processes and to develop a QAPI plan to improve the clinical outcome, if applicable. To assist facilities in self-identifying areas for improvement within their own facilities, the Facility Report Card, a previously developed QAPI tool, was again utilized in The Facility Report Card is a self assessment tool for facilities to record their outcomes for the various clinical indicators for comparison with the Texas outcomes, the MRB cut-points, National Practice Guideline targets, and the U.S. Clinical Indicator outcomes for the same indicators. 48 P age ESRD Network of Texas, Inc. (#14)

50 The 2011 Quality of Care Summary Report and revised 2011 Run Charts were posted to the Network #14 website. Texas facilities, LDO regional managers and the Texas nephrology community were notified of the website postings for use in QI activities. Tables 6 and 7 display trended Quality Indicator data. Refer to Clinical Indicator Section for description of Quality of Care Concern process and number of focus facilities identified using this process. Table 6. Network #14 Quality Indicator Report Trends * Quality Indicator - HD Percent of hemodialysis patients with URR > 65% Percent of hemodialysis patients with Kt/V > Percent of hemodialysis patients with HGB >11 g/dl Percent of hemodialysis patients with HGB < 10 g/dl Percent of hemodialysis patients with HGB >10 & < 12 g/dl Percent of hemodialysis patients with HGB >12 g/dl Percent of hemodialysis patients with ferritin >200ng/ml & < 800ng/ml na Percent of hemodialysis patients with ferritin > 800ng/ml Percent of hemodialysis patients with transferrin saturation >20% Percent of hemodialysis patients with albumin > 4.0mg/dl Percent of hemodialysis patients with phosphorous > 3.5 & < 5.5mg/dl Percent of hemodialysis patients with calcium > 8.4 & < 9.5mg/dl na Percent of hemodialysis patients with calcium > 8.4 & < 10.2mg/dl Quality Indicator - PD Percent of peritoneal patients with Kt/V> 1.7 (2007 K-DOQI) Percent of peritoneal patients with HGB >11 g/dl Percent of peritoneal patients with HGB < 10 g/dl Percent of peritoneal patients with HGB >10 & < 12 g/dl Percent of peritoneal patients with HGB >12 g/dl Percent of peritoneal patients with ferritin >200ng/ml & < 800ng/ml na Percent of peritoneal patients with ferritin > 800ng/ml Percent of peritoneal patients with transferrin saturation >20% Percent of peritoneal patients with albumin > 4.0mg/dl Percent of peritoneal patients with phosphorous > 3.5 & < 5.5mg/dl Percent of peritoneal patients with calcium > 8.4 & < 9.5mg/dl na Percent of peritoneal patients with calcium > 8.4 & < 10.2mg/dl *Report reflects data collected for 4 th quarter In 2011, after establishing cut points and notifying pediatric facilities of the QOC process, pediatric quality of care facilities were identified and notified of their outlier status. 49 P age ESRD Network of Texas, Inc. (#14)

51 Table 7. Network #14 Pediatric Quality Indicator Report Trends * Quality Indicator Pediatric HD Adequacy Percent of hemodialysis patients with URR > 65% Percent of hemodialysis patients with URR > 70% Percent of hemodialysis patients with Kt/V > *URR > 90% or < 10% & Kt/V derived from URR > 90% or < 10% not included. Quality Indicator Pediatric PD Adequacy Percent of peritoneal patients with Kt/V > Percent of peritoneal patients with Creatinine Clearance > 60 L/wk Quality Indicator Combined Pediatric HD & PD Percent of patients with HGB < 10 g/dl Percent of patients with HGB >10 & < 12 g/dl Percent of patients with HGB >12 g/dl Percent of patients with ferritin >200ng/ml & < 800ng/ml Percent of patients with ferritin > 800ng/ml Percent of patients with transferrin saturation >20% Percent of patients with albumin > 4.0mg/dl Percent of patients with phosphorus > 3.5 & < 5.5mg/dl Percent of patients with calcium > 8.4 & < 9.5mg/dl Percent of patients with calcium > 8.4 & < 10.2mg/dl *Report reflects data collected for 4 th quarter Data Source: 2009 & 2010 National ELAB Report & 2011 Preliminary National ELAB Report Data. MRB STRATEGIES FOR IMPROVING CLINICAL OUTCOMES THROUGH QI ACTIVITY The Network utilizes a multi-pronged approach per MRB recommendation that incorporates several strategies, outlined below. Provide Facility Specific Comparative Data As approved by CMS, the Network collects data on an annual basis using the Lab Data Collection Project (Elab) and produces facility specific feedback reports with means, percentiles, and proportion of patients meeting quality targets. The reports are provided to facility Medical Directors, Nurse Managers, and Administrators and include national and Network comparative data and K/DOQI Clinical Practice Guidelines (CPG) for each indicator, as well as address management of anemia, dialysis adequacy, bone and mineral metabolism, and serum albumin. Network #14 Quality of Care Indicators results are distributed with the facility-specific results and are posted on the website. Facility-specific data is provided to the Department of State Health Services (DSHS) surveyors upon request, prior to impending facility surveys. 50 Page ESRD Network of Texas, Inc. (#14)

52 Determine Quality of Care Concern cut-points The MRB conducts a blinded review of the statewide data and recommends cut-points that define minimal quality of care for each indicator. Utilizing Elab data for national comparison and Network outcomes for facility comparisons, the MRB recommends Quality of Care Concern action cut-points for each indicator. Identify and Intervene with Poor Performers For each of the CPM categories, the MRB performs an analysis of the statewide data and facility averages and reviews facility distribution charts to determine cut-points, as opposed to standard deviation cut-points, because data is not normally distributed. Facilities with one or more validated one year HD or PD QOC Concerns are notified of their potential QOC Concern Facility status and are directed to develop and implement an internal improvement plan that addresses the facility s outlier outcome(s). The notification letter states that it is the MRB s expectation that the facility QAPI committee will review the comparative data, evaluate current data, and develop and implement an improvement plan if facility outlier outcomes are not improved. Facilities are encouraged to request Network QI assistance when developing their improvement plan. Facilities with a two year QOC Concern for HD or PD in the selected MRB focus area are notified of their potential QOC Concern and, if confirmed as a QOC Concern, are required to implement a Network #14 monitored Quality Assessment and Performance Improvement (QAPI) Plan. Utilize comparative data to improve outcomes for all Network #14 hemodialysis and peritoneal dialysis patients In conjunction with Quality Improvement Projects, high performing and benchmark facilities are identified and best demonstrated practices are shared with all Texas facilities, in particular, low performing facilities. Quality of Care Concern cut points are used to identify facilities with outlier outcomes in order to protect and improve the health and safety of patients receiving care at facilities providing care that does not achieve desired outcomes. 51 P age ESRD Network of Texas, Inc. (#14)

53 The Network and MRB address the CPM indicators of management of anemia, dialysis adequacy, bone and mineral metabolism, and albumin through implementation of these strategies. Components of several Quality Improvement Projects and the Quality of Care Concern Improvement Projects, based on Elab data, are incorporated to optimize the implementation of MRB improvement strategies. NETWORK #14 QUALITY IMPROVEMENT PROJECT THE MOVING TARGET (HEMOGLOBIN > 12 GM/DL) Project Description On June 24, 2011, the FDA released a safety announcement on modified dosing recommendations to improve the use of Erythropoiesis-Stimulating Agents in (ESAs) in chronic kidney disease. The following ESA label changes were published: The ESA labels now warn: In controlled trials with CKD patients, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of greater than 11 gm/dl. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. ESA labels now recommend: For patients with CKD, consider starting ESA treatment when the hemoglobin level is less than 10 gm/dl. This advice does not define how far below 10 gm/dl is appropriate for an individual to initiate. This advice also does not recommend that the goal is to achieve a hemoglobin of 10 gm/dl or a hemoglobin above 10 gm/dl. Individualize dosing and use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions. Adjust dosing as appropriate. The drug label previously recommended that ESAs should be dosed to achieve and maintain hemoglobin levels with the target range of 10 to 12 gm/dl in CKD patients. This target concept has been removed from the label. The question regarding an appropriate target range is further complicated by differences on this matter found in other regulatory and scientific literature. For example, in Medicare s ESRD Quality Incentive Program (QIP) Final Rule, two of the three quality measures are related to hemoglobin: 1. Percentage of Medicare patients with average Hemoglobin less than 10.0 gm/dl and 2. Percentage of Medicare patients 52 Page ESRD Network of Texas, Inc. (#14)

54 with average Hemoglobin greater than 12.0 gm/dl. The emphasis on achieving appropriate Hemoglobin levels is further underscored with Medicare s ESRD Prospective Payment System (PPS) Final Rule issued on July 26, 2010, which aligns payment reduction with performance by giving a weight of 25 percent of the total facility performance score to Hemoglobin greater than 12.0 gm/dl. In keeping with the Medicare s ESRD Quality Incentive Program (QIP) FY 2012 and proposed FY 2014 changes, along with National Quality Forum s recommended Hemoglobin focus, the change in the black box warning from Amgen on June 29, 2011, and recent FDA revisions on June 24, 2011, the MRB had multiple discussions via committee meetings, s, and conference calls which occurred in April, May, June, and July to determine the best approach for a Network QIP related to Hemoglobin management. After further surveying the MRB members regarding recommendations for a Network Hemoglobin focus on July 12, 2011, it was the consensus of the MRB members to align Network QI activities with Hemoglobin greater than 12.0 gm/dl into a Quality Improvement Project The Moving Target. Background The MRB reviewed Network #14 performance compared to other Networks in all of the Hemoglobin ranges for adult HD and PD modalities as published in the Elab Project: National 2010 and Trends Elab Report (Charts 29 and 30). Notably, while having the second largest number of adult HD patients at 33,681 patients, Network #14 ranked second among Networks with the largest percentage of HD patients with Hemoglobin greater than 12.0 gm/dl at 28.1 percent. Chart 29: ESRD Networks & U.S. Comparison Percent of HD Patients with Hgb > 12.0 gm/dl % of Patients % 28.1% US Network ELAB th quarter data 53 P age ESRD Network of Texas, Inc. (#14)

55 For Peritoneal Dialysis, Network #14 has the third largest PD adult patient population according to the fourth quarter 2010 Elab data with 2,414 PD patients. The percent of adult PD patients with a mean Hemoglobin greater than 12.0 gm/dl was 32 percent in Network #14, compared to the U.S. mean Hemoglobin for greater than 12.0 gm/dl at 31 percent. Chart 30 ESRD Networks & U.S. Comparison Percent of PD Patients with Hgb > 12.0 gm/dl % of Patients % 32.0% US Network 38.4 ELAB th quarter data The MRB reviewed Network #14 s ranking with other Networks and standing in comparison to the U.S. mean for Hemoglobin greater than 12.0 gm/dl (Charts 29 and 30), Network #14 mean Hemoglobin trends over time (Charts 31 and 32), and facility distribution for Hemoglobin greater than 12.0 gm/dl within the Network. The MRB originally established a cut-point for facilities delivering HD and PD treatment to patients of less than 40 percent of a facility s patients with Hemoglobin greater than 12.0 gm/dl; however, the MRB revised the cut-point to less than or equal to 25 percent of a facility s patients with Hemoglobin greater than 12.0 gm/dl after a first round of data collection from potential outlier facilities showed that since most facilities had changed practice in such a short time, there were very few potential focus facilities remaining that would benefit from being involved with a QIP. 54 P age ESRD Network of Texas, Inc. (#14)

56 60 Chart 31 Distribution of Mean Hemoglobin Adult HD Patients Texas Oct-Dec Percent of Patients < >13 Mean Hgb (g/dl) 40 Chart 32 Distribution of Mean Hemoglobin Adult PD Patients Texas Oct-Dec Percent of Patients < >13 Mean Hgb (g/dl) In keeping with current industry literature, the objective of The Moving Target Hemoglobin QIP was to ensure that facilities have processes in place to effectively monitor and manage serum Hemoglobin levels in individual patients. 55 P age ESRD Network of Texas, Inc. (#14)

57 Barriers Rapidly changing ESA practices in response to FDA actions may alter identified focus facilities and require reconsideration of project selection criteria. Previous activities have led to an understanding of the barriers to increasing the percent of patients in the target range of Hemoglobin 10 to 12 gm/dl to include: Difficulty in titrating Erythropoietin Stimulating Agents (ESAs) to maintain small target range Lack of an anemia management protocol; protocol present but not followed; or protocol present, followed, but not monitored for effectiveness Failure to reduce or hold ESAs when a Hemoglobin level approaches or exceeds 12.0 gm/dl Reimbursement changes that affect the dosing of ESAs Changing Hemoglobin target ranges play a significant role in the variation of care and possibly unintended untoward consequences As each intervention facility conducts its own root cause analysis, additional barriers may be identified. Facility-specific interventions can then be customized to address specified problems. The effectiveness of the interventions will be evaluated based on each facility being able to show improvement and sustain that improvement over time. Work in and again in with nurse managers of targeted facilities confirmed the following barriers to achieving facility patients within a target Hemoglobin range: Lack of a structured QAPI program Lack of a structured data collection and analysis process Lack of structured policies, processes, and/or algorithms to improve anemia Goal for Improvement Seventy-five percent of targeted facilities will meet or exceed the Network cut-point for Hemoglobin greater than 12.0 gm/dl by January 31, Interventions Focus facilities were asked to gather the following information on run charts in December 2011 and during the first two months of 2012 and submit it to the Network for analysis: Percent of patients on ESAs with Hemoglobin greater than 12.0 gm/dl 56 P age ESRD Network of Texas, Inc. (#14)

58 Iron Management inclusive of percent of patients with Ferritin greater than 200ng and less than or equal to 800ng and Transferritin Saturation greater than 20 percent Due to concerns for potentially lower hemoglobin levels in patients and the narrow ESA titration window with the new anemia target, a Hemoglobin and Anemia Fact Sheet was developed for patients in coordination with the Patient Advisory Committee. The information on the Hemoglobin and Anemia Fact Sheet is intended to empower patients to be involved with their care and encourage patients to speak up if certain symptoms occur. The sheet was developed, tested for effectiveness with the Ask Me Three methodology by the Patient Advisory Committee (PAC), and met SMOG test for dissemination. The Hemoglobin and Anemia Fact Sheet includes notification to patients of new anemia targets, symptoms of which to be aware if hemoglobin gets too low, and how they can contribute to their care. It will be made available in 2012 to all providers and patients via the Network s website. Results of the Moving Target QIP will be reported in Activities to Improve Nutritional Management Provider outcome data in the Network for percent of patients with serum albumin greater than or equal to 4.0/3.7 gm/dl has historically matched the national average. The MRB recommends no additional QI focus because serum albumin is not actionable. NETWORK SPECIFIC QUALITY IMPROVEMENT PROJECT PATIENT SAFETY AND HEALTHCARE-ASSOCIATED INFECTIONS (HAIS) Background The Center for Disease Control and Prevention s (CDC s) March 2011 publication, Vitalsigns, highlighted the preventable and costly threat to patient safety that bloodstream infections in patients with central lines pose. Some of the information highlighted includes: About 350,000 people receive life-saving hemodialysis treatment at any given time, and about 8 in 10 of these patients start treatment through a central line Infections are one of the leading causes of hospitalization and death for patients on hemodialysis 57 P age ESRD Network of Texas, Inc. (#14)

59 About 37,000 bloodstream infections occurred in 2008 in hemodialysis patients with central lines A hemodialysis patient is 100 times more likely to get a bloodstream infection from MRSA than other people In fact, since 1994, rates of hospitalization for infection among hemodialysis patients have increased 45.8 percent, according to the 2010 Annual Data Report by the U.S. Renal Data System (USRDS). In another related USRDS report, one year cost for patients with central venous catheters are significantly higher than patients with arteriovenous fistulas ($79,364 vs. $58,585). Patients with arteriovenous fistulas have significantly lower hospitalizations due to infections (1.2 hospitalizations per year vs. 13.3). Healthcare-associated infections (HAIs) are among the leading causes of morbidity and mortality in the United States and the most common type of adverse event in the field of healthcare, according to the U.S. Department of Health and Human Services action plan to prevent HAIs in ESRD facilities. In March 2011, the CDC released the 2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections which recommend the use of hospitalspecific or collaborative based performance improvement initiatives for performance improvement activities, in which multifaceted strategies are bundled together to improve compliance with evidence-based recommended practices. Secondly, specific process and outcomes measures for tracking and feedback, such as rate of central line infections and proportion of central lines placed with all of individual bundle elements performed and documented, should be identified in individual institutions based on areas that have been identified for performance improvement. Emphasis on the care and maintenance of catheters once they are in place should be a focus of performance improvement and quality assurance in all programs. While much has been accomplished to decrease patients starting dialysis with an indwelling cuffed catheter and/or continuing dialysis with catheters as a viable permanent vascular access means to dialysis, the use of catheters for dialysis remains a significant risk to a patient s safety and deterrent to quality of life. Furthermore, there is variation from state to state and ESRD facility to ESRD facility regarding regulations on the surveillance of and reporting of access related infections. From an ESRD facility regulatory and licensing perspective, V-tag citations related to infection prevention and control account for nearly one-third of all CMS recertification survey citations in Texas ESRD facilities in 2010 (Chart 33). 58 P age ESRD Network of Texas, Inc. (#14)

60 Chart CMS Recertification Surveys Texas n=116 surveys Recertification Survey V tag Citations 30% Non IC IC 70% Source: CASPER (8/1/2011) IC: infection prevention & control In addition, dialysis HAIs are on the radar in the National Quality Forum s evaluation of ESRD measures. Furthermore, the Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2011 that updates Medicare policies and payment rates for dialysis facilities paid under the ESRD Prospective Payment System with provisions that will be effective for payments to dialysis facilities furnished on or after January 1, One of the new measures that CMS has adopted that will be used with other measures to score a facility s performance under the Quality Incentive Program (QIP) for performance year 2012 is whether the facility reports certain dialysis-related infections to the Centers for Disease Control and Prevention s (CDC s) National Healthcare Safety Network (NHSN). Network #14 believes that an organizational commitment to a culture of patient safety is a starting point on the road to the reduction of HAIs in ESRD patients. Project Description In the past, the MRB has not focused on infection control or healthcare-associated infections (HAIs) in dialysis patients in a structured or formal quality improvement project. Due to the current healthcare environment with HAIs on the rise and a regulatory focus on dialysis related HAIs in the future, the Medical Review Board decided to first address the infection control data collection processes and educational resources for facilities with a long-term goal of reviewing clinical measures once a uniform and nationally utilized system, such as the CROWNWeb system or the National Healthcare Safety Network (NHSN), has been deployed to ESRD facilities. 59 P age ESRD Network of Texas, Inc. (#14)

61 The K/DOQI guidelines currently recommend that less than 10 percent of patients dialyze with a catheter as sole access for greater than 90 days. Permanent catheters are highly associated with increased morbidity (infections or clotting episodes), mortality, and cost. Therefore, it is important to continually strive to decrease these catheters. The goal of reducing and eliminating medical errors, such as central-line associated bloodstream infections (CLABSIs), in a healthcare environment that is committed to improving patient safety is an opportunity for dialysis providers to make a positive impact on the lives of ESRD patients. Engaging care providers and patients through the implementation of a patient safety advocacy program like the 5-Diamond Patient Safety Program at a facility level is at the heart of Network #14 s specific quality improvement project, Combating Catheter Infections One Diamond at a Time. Quality Improvement Project Components ESRD providers in Texas, in collaboration with the Network, have a unique opportunity to embrace patient safety through three nationally known and recognized patient safety focuses (Chart 34): The 5-Diamond Patient Safety Program, developed by Network #1 New England and Network #5 Mid Atlantic Regional Coalition Speak-Up! Campaign, originally developed by the Joint Commission and modified by Network #14 for dialysis patients, with a seal of approval by review and endorsement of Network #14 s Patient Advisory Committee Reporting of dialysis-related HAIs to the National Healthcare Safety Network (NHSN) from the Centers for Disease Control and Prevention (CDC) Chart 34 National Safety Initiatives in Network #14 QIP 5-Diamond Patient Safety Program Patient Speak-Up Campaign National Healthcare Safety Network 60 P age ESRD Network of Texas, Inc. (#14)

62 Table 8. Component 5-Diamond Patient Safety Program Patient Speak Up! Campaign National Healthcare Safety Network (NHSN) Quality Improvement Project Components Description A self-paced program designed to assist dialysis facilities in building a culture of patient safety by providing educational modules that address various patient safety-related topics. A patient centered program designed to facilitate patients taking an active role in their care and patient safety with the provision of material to encourage patients to speak up and ask questions about their dialysis care. A secure, web-based data collection system for healthcare associated infections developed and managed by the CDC. Focus Facility Selection This Quality Improvement Project targeted twenty-seven focus facilities with a high bacteremia rate per 100 catheter months as reported in the 2011 Dialysis Facility Report Supplemental Report. Resources and strategies within the project were made available to all providers in Texas (Chart 35). Chart 35 Distribution of Network #14 Dialysis Facilities Bacteremia Rate > 0.0 per 100 Catheter Months July to December 2010 # of Facilities Facilities with 0.0 Bacteremia Rate per 100 Catheter Months % of Patients Source: 2011 Dialysis Facility Reports, UMKEEC 61 P age ESRD Network of Texas, Inc. (#14)

63 5-Diamond Patient Safety Program The 5-Diamond Patient Safety Program (5-Diamond), endorsed by the Renal Physicians Association (RPA) and the American Nephrology Nurses Association (ANNA) and embraced by many Networks in the past several years, is designed to heighten awareness of facility safety issues and empower change. Specific objectives of 5- Diamond include: Promote patient safety values Create an awareness of patient safety issues Help dialysis units learn more about specific areas of patient safety Build a patient safety culture in every dialysis unit The ESRD Network of Texas, Inc. rolled out the 5-Diamond program at the Network s Annual Conference in June 2011 at an educational session attended by over 55 dialysis nurses, facility administrators, physicians, and other dialysis professionals from Texas. Objectives of the session included discussion of how facilities can participate in 5- Diamond and describing how it promotes a culture of patient safety. One hundred percent of participants who returned an evaluation from the session said that they strongly agreed or agreed that as a result The number of of the session, they could describe how the program promotes a facilities enrolled patient safety culture environment. in 5 Diamond by December 2011 = 75 The Network sponsored another 5-Diamond Patient Safety Program promotional educational session via a webinar in November 2011, which was open to all dialysis providers in Texas, though attendance was required for the twentyseven focus facilities in the quality improvement project. Facilities select which modules they would like to complete based on individual needs of their facilities and patients. A 5-Diamond Patient Safety Program dedicated webpage was added to the Network s website for facility access to the The number of program. In 2011, there were thirteen modules from which to staff participating select (Table 9), with the Patient Safety Principles module being in 5 Diamond by the only required module for all participating facilities to December 2011 = 794 complete. During November 2011, national module revisions occurred, and, as a result, two additional modules (Communication and Constant Site Cannulation) will be added in 2012, bringing the total number of modules available to facilities to fifteen. 62 P age ESRD Network of Texas, Inc. (#14)

64 Table Diamond Patient Safety Program Modules Patient Safety Principles Emergency Preparedness Health Literacy Hand Hygiene Transplantation Patient Self Managed Care Slips, Trips, & Falls Sharps Safety Stenosis Surveillance Medication Missed Treatments Decreasing Patient & Reconciliation Flu Vaccination Provider Conflict Network #14 s Quality Improvement Analyst developed and coordinates a process for internal management of the 5- Diamond program and continues to refine it as needs arise (Chart 36). The number of patients impacted by 5 Diamond by December 2011 = 5224 START Chart 36 Internal Management of 5 Diamond Program Facility obtains 5 D application from NW website Facility submits required module paperwork Diamond status granted per module Application received Facility starts with PSP module Facility recognized in NW s newsletter Reviewed & approved if complete Facility notified of approval STOP Facility continues with modules until 5 Diamond status reached 63 P age ESRD Network of Texas, Inc. (#14)

65 Patient Campaign: Speak Up! Help Prevent Errors in Your Care To engage patients in taking an active role in their care and safety, the Speak Up! Campaign was organized by the Quality Improvement and Community Outreach Departments at the Network. First, Speak-Up! educational resources for patients were adopted from the Joint Commission and modified for the dialysis environment and the ESRD patient. Second, the resources were tested for effectiveness with the Ask Me Three methodology through the Network s Patient Advisory Committee. Analysis of effectiveness testing results showed that the Patient Speak Up! educational material was effective. Lastly, the material was translated into Spanish and was rolled out at the Network s Annual Conference June 24-25, 2011 and later made available to patients on the Patient Section of the Network s website. For the QIP, the twenty-seven focus facilities were provided several ideas on how to implement the Patient Speak-Up! Campaign at their facilities and were asked to begin the implementation with a checklist in December 2011, to be continued through the first two months of Lastly, Network #14 s Speak-Up! patient resources in English and Spanish were provided to the National 5- Diamond Patient Safety Program and are now available to all dialysis providers and patients throughout the U.S. National Healthcare Safety Network (NHSN) Education was provided to outpatient dialysis centers in fall 2011 regarding NHSN and the need for facilities to begin the enrollment process due to ESRD QIP regulatory changes for performance year 2012/payment year The Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2011 that updated Medicare policies and payment rates for dialysis facilities paid under the ESRD Prospective Payment System with provisions that will be effective for payments to dialysis facilities furnished on or after January 1, One of the new measures that CMS has adopted that will be used with other measures to score a facility s performance under the Quality Incentive Program (QIP) is whether the facility reports certain dialysis-related infections to the Centers for Disease Control and Prevention s (CDC s) National Healthcare Safety Network (NHSN). Plans are underway for extensive facility enrollment education and HAI reporting support by Network in early P age ESRD Network of Texas, Inc. (#14)

66 OTHER QUALITY IMPROVEMENT ACTIVITIES SUPPORTING HCQIP FACILITY-SPECIFIC QUALITY ASSESSMENT AND IMPROVEMENT PROJECTS (QAIPS) F.A.C.E. PROJECT FACILITY ASSESSMENT & CARE ENHANCEMENT PROJECT TEXAS DEPARTMENT OF STATE HEALTH SERVICES (DSHS) The Network and the DSHS ESRD Facility Licensure and Certification Division continued a collaborative and collegial relationship in support of Texas ESRD Facility Licensure Rules. In 2011, the Network MRB leaders and staff met with DSHS Licensure staff from all zones to discuss continuing opportunities to improve care delivered in Texas. The Network QI staff works closely with DSHS ESRD surveyors to provide technical assistance and information, including provision of facility specific and national core indicator outcome data, to assist with the evaluation of quality of care during survey activity. Project Description The ESRD Network of Texas, Inc. fosters and supports facilities in the development of Quality Improvement Programs that facilitate proactive identification of facility QAPI and safety concerns, as well as the implementation of quality initiatives to address those concerns. These initiatives may be derived from analysis of data from Fistula First, CPM, Lab Data Collection (Elab), or trended complaints and grievances. The Network QI Director and QI Coordinator, with assistance and oversight from the Executive Director, work with facilities to ensure a prompt response to problems and issues to allow for quick resolution. A partnership has been established with the State survey agency that facilitates improved care at the facility level through implementation of collaborative corrective action plans (CAP) to improve the quality and safety of dialysis related care. Project Design/Methodology MRB provides recommendations for implementation of DSHS directed CAP, monitors results monthly, and provides feedback and coaching. Seventy-five percent of DSHS Referral Facilities demonstrate the following at time of CAP release: QAPI minutes with trended, graphic depictions of facility outcomes and practices Documentation of Improvement Plans that address ineffective facility processes and outlier clinical outcomes 65 P age ESRD Network of Texas, Inc. (#14)

67 Evaluation in QAPI minutes of practices identified during initial survey as being life-threatening or potentially life-threatening to patients, from facility policies and procedures and resolution The purpose of the collaboration between DSHS and the MRB is to improve care and to ensure the provision of safe and effective care to ESRD patients in Texas. Care issues that have been identified are reviewed and resources and assistance are provided as required to facilitate the correction of the deficiencies. Following ESRD survey exit conference, DSHS surveyors notify Network staff that survey findings indicate a facility in their zone has actual or potential QOC or patient safety deficiencies that Care for over 1,593 patients was improved by this Network quality improvement activity. require MRB peer review Network QI staff produce a blinded Facility Profile that includes comparative data from the Dialysis Facility Reports, Quality of Care data, and facility history that is provided to the MRB through a MRB subcommittee with a report from DSHS. The notification indicates that a referral for an actual or potential QOC or patient safety concern has been identified and a MRB subcommittee conference call is scheduled to obtain MRB recommendations for Corrective Action Plan (CAP). MRB recommendations include, but are not limited to: o severity level (II or III) o suspension of life-threatening processes o request for utilization of monitor(s) and/or manager(s) to more thoroughly assess current facility processes and practices impacting QOC and patient safety o practice audits and required submission of monthly updates on process and protocol changes, educational initiatives, audit results, and QAPI results to the Network for QI staff and MRB review If the CAP includes use of facility managers and/or monitors, monthly updates are required on the facility s progress in meeting the terms of the CAP and improving care 66 P age ESRD Network of Texas, Inc. (#14)

68 After receipt of MRB CAP recommendations, DSHS Zone office notifies facility of the official CAP terms Based on monthly submission, Network QI staff provides technical assistance to the facility and monitors/managers in implementation of improvements in care delivery and the CAP requirements MRB reviews status of all DSHS Referral Facilities on a routine basis and makes additional recommendations Network QI staff instruct and mentor facilities with an extended CAP (past initial six-month time period) in the use of Rapid Cycle Improvement (RCI) methodology for process improvement Network QI staff provide technical assistance to the facility to facilitate strengthening the internal QAPI and monitoring by providing tools, strategies, and resources that facilitate optimal identification of facility improvement opportunities Network QI staff educate the facility on Quality Assessment and Performance Improvement (QAPI) to provide the methodology to address and correct the current CAP situation. Providing this education equips the facility to proactively identify and address patient safety and quality of care issues going forward. In 2011, DSHS referred 13 facilities to Network #14 s Medical Review Board for potential or serious concerns regarding quality, safety, and appropriateness of care deficiencies in these facilities. The MRB assisted DSHS by reviewing the concerns and recommending directed corrective actions, including use of monitors and managers when indicated. Care for over 1,593 patients was improved by this Network quality improvement activity. During 2011, the following deficient practices creating potential and/or actual life threatening quality of care deficiencies were cited by DSHS and reviewed by the MRB: Immediate jeopardy event: o A facility was identified to have missed disinfection of the reverse osmosis water treatment system for a period of approximately 3 months. After disinfection of the system had been initiated they failed to document and check for residual prior to using the water for patient care activities. The facility had to obtain corporate assistance for technical services to abate the immediate jeopardy situation. 67 P age ESRD Network of Texas, Inc. (#14)

69 Infection control practices in: o Disinfection practices o Use of Personal Protective Equipment by physician and staff o Hand washing o Catheter care including dressing changes o Vaccination schedules, administration, and monitoring o Blood wetted transducers not changed o Utilization of expired medications, hand sanitizer, and equipment Nursing services: o Patient care staff competency o Medication administration o RN staffing o Pre, intra, and post treatment assessment and management o Vascular access assessment and monitoring o Following physician orders o Patient Care Technicians removing catheter dressings Technical Safety: o Machine maintenance and integrity o Water safety o Reuse practices and procedures o Lack of training of Biomed Technicians o Incorrect chlorine testing process o Water treatment area not secured Comprehensive Assessment: o Completion by all Interdisciplinary Team members o Lack of Patient involvement o Completion of comprehensive Plan of Care Emergency Preparedness: o Inability to competently use emergency equipment o No contingency plan for water and water treatment o Lack of transfer agreement for emergency services o Missing fire & disaster drills quarterly Quality Assessment and Performance Improvement (QAPI)/Governing Body and Medical Director supervision and oversight: o Lack of evidence showing on-going review, tracking, trending, and analysis for key elements of care on a routine monthly basis o Hemodialysis adequacy 68 Page ESRD Network of Texas, Inc. (#14)

70 o Identification, reporting, and investigation of Adverse Occurrences o Vascular access management outcomes and practices o Social service and dietary assessments o Orientation for new employees o Patient Assessments and Plans of Care o Medical staff credentialing o Missing Patient Care Technicians delegation of duties Network #14 and MRB activities, in collaboration with the DSHS referral facilities, improved outcomes for 145 patients directly and potentially impacted 1,593 patients in Several referrals included complaints involving patients rights and sensitivity issues, such as unprofessional and insensitive staff behaviors and failure of staff to respond timely to patients requests for help. The MRB included specific corrective action recommendations for these deficiencies requiring clinics to perform sequential patient satisfaction surveys on a prescribed time frame and implement the Decreasing Patient- Provider Conflict (DPC) program. All referred facilities were required to provide protocol changes, education initiatives, practice audits, and quality management minutes to the Network and MRB for review for a period of six months. When DSHS required the use of temporary facility monitors or managers, the MRB requested monthly updates on their assessment of corrective actions. The MRB, assisted by Network personnel, reviewed the monthly updates and provided additional monitoring recommendations to DSHS. These recommendations are based on individual situations and may require additional training for the Medical Directors in relation to management and oversight of dialysis facilities and other comprehensive Medical Director Role responsibilities. During 2011, the MRB and Network staff participated in monitoring and improvement activities for a total of 17 facilities (Charts 37 and 38). Of these: 4 cases were carried over from the 2010 calendar year and 3 of these cases were successfully completed in the 2011 calendar year 13 cases started in 2011 and 11 of these cases were continued into 2012 and are being actively followed 69 P age ESRD Network of Texas, Inc. (#14)

71 Chart 37 DSHS Referral Facilities Followed in 2011 by Year of Referral, n= Chart 38 Disposition of DSHS Referrals at Year End 2011, n=17 Released 5 Continued 12 The Network assisted with development of corrective actions and provided education and support of facilities QAPI programs to improve clinical indicator outcomes at the request of facility leadership or when indicated by deficient processes. The following graphs demonstrate achievement of improved clinical outcomes in DSHS Referral Facilities at release from Corrective Action Plan monitoring (Charts 39-41). Chart 39 Released DSHS Referral Facilities With Improved Outcomes For All HD Indicators n=5 Improved all 4 indicators at time of release from CAP* 60.0% Improved upon 2 of the 4 indicators at time of release from CAP 40.0% * At time of referral, 5/5 (100%) met or exceeded MRB QOC cut point Chart 40 Released DSHS Referral Facilities With Improved Outcomes by Clinical Indicator n=5 Chart 41 DSHS Referral Facilities that Met MRB Clinical Indicator Cut Points at year end 2011 n=17 Adequacy 50.0 time of referral year end 2011 Anemia 80.0 Adequacy AVF Rate 40.0 Anemia Catheter >= 90 days Percent AVF Rate Catheter >= 90 days At time of referral, 5/5 (100%) met or exceeded MRB QOC cut point Percent P age ESRD Network of Texas, Inc. (#14)

72 Routine regulatory concerns/complaints received at the Network office are referred to DSHS for survey activity. In 2011, the Network referred 21 concerns, regarding regulatory issues to DSHS for investigation, 7 of which were possibly immediate and serious. The Network provided surveyors with numerous phone consultations. Of the cases referred to DSHS for investigations, 13 were substantiated, 6 were unsubstantiated, 1 was a voluntary termination, and 1 is unknown. ASSIST PROVIDERS IN ESTABLISHING AND MAINTAINING DYNAMIC, ONGOING QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT (QAPI) PROGRAMS Education in Quality Management/Improvement has been an integral component in achieving the long-range quality management plan of the Network. Guided by the MRB, this Network seeks to achieve a balance between the internal and external review approaches to the attainment of quality care and acceptable outcomes. The Network conducted the activities outlined below to achieve the objective of assisting providers to establish and maintain effective facility specific quality management programs. Network #14 Quality Improvement Manual The revised Network Quality Improvement Manual was provided to all 16 facilities that opened in 2011 and to facilities requesting additional copies. The manual includes basic quality improvement tools, techniques, and spreadsheets for the collection, tracking, and monitoring of hemodialysis and peritoneal dialysis core indicators and safety data. QAPI Consultations Network quality improvement personnel participated in telephone and on-site consultations with dialysis facilities requesting assistance to provide quality improvement strategies, best demonstrated practices, and QAPI tools that could be implemented to improve core indicator outcomes through facility-specific QAPI and to develop quality management programs or a specific quality improvement activity. In response to requests for educational and technical assistance, the Network provided facility staff with core indicator outcome data, copies of practice guidelines, technical assistance with QI projects, and QAPI program structure based on Network Quality Management Criteria and Standards. An example includes the QAPI Training, below. 71 P age ESRD Network of Texas, Inc. (#14)

73 QAPI Training The Network reviewed a QAPI program tool, previously developed in another Network, deemed it useful for facilities, and adapted it for use in Network #14. The use of this tool had been introduced in previous years to independent facilities in the state. Five facilities in 2011 were educated and coached on the implementation of the tool. Individual facilities are also provided with technical and educational assistance in QAPI processes and practices upon request. ADDITIONAL QUALITY IMPROVEMENT STRATEGIES Network #14 Criteria and Standards The Network MRB has developed and maintained criteria and standards that are reviewed and revised by the MRB periodically to guide the ESRD community in providing appropriate and quality care. Criteria and standards are recommended practice standards within the Network that can be utilized to create quality improvement studies, guide facility practice, provide standards for medical review decisions, and provide standards for grievance investigations. The Network #14 Criteria and Standards are maintained on the website where over 500 downloads were made in 2011 and provided upon request. The following areas of practice are addressed: Selection of modality and appropriateness of modality (2003) Physician qualifications and responsibilities in ESRD facilities and transplant (revised 2007) Nursing practice (revised 2007) Social Services Practice Recommendations (revised 2009) Nutrition care in ESRD facilities (revised 2004) Dialysis facility specific QAPI Care of ESRD patients in the outpatient peritoneal dialysis setting (revised 2007) Standard for Vascular Access QAPI (developed 2009) Support and Use of National Practice Guidelines All comparative data reports provided to facilities, as part of the Network s quality improvement projects and core indicator reporting, include references to the National 72 P age ESRD Network of Texas, Inc. (#14)

74 Kidney Foundation Dialysis Outcomes Quality Initiatives (K/DOQI) Clinical Practice Guidelines (CPG) and other sources. In addition, in support of the K/DOQI CPG, the Network highlighted K/DOQI recommendations in professional information. Specifically, the Network incorporated K/DOQI CPG and other national guidelines in vascular access management educational and quality improvement tools and the Quality of Care Facility Report Card. Certified Professional in Healthcare Quality The Executive Director and the Quality Improvement Coordinator met the requirements to maintain national credentialing as Certified Professionals in Healthcare Quality. QAPI Education Provided to Network #14 Professionals Outreach and QI education is provided in many venues and a variety of methods. Examples of such education in various care areas include: Vascular Access Prospective Stenosis Monitoring Sleeves Up Protocol for Converting AVG to Secondary AVF FFBI Vascular Access Tools and Resources NKF K/DOQI Vascular Access Clinical Practice Guidelines Updates Annual Cannulation Workshop Vascular Access Strategies - Best Demonstrated Practices Proven Strategies to Increase Fistula Rates Facility Self Assessment Practitioner s Resource Guide to Hemodialysis AV Fistulae Practitioner s Resource Guide to Physical Examination of Dialysis Vascular Access Atlas of Dialysis Vascular Access CD Patient Self-Management VA Educational Tools and Resources Vascular Access Coordinator Resource Manual Quality Improvement Processes Quality Improvement Criteria and Standards Nephrology Professional Criteria and Standards QAPI Run Charts Core Indicator Report Card 73 P age ESRD Network of Texas, Inc. (#14)

75 QI Technical Assistance Over 1,740 general technical assistance contacts were provided via phone calls and s. Quality Improvement provided technical assistance in areas such as infection control, data collection, form assistance, quality improvement processes, website orientation, referrals to other agencies for resources, and regulatory guidance. QI Process Tools and QAPI Meeting Recommendations, Tracking and Trending Tools, Adverse Patient Occurrence Tracking, Mortality Tracking, Death Review Form Regulatory Issues ESRD Facility Audit Tools for State and Federal Surveys CMS Conditions for Coverage CMS Conditions for Coverage Interpretive Guidelines CMS Conditions for Coverage Measures Assessment Tool Texas ESRD Licensure Rules and Regulations Texas Licensure Rules and Regulations Fact Sheet DSHS Report to Director Quality of Care Core Indicators 2011 ESRD Network of Texas Quality of Care Indicators Data Sheet How to utilize Core Indicator Run Charts to improve facility QI processes Other Increasing Modality Awareness Advanced Planning for End Of Life Care Immunizations Decreasing/eliminating Healthcare Associated Infections QI Resources on Website The following QAPI and outcome assessment tools are available on Network #14 s website (the number of downloads (n) for resources are provided where available): ESRD Network of Texas, Inc. (Network #14) QI Criteria and Standards (524) 74 P age ESRD Network of Texas, Inc. (#14)

76 Peritoneal Dialysis Resources (12,597) Hemodialysis (HD) and Peritoneal Dialysis (PD) Run Charts (1,170) Quality of Care Indicators Update (857) Five Diamond Patient Safety Program (849) QI Resources: QI Checklist, Orientation Questionnaire, Action Plan, Tracking Form, Reporting Form, Mortality Reporting and Trending Worksheet, HD and PD Core Indicator Reporting and Trending Worksheet, Individual Patient Death Review Form, HD & PD Adverse Patient Occurrence Tracking Worksheets (4,338) Vascular Access Tools and Resources (53,303) ESRD Regulatory documents federal and state (58,307) MEDICAL REVIEW BOARD INITIATIVES TO ENCOURAGE QAPI All improvement plans (IP) requested by the Medical Review Board included a QAPI component and submission of QAPI minutes and QI activities to demonstrate IP progress for Network review and intervention, if needed. In summary, the activities of Network #14 have been effective in achieving this goal as evidenced by, among other things detailed in this section: Achieving the highest percent increase (34.6%) among all ESRD Networks in the utilization of AVFs by prevalent patients with an additional 1,645 patients with AVF in 2011 Improving clinical outcomes with 145 patients directly impacted and an additional 1,593 patients potentially impacted Improved QAPI processes at the facility level for five released and eleven continuing facilities under a DSHS corrective action plan through collaborative initiatives and interventions among Network #14, MRB, and the State Agency Stimulating improvements in patient safety in Network #14 facilities through sharing of information related to specific patient safety issues among Network #14, MRB, and the State Agency and through the roll out of the 5-Diamond Patient Safety Program with 75 facilities enrolling in the program in P age ESRD Network of Texas, Inc. (#14)

77 Sixth highest ranking among Networks for percent of Hemodialysis patients with Kt/V > 1.2 (97.5%) Sixth highest ranking among Networks for percent of Hemodialysis patients with Hgb < 10.0 g/dl (12.6%) Eighth highest ranking among Networks for percent of Peritoneal Dialysis patients with TSAT > 20% (90.5%) Second highest ranking among Networks for percent of Hemodialysis patients with TSAT > 20% (90.3%) 76 P age ESRD Network of Texas, Inc. (#14)

78 GOAL- IMPROVE INDEPENDENCE, QUALITY OF LIFE, AND REHABILITATION OF INDIVIDUALS THROUGH SUPPORT FOR TRANSPLANTATION, USE OF SELF-CARE MODALITIES AND IN-CENTER SELF CARE, AS APPROPRIATE, THROUGH THE END OF LIFE In support of this goal the Network performed the following during 2011: REHABILITATION INITIATIVES The Rehabilitation Program of the ESRD Network of Texas, Inc. is designed to work with both professionals and patients to ensure that incident dialysis patients are informed of the benefits of continuing to work and assessed for rehabilitation services. Network #14 s Vocational Rehabilitation Referral Status (VRRS) form is a tool to assist facilities to identify suitable VR candidates to facilitate the VR referral process. In addition, Network #14 developed a Best Practices and Barriers tool to assist professionals in the identification process in The Network disseminated information and updates for professionals on vocational rehabilitation in the monthly electronic newsletter NetLink. Network #14 posters in all dialysis facilities promote assessment and referral to vocational rehabilitation. The Network gave additional instruction and information to facilities to persuade staff to inform and encourage their patients to continue to work and/or volunteer. Furthermore, the program is aimed at ensuring that rehabilitative opportunities are presented and available to all suitable ESRD patients. The Network continues to automatically distribute the Criteria and Standards to all new facilities and upon request to existing clinics. The Network collects vocational rehabilitation data from each facility from the CMS form that utilizes standardized CMS data elements and definitions. In 2011, the Network collected self-reported year end VR data on 12,938 patients aged The Network and MRB annually review the Vocational Rehabilitation Activity Report. In 2011, Texas facilities reported that 19.1 percent of patients between the age of 18 and 54 years were employed, while 3.1 percent of eligible patients were attending school full or part-time, as compared to 17.2 percent of patients employed and 2.9 percent attending school full or part-time in P age ESRD Network of Texas, Inc. (#14)

79 The percent of patients receiving services from VR or other VR related service providers (public or private) had steadily decreased from 4.2 percent in 2002 to 1.7 percent in In 2011, however, the number of patients utilizing VR services in Texas increased to 3 percent and broke the historical multi-year downward trend. The ESRD Network of Texas, Inc. continues to work with the Department of Assistive & Rehabilitative Services (DARS) in an effort to address the ongoing barriers to referral and the availability of services. As has been true for a number of years, vocational counselors are evaluated based upon the number of cases successfully placed in employment. Dialysis patients, because of their thrice weekly, four-hour treatments, are more difficult to place and require more time and effort on the part of the counselor. During the time it takes a vocational counselor to place one dialysis patient, he/she could place three to four easier cases and thus get a higher success rate within the performance system. This is a disincentive for the counselors to accept dialysis patients; however, recent changes to emphasize services to special needs populations may continue to prove a new motivation to focus on ESRD patients. In 2011, to promote vocational rehabilitation, the Network developed and distributed to professionals tools to assist rehabilitation with identifying patients appropriate for VR referrals. Facilities where no vocational activity was reported were requested to complete improvement plans. Facility specific reports with trended VR data are scheduled to be disseminated to facilities in This information will display VR activity compared with statewide averages and will also contain the Network facility posters to be made available to all patients that encourage VR, employment, and volunteering. Facilities with an opportunity to improve their VR efforts as compared to state averages are requested to review their VR programs and utilize the tools provided by the Network. The Network continues to partner with the Life Options Rehabilitation Advisory Council (LORAC) by highlighting and emphasizing their program in mail-outs and newsletters. This information is also posted to the Network #14 website. ADVANCED CARE PLANNING AND END OF LIFE Network #14 has long promoted Advanced Care Planning and appropriate End of Life Care. It encourages Advanced Care Planning at the facility level and encourages timely referrals for hospice when the end of life appears to be nearing. Articles and 78 P age ESRD Network of Texas, Inc. (#14)

80 announcements for community seminars on these subjects were published in the Network monthly newsletter NetLink. A panel, inclusive of two family members, presented Advanced Care Planning during the 2011 Annual Conference. The presentation included information from the Kidney End of Chart 42 Life Coalition and two Percent of Patients Referred to Hospice prior to personal stories. Death 30 Network #14 s Executive Director participated in the national Kidney End of Life Coalition and served as a member of the hospice 15 workgroup. 10 In 2011, 26 percent of 5 patients were referred for hospice care prior to death, 0 compared with only percent nationally in TX Nat'l. This compares favorably to previous years with a steady increase in hospice referrals since 2007, as shown in Chart 42. Additionally, of those patients who discontinued dialysis prior to death, 73 percent received a referral to hospice, compared with 73 percent nationally in 2010, indicating improved access to hospice. PROMOTING SELF CARE AND TRANSPLANTATION Patient self care has steadily risen since the early 2000s, as seen in Chart 43, but the percentage is low compared to the total ESRD population in Texas of over 39,000 patients on dialysis. To help further educate patients and professionals and raise awareness about the benefits to self care, the Network sponsored several presentations and publications about patient self care in Two presentations on educating patients about home modalities and one on motivating patients to self care were presented at the 2011 Annual Conference to professionals. 79 P age ESRD Network of Texas, Inc. (#14)

81 Chart 43 Patients Receiving Home Dialysis Numuber of Patients Following the implementation of revised federal regulations governing transplant centers in 2008 that required the centers to notify dialysis facilities of their selection criteria, the Network solicited and compiled into a booklet the criteria from all 23 transplant centers in Texas. During 2011 the Network updated the Selection Criteria for Texas Transplant Facilities booklet and distributed it to all dialysis and transplant centers in Texas, as well as posted it to the Network website. The booklet highlights differences in criteria to allow and promote selection of a transplant center to overcome barriers, such as Body Mass and various disease states, to transplantation between centers. In 2011, there were 14,934 downloads of this booklet. In addition, the Network began the adaptation of an interactive website for patient selection criteria for Transplant Hospitals, available on the Network #14 website in The transplant Chart 44 Patients Waiting for Transplant waitlist decreased % to 9,013 in 2011 from 9,052 in 2010, a 50.4% increase over 2005 (Chart 44). 80 P age ESRD Network of Texas, Inc. (#14)

82 In summary, the activities of the Network have been successful in promoting independence, vocational rehabilitation, and improved quality of life in the following ways: Continued increases were observed both in the number of patients participating in VR services and the number of patients attending school full or part-time in 2011 Activities to encourage self care have been successful as evidenced by a steady increase in patients receiving self care 81 P age ESRD Network of Texas, Inc. (#14)

83 GOAL- IMPROVE PATIENT PERCEPTION OF CARE AND EXPERIENCE OF CARE AND RESOLVE PATIENTS COMPLAINTS AND GRIEVANCES In support of this goal the Network performed the following during 2011: IMPROVING PATIENT PERCEPTION AND EXPERIENCE OF CARE Initiatives to Decrease Involuntary Patient Discharge (IVD) The Network actively works to decrease the number of patients that are involuntarily discharged from an ESRD facility by heightening awareness, conducting education and webinars, coaching facility staff, intervening in individual cases, and providing technical assistance as indicated. Information on involuntary discharge (IVD) and patterns of discharge from individual facilities are identified from data submitted monthly on the Patient Activity Report by the dialysis facilities. When a pattern of patient complaints or IVD is identified, the Network works individually with facilities providing objective input and training. The CMS Conditions for Coverage state that a facility must provide a 30-day written notice of discharge when an IVD is imminent, except in the event of an immediate and severe threat to staff or other patients safety. In each case, the facility is required to notify both the Network and the state agency of the IVD. The Network revised and continued use of an IVD checklist with accompanying memo, sending this tool to providers who contacted our office concerning an actual or atrisk IVD case. This material details Network #14 s position on Involuntary Discharges, recommended tools, and outlines expected actions of professionals providing care to prevent and resolve the issues precluding an IVD. The goal of these materials is to inform and strongly encourage providers to engage in a robust attempt to resolve issues prior to involuntary discharge as described in the Federal regulations. In 2011, the Network profiled IVD data from by cause, number of patients, percent of total patients, and by ownership. The Network sent comparative blinded data to the various corporations with a letter from the Executive Director and a Network #14 Position Statement on IVD from the MRB and Executive Committee. This statement made clear that IVD due to treatment non-adherence is not an acceptable reason for discharge. The Network also disseminated data with the position statement to all providers and medical directors, and it is believed this was instrumental in preventing IVDs from drastically increasing in P age ESRD Network of Texas, Inc. (#14)

84 There was a slight increase in the number of patients that received an IVD in While the patient population increased 4.7% over the last year, the percentage of total patients with IVD remains less than 1%. In 2011, the number of patients involuntarily discharged from facilities increased to 45 from 42 in This increase The leading represents less than one cause of IVDs in percent of the patient 2011 was population due to the severe or increased number of new immediate dialysis patients in the state threat, of Texas. The Network followed by Patient Services Coordinator tracked approximately 165 non payment cases of patients that were (Chart 45). either already discharged from a facility or were at risk for involuntary discharge. Network staff participated in twenty patient care conferences in 2011 to facilitate the resolution of issues that might result in involuntary discharge. A total of 40 cases were averted, enabling 40 patients to remain at their facilities due to the collaboration of the Network, facilities, and the patients. The percent of total patients that are involuntarily discharged remains less than 1 percent despite continued growth in the number of patients each year. Although the actual number (45) and percent (<0.1%) of patients discharged (Chart 46) is small, the adverse outcome for the patient is serious and can be life threatening. Twenty of the forty-five IVDs in 2011 were for severe or immediate threat by the patient. Chart Number of All Involuntary Discharges by Type N = Chart 46 Trending Involuntary Discharge Other Non Payment Cannot Meet Medical Need Severe Immediate Threat # Pts DC # Facilities DC Physician Termination Ongoing Disruptive/Abusive Behavior 6 7 Most of the physician terminations were due to non compliance P age ESRD Network of Texas, Inc. (#14)

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