Judith Kari Glenda Payne & The Transition Team

1. Using the ESRD Survey Process for the 2008 Conditions for Coverage Judith Kari Glenda Payne & The Transition Team

2. Objectives of This Presentation • Describe the expectations & challenges of an ESRD survey • Recognize ESRD standards of care & how these are used by surveyors • Describe data available to ESRD surveyors & its use in ESRD surveys • Describe tasks to be used to conduct the new ESRD survey • Demonstrate understanding of use of findings in constructing DPS & findings for CMS 2567

3. Spectrum of ESRD Services “ESRD benefit” & the ESRD CfC cover: • Outpatient dialysis in ESRD facility • In hospital (“hospital based”) or • Outside hospital (“independent”) or • Special purpose (for 8 months max.) • Training & support for home/self dialysis

4. Hospital-Based Dialysis • Based on integrated ownership & operation • NOT… • LOCATION • Shared service agreement • Patient referral agreement • At CFR 413.174

5. ESRD Benefit & the ESRD CfC Do NOT Cover • Dialysis in an inpatient setting • Acute dialysis (These are covered by hospital PPS & surveyed under Hospital COP) • Pre-ESRD: Stages 1-4 Chronic Kidney Disease (CKD)

6. CMS Expectations for State Oversight of ESRD Facilities • Conduct initial surveys as soon as scheduling allows; Tier 3 workload • Conduct resurveys, FY 2009 • Tier 2: 10%; must be from top 20% of outcomes list • Tier 3: 30%; 4 year interval maximum • Tier 4: 33%; 3 year interval average • Conduct complaint surveys • When warranted • Within specified timeframes

7. Challenges for ESRD Surveys • Surveys are technically & clinically complex: Not intuitive • Equipment & technologies keep changing: Need updated information • Large number of V-tags: ~400 • Recognized Standards: Need updated information • Workload competition: Not statutorily mandated

8. Specialization and Ongoing Training Are IMPORTANT

9. ESRD Survey Focus: Protect Patient Safety & Improve Patient Outcomes • Data is used to focus surveys • During survey, observations focus on identification of safety hazards • Water/dialysate • Reuse • Machine operation/maintenance • Direct care • IDT assessment, planning & delivery of care

10. Direct Partners in Guidelines & Standards: Incorporated in Regulations • AAMI: • RD52:2004 Dialysate for Hemodialysis • RD62:2001 Water for Hemodialysis • RD47:2002/03 Reuse of Hemodialyzers • CDC • RR-05: “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” • RR-10: “Recommendations for Placement of Catheters in Adults and Children” • NFPA • 2000 Life Safety Code

11. Partners in Standards • FDA • Approval of devices, including manufacturer’s guidelines • Reports on malfunctions • NKF • Kidney Disease Outcomes Quality Initiative (KDOQI) • Community-accepted guidelines for both “minimum” & “target” outcomes • NQF • Develop CPMs

12. Partners for Reference Standards • American Nephrology Nurses’ Association (ANNA) • Standards for nursing care • Guidelines for care • Renal Physicians Association • Kidney Patient Safety website • State Practice Acts

13. Surveyor Use of Standards & Guidelines • POC: The implemented POC must result in patient outcomes that meet minimum levels of defined standards • If “minimum” standards of care are not met, there must be a change to the POC implemented • QAPI: For facility: Each facility must provide care to their (group of) patients that meets defined standards • If “minimum” standards are not met, expect assessment of that aspect of the QAPI program

14. Measures Assessment Tool (MAT) • Developed to allow updating as Standards change • Includes both individual targets for patients & aggregate targets for facility use in QAPI • Included as an addendum to the Interpretative Guidance • Laminate for ease of use

15. The BASIC Survey Process • Used for recertification • Organized around TASKS • Focus of this session!

16. The INITIAL Survey Process Use the Basic survey process as the base for” • Initials • Complaints • Relocations • Change in service

17. STAR: Automated ESRD Survey • Surveyor Technical Assistant for Renal Disease (STAR) • An automated survey guide • Uses a wireless tablet PC • Guides YOU through the survey process • Roll-out in process

18. STAR … • Automatically produces a draft of Form CMS-2567 • Finds V-tags • Converts handwriting to typed text • Will be updated to the new CfC asap • Can still use STAR in the meantime • Use the crosswalk to convert findings to new tags

19. Pre-Survey Activities • Review of facility file • Problems, complaints • Previous surveys • Review of data • Outcomes List • Dialysis Facility Reports (DFRs) • Contact ESRD Network

20. Using Data/Outcomes in ESRD Survey • Pre-survey: • Use Outcomes List to select facilities • Use Dialysis Facility Reports to plan survey • During survey: • Use data to focus survey • Expect QAPI action if poor outcomes identified • Post-survey: • Data may define the citation level (i.e. standard, conditional, or Immediate Jeopardy)

21. What Type of Data Is Available for Surveyors? • ESRD Dialysis Facility Reports and Outcomes List developed for States for survey purposes: http://www.sph.umich.edu/kecc/usr/usr.htm • ESRD DFRs distributed to each state every September-October

22. ESRD Data Reports for Surveys • Outcomes List • Rank-ordered list of facilities (#1 is the lowest-ranked facility) • List is based on 3 factors: Adequacy of dialysis, anemia management & adjusted mortality rate • There is a positive correlation between ranking on the outcomes list & survey deficiencies

23. Clicker Question!! • My state uses the outcomes list to choose facilities for survey each year. • Yes • No • I don’t know • I don’t work for a state

24. ESRD Data Reports for Surveys 2. Dialysis Facility Reports • Facility characteristics, patient outcomes & practice patterns in the report • Summary text on the first five pages: compares facility data to State, Network & national levels

25. Clicker Question!! • I have easy access to the DFR for every survey. • Yes • No • I don’t know • I don’t work for a state

26. ESRD Data Reports for Surveys 2. Dialysis Facility Reports • Charts for the following: • Standardized mortality rates (SMRs) under 1.00 are better than average—the lower the better • Adequacy: Kt/V of 1.2 or greater is target • Hematocrit level 30-36% or hemoglobin level of 10-12 mg/dL are targets • These data are COMPARATIVE—updated numbers from the facility may not be comparative

27. Clicker Question!! • I routinely use the DFR for every survey. • Yes • No • I don’t know • I don’t work for a state

28. Why Do Surveyors Use Data? • To SELECT facilities to survey • To FOCUS the survey process onsite (look at current data, QAPI) • To DETERMINE the extent of noncompliance (enforcement)

29. What Other ESRD Data Is Available? • CROWNWeb • Dialysis Facility Compare (DFC): facility-specific data for the public at www.medicare.gov/dialysis • Network data: annual reports & other data at www.esrdncc.org • United States Renal Data System (USRDS) Annual Report at www.usrds.org

30. Coming Soon… CROWNWeb • New CfC requires all facilities to submit data electronically starting 2/1/09 • Will provide data on 100% of patients from each facility • DFRs in future will reflect data from CROWNWeb

31. 1. Pre-survey prep 2. Introductions 3. Tour/Observations 4. Entrance conference 5. Patient sample selection 6. Water treatment/ Dialysate preparation 7. Reprocessing/Reuse 8. Machine operation/ Maintenance 9. Home training dept review 10. Patient interviews 11. Medical record review 12. Personnel interviews 13. QAPI 14. Personnel record reviews 15. Decision making 16. Exit conference Survey Tasks

32. “Our Survey” Data Shows • DFR shows 76% of the patients have hematocrit (Hct) > 30% (State average = 89%)

33. Surveying Is Like a Puzzle • It takes more than 1 piece to solve it • You may have a different view at the end than you did at the beginning!

34. Task 2: Introductions • Is BRIEF • Introduces the members of the team to the person in charge • Briefly explains the purpose of the survey

35. Task 3: Tour/Observations Ongoing throughout survey • Physical environment • Infection control • Patient/staff interaction • Patient care delivery • Staffing • Medical records/logs in use

36. Task 3a: Environmental Tour 3a: ”Flash survey” of all areas: • Waiting room • Patient restrooms • Reuse room • Water /Dialysate areas • Home training area • Treatment area • Isolation

37. During the Tour • Is the environment safe & sanitary? (V111, 112, 122, 401, 402) • Free of hazards? (V401, 402) • Are patients treated with respect? (V452) • Are machine alarms set & responded to? (V402, 757) (From your new laminate on the survey process)

38. Task 3b: Observe Care • Infection control practices • Patient care • Dialysis machine & dialyzer use

39. Observe Care • Are staff following CDC recommendations & these regulations for prevention of transmission of infections? (V113, 115, 116, 117 & more!) • Are current records complete? (V726, 326) • Do staff respond to patient problems? (V543, 544, 546, 547, 549) • Is a Registered Nurse present? (V759) • Are trainees supervised? (V715, 760)

40. 3c: Emergency Equipment • Review for equipment function (V413) • Staff emergency preparedness (V409, 411) • Evacuation supplies present/in date (V408) • Fire extinguishers present (V417)

41. “Our Survey” Data Collection • During observations on 10/19/08 at 9:30 a.m., 12 of 18 dialyzers from the first shift to be reprocessed are noted to be bright red

42. Task 4: Entrance Conference • Purpose/ anticipated schedule • CMS 3427 to complete • Collect facility specific info: use STAR or worksheet & reference materials list • Request patient sampling info

43. Review the facility-specific data report with the manager Ask for current data Task 4: Entrance Conference Show me what you have done to improve!

44. Task 5: Patient Sample Selection • 10% sample (min=5; max=15) • Sample to include variety—all treatment modalities offered must be represented • Use info requested from facility to choose sample

45. Sample Selection • Current patient census by modality, with admit dates • Current HD patient listing by shift (seating chart) • Cumulative lab reports • Infection logs • Hospitalization logs • Vascular access information • Any pediatric patients • Residents of LTC facilities • “Our survey” sample would include some patients identified from cumulative lab reports as “challenges” for anemia management

46. Task 6: Water Treatment & Dialysate Preparation 6a-Observation/ Interview • Talk to the people doing the work • “Walk me through the water • Required components: • TWO carbon tanks; 10 min EBCT (V192, 195) • RO (V199, 200) or DI (V202, 203) • Observe chlorine /chloramine testing (V196, 197, 270)

47. Task 6b: Review Of Water Treatment Logs • Chemical analysis (V201, 206, 177) • Microbial surveillance: monthly CFU & EU (V213, 254); response to action levels (V178, 255) • Ch/chl testing (V196, 197, 270) • Daily logs: hardness (V191); RO/DI parameters (V199, 202)

48. Task 6c: Review Of Dialysate Prep & Delivery NEW! • Observe mixing if possible • Batches mixed on site: • Per DFU (V226) • Batch tested & verified (V229) • Bicarb not overmixed (V234) • Bicarb storage minimized (V233) • All containers labeled (V228) • Outlets labeled/color coded (V245, 246, 247) • Jugs: rinsed daily (V243), disinfected weekly (V244)

49. Task 7: Reuse Task 7a: Observations Of Reprocessing Procedures/ Interview With Reuse Personnel • Observe the entire reuse process: • Set up for use • Take down • Rinsing • Testing • Filling with germicide • Storage

50. Task 7b: Review of Reuse Logs • Reprocessing logs (V326) • Germicide vapor testing (V318) • Cultures/ LAL (V205, 314) • PM/repairs (V316); tested after repairs (V317) • QA: required audits done (V362-368); reviewed in QAPI (V635)