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

2. 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. 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. 4 Hospital-Based Dialysis  Based on integrated ownership & operation  NOT… LOCATION Shared service agreement Patient referral agreement  At CFR 413.174

5. 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. 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. 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

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9. 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. 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. 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. 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. 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. 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. 15 The BASIC Survey Process  Used for recertification  Organized around TASKS  Focus of this session!

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

17. 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. 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. 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. 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. 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. 22 ESRD Data Reports for Surveys 1. 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. 23 Clicker Question!!  My state uses the outcomes list to choose facilities for survey each year. 1.Yes 2.No 3.I don’t know 4.I don’t work for a state

24. 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. 25 Clicker Question!!  I have easy access to the DFR for every survey. 1.Yes 2.No 3.I don’t know 4.I don’t work for a state

26. 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. 27 Clicker Question!!  I routinely use the DFR for every survey. 1.Yes 2.No 3.I don’t know 4.I don’t work for a state

28. 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. 29 What Other ESRD Data Is Available?  CROWNWeb  Dialysis Facility Compare (DFC): facility-specific data for the public at www.medicare.gov/dialysis www.medicare.gov/dialysis  Network data: annual reports & other data at www.esrdncc.orgwww.esrdncc.org  United States Renal Data System (USRDS) Annual Report at www.usrds.org www.usrds.org

30. 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. 31 Survey Tasks 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

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

33. 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. 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. 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. 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. 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. 38 Task 3b: Observe Care  Infection control practices  Patient care  Dialysis machine & dialyzer use

39. 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. 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. 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. 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. 43 Task 4: Entrance Conference  Review the facility-specific data report with the manager  Ask for current data

44. 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. 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. 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. 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. 48 Task 6c: Review Of Dialysate Prep & Delivery  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. 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. 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)

51. 51 Task 7c: Centralized Reprocessing Note: Surveyor must review tasks 7a & 7b at the centralized reprocessing location  P&P at user ESRD facility for transportation & clinical use (V306)  Safe transport of dialyzers (V331)

52. 52 “Our Survey” Data Collection (cont.)  During observation of reuse practices at 10:00 a.m. on 10/19/08, you see that 6 of the 12 dialyzers used by patients on the first shift are dark red when brought to the reprocessing area for rinsing & reprocessing. 3 of these belong to the patients you interviewed, & they rinsed clear.

53. 53 Task 10: Patient Interviews  Try for a minimum of 5 patients  Can be same sample as records reviewed or different  Done in treatment area, waiting room, in private, or by phone  Use a structured interview guide— in STAR, our guide or “custom”

54. 54 Patient Interview Guide Ask the following:  How do you participate in your Plan of Care?* (V541, 556)  How does your dialyzer look when your treatment is finished— clear, pink or red?**(V547) (*=standard; **=custom)

55. 55 “Our Survey” Data Collection  During patient interviews, 3 of 5 patients tell you their dialyzer is always red when their treatment is finished  These 3 patients (#s 2, 4 & 5) were interviewed 10/19/08 from 11:30 to 1:15

56. 56 Task 11: Medical Record Review  Review 3-7 sampled records completely; focus remaining reviews on identified concerns  Use STAR or the record review worksheet  New focus: patient assessment & POC development  Refer to the MAT for current standards; if not met for individual patient, expect  to POC

57. 57 Task 11: Medical Record Review How will we know the POC is implemented? Physician’s orders Laboratory values IDT progress notes POC changes/ updates Dialysis flowsheets

58. 58 Task 11: Medical Record Review  Current tx orders: Time Frequency BFR/DFR Dialyzer Heparin dose ESA? Dose? Iron Rx?  Flow sheet: Tx delivered as Rx? Freq of B/P checks during tx as patient needs? Are febrile reactions addressed? Assessments?

59. 59 “Our Survey” Data Collection (cont.)  Laboratory reports for 3 patients who indicated their dialyzers are always red show a fall in Hct over the last 3 months; 2 additional records reviewed did not have this finding. Review of care plans, orders & progress notes finds no evaluation of the fall (Reviewed on 10/20/08).

60. 60 Task 12: Personnel Interviews  Done during the survey: “talking to the people doing the work”  Will include the nurse manager, water tech(s), reuse tech(s), patient care tech(s) & other nurse(s)  May include MSW, RD & medical director  If you have CfC findings, or findings related to medical director responsibilities, be sure & interview him/her

61. 61 “Our Survey” Data Collection  Nurse manager tells you that every dialyzer is to be rinsed clear when patient’s blood is returned at the end of treatment

62. 62 “Our Survey” Data Collection  3 patient care techs (#s 7, 9 & 12) tell you they have to finish the first shift of patients by 9:30 a.m. & sometimes they shorten the rinse- back procedure so the second shift of patients can start by 10:00. Interviews done on 10/20/08 from 9:15- 9:35

63. 63 Document Review  Review selected policies & procedures  “Our Survey” review of facility policy (# 96-01) which requires rinse-back of blood until the dialyzer is clear unless the dialyzer is clotted & blood cannot be returned (Reviewed on 10/20/08)

64. 64 Task 13: QAPI 13a) QAPI documentation/interview Areas that must be monitored include:  Dialysis adequacy (V629)  Medical injuries/errors (V634)  Nutritional status (V630)  Dialyzer reuse program (V635, 362- 368)  Mineral metabolism (V631) More…

65. 65 Task 13a: QAPI More areas that must be monitored:  Patient satisfaction & grievances (V636)  Anemia management (V632)  Infection control (V637)  Vascular access (V633)  Technical functions (V627)

66. 66 Task 13a: QAPI  Facility must prioritize those areas that affect patient safety (V639, 640)  Develop and implement action plans aimed at making/sustaining improvement (V638)  Home modalities included; PD outcomes reviewed separately (V628)

67. 67 Task 13b: QAPI: ER Prep  Must address fire, power failure, water supply interruption, natural disasters & care-related emergencies (V408)  Annual staff training (V409)  Patient education program (V412)  Annual contact with local disaster mgmt agency (V416)

68. 68 “Our Survey” Data Collection  QAPI minutes from 10/07–9/08 have no evidence of audits of reuse & no evidence management has identified any issue with blood return post-treatment  Facility staff have not reviewed their DRR nor compared their anemia management rate of 76% with the State average of 89%  Review done on 10/20/08

69. 69 Task 14: Personnel Record Review  Review personnel document completed by facility  Choose a sample to review for orientation (V760), competency (V681), qualifications (V682-691, 694, 696), licensure (V681), certifications (V695), etc.  Review PCT training & certification (V693-695)

70. 70 Task 15: Decision Making  Review the data collected  Determine what to cite, level of citation, & if additional observations, interviews or record reviews are needed.  Organize for exit: use STAR or notes to make a list of deficient findings; start with most serious finding.

71. 71 Task 16: Exit Conference  Provide an overview of survey activities; briefly summarize deficient practices identified  Answer questions  Describe next steps

72. 72 “Our Survey” Deficiency Presented Under the CfC QAPI: V635: Hemodialyzer reuse program (IG: the QAPI meeting minutes should demonstrate oversight of the reuse program …)

73. 73 Deficient Practice Statement Based on review of data, observations, patient & staff interviews & review of records, this facility did not identify a fall in the Hct measures of 3 of 5 sampled patients as potentially related to the facility processes of reuse, impacting all 44 patients who were included in the reuse program in this facility as of the survey date.

74. 74 Findings 1. Review of facility data revealed 76% of the patients in this facility achieved the target hematocrit level of 30% for management of anemia, compared to the average of 89% for the State

75. 75 Findings (cont.) 2. On 10/19/08 at 9:30 a.m., 12 of 18 dialyzers used for the first patient shift were observed to be bright red after completion of dialysis, indicating blood was left in the dialyzer rather than returned to the patient.

76. 76 Findings (cont.) 3. On 10/19/08, from 11:30 to 1:15 a.m., interviews of patient #s 2, 4 & 5 found that their dialyzers were “always red” when their treatments were completed. A dialyzer that is red in color after treatment is completed indicates clotting of the dialyzer or incomplete rinse-back of the blood in the tubing & dialyzer.

77. 77 Findings (cont.) 4. Observation of reuse practices at 10:00 a.m. on 10/19/08 found 6 of 12 dialyzers from the first patient shift were dark red when brought to the reprocessing area. These 6 included dialyzers for patient #s 2, 4 & 5. These dialyzers rinsed clear & were not clotted.

78. 78 Findings (cont.) 5. Interviews of staff member #s 7, 9 & 12 on 10/20/08 from 9:15 to 9:35 revealed they “had to finish” the first shift of patients by 9:30 a.m. & that they “sometimes shorten” the rinse-back procedure.

79. 79 Findings (cont.) 6. Review of records on 10/20/08 for patients 2, 4 & 5 revealed lab reports showing drops in hematocrit over the past 3 months: Jul. Aug. Sept. Patient 2: Hct 33.1 30 28 Patient 4: Hct 30 29 27.8 Patient 5: Hct 31 29 27 There was no evidence in progress notes, plans of care, or orders of evaluations for reasons for the drops in Hct.

80. 80 Findings (cont.) 7. Review of facility policy # 96-01 on 10/20/08 revealed staff were required to rinse back the patient’s blood until the dialyzer was clear unless the dialyzer was clotted & blood could not be returned

81. 81 Findings (cont.) 8. Review of QAPI minutes from October 2007-Sept 2008 on 10/20/08 at 3:00 p.m. found no evidence of: a.Audits of reuse practices b.Identification of any issue with blood return post-treatment c.Comparison of the facility’s anemia management rate of 76% with the State average of 89%

82. 82 Findings (cont.) All record review findings were verified with the nurse manager at the time of the finding. *****************************

83. 83 Goal: Positive Patient Outcomes  The renal community, State agency & Network work together to improve patient outcomes!

84. 84 We Challenge You to Continue a Lifetime of Learning:  Water  Reuse  Infection control  Machines & equipment  Clinically complex patients!

85. 85 Questions? Using the ESRD Survey Process for the 2008 Conditions for Coverage