1. Transition to Surveys with New ESRD Regulations What Does the Future Hold?

2. Objectives Demonstrate understanding of the background & rationale for changes to the current ESRD regulationsDemonstrate understanding of the background & rationale for changes to the current ESRD regulations Describe the implementation challenges for surveyors & facilitiesDescribe the implementation challenges for surveyors & facilities Discuss major changes from the current to the new regulationsDiscuss major changes from the current to the new regulations 2

3. The Long Journey 3

4. The ESRD Regulation Timeline 1976: First ESRD regulations published1976: First ESRD regulations published 70’s-90’s: Technical updates70’s-90’s: Technical updates 1994: Community Forum Meeting to begin complete rewrite of ESRD regulations1994: Community Forum Meeting to begin complete rewrite of ESRD regulations 2008: New ESRD regulations published2008: New ESRD regulations published 4

5. 1994 Community Forum: Outcome Change in Regulatory Focus FromTo First, paper reviews First, safety reviews –Water –Reuse –Infection control –Physical environment StructureOutcomes 5

6. 1994: Change in the Survey Process From a focus on: From a focus on: To a focus on: To a focus on: PoliciesPolicies ProceduresProcedures Personnel recordsPersonnel records Reviewing dataReviewing data Observing careObserving care Interviewing patientsInterviewing patients Interviewing the people doing the workInterviewing the people doing the work 6

7. 1994: Change in the Survey Process From a focus on To a focus on StructureOutcomes Practices: water treatment results, dialysis adequacyPractices: water treatment results, dialysis adequacy Data: Dialysis Facility ReportsData: Dialysis Facility Reports Community-set minimum standardsCommunity-set minimum standards 7

8. Common Themes on the Long Journey CMS & Kidney Community partnershipCMS & Kidney Community partnership Survey process is driven by outcomes & data, not structure & paperSurvey process is driven by outcomes & data, not structure & paper Striving for consistency & common understandingsStriving for consistency & common understandings 8

9. Rationale Behind the Changes 9

10. Rationale for ESRD Regulation Changes Increasing realization of the need for regulatory support for an outcomes focus across provider types Needed to drive improvements in careNeeded to drive improvements in care Critical if CMS moves to value-based pricing (aka, Pay for Performance)Critical if CMS moves to value-based pricing (aka, Pay for Performance) Necessary if CMS moves to bundled reimbursement for ESRD careNecessary if CMS moves to bundled reimbursement for ESRD care 10

11. Reasons for Change Changes in technologyChanges in technology –Water treatment: more complex –Changes in dialysis equipment Differences in care deliveryDifferences in care delivery –1970’s: few technicians; regulations are silent –2008: technicians provide most direct care; public is demanding regulation 11

12. Reasons for Changes Evidence Based Practice: ESRD community coming to consensus on minimum standards of careEvidence Based Practice: ESRD community coming to consensus on minimum standards of care –RPA’s Adequacy of Dialysis Report –K/DOQI Guidelines –Fistula First Breakthrough Initiative QAPI: accepted process of quality assessment across provider typesQAPI: accepted process of quality assessment across provider types Electronic data submission required to keep pace with growing ESRD population & need for current dataElectronic data submission required to keep pace with growing ESRD population & need for current data 12

13. Final ESRD Regulations Finally Published! April 3, 2008 13

14. Posted for Viewing http://www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDdisplayfinalrule.pdf (In Word = 625 pages) Targeted “Publish” Date: April 15

15. The Implementation Begins 14

16. What are the Effective Dates for these Rules? New Conditions for Coverage 6 months 10-14-08 Life Safety Code and Separate room for HBsAg+ patients 300 days 2-9-09 Certification of technicians hired after 10-4-08 18 months from hire Certification of existing technicians 24 months 4-15-10 15

17. New Rules Require New Data Infrastructures The Survey & Certification data system, ASPEN, must be updatedThe Survey & Certification data system, ASPEN, must be updated The automated ESRD data software, STAR, must be updatedThe automated ESRD data software, STAR, must be updated 16

18. New Rules Require New Interpretive Guidance Interpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & providersInterpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & providers Community input was sought for this guidance:Community input was sought for this guidance: –Draft document posted on the web & emailed to 10,000 CMS listserv subscribers –Community Forum in December 2007 for patients, professionals (all disciplines), providers, suppliers, organizations 17

19. Interpretive Guidelines 18

20. Implementation Challenges: Surveyors & Facilities Effective Date? 10-14-2008Effective Date? 10-14-2008 Lots of time? NOTLots of time? NOT 19

21. New Rules Require New & Updated Products New Survey ProtocolNew Survey Protocol New training courses & training materialsNew training courses & training materials Updated Frequently Asked QuestionsUpdated Frequently Asked Questions Updated STAR (automated ESRD survey process)Updated STAR (automated ESRD survey process) Updated communications websitesUpdated communications websites 20

22. Implementation for Facilities 1.Read the whole document (preamble & rule) 2.Review current practice (& policies) to be sure they meet rules 3.Identify staffing, practice, equipment, & training needs 4.Develop documentation tools to match the new rules (logs, audit tools, chart forms) 21

23. What are some of the major changes? 22

24. Infection Control From one tag to a Whole ConditionFrom one tag to a Whole Condition AdoptsAdopts –CDC’s 2001 Recommendations for Prevention of Infections in Hemodialysis –CDC’s 2002 Guidelines for the Prevention of Catheter-Related Infections 23

25. Infection Control HepatitisHepatitis –All new facilities must have a separate room Must report issues to Medical Director & QAPIMust report issues to Medical Director & QAPI 24

26. Water & Dialysate Adopts AAMI RD52:2004 as regulationAdopts AAMI RD52:2004 as regulation Written for the userWritten for the user Specifics & required monitoring detailed for all water treatment componentsSpecifics & required monitoring detailed for all water treatment components Separate requirements for water treatment for home hemo under Care at Home ConditionSeparate requirements for water treatment for home hemo under Care at Home Condition 25

27. Dialysate For the first time, specific regulations for dialysateFor the first time, specific regulations for dialysate AAMI RD52:2004 addresses acid & bicarbonate concentrate:AAMI RD52:2004 addresses acid & bicarbonate concentrate: –Labeling –Mixing –Distribution –Use 26

28. Water & Dialysate From ~8 tags to about 175 tags!From ~8 tags to about 175 tags! Very detailed & thoroughVery detailed & thorough Most questions will now have a regulatory answerMost questions will now have a regulatory answer Use RD52:2004 to update facility policy & practice for water treatment & dialysate preparation & distributionUse RD52:2004 to update facility policy & practice for water treatment & dialysate preparation & distribution 27

29. Reuse Adopts AAMI RD:47:2002/2003Adopts AAMI RD:47:2002/2003 Requires reuse be suspended if a cluster of adverse patient reactions is associated with reuseRequires reuse be suspended if a cluster of adverse patient reactions is associated with reuse 28

30. Physical Environment Life Safety Code (LSC) Requirements: Must meet provisions of NFPA 2000Must meet provisions of NFPA 2000 Grandfather clause for current facilities in non-sprinklered buildings if built prior to 1/1/2008Grandfather clause for current facilities in non-sprinklered buildings if built prior to 1/1/2008 State fire safety codes may be used in lieu of LSCState fire safety codes may be used in lieu of LSC Specific provisions of LSC may be waived in some casesSpecific provisions of LSC may be waived in some cases 29

31. Physical Environment Every facility must have an AED or a defibrillatorEvery facility must have an AED or a defibrillator (& ACLS qualified staff) (& ACLS qualified staff) All equipment maintained & operated according to manufacturer’s directionsAll equipment maintained & operated according to manufacturer’s directions Emergency preparedness for staff & patients, including disaster prep—get to know your local Emergency Ops CenterEmergency preparedness for staff & patients, including disaster prep—get to know your local Emergency Ops Center 30

32. Patients’ Rights To be treated with respect & dignity and to: Receive information on all modalities, including those not provided at the current facilityReceive information on all modalities, including those not provided at the current facility Receive alternative scheduling options [from other facilities] for working patientsReceive alternative scheduling options [from other facilities] for working patients Receive necessary services listed in the Plan of CareReceive necessary services listed in the Plan of Care 31

33. Patients’ Rights Be informed of the right to have an advance directiveBe informed of the right to have an advance directive Be informed about transfer & discharge policiesBe informed about transfer & discharge policies 32

34. Patient Assessment ComprehensiveComprehensive Interdisciplinary teamInterdisciplinary team Initial completed within the latter of 30 days or 13 HD treatmentsInitial completed within the latter of 30 days or 13 HD treatments Components required include anemia, adequacy, access, bone disease, nutrition, psychosocial status, home dialysis, transplant status, functional status, rehabComponents required include anemia, adequacy, access, bone disease, nutrition, psychosocial status, home dialysis, transplant status, functional status, rehab FYI: ANNA/NKF have developed a toolFYI: ANNA/NKF have developed a tool 33

35. Patient Assessment Comprehensive reassessment within 3 months of completion of the initial assessment for all patientsComprehensive reassessment within 3 months of completion of the initial assessment for all patients Adequacy assessedAdequacy assessed –monthly for HD; – every 3 months for PD Stable patients require annual reviewStable patients require annual review 34

36. Patient Assessment Assessments and plan of care done monthly for “unstable patients,” examples include: Extended or frequent hospitalizations;Extended or frequent hospitalizations; Marked deterioration in health status;Marked deterioration in health status; Significant change in psychosocial needs; orSignificant change in psychosocial needs; or Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. 35

37. Plan of Care No “cookie-cutter” approach allowedNo “cookie-cutter” approach allowed Must address identified needs = individualized!Must address identified needs = individualized! Initial: within 30 days or 13 outpatient hemodialysis treatments of admissionInitial: within 30 days or 13 outpatient hemodialysis treatments of admission Update: within 15 days of each re- assessmentUpdate: within 15 days of each re- assessment 36

38. Major Change: No LTP No expectation for a long term program or “signature” of transplant surgeonNo expectation for a long term program or “signature” of transplant surgeon Requirements for patients to be informed of all modalities (transplant & therapies not offered at their current clinic) are addressed under:Requirements for patients to be informed of all modalities (transplant & therapies not offered at their current clinic) are addressed under: –Patients’ Rights –Patient Assessment –Plan of Care 37

39. Care at Home Separate Condition for home therapiesSeparate Condition for home therapies Care at home must be equal in quality to care provided in-centerCare at home must be equal in quality to care provided in-center Training required for patient described in detailTraining required for patient described in detail Water treatment / dialysate separately addressed, including newer technologiesWater treatment / dialysate separately addressed, including newer technologies 38

40. Home Dialysis in Residential Institutions Interim: home dialysis in residential institutions will be addressed in Survey & Certification LetterInterim: home dialysis in residential institutions will be addressed in Survey & Certification Letter Long-Term: future rules will address this areaLong-Term: future rules will address this area 39

41. QAPI Condition levelCondition level Interdisciplinary teamInterdisciplinary team Process continuous & on-goingProcess continuous & on-going Outcome focused: use community accepted standards as targetsOutcome focused: use community accepted standards as targets Include patient satisfaction, infection control, medical injuries & medication errorsInclude patient satisfaction, infection control, medical injuries & medication errors Plan/Do/Check/Act: Close the loop!Plan/Do/Check/Act: Close the loop! 40

42. Special Purpose Renal Dialysis Facilities ForFor –Vacation camps –Facilities providing services in emergencies Approved for a maximum of 8 monthsApproved for a maximum of 8 months 41

43. Laboratory Services Dialysis facility must provide or make available appropriate lab servicesDialysis facility must provide or make available appropriate lab services Lab services must meet CLIA regulationsLab services must meet CLIA regulations 42

44. Personnel Defines individual qualifications:Defines individual qualifications: –Medical Director –Nurses: nurse manager, home training nurse, charge nurse, staff nurse –Dietitian –Social Worker Defines group qualifications:Defines group qualifications: –Patient care technicians –Water treatment system technicians 43

45. Personnel Patient Care Technician High school diploma or equivalencyHigh school diploma or equivalency Complete a (defined) training course, approved by Medical Director & Governing Body; under direction of RNComplete a (defined) training course, approved by Medical Director & Governing Body; under direction of RN Be certified by a State or national programBe certified by a State or national program –New employees: within 18 months of hire date (starts after 10/4/08) –Current employees: within 24 months of 4/4/08 44

46. Medical Director Accountable to the Governing BodyAccountable to the Governing Body Responsible for patient care and outcomesResponsible for patient care and outcomes Responsible for effective QAPI and Infection Control programsResponsible for effective QAPI and Infection Control programs 45

47. Medical Director Responsible to assure all staff, physicians & non-physician providers “adhere” to all policiesResponsible to assure all staff, physicians & non-physician providers “adhere” to all policies Must be engaged in any involuntary patient transfer or dischargeMust be engaged in any involuntary patient transfer or discharge 45

48. Medical Records Traditional rules on completeness & protection of medical recordsTraditional rules on completeness & protection of medical records Transfer requested records to the receiving facility within one dayTransfer requested records to the receiving facility within one day 46

49. Governance: RN Presence “An RN, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated.” 47

50. Governance: Patient Involuntary Discharge Specific requirements –Reassess the patient –Involve the Medical Director –Contact another facility and attempt to place –30 days notice unless threat to safety –Notify the Network and the State Agency FYI: Network “DPC” program contains tools to help prevent involuntary dischargesFYI: Network “DPC” program contains tools to help prevent involuntary discharges 48

51. Governance: Electronic Data Submission As of 2/1/09, every facility must electronically submit data on all patients, including data on clinical performance measures, to CMS. CROWN Web 49

52. What Does the Future Hold? and Lots of good work for you Lots of good work for us! 50

53. Thank You for... Partnering with CMS to enhance & inform the survey & certification workPartnering with CMS to enhance & inform the survey & certification work Providing data & outcomes to guide & direct our workProviding data & outcomes to guide & direct our work Improving consistency by helping us build Interpretive Guidelines with common understandingsImproving consistency by helping us build Interpretive Guidelines with common understandings 51

54. * Remember, the rules were only published Thursday… 52

55. Helpful CMS Websites ESRD Open Door Forum listserv http://www.cms.hhs.govAboutWebsites/ 20EmailUpdates.aspESRD Open Door Forum listserv http://www.cms.hhs.govAboutWebsites/ 20EmailUpdates.asp http://www.cms.hhs.govAboutWebsites/ 20EmailUpdates.asp http://www.cms.hhs.govAboutWebsites/ 20EmailUpdates.asp ESRD Center http://www.cms.hhs.gov/center/esrd.aspESRD Center http://www.cms.hhs.gov/center/esrd.asp http://www.cms.hhs.gov/center/esrd.asp 53