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

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

3. The Long Journey 3

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

5. 1994 Community Forum: Outcome
Change in Regulatory Focus
From To
First, paper reviews
First, safety reviews
Water
Reuse
Infection control
Physical environment
Structure
Outcomes 5

6. 1994: Change in the Survey Process
From a focus on:
To a focus on:
Policies
Procedures
Personnel records
Reviewing data
Observing care
Interviewing patients
Interviewing the people doing the work
As work continued on the revision of the ESRD regulations, the survey process was changed 6

7. 1994: Change in the Survey Process
From a focus on
To a focus on
Structure
Outcomes
Practices: water treatment results, dialysis adequacy
Data: Dialysis Facility Reports
Community-set minimum standards
As work continued on the revision of the ESRD regulations, the survey process was changed 7

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

9. Rationale Behind the Changes9

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 care
Critical if CMS moves to value-based pricing (aka, Pay for Performance)
Necessary if CMS moves to bundled reimbursement for ESRD care 10 10

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

12. Reasons for Changes
Evidence 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 types
Electronic data submission required to keep pace with growing ESRD population & need for current data 12 12

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

14. Targeted “Publish” Date: April 15
Posted for Viewing
AndCoPs/downloads/ESRD
displayfinalrule.pdf
(In Word = 625 pages)
Targeted “Publish” Date: April 15

15. The Implementation Begins14

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

17. New Rules Require New Data Infrastructures
The Survey & Certification data system, ASPEN, must be updated
The 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 & providers
Community input was sought for this guidance:
Draft document posted on the web & ed to 10,000 CMS listserv subscribers
Community Forum in December 2007 for patients, professionals (all disciplines), providers, suppliers, organizations 17

19. Interpretive Guidelines
Thanks for Your Help! 18 19

20. Implementation Challenges: Surveyors & Facilities
Effective Date?
Lots of time? NOT
Federal Register
April 15, 2008 19 20

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

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

23. What are some of the major changes?22 23

24. Infection Control From one tag to a Whole Condition Adopts
CDC’s 2001 Recommendations for Prevention of Infections in Hemodialysis
CDC’s 2002 Guidelines for the Prevention of Catheter-Related Infections
Okay, enough already! What is really in there?? 23 24

25. Infection Control Hepatitis
All new facilities must have a separate room
Must report issues to Medical Director & QAPI
Okay, enough already! What is really in there?? 24 25

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

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

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

29. Reuse Adopts AAMI RD:47:2002/2003
Requires 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 2000
Grandfather 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 LSC
Specific provisions of LSC may be waived in some cases 29

31. Physical Environment
Every facility must have an AED or a defibrillator
(& ACLS qualified staff)
All equipment maintained & operated according to manufacturer’s directions
Emergency 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 facility
Receive alternative scheduling options [from other facilities] for working patients
Receive necessary services listed in the Plan of Care 31

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

34. Patient Assessment Comprehensive Interdisciplinary team
Initial 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, rehab
FYI: ANNA/NKF have developed a tool 33

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

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

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

38. Major Change: No LTP
No 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:
Patients’ Rights
Patient Assessment
Plan of Care 37 38

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

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

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

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

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

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

45. Personnel Patient Care Technician High school diploma or equivalency
Complete a (defined) training course, approved by Medical Director & Governing Body; under direction of RN
Be 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 Body
Responsible for patient care and outcomes
Responsible for effective QAPI and Infection Control programs
Must actively participate in the QAPI program—and if QAPI Condition is out of compliance, so is the Condition of Medical Director.
Facility governing bodies and medical director need to consider what mechanisms they will need to have in place to achieve this—if an attending physician refuses to follow policy regarding the care planning process—what action can the Medical Director take? If staff members don’t follow policy regarding monitoring of patient during treatment, are those issues brought to the Medical Director for his attention? She/he will be expected to be responsible for non-adherence of staff and physicians and non-physician providers practicing in the dialysis facility.
The medical director must co-sign any order for involuntary patient transfer or discharge 45 46

47. Medical Director
Responsible to assure all staff, physicians & non-physician providers “adhere” to all policies
Must be engaged in any involuntary patient transfer or discharge
Must actively participate in the QAPI program—and if QAPI Condition is out of compliance, so is the Condition of Medical Director.
Facility governing bodies and medical director need to consider what mechanisms they will need to have in place to achieve this—if an attending physician refuses to follow policy regarding the care planning process—what action can the Medical Director take? If staff members don’t follow policy regarding monitoring of patient during treatment, are those issues brought to the Medical Director for his attention? She/he will be expected to be responsible for non-adherence of staff and physicians and non-physician providers practicing in the dialysis facility.
The medical director must co-sign any order for involuntary patient transfer or discharge 45 47

48. Medical Records
Traditional rules on completeness & protection of medical records
Transfer 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 discharges 48 50

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?
Opportunity to improve patient outcomes
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 work
Providing data & outcomes to guide & direct our work
Improving consistency by helping us build Interpretive Guidelines with common understandings 51

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

55. Helpful CMS Websites
ESRD Open Door Forum listserv
ESRD Center 53 55