Key Updates and Implementation Strategies for CMS Conditions for Coverage in Dialysis Facilities

1. Interpretative Guidance Development and Implementation of the CfC Judith Kari, CMS National Technical Director Glenda Payne, CMS Technical Advisor, RO 4 & 6

2. Objectives • Describe major changes to the Conditions for Coverage • Discuss the challenges of preparing for and implementing the new regulations • Demonstrate understanding of the most frequently cited deficiencies at this point and what Networks may do to help facilities be more ready for surveys

3. Major Changes to Regulations Subpart A: General 1. Compliance with Federal State & local laws and regulations Subpart B: Patient Safety 2. Infection control 3. Water and dialysate quality 4. Reuse of hemodialyzers 5. Physical environment

4. Subpart C: Patient Care 6. Patients’ rights 7. Patient assessment 8. Patient plan of care 9. Care at home 10. QAPI 11. Special purpose dialysis facilities 12. Laboratory services

5. Subpart D: Administration 13. Personnel qualifications 14. Responsibilities of the medical director 15. Medical records 16. Governance No More "Subpart U"

6. Preparing for Implementation: Development of the Interpretative Guidance • Community involvement • Draft document to listserv of 10K+ stakeholders • Community Forum (120 attended) • Revised draft to listserv • 1600 comments received and reviewed; used to craft final document • Evolutionary process • Began with a focus of surveyor guidance • Community feedback wanted more • Evolved in a broader way to address needs of community as well as the needs of surveyors

7. Development of the Interpretative Guidance • Focus on defining terms for clarity • Aim to ensure consistent interpretation by providers and surveyors • Involvement of CDC / AAMI • Active on-going dialog with CDC • Repeated review of the Water & Dialysate portion by the AAMI RD Committee • Survey Process separate • Developing specific process guides for initial and resurveys • Directed at the needs of the surveyors • Will be part of the State Operations Manual

8. Development of the Interpretative Guidance: Measures Assessment Tool (MAT) • Community based standards in an easily updated tool • Presented as part of the IG • Used by surveyors in reviewing PA/POC and QAPI • Issue: whether requirement for use of the CAHPS survey instrument should be reconsidered?

9. The Waivers • New Facility: Isolation Room • Based on distance and travel time to a facility with isolation capacity and willingness to accept patients • Qualifications of the Medical Director • Time limited, potentially renewable • Based on outcomes list • Life Safety Code • If compliance presents an unreasonable hardship • If the waivered requirement will not present a risk to patient safety

10. Phased-In Time Extensions • Single-Use Vials (end of June, 2009) • Water Storage Tanks (dependent on water cultures) • Interdisciplinary Patient Assessment (October 14, 2009) • CROWNWeb Data Submission (phased-in time line)

11. Education: Surveyors and Community • April 2008: NKF and ANNA National meetings (~500 providers) • Sept 2008: Update focused on new regs (~325 surveyors, providers, & NW staff) • Basic ESRD Training: 3 completed, based on new survey process and new regs (~130 surveyors) • STAR: updated to new regs: more comprehensive update in process

12. Education: Surveyors and Community Community outreach: • ANNA Web-ex: over 100 chapters nation-wide participated (~1500 providers) • NKF Coffee house conversations with patients: ESRD Support Team has participated in (three) of these hour long phone conferences; (>100 attendance at each) • Local, state and national presentations for ANNA, NKF, NANT, DaVita, various Networks

13. On-going Work of Implementation Survey & Certification Letters • 09-01: Interpretative Guidance • 09-13: Waivers & Phased-in Requirements • 09-24: LSC Administrative Information Letters • 09-16: CROWNWeb Phased-in Requirement For S&C letters: http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp Click on "Show only," then click the box "Show only items containing the following word" (type the S&C memo number in the field), and then click the button "Show Items."  The database should find the S&C memo you want.

14. On-going Work of Implementation State Operations Manual • Under construction • Will include Survey process for initials and resurvey • Will address survey and certification issues (e.g., adding services or stations; relocations; temporary closures, centralized reprocessing)

15. On-going Work of Implementation Implementation of LSC plan: • LSC survey required for all initial surveys effective 2/9/09 • LSC surveys for complaint allegations related to LSC requirements • A % of resurveys will include LSC after the ASPEN system is updated with the LSC K-tags for ESRD (Summer, 2009)

16. Survey Outcomes Early Report: April 2009

17. Condition Level Citations • Infection Control • Water & Dialysate Quality • Governance • QAPI • Responsibilities of the Medical Director • Patient Plan of Care • Physical Environment

18. Most Frequently Cited Deficiencies Infection Control • Clean & Disinfect surfaces • Wear gloves/hand hygiene • Items taken to station: D/D/D • Clean/dirty areas; med prep area • Wear gowns/PPE

19. Infection Control: Why Would This Be Cited? All about • HANDS • Supplies • Meds • Saline • Heparin • PPE

20. Most Frequently Cited Deficiencies • PA/POC • Assess B/P & fluid mgmt needs • Manage volume status • Medical Director Responsibilities • Ensure all adhere to P&P • Physical Environment • PM; follow manufacturer’s DFU

21. Patient Assessment: Assess B/P And Fluid Management Needs Why would this be cited? • Review of flow sheets = no evidence B/P is being monitored • Post weight does not = goal and no comment is made • Fluid removed and weights do not match and no comment is made Note: Surveyors are being taught to look at flow sheets for the implementation of the assessment-based plan of care

22. MD Resp: All Adhere To P&P Why would this be cited? Admission policies • Orders • Baseline H&P • Nursing assessment prior to 1st treatment • “Adhere to P&P”

23. PE: Equipment Maintenance; Follow DFU Why would this be cited? Equipment Repair & Maintenance Follow the DFU* *DFU= Directions for use

24. Another Word about PA/POC Here is a REAL opportunity to CHANGE the way care is delivered! Here is a REAL opportunity to: • INCREASE patient involvement and • INCREASE patient independence = Improved Satisfaction & Better Working Conditions For Everyone!

25. Correlation of PA & POC

26. Correlation of PA & POC

27. How Is This Supposed to Work? • PA: identifies intradialytic weight gains (IDWG) of greater than 12 pounds/treatment • POC: • IDT members (all) to work with patient on risks of excessive fluid gains and (RD) on ways to handle thirst • Agree to a goal for IDWG to be reduced by 10% each week until goal of no greater than 5 pounds is reached • Monitor IDWG each treatment. Praise positive actions (RN, PCT) • If IDWG remains at same levels at end of one month, review and revise POC

28. Your Help Is Needed! • Please post survey tools on your websites • Continue to provide educational opportunities for providers

29. Your Help Is Needed! • Promote consistent interpretation: if unsure, ask: ESRDsurvey@cms.hhs.gov

30. Your Help Is Needed! Educate providers: PA/POC: Here is a REAL opportunity to CHANGE the way care is delivered! Here is a REAL opportunity to: • INCREASE patient involvement and • INCREASE patient independence = Improved Satisfaction & Better Working Conditions For Everyone! Encourage making this work worthwhile—it is so not about paper or the form!

31. Your Help Is Needed Educate providers: QAPI • Lots of opportunity for improvement • Need “real world” examples and encouragement to develop skills

32. Questions? ESRDsurvey@cms.hhs.gov