Interpretative Guidance Development and Implementation of the CfC

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